Contemporary Outcomes of TAVR Using a Balloon-Expandable Valve in Patients With Severe Mitral Stenosis: Insights From the Transcatheter Valve Therapies Registry

Circ Cardiovasc Interv. 2024 Dec;17(12):e014216. doi: 10.1161/CIRCINTERVENTIONS.124.014216. Epub 2024 Nov 22.

Abstract

Background: While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves.

Methods: Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm2 area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm2 area) using propensity matching to minimize confounding variables.

Results: Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P<0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P=0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P<0.001) of patients with severe MS was observed.

Conclusions: MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.

Keywords: aortic stenosis; heart valve diseases; mitral stenosis; registries; transcatheter aortic valve replacement.

Publication types

  • Multicenter Study
  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Balloon Valvuloplasty* / adverse effects
  • Balloon Valvuloplasty* / mortality
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Hemodynamics
  • Humans
  • Male
  • Mitral Valve Stenosis* / diagnostic imaging
  • Mitral Valve Stenosis* / mortality
  • Mitral Valve Stenosis* / physiopathology
  • Mitral Valve Stenosis* / surgery
  • Mitral Valve Stenosis* / therapy
  • Mitral Valve* / diagnostic imaging
  • Mitral Valve* / physiopathology
  • Mitral Valve* / surgery
  • Postoperative Complications / mortality
  • Prosthesis Design*
  • Recovery of Function
  • Registries*
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index*
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome
  • United States