Background Preexisting valve pathology is common in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) placement. The indications and subsequent benefits of performing valvular procedures in these patients are unclear. The objective of this study was to determine the impact of performing concurrent surgical valve procedures in a large cohort of patients receiving LVADs. Methods One thousand one hundred six patients received the HeartMate II (HMII) LVAD in the bridge to transplant (n = 470) and destination therapy (n = 636) clinical trials. Of these, 374 patients (34%) had concurrent cardiac surgery procedures as follows: 242 patients (21%) with 281 concurrent valve procedures (VP) (aortic 80, mitral 45, and tricuspid 156), and 641 patients had only HMII LVAD. The focus of this study was to determine the clinical outcomes of patients undergoing HMII + VP compared with those who received HMII alone. Results Patients undergoing HMII + VP were significantly older, had higher blood urea nitrogen levels and central venous pressure, and decreased right ventricular stroke work index; intraoperatively, the median cardiopulmonary bypass times were also longer. The unadjusted 30-day mortality was significantly higher in patients undergoing HMII + VP (10.3% vs 4.8% for LVAD alone, P =.005). Subgroup analysis of individual VPs showed that higher mortality occurred in patients with HMII plus 2 or more VPs (13.5%, P =.04) followed by trends for increased mortality with HMII plus mitral alone (11.5%, P = NS), HMII plus aortic alone (10.9%, P = NS), and HMII plus tricuspid (8.9%, P = NS) procedures. Of these various groups, only patients undergoing HMII + isolated aortic VP (P =.001) and HMII + multiple VPs (P =.046) had significantly worse long-term survival compared with patients undergoing HMII alone. Right heart failure and right ventricular assist device use was increased in patients undergoing VPs, but there was no difference in the incidence of bleeding or stroke. Conclusions Patients frequently require concurrent VPs at the time of LVAD placement; these patients are sicker and have higher early mortality. Furthermore, right ventricular dysfunction is increased in these patients. Further studies to develop selection criteria for concurrent valve interventions are important to further improve clinical outcomes.
Bibliographical noteFunding Information:
This study was supported by Thoratec Corporation (Pleasanton, Calif) and HeartWare International Inc , Framingham, Mass.
Disclosures: Ranjit John reports grant support from Thoratec and HeartWare. All other authors have nothing to disclose with regard to commercial support.
Copyright 2014 Elsevier B.V., All rights reserved.