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Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States.

Publication ,  Journal Article
Malik, AO; Chhatriwalla, AK; Saxon, J; Hejjaji, V; Stebbins, A; Jones, PG; Cohen, DJ; Arnold, SV; Vemulapalli, S; Wegermann, ZK; Kosinski, A ...
Published in: Circ Cardiovasc Qual Outcomes
December 2020

BACKGROUND: Clinical 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. METHODS: All 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. RESULTS: Across 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. CONCLUSIONS: There 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.

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Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

December 2020

Volume

13

Issue

12

Start / End Page

e006878

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Risk Assessment
  • Registries
  • Recovery of Function
  • Postoperative Complications
  • Mitral Valve Insufficiency
  • Mitral Valve
 

Citation

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Malik, A. O., Chhatriwalla, A. K., Saxon, J., Hejjaji, V., Stebbins, A., Jones, P. G., … Spertus, J. A. (2020). Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States. Circ Cardiovasc Qual Outcomes, 13(12), e006878. https://doi.org/10.1161/CIRCOUTCOMES.120.006878
Malik, Ali O., Adnan K. Chhatriwalla, John Saxon, Vittal Hejjaji, Amanda Stebbins, Philip G. Jones, David J. Cohen, et al. “Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States.Circ Cardiovasc Qual Outcomes 13, no. 12 (December 2020): e006878. https://doi.org/10.1161/CIRCOUTCOMES.120.006878.
Malik AO, Chhatriwalla AK, Saxon J, Hejjaji V, Stebbins A, Jones PG, et al. Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States. Circ Cardiovasc Qual Outcomes. 2020 Dec;13(12):e006878.
Malik, Ali O., et al. “Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States.Circ Cardiovasc Qual Outcomes, vol. 13, no. 12, Dec. 2020, p. e006878. Pubmed, doi:10.1161/CIRCOUTCOMES.120.006878.
Malik AO, Chhatriwalla AK, Saxon J, Hejjaji V, Stebbins A, Jones PG, Cohen DJ, Arnold SV, Vemulapalli S, Wegermann ZK, Kosinski A, Spertus JA. Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States. Circ Cardiovasc Qual Outcomes. 2020 Dec;13(12):e006878.

Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

December 2020

Volume

13

Issue

12

Start / End Page

e006878

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Risk Assessment
  • Registries
  • Recovery of Function
  • Postoperative Complications
  • Mitral Valve Insufficiency
  • Mitral Valve