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. 2023 Jun 2:15:151-163.
doi: 10.1016/j.xjon.2023.05.008. eCollection 2023 Sep.

Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue

David A Heimansohn  1 , Craig Baker  2 , Evelio Rodriguez  3 , Hiroo Takayama  4 , Francois Dagenais  5 , David S Talton  6 , Mubashir A Mumtaz  7 , Philippe Pibarot  8 , John D Puskas  9 ; COMMENCE Trial Investigators
Affiliations

Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue

David A Heimansohn et al. JTCVS Open. .

Erratum in

  • Erratum: Notice of Correction.
    [No authors listed] [No authors listed] JTCVS Open. 2023 Dec 27;17:184. doi: 10.1016/j.xjon.2023.12.010. eCollection 2024 Feb. JTCVS Open. 2023. PMID: 38420550 Free PMC article.

Abstract

Objective: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE.

Methods: Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory.

Results: Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-free probabilities for all-cause mortality, structural valve deterioration, and reoperation were 79.9%, 98.7%, and 97.1%, respectively. Hemodynamic valve function measurements were stable through the 5-year follow-up period; valvular leaks were infrequently observed and primarily clinically insignificant/mild.

Conclusions: Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance.

Keywords: RESILIA tissue; bioprosthetic valve; mitral valve diseases; mitral valve replacement.

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Figures

None
Graphical abstract
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Freedom from death and structural valve deterioration at 5 yrs. in COMMENCE mitral patients.
Figure 1
Figure 1
CONSORT diagram.
Figure 2
Figure 2
Kaplan–Meier: overall survival and freedom from SVD. SVD, Structural valve deterioration; CI, confidence interval.
Figure 3
Figure 3
Echocardiography-derived valve hemodynamic outcomes over the follow-up period: A, Mean mitral pressure gradients; B, effective orifice area; C, Doppler velocity index (DVI); and D, peak velocity.
Figure 4
Figure 4
Paravalvular (A) and transvalvular (B) leak during the study period.
None
See this image and copyright information in PMC

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