Original article
Adult cardiac
Left Ventricular Assist Device Destination Therapy Versus Extended Criteria Cardiac Transplant

Presented at the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.
https://doi.org/10.1016/j.athoracsur.2009.12.058Get rights and content

Background

End-stage heart failure is a growing problem associated with a high mortality using conventional medical care. Although cardiac transplantation is an excellent treatment option, it is a limited resource and most patients are ineligible for cardiac transplantation using standard listing criteria. Increasingly, newer surgical options for these patients include the usage of marginal donor organs in an extended criteria–alternate list heart transplant program (EC-AL), or left ventricular assist devices as destination therapy (DT-LVAD). The purpose of this study was to compare baseline characteristics and outcomes after EC-AL versus DT-LVAD.

Methods

From March 2000 to August 2008, 153 consecutive patients who had been turned down for standard heart transplantation underwent either EC-AL or DT-LVAD. The most common reasons for standard heart transplant ineligibility for both groups were advanced age, diabetes mellitus with end-organ dysfunction, and significant renal insufficiency. Patients in the alternate list program received a donor organ that had been turned down by all other centers for standard list recipients. The most common reasons for donor heart refusal were decreased left ventricular function, left ventricle hypertrophy, or coronary artery disease. Outcomes for both groups were retrospectively reviewed after Institutional Review Board permission was obtained. Comparisons were also made between patients that had been matched by propensity score analysis.

Results

In all, 93 patients underwent EC-AL, and 60 underwent DT-LVAD. Baseline preoperative characteristics of both groups were similar except that 87% of DT-LVAD patients (52 of 60) required preoperative mechanical or inotropic support whereas only 51% of EC-AL patients (47 of 93) required support (p < 0.0001). Thirty-day operative mortality and 1-year survival were 2.5% and 82.2% for EC-AL and 6.7% and 77.5% DT-LVAD, respectively (p = 0.2411 and p = 0.5036). Overall survival at 3 years was better for EC-AL versus DT-LVAD. The DT-LVAD patients had improved survival compared with the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial DT-LVAD cohort, a historical control. These findings were corroborated in the analysis of propensity-matched patients.

Conclusions

Preoperatively, the DT-LVAD cohort was more unstable, with greater need for inotropes or mechanical support. Despite this, perioperative and 1-year mortality was similar for the two groups. Three-year survival was better for EC-AL. The DT-LVAD patient survival was better than that of the REMATCH DT-LVAD cohort.

Section snippets

Material and Methods

The Duke University Institutional Review Board approved the study design and protocol; individual patient consent was waived. All patients who presented to Duke University Medical Center between March 2000 and August 2008 with end-stage heart failure and who were ineligible for standard list cardiac transplantation were considered for EC-AL or DT-LVAD. Patients were screened for compliance, psychosocial stability, and appropriate insurance coverage. During this period, 153 consecutive patients

Results

Baseline and preoperative characteristics for the patients are shown in Table 1. The groups were similar except that DT-LVAD patients had higher body mass indices than EC-AL patients. Also, DT-LVAD patients appeared to be more decompensated as indicated by more need for intravenous inotrope support and greater preoperative central venous pressures. The incidence of prior cardiac surgery was higher among EC-AL patients. The EC-AL patients had a median preoperative mean pulmonary artery pressure

Comment

Advanced heart failure patients with class IV functional status and need for continuous intravenous inotropes have an 80% mortality at 1 year. Standard cardiac transplantation is not available for the majority of these patients [13]. Although both DT-LVAD and EC-AL have been proposed as therapeutic options for this group of patients, the two have never been compared [7, 8, 10, 11, 13, 14, 17].

We found that patients who were delegated to DT-LVAD more often required continuous intravenous

Acknowledgments

This work was funded by an unrestricted research grant from Thoratec Corporation (Pleasanton, CA) to Duke University Department of Surgery. All authors had full control of design of study, methods used, outcome determinants, analysis of data, and production of the written report.

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