Device Options
HeartMate II Destination Therapy Clinical Trial Data Highlights:
The HeartMate II Destination Therapy pivotal clinical trial was a prospective, randomized evaluation of the HeartMate II LVAS.
Patients were randomly assigned to treatment with the HeartMate II LVAS or to treatment with the HeartMateŽ XVE LVAS (control group) on a 2-1 basis, respectively.
The HeartMate XVE had been the gold standard device for destination therapy, based on the results from REMATCH trial, which demonstrated its superiority over medical therapy.
The DT trial involved 200 total patients at 38 sites in its primary cohort.
Also included in the primary analysis were data on 24 small BSA (body surface area) patients, who because of their body size, could not be randomized to the XVE.
The PMA filing included data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by a HeartMate XVE and based on the need for device replacement, elected to receive a HeartMate II as well as patients enrolled under Continuous Access Protocols (CAPs).
The objective of the DT trial was to determine the safety and efficacy of the HeartMate II LVAS for long-term support in advanced stage heart failure patients who did not qualify for cardiac transplantation.
After implantation, patients were followed for a two year period.
Key outcomes of the trial include:
Treating patients with HeartMate II leads to dramatically improved survival, functional capacity and quality of life unequaled by any other heart failure therapy.
Survival: The HeartMate II Destination Therapy trial demonstrated superior survival in this severely debilitated, high-risk advanced stage heart failure population with survival of 68 and 58 percent at one and two years.
The HeartMate II demonstrated a three-fold increase in survival at 24 months compared to XVE and six-fold increase compared to the medical therapy arm from the REMATCH trial.
Note: The DT patient population average age was 64 vs. BTT at 55; and the population had comorbidities/malignancies not qualifying them as cardiac transplant or BTT candidates (e.g. history of cancer, diabetes, obesity, pulmonary hypertension, renal dysfunction etc).
Quality of Life/Functional Capacity: Dramatic improvements in functional capacity and quality life have been established in both Bridge-to-Transplantation and Destination Therapy.
At baseline, 97 percent of DT trial patients were NYHA Class IV/IIIB. Seventy-five percent improved to Class I or II at 3 months and 80 percent were Class I or II at 24 months.
There was a substantial and sustained improvement in the HM II patients' 6-minute walk tests as the number of meters walked at two years more than doubled from baseline.
At two years, HeartMate II patients achieved a median 6-minute walk of 372 meters, more than the distance of 4 American football fields.
Improvement in quality of life was also substantial among HeartMate II DT patients as measured by both the Minnesota Living with Heart Failure (MLWHF) and Kansas City Cardiomyopathy (KCC) questionnaires. At baseline, the mean MLWHF score was 75.4, which studies have associated with NYHA Class IV heart failure and improved to a mean MLWHF score of 31.1 at two years, which has been associated with NYHA classification between I and II.
The improvement in quality of life as measured by the KCC questionnaire was equally substantial, more than doubling from a baseline score of 27.4 to a score of 69.9 at two years.
Significant Reduction of Adverse Events: There were significant reductions in major adverse events with HeartMate II compared to HeartMate XVE patients including device-related infections, non-device related infection, right heart failure, respiratory insufficiency, renal failure, and cardiac arrhythmias.
There were no failures of the primary pump mechanism.
Improved Patient Selection Criteria: Appropriate patients for this therapy may be easily selected, utilizing a simple screening methodology, allowing for positive outcomes.
By utilizing this model to identify patients who are at risk of mortality due to heart failure and referring those patients on for advanced therapies such as DT, clinicians should be able to achieve superior outcomes in their advanced heart failure patient populations.
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