DANISH is a major breakthrough trial published in NEJM on 29/09/2016 regarding Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. All content of this slide is Copy right of NEJM.
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SCAD is a rare, sometimes fatal, traumatic condition with approximately eighty percent of cases affecting women. The coronary artery can suddenly develop a tear, causing blood to flow between the layers which forces them apart, potentially causing a blockage of blood flow through the artery and a resulting heart attack. The condition may be related to female hormone levels, as it is often seen in post-partum women, or in women during or very near menstruation, but not always. It is not uncommon for SCAD to occur in people in good physical shape and with no known prior history of heart related illness. It is also not uncommon for SCAD to occur in people in their 20's, 30's, and 40's, as well as older.
Cardiac catheteriztion, Oximetery study in a patient with VSDPRAVEEN GUPTA
In this ppt i am going to discuss how to do cardiac catheterisation study, oximetry study and how to analyse its data in a patient with VSD who came to our hospital
Risk Stratification in Arrhythmic Right
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In this ppt i am going to discuss various spotters, including ECG, X-ray, fluroscopy images and there answers. These spotter now days asked in various DM cardiology exam conducted all over India, so it will help you in your DM Cardiology exam preperationn.
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Roger Pye is a world leading ECMO specialist. This talk on starting ECMO during CPR resuscitation is serious and backed up by some extraordinary cases. Roger presents his experience and the literature on this topic.
The presentation can be heard on wwwintensivecarenetwork.com.
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The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
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In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
1. Presenter Dr Praveen Gupta
Moderator Dr Raja Selvaraj
MD(Ped) DNB(Card) Fellowship in Cardiac EP(Toronto)
Cardiac Electrophysiologist
Associate Professor of Cardiology
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry | India 605006
Date 19/12/2016
1
4. • The trial was supported by unrestricted grants from Medtronic, St. Jude
Medical, TrygFonden, and the Danish Heart Foundation
• Kober disclosed relevant relationships with Sanofi and Novartis.
• McMurray disclosed relevant relationships with Cardiorentis, Amgen,
Novartis, Oxford University/Bayer, GlaxoSmithKline, Theracos, AbbVie,
AstraZeneca, Vifor-Fresnius Pharma, DalCor, Pfizer, Merck, and Bristol-
Myers Squibb.
4
5. Introduction
Background
ICD benefit well documented in ischemic heart diseases
No trial showed a significant effect of ICD with non-ischemic HF
Positive effect of ICD confined to New York Heart Association (NYHA) class II,
and no patients received concomitant CRT
Large proportion of these patients now receive CRT, and the impact of ICD
implantation in this setting is not well known
ICD implantation confers a risk of device-related complications
5
6. Introduction
Objective
DANISH study to investigate the effect of ICD implantation in patients with HF
and reduced ejection fraction not caused by coronary artery disease who receive
contemporary HF therapy including CRT
DANISH study will add insight into the rate of complications in a cohort where a
large proportion of patients will require implantation of multiple leads
6
8. Inclusion criteria
Clinical HF
Non-ischemic etiology
Optimal medical treatment
NYHA functional class II or III (patients in NYHA class IV could be
included if planned for CRT)
LVEF ≤35%
NT-proBNP N200 pg/mL (23.6 pmol/L)
8
9. Exclusion criteria
Dysregulated permanent atrial fibrillation (resting heart rate N100
beats/min)
Uncorrected congenital heart disease or valve obstruction
Obstructive cardiomyopathy, active myocarditis, constrictive pericarditis,
untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, and
active vasculitis due to collagen vascular disease
On the urgent waiting list for a heart transplant (UNOS category 1A or 1B,
or equivalent)
9
10. Exclusion criteria (Contd)
Recipient of
Major organ transplant
Receiving or received cytotoxic or cytostatic chemotherapy and/or
radiation therapy for malignancy within 6 m before randomization or
clinical evidence of current malignancy, with the following exceptions:
basal or squamous cell carcinoma of the skin, cervical intraepithelial
neoplasia, prostate cancer (if stable localized disease, with a life
expectancy of N2.5 y in the opinion of the investigator)
Known to be HIV positive, with an expected survival of b5 y due to HIV
Renal failure treated with dialysis
10
11. Exclusion criteria (Contd)
Recent (within 3 m) history of alcohol or illicit drug abuse disorder, based
on self-report
Any condition (eg, psychiatric illness) or situation that, in the investigator's
opinion, could put the participant at significant risk, confound the study
results, or interfere significantly with the participant's participation in the
study
Lack of informed consent
11
12. Intervention
Randomization performed on web-based system, using permuted-block
Non-ischemic etiology was determined by coronary angiogram, although a
normal computed tomography angiogram or nuclear myocardial perfusion
imaging study was acceptable
Patients could be included despite having 1 or 2 coronary artery stenoses, if
the extent of coronary artery disease did not explain the reduced left
ventricular systolic function
Decision to implant a CRT device made before randomization
Single or dual chamber ICD was implanted
12
13. Methods (Contd.)
Follow-up –
2 months
Every 6 months
Patients who receive ICD undergo regular follow-up by implantation center
13
15. Secondary outcomes
Time to sudden cardiac death
Time to cardiovascular death
Time to resuscitated cardiac arrest or sustained ventricular tachycardia
Change in quality of life from baseline (Quality of life is assessed by the
Minnesota Living with Heart Failure Questionnaire)
15
16. Statistical Analysis
Study designed to have 80% power to detect a 25% difference in total mortality between the
treatment groups.
At least 246 primary outcome events were required for the study to be conclusive, and we planned
to include 1000 patients.
Because the event rate and enrollment rate were lower than expected, the steering committee decided
to prolong enrollment until June 30, 2014, or until 1200 patients were included (whichever came
first) and to follow the last randomly assigned patient for at least 2 years.
Baseline characteristics compared between the groups with the use of chi-square and Wilcoxon tests
Outcomes analyzed with the use of time-to-event methods
Kaplan–Meier plots were calculated for total mortality, and cumulative incidence curves were
calculated for events with competing risk (sudden cardiac death and cardiovascular death)
16
17. Statistical Analysis
The analysis of the primary outcome was performed with a log-rank model
The proportional-hazard assumption was assessed with Schoenfeld residuals
Post hoc annual event rate ratios were derived from a Poisson regression
Prespecified subgroup analyses of the primary outcome were performed for the variables
All analyses were performed in the intention-to-treat population
Two sided P values of 0.05 or less were considered to indicate statistical significance.
Analyses were performed with SAS software, version 9.4 (SAS Institute), and R software, version
3.3.1 (R Project for Statistical Computing)
17
19. Result
From February 7, 2008, to June 30, 2014,
Total of 1116 patients were enrolled at five centers; 556 patients were
randomly assigned to the ICD group, and 560 patients were assigned to the
control group
Follow-up data for all outcomes were available through June 30, 2016
The median follow-up period was 67.6 months (interquartile range, 49 to
85), and no patients were lost to follow-up for the primary outcome
19
22. Result
• Primary outcome, death
from any cause, occurred in
120 patients (21.6%) in the
ICD group (4.4 events per
100 person-years) and in
131 patients (23.4%) in the
control group (5.0 events per
100 person-years)
• The hazard ratio for death
from any cause in the ICD
group, as compared with the
control group, was 0.87
(95% confidence interval
[CI] 0.68 to 1.12; P = 0.28)
22
Time-to-Event Curves for Death from Any Cause
23. Result
• Cardiovascular death
occurred in 77 patients
(13.8%) in the ICD
group and in 95
patients (17.0%) in the
control group (hazard
ratio, 0.77; 95% CI,
0.57 to 1.05; P = 0.10)
23
Time-to-Event Curves for Cardiovascular death
24. Result
Sudden cardiac
death occurred in 24
patients (4.3%) in
the ICD group and
in 46 patients
(8.2%) in the control
(hazard ratio, 0.50;
95% CI, 0.31 to
0.82; P = 0.005)
24
Time-to-Event Curves for Sudden Cardiac Death
25. Result
The clinical outcome of resuscitated
cardiac arrest or sustained ventricular
tachycardia occurred with similar
frequency in the two groups
Device infections in 4.9% in the ICD
and in 3.6% in the control (P = 0.29)
Patients not receiving CRT, the risk of
device infection was higher in the
ICD group than it was in the control
group (5.1% vs 0.8%) ( hazard ratio,
6.35; 95% CI, 1.38 to 58.87; P =
0.006).
Inappropriate shocks in 5.9% in the
ICD group
25
26. Result
With age there was a
significant treatment-by-
subgroup interaction (P =
0.009 )
The rate of death from any
cause was significantly lower
among patients younger than
68 years of age than among
patients 68 years of age or
older (hazard ratio, 0.64; 95%
CI, 0.45 to 0.90; = 0.01).
The effect of ICD implantation
was independent of CRT status
(P = 0.73 for the interaction)
26
28. Discussion
Implantation of an ICD in heart failure not caused by ischemic heart
disease did not provide an overall survival benefit, although the risk of
sudden cardiac death was halved with an ICD
No difference of ICD between patients with CRT and without CRT
Time-to-event curves diverge during initial 5 years and then converge
Rationale for long-term studies
28
29. Discussion
31% of deaths were due to noncardiovascular causes
Important interaction with age
Younger patients have a survival benefit with ICD
This is not surprising in an elderly population, but it highlights the
importance of selecting patients for ICD implantation carefully
Patients at higher risk more likely to benefit from ICD
29
30. Discussion
Lower likelihood of benefit in older patients might be used as an argument
for not implanting ICDs in frail patients
Long-term data from the Multicenter Automatic Defibrillator Implantation
Trial (MADIT) II indicate that clinical risk scores may make it possible to
identify the patients with ischemic heart disease who will benefit most from
ICD implantation
Such a method for identifying patients with nonischemic heart failure who
are at high risk for death from arrhythmia would be very useful
30
31. Discussion
The side effects associated with device implantation in our trial not trivial
Device related infections were not infrequent, but we did have a high
proportion of patients in both groups who were receiving CRT (which
requires implantation of an additional lead in the coronary sinus).
In addition, 10% of our patients already had a pacemaker and were
randomly assigned either to receive or not to receive an ICD upgrade; this
is a patient group that has not been included in most of the previous trials
31
The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. This can only be achieved through complete adherence and transparency by authors.
CONSORT 2010 was developed through collaboration and consensus between clinical trial methodologists, guideline developers, knowledge translation specialists, and journal editors (see CONSORT group ). CONSORT 2010 is the current version of the guideline and supersedes the 2001 and 1996 versions . It contains a 25-item checklist and flow diagram, freely available for viewing and downloading through this website