JACC. Cardiovascular interventions · 2023
1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.
Многоцентровое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Zahr Firas, Song Howard K, Chadderdon Scott, Gada Hemal, Mumtaz Mubashir, Byrne Timothy, Kirshner Merick, Sharma Samin, Kodali Susheel, George Isaac, Merhi William, Yarboro Leora, Sorajja Paul, Bapat Vinayak, Bajwa Tanvir, Weiss Eric, Thaden Jeremy J, Gearhart Elizabeth, Lim Scott, Reardon Michael, Adams David, Mack Michael, Leon Martin B
Аннотация
BACKGROUND: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients.
OBJECTIVES: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR.
METHODS: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria.
RESULTS: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores.
CONCLUSIONS: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.
OBJECTIVES: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR.
METHODS: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria.
RESULTS: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores.
CONCLUSIONS: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.