Clinical Outcomes After Implantation of a Centrifugal Flow Left Ventricular Assist Device and Concurrent Cardiac Valve Procedures

Abstract

Background— Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail. Methods and Results— Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P =0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2–3.3; P =0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8–4.8, P <0.0001]) as independent predictors while concurrent tricuspid valve procedures (TVP) were not predictors. Furthermore, patients with significant preimplant tricuspid regurgitation who did not receive a TVP experienced an increased rate of late RHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P =0.024). Conclusions— Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00751972.

Cardiac surgery 2014 reviewed

“…The authors found that gastrointestinal bleeding was present in almost half of the patients and they identified female gender and age as the most significant risk factors. The authors suggest that specific anticoagulation [59]. Similar findings specifically addressing concomitant tricuspid valve surgery were reported by Fujita et al [60] and Brewer et al [61].…”

Outcomes After Concomitant Procedures with Left Ventricular Assist Device Implantation: Implications by Device Type and Indication

“…Despite significant differences between groups, patients in the LVAD + TVP group had a comparable long-term survival and probability of device-related adverse events. Results differ from outcomes reported by John et al 8 for the HMII investigators, or results observed for the HVAD by Milano et al 9 A population of 37 patients implanted in a single center (Mayo Clinic) had concomitant tricuspid valve procedures (32 repairs, five replacements) for severe TR. The effects of a tricuspid valve procedure on TR and right ventricular remodeling were assessed comparing echocardiographic findings at baseline and 30 days after LVAD implantation.…”

“…8,9 As reported, we found that LVAD + TVP is the most common CP procedure performed at the time of LVAD implantation (42%). In our analysis, several important differences exist between groups with or without a CP.…”

“…Observed early mortality was, however, comparable between groups (p = 0.20). 2,9 Time-to-first device-related event was shorter in patients with a CP, whereas comparable survival between groups was observed. We observed a twofold increase in the incidence of gI bleeding in patients with a CP (all groups compared with LVAD alone; p < 0.001), whereas stroke risk, RV failure incidence, and long-term survival was comparable between cohorts.…”

“…6,7 Outcomes of performing CPs for both devices at the time of LVAD implantation have been separately reported in large controlled retrospective studies. 8,9 These results represent a post hoc analysis of existing datasets derived from landmark trials with strict inclusion criteria and no risk-adjusted groups for direct comparison. Understanding the challenges involved with these patients is critical, as the DT population and patients supported for a longer period of time continue to grow.…”