Abstract 14430: Outcomes in Advanced Heart Failure with Left Ventricular Assist Devices for Destination Therapy
Background: The initial HeartMate (HM) II LVAD Destination Therapy (DT) trial demonstrated significant improvements in outcomes compared to patients with pulsatile flow LVADs. Since then, additional patients have been enrolled in the DT trial. We examined the hypothesis that recent outcomes would be further improved due to better patient selection and/or patient care.
Methods: The Early group consisted of 133 patients implanted from March 2005 – May 2007, and the Late group of 252 patients from May 2007 – March 2009. Patient entry criteria were the same during the two time periods. Patient baseline characteristics, adverse events, and quality of life outcomes were compared.
Results: Baseline characteristics were similar between Early and Late groups: age (62 vs 63), ischemic etiology (66% vs 58%), prior stroke (16% vs. 14%), NYHA class IIIB (21% vs 25%), inotropic support (77% each), LV ejection fraction (17% each), serum creatinine and ALT. Mean LVAD support durations were 1.7 and 1.3 years for Early and Late groups (longest: 3.7 and 2.8 years), and cumulative followup was 211 and 321 pt-years. Adverse event rates were similar for bleeding requiring transfusion (1.66 vs. 1.56 events per pt yr), ischemic stroke (0.06 vs. 0.06), and non-device related infections (0.76 vs. 0.61). However, device-related infections (percutaneous lead and pocket) (0.48 vs. 0.26; p<0.001) and hemorrhagic stroke (0.07 vs. 0.03; p=0.02) were substantially lower. Patients in the Late group demonstrated a trend of improved survival (Figure). Quality of life improvements of over 35 points with the Kansas City Cardiomyopathy Questionaire were experienced in both groups during LVAD support.
Conclusions: The proven benefit of Destination Therapy with the HM II LVAD is confirmed in subsequent advanced heart failure patients. Moreover, there is a strong trend for improvements in survival and adverse event rates, which we believe are due to better patient care rather than patient selection.
- © 2010 by American Heart Association, Inc.