HeartRecovery.com: why heart recovery

Why Heart Recovery

Heart failure can happen to anyone, at anytime. In fact, according to the National Heart, Lung and Blood Institute five million people in the U. S. have heart failure and the number is growing. Each year, another 550,000 people are diagnosed for the first time. It contributes to or causes about 300,000 deaths each year.

Though there are many different causes of heart failure, the disease is often categorized as being either acute (sudden) or chronic (gradual over time).

There are approximately 635,000 U.S. patients with acute heart failure each year (2006 American Heart Association Statistics), many of whom have never had any previous heart problems. Then, without much warning sudden heart failure can develop.

**If you or one of your family members is experiencing chest pain or difficulty breathing it is important to see a doctor as soon as possible.**

Common Causes for Acute Heart Failure

Post Cardiotomy Cardiogenic Shock:: Shock that takes place during open heart surgery, as a result the patient cannot come off heart-lung support. (~1-2% Heart Surgeries)
Acute Myocardial Infarction or Heart Attack-Card. Shock:: Damage to heart muscle that causes cells to die. (~7% AMI's)
Myocarditis:: Inflammation of the heart muscle brought on by a virus or bacteria. (U.S.~4K year)

Treatment Options

Patients who experience a heart attack (acute myocardial infarction or AMI) followed by cardiogenic shock, or other acute cardiac events such as myocarditis, might require support to their weakened heart in order for it to continue to circulate blood to the body. Currently, the first-line of therapy for a patient with diminished heart function is the use of drugs called inotropes, which strengthen the contractions of the heart. These medications are often used in conjunction with Intra-Aortic Balloon Pumps (IABPs), which are medical devices placed in the descending aorta that inflate and deflate in response to a patient's heart contractions. For some patients, use of inotropes actually weakens the heart over time as they force the muscle to work harder, when it would benefit from rest. For patients with little or no heart function, medications and IABPs are not sufficient.

For patients who require more support, external Ventricular Assist Devices (VADs) can be used. These can provide support to a patient's heart for several months. VADs are inserted into the right, left or both ventricles via a cannula to treat patients suffering from reversible ventricular dysfunction. Typical patients have undergone successful cardiac surgery and subsequently developed low cardiac output, or have suffered from acute cardiac disorders leading to hemodynamic instability and need more support than an IABP and inotropes can provide.

Recovering a Patient's Native Heart is the Best Option

For patients who are otherwise healthy, it is often possible to recover the heart and thereby avoid a heart transplant. Unlike most other muscles in the body, the heart must work constantly, even after a damaging and traumatic event like a heart attack. By using a minimally intrusive VAD to perform the function of the heart, physicians can allow their patients' hearts time to rest and potentially recover.

Heart transplant surgery means a lifetime of immunosuppressive medications-which can cost roughly $30-50,000 annually and have an impact on quality of life as they suppress the entire immune system making a person more susceptible to common viruses and bacteria, cause frequent hospital visits and side effects. Other side effects include co-morbidities such as diabetes and having to endure routine biopsies to make sure the organ is not being rejected. On average 50 percent of heart transplant recipients are still alive 10 years out from their surgery. In addition, only 2,100 heart transplants are performed on average each year in the U.S., as there are few donor hearts available for the thousands of patients in-need. It is a preferable option for patients who can recover their hearts to do so-allowing the few donor hearts to go to the patients who have no chance of recovering the natural function of their heart.

The Abiomed BVS 5000 and AB5000 are both FDA approved as bridge-to-recovery devices. In fact, these are the only ventricular assist devices with labeling for Heart Recovery. These devices encourage recovery as they are gentle on the heart, utilizing thin cannulae inserted through a small incision, rather than more traumatic bridge-to-transplant devices that core the ventricles.

Transplant can still be an Option for patients who do not recover their hearts

Insurance Information

Recently, the Centers for Medicare and Medicaid Services (CMS) updated the reimbursement for the successful recovery of the native heart with external VADs. This change, which went in effect on October 1, 2005, provides more than 70% increased reimbursement for this device. Most major insurance carriers currently reimburse for ventricular assist devices used for recovering the patient's native heart. The recent changes made by CMS further support the need for increased focus on recovery as prevention-based care that can reduce the excess demand for heart transplants or chronic cardiac device support.

Where can I find more information?

More information is available at www.abiomed.com. These devices are used around the world by transplant and non-transplant centers alike. Your local hospital may be able to provide additional detail.

GLOSSARY OF TERMS

Acute Myocardial Infarction (AMI): Also called heart attack, usually caused by a blocked coronary artery, which prevents blood and oxygen from nourishing the heart muscle.
AngioFlex™: A proprietary Abiomed material.
Angiogram: A series of x-rays of the blood vessels in the heart taken in rapid sequence following the injection of a contrast substance into the blood stream.
Angioplasty: Performed in the catheterization lab in which a catheter-guided balloon is used to open a narrowed coronary artery. A stent (a wire-mesh tube that expands to hold the artery open) is usually placed at the narrowed section during angioplasty.
Anticoagulants: Non habit-forming medications that keep existing blood clots from growing larger as well as prevent the formation of new blood clots.
Aorta: The large arterial trunk that carries blood from the heart to be distributed by branch arteries through the body.
Arteries: The thick, muscular tubes that carry blood away from the heart.
Bi-VAD: Bi-Ventricular Assist Device. Supports both sides of the heart
Blood thinner: Medication used to prevent blood clots or keep the blood in a liquid form (for example, Coumadin®).
Blood vessels: An extensive network of flexible tubes that carries blood to and from the heart and throughout the body. The blood vessels are the transportation system of the body. The blood vessels include arteries, capillaries and veins.
Bridge-to-recovery: A medical device that can support the heart until it is able to recover and operate fully on its own.
Bridge-to-transplant: A medical device that can temporarily function in place of a heart until a suitable heart transplant becomes available.
CABG (pronounced "Cabbage"): Coronary Artery Bypass Grafting. A heart surgery procedure that treats the symptoms of coronary artery disease. CABG surgery reroutes (or 'bypasses') the blood flow around the blockages in the coronary arteries, restoring blood flow to the heart muscle itself.
Cannulae: Tubes that connect the heart and blood vessels to a mechanical pump.
Console: The part of the system that drives the blood pumps, thus allowing the blood to flow through its normal cycle. The console is powered by electricity and has a back up battery.
Cardiogenic shock (CS): A condition that often takes place after a heart attack when cells in the heart start to die, due to the failure of the heart to pump an adequate amount of blood to the heart.
Catheterization lab: A facility in most hospitals in which minimally invasive cardiac procedures, like stent placement and angioplasty take place, most often by a cardiologist via a catheter. The lab is often one of the first stops in the hospital for patients experiencing cardiac problems, before they move to the surgical suite where more invasive procedures, like VAD placement or cardiac surgery, take place.
CE-Mark: The approval of manufacturing and quality systems identified with the ISO 9001 certification. This label allows a medical device company to commercialize products in Europe.
CMS: The Centers for Medicare and Medicaid Services, a division of Health & Human Services (HHS), the largest payer of healthcare in the U.S. Patients over 65 or with disabilities qualify for coverage from the U.S. Government.
Coronary Heart Disease (CHD): A disease in which plaque deposits containing cholesterol atherosclerosis and fat globules are deposited within the arteries.
Destination Therapy: A permanent implant. It can consist of a device or a transplant to assist or replace the heart.
Heart Failure: Heart failure is almost always a chronic, long-term condition, although it can sometimes develop suddenly. This condition may affect the right side, the left side, or both sides of the heart. As the heart's pumping action is lost, blood may back up into other areas of the body, including: the liver, the gastrointestinal tract and extremities (right-sided heart failure), the lungs (left-sided heart failure). Class 4 heart failure is the condition when a patient is exhausted, short of breath or fatigued when just sitting still or lying down in bed.
Inotropes: Inotropes are non-habit-forming medications that strengthen the contractions of the heart.
Interventional cardiology: A specialized area of medicine that focuses on diagnostics, treatment and management of patients with cardiovascular disease.
Intra-aortic balloon pump (IABP): IABP is a medical device that works by squeezing the Aorta but does not unload blood from the ventricle. It is reserved for critically ill people. Though imperfect, an IABP is able to save some critically ill people.
Ischemic: A decrease in the blood and oxygen supply to an organ or tissue in the body.
Left atrium: Receives oxygen enriched blood from the lungs and passes this on to the left ventricle.
Left ventricle: Receives blood from the left atrium and pumps it to the aorta, supplying the entire body with blood.
Myocardial revascularization: Restoring blood flow to the myocardium (heart muscle).
Myocarditis: Inflammation of the heart muscle brought on by a virus or bacteria, which may even result from allergic reaction.
Open heart centers: Hospitals that perform open heart surgery such as valve repair or replacement, coronary artery bypass, or any other non-transplant procedure.
Paracorporeal: Refers to "outside the body," describes the location of the ABIOMED Ventricular Assist Device lying on top of the abdomen.
Pulmonary artery: Receives blood from the right ventricle and passes it to the lungs where it is enriched with oxygen.
Post Cardiotomy Cardiogenic Shock (PCCS): Cardiogenic shock that takes place during open heart surgery, often as a result the patient cannot come off heart-lung support machine.
REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure): A randomized study sponsored by the National Heart, Lung and Blood Institute (NHLBI) that evaluated LVADs as long-term destination therapy. Compared with previous trials, REMATCH enrolled patients with far more advanced heart failure. Although investigators had hoped to further optimize standard therapy, nearly all patients randomized to medical therapy (the non-LVAD group) were already receiving optimal medical management (OMM).
Right atrium: Receives oxygen depleted blood from the body and passes it on to the right ventricle.
Right ventricle: Receives blood from the right atrium and pumps it through the pulmonary artery into the lungs where it is enriched with oxygen.
Six Sigma: A set of statistical tools used to solve problems and improve processes. Used in manufacturing, engineering and hospitals for continuous improvement.
Transplant center: Hospitals that perform heart transplants. About 2,200 transplants are performed each year at approximately 100 centers in the U.S.
VAD: Ventricular Assist Device. A ventricular assist device (VAD) is a mechanical pump device that is surgically implanted or attached externally with a cannulae. It helps maintain the pumping ability of a heart that cannot effectively work on its own. They can be LVAD (left VAD), RVAD (right) or BiVAD (both side).
Valves: Flap-like structures that maintain blood flow in one direction only, through the heart and pump.
Vasodilators: Agents that open vessels by relaxing their muscular walls. For example, nitroglycerin is a vasodilator.