JACC. Cardiovascular interventions · 2026
30-Day Outcomes of a Single-Stage Transfemoral Mitral Valve Replacement System in Severe Mitral Valve Disease.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Yadav Pradeep K, Vahl Torsten P, Thourani Vinod H, Latib Azeem, Chehab Bassem M, Rinaldi Michael, Makkar Raj, Rogers Jason H, Rodés-Cabau Josep, Singh Gagan, Gössl Mario, Sorajja Paul, Reardon Michael J, Goel Sachin, Kapadia Samir, Krishnaswamy Amar, Ranard Lauren S, Khalique Omar, Asch Federico M, Evans Michael, Granada Juan F
Аннотация
BACKGROUND: Transfemoral (TF) transcatheter mitral valve replacement (TMVR) has emerged as a therapeutic alternative for the treatment of patients with symptomatic mitral valve disease in patients with high surgical risk.
OBJECTIVES: The aim of this study was to present 30-day outcomes among all patients included in both the early feasibility study (EFS) and compassionate use experience using the Cephea TF TMVR system.
METHODS: Thirty-one consecutive high-risk patients with symptomatic mitral valve disease were enrolled under an EFS protocol (n = 24) or treated under compassionate use (n = 7) with TF TMVR from August 2021 to June 2024. The cohort mean age was 75.0 ± 8.1 years, with mean Society of Thoracic Surgeons Predicted Risk of Mortality of 6.4% ± 2.9%. Procedural outcomes and survival through 30 days were reported for all patients; additionally, subjects enrolled in the EFS had comprehensive follow-up visits including independent echocardiographic core laboratory measurements.
RESULTS: All patients had mitral regurgitation (MR) grade ≥III (93.5%) or isolated mitral stenosis (6.5%); 25.8% had severe mitral annular calcification. The prosthetic valve was implanted in 96.8% of attempted subjects (30 of 31), with a mean device time of 56 ± 32 minutes. One subject was converted to surgical bioprosthetic mitral valve implantation. There were no procedural deaths or strokes. The primary safety endpoint of 30-day survival was achieved in 97% of patients (30 of 31); the primary efficacy endpoint of MR reduction to mild or less was achieved in 100% of patients with evaluable echocardiograms (27 of 27).
CONCLUSIONS: TF TMVR in patients with complex anatomies achieved a high rate of implantation success, low 30-day mortality, and no significant residual MR.
OBJECTIVES: The aim of this study was to present 30-day outcomes among all patients included in both the early feasibility study (EFS) and compassionate use experience using the Cephea TF TMVR system.
METHODS: Thirty-one consecutive high-risk patients with symptomatic mitral valve disease were enrolled under an EFS protocol (n = 24) or treated under compassionate use (n = 7) with TF TMVR from August 2021 to June 2024. The cohort mean age was 75.0 ± 8.1 years, with mean Society of Thoracic Surgeons Predicted Risk of Mortality of 6.4% ± 2.9%. Procedural outcomes and survival through 30 days were reported for all patients; additionally, subjects enrolled in the EFS had comprehensive follow-up visits including independent echocardiographic core laboratory measurements.
RESULTS: All patients had mitral regurgitation (MR) grade ≥III (93.5%) or isolated mitral stenosis (6.5%); 25.8% had severe mitral annular calcification. The prosthetic valve was implanted in 96.8% of attempted subjects (30 of 31), with a mean device time of 56 ± 32 minutes. One subject was converted to surgical bioprosthetic mitral valve implantation. There were no procedural deaths or strokes. The primary safety endpoint of 30-day survival was achieved in 97% of patients (30 of 31); the primary efficacy endpoint of MR reduction to mild or less was achieved in 100% of patients with evaluable echocardiograms (27 of 27).
CONCLUSIONS: TF TMVR in patients with complex anatomies achieved a high rate of implantation success, low 30-day mortality, and no significant residual MR.
Предметные рубрики MeSH
HumansFemaleAgedMitral Valve InsufficiencyTime FactorsMaleTranscatheter Mitral Valve ReplacementMitral ValveSeverity of Illness IndexRisk FactorsAged, 80 and overFeasibility StudiesHeart Valve ProsthesisTreatment OutcomeRecovery of FunctionCompassionate Use TrialsFemoral ArteryMitral Valve StenosisCatheterization, PeripheralRisk AssessmentProsthesis Design