Transcatheter Valve-in-Valve Implantation for Degenerated Mitral or Tricuspid Bioprosthetic Valves: A Heath Technology Assessment.

Abstract

Background: Bioprosthetic valves used to treat mitral or tricuspid valve disease can be expected to deteriorate and eventually fail after 10 to 15 years. For patients who are considered inoperable or high-risk for surgery, medical management (i.e., drug therapy, the current standard of care in Ontario) does not significantly alter the course of valvular heart disease or improve degenerated bioprosthetic valves. An alternative for these patients is transcatheter mitral or tricuspid valve-in-valve implantation (TMViV or TTViV). We conducted a health technology assessment of transcatheter valve-in-valve implantation for adults with degenerated mitral or tricuspid bioprosthetic valves who are considered inoperable or high-risk for surgery, which included an evaluation of effectiveness, safety, the budget impact of publicly funding TMViV or TTViV, and patient preferences and values.

Methods: We leveraged a previously published systematic review, supplementing the work with two new registry studies identified during the development of this report. We assessed the risk of bias of each included study using the Downs and Black checklist and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. As the earlier systematic review did not identify any cost-effectiveness studies, we conducted a hand search of the grey literature using targeted websites to identify relevant cost-effectiveness studies. We analyzed the budget impact of publicly funding transcatheter valve-in-valve implantation for adults with degenerated mitral or tricuspid bioprostheses who are considered inoperable or high-risk for surgery in Ontario. To contextualize the potential value of TMViV and TTViV, we spoke with people who had experience with heart valve replacement or who were awaiting heart valve replacement.

Results: We included 19 studies in the clinical evidence review. No studies compared TMViV or TTViV to medical management (standard care). TMViV was associated with in-hospital, 30-day and 1-year mortality rates of 0% to 5%, 0% to 15%, and 14% to 27%, respectively (GRADE: Very low). TTViV was associated with 30-day and 1-year mortality rates of 0% to 3% and 0% to 14%, respectively (GRADE: Very low). Patients experienced functional improvement related to their heart failure symptoms after TMViV or TTViV. Compared to before the intervention, both TMViV and TTViV were associated with a decrease in the number of patients with New York Heart Association class III or IV symptoms in hospital and at 30-day follow-up (GRADE: Low). We identified no relevant cost-effectiveness studies from our targeted search. The annual budget impact of publicly funding TMViV and TTViV in Ontario over the next 5 years ranges from an additional $0.35 million in year 1 to a cost saving of $0.19 million in year 5, for a total cost saving of $0.33 million. The people we spoke to who had bioprosthetic heart valve failure reported the negative effects of valvular heart disease and described their positive perceptions of transcatheter valve-in-valve implantation. They valued the minimally invasive nature of transcatheter procedures and the quick recovery time.

Conclusions: TMViV or TTViV may reduce mortality, but the evidence is very uncertain. TMViV or TTViV may improve heart failure symptoms. We estimated that publicly funding TMViV and TTViV in Ontario would result in a cost saving of $0.33 million over the next 5 years. People with valvular heart disease reported their preference for a minimally invasive transcatheter procedure with a quick recovery time.