Clancy Mullan1, Cesar Caraballo2, Neal G Ravindra3, P Elliott Miller4, Makoto Mori1, Megan McCullough5, John-Ross D Clarke6, Muhammad Anwer1, Eric J Velazquez5, Arnar Geirsson1, Nihar R Desai7, Tariq Ahmad8. 1. Division of Cardiac Surgery, Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. 2. Center for Outcomes Research & Evaluation (CORE), Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. 3. Cardiovascular Research Center and Department of Computer Science, Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. 4. Section of Cardiovascular Medicine, Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut; Yale National Clinician Scholars Program, Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. 5. Section of Cardiovascular Medicine, Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. 6. Department of Internal Medicine (Bridgeport Hospital), Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. 7. Center for Outcomes Research & Evaluation (CORE), Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. 8. Center for Outcomes Research & Evaluation (CORE), Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale School of Medicine and Yale New Haven Health, New Haven, Connecticut. Electronic address: tariq.ahmad@yale.edu.
Abstract
BACKGROUND: Tricuspid regurgitation (TR) is common in patients with end-stage heart failure receiving left ventricular assist devices (LVADs), but the benefit of concomitant tricuspid valve procedures (TVPs) remains uncertain. This study examined the impact of TVP at the time of LVAD implantation on clinical outcomes and quality of life (QOL) metrics. METHODS: We included adult patients in the Interagency Registry for Mechanical Circulatory Support database with various degrees of TR who received continuous-flow LVADs from 2008 to 2017. Patients undergoing concomitant TVP were compared with those without the intervention in a stratified analysis. Descriptive analyses, survival analyses, and Andersen‒Gill hazard models were used as appropriate to examine associations with clinical and patient-centered QOL outcomes. RESULTS: Our analysis included 8,263 (53.1%) mild, 4,252 (33.3%) moderate, and 2,100 (13.5%) severe TR cases. TVP rate increased with severity: 8.6% of mild, 18.0% of moderate, and 43.9% of severe cases. TVP was not associated with survival benefit in cases of mild (adjusted hazard ratio [aHR]: 0.97, 95% CI: 0.79-1.19, p = 0.75), moderate (aHR: 1.03, 95% CI: 0.88-1.20, p = 0.72), or severe (aHR: 1.20, 95% CI: 0.98-1.48, p = 0.08) TR. For patients with combined moderate or severe TR, TVP was associated with increased mortality (log-rank p < 0.01, aHR: 1.13, 95% CI: 1.00-1.27, p = 0.04). After adjusting for TR severity, TVP was associated with increased risk of bleeding, arrhythmia, and stroke (p < 0.01 each) and no improvements in QOL (p > 0.05). CONCLUSIONS: TVP at the time of LVAD implantation was not associated with either improved survival or QOL, and there were associations with increased risk of adverse events among patients with moderate and severe TR.
BACKGROUND:Tricuspid regurgitation (TR) is common in patients with end-stage heart failure receiving left ventricular assist devices (LVADs), but the benefit of concomitant tricuspid valve procedures (TVPs) remains uncertain. This study examined the impact of TVP at the time of LVAD implantation on clinical outcomes and quality of life (QOL) metrics. METHODS: We included adult patients in the Interagency Registry for Mechanical Circulatory Support database with various degrees of TR who received continuous-flow LVADs from 2008 to 2017. Patients undergoing concomitant TVP were compared with those without the intervention in a stratified analysis. Descriptive analyses, survival analyses, and Andersen‒Gill hazard models were used as appropriate to examine associations with clinical and patient-centered QOL outcomes. RESULTS: Our analysis included 8,263 (53.1%) mild, 4,252 (33.3%) moderate, and 2,100 (13.5%) severe TR cases. TVP rate increased with severity: 8.6% of mild, 18.0% of moderate, and 43.9% of severe cases. TVP was not associated with survival benefit in cases of mild (adjusted hazard ratio [aHR]: 0.97, 95% CI: 0.79-1.19, p = 0.75), moderate (aHR: 1.03, 95% CI: 0.88-1.20, p = 0.72), or severe (aHR: 1.20, 95% CI: 0.98-1.48, p = 0.08) TR. For patients with combined moderate or severe TR, TVP was associated with increased mortality (log-rank p < 0.01, aHR: 1.13, 95% CI: 1.00-1.27, p = 0.04). After adjusting for TR severity, TVP was associated with increased risk of bleeding, arrhythmia, and stroke (p < 0.01 each) and no improvements in QOL (p > 0.05). CONCLUSIONS: TVP at the time of LVAD implantation was not associated with either improved survival or QOL, and there were associations with increased risk of adverse events among patients with moderate and severe TR.
Authors: Julia Riebandt; Anne Schaefer; Dominik Wiedemann; Thomas Schlöglhofer; Günther Laufer; Sigrid Sandner; Daniel Zimpfer Journal: Ann Cardiothorac Surg Date: 2021-03