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Guest Columnist Author: Keyur B. Shah, M.D.; Daniel P. Tang, M.D.; Michael Hess, M.D; and Vigneshwar Kasirajan, M.D. Virginia Commonwealth University, Richmond, Va. Last Updated: Sep 7, 2017 - 10:06:33 PM



Study Underway to Evaluate New Driver Designed To Provide Total Artificial Heart Patients With The Ability To Live At Home

By Keyur B. Shah, M.D.; Daniel P. Tang, M.D.; Michael Hess, M.D; and Vigneshwar Kasirajan, M.D. Virginia Commonwealth University, Richmond, Va.
Sep 7, 2010 - 3:35:59 PM



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The Situation

(HealthNewsDigest.com) - Cardiovascular disease (CVD) is the leading cause of death in the U.S. for both men and women, with an estimated 80,000,000 (one in three)1 adults having one or more types of CVD. Approximately 5,700,0001 people currently suffer from heart failure and 670,000 new cases are diagnosed annually.

Of the nearly 300,000 annual deaths in the U.S. attributed to heart failure, it is estimated that up to 100,000 people could benefit from mechanical circulatory support devices, which are surgically implanted mechanical pumps that provide blood flow to supplement or replace the blood flow normally generated by the native heart. When patients progress to end-stage biventricular failure, where both sides of the heart fail to pump enough blood to sustain the body, vital organs like the kidneys, lungs, liver and brain are starved of oxygen and nutrients, and start to shut down. For transplant-eligible patients suffering from end-stage biventricular failure, there are two treatment options: an immediate donor heart transplant or a mechanical circulatory support device to serve as a “bridge to transplant.”

The Challenge

Many patients who are candidates for heart transplantation, the definitive therapy for late stage heart disease, die on the waiting list. In fact, while the number of people on the heart transplant wait list continues to grow, for the last 20 years, the supply of donor hearts has remained flat, with approximately 2,100 available each year in the U.S.

Heart failure patients are treated under the vigilant guidance of their cardiologists, but their disease inevitably progresses. Mechanical circulatory support offers these patients increased blood flow, which helps improve end-organ perfusion. Most importantly, these devices buy time for recovery of organ function and for a donor heart to become available for transplant.

Mechanical Circulatory Support Devices

The options for implantable mechanical circulatory support devices for heart failure include left ventricular assist devices (LVAD) and the Total Artificial Heart (TAH). A typical LVAD provides additional blood flow by drawing blood out of the left ventricle and pumping it into the aorta, which provides blood flow to the rest of the body. While an LVAD can help slow the progression of heart failure, it cannot stop it. Similar to a heart transplant, the Total Artificial Heart replaces both of the native ventricles, and all four cardiac valves. It is the only device that eliminates the symptoms and source of end-stage biventricular heart failure. By replacing the damaged heart, the Total Artificial Heart also eliminates native heart complications including:

* right ventricular failure
* arrhythmias
* blood clots in the ventricles

The Total Artificial Heart

Currently, the only temporary Total Artificial Heart approved by the U.S. Food and Drug Administration (FDA) is the SynCardia temporary Total Artificial Heart. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles. This high volume of safe blood flow helps vital organs recover faster and makes patients better candidates for their heart transplant.

The Total Artificial Heart has proven to be effective therapy for bridging near-death patients to heart transplantation. There have been over 850 implants, accounting for more than 200 patient years of life on the device worldwide.

418-lb Driver Confines Patients to the Hospital

Enthusiasm for utilizing the Total Artificial Heart has been limited because patients with the device are connected to a 418-pound pneumatic driver nicknamed “Big Blue,” which powers the Total Artificial Heart but does not allow hospital discharge. While these clinically stable patients continue to rehabilitate in the hospital, they are forced to live apart from their families. Being trapped in the hospital is physically, financially and emotionally draining for these otherwise stable patients.

Life Outside the Hospital for Total Artificial Heart Patients

The FDA, however, has recently granted conditional approval for the 13.5 lb Freedom™ portable driver to undergo an Investigational Device Exemption (IDE) clinical study in the United States. Through the IDE study, stable patients who meet enrollment criteria will have the option to be discharged from the hospital supported by the portable battery power of the Freedom driver. This pneumatic driver is designed to be carried in a backpack or shoulder bag. The driver is intended to allow patients with the Total Artificial Heart to await heart transplantation at home with their families rather than in the hospital. For ease of use, the Freedom driver utilizes a ‘dark cockpit design’ meaning the patient is only alerted when something requires their attention, such as low-battery power. While data on the safety and efficacy of the Freedom driver will be available only after completion of the study, it has already received CE approval for commercial use in Europe.

Post Surgical Management

A majority of patients are medically stable within the first month of receiving the Total Artificial Heart. Once stable, patients begin an aggressive program of physical rehabilitation. It is from this time forward until they receive a matching donor heart (average wait in 2009: 144 days) that stable patients may be able to live at home through the IDE clinical study while eliminating most in-hospital costs for this portion of their care.

The IDE clinical study is expected to enroll 60 patients and will follow them until 90 days of Freedom support, transplant or death. The institutions currently certified to participate in the IDE clinical study for the Freedom portable driver include many of the nation’s most prestigious transplant hospitals.

To learn more about the Total Artificial Heart and the Freedom driver visit: www.syncardia.com or Virginia Commonwealth University Medical Center at http://www.pauleyheart.vcu.edu/

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