Tiffany Patterson1, John Gregson2, Andrejs Erglis3, Jubin Joseph1, Ronak Rajani1, Karen Wilson1, Bernard Prendergast1, Stephen Worthley4, David Hildick-Smith5, Tony Rafter6, Alan Whelan7, Federico De Marco8, Mark Horrigan9, Simon R Redwood1. 1. Cardiovascular Department, Kings College London, St Thomas' Hospital, London, UK. 2. London School of Hygiene and Tropical Medicine, London, UK. 3. Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia. 4. GenesisCare, Alexandria, Australia. 5. Sussex Cardiac Centre, Brighton & Sussex University Hospitals, Brighton, UK. 6. HeartCare Partners, Brisbane, Australia. 7. HeartCare WA, Perth, Australia. 8. IRCCS Policlinico San Donato, San Donato Milanese (Milan), Italy. 9. Austin Health, HeartCare Victoria, Melbourne, Australia.
Abstract
AIMS: We report the 2-year outcomes of the MitrAl ValvE RepaIr Clinical (MAVERIC) trial. Functional mitral regurgitation (FMR) is associated with poor outcomes for which there remains an unmet clinical need. ARTO is a transcatheter annular reduction device for the treatment of FMR and an emerging alternative for patients at high surgical risk. The MAVERIC trial was designed to evaluate the safety and performance of the ARTO system in FMR and heart failure (HF). METHODS AND RESULTS: MAVERIC is an international multicentre, prospective, single arm study enrolling patients with FMR grade ≥ 2, New York Heart Association (NYHA) class ≥II symptoms despite maximal medical therapy. Patients were excluded if they had significant structural mitral valve abnormality or life expectancy <1 year. The primary outcome measures were a composite safety outcome and efficacy defined as mitral regurgitation (MR) reduction 30 days post-procedure. Secondary outcome measures included safety, change in MR grade, NYHA class and hospitalization for HF at 2 years. Forty-five patients were enrolled. The composite safety outcome was met (2/45 adverse events at 30 days) and no device-related deaths occurred at 2-year follow-up. A sustained reduction in MR [grade < 2: 21/31 (68%) vs. 31/31(0%); P < 0.0001], left ventricular end-diastolic volume index (90.0 ± 30 vs. 106 ± 26 mL/m2 ; P = 0.004) and anteroposterior diameter (35.5 ± 4.7 vs. 41.4 ± 4.6 mm; P < 0.0001) was seen at 2 years compared to baseline. Progressive symptomatic improvement [NYHA class ≤II: 27/34 (80%) vs. 12/34 (36%); P < 0.0001] and a reduction in HF hospitalizations (19.8% 2 years post vs. 52.3% 2 years prior; P < 0.001) were seen at 2 years compared to baseline. CONCLUSIONS: The ARTO system is a safe and effective treatment for FMR with reductions in left ventricular end-diastolic volumes sustained to 2 years.
AIMS: We report the 2-year outcomes of the MitrAl ValvE RepaIr Clinical (MAVERIC) trial. Functional mitral regurgitation (FMR) is associated with poor outcomes for which there remains an unmet clinical need. ARTO is a transcatheter annular reduction device for the treatment of FMR and an emerging alternative for patients at high surgical risk. The MAVERIC trial was designed to evaluate the safety and performance of the ARTO system in FMR and heart failure (HF). METHODS AND RESULTS: MAVERIC is an international multicentre, prospective, single arm study enrolling patients with FMR grade ≥ 2, New York Heart Association (NYHA) class ≥II symptoms despite maximal medical therapy. Patients were excluded if they had significant structural mitral valve abnormality or life expectancy <1 year. The primary outcome measures were a composite safety outcome and efficacy defined as mitral regurgitation (MR) reduction 30 days post-procedure. Secondary outcome measures included safety, change in MR grade, NYHA class and hospitalization for HF at 2 years. Forty-five patients were enrolled. The composite safety outcome was met (2/45 adverse events at 30 days) and no device-related deaths occurred at 2-year follow-up. A sustained reduction in MR [grade < 2: 21/31 (68%) vs. 31/31(0%); P < 0.0001], left ventricular end-diastolic volume index (90.0 ± 30 vs. 106 ± 26 mL/m2 ; P = 0.004) and anteroposterior diameter (35.5 ± 4.7 vs. 41.4 ± 4.6 mm; P < 0.0001) was seen at 2 years compared to baseline. Progressive symptomatic improvement [NYHA class ≤II: 27/34 (80%) vs. 12/34 (36%); P < 0.0001] and a reduction in HF hospitalizations (19.8% 2 years post vs. 52.3% 2 years prior; P < 0.001) were seen at 2 years compared to baseline. CONCLUSIONS: The ARTO system is a safe and effective treatment for FMR with reductions in left ventricular end-diastolic volumes sustained to 2 years.
Authors: Angela McInerney; Luis Marroquin-Donday; Gabriela Tirado-Conte; Breda Hennessey; Carolina Espejo; Eduardo Pozo; Alberto de Agustín; Nieves Gonzalo; Pablo Salinas; Iván Núñez-Gil; Antonio Fernández-Ortiz; Hernan Mejía-Rentería; Fernando Macaya; Javier Escaned; Luis Nombela-Franco; Pilar Jiménez-Quevedo Journal: J Clin Med Date: 2022-05-22 Impact factor: 4.964