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Original Investigation
November 21, 2018

Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 YearAnalysis of the Transcatheter Valve Therapy Registry

Author Affiliations
  • 1Saint Luke’s Mid America Heart Institute, Kansas City, Missouri
  • 2University of Missouri, Kansas City
  • 3Duke University, Durham, North Carolina
  • 4Baylor Scott and White Health, Plano, Texas
  • 5Lahey Hospital and Medical Center, Boston, Massachusetts
  • 6Baim Institute for Clinical Research, Boston, Massachusetts
  • 7Saint Vincent Medical Center, Indianapolis, Indiana
  • 8University of Colorado School of Medicine, Aurora
JAMA Cardiol. Published online November 21, 2018. doi:10.1001/jamacardio.2018.3359
Key Points

Question  What are the health status outcomes after transcatheter edge-to-edge mitral valve repair (TMVR) in routine clinical practice?

Findings  Analysis of a large, registry-based US cohort showed that health status was poor prior to TMVR, improved significantly within 30 days (with a mean Kansas City Cardiomyopathy Questionnaire score increase from 42 to 67 points), and remained stable through 1 year among surviving patients. Arrhythmias, lung disease, and poor baseline health status were independently associated with less health status recovery; high rates of missing health status data are a concern for this registry-based study.

Meaning  While long-term mortality remains high among surviving patients with available data, the health status benefits of edge-to-edge TMVR appear to be robust and consistent across patients.

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 < .001), representing a large clinical improvement. The KCCQ scores remained stable from 30 days to 1 year after TMVR, with no further significant increase or decline. On multivariable analysis, atrial fibrillation (−2.2 [95% CI, −3.7 to −0.6] points; P = .01), permanent pacemaker (−2.1 [95% CI, −3.7 to −0.4] points; P = .01), severe lung disease (−3.9 [95% CI, −6.2 to −1.5] points; P = .001), home oxygen (−2.7 [95% CI, −4.9 to −0.4] points; P = .02), and lower KCCQ scores at baseline (3.9 points for each 10-point increase [95% CI, 3.6-4.2]; P < .001) were independently associated with lower 30-day KCCQ-OS scores. In-hospital renal failure was uncommon but was also associated with significant reductions in 30-day KCCQ-OS scores (−7.3 [95% CI −13.3 to −1.2] points). In estimates calculated with inverse probability weighting, after 1 year after TMVR, 54.2% (95% CI 52.2%-56.1%) of patients were alive and well; 23.0% had died, 21.9% had persistently poor health status (KCCQ-OS <60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline.

Conclusions and Relevance  In a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data. While long-term mortality remains high, most surviving patients demonstrate improvements in symptoms, functional status, and quality of life, with only modest differences by patient-level factors.

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