SlideShare a Scribd company logo
1 of 43
Gianella Espinosa
(
Olivier Ritter
BEM Bachelor
10/09/2012
) (
A l’attention d
’
Anne-Catherine
Guitard
) (
INTERNSHIP REPORT
)
Contents
Context 2
What is Cardiac Mapping? 2
The Product 3
The Mission 4
What is atrial fibrillation? 5
Clinical cases 6
Global Market Needs Analysis 7
Normal anatomy and physiology of the heart 7
Pathophysiology, Causal factors & Disease progression 8
Clinical Presentation & Outcomes 11
Treatments of Atrial fibrillation 12
Epidemiology 14
Economic Burden 17
Appendices
Context
Heart disease is the number one cause of death in the United
States. Cardiac arrhythmias—an irregular heartbeat—affects 2.2
million Americans. Congestive heart failure—the inability to
pump blood properly—affects nearly 5 million Americans.
Conventional treatments such as ablation and cardiac
resynchronization therapy (CRT) can improve patients’ lives;
but clinical outcomes have not reached the intended levels of
success.
Catheter ablation success rates have ranged between 40-85
percent, resulting in need for repeat procedures in 40-50 percent
of the cases. For CRT patients, success is highly dependent on
selecting the right patient, placing the lead in the best location
for that patient, and optimizing the device settings.
Currently, 1/3 of all patients with CRT devices do not respond
to treatment, leading to continued progression of heart failure,
increased patient morbidity, and an increasing financial burden
to the healthcare system.What is Cardiac Mapping?
Mapping the electrical activity of the heart is a critical
component for the diagnosis and treatment of heart disease.
Many advanced therapies (such as ablation for the treatment of
arrhythmias) require detailed electroanatomic mapping.
Currently, mapping is performed in an electrophysiology (EP)
lab, during which mapping catheters are inserted into the heart
and carefully moved to various locations around the heart to
map and identify the origins of the arrhythmia. Once the origin
of the arrhythmia is identified, the specific tissue is destroyed
by ablation. Current catheter mapping technologies have several
limitations including:
· Risks and limitations associated with being an invasive and
time consuming procedure.
· Current point-to-point mapping technology does not provide
simultaneous, beat-by-beat mapping. Electrical activity has to
be skillfully aggregated and annotated to make sense of the
information provided by these point-to-point mapping systems.
· Does not provide the whole picture (bi-atrial or bi-ventricular)
of electrical activity. Only provides mapping information one
chamber at a time.
· Does not fit into the current work flow of device based
therapy (e.g. Cardiac resynchronization therapy devices for
heart failure).
Catheter ablation has evolved to become a mainstream treatment
for arrhythmias, while mapping to identify ablation treatment
targets and confirm success of therapy has emerged as its
significant and critical counterpart.
For device-based therapy like Cardiac Resynchronization
Therapy (CRT) for heart failure, point-to-point, non-
simultaneous catheter mapping provides very limited benefit
while adding cost and complexity to the procedure. Therefore,
there is no practical mapping solution available for use today.
CardioInsight's ECVUE system has the potential to substantially
improve EP clinical practice by addressing significant unmet
clinical needs associated with current mapping technologies.The
Product
CardioInsight, a Cleveland-based medical device company, was
founded in 2006 to commercialize a breakthrough technology
designed to improve the diagnosis and treatment of electrical
disorders of the heart.
The ECVUE system gathers electrical information about the
heart from a proprietary, multi-sensor electrode "vest" placed
on a patient’s body and combines it with images from a CT scan
to provide 3D maps of the electrical activity of the heart. Unlike
conventional catheter-based mapping methods, the ECVUE ™
system is non-invasive and provides a view of the entire heart’s
electrical activity in a single beat, enabling
electrophysiologistso better guide treatments to localize
arrhythmias, or optimize the placement and settings of CRT
devices, such as pacemakers
CardioInsight’s ECVUE mapping system is a non-invasive,
single-beat electrocardiographic mapping system with the
unique ability to make the diagnosis and treatment guidance of
cardiac arrhythmias and heart failure simpler, faster, and safer.
The ECVUE system is comprised of:
· Proprietary single use, disposable multi-electrode vest that
gathers body surface electrical signals, and
· Advanced data analysis and visualization workstation that
generates real-time, 3D images of the electrical activity of the
heart.
From the simple to use multi-electrode vest, to the intuitive,
customizable data analysis and visualization workstation, the
ECVUE system offers a comprehensive tool that creates a new
paradigm in cardiac mapping that for the first time extends the
use of advanced cardiac mapping outside the existing confines
of the EP lab.
ECVUE is commercially available in Europe for assisting
electrophysiologists with the diagnosis of cardiac arrhythmias.
The Company continues to work with leading centers world-
wide to further strengthen its clinical value proposition in
simplifying mapping of arrhythmias and development of
panoramic biatrial mapping for atrial fibrillation. CardioInsight
is also developing the only 3D mapping product for CRT, which
is expected to have a significant impact in patient selection,
lead placement and optimization.
ECVUE is the first advanced mapping technology to non-
invasively generate real-time, 3D electrical maps of the whole
heart in a single beat.THE MISSION
As the company prepares for commercialization, discussions
with key industry players, as well as future fundraising
activities, this business planning and valuation assessment
becomes increasingly critical.
My supervisor, Kevin Mendelsohn, vice-president of the
company and in charge of finance & corporate development,
proposed that I work on a project that would culminate in the
generation of a business plan to detail and quantify the value of
our mapping system for atrial fibrillation (a certain type of
arrhythmia) mapping, include detailing the unique clinical
applications of the system, quantifying the patient populations,
analyzing the competition, evaluating the pricing structure, and
ultimately generating a "value" of the opportunity.
My mission was supposed to be based for one half in Bordeaux,
in order for me to work with the CHU, one of the leading
centers working with the company, and the other half in the
head office in Cleveland to finalize the project.
I started this project by doing a lot of reading, as I had very
little background on electrophysiology and specifically on the
subject of atrial fibrillation. I then worked on the outline of my
report (see Appendices) and once validated by my supervisor, I
could begin my research.
Throughout the whole period of the internship, Kevin and I
communicated via Skype at least once a week, and he was
always very responsive when I asked for clarifications on the
project through emails.
In this report I will try to detail the various steps I took to reach
the final global market needs analysis, and will give an excerpt
of each section, as this project was my only mission this
summer.
What is atrial fibrillation?
Atrial fibrillation, or AF, is the most common type of
arrhythmia. An arrhythmia is a problem with the rate or rhythm
of the heartbeat. During an arrhythmia, the heart can beat too
fast, too slow, or with an irregular rhythm.
AF occurs if rapid, disorganized electrical signals cause the
heart's two upper chambers (the atria) to fibrillate. The term
"fibrillate" means to contract very fast and irregularly. In AF,
blood pools in the atria. It isn't pumped completely into the
heart's two lower chambers, called the ventricles. As a result,
the heart's upper and lower chambers don't work together as
they should.
The heart has a natural pacemaker, called the “sinus node,” that
makes electrical signals. These signals cause the heart to
contract and pump blood.
With atrial fibrillation, random electrical activity interrupts the
normal conduction rhythm and prevents the atria from properly
contracting.
People who have AF may not feel symptoms. However, even
when AF isn't noticed, it can increase the risk of stroke. In some
people, AF can cause palpitations, chest pain, dizziness or heart
failure, especially if the heart rhythm is very rapid. AF may
happen rarely or every now and then, or it may become an
ongoing or long-term heart problem that lasts for years.
(
An ECG recording of normal heart rhythm
)
(
An ECG recording of atrial fibrillation
)Clinical cases
Some of my first dayswere spent at the hospital to assist to
some cases and see the product in action.
The first patient I saw was a 45 years old man who was to be
ablated for a Wolff–Parkinson–White syndrome (WPW), one of
several disorders of the conduction system of the heart that are
commonly referred to as pre-excitation syndromes. While the
majority of individuals with WPW remain asymptomatic
throughout their entire lives, there is a risk of sudden cardiac
death associated with the syndrome. While at the hospital I was
following Sandra, the CardioInsight employee conducting
ECVUE cases everyday with the physicians of the Haut-
Leveque hospitalin Pessac. We went to the patient’s room
before he was sent down to the CT scan, when she explained the
technique to him and asked for his authorization, since the
product is still in the clinical testing phase. He was quite
interested, asked questions about the system, and approved. He
even asked me to take a picture with the vest on for his kids!
I found the installation very easy. Two cables provide a link
between the vest and the system’s central unit. Sandra realized a
segmentation of the scan images, in the operating room before
the physician arrived, and the located the area of the bundle of
Kent responsible for the arrhythmias after the software
generated the 3D visualization. I was simply amazed. Then the
physician arrived and punctured soon after having seen the 3D
map. 20 minutes later, she had the ablation catheter in the area
of concern, and after 5 seconds, the pre-excitation had
disappeared on the monitor. That’s when I really realized the
capacity of the system to make everything easier for both the
patient and the physicians.
The second case was an aged woman with tachycardia. She was
mapped using ECVUE in the operating room, and was ablated
without a break as well.
The third patient was about 45 and suffered from paroxysmal
ventricular tachycardia (VT) since the age of 25. He had an
ICD, changed 2 times. They had recorded that the VT was
preceded by a short series of extrasystoles. The system was here
to be used to map the electrical activity of the heart during that
very first extrasystole, in the patient’s room. Given the
earliness of the disorder, he was used to the various other
techniques, and was also intrigued by this new vest and the
mapping. The physician attempted to trigger the VT by
stimulation using the programmer of the ICD. 4 or 5
morphologies of extrasystole came out, which they had to settle
for, but never the one that led to the VT.
Another invasive 3D mapping system of 2 catheters, one for the
endocardium and one for the epicardium, was used the day after
on this same patient, who as a result, spent half a day on the
table.
The last case was a patient who needed an ICD implantation. As
mentioned in the product section, ECVUE can also be used in
CRT patients notably regarding patient selection, device lead
placement and programing optimization. But this operation was
quite unique in that a new sophisticated robotic platform, the da
Vinci System, was here to be used for CRT implantation for one
of the first times in Europe.With da Vinci, small incisions are
used to introduce miniaturized wristed instruments and a high-
definition 3D camera, helping doctors to take surgery beyond
the limits of the human hand. Kevin, my supervisor, suggested
that I assisted to the procedure to measure the feasibility of a
joint utilization with ECVUE. GLOBAL MARKETNEEDS
ANALYSISNormal anatomy and physiology of the heart
Obtaining a basic working knowledge of the normal anatomy
and physiology of the organ that is affected by a need is
important because it establishes a baseline against which
abnormalities are understood. This research also provided me
with an understanding of important vocabulary and context as I
delved into further research. The disease is much easier to
comprehend if the anatomy of the affected organ or organ
system is clearly understood and can be visualized.
Once I learned about normal patterns of function within an
affected area, I had a basis for understanding how the disease
functions.
In the case of AF, I began by determining that AF is a disease
of the heart, which is part of the cardiovascular system. As the
heart is the primarily affected organ, I then focused on
investigating the basic gross anatomy of the heart and its
normal function. Understanding the heart’s size, location, and
position in relation to other structures quickly establishes a
baseline context for investigating more complex concepts and
interactions, such as how the electrical system of the heart
establishes a rhythm that affects the organ’s ability to
mechanically contract.
The human heart has four chambers, two superior atria and to
inferior ventricles. The atria are the loading chambers and the
ventricles are the pumping chambers. The pathway of blood
through the human heart consists of a pulmonary circuit and a
systemic circuit. Deoxygenated blood, coming from peripheral
organs, flows through the heart in one direction, entering
through the vena cavas (SVC& IVC) into the right atrium (RA)
and is pumped through the tricuspid valve during the passive
filling of the right ventricle (RV). Then blood is pumped out
through the pulmonary valve to the pulmonary arteries into the
lungs to be oxygenated. It returns from the lungs through the
pulmonary veins (PVs) to the left atrium (LA) where it is
pumped through the mitral valve during the passive filling of
the left ventricle.Then oxygenated blood leaves LV through the
aortic valve to the aorta. Blood is then distributed to the whole
body.
The left ventricle is the largest and strongest chamber of the
heart, as it must pump blood around the whole body, whereas
the atria pump blood into the ventricles and the right ventricle
into the lungs, and their walls are therefore much thinner.
[…]
The relative position of those anatomic structures between each
other is a determining factor of the heart’s conduction
pathways. The pumping action of the heart depends on precise
electrical coordination between the atria and ventricles. As the
signal travels from top to bottom, it causes the heart to contract
and pump blood.
· The P wave is a small deflection wave that represents atrial
depolarization (the summation of all atrial cells depolarization).
· The three waves of the QRS complex represent ventricular
depolarization.
· T waves represent ventricular repolarization (atrial
repolarization is obscured by the large QRS complex).
The electrocardiogram is recorded from10electrodes placed
onthe patient's body, which can record12 leads. The shape
ofthenormal ECGof a patientis identicalto anotherofthe same
age. Theabnormalitiesmay be characteristicof agiven disease,
ormaybe common todifferent pathologies.The ECGcan
diagnoserhythm disordersand theircoarse localization.
Inanycase, the ECG does not allow the precise determination of
the focal origin or the reentrant circuit responsible for the
arrhythmia.Pathophysiology, Causal factors & Disease
progression
Once I established an understanding of anatomy and physiology
of the heart in a healthy individual, then I could examine how
the disease disturbs the normal structure and function.
When investigating pathophysiology, the first step was to better
understand how the disease works from a biologic and
physiologic perspective, and then how this affects the normal
function of the organ. The second step was to identify the risk
factors and causal
associations (e.g., genetics, age, associated diseases, and
lifestyle) that characterize the disease. Finally, I could seek to
understand the disease progression. Disease progression
examines the rate (e.g., days, weeks, or years) at which the
disease leads to abnormal function. This includes the peak age
of the effect and the types of changes that occur at each stage of
the disease.
In the case of AF, I explored how the heart might be structurally
altered, leading to abnormal function, and whether or not the
condition can lead to structural changes in the organ. I also
looked at the common causes of AF, the primary risk factors,
and how AF progresses. I spent quite a bit of time
understanding the different types of AF and the unique
characteristics of each variation of the disease. This included
looking at which type of AF is most common among different
groups of patients, whether all AF patients progress in the same
way (or if progression is more directly affected by other factors
such as coexisting conditions), and how likely patients are to
progress from one type of AF to another.
Pathophysiology
During AF, ventricular and atrial activities become irregular
and unsynchronized and rapid irregular discharges come from
various areas in the atria. There are several “triggersites”,
which create a pattern of rapid and apparently chaotic electrical
activity that is characteristic of AF. The majority of these focal
sources (approximately 94 percent) are located in areas inside
the muscular sleeve of the four pulmonary veins, at their
connection to the left atrium. Other less common areas include
the superior vena cava, right and left trial free walls, and the
coronary sinus. Though not fullyunderstood, inflammation and
injury to the cardiac atrial cell structure related to causal
factors may predispose to abnormal electricaldischarges that can
initiate and maintain AF. However, any kind of myocardial
disease may induce impair ment of atrial cellular physiology, at
the origin of AF.As a result of these irregular discharges, the
“electrical” atrial rate (not the contraction rate) isbetween 300
and 600 times per minute. Thisresult in improper filling and
ejection of blood, as well asa decreased efficiency of the heart’s
pumping process.
Since all electrical activity from the atria can typically only get
to the ventricle via the AV node, the AV node is able to filter
many of the irregular electrical discharges associated
with AF, preventing the rapid rate of the atrial beat from being
conducted into the ventricles. However, not all of the signals
are blocked and AF is often accompanied by irregular
ventricular beating, at 50 to 200 per minute.
[…]
On the electrocardiogram, AF is described by the absence of
consistent P waves; instead there are rapid oscillations or
fibrillatory waves that vary in size, shape and timing and are
generally associated with an irregular ventricular response when
atrioventricular (AV) conduction is intact.
The patient may experience AF as palpitations, chest pain, and
dizziness. In many cases, however, it may occur
asymptomatically.
Causes and Associated Conditions
AF is often an electrical manifestation of underlying cardiac
disease. Nonetheless, approximately 30% to 45% of cases of
paroxysmal AF and 20% to 25% of cases of persistent AF occur
in younger patients with “lone AF”, defined as AF without overt
structural heart disease. AF can present as an isolated or
familial arrhythmia, although a responsible underlying disease
may appear over time. Although AF may occur without
underlying heart disease in the elderly, the changes in cardiac
structure and function that accompany aging, such as an
increase in myocardial stiffness, may be associated with AF,
just as heart disease in older patients may be coincidental and
unrelated to AF.
Concomitant medical conditions have an additive effect on the
perpetuation of AF by promoting a substrate that maintains AF.
Conditions associated with AF are also markers for global
cardiovascular risk and/or cardiac damage rather than simply
causative factors.
·
10
· Ageing
· Hypertension
· Symptomatic heart failure
· Tachycardiomyopathy
· Valvular heart diseases
· Cardiomyopathies
· Atrial septal defect
· Other congenital heart defects
· Coronary artery disease
· Overt thyroid dysfunction
· Obesity
· Diabetes mellitus
· Sleep apnea
· Chronic renal disease
Many dietary and lifestyle factors have also been associated
with AF. These include excessive alcohol or caffeine
consumption and emotional or physical stress.
Disease progression& Classification
The clinical course of AF is frequently progressive, often
beginning with increased ectopy (premature atrial contractions),
progressing to brief runs of AF that are typically transientand
self-terminating. Over a period of time ranging from months to
years,episodes of AF tend to increase in duration, sometimes
becoming persistent.
Clinically, it is reasonable to distinguish five types of AF based
on the presentation and duration of the arrhythmia: first
diagnosed, paroxysmal, persistent, long-standing persistent and
permanent AF.
Terminology
Clinical features
Pattern
First-diagnosed
Symptomatic
Asymptomatic (first detected)
Onset unknown (first detected)
May or may not reoccur
Paroxysmal
Spontaneous termination
<7 days and most often <48h
Recurrent
Persistent
Not self-terminating
Lasting >7 days or prior cardioversion
Recurrent
Long-standing persistent
Not self-terminating
Lasting >1 year when it is decided to adopt a rhythm control
strategy.
Recurrent
Permanent
Not terminated
Terminated but relapsed
No cardioversion attempt
Established
This classification is useful for clinical management of AF
patients, especially when AF-related symptoms are also
considered. Many therapeutic decisions require careful
consideration of additional individual factors and co-
morbidities.
The “natural time course” of atrial fibrillation, a flowchart that
I created to describe the clinical progression of the disease and
the associated therapies.
Clinical Presentation & Outcomes
While researching clinical presentation I focused on the impact
of the disease on the patient. I emphasized the symptoms (what
the patient says s/he experiences) and the signs (what the astute
healthcare provider identifies or observes during the patient
examination) of the disease. Gaining an understanding of
clinical presentation was important because it is often the target
for improved care and the development of new therapies that
address identified needs. When evaluating clinical presentation,
it seemed important to describe what patients complain about
when they see a clinician and how they feel. Patients with the
same disease may present differently based on a number of
factors, such as age, gender, ethnicity, and coexisting
conditions. Since every individual is different, each is likely to
experience symptoms slightly differently. Ultimately, clinical
presentation manifested itself in the signs/symptoms that result
from the primary effect of the disease or from the long-term
consequences of having and managing the disease over time.
In the case of AF, I sought to understand the most common
symptoms for patients with the disease, how they feel with AF,
and the signs most commonly observed by physicians in patients
with the disease. I also considered whether all AF patients are
affected by the same symptoms and what factors have the
greatest impact on symptoms presented (e.g., age, coexisting
conditions). For example, young patients are much more likely
to report symptoms of palpitations with AF than older ones.
This may directly impact the goal of therapy for different age
groups.
Importantly, clinical outcomes are different from symptoms.
Outcomes generally refer to hard data points associated with a
disease that can be measured. The two most important types of
clinical outcomes to consider are morbidity and mortality.
Morbidity refers to the severity of the disease and its associated
complications. Measures of morbidity may be evaluated using
quality of life questionnaires, or they can be assessed by more
specific endpoints such as distance walked in six minutes,
hospital admissions, or a clinical event that does not cause
immediate death (e.g., stroke, heart attack). Mortality refers to
the death rate associated with a disease. Clinical outcomes are
particularly important as they often serve as endpoints for
clinical trials since they can be assessed more easily and
objectively than symptoms and have a direct impact on cost.
In the AF case, key clinical outcomes to address were the
morbidities associated with AF, their likelihood of occurrence,
and what factors have the greatest impact on morbidities (e.g.,
age).
AF has a heterogeneous clinical presentation, occurring in the
presence or absence of detectable heart disease. An episode of
AF may be self-limited or require medical intervention for
termination.
The adverse effects of AF are the result of haemodynamic
changes related to the rapid and/or irregular heart rhythm, and
thromboembolic complications related to a prothrombotic state
associated with the arrhythmia. Onset of AF can result in a
reduction in cardiac output of up to 10–20% regardless of
ventricular rate. The presence of fast ventricular rates can push
an already compromised ventricle into heart failure.
[…]
While patients can be asymptomatic, many experience a wide
variety of symptoms as a consequence of the hemodynamic
dysfunction. The lost of the synchronous atrial activity, the
irregular ventricular response, the rapid heart rate, and the
impaired coronary blood flow all contribute to the mechanism.
Palpitations, fatigue, and dizziness can be quiet common, while
symptoms related to congestive heart failure including dyspnea
and angina can develop in more severe cases.
[…]
AF is associated with increased rates of death, stroke and
otherthrombo-embolic events, heart failure and
hospitalizations,degraded quality of life, reduced exercise
capacity, and left ventricular(LV) dysfunction
Treatments of Atrial fibrillation
The goal of any treatment is to improve outcomes in those
patients with a disease or disorder. Treatment analysis involved
detailed research to understand what established and emerging
therapies exist, how and when they are used, how and why they
work, their effectiveness, and their economics. This analysis
also provided me with an understanding of the clinical and
patient-related requirements that any new treatment must meet
to be equivalent or superior to existing alternatives. It further
establishes a baseline of knowledge against which the
uniqueness and other merits of ECVUE can be evaluated.
There are two ways to approach the treatment of AF using
drugs: rate control and rhythm control, which are often
associated given the similarity of the medication used in both
strategies.
Rate control
Rate control lowers the heart rate closer to normal, usually 60
to 100 bpm, without trying to convert to a regular rhythm. It is
about minimizing the effect of AF on the ventricular rate by the
prescription of medication increasing the degree of block at the
level of the AV and decreasing the number of impulses that
conduct into the ventricles.
Catheter ablation of the AV junction (AV node/Bundle of His)
combined with pacemaker implantation can be carried out if the
ventricular rate cannot be managed by medication, but the
introduction of a foreign body may have its own complications.
Rhythm control
In the case of rhythm control, it is about terminating AF and
maintaining SR in a process called cardioversion. This approach
is most important in the acute setting of AF, notably when first-
diagnosed, using medication. In case of persistent or long-
standing AF, cardioversion is often electrical, and involves the
restoration of normal heart rhythm through the application of a
DC electrical shock. In those cases, the treatments are only
palliatives, in the sense that the objective is to terminate the
fibrillation and restore SR without fundamentally modifying the
substrate. On the other hand, catheter ablation or the Maze
procedure, carried out most often on the LA, is meant to modify
the substrate of AF, by removing the trigger zones (such as
PVs) or the abnormal conduction channels (fibrotic tissue)
generated by the arrhythmia over time.
[…]
As far as mortality is concerned, the AFFIRM trial showed that
there is lower mortality using rate control with anticoagulation
treatment versus rhythm control treatment and the difference
increases up to 5 years (end of study).
Anticoagulation
In every case, the prevention of complications is imperative and
dictates the therapeutic techniques that will be performed.
Anticoagulation is designed to prevent the thrombo-embolic risk
associated with AF. Beyond anticoagulants, alternatives are
proposed, such as the Left Atrial Appendage (LAA) Closure, to
prevent blood clot formation in patients with AF, given that
90% of them form in the LAA.
Ablation
Catheter ablation techniques are constantly evolving. Initial
catheter ablations attempted to recreate the lesion set used in
the open-chest Cox maze procedure by creating linear ablation
lines that interrupted the AF wavelets. However, doctors had
difficulty duplicating the Cox maze lesion set during a closed-
chest catheter ablation. The procedure had high complication
rates and required long fluoroscopy times.
[…]
Research in Bordeaux, France, by Michel Haïssaguerre, MD,
and colleagues, suggested that electrophysiologists didn't need
to duplicate the Cox maze lesion set. Dr. Haïssaguerre's group
found that over 90% of AF is triggered in or near the pulmonary
veins. As a result of these findings, a new type of catheter
ablation technique, called Segmental Pulmonary Vein Isolation
or Ostial Pulmonary Vein Isolation, was created. Dr.
Haïssaguerre and his colleagues used radiofrequency energy to
ablate the pulmonary vein ostium, the opening to the pulmonary
veins. When "isolated", pulmonary veins can no longer be a
trigger point for atrial fibrillation. Dr.Haïssaguerre and his
colleagues were able to terminate atrial fibrillation in, and stop
prescribing antiarrhythmic drugs for, 62% (28) of patients in the
study.
Electrical Cardioversion
Electrical cardioversion is a process by which the heart is
shocked to convert it from an irregular rhythm back into a
normal sinus rhythm.
For patients in persistent AF, electrical cardioversion may be
done early in the process to stop the AF and put the heart back
into normal sinus rhythm. For other AF patients, electrical
cardioversion may not be tried until later, when medication has
stopped working.
Epidemiology
While conducting research on epidemiology, I included data for
the disease as a whole, as well as the most relevant patient
subsegments. I tried to find information about disease
dynamics, such as growth rate, to illustrate how the disease will
impact society in the future.
Epidemic, a term generally used to describe a rapidly spreading
infectious disease within a population, has recently been used to
describe the rising prevalence of atrial fibrillation (AF). The
prevalence, defined as the proportion of a population affected
by the disease at a point in time (and probably the incidence,
defined as the rate at which new cases occur in a population
during a specified time period) of AF is rising for reasons that
are not completely known. The rising incidence of the
etiological factors of AF, such as the aging population and a
higher prevalence of cardiovascular diseases, only partly
explains this phenomenon.
Prevalence
Estimates of the overall adult prevalence of AF in the United
States range from 1 to 6%. Because the prevalence of AF rises
sharply with age, these estimates must be interpreted in the
context of the age distribution in the samples studied. Most
studies indicate that the overall prevalence of AF exceeds 5% in
individuals aged 70 and above.
[…]
The medical community has been helped by the foresight of
investigators who designed and executed several longterm
population-based studies, that have provided valuable
information about the epidemiology of AF. Even with
significant differences in the methodology and populations
studied, the remarkably similar results point to the rather
homogeneous prevalence of AF in the Western world.
Trends in Prevalence & Implications
Several studies indicate that the prevalence of AF has been
increasing in the past several decades. Estimates from the
National Ambulatory Medical Care Survey indicate that office
visits for AF increased from 1.3 to 3.1 million between 1980
and 1992. Hospital discharges for AF in individuals over age 65
increased from 30.6 to 59.5 per 10,000 between 1982 and 1993.
The increasing prevalence has been confirmed by more recent
data published in the National Heart, Lung, and Blood
Institute’s Chartbook. Between 1980 and 1999, AF
hospitalizations increased 80%for patients aged 45 to 65 and
doubled for patients 65 years of age and older.
The aging of the population alone is expected to raise the
number of individuals with AF from just over 2 million in 1995
to more than 3 million by 2020 and 5.6 million by 2050.
However, increases in the prevalence of AF may also be driven
by factors other than aging.
However, population studies may underestimate the prevalence
of AF for two reasons: AF may not be present at the follow-up
time, and a significant population may have asymptomatic
episodes. According to the U.S. Census Bureau Population
Projections Program, the number of Americans aged 65 years or
older will increase substantially to more than 20% of the
population (82 million) by the year 2050. This aging of the
population is projected to result in a 2.5-fold rise in AF
prevalence.
The economic consequences of this arrhythmia are highlighted
by the fact that AF is the most common arrhythmia among
patients hospitalized in the United States with a primary
diagnosis of an arrhythmia.
With the expected rise in the elderly population and the
prevalence of AF, preventive measures to reduce its incidence
will have profound societal benefits. Although proven
preventive measures are lacking, control of risk factors such as
hypertension and MI appear prudent.
Economic Burden
The focus of economic research was to understand the
distribution of costs. I looked at the aggregate, system-level
cost of AF on an annual basis, the annual condition costs of AF,
the evaluation and treatment-related annual cost, the annual cost
of hospitalization, and the annual cost of lost productivity from
absenteeism due to AF.Economic Considerations
Given its large and growing prevalence, AF has substantial
economic impact. Proper economic analysis of AF requires
explicit definitions of perspective, costs, and outcomes.
Perspective is the vantage point from which costs and outcomes
are assessed. For example, costs can be quantified from the
perspective of the patient. In this case, potential costs include
AF symptoms, discomfort from therapy, and time lost from
work. In contrast, potential costs from the perspective of a
payor, such as a health insurance company, include covered
services for hospitalization or other treatments and
administrative costs in processing claims. Ultimately, a societal
perspective, in which all costs and outcomes are assessed
regardless of who pays the costs or experiences the outcomes,
provides the most complete insight into the economic impact of
AF.
In cost accounting, costs should be clearly distinguished from
the charges assessed by physicians, hospitals, and other health
care providers and should reflect the actual financial resources
required to provide care. Costs can be divided into direct and
indirect costs.
Direct costs are those incurred directly from medical care and
include inpatient costs (hospital fees, physician fees, procedure
and therapy costs) and follow-up costs (physician visits,
outpatient testing, medications, home health care providers,
long-term care, and future hospitalizations).
Indirect costs quantify the remaining nonmedical impact of AF,
such as missed days of work and lost productivity. If possible,
costs are usually presented in terms of dollar (or other currency)
expenditure. When assessment of monetary costs is difficult,
such as for mortality or decreased quality of life, proxy values
such as lost years of work or lost productivity are used.Atrial
Fibrillation Condition Costs
Atrial fibrillation increases the risk of a variety of adverse
outcomes, most notably stroke. It also has an impact on
mortality, impairs quality of life, decreases productivity, and
increases hospitalization rates. All of these adverse outcomes
have substantial costs.`
Stroke
Stroke is the most debilitating complication of AF. With its
associated hypercoagulable state, structural abnormalities in the
fibrillating atria, and relative blood stasis, AF fulfills
Virchow’s triad for the development of thrombi and their
subsequent embolization to the cerebral vasculature. As a result,
stroke is five times more likely to occur in AF patients than in
age-matched controls.
Indirect care costs (time and opportunity costs of nonpaid
caregivers for cerebrovascular accident [CVA] patients)
exceeded £1.7 billion ($3.12 billion). For an individual patient,
the mean estimated lifetime cost of a stroke, including inpatient
care, rehabilitation, and follow-up care for lasting deficits, is
$140,000.
[…]
Acute care costs, such as hospitalization, diagnostic testing,
initial therapy, and rehabilitation, are substantial. The average
estimated cost for the first 30 days of stroke care is
$13,000/patient for mild strokes and $20,000/patient for severe
strokes. In addition, inpatient costs can account for 70% of the
overall cost of the first year after stroke. Wolf and colleagues
illustrated costs of acute care in the first year after stroke using
1991 Medicare data. Among men aged 65 to 74, Medicare spent
$21,231 per patient, 95% of which was spent on acute care
needs.
Mortality
Multiple national and international cohorts describe an
independent association between AF and mortality. The
mechanism by which AF confers this independent mortality risk
is poorly understood. Nonetheless, the Framingham Heart Study
illustrated an age-adjusted 1.5 to 1.9 hazard ratio for mortality
among patients with AF compared with those without AF.
It showed an increased likelihood of mortality or major
cardiovascular events (congestive heart failure, MI, resuscitated
cardiac arrest, or stroke) among those patients who developed
AF compared to those who did not. Mortality costs are difficult
to compute and are generally unavailable. Regardless, the
burden of AF, its associated mortality, and its effect on lost
earnings and productivity imply substantial societal costs.
Quality of Life
Atrial fibrillation adversely affects patients’ quality of life.
Patients with AF and poor rate control have palpitations,
fatigue, shortness of breath, or lightheadedness, especially if
they have underlying cardiac or pulmonary disease. However,
even asymptomatic AF patients experience lower perceived
health and life satisfaction compared to patients without AF,
possibly because of the burden of the diagnosis and its attendant
needs for medical care and therapies. This reduction in quality
of life has a direct impact on costs. Although quantification of
quality of life in monetary terms is difficult, symptoms and poor
functional status can lead to lost productivity, both
professionally and personally.
Productivity
Atrial fibrillation results in significant indirect nonmedical
costs, such as lost work and productivity. For example, a French
survey of AF patients found that costs caused by missed work
accounted for 6% of total AF costs. In addition to the workers
affected by this condition, employers face increased costs, not
only from decreased productivity, but also from increased
insurance premiums to cover affected employees. A U.S. study
of 16 employers, conducted from 1999 to 2002, found large cost
differences between employees with AF and those without.
Annually, excess direct medical costs for AF patients were
$12,349 per patient, and excess indirect medical costs were
$2,524 per patient, as compared to patients without AF.
Although they account for a relatively small portion of overall
AF costs, these indirect medical costs play a meaningful role in
the overall economic impact of the condition.Evaluation and
Treatment Costs
Acute Management
Patients with new-onset AF, or an exacerbation of previously
diagnosed AF, often require extensive evaluation and treatment.
Management approaches for AF vary dependent on patients’
hemodynamic stability, symptoms and comorbidities, and the
duration of the AF episode. A new diagnosis of AF, either in
isolation or in association with another medical condition such
as congestive heart failure, initiates an investigation into its
cause. These investigations, which can include laboratory
testing, monitoring, cardiac imaging, and hospitalization, play a
significant role in the economic impact of AF. One study
analyzed costs between AF patients who were hospitalized and
those discharged from an emergency department. Admitted
patients incurred mean costs of $2,012 in their care compared to
$1,878 among discharged patients. A French survey of AF
patients found that consultations and investigations for AF
patients drove 9% and 8%, respectively, of their overall costs of
AF care.
Chronic Management
After the initial evaluation and treatment of an acute AF
episode, focus turns to arrhythmia control and anticoagulation.
Arrhythmia control involves antiarrhythmic or atrioventricular
(AV) nodal blocking medications. Rhythm control of AF with
antiarrhythmic medications can reduce symptoms, improve
functional capacity, and lower both stroke and mortality risk.
These benefits must be weighed against the potentially
dangerous side effects associated with antiarrhythmic
medications. An alternative method of AF management is rate
control strategies with AV nodal blocking agents.
[…]
Two studies demonstrated cost savings in the rate control arm,
even after sensitivity analyses. In the 2000 RACE study, mean
costs of rate control were 7,386 ($7,017), while mean costs of
rhythm control were 8,284 ($7,870).In the AFFIRM trial, the
incremental cost of rhythm control over rate control was nearly
$1,500 per patient per year. Several interventional procedures
are an alternative to medication-based antiarrhythmic strategies
for AF management. Catheter-based AV node modification or
ablation can be used to treat highly symptomatic patients or
patients who cannot tolerate rate-controlling agents. The
procedure can improve symptoms, functional capacity, and LV
function.
In a 1997 report, costs of AV node modification were $19,389,
and costs of the AV node ablation were $28,485. Over time,
with technical advances, these costs will likely decline, as
evidenced by 2003 costs of $17,173 for AV nodal ablation.
Future Directions
Although the current burden of AF, both in the United States
and abroad, is already large, forecasts predict major increases
over the coming decades. As the population ages and survival
from other cardiac conditions that predispose to AF increases,
the prevalence of AF will likely rise. Projections for the number
of adults in the United States with AF in 2050 range between
5.6 and 15.9 million, as compared to 2.2 million in 2006.
Approximately 50% of this projected population will be over
the age of 85 years. As the numbers of AF patients increase, AF
care costs will also increase. In the 2004 U.K. survey of AF
patients, costs rose from 0.62% (£244 million, or $418 million)
of the National Health Service (NHS) budget in 1995 to 0.97%
(£459 million, or $788 million) of the 2000 NHS budget.
[…]
Future developments in AF care, such as new anticoagulants and
procedures, could have a significant impact on costs. For
example, direct antithrombin agents or new antiplatelet
combinations may show efficacy in AF-related stroke
prevention. Since these new therapies do not require the
intensive monitoring required by warfarin, substantial cost
savings could be realized. Similarly, innovations or
improvements in interventional procedures such as ECVUE,
both in efficacy and safety, could also affect costs. Atrial
fibrillation presents significant challenges to both individual
practitioners and policymakers. With its substantial costs in
diagnosis, treatment, and outcomes, it will become increasingly
important to determine the best strategies in caring for these
patients.
Discussion
When I was first proposed the project, I just could not turn it
down. I immediately saw the revolutionary aspect of ECVUE
and was thrilled to work on it at such early stages. I must say
that I got quite a good grasp of what a biomedical start-up can
be, how it performs and what challenges it must overcome on a
daily basis.
At first, the amount of information was quite overwhelming,
given that I had no background in the field, and the fact that
most of the information I needed was to be extracted from
studies in English written by physicians, for physicians. But
after a while I became familiar with the vocabulary and
concepts, and could focus on delivering a high-quality
report.The theoretical knowledge in Marketing and Business
Planning that I gathered during two years has proved to be very
useful, mostly regarding methodology of research.
As mentioned previously, my mission was supposed to be based
for one half in Bordeaux, in order for me to work with the CHU
in the first place, and the other half in the head office in
Cleveland to finalize the project. Unfortunately, my supervisor
took last minute vacation for 2 weeks in August. This resulted
in an internship almost completely from home, by
correspondence. While it enabled me to learn how to work
independently, using only technology to communicate with the
firm, I missed the relational side of the experience.
Besides, the procedures I was given the opportunity to attend
were fascinating. I have always been interested by technology
and innovations, especially in the medical field, and I realize
that seeing this kind of operations was a unique chance.
Overall, this internship at CardioInsight this year has been very
rewarding on many levels, and I am pleased to say that my
contract was extended for at least another month, outside the
internship framework.
The Unauthorized Autobiography of Me
By Sherman Alexie
Late summer night on the Spokane Indian Reservation. Ten
Indians are playing basketball on a court barely illuminated by
the streetlight above them. They will play until the brown,
leather ball is invisible in the dark. They will play until an
errant pass jams a finger, knocks a pair of glasses off the face,
smashes a nose and draws blood. They will play until the ball
bounces off the court and disappears into the shadows.
This may be all you need to know about Native American
literature.
* * *
Thesis: I have never met a Native American. Thesis repeated: I
have met thousands of Indians.
* * *
November 1994, Manhattan: PEN American panel on Indian
Literature. N. Scott Momaday, James Welch, Gloria Miguel, Joy
Harjo, me. Two or three hundred people in the audience. Mostly
non-Indians, an Indian or three. Questions and answers.
"Why do you insist on calling yourselves Indian?" asks a white
woman in a nice hat. "It's so demeaning."
"Listen," I say. "The word belongs to us now. We are Indians.
That has nothing to do with Indians from India. We are not
American Indians. We are Indians, pronounced In-din. It
belongs to us. We own it and we're not going to give it back."
So much has been taken from us that we hold onto the smallest
things left with all the strength we have.
* * *
1976: Winter on the Spokane Indian Reservation. My two
cousins, S and G, have enough money for gloves. They buy
them at Irene's Grocery Store. Irene is a white woman who has
lived on our reservation since the beginning of time. I have no
money for gloves. My hands are bare.
We build snow fortresses on the football field. Since we are
Indian boys playing, there must be a war. We stockpile
snowballs. S and G build their fortress on the fifty-yard line. I
build mine on the thirty-yard line. We begin our little war.
My cousins are good warriors. They throw snowballs with
precision. I am bombarded, under siege, defeated quickly. My
cousins bury me in the snow. My grave is shallow. If my
cousins knew how to dance, they might have danced on my
grave. But they know how to laugh, so they laugh. They are my
cousins, meaning we are related in the Indian way. My father
drank beers with their father for most of two decades, and that
is enough to make us relatives. Indians gather relatives like
firewood, protection against the cold. I am buried in the snow,
cold, without protection. My hands are bare.
After a short celebration, my cousins exhume me. I am too cold
to fight. Shivering, I walk home, anxious for warmth. I know
my mother is home. She is probably sewing a quilt. She is
always sewing quilts. If she sells a quilt, we have dinner. If she
fails to sell a quilt, we go hungry. My mother has never failed
to sell a quilt. But the threat of hunger is always there.
When I step into the house, my mother is sewing yet another
quilt. She is singing a song under her breath. You might assume
she is singing a highly traditional Spokane Indian song. In fact,
she is singing Donna Fargo's "The Happiest Girl in the Whole
USA." Improbably, this is a highly traditional Spokane Indian
song. The living room is dark in the late afternoon. The house is
cold. My mother is wearing her coat and shoes.
"Why don't you turn up the heat?" I ask my mother.
"No electricity," she says.
"Power went out?" I ask.
"Didn't pay the bill," she says.
I am colder. I inhale, exhale, my breath visible inside the house.
I can hear a car sliding on the icy road outside. My mother is
making a quilt. This quilt will pay for the electricity. Her
fingers are stiff and painful from the cold. She is sewing as fast
as she can.
* * *
On the jukebox in the bar: Hank Williams, Patsy Cline, Johnny
Cash, Charlie Rich, Freddy Fender, Donna Fargo.
On the radio in the car: Creedence Clearwater Revival, Three
Dog Night, Blood Sweat & Tears, Janis Joplin, early Stones,
earlier Beatles.
On the stereo in the house: Glen Campbell, Roy Orbison,
Johnny Horton, Loretta Lynn, "The Ballad of the Green Beret."
* * *
1975: Mr. Manley, the fourth grade music teacher, sets a row of
musical instruments in front of us. From left to right, a flute,
clarinet, French horn, trombone, trumpet, tuba, drum. We're
getting our first chance to play this kind of music.
"Now," he explains, "I want all of you to line up behind the
instrument you'd like to learn how to play."
Dawn, Loretta, and Karen line up behind the flute. Melissa and
Michelle behind the clarinet. Lori and Willette, the French horn.
All ten Indian boys line up behind the drum.
* * *
1970: My sister Mary is beautiful. She is fourteen years older
than me. She wears short skirts and nylons because she is
supposed to wear short skirts and nylons. It is expected. Her
black hair is combed long, straight. Often, she sits in her
favorite chair, the fake leather lounger we rescued from the
dump. Holding a hand mirror, she combs her hair, applies her
make-up. Much lipstick and eye shadow, no foundation. She is
always leaving the house. I do not know where she goes.
I do remember sitting at her feet, rubbing my cheek against her
nyloned calf, while she waited for her ride. In Montana in 1981,
she died in an early morning fire. At the time, I was sleeping at
a friend's house in Washington state. I was not dreaming of my
sister.
* * *
"Sherman," says the critic, "How does the oral tradition apply to
your work?"
"Well," I say, as I hold my latest book close to me, "It doesn't
apply at all because I typed this. And when I'm typing, I'm
really, really quiet."
* * *
1977: Summer. Steve and I want to attend the KISS concert in
Spokane. KISS is very popular on my reservation. Gene
Simmons, the bass player. Paul Stanley, lead singer and rhythm
guitarist. Ace Frehley, lead guitar. Peter Criss, drums. All four
hide their faces behind elaborate make-up. Simmons the devil,
Stanley the lover, Frehley the space man, Criss the cat.
The songs: "Do You Love Me," "Calling Dr. Love," "Love
Gun," "Makin' Love," "C'mon and Love Me."
Steve and I are too young to go on our own. His uncle and aunt,
born-again Christians, decide to chaperon us. Inside the
Spokane Coliseum, the four of us find seats far from the stage
and the enormous speakers. Uncle and Aunt wanted to avoid the
bulk of the crowd, but have landed us in the unofficial pot-
smoking section. We are overwhelmed by the sweet smoke.
Steve and I cover our mouths and noses with Styrofoam cups
and try to breathe normally.
KISS opens their show with staged explosions, flashing red
lights, a prolonged guitar solo by Frehley. Simmons spits fire.
The crowd rushes the stage. All the pot smokers in our section
hold lighters, tiny flames flickering, high above their heads.
The songs are so familiar we know all the words. The audience
sings along.
The songs: "Let Me Go, Rock `n' Roll," "Detroit Rock City,"
"Rock and Roll All Nite."
The decibel level is tremendous. Steve and I can feel the sound
waves crashing against the Styrofoam cups we hold over our
faces. Aunt and Uncle are panicked, finally convinced that the
devil plays a mean guitar. This is too much for them. It is also
too much for Steve and me, but we pretend to be disappointed
when Aunt and Uncle drag us out of the Coliseum.
During the drive home, Aunt and Uncle play Christian music on
the radio. Loudly and badly, they sing along. Steve and I are in
the back of the Pacer, looking up through the strangely curved
rear window. There is a meteor shower, the largest in a decade.
Steve and I smell like pot smoke. We smile at this. Our ears
ring. We make wishes on the shooting stars, though both of us
know that a shooting star is not a star. It's just a sliver of stone.
* * *
I made a very conscious decision to marry an Indian woman,
who made a very conscious decision to marry me.
Our hope: to give birth to and raise Indian children who love
themselves. That is the most revolutionary act.
* * *
1982: I am the only Indian student at Reardan High, an all-
white school in a small farm town just outside my reservation. I
am in the pizza parlor, sharing a deluxe with my white friends.
We are talking and laughing. A drunk Indian walks in. He
staggers to the counter and orders a beer. The waiter ignores
him. We are all silent.
At our table, S is shaking her head. She leans toward us as if to
share a secret.
"Man," she says, "I hate Indians."
* * *
I am curious about the writers who identify themselves as
mixed-blood Indians. Is it difficult for them to decide which
container they should put their nouns and verbs into?
Invisibility, after all, can be useful, as a blonde, Aryan-featured
Jew in Germany might have found during World War II. Then
again, I think of the horror stories that such a pale undetected
Jew could tell about life during the Holocaust.
* * *
An Incomplete List of People I Wish Were Indian
Kareem Abdul-Jabbar Adam Muhammad Ali Susan B. Anthony
Jimmy Carter Patsy Cline D.B. Cooper Robert DeNiro Emily
Dickinson Isadora Duncan Amelia Earhart Eve Diane Fossey
Jesus Christ Robert Johnson Helen Keller Billie Jean King
Martin Luther King, Jr. John Lennon Mary Magdalene Pablo
Neruda Flannery O'Connor Rosa Parks Wilma Rudolph Sappho
William Shakespeare Bruce Springsteen Meryl Streep John
Steinbeck Superman Harriet Tubman Voltaire Walt Whitman
* * *
1995: Summer. Seattle, Washington. I am idling at a red light
when a car filled with white boys pulls up beside me. The white
boy in the front passenger seat leans out his window.
"I hate you Indian motherfuckers," he screams.
I quietly wait for the green light.
1978: David, Randy, Steve, and I decide to form a reservation
doowop group, like the Platters. During recess, we practice
behind the old tribal school. Steve, a falsetto, is the best singer.
I am the worst singer, but have the deepest voice, and am
therefore an asset.
"What songs do you want to sing?" asks David.
"Tracks of My Tears," says Steve, who always decides these
kind of things.
We sing, desperately trying to remember the lyrics to that song.
We try to remember other songs. We remember the chorus to
most, the first verse of a few, and only one in its entirety. For
some reason, we all know the lyrics of "Monster Mash."
However, I'm the only one who can manage to sing with the
pseudo-Transylvanian accent that the song requires. This
dubious skill makes me the lead singer, despite Steve's protests.
"We need a name for our group," says Randy.
"How about The Warriors?" I ask.
Everybody agrees. We've watched a lot of Westerns.
We sing "Monster Mash" over and over. We want to be famous.
We want all the little Indian girls to shout our names. Finally,
after days of practice, we are ready for our debut. Walking in
line like soldiers, the four of us parade around the playground.
We sing "Monster Mash." I am in front, followed by Steve,
David, then Randy, who is the shortest, but the toughest fighter
our reservation has ever known. We sing. We are The Warriors.
All the other Indian boys and girls line up behind us as we
march. We are heroes. We are loved. I sing with everything I
have inside of me: pain, happiness, anger, depression, heart,
soul, small intestine. I sing and am rewarded with people who
listen.
That is why I am a poet.
* * *
I remember watching Richard Nixon, during the Watergate
affair, as he held a press conference and told the entire world
that he was not a crook.
For the first time, I understood that storytellers could be bad
people.
* * *
Poetry = Anger x Imagination
* * *
Every time I venture into the bookstore, I find another book
about Indians. There are hundreds of books about Indians
published every year, yet so few are written by Indians. I gather
all the books written about Indians. I discover:
A book written by a person who identifies as mixed-blood will
sell more copies than a book written by a person who identifies
as strictly Indian.
A book written by a non-Indian will sell more copies than a
book written by either a mixed-blood or an Indian writer.
Reservation Indian writers are rarely published in any form.
A book about Indian life in the past, whether written by a non-
Indian, mixed-blood, or Indian, will sell more copies than a
book about Indian life in the twentieth century.
If you are a non-Indian writing about Indians, it is almost
guaranteed that something positive will be written about you by
Tony Hillerman.
Indian writers who are women will be compared with Louise
Erdrich. Indian writers who are men will be compared with
Michael Dorris.
A very small percentage of the readers of Indian literature have
heard of Simon J. Ortiz. This is a crime.
Books about the Sioux sell more copies than all of the books
written about other tribes combined.
Mixed-blood writers often write about any tribe which interests
them, whether or not they are related to that tribe.
Writers who use obvious Indian names, such as Eagle Woman
and Pretty Shield, are usually non-Indian.
Non-Indian writers usually say "Great Spirit," "Mother Earth,"
"Two-Legged, Four-Legged, and Winged." Mixed-blood writers
usually say "Creator, "Mother Earth," "Two-Legged, Four-
Legged, and Winged." Indian writers usually say "God,"
"Mother Earth," "Human Being, Dog, and Bird."
If a book about Indians contains no dogs, then it was written by
a non-Indian or mixed-blood writer.
If on the cover of a book there are winged animals who aren't
supposed to have wings, then it was written by a non-Indian.
Successful non-Indian writers are viewed as well-informed
about Indian life. Successful mixed-blood writers are viewed as
wonderful translators of Indian life. Successful Indian writers
are viewed as traditional storytellers of Indian life.
Very few Indian and mixed-blood writers speak their tribal
languages. Even fewer non-Indian writers speak their tribal
languages.
Indians often write exclusively about reservation life, even if
they never lived on a reservation.
Mixed-bloods often write exclusively about Indians, even if
they grew up in non-Indian communities.
Non-Indian writers always write about reservation life.
Nobody has written the great urban Indian novel yet.
Most non-Indians who write about Indians are fiction writers.
Fiction about Indians sells.
* * *
Have you stood in a crowded room where nobody looks like
you? If you are white, have you stood in a room full of black
people? Are you an Irish man who has strolled through the
streets of Compton? If you are black, have you stood in a room
full of white people? Are you an African-American man who
has played the back nine at the local country club? If you are a
woman, have you stood in a room full of men? Are you Sandra
Day O'Connor or Ruth Ginsberg?
Since I left the reservation, almost every room I enter is filled
with people who do not look like me. There are only two
million Indians in this country. We could all fit into one
medium-sized city. Someone should look into it.
Often, I am most alone in bookstores where I am reading from
my work. I look up from the page at white faces. This is
frightening.
* * *
There is an apple tree outside my grandmother's house on the
reservation. The apples are green; my grandmother's house is
green. This is the game: My siblings and I try to sneak apples
from the tree. Sometimes, our friends will join our raiding
expeditions. My grandmother believes green apples are poison
and is simply trying to protect us from sickness. There is
nothing biblical about this story.
The game has rules. We always have to raid the tree during
daylight. My grandmother has bad eyes and it would be unfair
to challenge her in the dark. We all have to approach the tree at
the same time. Arnold, my older brother. Kim and Arlene, my
younger twin sisters. We have to climb the tree to steal apples,
ignoring the fruit which hangs low to the ground.
Arnold is the best apple thief on the reservation. He is chubby,
but quick. He is fearless in the tree, climbing to the top for the
plumpest apples. He hangs from a branch with one arm, reaches
for apples with the other, and fills his pockets with his booty. I
love him like crazy. My sisters are more conservative. Often
they grab one apple and eat it quickly, sitting on a sturdy
branch. I always like the green apples with a hint of red. While
we are busy raiding the tree, we also keep an eye on our
grandmother's house. She is a big woman, nearly six feet tall.
At the age of seventy, she can still outrun any ten-year-old.
Arnold, of course, is always the first kid out of the tree. He
hangs from a branch, drops to the ground, and screams loudly,
announcing our presence to our grandmother. He runs away,
leaving my sisters and me stuck in the tree. We scramble to the
ground and try to escape.
"Junior," she shouts and I freeze. That's the rule. Sometimes a
dozen Indian kids have been in that tree, scattering in random
directions when our grandmother bursts out of the house. If she
remembers your name, you are a prisoner of war. And, believe
me, no matter how many kids are running away, my
grandmother always remembers my name.
My grandmother died when I was fourteen years old. I miss her.
I miss everybody.
"Junior," she shouts and I close my eyes in disgust. Captured
again! I wait as she walks up to me. She holds out her hand and
I give her the stolen apples. Then she smacks me gently on the
top of my head. I am free to run then, pretending she never
caught me in the first place. I try to catch up with the others.
Running through the trees surrounding my grandmother's house,
I shout out their names.
* * *
So many people claim to be Indian, speaking of an Indian
grandmother, a warrior grandfather. Suppose the United States
government announced that all Indians had to return to their
reservation. How many of these people would not shove that
Indian ancestor back into the closet?
* * *
My mother still makes quilts. My wife and I sleep beneath one.
My brother works for our tribal casino. One sister works for our
bingo hall, while the other works in the tribal finance
department. Our adopted little brother, James, who is actually
our second cousin, is a freshman at Reardan High School. He
can run the mile in five minutes.
My father is an alcoholic. He used to leave us for weeks at a
time to drink with his friends and cousins. I missed him so
much I'd cry myself sick.
I could always tell when he was going to leave. He would be
tense, quiet, unable to concentrate. He'd flip through magazines
and television channels. He'd open the refrigerator door, study
its contents, shut the door, and walk away. Five minutes later,
he'd be back at the fridge, rearranging items on the shelves. I
would follow him from place to place, trying to prevent his
escape.
Once, he went into the bathroom, which had no windows, while
I sat outside the only door and waited for him. I could not hear
him inside. I knocked on the thin wood. I was five years old.
"Are you there?" I asked. "Are you still there?"
Every time he left, I ended up in the emergency room. But I
always got well and he always came back. He'd walk in the door
without warning. We'd forgive him.
Years later, I am giving a reading at a bookstore in Spokane,
Washington. There is a large crowd. I read a story about an
Indian father who leaves his family for good. He moves to a city
a thousand miles away. Then he dies. It is a sad story. When I
finish, a woman in the front row breaks into tears.
"What's wrong?" I ask her.
"I'm so sorry about your father," she says.
"Thank you," I say, "But that's my father sitting right next to
you."
1
1. Read and understand the case. Show your Analysis and
Reasoning and make it clear you understand the material. Be
sure to incorporate the concepts of the chapter we are studying
to show your reasoning. Dedicate at least one sub-heading to
each following outline topic:
Facts [Summarize only those facts critical to the outcome of the
case]
Issue [Note the central question or questions on which the case
turns]
Explain the applicable law(s). Use the textbook here. The law
should come from the same chapter as the case. Be sure to use
citations from the textbook including page numbers.
Holding [How did the court resolve the issue(s)? Who won?]
Reasoning [Explain the logic that supported the court's
decision]
2. Wrap up with a Conclusion. This should summarize the key
aspects of the decision and also your recommendations on the
court's ruling.
3. Include citations and a reference page with your sources. Use
APA style citations and references.

More Related Content

Similar to Gianella Espinosa (Olivier RitterBEM Bache.docx

VectraplexECGFinal Brochure 3.1
VectraplexECGFinal Brochure 3.1VectraplexECGFinal Brochure 3.1
VectraplexECGFinal Brochure 3.1Josh Skinner
 
IRJET- A Survey on Classification and identification of Arrhythmia using Mach...
IRJET- A Survey on Classification and identification of Arrhythmia using Mach...IRJET- A Survey on Classification and identification of Arrhythmia using Mach...
IRJET- A Survey on Classification and identification of Arrhythmia using Mach...IRJET Journal
 
Detection and Classification of ECG Arrhythmia using LSTM Autoencoder
Detection and Classification of ECG Arrhythmia using LSTM AutoencoderDetection and Classification of ECG Arrhythmia using LSTM Autoencoder
Detection and Classification of ECG Arrhythmia using LSTM AutoencoderIRJET Journal
 
Echocardiography Analysis
Echocardiography AnalysisEchocardiography Analysis
Echocardiography AnalysisLaura Arrigo
 
Introduction To Electrophysiology
Introduction To ElectrophysiologyIntroduction To Electrophysiology
Introduction To Electrophysiologyjmlafroscia
 
Electrocardiograph
ElectrocardiographElectrocardiograph
Electrocardiographgoory
 
Electrocardiograph11
Electrocardiograph11Electrocardiograph11
Electrocardiograph11goory
 
What is a Brain CT Imaging Perfusion Study?
What is a Brain CT Imaging Perfusion Study?What is a Brain CT Imaging Perfusion Study?
What is a Brain CT Imaging Perfusion Study?Carestream
 
Artificial Cardiac pacemaker |medical device that generates electrical impulses
Artificial Cardiac pacemaker |medical device that generates electrical impulses Artificial Cardiac pacemaker |medical device that generates electrical impulses
Artificial Cardiac pacemaker |medical device that generates electrical impulses NEHA MALIK
 
Tachycardia discriminating algorithms and trouble shooting of ICDs
Tachycardia discriminating algorithms and trouble shooting of ICDsTachycardia discriminating algorithms and trouble shooting of ICDs
Tachycardia discriminating algorithms and trouble shooting of ICDsRaghu Kishore Galla
 

Similar to Gianella Espinosa (Olivier RitterBEM Bache.docx (13)

VectraplexECGFinal Brochure 3.1
VectraplexECGFinal Brochure 3.1VectraplexECGFinal Brochure 3.1
VectraplexECGFinal Brochure 3.1
 
IRJET- A Survey on Classification and identification of Arrhythmia using Mach...
IRJET- A Survey on Classification and identification of Arrhythmia using Mach...IRJET- A Survey on Classification and identification of Arrhythmia using Mach...
IRJET- A Survey on Classification and identification of Arrhythmia using Mach...
 
Detection and Classification of ECG Arrhythmia using LSTM Autoencoder
Detection and Classification of ECG Arrhythmia using LSTM AutoencoderDetection and Classification of ECG Arrhythmia using LSTM Autoencoder
Detection and Classification of ECG Arrhythmia using LSTM Autoencoder
 
Case study
Case studyCase study
Case study
 
Atrial Septal Disease
Atrial Septal DiseaseAtrial Septal Disease
Atrial Septal Disease
 
Echocardiography Analysis
Echocardiography AnalysisEchocardiography Analysis
Echocardiography Analysis
 
50620130101003
5062013010100350620130101003
50620130101003
 
Introduction To Electrophysiology
Introduction To ElectrophysiologyIntroduction To Electrophysiology
Introduction To Electrophysiology
 
Electrocardiograph
ElectrocardiographElectrocardiograph
Electrocardiograph
 
Electrocardiograph11
Electrocardiograph11Electrocardiograph11
Electrocardiograph11
 
What is a Brain CT Imaging Perfusion Study?
What is a Brain CT Imaging Perfusion Study?What is a Brain CT Imaging Perfusion Study?
What is a Brain CT Imaging Perfusion Study?
 
Artificial Cardiac pacemaker |medical device that generates electrical impulses
Artificial Cardiac pacemaker |medical device that generates electrical impulses Artificial Cardiac pacemaker |medical device that generates electrical impulses
Artificial Cardiac pacemaker |medical device that generates electrical impulses
 
Tachycardia discriminating algorithms and trouble shooting of ICDs
Tachycardia discriminating algorithms and trouble shooting of ICDsTachycardia discriminating algorithms and trouble shooting of ICDs
Tachycardia discriminating algorithms and trouble shooting of ICDs
 

More from budbarber38650

 Assignment 1 Discussion Question Prosocial Behavior and Altrui.docx
 Assignment 1 Discussion Question Prosocial Behavior and Altrui.docx Assignment 1 Discussion Question Prosocial Behavior and Altrui.docx
 Assignment 1 Discussion Question Prosocial Behavior and Altrui.docxbudbarber38650
 
● what is name of the new unit and what topics will Professor Moss c.docx
● what is name of the new unit and what topics will Professor Moss c.docx● what is name of the new unit and what topics will Professor Moss c.docx
● what is name of the new unit and what topics will Professor Moss c.docxbudbarber38650
 
…Multiple intelligences describe an individual’s strengths or capac.docx
…Multiple intelligences describe an individual’s strengths or capac.docx…Multiple intelligences describe an individual’s strengths or capac.docx
…Multiple intelligences describe an individual’s strengths or capac.docxbudbarber38650
 
• World Cultural Perspective Paper Final SubmissionResources.docx
• World Cultural Perspective Paper Final SubmissionResources.docx• World Cultural Perspective Paper Final SubmissionResources.docx
• World Cultural Perspective Paper Final SubmissionResources.docxbudbarber38650
 
•       Write a story; explaining and analyzing how a ce.docx
•       Write a story; explaining and analyzing how a ce.docx•       Write a story; explaining and analyzing how a ce.docx
•       Write a story; explaining and analyzing how a ce.docxbudbarber38650
 
•Use the general topic suggestion to form the thesis statement.docx
•Use the general topic suggestion to form the thesis statement.docx•Use the general topic suggestion to form the thesis statement.docx
•Use the general topic suggestion to form the thesis statement.docxbudbarber38650
 
•The topic is culture adaptation ( adoption )16 slides.docx
•The topic is culture adaptation ( adoption )16 slides.docx•The topic is culture adaptation ( adoption )16 slides.docx
•The topic is culture adaptation ( adoption )16 slides.docxbudbarber38650
 
•Choose 1 of the department work flow processes, and put together a .docx
•Choose 1 of the department work flow processes, and put together a .docx•Choose 1 of the department work flow processes, and put together a .docx
•Choose 1 of the department work flow processes, and put together a .docxbudbarber38650
 
‘The problem is not that people remember through photographs, but th.docx
‘The problem is not that people remember through photographs, but th.docx‘The problem is not that people remember through photographs, but th.docx
‘The problem is not that people remember through photographs, but th.docxbudbarber38650
 
·                                     Choose an articleo.docx
·                                     Choose an articleo.docx·                                     Choose an articleo.docx
·                                     Choose an articleo.docxbudbarber38650
 
·You have been engaged to prepare the 2015 federal income tax re.docx
·You have been engaged to prepare the 2015 federal income tax re.docx·You have been engaged to prepare the 2015 federal income tax re.docx
·You have been engaged to prepare the 2015 federal income tax re.docxbudbarber38650
 
·Time Value of MoneyQuestion A·Discuss the significance .docx
·Time Value of MoneyQuestion A·Discuss the significance .docx·Time Value of MoneyQuestion A·Discuss the significance .docx
·Time Value of MoneyQuestion A·Discuss the significance .docxbudbarber38650
 
·Reviewthe steps of the communication model on in Ch. 2 of Bus.docx
·Reviewthe steps of the communication model on in Ch. 2 of Bus.docx·Reviewthe steps of the communication model on in Ch. 2 of Bus.docx
·Reviewthe steps of the communication model on in Ch. 2 of Bus.docxbudbarber38650
 
·Research Activity Sustainable supply chain can be viewed as.docx
·Research Activity Sustainable supply chain can be viewed as.docx·Research Activity Sustainable supply chain can be viewed as.docx
·Research Activity Sustainable supply chain can be viewed as.docxbudbarber38650
 
·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docx
·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docx·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docx
·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docxbudbarber38650
 
·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docx
·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docx·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docx
·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docxbudbarber38650
 
·Observe a group discussing a topic of interest such as a focus .docx
·Observe a group discussing a topic of interest such as a focus .docx·Observe a group discussing a topic of interest such as a focus .docx
·Observe a group discussing a topic of interest such as a focus .docxbudbarber38650
 
·Identify any program constraints, such as financial resources, .docx
·Identify any program constraints, such as financial resources, .docx·Identify any program constraints, such as financial resources, .docx
·Identify any program constraints, such as financial resources, .docxbudbarber38650
 
·Double-spaced·12-15 pages each chapterThe followi.docx
·Double-spaced·12-15 pages each chapterThe followi.docx·Double-spaced·12-15 pages each chapterThe followi.docx
·Double-spaced·12-15 pages each chapterThe followi.docxbudbarber38650
 
© 2019 Cengage. All Rights Reserved. Linear RegressionC.docx
© 2019 Cengage. All Rights Reserved.  Linear RegressionC.docx© 2019 Cengage. All Rights Reserved.  Linear RegressionC.docx
© 2019 Cengage. All Rights Reserved. Linear RegressionC.docxbudbarber38650
 

More from budbarber38650 (20)

 Assignment 1 Discussion Question Prosocial Behavior and Altrui.docx
 Assignment 1 Discussion Question Prosocial Behavior and Altrui.docx Assignment 1 Discussion Question Prosocial Behavior and Altrui.docx
 Assignment 1 Discussion Question Prosocial Behavior and Altrui.docx
 
● what is name of the new unit and what topics will Professor Moss c.docx
● what is name of the new unit and what topics will Professor Moss c.docx● what is name of the new unit and what topics will Professor Moss c.docx
● what is name of the new unit and what topics will Professor Moss c.docx
 
…Multiple intelligences describe an individual’s strengths or capac.docx
…Multiple intelligences describe an individual’s strengths or capac.docx…Multiple intelligences describe an individual’s strengths or capac.docx
…Multiple intelligences describe an individual’s strengths or capac.docx
 
• World Cultural Perspective Paper Final SubmissionResources.docx
• World Cultural Perspective Paper Final SubmissionResources.docx• World Cultural Perspective Paper Final SubmissionResources.docx
• World Cultural Perspective Paper Final SubmissionResources.docx
 
•       Write a story; explaining and analyzing how a ce.docx
•       Write a story; explaining and analyzing how a ce.docx•       Write a story; explaining and analyzing how a ce.docx
•       Write a story; explaining and analyzing how a ce.docx
 
•Use the general topic suggestion to form the thesis statement.docx
•Use the general topic suggestion to form the thesis statement.docx•Use the general topic suggestion to form the thesis statement.docx
•Use the general topic suggestion to form the thesis statement.docx
 
•The topic is culture adaptation ( adoption )16 slides.docx
•The topic is culture adaptation ( adoption )16 slides.docx•The topic is culture adaptation ( adoption )16 slides.docx
•The topic is culture adaptation ( adoption )16 slides.docx
 
•Choose 1 of the department work flow processes, and put together a .docx
•Choose 1 of the department work flow processes, and put together a .docx•Choose 1 of the department work flow processes, and put together a .docx
•Choose 1 of the department work flow processes, and put together a .docx
 
‘The problem is not that people remember through photographs, but th.docx
‘The problem is not that people remember through photographs, but th.docx‘The problem is not that people remember through photographs, but th.docx
‘The problem is not that people remember through photographs, but th.docx
 
·                                     Choose an articleo.docx
·                                     Choose an articleo.docx·                                     Choose an articleo.docx
·                                     Choose an articleo.docx
 
·You have been engaged to prepare the 2015 federal income tax re.docx
·You have been engaged to prepare the 2015 federal income tax re.docx·You have been engaged to prepare the 2015 federal income tax re.docx
·You have been engaged to prepare the 2015 federal income tax re.docx
 
·Time Value of MoneyQuestion A·Discuss the significance .docx
·Time Value of MoneyQuestion A·Discuss the significance .docx·Time Value of MoneyQuestion A·Discuss the significance .docx
·Time Value of MoneyQuestion A·Discuss the significance .docx
 
·Reviewthe steps of the communication model on in Ch. 2 of Bus.docx
·Reviewthe steps of the communication model on in Ch. 2 of Bus.docx·Reviewthe steps of the communication model on in Ch. 2 of Bus.docx
·Reviewthe steps of the communication model on in Ch. 2 of Bus.docx
 
·Research Activity Sustainable supply chain can be viewed as.docx
·Research Activity Sustainable supply chain can be viewed as.docx·Research Activity Sustainable supply chain can be viewed as.docx
·Research Activity Sustainable supply chain can be viewed as.docx
 
·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docx
·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docx·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docx
·DISCUSSION 1 – VARIOUS THEORIES – Discuss the following in 150-.docx
 
·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docx
·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docx·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docx
·Module 6 Essay ContentoThe ModuleWeek 6 essay require.docx
 
·Observe a group discussing a topic of interest such as a focus .docx
·Observe a group discussing a topic of interest such as a focus .docx·Observe a group discussing a topic of interest such as a focus .docx
·Observe a group discussing a topic of interest such as a focus .docx
 
·Identify any program constraints, such as financial resources, .docx
·Identify any program constraints, such as financial resources, .docx·Identify any program constraints, such as financial resources, .docx
·Identify any program constraints, such as financial resources, .docx
 
·Double-spaced·12-15 pages each chapterThe followi.docx
·Double-spaced·12-15 pages each chapterThe followi.docx·Double-spaced·12-15 pages each chapterThe followi.docx
·Double-spaced·12-15 pages each chapterThe followi.docx
 
© 2019 Cengage. All Rights Reserved. Linear RegressionC.docx
© 2019 Cengage. All Rights Reserved.  Linear RegressionC.docx© 2019 Cengage. All Rights Reserved.  Linear RegressionC.docx
© 2019 Cengage. All Rights Reserved. Linear RegressionC.docx
 

Recently uploaded

The Most Excellent Way | 1 Corinthians 13
The Most Excellent Way | 1 Corinthians 13The Most Excellent Way | 1 Corinthians 13
The Most Excellent Way | 1 Corinthians 13Steve Thomason
 
microwave assisted reaction. General introduction
microwave assisted reaction. General introductionmicrowave assisted reaction. General introduction
microwave assisted reaction. General introductionMaksud Ahmed
 
Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)eniolaolutunde
 
A Critique of the Proposed National Education Policy Reform
A Critique of the Proposed National Education Policy ReformA Critique of the Proposed National Education Policy Reform
A Critique of the Proposed National Education Policy ReformChameera Dedduwage
 
Beyond the EU: DORA and NIS 2 Directive's Global Impact
Beyond the EU: DORA and NIS 2 Directive's Global ImpactBeyond the EU: DORA and NIS 2 Directive's Global Impact
Beyond the EU: DORA and NIS 2 Directive's Global ImpactPECB
 
SOCIAL AND HISTORICAL CONTEXT - LFTVD.pptx
SOCIAL AND HISTORICAL CONTEXT - LFTVD.pptxSOCIAL AND HISTORICAL CONTEXT - LFTVD.pptx
SOCIAL AND HISTORICAL CONTEXT - LFTVD.pptxiammrhaywood
 
Accessible design: Minimum effort, maximum impact
Accessible design: Minimum effort, maximum impactAccessible design: Minimum effort, maximum impact
Accessible design: Minimum effort, maximum impactdawncurless
 
Sanyam Choudhary Chemistry practical.pdf
Sanyam Choudhary Chemistry practical.pdfSanyam Choudhary Chemistry practical.pdf
Sanyam Choudhary Chemistry practical.pdfsanyamsingh5019
 
“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...
“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...
“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...Marc Dusseiller Dusjagr
 
mini mental status format.docx
mini    mental       status     format.docxmini    mental       status     format.docx
mini mental status format.docxPoojaSen20
 
Activity 01 - Artificial Culture (1).pdf
Activity 01 - Artificial Culture (1).pdfActivity 01 - Artificial Culture (1).pdf
Activity 01 - Artificial Culture (1).pdfciinovamais
 
Q4-W6-Restating Informational Text Grade 3
Q4-W6-Restating Informational Text Grade 3Q4-W6-Restating Informational Text Grade 3
Q4-W6-Restating Informational Text Grade 3JemimahLaneBuaron
 
How to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptxHow to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptxmanuelaromero2013
 
1029 - Danh muc Sach Giao Khoa 10 . pdf
1029 -  Danh muc Sach Giao Khoa 10 . pdf1029 -  Danh muc Sach Giao Khoa 10 . pdf
1029 - Danh muc Sach Giao Khoa 10 . pdfQucHHunhnh
 
Organic Name Reactions for the students and aspirants of Chemistry12th.pptx
Organic Name Reactions  for the students and aspirants of Chemistry12th.pptxOrganic Name Reactions  for the students and aspirants of Chemistry12th.pptx
Organic Name Reactions for the students and aspirants of Chemistry12th.pptxVS Mahajan Coaching Centre
 
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptxPOINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptxSayali Powar
 
Student login on Anyboli platform.helpin
Student login on Anyboli platform.helpinStudent login on Anyboli platform.helpin
Student login on Anyboli platform.helpinRaunakKeshri1
 
Separation of Lanthanides/ Lanthanides and Actinides
Separation of Lanthanides/ Lanthanides and ActinidesSeparation of Lanthanides/ Lanthanides and Actinides
Separation of Lanthanides/ Lanthanides and ActinidesFatimaKhan178732
 
Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...
Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...
Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...RKavithamani
 

Recently uploaded (20)

The Most Excellent Way | 1 Corinthians 13
The Most Excellent Way | 1 Corinthians 13The Most Excellent Way | 1 Corinthians 13
The Most Excellent Way | 1 Corinthians 13
 
microwave assisted reaction. General introduction
microwave assisted reaction. General introductionmicrowave assisted reaction. General introduction
microwave assisted reaction. General introduction
 
Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)
 
A Critique of the Proposed National Education Policy Reform
A Critique of the Proposed National Education Policy ReformA Critique of the Proposed National Education Policy Reform
A Critique of the Proposed National Education Policy Reform
 
Beyond the EU: DORA and NIS 2 Directive's Global Impact
Beyond the EU: DORA and NIS 2 Directive's Global ImpactBeyond the EU: DORA and NIS 2 Directive's Global Impact
Beyond the EU: DORA and NIS 2 Directive's Global Impact
 
SOCIAL AND HISTORICAL CONTEXT - LFTVD.pptx
SOCIAL AND HISTORICAL CONTEXT - LFTVD.pptxSOCIAL AND HISTORICAL CONTEXT - LFTVD.pptx
SOCIAL AND HISTORICAL CONTEXT - LFTVD.pptx
 
Accessible design: Minimum effort, maximum impact
Accessible design: Minimum effort, maximum impactAccessible design: Minimum effort, maximum impact
Accessible design: Minimum effort, maximum impact
 
Sanyam Choudhary Chemistry practical.pdf
Sanyam Choudhary Chemistry practical.pdfSanyam Choudhary Chemistry practical.pdf
Sanyam Choudhary Chemistry practical.pdf
 
“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...
“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...
“Oh GOSH! Reflecting on Hackteria's Collaborative Practices in a Global Do-It...
 
mini mental status format.docx
mini    mental       status     format.docxmini    mental       status     format.docx
mini mental status format.docx
 
Activity 01 - Artificial Culture (1).pdf
Activity 01 - Artificial Culture (1).pdfActivity 01 - Artificial Culture (1).pdf
Activity 01 - Artificial Culture (1).pdf
 
Q4-W6-Restating Informational Text Grade 3
Q4-W6-Restating Informational Text Grade 3Q4-W6-Restating Informational Text Grade 3
Q4-W6-Restating Informational Text Grade 3
 
How to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptxHow to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptx
 
Staff of Color (SOC) Retention Efforts DDSD
Staff of Color (SOC) Retention Efforts DDSDStaff of Color (SOC) Retention Efforts DDSD
Staff of Color (SOC) Retention Efforts DDSD
 
1029 - Danh muc Sach Giao Khoa 10 . pdf
1029 -  Danh muc Sach Giao Khoa 10 . pdf1029 -  Danh muc Sach Giao Khoa 10 . pdf
1029 - Danh muc Sach Giao Khoa 10 . pdf
 
Organic Name Reactions for the students and aspirants of Chemistry12th.pptx
Organic Name Reactions  for the students and aspirants of Chemistry12th.pptxOrganic Name Reactions  for the students and aspirants of Chemistry12th.pptx
Organic Name Reactions for the students and aspirants of Chemistry12th.pptx
 
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptxPOINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
 
Student login on Anyboli platform.helpin
Student login on Anyboli platform.helpinStudent login on Anyboli platform.helpin
Student login on Anyboli platform.helpin
 
Separation of Lanthanides/ Lanthanides and Actinides
Separation of Lanthanides/ Lanthanides and ActinidesSeparation of Lanthanides/ Lanthanides and Actinides
Separation of Lanthanides/ Lanthanides and Actinides
 
Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...
Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...
Privatization and Disinvestment - Meaning, Objectives, Advantages and Disadva...
 

Gianella Espinosa (Olivier RitterBEM Bache.docx

  • 1. Gianella Espinosa ( Olivier Ritter BEM Bachelor 10/09/2012 ) ( A l’attention d ’ Anne-Catherine Guitard ) ( INTERNSHIP REPORT ) Contents Context 2 What is Cardiac Mapping? 2 The Product 3 The Mission 4 What is atrial fibrillation? 5 Clinical cases 6 Global Market Needs Analysis 7 Normal anatomy and physiology of the heart 7
  • 2. Pathophysiology, Causal factors & Disease progression 8 Clinical Presentation & Outcomes 11 Treatments of Atrial fibrillation 12 Epidemiology 14 Economic Burden 17 Appendices Context Heart disease is the number one cause of death in the United States. Cardiac arrhythmias—an irregular heartbeat—affects 2.2 million Americans. Congestive heart failure—the inability to pump blood properly—affects nearly 5 million Americans. Conventional treatments such as ablation and cardiac resynchronization therapy (CRT) can improve patients’ lives; but clinical outcomes have not reached the intended levels of success. Catheter ablation success rates have ranged between 40-85 percent, resulting in need for repeat procedures in 40-50 percent of the cases. For CRT patients, success is highly dependent on selecting the right patient, placing the lead in the best location for that patient, and optimizing the device settings. Currently, 1/3 of all patients with CRT devices do not respond to treatment, leading to continued progression of heart failure, increased patient morbidity, and an increasing financial burden to the healthcare system.What is Cardiac Mapping? Mapping the electrical activity of the heart is a critical component for the diagnosis and treatment of heart disease. Many advanced therapies (such as ablation for the treatment of arrhythmias) require detailed electroanatomic mapping. Currently, mapping is performed in an electrophysiology (EP) lab, during which mapping catheters are inserted into the heart and carefully moved to various locations around the heart to map and identify the origins of the arrhythmia. Once the origin of the arrhythmia is identified, the specific tissue is destroyed by ablation. Current catheter mapping technologies have several limitations including:
  • 3. · Risks and limitations associated with being an invasive and time consuming procedure. · Current point-to-point mapping technology does not provide simultaneous, beat-by-beat mapping. Electrical activity has to be skillfully aggregated and annotated to make sense of the information provided by these point-to-point mapping systems. · Does not provide the whole picture (bi-atrial or bi-ventricular) of electrical activity. Only provides mapping information one chamber at a time. · Does not fit into the current work flow of device based therapy (e.g. Cardiac resynchronization therapy devices for heart failure). Catheter ablation has evolved to become a mainstream treatment for arrhythmias, while mapping to identify ablation treatment targets and confirm success of therapy has emerged as its significant and critical counterpart. For device-based therapy like Cardiac Resynchronization Therapy (CRT) for heart failure, point-to-point, non- simultaneous catheter mapping provides very limited benefit while adding cost and complexity to the procedure. Therefore, there is no practical mapping solution available for use today. CardioInsight's ECVUE system has the potential to substantially improve EP clinical practice by addressing significant unmet clinical needs associated with current mapping technologies.The Product CardioInsight, a Cleveland-based medical device company, was founded in 2006 to commercialize a breakthrough technology designed to improve the diagnosis and treatment of electrical disorders of the heart. The ECVUE system gathers electrical information about the heart from a proprietary, multi-sensor electrode "vest" placed on a patient’s body and combines it with images from a CT scan to provide 3D maps of the electrical activity of the heart. Unlike conventional catheter-based mapping methods, the ECVUE ™ system is non-invasive and provides a view of the entire heart’s electrical activity in a single beat, enabling
  • 4. electrophysiologistso better guide treatments to localize arrhythmias, or optimize the placement and settings of CRT devices, such as pacemakers CardioInsight’s ECVUE mapping system is a non-invasive, single-beat electrocardiographic mapping system with the unique ability to make the diagnosis and treatment guidance of cardiac arrhythmias and heart failure simpler, faster, and safer. The ECVUE system is comprised of: · Proprietary single use, disposable multi-electrode vest that gathers body surface electrical signals, and · Advanced data analysis and visualization workstation that generates real-time, 3D images of the electrical activity of the heart. From the simple to use multi-electrode vest, to the intuitive, customizable data analysis and visualization workstation, the ECVUE system offers a comprehensive tool that creates a new paradigm in cardiac mapping that for the first time extends the use of advanced cardiac mapping outside the existing confines of the EP lab. ECVUE is commercially available in Europe for assisting electrophysiologists with the diagnosis of cardiac arrhythmias. The Company continues to work with leading centers world- wide to further strengthen its clinical value proposition in simplifying mapping of arrhythmias and development of panoramic biatrial mapping for atrial fibrillation. CardioInsight is also developing the only 3D mapping product for CRT, which is expected to have a significant impact in patient selection, lead placement and optimization. ECVUE is the first advanced mapping technology to non- invasively generate real-time, 3D electrical maps of the whole heart in a single beat.THE MISSION As the company prepares for commercialization, discussions with key industry players, as well as future fundraising activities, this business planning and valuation assessment becomes increasingly critical. My supervisor, Kevin Mendelsohn, vice-president of the
  • 5. company and in charge of finance & corporate development, proposed that I work on a project that would culminate in the generation of a business plan to detail and quantify the value of our mapping system for atrial fibrillation (a certain type of arrhythmia) mapping, include detailing the unique clinical applications of the system, quantifying the patient populations, analyzing the competition, evaluating the pricing structure, and ultimately generating a "value" of the opportunity. My mission was supposed to be based for one half in Bordeaux, in order for me to work with the CHU, one of the leading centers working with the company, and the other half in the head office in Cleveland to finalize the project. I started this project by doing a lot of reading, as I had very little background on electrophysiology and specifically on the subject of atrial fibrillation. I then worked on the outline of my report (see Appendices) and once validated by my supervisor, I could begin my research. Throughout the whole period of the internship, Kevin and I communicated via Skype at least once a week, and he was always very responsive when I asked for clarifications on the project through emails. In this report I will try to detail the various steps I took to reach the final global market needs analysis, and will give an excerpt of each section, as this project was my only mission this summer. What is atrial fibrillation? Atrial fibrillation, or AF, is the most common type of arrhythmia. An arrhythmia is a problem with the rate or rhythm of the heartbeat. During an arrhythmia, the heart can beat too fast, too slow, or with an irregular rhythm. AF occurs if rapid, disorganized electrical signals cause the heart's two upper chambers (the atria) to fibrillate. The term "fibrillate" means to contract very fast and irregularly. In AF,
  • 6. blood pools in the atria. It isn't pumped completely into the heart's two lower chambers, called the ventricles. As a result, the heart's upper and lower chambers don't work together as they should. The heart has a natural pacemaker, called the “sinus node,” that makes electrical signals. These signals cause the heart to contract and pump blood. With atrial fibrillation, random electrical activity interrupts the normal conduction rhythm and prevents the atria from properly contracting. People who have AF may not feel symptoms. However, even when AF isn't noticed, it can increase the risk of stroke. In some people, AF can cause palpitations, chest pain, dizziness or heart failure, especially if the heart rhythm is very rapid. AF may happen rarely or every now and then, or it may become an ongoing or long-term heart problem that lasts for years. ( An ECG recording of normal heart rhythm ) ( An ECG recording of atrial fibrillation )Clinical cases Some of my first dayswere spent at the hospital to assist to some cases and see the product in action. The first patient I saw was a 45 years old man who was to be ablated for a Wolff–Parkinson–White syndrome (WPW), one of several disorders of the conduction system of the heart that are commonly referred to as pre-excitation syndromes. While the majority of individuals with WPW remain asymptomatic
  • 7. throughout their entire lives, there is a risk of sudden cardiac death associated with the syndrome. While at the hospital I was following Sandra, the CardioInsight employee conducting ECVUE cases everyday with the physicians of the Haut- Leveque hospitalin Pessac. We went to the patient’s room before he was sent down to the CT scan, when she explained the technique to him and asked for his authorization, since the product is still in the clinical testing phase. He was quite interested, asked questions about the system, and approved. He even asked me to take a picture with the vest on for his kids! I found the installation very easy. Two cables provide a link between the vest and the system’s central unit. Sandra realized a segmentation of the scan images, in the operating room before the physician arrived, and the located the area of the bundle of Kent responsible for the arrhythmias after the software generated the 3D visualization. I was simply amazed. Then the physician arrived and punctured soon after having seen the 3D map. 20 minutes later, she had the ablation catheter in the area of concern, and after 5 seconds, the pre-excitation had disappeared on the monitor. That’s when I really realized the capacity of the system to make everything easier for both the patient and the physicians. The second case was an aged woman with tachycardia. She was mapped using ECVUE in the operating room, and was ablated without a break as well. The third patient was about 45 and suffered from paroxysmal ventricular tachycardia (VT) since the age of 25. He had an ICD, changed 2 times. They had recorded that the VT was preceded by a short series of extrasystoles. The system was here to be used to map the electrical activity of the heart during that very first extrasystole, in the patient’s room. Given the earliness of the disorder, he was used to the various other techniques, and was also intrigued by this new vest and the mapping. The physician attempted to trigger the VT by stimulation using the programmer of the ICD. 4 or 5 morphologies of extrasystole came out, which they had to settle
  • 8. for, but never the one that led to the VT. Another invasive 3D mapping system of 2 catheters, one for the endocardium and one for the epicardium, was used the day after on this same patient, who as a result, spent half a day on the table. The last case was a patient who needed an ICD implantation. As mentioned in the product section, ECVUE can also be used in CRT patients notably regarding patient selection, device lead placement and programing optimization. But this operation was quite unique in that a new sophisticated robotic platform, the da Vinci System, was here to be used for CRT implantation for one of the first times in Europe.With da Vinci, small incisions are used to introduce miniaturized wristed instruments and a high- definition 3D camera, helping doctors to take surgery beyond the limits of the human hand. Kevin, my supervisor, suggested that I assisted to the procedure to measure the feasibility of a joint utilization with ECVUE. GLOBAL MARKETNEEDS ANALYSISNormal anatomy and physiology of the heart Obtaining a basic working knowledge of the normal anatomy and physiology of the organ that is affected by a need is important because it establishes a baseline against which abnormalities are understood. This research also provided me with an understanding of important vocabulary and context as I delved into further research. The disease is much easier to comprehend if the anatomy of the affected organ or organ system is clearly understood and can be visualized. Once I learned about normal patterns of function within an affected area, I had a basis for understanding how the disease functions. In the case of AF, I began by determining that AF is a disease of the heart, which is part of the cardiovascular system. As the heart is the primarily affected organ, I then focused on investigating the basic gross anatomy of the heart and its normal function. Understanding the heart’s size, location, and position in relation to other structures quickly establishes a
  • 9. baseline context for investigating more complex concepts and interactions, such as how the electrical system of the heart establishes a rhythm that affects the organ’s ability to mechanically contract. The human heart has four chambers, two superior atria and to inferior ventricles. The atria are the loading chambers and the ventricles are the pumping chambers. The pathway of blood through the human heart consists of a pulmonary circuit and a systemic circuit. Deoxygenated blood, coming from peripheral organs, flows through the heart in one direction, entering through the vena cavas (SVC& IVC) into the right atrium (RA) and is pumped through the tricuspid valve during the passive filling of the right ventricle (RV). Then blood is pumped out through the pulmonary valve to the pulmonary arteries into the lungs to be oxygenated. It returns from the lungs through the pulmonary veins (PVs) to the left atrium (LA) where it is pumped through the mitral valve during the passive filling of the left ventricle.Then oxygenated blood leaves LV through the aortic valve to the aorta. Blood is then distributed to the whole body. The left ventricle is the largest and strongest chamber of the heart, as it must pump blood around the whole body, whereas the atria pump blood into the ventricles and the right ventricle into the lungs, and their walls are therefore much thinner. […] The relative position of those anatomic structures between each other is a determining factor of the heart’s conduction pathways. The pumping action of the heart depends on precise electrical coordination between the atria and ventricles. As the signal travels from top to bottom, it causes the heart to contract and pump blood.
  • 10. · The P wave is a small deflection wave that represents atrial depolarization (the summation of all atrial cells depolarization). · The three waves of the QRS complex represent ventricular depolarization. · T waves represent ventricular repolarization (atrial repolarization is obscured by the large QRS complex). The electrocardiogram is recorded from10electrodes placed onthe patient's body, which can record12 leads. The shape ofthenormal ECGof a patientis identicalto anotherofthe same age. Theabnormalitiesmay be characteristicof agiven disease, ormaybe common todifferent pathologies.The ECGcan diagnoserhythm disordersand theircoarse localization. Inanycase, the ECG does not allow the precise determination of the focal origin or the reentrant circuit responsible for the arrhythmia.Pathophysiology, Causal factors & Disease progression Once I established an understanding of anatomy and physiology of the heart in a healthy individual, then I could examine how the disease disturbs the normal structure and function. When investigating pathophysiology, the first step was to better understand how the disease works from a biologic and physiologic perspective, and then how this affects the normal function of the organ. The second step was to identify the risk factors and causal associations (e.g., genetics, age, associated diseases, and lifestyle) that characterize the disease. Finally, I could seek to understand the disease progression. Disease progression examines the rate (e.g., days, weeks, or years) at which the disease leads to abnormal function. This includes the peak age of the effect and the types of changes that occur at each stage of the disease. In the case of AF, I explored how the heart might be structurally
  • 11. altered, leading to abnormal function, and whether or not the condition can lead to structural changes in the organ. I also looked at the common causes of AF, the primary risk factors, and how AF progresses. I spent quite a bit of time understanding the different types of AF and the unique characteristics of each variation of the disease. This included looking at which type of AF is most common among different groups of patients, whether all AF patients progress in the same way (or if progression is more directly affected by other factors such as coexisting conditions), and how likely patients are to progress from one type of AF to another. Pathophysiology During AF, ventricular and atrial activities become irregular and unsynchronized and rapid irregular discharges come from various areas in the atria. There are several “triggersites”, which create a pattern of rapid and apparently chaotic electrical activity that is characteristic of AF. The majority of these focal sources (approximately 94 percent) are located in areas inside the muscular sleeve of the four pulmonary veins, at their connection to the left atrium. Other less common areas include the superior vena cava, right and left trial free walls, and the coronary sinus. Though not fullyunderstood, inflammation and injury to the cardiac atrial cell structure related to causal factors may predispose to abnormal electricaldischarges that can initiate and maintain AF. However, any kind of myocardial disease may induce impair ment of atrial cellular physiology, at the origin of AF.As a result of these irregular discharges, the “electrical” atrial rate (not the contraction rate) isbetween 300 and 600 times per minute. Thisresult in improper filling and ejection of blood, as well asa decreased efficiency of the heart’s pumping process. Since all electrical activity from the atria can typically only get to the ventricle via the AV node, the AV node is able to filter many of the irregular electrical discharges associated with AF, preventing the rapid rate of the atrial beat from being
  • 12. conducted into the ventricles. However, not all of the signals are blocked and AF is often accompanied by irregular ventricular beating, at 50 to 200 per minute. […] On the electrocardiogram, AF is described by the absence of consistent P waves; instead there are rapid oscillations or fibrillatory waves that vary in size, shape and timing and are generally associated with an irregular ventricular response when atrioventricular (AV) conduction is intact. The patient may experience AF as palpitations, chest pain, and dizziness. In many cases, however, it may occur asymptomatically. Causes and Associated Conditions AF is often an electrical manifestation of underlying cardiac disease. Nonetheless, approximately 30% to 45% of cases of paroxysmal AF and 20% to 25% of cases of persistent AF occur in younger patients with “lone AF”, defined as AF without overt structural heart disease. AF can present as an isolated or familial arrhythmia, although a responsible underlying disease may appear over time. Although AF may occur without underlying heart disease in the elderly, the changes in cardiac structure and function that accompany aging, such as an increase in myocardial stiffness, may be associated with AF, just as heart disease in older patients may be coincidental and unrelated to AF. Concomitant medical conditions have an additive effect on the perpetuation of AF by promoting a substrate that maintains AF. Conditions associated with AF are also markers for global cardiovascular risk and/or cardiac damage rather than simply
  • 13. causative factors. · 10 · Ageing · Hypertension · Symptomatic heart failure · Tachycardiomyopathy · Valvular heart diseases · Cardiomyopathies · Atrial septal defect · Other congenital heart defects · Coronary artery disease · Overt thyroid dysfunction · Obesity · Diabetes mellitus · Sleep apnea · Chronic renal disease Many dietary and lifestyle factors have also been associated with AF. These include excessive alcohol or caffeine consumption and emotional or physical stress. Disease progression& Classification The clinical course of AF is frequently progressive, often beginning with increased ectopy (premature atrial contractions), progressing to brief runs of AF that are typically transientand self-terminating. Over a period of time ranging from months to years,episodes of AF tend to increase in duration, sometimes becoming persistent. Clinically, it is reasonable to distinguish five types of AF based on the presentation and duration of the arrhythmia: first diagnosed, paroxysmal, persistent, long-standing persistent and permanent AF.
  • 14. Terminology Clinical features Pattern First-diagnosed Symptomatic Asymptomatic (first detected) Onset unknown (first detected) May or may not reoccur Paroxysmal Spontaneous termination <7 days and most often <48h Recurrent Persistent Not self-terminating Lasting >7 days or prior cardioversion Recurrent Long-standing persistent Not self-terminating Lasting >1 year when it is decided to adopt a rhythm control strategy. Recurrent Permanent Not terminated Terminated but relapsed No cardioversion attempt Established This classification is useful for clinical management of AF patients, especially when AF-related symptoms are also considered. Many therapeutic decisions require careful consideration of additional individual factors and co- morbidities. The “natural time course” of atrial fibrillation, a flowchart that I created to describe the clinical progression of the disease and
  • 15. the associated therapies. Clinical Presentation & Outcomes While researching clinical presentation I focused on the impact of the disease on the patient. I emphasized the symptoms (what the patient says s/he experiences) and the signs (what the astute healthcare provider identifies or observes during the patient examination) of the disease. Gaining an understanding of clinical presentation was important because it is often the target for improved care and the development of new therapies that address identified needs. When evaluating clinical presentation, it seemed important to describe what patients complain about when they see a clinician and how they feel. Patients with the same disease may present differently based on a number of factors, such as age, gender, ethnicity, and coexisting conditions. Since every individual is different, each is likely to experience symptoms slightly differently. Ultimately, clinical presentation manifested itself in the signs/symptoms that result from the primary effect of the disease or from the long-term consequences of having and managing the disease over time. In the case of AF, I sought to understand the most common symptoms for patients with the disease, how they feel with AF, and the signs most commonly observed by physicians in patients with the disease. I also considered whether all AF patients are affected by the same symptoms and what factors have the greatest impact on symptoms presented (e.g., age, coexisting conditions). For example, young patients are much more likely to report symptoms of palpitations with AF than older ones. This may directly impact the goal of therapy for different age groups. Importantly, clinical outcomes are different from symptoms. Outcomes generally refer to hard data points associated with a disease that can be measured. The two most important types of clinical outcomes to consider are morbidity and mortality. Morbidity refers to the severity of the disease and its associated complications. Measures of morbidity may be evaluated using quality of life questionnaires, or they can be assessed by more
  • 16. specific endpoints such as distance walked in six minutes, hospital admissions, or a clinical event that does not cause immediate death (e.g., stroke, heart attack). Mortality refers to the death rate associated with a disease. Clinical outcomes are particularly important as they often serve as endpoints for clinical trials since they can be assessed more easily and objectively than symptoms and have a direct impact on cost. In the AF case, key clinical outcomes to address were the morbidities associated with AF, their likelihood of occurrence, and what factors have the greatest impact on morbidities (e.g., age). AF has a heterogeneous clinical presentation, occurring in the presence or absence of detectable heart disease. An episode of AF may be self-limited or require medical intervention for termination. The adverse effects of AF are the result of haemodynamic changes related to the rapid and/or irregular heart rhythm, and thromboembolic complications related to a prothrombotic state associated with the arrhythmia. Onset of AF can result in a reduction in cardiac output of up to 10–20% regardless of ventricular rate. The presence of fast ventricular rates can push an already compromised ventricle into heart failure. […] While patients can be asymptomatic, many experience a wide variety of symptoms as a consequence of the hemodynamic dysfunction. The lost of the synchronous atrial activity, the irregular ventricular response, the rapid heart rate, and the impaired coronary blood flow all contribute to the mechanism. Palpitations, fatigue, and dizziness can be quiet common, while symptoms related to congestive heart failure including dyspnea and angina can develop in more severe cases. […] AF is associated with increased rates of death, stroke and otherthrombo-embolic events, heart failure and
  • 17. hospitalizations,degraded quality of life, reduced exercise capacity, and left ventricular(LV) dysfunction Treatments of Atrial fibrillation The goal of any treatment is to improve outcomes in those patients with a disease or disorder. Treatment analysis involved detailed research to understand what established and emerging therapies exist, how and when they are used, how and why they work, their effectiveness, and their economics. This analysis also provided me with an understanding of the clinical and patient-related requirements that any new treatment must meet to be equivalent or superior to existing alternatives. It further establishes a baseline of knowledge against which the uniqueness and other merits of ECVUE can be evaluated. There are two ways to approach the treatment of AF using drugs: rate control and rhythm control, which are often associated given the similarity of the medication used in both strategies. Rate control Rate control lowers the heart rate closer to normal, usually 60 to 100 bpm, without trying to convert to a regular rhythm. It is about minimizing the effect of AF on the ventricular rate by the prescription of medication increasing the degree of block at the level of the AV and decreasing the number of impulses that conduct into the ventricles. Catheter ablation of the AV junction (AV node/Bundle of His) combined with pacemaker implantation can be carried out if the ventricular rate cannot be managed by medication, but the introduction of a foreign body may have its own complications. Rhythm control In the case of rhythm control, it is about terminating AF and maintaining SR in a process called cardioversion. This approach is most important in the acute setting of AF, notably when first-
  • 18. diagnosed, using medication. In case of persistent or long- standing AF, cardioversion is often electrical, and involves the restoration of normal heart rhythm through the application of a DC electrical shock. In those cases, the treatments are only palliatives, in the sense that the objective is to terminate the fibrillation and restore SR without fundamentally modifying the substrate. On the other hand, catheter ablation or the Maze procedure, carried out most often on the LA, is meant to modify the substrate of AF, by removing the trigger zones (such as PVs) or the abnormal conduction channels (fibrotic tissue) generated by the arrhythmia over time. […] As far as mortality is concerned, the AFFIRM trial showed that there is lower mortality using rate control with anticoagulation treatment versus rhythm control treatment and the difference increases up to 5 years (end of study). Anticoagulation In every case, the prevention of complications is imperative and dictates the therapeutic techniques that will be performed. Anticoagulation is designed to prevent the thrombo-embolic risk associated with AF. Beyond anticoagulants, alternatives are proposed, such as the Left Atrial Appendage (LAA) Closure, to prevent blood clot formation in patients with AF, given that 90% of them form in the LAA. Ablation Catheter ablation techniques are constantly evolving. Initial catheter ablations attempted to recreate the lesion set used in the open-chest Cox maze procedure by creating linear ablation lines that interrupted the AF wavelets. However, doctors had difficulty duplicating the Cox maze lesion set during a closed-
  • 19. chest catheter ablation. The procedure had high complication rates and required long fluoroscopy times. […] Research in Bordeaux, France, by Michel Haïssaguerre, MD, and colleagues, suggested that electrophysiologists didn't need to duplicate the Cox maze lesion set. Dr. Haïssaguerre's group found that over 90% of AF is triggered in or near the pulmonary veins. As a result of these findings, a new type of catheter ablation technique, called Segmental Pulmonary Vein Isolation or Ostial Pulmonary Vein Isolation, was created. Dr. Haïssaguerre and his colleagues used radiofrequency energy to ablate the pulmonary vein ostium, the opening to the pulmonary veins. When "isolated", pulmonary veins can no longer be a trigger point for atrial fibrillation. Dr.Haïssaguerre and his colleagues were able to terminate atrial fibrillation in, and stop prescribing antiarrhythmic drugs for, 62% (28) of patients in the study. Electrical Cardioversion Electrical cardioversion is a process by which the heart is shocked to convert it from an irregular rhythm back into a normal sinus rhythm. For patients in persistent AF, electrical cardioversion may be done early in the process to stop the AF and put the heart back into normal sinus rhythm. For other AF patients, electrical cardioversion may not be tried until later, when medication has stopped working. Epidemiology While conducting research on epidemiology, I included data for the disease as a whole, as well as the most relevant patient subsegments. I tried to find information about disease dynamics, such as growth rate, to illustrate how the disease will impact society in the future. Epidemic, a term generally used to describe a rapidly spreading
  • 20. infectious disease within a population, has recently been used to describe the rising prevalence of atrial fibrillation (AF). The prevalence, defined as the proportion of a population affected by the disease at a point in time (and probably the incidence, defined as the rate at which new cases occur in a population during a specified time period) of AF is rising for reasons that are not completely known. The rising incidence of the etiological factors of AF, such as the aging population and a higher prevalence of cardiovascular diseases, only partly explains this phenomenon. Prevalence Estimates of the overall adult prevalence of AF in the United States range from 1 to 6%. Because the prevalence of AF rises sharply with age, these estimates must be interpreted in the context of the age distribution in the samples studied. Most studies indicate that the overall prevalence of AF exceeds 5% in individuals aged 70 and above. […] The medical community has been helped by the foresight of investigators who designed and executed several longterm population-based studies, that have provided valuable information about the epidemiology of AF. Even with significant differences in the methodology and populations studied, the remarkably similar results point to the rather homogeneous prevalence of AF in the Western world.
  • 21. Trends in Prevalence & Implications Several studies indicate that the prevalence of AF has been increasing in the past several decades. Estimates from the National Ambulatory Medical Care Survey indicate that office visits for AF increased from 1.3 to 3.1 million between 1980 and 1992. Hospital discharges for AF in individuals over age 65 increased from 30.6 to 59.5 per 10,000 between 1982 and 1993. The increasing prevalence has been confirmed by more recent data published in the National Heart, Lung, and Blood Institute’s Chartbook. Between 1980 and 1999, AF hospitalizations increased 80%for patients aged 45 to 65 and doubled for patients 65 years of age and older. The aging of the population alone is expected to raise the number of individuals with AF from just over 2 million in 1995 to more than 3 million by 2020 and 5.6 million by 2050. However, increases in the prevalence of AF may also be driven by factors other than aging. However, population studies may underestimate the prevalence of AF for two reasons: AF may not be present at the follow-up time, and a significant population may have asymptomatic episodes. According to the U.S. Census Bureau Population Projections Program, the number of Americans aged 65 years or older will increase substantially to more than 20% of the population (82 million) by the year 2050. This aging of the population is projected to result in a 2.5-fold rise in AF prevalence.
  • 22. The economic consequences of this arrhythmia are highlighted by the fact that AF is the most common arrhythmia among patients hospitalized in the United States with a primary diagnosis of an arrhythmia. With the expected rise in the elderly population and the prevalence of AF, preventive measures to reduce its incidence will have profound societal benefits. Although proven preventive measures are lacking, control of risk factors such as hypertension and MI appear prudent. Economic Burden The focus of economic research was to understand the distribution of costs. I looked at the aggregate, system-level cost of AF on an annual basis, the annual condition costs of AF, the evaluation and treatment-related annual cost, the annual cost of hospitalization, and the annual cost of lost productivity from absenteeism due to AF.Economic Considerations Given its large and growing prevalence, AF has substantial economic impact. Proper economic analysis of AF requires explicit definitions of perspective, costs, and outcomes.
  • 23. Perspective is the vantage point from which costs and outcomes are assessed. For example, costs can be quantified from the perspective of the patient. In this case, potential costs include AF symptoms, discomfort from therapy, and time lost from work. In contrast, potential costs from the perspective of a payor, such as a health insurance company, include covered services for hospitalization or other treatments and administrative costs in processing claims. Ultimately, a societal perspective, in which all costs and outcomes are assessed regardless of who pays the costs or experiences the outcomes, provides the most complete insight into the economic impact of AF. In cost accounting, costs should be clearly distinguished from the charges assessed by physicians, hospitals, and other health care providers and should reflect the actual financial resources required to provide care. Costs can be divided into direct and indirect costs. Direct costs are those incurred directly from medical care and include inpatient costs (hospital fees, physician fees, procedure and therapy costs) and follow-up costs (physician visits, outpatient testing, medications, home health care providers, long-term care, and future hospitalizations). Indirect costs quantify the remaining nonmedical impact of AF, such as missed days of work and lost productivity. If possible, costs are usually presented in terms of dollar (or other currency) expenditure. When assessment of monetary costs is difficult, such as for mortality or decreased quality of life, proxy values such as lost years of work or lost productivity are used.Atrial Fibrillation Condition Costs Atrial fibrillation increases the risk of a variety of adverse outcomes, most notably stroke. It also has an impact on mortality, impairs quality of life, decreases productivity, and increases hospitalization rates. All of these adverse outcomes have substantial costs.`
  • 24. Stroke Stroke is the most debilitating complication of AF. With its associated hypercoagulable state, structural abnormalities in the fibrillating atria, and relative blood stasis, AF fulfills Virchow’s triad for the development of thrombi and their subsequent embolization to the cerebral vasculature. As a result, stroke is five times more likely to occur in AF patients than in age-matched controls. Indirect care costs (time and opportunity costs of nonpaid caregivers for cerebrovascular accident [CVA] patients) exceeded £1.7 billion ($3.12 billion). For an individual patient, the mean estimated lifetime cost of a stroke, including inpatient care, rehabilitation, and follow-up care for lasting deficits, is $140,000. […] Acute care costs, such as hospitalization, diagnostic testing, initial therapy, and rehabilitation, are substantial. The average estimated cost for the first 30 days of stroke care is $13,000/patient for mild strokes and $20,000/patient for severe strokes. In addition, inpatient costs can account for 70% of the overall cost of the first year after stroke. Wolf and colleagues illustrated costs of acute care in the first year after stroke using 1991 Medicare data. Among men aged 65 to 74, Medicare spent $21,231 per patient, 95% of which was spent on acute care needs. Mortality Multiple national and international cohorts describe an independent association between AF and mortality. The mechanism by which AF confers this independent mortality risk is poorly understood. Nonetheless, the Framingham Heart Study illustrated an age-adjusted 1.5 to 1.9 hazard ratio for mortality among patients with AF compared with those without AF. It showed an increased likelihood of mortality or major cardiovascular events (congestive heart failure, MI, resuscitated
  • 25. cardiac arrest, or stroke) among those patients who developed AF compared to those who did not. Mortality costs are difficult to compute and are generally unavailable. Regardless, the burden of AF, its associated mortality, and its effect on lost earnings and productivity imply substantial societal costs. Quality of Life Atrial fibrillation adversely affects patients’ quality of life. Patients with AF and poor rate control have palpitations, fatigue, shortness of breath, or lightheadedness, especially if they have underlying cardiac or pulmonary disease. However, even asymptomatic AF patients experience lower perceived health and life satisfaction compared to patients without AF, possibly because of the burden of the diagnosis and its attendant needs for medical care and therapies. This reduction in quality of life has a direct impact on costs. Although quantification of quality of life in monetary terms is difficult, symptoms and poor functional status can lead to lost productivity, both professionally and personally. Productivity Atrial fibrillation results in significant indirect nonmedical costs, such as lost work and productivity. For example, a French survey of AF patients found that costs caused by missed work accounted for 6% of total AF costs. In addition to the workers affected by this condition, employers face increased costs, not only from decreased productivity, but also from increased insurance premiums to cover affected employees. A U.S. study of 16 employers, conducted from 1999 to 2002, found large cost differences between employees with AF and those without. Annually, excess direct medical costs for AF patients were $12,349 per patient, and excess indirect medical costs were $2,524 per patient, as compared to patients without AF. Although they account for a relatively small portion of overall AF costs, these indirect medical costs play a meaningful role in
  • 26. the overall economic impact of the condition.Evaluation and Treatment Costs Acute Management Patients with new-onset AF, or an exacerbation of previously diagnosed AF, often require extensive evaluation and treatment. Management approaches for AF vary dependent on patients’ hemodynamic stability, symptoms and comorbidities, and the duration of the AF episode. A new diagnosis of AF, either in isolation or in association with another medical condition such as congestive heart failure, initiates an investigation into its cause. These investigations, which can include laboratory testing, monitoring, cardiac imaging, and hospitalization, play a significant role in the economic impact of AF. One study analyzed costs between AF patients who were hospitalized and those discharged from an emergency department. Admitted patients incurred mean costs of $2,012 in their care compared to $1,878 among discharged patients. A French survey of AF patients found that consultations and investigations for AF patients drove 9% and 8%, respectively, of their overall costs of AF care. Chronic Management After the initial evaluation and treatment of an acute AF episode, focus turns to arrhythmia control and anticoagulation. Arrhythmia control involves antiarrhythmic or atrioventricular (AV) nodal blocking medications. Rhythm control of AF with antiarrhythmic medications can reduce symptoms, improve functional capacity, and lower both stroke and mortality risk. These benefits must be weighed against the potentially dangerous side effects associated with antiarrhythmic medications. An alternative method of AF management is rate control strategies with AV nodal blocking agents. […] Two studies demonstrated cost savings in the rate control arm,
  • 27. even after sensitivity analyses. In the 2000 RACE study, mean costs of rate control were 7,386 ($7,017), while mean costs of rhythm control were 8,284 ($7,870).In the AFFIRM trial, the incremental cost of rhythm control over rate control was nearly $1,500 per patient per year. Several interventional procedures are an alternative to medication-based antiarrhythmic strategies for AF management. Catheter-based AV node modification or ablation can be used to treat highly symptomatic patients or patients who cannot tolerate rate-controlling agents. The procedure can improve symptoms, functional capacity, and LV function. In a 1997 report, costs of AV node modification were $19,389, and costs of the AV node ablation were $28,485. Over time, with technical advances, these costs will likely decline, as evidenced by 2003 costs of $17,173 for AV nodal ablation. Future Directions Although the current burden of AF, both in the United States and abroad, is already large, forecasts predict major increases over the coming decades. As the population ages and survival from other cardiac conditions that predispose to AF increases, the prevalence of AF will likely rise. Projections for the number of adults in the United States with AF in 2050 range between 5.6 and 15.9 million, as compared to 2.2 million in 2006. Approximately 50% of this projected population will be over the age of 85 years. As the numbers of AF patients increase, AF care costs will also increase. In the 2004 U.K. survey of AF patients, costs rose from 0.62% (£244 million, or $418 million) of the National Health Service (NHS) budget in 1995 to 0.97% (£459 million, or $788 million) of the 2000 NHS budget. […] Future developments in AF care, such as new anticoagulants and procedures, could have a significant impact on costs. For example, direct antithrombin agents or new antiplatelet combinations may show efficacy in AF-related stroke prevention. Since these new therapies do not require the intensive monitoring required by warfarin, substantial cost
  • 28. savings could be realized. Similarly, innovations or improvements in interventional procedures such as ECVUE, both in efficacy and safety, could also affect costs. Atrial fibrillation presents significant challenges to both individual practitioners and policymakers. With its substantial costs in diagnosis, treatment, and outcomes, it will become increasingly important to determine the best strategies in caring for these patients. Discussion When I was first proposed the project, I just could not turn it down. I immediately saw the revolutionary aspect of ECVUE and was thrilled to work on it at such early stages. I must say that I got quite a good grasp of what a biomedical start-up can be, how it performs and what challenges it must overcome on a daily basis. At first, the amount of information was quite overwhelming, given that I had no background in the field, and the fact that most of the information I needed was to be extracted from studies in English written by physicians, for physicians. But after a while I became familiar with the vocabulary and concepts, and could focus on delivering a high-quality report.The theoretical knowledge in Marketing and Business Planning that I gathered during two years has proved to be very useful, mostly regarding methodology of research.
  • 29. As mentioned previously, my mission was supposed to be based for one half in Bordeaux, in order for me to work with the CHU in the first place, and the other half in the head office in Cleveland to finalize the project. Unfortunately, my supervisor took last minute vacation for 2 weeks in August. This resulted in an internship almost completely from home, by correspondence. While it enabled me to learn how to work independently, using only technology to communicate with the firm, I missed the relational side of the experience. Besides, the procedures I was given the opportunity to attend were fascinating. I have always been interested by technology and innovations, especially in the medical field, and I realize that seeing this kind of operations was a unique chance. Overall, this internship at CardioInsight this year has been very rewarding on many levels, and I am pleased to say that my contract was extended for at least another month, outside the internship framework. The Unauthorized Autobiography of Me By Sherman Alexie Late summer night on the Spokane Indian Reservation. Ten Indians are playing basketball on a court barely illuminated by the streetlight above them. They will play until the brown, leather ball is invisible in the dark. They will play until an errant pass jams a finger, knocks a pair of glasses off the face, smashes a nose and draws blood. They will play until the ball bounces off the court and disappears into the shadows. This may be all you need to know about Native American literature. * * * Thesis: I have never met a Native American. Thesis repeated: I
  • 30. have met thousands of Indians. * * * November 1994, Manhattan: PEN American panel on Indian Literature. N. Scott Momaday, James Welch, Gloria Miguel, Joy Harjo, me. Two or three hundred people in the audience. Mostly non-Indians, an Indian or three. Questions and answers. "Why do you insist on calling yourselves Indian?" asks a white woman in a nice hat. "It's so demeaning." "Listen," I say. "The word belongs to us now. We are Indians. That has nothing to do with Indians from India. We are not American Indians. We are Indians, pronounced In-din. It belongs to us. We own it and we're not going to give it back." So much has been taken from us that we hold onto the smallest things left with all the strength we have. * * * 1976: Winter on the Spokane Indian Reservation. My two cousins, S and G, have enough money for gloves. They buy them at Irene's Grocery Store. Irene is a white woman who has lived on our reservation since the beginning of time. I have no money for gloves. My hands are bare. We build snow fortresses on the football field. Since we are Indian boys playing, there must be a war. We stockpile snowballs. S and G build their fortress on the fifty-yard line. I build mine on the thirty-yard line. We begin our little war. My cousins are good warriors. They throw snowballs with precision. I am bombarded, under siege, defeated quickly. My cousins bury me in the snow. My grave is shallow. If my
  • 31. cousins knew how to dance, they might have danced on my grave. But they know how to laugh, so they laugh. They are my cousins, meaning we are related in the Indian way. My father drank beers with their father for most of two decades, and that is enough to make us relatives. Indians gather relatives like firewood, protection against the cold. I am buried in the snow, cold, without protection. My hands are bare. After a short celebration, my cousins exhume me. I am too cold to fight. Shivering, I walk home, anxious for warmth. I know my mother is home. She is probably sewing a quilt. She is always sewing quilts. If she sells a quilt, we have dinner. If she fails to sell a quilt, we go hungry. My mother has never failed to sell a quilt. But the threat of hunger is always there. When I step into the house, my mother is sewing yet another quilt. She is singing a song under her breath. You might assume she is singing a highly traditional Spokane Indian song. In fact, she is singing Donna Fargo's "The Happiest Girl in the Whole USA." Improbably, this is a highly traditional Spokane Indian song. The living room is dark in the late afternoon. The house is cold. My mother is wearing her coat and shoes. "Why don't you turn up the heat?" I ask my mother. "No electricity," she says. "Power went out?" I ask. "Didn't pay the bill," she says. I am colder. I inhale, exhale, my breath visible inside the house. I can hear a car sliding on the icy road outside. My mother is making a quilt. This quilt will pay for the electricity. Her fingers are stiff and painful from the cold. She is sewing as fast as she can.
  • 32. * * * On the jukebox in the bar: Hank Williams, Patsy Cline, Johnny Cash, Charlie Rich, Freddy Fender, Donna Fargo. On the radio in the car: Creedence Clearwater Revival, Three Dog Night, Blood Sweat & Tears, Janis Joplin, early Stones, earlier Beatles. On the stereo in the house: Glen Campbell, Roy Orbison, Johnny Horton, Loretta Lynn, "The Ballad of the Green Beret." * * * 1975: Mr. Manley, the fourth grade music teacher, sets a row of musical instruments in front of us. From left to right, a flute, clarinet, French horn, trombone, trumpet, tuba, drum. We're getting our first chance to play this kind of music. "Now," he explains, "I want all of you to line up behind the instrument you'd like to learn how to play." Dawn, Loretta, and Karen line up behind the flute. Melissa and Michelle behind the clarinet. Lori and Willette, the French horn. All ten Indian boys line up behind the drum. * * * 1970: My sister Mary is beautiful. She is fourteen years older than me. She wears short skirts and nylons because she is supposed to wear short skirts and nylons. It is expected. Her black hair is combed long, straight. Often, she sits in her favorite chair, the fake leather lounger we rescued from the dump. Holding a hand mirror, she combs her hair, applies her make-up. Much lipstick and eye shadow, no foundation. She is
  • 33. always leaving the house. I do not know where she goes. I do remember sitting at her feet, rubbing my cheek against her nyloned calf, while she waited for her ride. In Montana in 1981, she died in an early morning fire. At the time, I was sleeping at a friend's house in Washington state. I was not dreaming of my sister. * * * "Sherman," says the critic, "How does the oral tradition apply to your work?" "Well," I say, as I hold my latest book close to me, "It doesn't apply at all because I typed this. And when I'm typing, I'm really, really quiet." * * * 1977: Summer. Steve and I want to attend the KISS concert in Spokane. KISS is very popular on my reservation. Gene Simmons, the bass player. Paul Stanley, lead singer and rhythm guitarist. Ace Frehley, lead guitar. Peter Criss, drums. All four hide their faces behind elaborate make-up. Simmons the devil, Stanley the lover, Frehley the space man, Criss the cat. The songs: "Do You Love Me," "Calling Dr. Love," "Love Gun," "Makin' Love," "C'mon and Love Me." Steve and I are too young to go on our own. His uncle and aunt, born-again Christians, decide to chaperon us. Inside the Spokane Coliseum, the four of us find seats far from the stage and the enormous speakers. Uncle and Aunt wanted to avoid the bulk of the crowd, but have landed us in the unofficial pot- smoking section. We are overwhelmed by the sweet smoke. Steve and I cover our mouths and noses with Styrofoam cups
  • 34. and try to breathe normally. KISS opens their show with staged explosions, flashing red lights, a prolonged guitar solo by Frehley. Simmons spits fire. The crowd rushes the stage. All the pot smokers in our section hold lighters, tiny flames flickering, high above their heads. The songs are so familiar we know all the words. The audience sings along. The songs: "Let Me Go, Rock `n' Roll," "Detroit Rock City," "Rock and Roll All Nite." The decibel level is tremendous. Steve and I can feel the sound waves crashing against the Styrofoam cups we hold over our faces. Aunt and Uncle are panicked, finally convinced that the devil plays a mean guitar. This is too much for them. It is also too much for Steve and me, but we pretend to be disappointed when Aunt and Uncle drag us out of the Coliseum. During the drive home, Aunt and Uncle play Christian music on the radio. Loudly and badly, they sing along. Steve and I are in the back of the Pacer, looking up through the strangely curved rear window. There is a meteor shower, the largest in a decade. Steve and I smell like pot smoke. We smile at this. Our ears ring. We make wishes on the shooting stars, though both of us know that a shooting star is not a star. It's just a sliver of stone. * * * I made a very conscious decision to marry an Indian woman, who made a very conscious decision to marry me. Our hope: to give birth to and raise Indian children who love themselves. That is the most revolutionary act. * * *
  • 35. 1982: I am the only Indian student at Reardan High, an all- white school in a small farm town just outside my reservation. I am in the pizza parlor, sharing a deluxe with my white friends. We are talking and laughing. A drunk Indian walks in. He staggers to the counter and orders a beer. The waiter ignores him. We are all silent. At our table, S is shaking her head. She leans toward us as if to share a secret. "Man," she says, "I hate Indians." * * * I am curious about the writers who identify themselves as mixed-blood Indians. Is it difficult for them to decide which container they should put their nouns and verbs into? Invisibility, after all, can be useful, as a blonde, Aryan-featured Jew in Germany might have found during World War II. Then again, I think of the horror stories that such a pale undetected Jew could tell about life during the Holocaust. * * * An Incomplete List of People I Wish Were Indian Kareem Abdul-Jabbar Adam Muhammad Ali Susan B. Anthony Jimmy Carter Patsy Cline D.B. Cooper Robert DeNiro Emily Dickinson Isadora Duncan Amelia Earhart Eve Diane Fossey Jesus Christ Robert Johnson Helen Keller Billie Jean King Martin Luther King, Jr. John Lennon Mary Magdalene Pablo Neruda Flannery O'Connor Rosa Parks Wilma Rudolph Sappho William Shakespeare Bruce Springsteen Meryl Streep John Steinbeck Superman Harriet Tubman Voltaire Walt Whitman * * *
  • 36. 1995: Summer. Seattle, Washington. I am idling at a red light when a car filled with white boys pulls up beside me. The white boy in the front passenger seat leans out his window. "I hate you Indian motherfuckers," he screams. I quietly wait for the green light. 1978: David, Randy, Steve, and I decide to form a reservation doowop group, like the Platters. During recess, we practice behind the old tribal school. Steve, a falsetto, is the best singer. I am the worst singer, but have the deepest voice, and am therefore an asset. "What songs do you want to sing?" asks David. "Tracks of My Tears," says Steve, who always decides these kind of things. We sing, desperately trying to remember the lyrics to that song. We try to remember other songs. We remember the chorus to most, the first verse of a few, and only one in its entirety. For some reason, we all know the lyrics of "Monster Mash." However, I'm the only one who can manage to sing with the pseudo-Transylvanian accent that the song requires. This dubious skill makes me the lead singer, despite Steve's protests. "We need a name for our group," says Randy. "How about The Warriors?" I ask. Everybody agrees. We've watched a lot of Westerns. We sing "Monster Mash" over and over. We want to be famous. We want all the little Indian girls to shout our names. Finally,
  • 37. after days of practice, we are ready for our debut. Walking in line like soldiers, the four of us parade around the playground. We sing "Monster Mash." I am in front, followed by Steve, David, then Randy, who is the shortest, but the toughest fighter our reservation has ever known. We sing. We are The Warriors. All the other Indian boys and girls line up behind us as we march. We are heroes. We are loved. I sing with everything I have inside of me: pain, happiness, anger, depression, heart, soul, small intestine. I sing and am rewarded with people who listen. That is why I am a poet. * * * I remember watching Richard Nixon, during the Watergate affair, as he held a press conference and told the entire world that he was not a crook. For the first time, I understood that storytellers could be bad people. * * * Poetry = Anger x Imagination * * * Every time I venture into the bookstore, I find another book about Indians. There are hundreds of books about Indians published every year, yet so few are written by Indians. I gather all the books written about Indians. I discover: A book written by a person who identifies as mixed-blood will sell more copies than a book written by a person who identifies as strictly Indian.
  • 38. A book written by a non-Indian will sell more copies than a book written by either a mixed-blood or an Indian writer. Reservation Indian writers are rarely published in any form. A book about Indian life in the past, whether written by a non- Indian, mixed-blood, or Indian, will sell more copies than a book about Indian life in the twentieth century. If you are a non-Indian writing about Indians, it is almost guaranteed that something positive will be written about you by Tony Hillerman. Indian writers who are women will be compared with Louise Erdrich. Indian writers who are men will be compared with Michael Dorris. A very small percentage of the readers of Indian literature have heard of Simon J. Ortiz. This is a crime. Books about the Sioux sell more copies than all of the books written about other tribes combined. Mixed-blood writers often write about any tribe which interests them, whether or not they are related to that tribe. Writers who use obvious Indian names, such as Eagle Woman and Pretty Shield, are usually non-Indian. Non-Indian writers usually say "Great Spirit," "Mother Earth," "Two-Legged, Four-Legged, and Winged." Mixed-blood writers usually say "Creator, "Mother Earth," "Two-Legged, Four- Legged, and Winged." Indian writers usually say "God," "Mother Earth," "Human Being, Dog, and Bird."
  • 39. If a book about Indians contains no dogs, then it was written by a non-Indian or mixed-blood writer. If on the cover of a book there are winged animals who aren't supposed to have wings, then it was written by a non-Indian. Successful non-Indian writers are viewed as well-informed about Indian life. Successful mixed-blood writers are viewed as wonderful translators of Indian life. Successful Indian writers are viewed as traditional storytellers of Indian life. Very few Indian and mixed-blood writers speak their tribal languages. Even fewer non-Indian writers speak their tribal languages. Indians often write exclusively about reservation life, even if they never lived on a reservation. Mixed-bloods often write exclusively about Indians, even if they grew up in non-Indian communities. Non-Indian writers always write about reservation life. Nobody has written the great urban Indian novel yet. Most non-Indians who write about Indians are fiction writers. Fiction about Indians sells. * * * Have you stood in a crowded room where nobody looks like you? If you are white, have you stood in a room full of black people? Are you an Irish man who has strolled through the streets of Compton? If you are black, have you stood in a room full of white people? Are you an African-American man who has played the back nine at the local country club? If you are a
  • 40. woman, have you stood in a room full of men? Are you Sandra Day O'Connor or Ruth Ginsberg? Since I left the reservation, almost every room I enter is filled with people who do not look like me. There are only two million Indians in this country. We could all fit into one medium-sized city. Someone should look into it. Often, I am most alone in bookstores where I am reading from my work. I look up from the page at white faces. This is frightening. * * * There is an apple tree outside my grandmother's house on the reservation. The apples are green; my grandmother's house is green. This is the game: My siblings and I try to sneak apples from the tree. Sometimes, our friends will join our raiding expeditions. My grandmother believes green apples are poison and is simply trying to protect us from sickness. There is nothing biblical about this story. The game has rules. We always have to raid the tree during daylight. My grandmother has bad eyes and it would be unfair to challenge her in the dark. We all have to approach the tree at the same time. Arnold, my older brother. Kim and Arlene, my younger twin sisters. We have to climb the tree to steal apples, ignoring the fruit which hangs low to the ground. Arnold is the best apple thief on the reservation. He is chubby, but quick. He is fearless in the tree, climbing to the top for the plumpest apples. He hangs from a branch with one arm, reaches for apples with the other, and fills his pockets with his booty. I love him like crazy. My sisters are more conservative. Often they grab one apple and eat it quickly, sitting on a sturdy branch. I always like the green apples with a hint of red. While
  • 41. we are busy raiding the tree, we also keep an eye on our grandmother's house. She is a big woman, nearly six feet tall. At the age of seventy, she can still outrun any ten-year-old. Arnold, of course, is always the first kid out of the tree. He hangs from a branch, drops to the ground, and screams loudly, announcing our presence to our grandmother. He runs away, leaving my sisters and me stuck in the tree. We scramble to the ground and try to escape. "Junior," she shouts and I freeze. That's the rule. Sometimes a dozen Indian kids have been in that tree, scattering in random directions when our grandmother bursts out of the house. If she remembers your name, you are a prisoner of war. And, believe me, no matter how many kids are running away, my grandmother always remembers my name. My grandmother died when I was fourteen years old. I miss her. I miss everybody. "Junior," she shouts and I close my eyes in disgust. Captured again! I wait as she walks up to me. She holds out her hand and I give her the stolen apples. Then she smacks me gently on the top of my head. I am free to run then, pretending she never caught me in the first place. I try to catch up with the others. Running through the trees surrounding my grandmother's house, I shout out their names. * * * So many people claim to be Indian, speaking of an Indian grandmother, a warrior grandfather. Suppose the United States government announced that all Indians had to return to their reservation. How many of these people would not shove that Indian ancestor back into the closet?
  • 42. * * * My mother still makes quilts. My wife and I sleep beneath one. My brother works for our tribal casino. One sister works for our bingo hall, while the other works in the tribal finance department. Our adopted little brother, James, who is actually our second cousin, is a freshman at Reardan High School. He can run the mile in five minutes. My father is an alcoholic. He used to leave us for weeks at a time to drink with his friends and cousins. I missed him so much I'd cry myself sick. I could always tell when he was going to leave. He would be tense, quiet, unable to concentrate. He'd flip through magazines and television channels. He'd open the refrigerator door, study its contents, shut the door, and walk away. Five minutes later, he'd be back at the fridge, rearranging items on the shelves. I would follow him from place to place, trying to prevent his escape. Once, he went into the bathroom, which had no windows, while I sat outside the only door and waited for him. I could not hear him inside. I knocked on the thin wood. I was five years old. "Are you there?" I asked. "Are you still there?" Every time he left, I ended up in the emergency room. But I always got well and he always came back. He'd walk in the door without warning. We'd forgive him. Years later, I am giving a reading at a bookstore in Spokane, Washington. There is a large crowd. I read a story about an Indian father who leaves his family for good. He moves to a city a thousand miles away. Then he dies. It is a sad story. When I finish, a woman in the front row breaks into tears.
  • 43. "What's wrong?" I ask her. "I'm so sorry about your father," she says. "Thank you," I say, "But that's my father sitting right next to you." 1 1. Read and understand the case. Show your Analysis and Reasoning and make it clear you understand the material. Be sure to incorporate the concepts of the chapter we are studying to show your reasoning. Dedicate at least one sub-heading to each following outline topic: Facts [Summarize only those facts critical to the outcome of the case] Issue [Note the central question or questions on which the case turns] Explain the applicable law(s). Use the textbook here. The law should come from the same chapter as the case. Be sure to use citations from the textbook including page numbers. Holding [How did the court resolve the issue(s)? Who won?] Reasoning [Explain the logic that supported the court's decision] 2. Wrap up with a Conclusion. This should summarize the key aspects of the decision and also your recommendations on the court's ruling. 3. Include citations and a reference page with your sources. Use APA style citations and references.