Abstract 1762: An Emerging Option for Women with Advanced Heart Failure: Results of the HeartMate II Continuous Flow Left Ventricular Assist Device Bridge to Transplant Trial
Introduction: Women with advanced heart failure (HF) are under-represented in left ventricular assist device (LVAD) trials. Only 9–16% of patients (pts) studied in investigations of the first generation HeartMate pulsatile LVADs were women. Many women were excluded from participation based on the relatively large LVAD:body size relationship. We report the experience of women implanted with a new, smaller (25% weight of the pulsatile pump) continuous flow LVAD in the HeartMate II (HMII) bridge to transplantation trial.
Methods: 231 pts (23% female) with NYHA Class IV HF received the HM II as a bridge to cardiac transplantation at 40 centers. We compared changes in functional capacity and outcomes between female (F) and male (M) recipients.
Results: Pt baseline characteristics are shown (Table⇓). Out of 194 patients with 6 mo followup, the percent of patients who survived to undergo transplant, device explantation after ventricular recovery, or were ongoing at 180 days of support were similar (79.5%F vs. 80.6%M). RV dysfunction requiring temporary RVAD occurred in 10 pts (9.0% F, 4.0% M). Perioperative stroke (day 0–2) occurred in 6 pts (3.3%F, 2.2% M), and stroke after day 2 in 12 pts (13.6% F, 4.0% M). After 3 months of support 76% F and 57% M increased their 6 minute walk distance > 200 m, and 84% F and 84% M had NYHA functional class I or II symptoms. Median duration of support (F: 175, range 8 – 667 days vs. M: 130, range 0 – 693 days) were similar. The 11 smallest pts were all F with BSA < 1.5 m2 and 100% were survivors at 180 days.
Conclusion: The HM II LVAD offers an emerging therapeutic option to women with advanced HF who were previously denied implantable LVADs due to smaller body size, with results equivalent to those from men.