CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.

 

Begin main content

Transcatheter Aortic Valve Implantation for Degenerated Mitral or Tricuspid Bioprostheses: A Review of Clinical Effectiveness and Cost-Effectiveness

Last updated: October 13, 2020
Project Number: RD0057-000
Product Line: Rapid Response
Research Type: Device
Report Type: Peer-reviewed summary with critical appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of transcatheter aortic valve implantation for degenerated mitral or tricuspid bioprostheses?
  2. What is the cost-effectiveness of transcatheter aortic valve implantation for degenerated mitral or tricuspid bioprostheses?

Key Message

Nineteen studies were retrieved surrounding the clinical effectiveness of transcatheter aortic valve implantation for patients with degenerated mitral or tricuspid valve bioprostheses, comprising one systematic review of single arm studies, two non-randomized studies with comparator groups, and 16 single-arm studies with no comparator groups.

Two retrospective cohort studies in patients with degenerated mitral valve bioprostheses reported no difference for in-hospital mortality, or mortality at one and two years, for transcatheter mitral valve-in-valve procedures compared to surgical replacement. One study also concluded that there was a trend towards improved clinical outcomes, such as reduced rates of stroke and bleeding, for transcatheter procedures compared to surgical replacement; however, these differences were not statistically significant. There were serious limitations in both studies related to selection bias, bias due to confounding, and small sample size (121 patients in one study and 61 patients in the other study).

One systematic review and 12 single arm studies evaluated transcatheter valve-in-valve procedures for degenerated mitral valve bioprostheses in patients at high risk for surgery. Four single arm studies evaluated transcatheter valve-in-valve procedures for degenerated tricuspid valves in patients at high risk for surgery. Authors of these studies concluded, based on low rates of mortality, complications, and adverse effects, that transcatheter procedures were feasible, effective, and safe. New York Heart Association functional class improved after the procedure compared to baseline, suggesting that transcatheter valve-in-valve procedures for degenerated mitral or tricuspid valves lead to improved patient function and symptoms compared to baseline. These single arm studies were mostly small (11 out of 12 mitral valve studies had sample sizes ≤ 60 and three out of four tricuspid valve studies had sample sizes ≤ 7) and lacked comparison groups, making it impossible to judge the benefits and harms of transcatheter approaches relative to surgery or medical management. Authors of these studies acknowledged the need for larger, long-term studies.

No relevant economic evaluations were identified and thus the cost-effectiveness of transcatheter aortic valve implantation for degenerated mitral or tricuspid valves is unclear.

Despite identifying nineteen eligible studies for this report, the limitations and methodological concerns with current body of evidence suggest that further research is necessary to establish the clinical effectiveness and cost-effectiveness of transcatheter aortic valve implantation for degenerated mitral or tricuspid bioprostheses compared to open-heart surgical procedures and medical management. While it may be challenging or impossible to conduct randomized studies (given high or prohibitive risk for re-do surgery) or mitigate selection bias in this context, future studies of transcatheter aortic valve implantation for degenerated mitral or tricuspid valves should feature larger sample sizes, comparator groups, and appropriate techniques to minimize selection bias and bias due to confounding, particularly confounding by indication, in order to generate higher-quality evidence.