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A GUIDE TO CAUSES OF
RENA L FA I L U R E A N D S T R O K ES
          C O R O N A RY S U R G E RY
FOLLOWING




                Anapol Schwartz | Attorneys at Law
866-735-2792
WWW.ANAPOLSCHWARTZ.COM

JIM RONCA, ESQ. - JRONCA@ANAPOLSCHWARTZ.COM
SOL WEISS, ESQ. - SWEISS@ANAPOLSCHWARTZ.COM
1710 SPRUCE STREET, PHILADELPHIA, PA 19103


DISCLAIMER: This information is not intended to replace the advice of a doctor. Please use this information to
help in your conversation with you doctor. This is general background information and should not be followed as
medical advice. Please consult your doctor regarding all medical questions and for all medical treatment.
Anapol Schwartz | Attorneys at Law


                                                                                             LINKS TO CONTENTS:
                                                                                             CABG
                                                                                                 What is CABG?
                                                                                                 Who is eligible for CABG?
                                                                                                 What happens during CABG?
                                                                                                 What happens after CABG surgery?
                                                                                                 How long is the recovery from CABG?
                                                                                             Drug Eluting Stents

CABG - CORONARY ARTERY BYPASS                                                                Cardiac Surgery - risks and benefits

GRAFT SURGERY                                                                                    Cardiac surgery - What can go wrong?
                                                                                                 DES - What can go wrong?
WHAT IS CABG? (PRONOUNCED: CABBAGE)                                                              Cardiac surgery drugs
                                                                                                    New England Journal of Medicine
CABG is a surgical procedure used to treat patients with coronary artery block-
ages. During the procedure, a heart surgeon creates an alternate path for                              Renal Failures caused by Trasylol
blood to flow to the heart muscle by going around, or bypassing, a blocked                             (generic - aprotinin), cardiac surgery drug
section of an artery. Hence, the phrase, heart bypass surgery. CABG is                           What to do if you suffered renal failure?
typically recommended for severe blockages that are not treatable by other
                                                                                                    Dialysis
methods.
                                                                                                    Legal options if dialysis caused by
The surgeon typically gains access to the heart by cutting the sternum (breast                      Trasylol (Aprotinin)
bone). Often blood vessels are removed from the patient’s leg or detached                        What to do if you suffer a stroke?
from the chest wall and grafted to the blocked artery. Once the grafts have
been attached, oxygen rich blood will flow through the new bypass vessel,                           Stroke centers
avoiding the blockage completely.                                                                   Legal options if stroke caused by DES
                                                                                             Checklists
CABG is performed by a cardiothoracic surgeon under general anesthesia and
generally takes between two and six hours depending on the number of                         Support Groups
bypasses to be completed. Patients might have more than one blockage, so
                                                                                             Resources on the Web
several bypasses may be needed. After the procedure is completed, most
patients stay in the hospital for several days and face a rehabilitation period of
one to two months.                                                                           DISCLAIMER: This information is not intended to
                                                                                             replace the advice of a doctor. Please use this informa-
The goals of CABG are to relieve symptoms of coronary artery disease includ-                 tion to help in your conversation with you doctor. This
                                                                                             is general background information and should not be
ing angina, enable the patient to resume a normal lifestyle and to lower the risk            followed as medical advice. Please consult your doctor
of a heart attack or other heart related problems. Coronary artery bypass graft              regarding all medical questions and for all medical
surgery is widely performed in the United States. It is estimated that more than             treatment.
800,000 CABG procedures are performed worldwide every year.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                           page 2 of 16
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     WHO IS ELIGIBLE FOR CABG SURGERY?

     Not everyone is a candidate for CABG — the decision to prescribe cardiac bypass
     surgery depends on several factors including the extent of cardiovascular
     disease, the severity of symptoms, your age, and other medical conditions. The
     heart specialist and surgeon will determine the best method of treatment and your
     eligibility.


     WHAT HAPPENS DURING CABG SURGERY?
     The surgery generally lasts from two to six hours, depending on the number of
     arteries being bypassed. After general anesthesia is administered, the surgeon
     removes the veins or prepares the arteries for grafting.




    GRAFT PREPARATION
    There are several types of bypass grafts that can be used. The decision to use which grafts depends on the location of the blockage,
    the amount of the blockage, and the size of the patient’s coronary arteries.

    Internal mammary arteries or internal thoracic arteries are the most common bypass grafts because they show the best long-term
    results. In most cases, these arteries can be kept intact at their origin because they have their own oxygen-rich blood supply, and are then
    sewn to the coronary artery below the site of the blockage. If the surgeon removes the mammary artery from its origin, it is called a free
    mammary artery. Over the last decade, more than 90 percent of all patients received at least one internal artery graft.

    The radial (arm) artery is another common type of arterial graft. There are two arteries in the arm, the ulnar and radial arteries. Most
    people receive blood to their arm from the ulnar artery and will not have any side effects if the radial artery is used. Careful preoperative
    and intra-operative tests determine if the radial artery can be used. If the radial artery is used as the graft, the patient may be required to
    take a calcium channel blocker medication for several months after surgery. This medication helps keep the artery open. Some people
    report numbness in the wrist after surgery. However, long-term sensory loss or numbness is uncommon.

    The gastroepiploic artery to the stomach and the inferior epigastric artery to the abdominal wall are less commonly used for grafting.

    Saphenous (leg) veins can be used as bypass grafts. Minimally invasive saphenous vein removal does not require a long incision. One
    to two incisions are made at the knee and a small incision is made at the groin. This results in less scarring and a faster recovery.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                          page 3 of 16
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Anapol Schwartz | Attorneys at Law


    SURGICAL PROCEDURE
    To bypass the blockage, the surgeon makes a small opening just below the blockage in the
    diseased coronary artery. If a saphenous (leg) or radial (arm) vein is used, one end is connected
    to the coronary artery and the other to the aorta. If a mammary artery is used, one end is
    connected to the coronary artery while the other remains attached to the aorta. The graft is sewn
    into the opening, redirecting the blood flow around this blockage.

    The procedure is repeated until all affected coronary arteries are treated. It is common for three
    or four coronary arteries to be bypassed during surgery.

    HEART-LUNG MACHINE / ON-PUMP SURGERY
    The heart-lung machine maintains life despite the lack of a heartbeat, removing carbon dioxide from the blood and replacing it with
    oxygen before pumping it around the body. During surgery, the heart-lung bypass machine (called on-pump surgery) is used to take over
    for the heart and lungs, allowing the circulation of blood throughout the rest of the body. The heart’s beating is stopped so the surgeon
    can perform the bypass procedure on a still heart. The heart-lung machine has saved countless lives.




    OFF-PUMP OR BEATING HEART BYPASS SURGERY
    Off-pump or beating CABG surgery allows surgeons to perform surgery on the heart while it is still beating; thusly, the heart-
    lung machine is not used. The surgeon uses advanced operating equipment to stabilize portions of the heart and bypass the blocked
    artery in a highly controlled operative environment. Meanwhile, the rest of the heart keeps pumping and circulating blood to the body.

    Off-pump coronary artery bypass graft surgery may be performed in certain patients with coronary artery disease. With present
    technology, all arteries on the heart can be bypassed off-pump. It may be ideal for certain patients who are at increased risk for compli-
    cations from cardiopulmonary bypass, such as those who have heavy aortic calcification, carotid artery stenosis, prior stroke, or
    compromised pulmonary or renal function. Not all patients are a candidate. Who undergoes off-pump surgery is made at the time of
    surgery when the patient's heart and arteries are evaluated more closely.

    The goal of off-pump bypass surgery is to decrease the morbidity of CABG surgery, such as stroke, renal failure, and the need
    for blood transfusion. Also of great interest is the possibility that the off-pump approach may lessen the risk of what are called cogni-
    tive changes that have been seen in many patients who underwent CABG with cardiopulmonary bypass. These short-term changes
    include memory loss, difficulty thinking clearly, and problems concentrating for lengthy periods. They usually improve over the months
    following surgery.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                       page 4 of 16
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  WHAT HAPPENS AFTER                                                      HOW LONG IS THE RECOVERY
  CABG SURGERY?                                                           FROM CABG SURGERY?
  Patients are typically observed for 24 to 36 hours in                   Everyone’s recovery from coronary artery bypass graft (CABG)
  the CICU (cardiac intensive care unit). The CICU has                    surgery is a little different. Your road to recovery has many steps,
  limited visitation hours. When you first wake up in the                 including time in the hospital, time at home, and participation in a
  CICU, you will be groggy or slightly disoriented. This                  rehabilitation program. Recovery from CABG surgery is a long
  is normal. You will still have a tube in your mouth,                    process. Recovery from major surgery has both physical and
  connecting you to breathing monitors and apparatus.                     emotional aspects. How fast you recover physically will depend on
  Until you are able to breathe on your own, you will                     your health before CABG surgery. You will probably have some pain.
  have difficulty talking (because of the tube) and will be               You may also feel frustrated, angry, or lonely. It is important that you
  unable to eat.                                                          have emotional support from friends, family, and medical staff during
                                                                          your recovery.
  There are numerous monitors and machines in the
  CICU. Nurses will be watching your vital signs
                                                                          Your doctor will place you on a specialized postoperative rehabilita-
  (temperature, pulse, and breathing) constantly to
                                                                          tion and prevention program, which usually includes supervised
  make sure that you are recovering as expected. You
                                                                          exercise, dietary, and lifestyle changes. You should be careful to
  may find your hands strapped down so that you
                                                                          protect the area around the leg or arm from which the vein was
  cannot disconnect any of the monitoring wires. Once
                                                                          harvested which may take a few months to return to normal.
  your condition has stabilized (approximately 24 to 36
  hours), you will be moved to a regular hospital room,
                                                                          Full recovery from coronary artery bypass graft surgery takes around
  where you can have more frequent visitors and rest
                                                                          two months. Most patients are able to drive in about three to eight
  more peacefully.
                                                                          weeks after surgery. Your doctor will provide specific guidelines for
                                                                          your recovery and return to work, including specific instructions on
  The overall hospital stay, including both the CICU and
                                                                          activity and how to care for your incision and general health after the
  a regular hospital room, is between five and six days
                                                                          surgery.
  if you undergo a traditional bypass surgery. You will
  receive medications in order to cope with the immedi-
                                                                          While you are recovering from CABG surgery, you will also be:
  ate surgical recovery. However, your doctor should
                                                                            • Caring for your wounds
  talk to you about the difference between pains from
  the incision versus pain due to low blood supply to the                   • Taking medications
  heart muscle following surgery. If you have any ques-                     • Monitoring your weight
  tions about chest pain, contact your doctor. Even if                      • Improving heart and lung health
  you have had prior surgeries, be aware that bypass
                                                                            • Attending cardiac rehabilitation.
  patients undergo a more painful recovery than do
                                                                            • Making changes in your lifestyle by quitting smoking, eating
  other surgery patients. You must demonstrate that
                                                                              a heart-healthy diet, exercising, and lowering stress levels
  you are capable of performing basic daily activities
  like walking, sitting upright for at least 60 minutes,
                                                                          These changes are not just during your CABG recovery but for the
  eating, and digesting food prior to being released.
                                                                          rest of your life.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                         page 5 of 16
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    HOW SUCCESSFUL IS CABG SURGERY?

    Studies have shown in 80 to 95 percent of patients, bypasses made with segments
    of the mammary artery still performed efficiently 10 years after surgery. Two-thirds to
    75 percent of patients who received grafts from leg veins still had satisfactorily
    unrestricted blood flow after 10 years. Even if your graft becomes blocked, you may
    not need additional bypass surgery. However, you may be a candidate for balloon
    angioplasty and insertion of a stent.




    DRUG ELUTING STENTS (DES)

    A stent is a small, lattice-shaped, metal tube that is inserted permanently into an
    artery. The stent helps hold open an artery so that blood can flow through it. Drug-
    eluting stents are stents that contain drugs that potentially reduce the chance that
                                                                                                           NO GUARANTEES
    arteries will become blocked again.
                                                                                                           FOR STENTS
    A stent is used to hold open an artery that has become too narrow due to atheroscle-
    rosis where plaque builds up on the inner walls of arteries. As the artery walls                       While stents virtually eliminated many
    thicken, the pathway for blood narrows. This can slow or block blood flow.                             of the complications of abrupt artery
                                                                                                           closure, restenosis persisted. Although
    A stent is inserted through a main artery in the groin (femoral artery) or arm (brachial               the rates were somewhat lower, bare
    artery) and threaded up to the narrowed section of the artery with a tiny catheter                     metal stents still experienced re-
    (balloon catheter.)                                                                                    blocking (typically at six-months) in
                                                                                                           about 25 percent of cases, requiring a
    When it reaches the right location, the balloon is slightly inflated to push the plaque                repeat procedure. The interventional
    out of the way and expand the artery (balloon angioplasty). Some stents are                            cardiology community also learned that
    stretched open (expanded) by the balloon at the same time as the artery. Other                         restenosis, rather than being a recur-
    stents are inserted into the artery immediately after the angioplasty procedure.                       rence of coronary artery disease,
                                                                                                           actually was the body's response to the
    Once in place, the stent helps hold artery open so that the heart muscle gets enough                   controlled injury of angioplasty and was
    blood. The stent acts as a scaffold, remaining in place permanently to help keep the                   characterized by growth of smooth
    artery open. Drug-eluting stents contain a drug that is released locally over a period                 muscle cells — roughly analogous to a
    of time.                                                                                               scar forming over an injury.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                        page 6 of 16
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    BRIEF HISTORY OF STENTING
    The concept of the stent grew directly out of interventional cardiologists' experience with angioplasty balloons in the first decade of use
    (1977-87). Sometimes the wall of the coronary artery became weakened after balloon dilatation. Although the artery would be opened
    successfully using a balloon, in a small percentage of cases, the artery would collapse after the balloon was deflated when the patient
    had been moved to the recovery room. Since there was no interventional fix available, the only option was emergency bypass graft
    surgery to repair the problem.

    Another problem soon became evident as well. Approximately 30 percent of all coronary arteries began to close up again after balloon
    angioplasty. By the mid 1980s various radiologists and cardiologists were working on solutions to these problems, designing new
    devices in hopes they would provide more safety and durability to the procedures. Lasers, tiny shavers, rotational polishers — many
    tools were miniaturized to be delivered via catheter.

    One such device was the stent — a metal tube or scaffold that was inserted after balloon angioplasty. The stent itself was mounted on
    a balloon and could be opened once inside the coronary artery. In 1986, working in Toulouse, France, Jacques Puel and Ulrich Sigwart
    inserted the first stent into a human coronary artery. In 1994, the first Palmaz-Schatz stent was approved for use in the United States.
    Over the next decade, several generations of bare metal stents were developed, with each succeeding one being more flexible and
    easier to deliver to the narrowing.




                                                STENT WARS
                                                Heart disease is here to stay. Let the stent wars begin. The status and availability of drug-
                                                eluting stents is the subject of many legal disputes. Stents have been adopted so quickly that
                                                they have doubled the world market for stents usage to $5 billion annually. It is easy to under-
                                                stand the flurry of activity among and between all of the competing device manufacturers.

                                                Currently only two drug-eluting stents, the Cordis CYPHER™ sirolimus-eluting stent and the
                                                Boston Scientific TAXUS™ paclitaxel-eluting stent system, have received FDA approval for
                                                sale in the United States (the Cypher stent in April 2003; the Taxus stent was approved a
                                                year later in March 2004) as well as the CE mark for sale in Europe. In addition, Medtronic's
                                                Endeavor stent which uses ABT-578, a drug made by Abbott, was approved in Europe in
                                                April 2005. Abbott had its own Zomaxx stent in clinical trials, but cancelled its development
                                                in the fall of 2006, opting instead to market the Xience stent, which it co-acquired as part of
                                                the Boston Scientific/Guidant/Abbott merger agreement. Boston Scientific has launched its
                                                second generation Taxus Liberte stent in Europe and is also going to be marketing the
                                                Xience, under the brand name Promus.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                         page 7 of 16
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                                                           Meanwhile, a number of new second and third
                                                           generation stent technologies are in research,
                                                           clinical trial phases, or have achieved marketing
                                                           approval outside the United States.
                                                           A new stent design by Conor MedSystems was approved in Europe in February
                                                           2006. Conor's CoStar stent utilizes a bioresorbable polymer to deliver the anti-
                                                           restenosis drug, so that after a few months of drug elution, the stent in effect
                                                           becomes a bare metal stent — which may eliminate the concern of late stent throm-
                                                           bosis present in permanent polymer stents. And both Abbott and Germany-based
                                                           Biotronik are testing a completely bioabsorable stent which will totally disappear
                                                           after it has done its work.




                                                           FDA WARNING: STENT THROMBOSIS
                                                           The issue of stent thrombosis also is being examined in more depth. In October
                                                           2003, the FDA issued a warning regarding cases of sub-acute thrombosis (blood
                                                           clotting) with the CYPHER stent that resulted in some deaths. Upon further study,
                                                           it seemed that the incidence of thrombosis was no greater than that with bare metal
                                                           stents.

                                                           Late stent thrombosis was one of the major issues discussed at the FDA scheduled
                                                           a public meeting in early December 2006 on the issue. For the first time since their
CARDIAC SURGERY -                                          introduction, the use of drug-eluting stents began to decrease slightly in late 2006,
                                                           due to these concerns. Many cardiologists feel the issue has been over amplified,
RISKS AND BENEFITS
                                                           but many are also beginning to re-examine whether some patients will really have
                                                           that much of a benefit over the older bare metal stents — especially patients whose
Cardiac surgery saves thousands of lives
every day and hundreds of thousands of                     blockages are judged to be at very low risk for restenosis.
lives every year. But cardiac surgery is not
without risks. Even in the most knowledge-                 There is some evidence, however, that drug-eluting stents may be susceptible to
able and experienced hands of medical                      an event known as late stent thrombosis, where the blood-clotting inside the stent
experts, patients will still suffer from compli-
                                                           can occur one or more years post-stent. While this has been seen rarely in both the
cations such as stroke, kidney failure, and
                                                           Taxus and Cypher stent, thrombosis is extremely dangerous, fatal in over one third
kidney dialysis, blood clotting, heart attacks,
                                                           of cases. To prevent thrombosis, the above-mentioned post-stent antiplatelet
and death caused by human error, defective
                                                           therapy is very important and patients should not stop taking aspirin, Plavix or Ticlid
medical devices such as drug eluting stents,
and unsafe drugs like aprotinin/Trasylol.                  without consulting with their interventional cardiologist.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                          page 8 of 16
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    DRUG ELUTING STENTS: WHAT CAN GO WRONG?

    Stent placement can cause infection, blood clots, and bleeding at the site of the stent.
    Other rare complications of coronary stents include chest pain, heart attack, or tearing
    of blood vessel. The stent can move out of place (stent migration). In some cases,
    plaque can reappear in the stented artery (stent restenosis). Ask your doctor about the
    additional risks and restrictions associated with stents and drug eluting stents.
    The types of adverse events seen with the drug-eluting stent were similar to those that occurred with the uncoated stent. Patients who
    are allergic to sirolimus or to stainless steel should not receive a Cypher stent. Caution is also recommended for people who have had
    recent cardiac surgery and for women who may be pregnant or who are nursing. Patients who receive the drug-eluting stent will likely
    need to take certain kinds of anti-platelet drugs for at least several months. A failure to do so can result in the formation of clots.

    The risk in some cases is a failure of the doctor to keep a patient on anti-platelet drugs (Plavix, Ticlid, Aspirin) for the correct time period.
    If a patient is taken off of those drugs too soon, there is an increased potential for clots causing heart attack or stroke. In those
    situations, where a stroke or heart attack occurred after a doctor has taken the patient off of the anti-platelet medication, one should
    consider consulting a lawyer about whether or not this medical decision constituted a deviation of the proper standards of medical care.




                                                CABG SURGERY: WHAT CAN GO WRONG?
                                                During heart bypass surgery, Aprotinin/Trasylol is an injection used to prevent excessive
                                                blood loss. Aprotinin has been linked to encephalopathy and degenerative brain diseases.
                                                Aprotinin/Trasylol doubles the risk of kidney failure and stroke and increases the risk of heart
                                                failure or heart attack by 55 percent. There are risks of renal failure with CABG even without
                                                Trasylol, related to how long a patient is on the heart lung machine.

                                                There are other generic alternatives to be used in CABG surgeries. Among them are Amicar
                                                (aminocaproic acid) and Cyklokapron (tranexamic acid. Also studied, these generic drugs
                                                were confirmed to be both safe and effective. Some researchers estimated that if hospitals
                                                stopped using Trasylol and instead used the above generic drugs, it would save 9,000 to
                                                11,000 people every year from kidney dialysis.

                                                The differences in bypass surgery drug costs are also alarming:
                                                    • Trasylol (aprotinin) costs $1,300 per dose (manufactured by Bayer AG)
                                                    • Amicar costs only $11 per dose (generic, off-label use)
                                                    • Cyklokapron costs $44 per dose (generic, off-label use)




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                             page 9 of 16
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  MEDICAL STUDY: NEW ENGLAND                                                                            DO YOU HAVE RENAL
  JOURNAL OF MEDICINE (JAN. 2006)*                                                                      (KIDNEY) FAILURE?
  Aprotinin/Trasylol - Renal Failure                                                                     What is kidney failure?
  The results, published in New England Journal of Medicine, are based on an indepen-                   Healthy kidneys clean your blood by
  dent, non-commercial, observational study conducted by The Ischemia Research and                      removing excess fluid, minerals, and
  Education Foundation (IREF).                                                                          wastes. They also make hormones that
                                                                                                        keep your bones strong and your blood
  The study offered compelling evidence of Trasylol’s serious risks and strongly                        healthy. When your kidneys fail, harmful
  suggested discontinuation and replacement with either of the two alternative generic                  wastes build up in your body, your blood
  and far less costly medications proven safe in this study.                                            pressure may rise, and your body may
                                                                                                        retain excess fluid and not make enough
  Trasylol’s troubling concerns include that it has been on the market three times as                   red blood cells. When this happens, you
  long as Vioxx but few safety studies have been conducted since its approval; life                     need treatment to replace the work of
  threatening complications have occurred more frequently than Vioxx; and there are                     your failed kidneys.
  much cheaper and safer alternatives available.

  The New England Journal of Medicine article states that replacing aprotinin with one
  of two safe generic drugs would annually prevent as many as 11,050 dialysis compli-
  cations; save at least $1 billion in healthcare mainly, kidney dialysis costs; and reduce
  drug costs by at least $250 million. In the US these generic drugs do not have an FDA
  approved indication for this purpose, but are being used by doctors quot;off label.quot;

  Aprotinin was approved by the U.S. Food and Drug Administration in 1993 and is
  manufactured by Bayer under the brand name Trasylol. Over the past three years,
  Trasylol sales have accelerated with the 2006 projected sales in excess of $600
  million.

  The article further states that as many as 10,000 patients may be unnecessarily on
  dialysis today due to aprotinin use. This serious impact on human lives underscores
  once again the necessity for meticulous, post — approval surveillance, as well as
  ongoing, unbiased analysis of drug safety — all conducted by entirely independent
  entities.

  Among primary surgery patients, aprotinin also increased risk of heart attack by 48
  percent, heart failure by 109 percent and strokes by 181 percent.

  * N Engl J Med 2006;354:353-65. Copyright © 2006 Massachusetts Medical Society.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                     page 10 of 16
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    WHAT IS DIALYSIS?
    There are two kinds of dialysis: hemodialysis and peritoneal.

    Hemodialysis cleans and filters your blood using a machine to temporarily rid your body of
    harmful wastes, extra salt, and extra water. Hemodialysis helps control blood pressure and
    helps your body keep the proper balance of important chemicals such as potassium,
    sodium, calcium, and bicarbonate.

    Hemodialysis uses a special filter called a dialyzer that functions as an artificial kidney to
    clean your blood. During treatment, your blood travels through tubes into the dialyzer,
    which filters out wastes and extra water. Then the cleaned blood flows through another set
    of tubes back into your body. The dialyzer is connected to a machine that monitors blood
    flow and removes wastes from the blood.

    Hemodialysis is usually needed three times a week. Each treatment lasts from three to five
    or more hours. During treatment, you can read, write, sleep, talk, or watch TV. Patients on
    hemodialysis must follow a strict, limited diet. Hemodialysis can be done at the dialysis
    center or at home with training.

    Peritoneal dialysis is another procedure that removes extra water, wastes, and chemicals from your body. This type of dialysis uses the
    lining of your abdomen to filter your blood. This lining is called the peritoneal membrane and acts as the artificial kidney.

    With peritoneal dialysis, a mixture of minerals and sugar dissolved in water, called dialysis solution, travels through a soft tube into your
    abdomen. The sugar, called dextrose, draws wastes, chemicals, and extra water from the tiny blood vessels in your peritoneal mem-
    brane into the dialysis solution. After several hours, the used solution is drained from your abdomen through the tube, taking the wastes
    from your blood with it. Then you fill your abdomen with fresh dialysis solution, and the cycle is repeated. The process of draining and
    refilling is called an exchange.

    There are two types of peritoneal dialysis and both are usually performed by the patient without help from a partner. CAPD is a form of
    self-treatment that needs no machine. However, with CCPD, you need a machine to drain and refill your abdomen. The most common
    problem with peritoneal dialysis is peritonitis, a serious abdominal infection. This infection can occur if the opening where the catheter
    enters your body becomes infected or if contamination occurs as the catheter is connected or disconnected from the bags.

    Unfortunately, dialysis does not cure kidney failure. Hemodialysis and peritoneal dialysis are treatments that help replace the work your
    kidneys did. These treatments help you feel better and live longer. Although patients with kidney failure are now living longer than ever,
    over the years kidney disease can cause problems such as heart disease, bone disease, arthritis, nerve damage, infertility, and malnutri-
    tion. These problems won't go away with dialysis.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                         page 11 of 16
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    WHAT ARE THE LEGAL OPTIONS IF YOUR KIDNEY FAILURE IS CAUSED
    BY TRASYLOL (APROTININ)?
    If you or a loved one has kidney failure as the result of being injected with Trasylol during cardiac bypass surgery, you may want to
    contact a law firm about your options. According to an independent study reported in the New England Journal of Medicine over 11,000
    cases of dialysis complications occurred after being injected with Trasylol during CABG surgery. Are you one of them?

    Law firms such as Anapol Schwartz have successfully pursued numerous unsafe drug cases. Most likely you have questions and they
    will have answers. Contact a lawyer for a free legal consultation today. With Anapol Schwartz, there is never an obligation to continue
    and your information will be kept private.




    WHAT TO DO IF YOU SUFFERED A STROKE?
    Stroke affects nearly four out of five Americans, either actual stroke victims or someone they know. A stroke occurs when the blood
    supply to part of the brain is suddenly interrupted or when a blood vessel in the brain bursts, spilling blood into the spaces surrounding
    brain cells. Brain cells die when they no longer receive oxygen and nutrients from the blood or there is sudden bleeding into or around
    the brain.


    STROKE RISK FACTORS
    Several factors increase your risk of stroke. The more risk factors you have, the greater your
    chance of having a stroke. Some of these you can’t control, such as your age, your family
    health history, race, and gender. But you can modify, treat, or control most risk factors to lower
    your risk.

    Risks that can be controlled with medical treatment and lifestyle changes:
        • High blood pressure                    • High blood cholesterol
        • Diabetes                               • Obesity
        • Cigarette smoking                      • Heart disease
        • TIA (small strokes - take aspirin)

    How to recognize a stroke — try the 60 second test:
    1. Ask the individual to smile.
    2. Ask him to raise both arms.
    3. Ask the person to repeat a simple sentence, like…It is sunny out today.
    If the person has trouble with any of these tasks, call 911 immediately.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                      page 12 of 16
Read more information online at http://www.anapolschwartz.com.
Anapol Schwartz | Attorneys at Law


                                                                                           Stroke patients will most like display:
  STROKES CAUSE DISABILITY
  Stroke is the number one cause of adult disability, leaving two of every                 • Motor impairment and loss of sensation often on
                                                                                             one side of the body
  three survivors with significant physical and emotional after effects. And
  for too long, there has not been a strong option to help survivors and                   • Difficulty with speech
  their families once they've completed their immediate rehabilitation and
                                                                                           • Limited visual fields and trouble with visual
  their health care support system ends.
                                                                                             perception
  Stroke Centers                                                                           • Loss of emotional control and changes in mood
                                                                                           • Cognitive deficits
  When someone suffers a stroke, they feel terribly alone, often angry, and
                                                                                           • Problems with memory
  depressed. Stroke centers help bring light into people's lives - and the
  lives of their families and caregivers. Stroke is not a death sentence;                  • Problems with judgment
  rather, it’s a chance for a fresh start.
                                                                                           • Problems with problem solving
                                                                                           • Combination of all or some of the above
  The American Stroke Foundation does not duplicate existing services but
  complements them by providing the missing link in nurturing stroke
  survivors... and those who care for them. People who could barely utter
  words are speaking in sentences. Every day brings a new miracle.

  American Stroke Foundation             National Institute of Neurological
  www.stroke-site.org                    Disorders and Stroke
                                         www.ninds.nih.gov
  American Stroke Association
  www.strokeassociation.org              Brain Attack Coalition
  1-888-4STROKE                          www.stroke-site.org
                                         301-496-5751
  National Stroke Association
  www.stroke.org
  1-800-STROKES



 WHAT ARE YOUR LEGAL OPTIONS IF YOU’VE SUFFERED A STROKE CAUSED FROM
 DRUG ELUTING STENTS?
 If you or a loved one has experienced a stroke as the result of being injected with Trasylol during cardiac bypass surgery or from drug eluting
  stents, you may want to contact a law firm about your options. Unsafe drugs, failure to properly administer the correct drugs, and defective
  medical devices may be the cause of your cardiovascular-related stroke.

 The law firm of Anapol Schwartz has successfully pursued medical malpractice, unsafe drug and defective medical device cases. Most likely
 you have questions and the attorneys at Anapol Schwartz will have answers. Contact a lawyer at Anapol Schwartz for a free legal consulta-
 tion today. With Anapol Schwartz, there is never an obligation to continue and your information will be kept private.




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                         page 13 of 16
Read more information online at http://www.anapolschwartz.com.
Anapol Schwartz | Attorneys at Law


    CHECKLISTS
                                                                           8 things to ask your doctor before CABG surgery
     7 questions to ask about dialysis
                                                                           1. Am I a candidate for CABG surgery?
    1. What kind of dialysis is right for me?
                                                                           2. What kind of graft will I receive?
    2. Can I go to the dialysis of my choice?
                                                                           3. Is one kind of graft more beneficial than another kind
    3. How much time per week will I spend in dialysis?
                                                                               of graft?
    4. Can I afford dialysis?
                                                                           4. Will I have on pump surgery or off pump surgery?
    5. How can I finance dialysis?
                                                                           5. Will I be in pain?
    6. Will I be able to keep working and have a normal life?
                                                                           6. Are there any serious complications from the surgery?
    7. Will dialysis cure me?
                                                                           7. How long is the recovery period?
                                                                           8. What will my long term prognosis be?
    3 ways to recognize a stroke (within 60 seconds)
    1. Inability to smile
    2. Inability to raise both hands over your head
    3. Inability to recite a simple sentence




    SUPPORT GROUPS
    American Association of                           Life Options Rehabilitation Program
    Kidney Patients                                   c/o Medical Education Institute, Inc.
    3505 East Frontage Road                           414 D'Onofrio Drive Suite 200
    Suite 315                                         Madison, WI 53719
    Tampa, FL 33607                                   Phone: 1-800-468-7777 or 608-232-2333              National Kidney & Urologic
    Phone: 1-800-749-2257                             Email: lifeoptions@MEIresearch.org                 Disease Center
    Fax: 813-636-8122                                 Internet: www.lifeoptions.org                      3 Information Way
    Email: info@aakp.org                              www.kidneyschool.org                               Bethesda, MD 20892-3580
    Internet: www.aakp.org                                                                               Phone: 1-800-891-5390
                                                      National Kidney Foundation
                                                                                                         Fax: 703-738-4929
    American Kidney Fund                              30 East 33rd Street
                                                                                                         Email: nkudic@info.niddk.nih.gov
    6110 Executive Boulevard                          New York, NY 10016
                                                                                                         Internet: kidney.niddk.nih.gov
    Suite 1010                                        Phone: 1-800-622-9010 or 212-889-2210
    Rockville, MD 20852                               Fax: 212-689-9261
    Phone: 1-800-638-8299 or 301-881-3052             Email: info@kidney.org
    Fax: 301-881-0898                                 Internet: www.kidney.org
    Email: helpline@akfinc.org
    Internet: www.kidneyfund.org




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                       page 14 of 16
Read more information online at http://www.anapolschwartz.com.
Anapol Schwartz | Attorneys at Law


    RESOURCES ON THE WEB
                                                                                   Mayo Clinic: DES - www.mayoclinic.com
    Cleveland Clinic: CABG explanation -
                                                                                   Opinion piece about drug eluting stents
    www.clevelandclinic.org Detailed explanation about coronary
    artery bypass graft surgery
                                                                                   Angioplasty - www.angioplasty.org
    Stroke Risk Factors - www.americanstroke.org                                   All about angioplasty surgery
    Risks, symptoms and how to reduce risk factors
                                                                                   Washington Post: Stent Safety Concerns -
    American Stroke Association - www.americanstroke.org                           www.washingtonpost.com
                                                                                   Recent research has raised alarm about the safety of a
    Life after stroke - what to expect, advocacy news, stroke info
                                                                                   new generation of stents that have quickly become the
    for healthcare professionals
                                                                                   most commonly used devices for treating millions of
    Heart Info - www.heartinfo.org                                                 heart-disease patients.
    A patient’s guide to bypass surgery
                                                                                   FDA: Trasylol Advisor Press Release - www.fda.gov
    CABG Recovery - www.webmd.com                                                  Trasylol (aprotinin) linked to higher risks of serious side
                                                                                   effects including kidney problems, heart attacks and strokes
    General timeline for heart bypass recovery,
                                                                                   in patients who undergo artery bypass graft surgery.
    setting recovery goals

    Stents: Heart Health Online - www.fda.gov                                      FDA: Trasylol Advisory - www.fda.gov
    What is a stent? What are the risks?




                                                                                                          HOW TO CONTACT US
    CONTACT A LAWYER / FREE
    NO-OBLIGATION CONSULTATION                                                                            Internet:
                                                                                                             www.anapolschwartz.com
   Please contact us for a free no-obligation consultation. The more information that you
                                                                                                          Toll Free:
   can provide, the more helpful it will be. You are under no obligation to continue. Any
                                                                                                             866-735-2792
   information you provide will be held in the strictest of confidence.
                                                                                                          Email:
   If you have questions, please call us toll-free at 1-866-735-2792.                                        jronca@anapolschwartz.com
                                                                                                             sweiss@anapolschwartz.com
   Thank you.                                                                                             Mail:
                                                                                                             1710 Spruce Street,
                                                                                                             Philadelphia, PA 19103




Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved.
                                                                                                                                      page 15 of 16
Read more information online at http://www.anapolschwartz.com.
Anapol Schwartz | Attorneys at Law
SPONSORED BY:
ANAPOL SCHWARTZ WEISS COHAN FELDMAN & SMALLEY

JIM RONCA, ESQ. - JRONCA@ANAPOLSCHWARTZ.COM
SOL WEISS, ESQ. - SWEISS@ANAPOLSCHWARTZ.COM
1710 SPRUCE STREET, PHILADELPHIA, PA 19103

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Renal Failure Guide

  • 1. A GUIDE TO CAUSES OF RENA L FA I L U R E A N D S T R O K ES C O R O N A RY S U R G E RY FOLLOWING Anapol Schwartz | Attorneys at Law 866-735-2792 WWW.ANAPOLSCHWARTZ.COM JIM RONCA, ESQ. - JRONCA@ANAPOLSCHWARTZ.COM SOL WEISS, ESQ. - SWEISS@ANAPOLSCHWARTZ.COM 1710 SPRUCE STREET, PHILADELPHIA, PA 19103 DISCLAIMER: This information is not intended to replace the advice of a doctor. Please use this information to help in your conversation with you doctor. This is general background information and should not be followed as medical advice. Please consult your doctor regarding all medical questions and for all medical treatment.
  • 2. Anapol Schwartz | Attorneys at Law LINKS TO CONTENTS: CABG What is CABG? Who is eligible for CABG? What happens during CABG? What happens after CABG surgery? How long is the recovery from CABG? Drug Eluting Stents CABG - CORONARY ARTERY BYPASS Cardiac Surgery - risks and benefits GRAFT SURGERY Cardiac surgery - What can go wrong? DES - What can go wrong? WHAT IS CABG? (PRONOUNCED: CABBAGE) Cardiac surgery drugs New England Journal of Medicine CABG is a surgical procedure used to treat patients with coronary artery block- ages. During the procedure, a heart surgeon creates an alternate path for Renal Failures caused by Trasylol blood to flow to the heart muscle by going around, or bypassing, a blocked (generic - aprotinin), cardiac surgery drug section of an artery. Hence, the phrase, heart bypass surgery. CABG is What to do if you suffered renal failure? typically recommended for severe blockages that are not treatable by other Dialysis methods. Legal options if dialysis caused by The surgeon typically gains access to the heart by cutting the sternum (breast Trasylol (Aprotinin) bone). Often blood vessels are removed from the patient’s leg or detached What to do if you suffer a stroke? from the chest wall and grafted to the blocked artery. Once the grafts have been attached, oxygen rich blood will flow through the new bypass vessel, Stroke centers avoiding the blockage completely. Legal options if stroke caused by DES Checklists CABG is performed by a cardiothoracic surgeon under general anesthesia and generally takes between two and six hours depending on the number of Support Groups bypasses to be completed. Patients might have more than one blockage, so Resources on the Web several bypasses may be needed. After the procedure is completed, most patients stay in the hospital for several days and face a rehabilitation period of one to two months. DISCLAIMER: This information is not intended to replace the advice of a doctor. Please use this informa- The goals of CABG are to relieve symptoms of coronary artery disease includ- tion to help in your conversation with you doctor. This is general background information and should not be ing angina, enable the patient to resume a normal lifestyle and to lower the risk followed as medical advice. Please consult your doctor of a heart attack or other heart related problems. Coronary artery bypass graft regarding all medical questions and for all medical surgery is widely performed in the United States. It is estimated that more than treatment. 800,000 CABG procedures are performed worldwide every year. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 2 of 16 Read more information online at http://www.anapolschwartz.com.
  • 3. Anapol Schwartz | Attorneys at Law WHO IS ELIGIBLE FOR CABG SURGERY? Not everyone is a candidate for CABG — the decision to prescribe cardiac bypass surgery depends on several factors including the extent of cardiovascular disease, the severity of symptoms, your age, and other medical conditions. The heart specialist and surgeon will determine the best method of treatment and your eligibility. WHAT HAPPENS DURING CABG SURGERY? The surgery generally lasts from two to six hours, depending on the number of arteries being bypassed. After general anesthesia is administered, the surgeon removes the veins or prepares the arteries for grafting. GRAFT PREPARATION There are several types of bypass grafts that can be used. The decision to use which grafts depends on the location of the blockage, the amount of the blockage, and the size of the patient’s coronary arteries. Internal mammary arteries or internal thoracic arteries are the most common bypass grafts because they show the best long-term results. In most cases, these arteries can be kept intact at their origin because they have their own oxygen-rich blood supply, and are then sewn to the coronary artery below the site of the blockage. If the surgeon removes the mammary artery from its origin, it is called a free mammary artery. Over the last decade, more than 90 percent of all patients received at least one internal artery graft. The radial (arm) artery is another common type of arterial graft. There are two arteries in the arm, the ulnar and radial arteries. Most people receive blood to their arm from the ulnar artery and will not have any side effects if the radial artery is used. Careful preoperative and intra-operative tests determine if the radial artery can be used. If the radial artery is used as the graft, the patient may be required to take a calcium channel blocker medication for several months after surgery. This medication helps keep the artery open. Some people report numbness in the wrist after surgery. However, long-term sensory loss or numbness is uncommon. The gastroepiploic artery to the stomach and the inferior epigastric artery to the abdominal wall are less commonly used for grafting. Saphenous (leg) veins can be used as bypass grafts. Minimally invasive saphenous vein removal does not require a long incision. One to two incisions are made at the knee and a small incision is made at the groin. This results in less scarring and a faster recovery. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 3 of 16 Read more information online at http://www.anapolschwartz.com.
  • 4. Anapol Schwartz | Attorneys at Law SURGICAL PROCEDURE To bypass the blockage, the surgeon makes a small opening just below the blockage in the diseased coronary artery. If a saphenous (leg) or radial (arm) vein is used, one end is connected to the coronary artery and the other to the aorta. If a mammary artery is used, one end is connected to the coronary artery while the other remains attached to the aorta. The graft is sewn into the opening, redirecting the blood flow around this blockage. The procedure is repeated until all affected coronary arteries are treated. It is common for three or four coronary arteries to be bypassed during surgery. HEART-LUNG MACHINE / ON-PUMP SURGERY The heart-lung machine maintains life despite the lack of a heartbeat, removing carbon dioxide from the blood and replacing it with oxygen before pumping it around the body. During surgery, the heart-lung bypass machine (called on-pump surgery) is used to take over for the heart and lungs, allowing the circulation of blood throughout the rest of the body. The heart’s beating is stopped so the surgeon can perform the bypass procedure on a still heart. The heart-lung machine has saved countless lives. OFF-PUMP OR BEATING HEART BYPASS SURGERY Off-pump or beating CABG surgery allows surgeons to perform surgery on the heart while it is still beating; thusly, the heart- lung machine is not used. The surgeon uses advanced operating equipment to stabilize portions of the heart and bypass the blocked artery in a highly controlled operative environment. Meanwhile, the rest of the heart keeps pumping and circulating blood to the body. Off-pump coronary artery bypass graft surgery may be performed in certain patients with coronary artery disease. With present technology, all arteries on the heart can be bypassed off-pump. It may be ideal for certain patients who are at increased risk for compli- cations from cardiopulmonary bypass, such as those who have heavy aortic calcification, carotid artery stenosis, prior stroke, or compromised pulmonary or renal function. Not all patients are a candidate. Who undergoes off-pump surgery is made at the time of surgery when the patient's heart and arteries are evaluated more closely. The goal of off-pump bypass surgery is to decrease the morbidity of CABG surgery, such as stroke, renal failure, and the need for blood transfusion. Also of great interest is the possibility that the off-pump approach may lessen the risk of what are called cogni- tive changes that have been seen in many patients who underwent CABG with cardiopulmonary bypass. These short-term changes include memory loss, difficulty thinking clearly, and problems concentrating for lengthy periods. They usually improve over the months following surgery. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 4 of 16 Read more information online at http://www.anapolschwartz.com.
  • 5. Anapol Schwartz | Attorneys at Law WHAT HAPPENS AFTER HOW LONG IS THE RECOVERY CABG SURGERY? FROM CABG SURGERY? Patients are typically observed for 24 to 36 hours in Everyone’s recovery from coronary artery bypass graft (CABG) the CICU (cardiac intensive care unit). The CICU has surgery is a little different. Your road to recovery has many steps, limited visitation hours. When you first wake up in the including time in the hospital, time at home, and participation in a CICU, you will be groggy or slightly disoriented. This rehabilitation program. Recovery from CABG surgery is a long is normal. You will still have a tube in your mouth, process. Recovery from major surgery has both physical and connecting you to breathing monitors and apparatus. emotional aspects. How fast you recover physically will depend on Until you are able to breathe on your own, you will your health before CABG surgery. You will probably have some pain. have difficulty talking (because of the tube) and will be You may also feel frustrated, angry, or lonely. It is important that you unable to eat. have emotional support from friends, family, and medical staff during your recovery. There are numerous monitors and machines in the CICU. Nurses will be watching your vital signs Your doctor will place you on a specialized postoperative rehabilita- (temperature, pulse, and breathing) constantly to tion and prevention program, which usually includes supervised make sure that you are recovering as expected. You exercise, dietary, and lifestyle changes. You should be careful to may find your hands strapped down so that you protect the area around the leg or arm from which the vein was cannot disconnect any of the monitoring wires. Once harvested which may take a few months to return to normal. your condition has stabilized (approximately 24 to 36 hours), you will be moved to a regular hospital room, Full recovery from coronary artery bypass graft surgery takes around where you can have more frequent visitors and rest two months. Most patients are able to drive in about three to eight more peacefully. weeks after surgery. Your doctor will provide specific guidelines for your recovery and return to work, including specific instructions on The overall hospital stay, including both the CICU and activity and how to care for your incision and general health after the a regular hospital room, is between five and six days surgery. if you undergo a traditional bypass surgery. You will receive medications in order to cope with the immedi- While you are recovering from CABG surgery, you will also be: ate surgical recovery. However, your doctor should • Caring for your wounds talk to you about the difference between pains from the incision versus pain due to low blood supply to the • Taking medications heart muscle following surgery. If you have any ques- • Monitoring your weight tions about chest pain, contact your doctor. Even if • Improving heart and lung health you have had prior surgeries, be aware that bypass • Attending cardiac rehabilitation. patients undergo a more painful recovery than do • Making changes in your lifestyle by quitting smoking, eating other surgery patients. You must demonstrate that a heart-healthy diet, exercising, and lowering stress levels you are capable of performing basic daily activities like walking, sitting upright for at least 60 minutes, These changes are not just during your CABG recovery but for the eating, and digesting food prior to being released. rest of your life. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 5 of 16 Read more information online at http://www.anapolschwartz.com.
  • 6. Anapol Schwartz | Attorneys at Law HOW SUCCESSFUL IS CABG SURGERY? Studies have shown in 80 to 95 percent of patients, bypasses made with segments of the mammary artery still performed efficiently 10 years after surgery. Two-thirds to 75 percent of patients who received grafts from leg veins still had satisfactorily unrestricted blood flow after 10 years. Even if your graft becomes blocked, you may not need additional bypass surgery. However, you may be a candidate for balloon angioplasty and insertion of a stent. DRUG ELUTING STENTS (DES) A stent is a small, lattice-shaped, metal tube that is inserted permanently into an artery. The stent helps hold open an artery so that blood can flow through it. Drug- eluting stents are stents that contain drugs that potentially reduce the chance that NO GUARANTEES arteries will become blocked again. FOR STENTS A stent is used to hold open an artery that has become too narrow due to atheroscle- rosis where plaque builds up on the inner walls of arteries. As the artery walls While stents virtually eliminated many thicken, the pathway for blood narrows. This can slow or block blood flow. of the complications of abrupt artery closure, restenosis persisted. Although A stent is inserted through a main artery in the groin (femoral artery) or arm (brachial the rates were somewhat lower, bare artery) and threaded up to the narrowed section of the artery with a tiny catheter metal stents still experienced re- (balloon catheter.) blocking (typically at six-months) in about 25 percent of cases, requiring a When it reaches the right location, the balloon is slightly inflated to push the plaque repeat procedure. The interventional out of the way and expand the artery (balloon angioplasty). Some stents are cardiology community also learned that stretched open (expanded) by the balloon at the same time as the artery. Other restenosis, rather than being a recur- stents are inserted into the artery immediately after the angioplasty procedure. rence of coronary artery disease, actually was the body's response to the Once in place, the stent helps hold artery open so that the heart muscle gets enough controlled injury of angioplasty and was blood. The stent acts as a scaffold, remaining in place permanently to help keep the characterized by growth of smooth artery open. Drug-eluting stents contain a drug that is released locally over a period muscle cells — roughly analogous to a of time. scar forming over an injury. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 6 of 16 Read more information online at http://www.anapolschwartz.com.
  • 7. Anapol Schwartz | Attorneys at Law BRIEF HISTORY OF STENTING The concept of the stent grew directly out of interventional cardiologists' experience with angioplasty balloons in the first decade of use (1977-87). Sometimes the wall of the coronary artery became weakened after balloon dilatation. Although the artery would be opened successfully using a balloon, in a small percentage of cases, the artery would collapse after the balloon was deflated when the patient had been moved to the recovery room. Since there was no interventional fix available, the only option was emergency bypass graft surgery to repair the problem. Another problem soon became evident as well. Approximately 30 percent of all coronary arteries began to close up again after balloon angioplasty. By the mid 1980s various radiologists and cardiologists were working on solutions to these problems, designing new devices in hopes they would provide more safety and durability to the procedures. Lasers, tiny shavers, rotational polishers — many tools were miniaturized to be delivered via catheter. One such device was the stent — a metal tube or scaffold that was inserted after balloon angioplasty. The stent itself was mounted on a balloon and could be opened once inside the coronary artery. In 1986, working in Toulouse, France, Jacques Puel and Ulrich Sigwart inserted the first stent into a human coronary artery. In 1994, the first Palmaz-Schatz stent was approved for use in the United States. Over the next decade, several generations of bare metal stents were developed, with each succeeding one being more flexible and easier to deliver to the narrowing. STENT WARS Heart disease is here to stay. Let the stent wars begin. The status and availability of drug- eluting stents is the subject of many legal disputes. Stents have been adopted so quickly that they have doubled the world market for stents usage to $5 billion annually. It is easy to under- stand the flurry of activity among and between all of the competing device manufacturers. Currently only two drug-eluting stents, the Cordis CYPHER™ sirolimus-eluting stent and the Boston Scientific TAXUS™ paclitaxel-eluting stent system, have received FDA approval for sale in the United States (the Cypher stent in April 2003; the Taxus stent was approved a year later in March 2004) as well as the CE mark for sale in Europe. In addition, Medtronic's Endeavor stent which uses ABT-578, a drug made by Abbott, was approved in Europe in April 2005. Abbott had its own Zomaxx stent in clinical trials, but cancelled its development in the fall of 2006, opting instead to market the Xience stent, which it co-acquired as part of the Boston Scientific/Guidant/Abbott merger agreement. Boston Scientific has launched its second generation Taxus Liberte stent in Europe and is also going to be marketing the Xience, under the brand name Promus. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 7 of 16 Read more information online at http://www.anapolschwartz.com.
  • 8. Anapol Schwartz | Attorneys at Law Meanwhile, a number of new second and third generation stent technologies are in research, clinical trial phases, or have achieved marketing approval outside the United States. A new stent design by Conor MedSystems was approved in Europe in February 2006. Conor's CoStar stent utilizes a bioresorbable polymer to deliver the anti- restenosis drug, so that after a few months of drug elution, the stent in effect becomes a bare metal stent — which may eliminate the concern of late stent throm- bosis present in permanent polymer stents. And both Abbott and Germany-based Biotronik are testing a completely bioabsorable stent which will totally disappear after it has done its work. FDA WARNING: STENT THROMBOSIS The issue of stent thrombosis also is being examined in more depth. In October 2003, the FDA issued a warning regarding cases of sub-acute thrombosis (blood clotting) with the CYPHER stent that resulted in some deaths. Upon further study, it seemed that the incidence of thrombosis was no greater than that with bare metal stents. Late stent thrombosis was one of the major issues discussed at the FDA scheduled a public meeting in early December 2006 on the issue. For the first time since their CARDIAC SURGERY - introduction, the use of drug-eluting stents began to decrease slightly in late 2006, due to these concerns. Many cardiologists feel the issue has been over amplified, RISKS AND BENEFITS but many are also beginning to re-examine whether some patients will really have that much of a benefit over the older bare metal stents — especially patients whose Cardiac surgery saves thousands of lives every day and hundreds of thousands of blockages are judged to be at very low risk for restenosis. lives every year. But cardiac surgery is not without risks. Even in the most knowledge- There is some evidence, however, that drug-eluting stents may be susceptible to able and experienced hands of medical an event known as late stent thrombosis, where the blood-clotting inside the stent experts, patients will still suffer from compli- can occur one or more years post-stent. While this has been seen rarely in both the cations such as stroke, kidney failure, and Taxus and Cypher stent, thrombosis is extremely dangerous, fatal in over one third kidney dialysis, blood clotting, heart attacks, of cases. To prevent thrombosis, the above-mentioned post-stent antiplatelet and death caused by human error, defective therapy is very important and patients should not stop taking aspirin, Plavix or Ticlid medical devices such as drug eluting stents, and unsafe drugs like aprotinin/Trasylol. without consulting with their interventional cardiologist. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 8 of 16 Read more information online at http://www.anapolschwartz.com.
  • 9. Anapol Schwartz | Attorneys at Law DRUG ELUTING STENTS: WHAT CAN GO WRONG? Stent placement can cause infection, blood clots, and bleeding at the site of the stent. Other rare complications of coronary stents include chest pain, heart attack, or tearing of blood vessel. The stent can move out of place (stent migration). In some cases, plaque can reappear in the stented artery (stent restenosis). Ask your doctor about the additional risks and restrictions associated with stents and drug eluting stents. The types of adverse events seen with the drug-eluting stent were similar to those that occurred with the uncoated stent. Patients who are allergic to sirolimus or to stainless steel should not receive a Cypher stent. Caution is also recommended for people who have had recent cardiac surgery and for women who may be pregnant or who are nursing. Patients who receive the drug-eluting stent will likely need to take certain kinds of anti-platelet drugs for at least several months. A failure to do so can result in the formation of clots. The risk in some cases is a failure of the doctor to keep a patient on anti-platelet drugs (Plavix, Ticlid, Aspirin) for the correct time period. If a patient is taken off of those drugs too soon, there is an increased potential for clots causing heart attack or stroke. In those situations, where a stroke or heart attack occurred after a doctor has taken the patient off of the anti-platelet medication, one should consider consulting a lawyer about whether or not this medical decision constituted a deviation of the proper standards of medical care. CABG SURGERY: WHAT CAN GO WRONG? During heart bypass surgery, Aprotinin/Trasylol is an injection used to prevent excessive blood loss. Aprotinin has been linked to encephalopathy and degenerative brain diseases. Aprotinin/Trasylol doubles the risk of kidney failure and stroke and increases the risk of heart failure or heart attack by 55 percent. There are risks of renal failure with CABG even without Trasylol, related to how long a patient is on the heart lung machine. There are other generic alternatives to be used in CABG surgeries. Among them are Amicar (aminocaproic acid) and Cyklokapron (tranexamic acid. Also studied, these generic drugs were confirmed to be both safe and effective. Some researchers estimated that if hospitals stopped using Trasylol and instead used the above generic drugs, it would save 9,000 to 11,000 people every year from kidney dialysis. The differences in bypass surgery drug costs are also alarming: • Trasylol (aprotinin) costs $1,300 per dose (manufactured by Bayer AG) • Amicar costs only $11 per dose (generic, off-label use) • Cyklokapron costs $44 per dose (generic, off-label use) Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 9 of 16 Read more information online at http://www.anapolschwartz.com.
  • 10. Anapol Schwartz | Attorneys at Law MEDICAL STUDY: NEW ENGLAND DO YOU HAVE RENAL JOURNAL OF MEDICINE (JAN. 2006)* (KIDNEY) FAILURE? Aprotinin/Trasylol - Renal Failure What is kidney failure? The results, published in New England Journal of Medicine, are based on an indepen- Healthy kidneys clean your blood by dent, non-commercial, observational study conducted by The Ischemia Research and removing excess fluid, minerals, and Education Foundation (IREF). wastes. They also make hormones that keep your bones strong and your blood The study offered compelling evidence of Trasylol’s serious risks and strongly healthy. When your kidneys fail, harmful suggested discontinuation and replacement with either of the two alternative generic wastes build up in your body, your blood and far less costly medications proven safe in this study. pressure may rise, and your body may retain excess fluid and not make enough Trasylol’s troubling concerns include that it has been on the market three times as red blood cells. When this happens, you long as Vioxx but few safety studies have been conducted since its approval; life need treatment to replace the work of threatening complications have occurred more frequently than Vioxx; and there are your failed kidneys. much cheaper and safer alternatives available. The New England Journal of Medicine article states that replacing aprotinin with one of two safe generic drugs would annually prevent as many as 11,050 dialysis compli- cations; save at least $1 billion in healthcare mainly, kidney dialysis costs; and reduce drug costs by at least $250 million. In the US these generic drugs do not have an FDA approved indication for this purpose, but are being used by doctors quot;off label.quot; Aprotinin was approved by the U.S. Food and Drug Administration in 1993 and is manufactured by Bayer under the brand name Trasylol. Over the past three years, Trasylol sales have accelerated with the 2006 projected sales in excess of $600 million. The article further states that as many as 10,000 patients may be unnecessarily on dialysis today due to aprotinin use. This serious impact on human lives underscores once again the necessity for meticulous, post — approval surveillance, as well as ongoing, unbiased analysis of drug safety — all conducted by entirely independent entities. Among primary surgery patients, aprotinin also increased risk of heart attack by 48 percent, heart failure by 109 percent and strokes by 181 percent. * N Engl J Med 2006;354:353-65. Copyright © 2006 Massachusetts Medical Society. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 10 of 16 Read more information online at http://www.anapolschwartz.com.
  • 11. Anapol Schwartz | Attorneys at Law WHAT IS DIALYSIS? There are two kinds of dialysis: hemodialysis and peritoneal. Hemodialysis cleans and filters your blood using a machine to temporarily rid your body of harmful wastes, extra salt, and extra water. Hemodialysis helps control blood pressure and helps your body keep the proper balance of important chemicals such as potassium, sodium, calcium, and bicarbonate. Hemodialysis uses a special filter called a dialyzer that functions as an artificial kidney to clean your blood. During treatment, your blood travels through tubes into the dialyzer, which filters out wastes and extra water. Then the cleaned blood flows through another set of tubes back into your body. The dialyzer is connected to a machine that monitors blood flow and removes wastes from the blood. Hemodialysis is usually needed three times a week. Each treatment lasts from three to five or more hours. During treatment, you can read, write, sleep, talk, or watch TV. Patients on hemodialysis must follow a strict, limited diet. Hemodialysis can be done at the dialysis center or at home with training. Peritoneal dialysis is another procedure that removes extra water, wastes, and chemicals from your body. This type of dialysis uses the lining of your abdomen to filter your blood. This lining is called the peritoneal membrane and acts as the artificial kidney. With peritoneal dialysis, a mixture of minerals and sugar dissolved in water, called dialysis solution, travels through a soft tube into your abdomen. The sugar, called dextrose, draws wastes, chemicals, and extra water from the tiny blood vessels in your peritoneal mem- brane into the dialysis solution. After several hours, the used solution is drained from your abdomen through the tube, taking the wastes from your blood with it. Then you fill your abdomen with fresh dialysis solution, and the cycle is repeated. The process of draining and refilling is called an exchange. There are two types of peritoneal dialysis and both are usually performed by the patient without help from a partner. CAPD is a form of self-treatment that needs no machine. However, with CCPD, you need a machine to drain and refill your abdomen. The most common problem with peritoneal dialysis is peritonitis, a serious abdominal infection. This infection can occur if the opening where the catheter enters your body becomes infected or if contamination occurs as the catheter is connected or disconnected from the bags. Unfortunately, dialysis does not cure kidney failure. Hemodialysis and peritoneal dialysis are treatments that help replace the work your kidneys did. These treatments help you feel better and live longer. Although patients with kidney failure are now living longer than ever, over the years kidney disease can cause problems such as heart disease, bone disease, arthritis, nerve damage, infertility, and malnutri- tion. These problems won't go away with dialysis. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 11 of 16 Read more information online at http://www.anapolschwartz.com.
  • 12. Anapol Schwartz | Attorneys at Law WHAT ARE THE LEGAL OPTIONS IF YOUR KIDNEY FAILURE IS CAUSED BY TRASYLOL (APROTININ)? If you or a loved one has kidney failure as the result of being injected with Trasylol during cardiac bypass surgery, you may want to contact a law firm about your options. According to an independent study reported in the New England Journal of Medicine over 11,000 cases of dialysis complications occurred after being injected with Trasylol during CABG surgery. Are you one of them? Law firms such as Anapol Schwartz have successfully pursued numerous unsafe drug cases. Most likely you have questions and they will have answers. Contact a lawyer for a free legal consultation today. With Anapol Schwartz, there is never an obligation to continue and your information will be kept private. WHAT TO DO IF YOU SUFFERED A STROKE? Stroke affects nearly four out of five Americans, either actual stroke victims or someone they know. A stroke occurs when the blood supply to part of the brain is suddenly interrupted or when a blood vessel in the brain bursts, spilling blood into the spaces surrounding brain cells. Brain cells die when they no longer receive oxygen and nutrients from the blood or there is sudden bleeding into or around the brain. STROKE RISK FACTORS Several factors increase your risk of stroke. The more risk factors you have, the greater your chance of having a stroke. Some of these you can’t control, such as your age, your family health history, race, and gender. But you can modify, treat, or control most risk factors to lower your risk. Risks that can be controlled with medical treatment and lifestyle changes: • High blood pressure • High blood cholesterol • Diabetes • Obesity • Cigarette smoking • Heart disease • TIA (small strokes - take aspirin) How to recognize a stroke — try the 60 second test: 1. Ask the individual to smile. 2. Ask him to raise both arms. 3. Ask the person to repeat a simple sentence, like…It is sunny out today. If the person has trouble with any of these tasks, call 911 immediately. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 12 of 16 Read more information online at http://www.anapolschwartz.com.
  • 13. Anapol Schwartz | Attorneys at Law Stroke patients will most like display: STROKES CAUSE DISABILITY Stroke is the number one cause of adult disability, leaving two of every • Motor impairment and loss of sensation often on one side of the body three survivors with significant physical and emotional after effects. And for too long, there has not been a strong option to help survivors and • Difficulty with speech their families once they've completed their immediate rehabilitation and • Limited visual fields and trouble with visual their health care support system ends. perception Stroke Centers • Loss of emotional control and changes in mood • Cognitive deficits When someone suffers a stroke, they feel terribly alone, often angry, and • Problems with memory depressed. Stroke centers help bring light into people's lives - and the lives of their families and caregivers. Stroke is not a death sentence; • Problems with judgment rather, it’s a chance for a fresh start. • Problems with problem solving • Combination of all or some of the above The American Stroke Foundation does not duplicate existing services but complements them by providing the missing link in nurturing stroke survivors... and those who care for them. People who could barely utter words are speaking in sentences. Every day brings a new miracle. American Stroke Foundation National Institute of Neurological www.stroke-site.org Disorders and Stroke www.ninds.nih.gov American Stroke Association www.strokeassociation.org Brain Attack Coalition 1-888-4STROKE www.stroke-site.org 301-496-5751 National Stroke Association www.stroke.org 1-800-STROKES WHAT ARE YOUR LEGAL OPTIONS IF YOU’VE SUFFERED A STROKE CAUSED FROM DRUG ELUTING STENTS? If you or a loved one has experienced a stroke as the result of being injected with Trasylol during cardiac bypass surgery or from drug eluting stents, you may want to contact a law firm about your options. Unsafe drugs, failure to properly administer the correct drugs, and defective medical devices may be the cause of your cardiovascular-related stroke. The law firm of Anapol Schwartz has successfully pursued medical malpractice, unsafe drug and defective medical device cases. Most likely you have questions and the attorneys at Anapol Schwartz will have answers. Contact a lawyer at Anapol Schwartz for a free legal consulta- tion today. With Anapol Schwartz, there is never an obligation to continue and your information will be kept private. Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 13 of 16 Read more information online at http://www.anapolschwartz.com.
  • 14. Anapol Schwartz | Attorneys at Law CHECKLISTS 8 things to ask your doctor before CABG surgery 7 questions to ask about dialysis 1. Am I a candidate for CABG surgery? 1. What kind of dialysis is right for me? 2. What kind of graft will I receive? 2. Can I go to the dialysis of my choice? 3. Is one kind of graft more beneficial than another kind 3. How much time per week will I spend in dialysis? of graft? 4. Can I afford dialysis? 4. Will I have on pump surgery or off pump surgery? 5. How can I finance dialysis? 5. Will I be in pain? 6. Will I be able to keep working and have a normal life? 6. Are there any serious complications from the surgery? 7. Will dialysis cure me? 7. How long is the recovery period? 8. What will my long term prognosis be? 3 ways to recognize a stroke (within 60 seconds) 1. Inability to smile 2. Inability to raise both hands over your head 3. Inability to recite a simple sentence SUPPORT GROUPS American Association of Life Options Rehabilitation Program Kidney Patients c/o Medical Education Institute, Inc. 3505 East Frontage Road 414 D'Onofrio Drive Suite 200 Suite 315 Madison, WI 53719 Tampa, FL 33607 Phone: 1-800-468-7777 or 608-232-2333 National Kidney & Urologic Phone: 1-800-749-2257 Email: lifeoptions@MEIresearch.org Disease Center Fax: 813-636-8122 Internet: www.lifeoptions.org 3 Information Way Email: info@aakp.org www.kidneyschool.org Bethesda, MD 20892-3580 Internet: www.aakp.org Phone: 1-800-891-5390 National Kidney Foundation Fax: 703-738-4929 American Kidney Fund 30 East 33rd Street Email: nkudic@info.niddk.nih.gov 6110 Executive Boulevard New York, NY 10016 Internet: kidney.niddk.nih.gov Suite 1010 Phone: 1-800-622-9010 or 212-889-2210 Rockville, MD 20852 Fax: 212-689-9261 Phone: 1-800-638-8299 or 301-881-3052 Email: info@kidney.org Fax: 301-881-0898 Internet: www.kidney.org Email: helpline@akfinc.org Internet: www.kidneyfund.org Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 14 of 16 Read more information online at http://www.anapolschwartz.com.
  • 15. Anapol Schwartz | Attorneys at Law RESOURCES ON THE WEB Mayo Clinic: DES - www.mayoclinic.com Cleveland Clinic: CABG explanation - Opinion piece about drug eluting stents www.clevelandclinic.org Detailed explanation about coronary artery bypass graft surgery Angioplasty - www.angioplasty.org Stroke Risk Factors - www.americanstroke.org All about angioplasty surgery Risks, symptoms and how to reduce risk factors Washington Post: Stent Safety Concerns - American Stroke Association - www.americanstroke.org www.washingtonpost.com Recent research has raised alarm about the safety of a Life after stroke - what to expect, advocacy news, stroke info new generation of stents that have quickly become the for healthcare professionals most commonly used devices for treating millions of Heart Info - www.heartinfo.org heart-disease patients. A patient’s guide to bypass surgery FDA: Trasylol Advisor Press Release - www.fda.gov CABG Recovery - www.webmd.com Trasylol (aprotinin) linked to higher risks of serious side effects including kidney problems, heart attacks and strokes General timeline for heart bypass recovery, in patients who undergo artery bypass graft surgery. setting recovery goals Stents: Heart Health Online - www.fda.gov FDA: Trasylol Advisory - www.fda.gov What is a stent? What are the risks? HOW TO CONTACT US CONTACT A LAWYER / FREE NO-OBLIGATION CONSULTATION Internet: www.anapolschwartz.com Please contact us for a free no-obligation consultation. The more information that you Toll Free: can provide, the more helpful it will be. You are under no obligation to continue. Any 866-735-2792 information you provide will be held in the strictest of confidence. Email: If you have questions, please call us toll-free at 1-866-735-2792. jronca@anapolschwartz.com sweiss@anapolschwartz.com Thank you. Mail: 1710 Spruce Street, Philadelphia, PA 19103 Guide to Causes of Renal Failure and Strokes Following Coronary Surgery by Anapol Schwartz Law Firm. © 2007 All Rights Reserved. page 15 of 16 Read more information online at http://www.anapolschwartz.com.
  • 16. Anapol Schwartz | Attorneys at Law SPONSORED BY: ANAPOL SCHWARTZ WEISS COHAN FELDMAN & SMALLEY JIM RONCA, ESQ. - JRONCA@ANAPOLSCHWARTZ.COM SOL WEISS, ESQ. - SWEISS@ANAPOLSCHWARTZ.COM 1710 SPRUCE STREET, PHILADELPHIA, PA 19103