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Concomitant aortic valve procedures in patients undergoing implantation of continuous-flow left ventricular assist devices: An INTERMACS database analysis.

ABSTRACT: Management of existing aortic insufficiency (AI) and mechanical aortic valves in patients undergoing left ventricular assist device (LVAD) implantation remains controversial. Surgical options to address these issues include closure, repair or replacement of the valve.Continuous-flow LVAD/biventricular VAD patients entered into the INTERMACS database between June 2006 and December 2012 were included (n = 5,344) in this analysis. Outcomes were compared between patients who underwent aortic valve (AV) closure (n = 125), repair (n = 95) and replacement (n = 85).Among patients who underwent an AV procedure, actuarial survival was significantly reduced for AV closures (63.2%) compared with AV repairs (76.8%) and replacements (71.8%) (p = 0.0003). Differences were greater between groups when only INTERMACS Level 1 or 2 patients were analyzed (p = 0.003). After multivariate adjustment, AV closure remained a significant risk factor for mortality (hazard ratio = 1.87, 95% confidence interval 1.39 to 2.53, p < 0.0001). At 6 to 12 months post-operatively, moderate to severe AI developed in 19%, 5%, 9% and 10% of patients with available echocardiography who underwent repair, closure, replacement and no intervention, respectively (p < 0.0001). Competing outcomes demonstrate that, at 1-year, fewer patients with AV closures were transplanted compared with patients with repairs/replacements (14% vs 19%). No differences were observed between groups with respect to cause of death, re-hospitalization, right heart failure or stroke.AV closure was associated with increased mortality when compared with repair or replacement in patients with AI who underwent LVAD insertion. The reasons for this association require further investigation. This is the largest study to date to examine concomitant AV procedures in patients undergoing LVAD insertion.

SUBMITTER: Robertson JO

PROVIDER: S-EPMC4433438 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Concomitant aortic valve procedures in patients undergoing implantation of continuous-flow left ventricular assist devices: An INTERMACS database analysis.

Robertson Jason O JO Naftel David C DC Myers Susan L SL Prasad Sunil S Mertz Gail D GD Itoh Akinobu A Pagani Francis D FD Kirklin James K JK Silvestry Scott C SC

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 20141115 6

<h4>Background</h4>Management of existing aortic insufficiency (AI) and mechanical aortic valves in patients undergoing left ventricular assist device (LVAD) implantation remains controversial. Surgical options to address these issues include closure, repair or replacement of the valve.<h4>Methods</h4>Continuous-flow LVAD/biventricular VAD patients entered into the INTERMACS database between June 2006 and December 2012 were included (n = 5,344) in this analysis. Outcomes were compared between pa ...[more]

PMID: 25511747

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Project description:ObjectivesThis study examined patient outcomes after left ventricular assist device (LVAD) implantation across a range of center surgical volumes.BackgroundIn order for a center to qualify for reimbursement, Centers for Medicare and Medicaid Services (CMS) requires it to implant ≥10 LVADs or total artificial hearts over a 3-year period. The impact of center LVAD surgical volumes on patient outcomes has not been thoroughly scrutinized.MethodsCenter volumes were provided for 7,416 patients undergoing LVAD implantation who were enrolled in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Center LVAD volume was categorized as either very low (≤10 implants/year, n = 617), low (11 to 30 implants/year, n = 2,561), medium (31 to 50 implants/year, n = 2,458), or high (>50 implants/year, n = 1,750). The main outcome of interest was patient survival based on center volume derived from Kaplan-Meier and multivariate Cox regression.ResultsOverall survival was associated with center volume (p = 0.003), as follows: 71 ± 1.8% (very low volume), 81 ± 0.8% (low volume), 83 ± 0.8% (medium volume), and 79 ± 1.0% (high volume) at 1 year. Compared with medium volume centers, the 90-day mortality was higher in very low volume (odds ratio [OR]: 1.35; p = 0.04) and high volume (OR: 1.28; p = 0.018) VAD centers. The adjusted hazard ratios (HRs) for mortality were 1.32 (95% confidence interval [CI]: 1.11 to 1.56), 1.07 (95% CI: 0.95 to 1.21), and 1.17 (95% CI: 1.03 to 1.30) for very low, low, and high volume centers, respectively. Center volume did not predict mortality (p = 0.25; n = 3,688) in INTERMACS profile 1 patients (patients who had sustained cardiogenic shock) and profile 2 patients (patients with progressive hemodynamic decline despite inotropes).ConclusionsCenter volume correlates with post-VAD survival, with worse survival noted at very-low volume centers. These findings suggest that current U.S. VAD center standards warrant reconsideration.

Dataset Information

Concomitant aortic valve procedures in patients undergoing implantation of continuous-flow left ventricular assist devices: An INTERMACS database analysis.

Publications

Concomitant aortic valve procedures in patients undergoing implantation of continuous-flow left ventricular assist devices: An INTERMACS database analysis.

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