Apex of the Heart – the lowest superficial part of the heart

Artery – vessels that carry oxygenated blood away from the heart to the rest of the body

Cannula - small flexible tube that can be inserted into the body

Cardio Disease - another name for heart disease, a disorder that affects the heart

Cardiovascular Disease - any disease of the heart or blood vessels

Heart Disease - a disorder that affects the heart

Heart Failure - failure of the heart to pump blood with normal efficiency

Left Ventricle - lower left chamber of the heart, it receives blood from the left atrium and pumps the blood out through the aorta to the rest of the body

Left Ventricular Assist Device (LVAD) - a mechanical device that performs the functions of the failing ventricle to restore normal blood flow

Percutaneous – a procedure or passage through the skin

Pulmonary Artery – one of two arteries that carry blood to lungs to pick up a fresh supply of oxygen

Ventricle – lower chamber(s) of the heart

Heart failure is a condition in which the structure or function of the heart does not allow for sufficient cardiac output, or blood flow, to satisfy the body’s needs. It is different from cardiac arrest, a situation in which there is no cardiac output at all. When activity levels are normal and the blood flow is low, it is often referred to as congestive heart failure.

Classification of Heart Failure

There are many different ways to categorize heart failure, including:

• The side of the heart involved (left heart failure vs. right heart failure).
• Whether the abnormality is due to contraction or relaxation of the heart (systolic dysfunction vs. diastolic dysfunction).
• Whether the problem is primarily increased venous back pressure (behind) the heart or failure to supply adequate arterial perfusion (in front of) the heart (backward vs. forward failure).
• Whether the abnormality is due to low cardiac output with high systemic vascular resistance or high cardiac output with low vascular resistance (low-output heart failure vs. high-output heart failure).
• The degree of functional impairment conferred by the abnormality (as in the NYHA functional classification).

New York Heart Association (NYHA) Functional Classification

The NYHA Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain.

The classes (I-IV) are:

• Class I: No limitation is experienced in any activities; there are no symptoms from ordinary activities.
• Class II: Slight, mild limitation of activity; the patient is comfortable at rest or with mild exertion.
• Class III: Marked limitation of any activity; the patient is comfortable only at rest.
• Class IV: Any physical activity brings on discomfort and symptoms occur at rest.

This score documents the severity of symptoms, and can be used to assess response to treatment. While its use is widespread, the NYHA score is not very reproducible and doesn’t reliably predict the walking distance or exercise tolerance in formal testing.

American College of Cardiology (ACC) Classification System

In its 2001 guidelines, the American College of Cardiology (ACC) / American Heart Association (AHA) working group introduced four stages of heart failure:

• Stage A: Patients at high risk for developing heart failure in the future, but no functional or structural heart disorder.
• Stage B: Structural heart disorder, but no symptoms at any stage.
• Stage C: Previous or current symptoms of heart failure in the context of an underlying structural heart problem, but managed with medical treatment.
• Stage D: Advanced disease requiring hospital-based support, a heart transplant, or palliative care.

The ACC staging system is useful in that Stage A encompasses “pre-heart failure” – a stage where intervention with treatment can presumably prevent progression to overt symptoms. ACC Stage A does not have a corresponding NYHA class. ACC Stage B would correspond to NYHA Class I. ACC Stage C corresponds to NYHA Class II and III, while ACC Stage D overlaps with NYHA Class IV.

How Do Left Ventricular Assist Devices Help?

Patients with NYHA Class III or IV heart failure may benefit from a current treatment that involves the use of the Heartmate II, which is a left ventricular assist device (LVAD). LVADs are battery-operated mechanical pump-type devices that are surgically implanted on the upper part of the abdomen. They take blood from the left ventricle and pump it through the aorta. LVADs are becoming more common and are often used by patients who have to wait for heart transplants.

Related Articles:

• Left Ventricular Assist Devices
• Heartmate II LVAD Recall

Established in 1976, Thoratec Corporation now offers the broadest range of products for treating chronic heart failure patients. Since merging with Thermo Cardiosystems Inc. in 2001, they have become the world leader in mechanical circulatory support. 

Thoratec develops, manufactures and markets proprietary medical devices used for circulatory support, vascular graft applications, point-of- care diagnostic test systems and skin incision products. A world leader in products to treat cardiovascular disease, Thoratec offers the broadest range of mechanical circulatory support devices available. With its strong commitment to clinical affairs and research, Thoratec Corporation is also a frontrunner in a wide range of emerging markets driven by the development of advanced technology and the approval of new therapy and product indications.

Company Mission

The Thoratec Corporation utilizes the latest technologies to create a variety of products that assist patients with failing hearts allowing them to live normal, full lives.

Products by Thoratec

• Thoratec® PVAD™ (Paracorporeal Ventricular Assist Device)
• Thoratec® IVAD™ (Implantable Ventricular Assist Device)
• HeartMate® I LVAS (Left Ventricular Assist System)
• HeartMate II® LVAS* (Left Ventricular Assist System)
• Thoratec® CentriMag® Blood Pump

If you or a loved one have been injured by the HeartMate II LVAS’s defective percutaneous lead, you need to speak with a qualified attorney that can review your inforamtion and determine if you have a case. When you are looking for the right partnership, here are a few things to keep in mind:

• Frequently word of mouth is a reliable means of finding a good legal representative. A trusted friend or relative who has had cause to use and successfully win a product liability case with an attorney is a good place to start.
• If that isn’t possible, go online and search for one. There are numerous organizations available in your state that can assist you with your case, and may even offer you the telephone numbers of former clients who are willing to testify on the law office’s behalf.
• For access to qualified lawyers in your area, complete the “Contact Us” form located on this site, you will receive information from qualified lawyers in your area who have experience in product liability and are able to review your case.

Make sure that the lawyer who represents you is a fully qualified graduate of an accredited law school and has passed all required bar exams. Of course, it is preferable to find someone who has extensive experience with product liability cases.

The early VADs emulated the heart by using a “pulsatile” action where blood is alternately sucked into the pump from the left ventricle then forced out into the aorta. Devices of this kind include the HeartMate, which was approved for use in the U.S. by the FDA in October 1994. These devices are commonly referred to as first generation VADs.

More recent work has concentrated on continuous flow pumps, which can be roughly categorized as either centrifugal pumps or axial flow impeller driven pumps. These pumps have the advantage of greater simplicity resulting in smaller size and greater reliability. These devices are referred to as second generation VADs. A side effect is that users will not have a pulse or that the pulse intensity will be seriously reduced, and users will need to carry documentation saying that the lack of a pulse does not mean that they are dead.

Third generation VADs suspend the impeller in the pump using either hydrodynamic or electromagnetic suspension, thus removing the need for bearings and reducing the number of moving parts to one.

Another technology undergoing clinical trials is the use of transcutaneous induction to power and control the device rather than using percutaneous cables. Apart from the obvious cosmetic advantage, this reduces the risk of infection and the consequent need to take preventative action. A pulsatile pump using this technology has CE Mark approval (meets European guidelines) and is in clinical trials for U.S. FDA approval.

On October 24, 2008, Thoratec issued a world-wide recall of the Heartmate II Left Ventricular Assist System (LVAS) with catalogue numbers 1355 and 102139. These systems have ben distributed since the beginning of clinical studies starting in November 2003. According to the FDA Recall information:

Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Anyone who has is currently supported by the HeartMate II LVAS should contact their doctor immediately so that the percutaneous lead can be assessed for wear and fatigue. There has been 27 confirmed cases where the system needed to be replaced. Five deaths have resulted in patients who were unable to receive a pump replacement.

If you or a loved one has been injured by from this defective product, contact us immediately to find out your legal rights.

HeartMate II Left Ventricular Assist System is Thoratec’s newest Left Ventricular Assist Device (LVAD). Its goal is to provide up to 10 years of circulatory support to patients suffering from heart failure. By helping maintain appropriate levels of blood flow, HeartMate II LVAS helps patients survive and live fuller lives.

How Does It Work?

The HeartMate II device is compact in size and is surgically implanted into the patient’s abdomen. It is most commonly used with patients who are suffering from chronic heart failure. Blood enters the device through a tube that is connected to the left ventrical of the heart. As the heart beats, the blood is emptied into the device and a second feature, a flexible diaphragm moved by a pusher plate, drives the blood onward to the aorta. Once the blood reaches the aorta, the main artery that supplies the body with blood, it is dispersed to the rest of the body. The HeartMate can sufficiently pump 10 liters of blood per minute, which is ample blood for the body to maintain normal activity levels.

Who Can Benefit from the HeartMate II?

Ventricular assist devices (VADs) are most commonly used with patients who are suffering from heart failure and have expended all other treatment options with little success. In most cases, the HeartMate is implemented with those patients who have reached stage IV of the disease and/or are in a chronic condition and are waiting for an available transplant.

There are many potential Thoratec HeartMate II cases currently under investigation across the United States. Anyone who is currently using a Thoratec HeartMate II Left Ventricular Assist System with catalogue numbers 1355 to 102139 is impacted by this FDA recall. The percutaneous lead that connects The Thoratec HeartMate 2 Left Ventrical Assist System with the System Controller has been found to wear or fatigue over time. This wearing down could interrupt pump function, resulting in surgery to replace the heart blood pump or potentially result in death.

What Should You Do?

First, anyone affected by this recall should contact their physician to check the percutaneous lead on their device and get answers to any questions about what this may mean for their health. Seek medical attention immediately if you suspect damage to the percutaneous lead. We have HeartMate pump lawyers that are investigating potential lawsuits for individuals who have required medical treatment as a result of potential damage to the percutaneous lead. To review your legal rights, request a consultation and claim evaluation, please complete our contact us form and we will connect you with a qualified, product liability lawyer in your area.

The statute of limitations are particular to each state in the United States. They have to do with products, including medical devices, that cause personal injury or death resulting from its proper usage. Specifically, the statute of limitations sets forth boundaries under which you may or may not file suit against a corporation due to the use of its product.

It is best to consult with a lawyer who is familiar with your state’s statue of limitations. If you need assistance finding a lawyer, fill out the “Contact Us” form to receive information on lawyers who are expertised in product liability and statute of limitations, and are able to assist you.

What Type of Limitations Exist?

It depends on where you live. Essentially most statutes insist that you can only file suit during the time that the product has caused you injury. However, there is an allowance for “delayed discovery”, meaning the statute of limitations doesn’t begin until you discover the injury.

What Is Product Liability?

In any given product liability case, including that of HeartMate II, you don’t have to prove negligence. Product liability instead refers to strict liability, meaning that the product was defective, it injured you, and it is the cause of your injury.

There can be one or there can be several issues in a product liability case including the following:

• The use of a defective product, in this case the Thoratec HeartMate II LVAS.
• The use of the product when it was not defective but caused unexpected and extreme harm during usage.

Who Is Held Responsible?

The manufacturer against whom the lawsuit was filed, in this case Thoratec may be held responsible if you win your case.

What Types of Damages Will I Recover?

That is entirely dependent upon your individual case, your personal injuries or death of a loved one and the decision of the presiding judge. There are four types of damages you may receive including compensatory, covering your medical bills, pain and suffering, for emotion and physical angst, loss of consortium (negative effects on your relationship with your spouse) and punitive damages, wherein the court’s intention is to ensure the defendant, in this case Thoratec, never repeats the same offense.

First, understand the definition of “product liability”. A product liability, in this case referring to Heartmate II LVAD, means that a product you used correctly, caused extreme and unusually long-term damage to you or a loved one in some manner. If you suffered stress or injury due to failure of the percutaneous lead in the Heartmate II LVAD, you need to consider several issues before filing a product liability lawsuit.

What Are the Statute of Limitations?

The statute of limitations determines the length of time in which you have to file suit against the defendant, in this case it will likely be Thoratec. This statute is different in every state and it doesn’t last long, so it is in your best interest to act quickly.

Who Is Eligible?

Anyone who has been affected by the FDA recall for the defective percutaneous leads on the Thoratec Heartmate II LVAD is eligible to bring suit against Thoratec.

Questions to Ask Before Hiring a Product Liability Attorney

1. Will it cost me a lot of money to file a lawsuit? It depends on your attorney and even on the state where you live. Many product liability cases use a “contingency fee”, meaning your attorney only gets paid in the event that you win your case. If you do win, then your attorney receives a percentage of your settlement.
2. What do I need to provide to my lawyer? There is a long list of documents your lawyer needs in order to accurately represent you in court. Some of these documents include your HeartMate II LVAS information; medical receipts; copies of your medical records; time you missed from work; a journal wherein you documented all of your experiences since beginning the treatment. There may also be other documents your lawyer will ask you to provide.

Understanding Settlements

It can be more difficult to win a product liability case than you might think. Keeping a journal and documenting everything in terms of your HeartMate II LVAS use from the time you began it until the time you discovered personal injury is very wise. If you haven’t done so, begin now.

If you did not use your HeartMate II LVAS in the proper manner that was suggested to you by both your medical advisor and the instructions that came with the product, then Thoratec may not be held liable. In other words, you will be held responsible for your own injuries and not be allotted a settlement if you didn’t use the device properly.

In the event that you do win your case, congratulations! That said, there are different types of settlements your lawyer may pursue although you may not be awarded all of these:

• Punitive damages – Lately, many jurisdictions are limiting punitive damages. These damages are brought against the defendant in an effort to dissuade the defendant not to commit any such act again in the future. In many states, there is a constitutional limit on punitive damages; however, this is not true of federal cases.
• Compensatory damages – These damages are most common should you win your case. They will cover your medical bills and time away from work due to injury from the Heartmate device.
• Pain and suffering – Just as the name implies, these damages are brought against the defendant for causing you pain and suffering due to your usage of HeartMate II.
• Loss of consortium – If you and your spouse have suffered in your relationship with one another (including the death of your spouse if he/she was using the device), then you may also receive damages due to loss of consortium (the benefits of a family relationship).