SCHOOL OF MEDICINE • DEPARTMENT OF MEDICINE

An alternative one-on-one, patient-oriented approach

The Advanced Heart Failure & Transplant Center at University Hospitals Harrington-McLaughlin Heart & Vascular Institute offers the community treatments for advanced heart disease and advanced heart failure. The Center specializes in pharmacologic and device therapy, mechanical ventricular assist devices (VADs), heart transplantation, investigational therapies and palliative care.

According to James C. Fang, MD, Medical Director, Advanced Heart Failure & Transplant Center; Associate Chief for Clinical Affairs, UH Harrington-McLaughlin Heart & Vascular Institute; and Professor, Case Western Reserve University School of Medicine, “The mission of the Advanced Heart Failure & Transplant Center is to provide the latest and most effective therapies to patients in Northeast Ohio and surrounding regions in a personalized one-on-one, patient-centered approach.”

With a high level of expertise in treating heart failure, performing heart transplants, and implanting VADs (also known as heart pumps), the Center offers another sophisticated site in Ohio for patients to consider for their heart and vascular health. One of the most important services provided by the physicians at the Center is their ability to review a patient’s current medical and device therapies and then to provide other treatment options to improve their prognosis and quality of life. “At University Hospitals Case Medical Center, we offer many options and a very personalized approach. We are proud of the fact that we offer very individualized care,” says Dr. Fang. “Many patients don’t recognize that they are suffering needlessly.”

The VAD Option
Patients seen at the Center have refractory congestive heart failure and continue to be short of breath despite medications, device therapy (such as biventricular pacemakers) and heart surgery. These patients find that even doing simple activities like taking a shower or sitting in a chair are difficult. In addition, they cannot stay out of the hospital for very long – they are often regularly admitted for shortness of breath and fluid buildup in the legs. Such patients may be candidates for heart transplantation or a VAD.

VADs are sophisticated, miniaturized pumps that help the heart to provide sufficient blood flow throughout the patient’s body. “VADs are the newest form of a mechanical heart,” says Dr. Fang. A healthy heart can normally pump about 5 L of blood per minute around the body at rest. If, for example, a patient’s heart can pump only 1 L of blood per minute, the VAD will pump an additional 4 L, for a total of 5 L of blood per minute. “The heart pump helps,” notes Dr. Fang, “without entirely taking over the function of the heart.”

Typically, heart pumps are used temporarily while a patient awaits a heart transplant. Current first generation VADs, such as the Thoratec Heartmate XVE, are also used as a “destination” therapy – a permanent solution for heart failure. These devices can function for 12 to 18 months before they must be replaced. It is anticipated that a new, second generation of heart pumps, now undergoing investigational study, will increase the duration of ventricular assistance to two to four years. Nationwide about 2,500 heart transplant operations are performed annually and the Advanced Heart Failure & Transplant Center’s heart surgeons have collectively performed hundreds of heart transplants.

Cutting-edge Technology
A second-generation device, the Heartmate II, made by Thoratec Corp., is about the size of a D flashlight battery. Once surgically implanted in the heart, the device pumps blood throughout the circulatory system, just as water flows through a garden hose, via an impeller (a corkscrew-type device) that spins at close to 10,000 RPM. The team has implanted this device in two patients this year as a bridge to heart transplant. Dr. Fang’s colleague, Arie Blitz, MD, Director, Heart Transplantation and Mechanical Circulatory Assistance, University Hospitals Case Medical Center; and Assistant Professor, Case Western Reserve University School of Medicine, reports that “both patients have done exceedingly well and continue to have the device in place.” According to Dr. Fang, the Heartmate II may be approved for “destination” therapy in patients with heart failure in the first quarter of 2010.

Dr. Fang and his team at the Advanced Heart Failure & Transplant Center have also been involved in investigational clinical trials using some of these new VADs. Dr. Fang’s team is participating in a clinical trial evaluation of the Jarvik heart, which also uses an impeller to produce blood flow. This investigational device was implanted in a patient as a bridge to heart transplant, and the transplant was performed after the device had been in place for one year. The patient is doing well, notes Dr. Blitz. Worldwide, the Jarvik heart trial has been ongoing for several years, with dozens of patients now enrolled.

Yet another VAD used at the Center is the Impella, made by Abiomed Inc. It is presently used for individuals with catastrophic heart attack or for those who require a very high-risk angioplasty. The Impella is inserted into the heart via the groin using a catheter and is only for short-term use. “The first time we used it, this device saved the life of our patient who would otherwise not have survived,” reports Dr. Blitz.

Dr. Fang’s team was the first in Northeast Ohio to place the Jarvik heart and the Impella in heart patients. The team is involved in two of the clinical trials examining the Impella. While patients with the Heartmate II or the Jarvik heart are ambulatory after recovering from surgery, those who receive the Impella must lie in bed while the device is in place.

It is envisioned that at some point more durable and smaller VADs that can be implanted without surgery could be used as a “destination” therapy – and a heart transplant may never be needed. Although clinical studies of the long-term use of the newer VADs are part of research programs, Dr. Fang reports that the results from such studies are encouraging.