Multicenter Evaluation of an Intrapericardial Left Ventricular Assist System

Study Questions:

What is the safety and efficacy of the HeartWare Ventricular Assist Device (HVAD; HeartWare Inc., Framingham, MA) implanted into transplant candidates with end-stage heart failure?

Methods:

This was a multicenter, nonrandomized, prospective, single-arm study of the HVAD implanted into 50 cardiac transplant candidates at five medical centers in Europe and Australia. The primary outcome of interest was survival to heart transplant, device explant for recovery, or continued support at 180 days.

Results:

Median (range) patient age was 49 (20-75) years, 86% were male, 92% were INTERMACS profiles 2 or 3, and 100% were on preoperative inotropes. The median duration of support was 322 (12-847) days. There were 41 survivors (82%) at study completion and nine deaths (18%), which occurred after a median 94 (13-515) days of support. Of the survivors, cardiac transplant occurred in 40% (n = 20), 8% (n = 4) had pump explantation for myocardial recovery, and 34% (17) remained on support at 2 years. Actuarial survival at 6, 12, and 24 months after device implant was 90%, 84%, and 79%, respectively, compared with Seattle Heart Failure Model (SHFM) predicted survivals of 73%, 58%, and 40% with continued medical therapy. The hazard ratio for HVAD therapy at 1 year using the SHFM predictions as a hypothetical control was 0.29 (p < 0.001). The average readmission rate following HVAD implant was 1.2 admissions/patient-year, which was a 74% reduction when compared to the year prior to device implant. The adverse event rate was 1.9 events/patient-year and included surgical bleeding (0.23 events/patient-year), device replacement (0.15 events/patient-year), right heart failure (0.06 events/patient-year), and driveline infection (0.20 events/patient-year). Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire significantly improved in all areas from baseline by 6 months postoperative.

Conclusions:

The HVAD can be used to safely and effectively support transplant candidates with end-stage heart failure.

Perspective:

The HVAD is a new centrifigual flow device that offers promise for long-term cardiac support of end-stage heart failure. The design of this device is attractive surgically because of its small size and intrapericardial location, potentially reducing operative time, bleeding, and infection risks. In this small study of stage D heart failure patients (all of whom were on inotropes), prognosis with medical therapy alone was estimated to be very poor (<50% survival at 1 year), but outcomes following HVAD implant at 12 and 24 months were outstanding. Quality of life improvements were commensurate with prior VAD studies. Larger trials are underway to examine the HVAD’s performance in both bridge to transplant (ADVANCE) and destination therapy (ENDURANCE) populations. Stay tuned….

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Mechanical Circulatory Support

Keywords: Survivors, Heart Diseases, Prognosis, Operative Time, Kansas, Heart-Assist Devices, Cardiomyopathies, Australia, Heart Failure, Europe, Heart Transplantation


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