Dataset Information

Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year: Analysis of the Transcatheter Valve Therapy Registry.

ABSTRACT: Importance:Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation. Objective:To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement. Design, Setting, and Participants:This cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, which contains data on patients with severe mitral regurgitation treated with TMVR from 2013 through 2017 in 217 US hospitals. Main Outcomes and Measures:Change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]; range 0-100 points, with higher scores indicating better health status) at 30 days and 1 year after TMVR. We also examined factors associated with health status at 30 days after TMVR, by means of multivariable linear regression using a generalized estimating equations approach to account for clustering of patients within sites. Results:The KCCQ data were available in 81.2% at baseline, 69.3% of survivors at 30 days, and 47.4% of survivors at 1 year. Among 4226 patients who underwent TMVR, survived 30 days, and completed the KCCQ at baseline and follow-up, the KCCQ-OS increased from 41.9 before TMVR to 66.7 at 30 days (mean change 24.8 [95% CI, 24.0-25.6] points; P?

SUBMITTER: Arnold SV

PROVIDER: S-EPMC6583100 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year: Analysis of the Transcatheter Valve Therapy Registry.

Arnold Suzanne V SV Li Zhuokai Z Vemulapalli Sreekanth S Baron Suzanne J SJ Mack Michael J MJ Kosinski Andrzej S AS Reynolds Matthew R MR Hermiller James B JB Rumsfeld John S JS Cohen David J DJ

JAMA cardiology 20181201 12

<h4>Importance</h4>Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation.<h4>Objective</h4>To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement.<h4>Design, setting, and participants</h4>This cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Reg ...[more]

PMID: 30476950

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Project description:BackgroundClinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown.MethodsAll patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients' baseline health status accounted for variability in outcomes, the proportion of variability (R2) explained by sequentially adding these variables to the model was quantified.ResultsAcross 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients' baseline KCCQ-OS score (R2=25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume.ConclusionsThere is moderate variation across sites in their patients' achievement of health status benefits from TMVr, with patient's baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr.

Project description:IntroductionMitral valve repair has been established as the preferred treatment option in the management of degenerative mitral valve disease. Compared with other surgical treatment options, mitral valve repair is associated with increased survival and decreased rates of both complications and reoperations. However, among patients undergoing mitral valve repair, little is known about the predictors of postoperative outcomes. The purpose of this study is to identify preoperative patient risk factors associated with postoperative morbidity and mortality within 30 days of mitral valve repair.MethodsData was derived from the American College of Surgeons National Surgical Quality Improvement Program database to assess patients who underwent mitral valve repair from 2011 through 2017. Preoperative risk factors were analyzed to determine their association with a variety of postoperative 30-day outcome measures.ResultsOne thousand three hundred and sixty-six patients underwent mitral valve repair; 849 (62.2%) males and 517 (37.8%) females. Ages ranged from 18 to 90 years, with a mean age of 64 years. The overall 30-day mortality was 3.1% (43 patients). Among the 12 identified risk factors associated with increased mortality on univariate analysis, pre-operative hematocrit level was the only variable significantly correlated with mortality after undergoing multivariate analysis. 259 patients (19.1%) were discharged to a location other than home, an outcome associated with 22 identified risk factors. Among these risk factors, female gender, age, dialysis, pre-operative serum sodium, pre-operative serum albumin, and partial or full living dependency remained statistically significant following multivariate analysis. 126 patients (9.2%) experienced unplanned readmission. This outcome was associated with five risk factors, of which only dyspnea upon mild exertion was significant on multivariate analysis. Reoperation occurred in 105 patients (7.7%). Of the seven identified variables associated with reoperation, patient age, pre-operative platelet count, dyspnea upon mild exertion were independent predictors on multivariate analysis. 53 patients (3.9%) underwent reintubation, which was associated with 11 identified risk factors. Among them, patient age and pre-operative INR value were predictive of reintubation on multivariate analysis. 26 patients (1.9%) experienced stroke, of whom age was the only associated risk factor on both univariate and multivariate analysis. 31 patients (2.3%) experienced acute renal failure, which correlated with 11 risk factors on univariate analysis. Of these, only patient age and pre-operative hematocrit were identified as independent predictors on multivariate analysis.ConclusionsOutcomes are good following mitral valve repair. Although a substantial number of risk factors were found to be associated with adverse outcomes, only a small subset remained statistically significant following multivariate analysis. Identification of these risk factors may help guide clinical decision making with respect to which patients are the best candidates to undergo mitral valve repair.

Dataset Information

Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year: Analysis of the Transcatheter Valve Therapy Registry.

Publications

Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year: Analysis of the Transcatheter Valve Therapy Registry.

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