Outcomes in Advanced Heart Failure Patients With Left Ventricular Assist Devices for Destination Therapy

Abstract

Background— The HeartMate II (HMII) destination therapy (DT) trial demonstrated significant improvements in outcomes in continuous-flow left ventricular assist devices compared with patients implanted with the pulsatile-flow HeartMate XVE. The primary hypothesis of the current study is that trial patients enrolled after the initial data cohort would have better clinical outcomes. Methods and Results— Two hundred eighty-one patients who underwent HMII for DT from May 2007 to March 2009 (Mid Trial [MT] group) were compared with the initial 133 HMII patients from March 2005 to May 2007 (Early Trial [ET] group). Patient entry criteria were the same during the 2 time periods. Survival, adverse events, and quality of life were compared between the 2 groups. Baseline characteristics were similar between the groups. Compared with the ET group, patients in the MT group had reduced adverse event rates for bleeding requiring transfusions (1.66 versus 1.13 events per patient-year, P <0.001), sepsis (0.38 versus 0.27, P =0.025), device-related infections (0.47 versus 0.27, P <0.001), and hemorrhagic stroke (0.07 versus 0.03, P =0.01). Other event rates were similar between groups including ischemic stroke (0.06 versus 0.05 events per patient-year, P =0.57). Survival at 1 year in the MT group was 73% versus 68% in the ET group ( P =0.21). Additionally, there was a significant reduction in deaths caused by hemorrhagic stroke ( P =0.01). Quality of life improvements were significant in both the groups ( P <0.001). Conclusions— The benefit of DT therapy with the HMII is confirmed in subsequent trial patients, with improved adverse event rates and a strong trend for improvements in survival. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00121485.

Cost of Ventricular Assist Devices

“…8 Initial clinical trials of older pulsatile flow LVADs used as destination therapy demonstrated 1-year survival of 52%, 9 and more recent studies of continuous flow pumps, used for the same indication, showed 1-year survival of 73%. 10 These studies also documented improvements in functionality and quality of life relative to that seen with medicallytreated HF. With the observed gains in longevity, functionality, and quality of life in destination VAD recipients, mechanical circulatory support compares favorably with heart transplantation, the only long-term solution for patients with end-stage HF just a decade ago.…”

Long-term use of left ventricular assist devices: a report on clinical outcomes

“…20 In regards to long-term LVAD support, the HMII DT trial reported 2-year survival rates increasing from 58% to 63% in the current era. 21 We report lower mortality at our centre, potentially attributable to our rigorous patient selection process and interprofessional LVAD education. Notably, our results implicated the index admission as the highest-risk time period for LVAD mortality, implicating patient selection as a major contributor.…”

“…10,[16][17][18][19]21 The limited literature examining postoperative LOS in the LVAD population varies widely, ranging from 17 days to 25 days. 16,18 Compared with other centres, our centre leans toward having increased length of postoperative stays.…”

Ethical Dilemmas Surrounding the Use of Ventricular Assist Devices in Supporting Patients with End-Stage Organ Dysfunction

“…In the best-case scenario, it results in an appreciable improvement in quality of life until transplantation, with significant recovery thereafter. 3,[10][11][12][13][14] However, realization of this outcome rests on many contingencies and inevitably involves burdens. 9,15 It is important to recognize that consequences must be evaluated based on the values of the individuals affected.…”