Small Mitral Valve Orifice Area in Mitral Valve Transcatheter Edge-to-Edge Repair: The REPAIR Study.
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von Stein Philipp, von Stein Jennifer, Schindhelm Florian, Rudolph Felix, Sagmeister Paula, Haurand Jean Marc, Jobst Jannik, Gröger Matthias, Stolz Lukas, Schulz Carl, Mues Christoph Alexander, Mustafa Donika, Hoerbrand Isabel A, Sugiura Atsushi, Wolff Charlotte, Lurz Philipp, Jahn Philipp, Ascione Guido, Guthoff Henning, Baldus Stephan, Rottbauer Wolfgang, Gerçek Muhammed, Pfister Roman, Rassaf Tienush, Weber Marcel, Konstandin Mathias, Möllmann Helge, Schofer Niklas, Hausleiter Jörg, Kessler Mirjam, Unsöld Bernhard, Horn Patrick, Kister Tobias, Rudolph Volker, Mahabadi Amir Abbas, Granada Juan F, Mauri Victor, REPAIR Investigators
Аннотация
OBJECTIVES: The objective of the study was to compare procedural, echocardiographic, and clinical outcomes after PASCAL M-TEER according to baseline 3D-MVOA.
METHODS: Patients with available baseline 3D-MVOA from the investigator-initiated multicenter REPAIR registry were stratified by 3D-MVOA (<4 vs ≥4 cm2). Outcomes included Mitral Valve Academic Research Consortium-defined technical success, MR ≤1+ at discharge, ≥1 NYHA functional class improvement at 30-days, and 1-year all-cause mortality.
RESULTS: Among 1,189 patients (mean age 78 ± 9 years, 44% female, 86% NYHA functional class III/IV, mean 3D-MVOA 4.9 ± 1.6 cm2, 45% secondary MR), 338 (28%) had baseline 3D-MVOA <4 cm2 and 851 (72%) ≥4 cm2. Technical success was achieved in 95.9% vs 98.2% (P = 0.028) and MR reduction to ≤1+ in 72% vs 72% (P > 0.999), respectively. At 30 days, NYHA functional class improved in 61% vs 64% (P = 0.532). One-year all-cause mortality was 13.0% (95% CI: 8.5% to 17.4%) vs 13.6% (95% CI: 10.9% to 16.3%; P = 0.760); adjusted HR (<vs ≥ 4 cm2): 1.05 (95% CI: 0.67-1.63; P = 0.842).
CONCLUSIONS: Almost one-third of patients with available measurements had baseline 3D-MVOA <4 cm2. Technical success was modestly lower, whereas MR reduction and 1-year clinical outcomes did not differ significantly. These data are consistent with the feasibility of PASCAL M-TEER in carefully selected patients with small 3D-MVOA at experienced centers.