Medical Device Daily Associate

Data from a newly published study demonstrated improved outcomes of patients implanted with Thoratec’s (Pleasanton, California) HeartMate XVE Left Ventricular Assist Device (LVAD) for ongoing, permanent support for late-stage heart failure, otherwise known as destination therapy (DT), the company said.

This and other findings were reported in an article, “Long-Term ‘Destination Therapy’ with the HeartMate XVE Left Ventricular Assist Device: Improved Outcomes since the REMATCH Study,” published in the May/June edition of Congestive Heart Failure by James Long, MD, and his colleagues. Long is the head of the Utah Artificial Heart Program at LDS Hospital (Salt Lake City).

Among the findings were that destination therapy LVAD therapy patients showed marked improvement even over the landmark Randomized Evaluation of Mechanical Assistance Therapy as an Alternative in Congestive Heart Failure (REMATCH) study, with an increase of one year survival to 61% from 52%.

With few advances in optimal medical management (OMM) since REMATCH, and continued improvements in LVADs, the paper reported a nearly 150% one-year survival benefit for DT LVAD therapy vs. OMM in this patient population.

The findings also demonstrated a 61% decrease in adverse events including an eight-fold reduction in sepsis deaths, the leading cause of mortality in REMATCH. The study attributes these improved outcomes to device enhancements and better patient management practices.

The results are the first since the REMATCH study in 2001 that found long-term use of an LVAD improved survival rates and quality of life for heart failure patients compared with those treated with OMM involving maximum drug therapy, diet and exercise.

The FDA approved the company’s HeartMate VE for DT in November 2002 as a result of the REMATCH study (Medical Device Daily, Nov. 8, 2002). That was followed by the Heartmate XVE – which the LDS Hospital study evaluated – in April 2003 (MDD, April 8, 2003). HeartMate continues to be the only LVAD approved for the destination therapy indication in the U.S.

The new study evaluated 42 patients from the four highest-volume centers, based on Thoratec’s FDA-mandated Destination Therapy Registry. Those centers were LDS Hospital; Advocate Christ Medical (Oaklawn, Illinois); Duke University Medical Center (Durham, North Carolina); and Texas Heart Institute Medical Center (Houston).

In addition to product improvements, the authors attributed patient management best practices, such as nutritional support, infection control and patient selection, for the improved outcomes.

Jason Mills, a medical technology analyst for First Albany Capital (San Francisco), also noted in a research report that during Thoratec’s 1Q05 earnings call at the end of April, 18-month data from LDS demonstrated that the XVE’s freedom from catastrophic device malfunction had increased at that center to 74% from 51% with the Heartmate VE in REMATCH. This new study also showed that length of stay had declined 40% vs. its experience in the REMATCH trial, cost to transplantation has declined 33%, and cost associated with rehospitalization had declined.

“In our view,” said Mills, “LVAD therapy could be at a favorable inflection point, from which we think solid, sustainable VAD growth is possible. Physicians are increasingly focusing on the concept of ‘sustained support,’ which is contributing to an accelerating practice of ‘bridging’ patients who, before HM-XVE destination therapy approval, were not bridged.”

As part of Thoratec’s effort to provide best practice guidelines for patient selection and management, the company along with the Park City Work Group, a 25-member multidisciplinary group of heart failure clinicians from throughout the U.S., issued and disseminated the Advanced Practice Guidelines for HeartMate Destination Therapy. The group consists of cardiac surgeons, heart failure cardiologists, infectious disease specialists, VAD coordinators, anesthesiologists and intensivists nationwide.

“The continued improvement of survival for these destination therapy LVAD patients is even more impressive given that the impact of LVAD therapy during REMATCH was the most significant effect ever observed for any heart failure therapy,” said Long. “By making these incremental steps, we are expanding the possibilities for helping the many late-stage heart failure patients who have little hope from conventional medical treatments by providing them the opportunity to benefit from advanced therapies.”

A company spokesperson told Medical Device Daily that the Advanced Practice Guidelines have greatly contributed to the improved patient outcomes seen in this study, “especially getting the patients from the cardiologist to the cardiac surgeons who then can recommend implanting patients with the HeartMate. That’s a key factor because sometimes cardiologists may hold on to a patient and then when they’re too far gone they send them to someone else.”

The spokesperson also noted that the Park City Work Group plays a critical role in enforcing these outcomes. “They put in their two cents as to how to treat the patient pre-, post- and peri-operation.”

“Thoratec has worked collaboratively with the clinical community on the development and dissemination of patient management best practices that improve life expectancy and quality of life,” said Jeff Nelson, president of Thoratec’s cardiovascular division in a statement. “The results of these efforts combined with the continued innovation of our next-generation assist devices demonstrate our commitment to developing device-based therapies for meeting the needs of heart failure patients and their physicians.”

Thoratec is currently enrolling patients in a Phase II pivotal trial for its next-generation heart assist device, the HeartMate II Left Ventricular Assist System (LVAS). The HeartMate II is a continuous-flow device designed to provide long-term cardiac support for patients who are in late-stage heart failure. An implantable LVAS powered by a rotary pumping mechanism, it weighs about 14 ounces and is significantly smaller than its pulsatile forebears, and so can be used in smaller individuals.

The HeartMate II is designed to have a much longer functional life than other approved devices, according to the company, and to operate more simply and quietly. Due to its small size, it also is easier to implant than pulsatile devices.

Mills said his firm believes the HeartMate II, which is currently enrolling both bridge-to-transplant and DT patients in its pivotal trial, could eventually represent a “paradigm shift in this industry, and could drive VAD growth markedly above any preliminary estimates we or the Street [are] carrying for 2006 and beyond.”

He said they believe that CE mark approval for the Heartmate II could come by year-end 2005 and think FDA approval could be granted by year-end 2006.

The company also has in development a second non-pulsatile pump, the HeartMate III, which instead of using axial flow employs a “centrifugal flow,” non-pulsatile approach. That pump is still in preclinical evaluation.