TY - JOUR
T1 - Mitral valve repair with the semirigid MEMO 4D annuloplasty ring
T2 - early clinical and echocardiographic outcomes from the MANTRA study
AU - Dzemali, Omer
AU - Rodriguez Cetina Biefer, Hector
AU - Di Eusanio, Marco
AU - Fabre, Olivier
AU - Troise, Giovanni
AU - Bonaros, Nikolaos
AU - Grimaldi, Francesco
AU - Choi, Yeong-Hoon
AU - Santarpino, Giuseppe
AU - Baeza, Cristian
AU - Pollari, Francesco
AU - Marcheix, Bertrand
AU - Pacini, Davide
AU - Argano, Vincenzo
AU - Baghai, Max
AU - Bhabra, Moninder
AU - Mazzaro, Enzo
AU - Badano, Luigi
AU - Kempfert, Joerg
N1 - Pollari: Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany; Santarpino: externe Aff.
PY - 2024/12/12
Y1 - 2024/12/12
N2 - OBJECTIVES: Memo 4D is a semi-rigid ring with an exclusive saddle shape and progressive increased anteroposterior diameter. This preliminary analysis reports 30-day clinical and haemodynamic outcomes of the MANTRA Memo 4D sub-study.METHODS: MANTRA is an "umbrella" prospective, multicentre, worldwide post-market study to collect real-life safety and performance data on the Corcym devices. Clinical and echocardiographic outcomes were gathered preoperatively, at discharge and each follow-up. KCCQ-12 questionnaires were collected preoperatively and at 30-days. Echocardiographic studies were performed per a predefined protocol and assessed by an independent core-lab.RESULTS: 166 patients (52, 31.3% female, mean age 60.7 ± 11.4 years) underwent mitral valve repair with Memo 4D in 17 international institutions, between July 2021 and June 2023 (enrollment is still ongoing). Primary was the most common aetiology (157, 94.6%), of which 33 cases of Barlow's disease, (19.9%); secondary mitral regurgitation was present in (6 cases, (3.6%). Thirty-day mortality was 0.6% (1). One stroke event (0.6%), one acute kidney failure (0.6%), one myocardial infarction (0.6%) and two reoperations within 30 days were reported.Surgery marked improvement in the patient's NYHA class associated with a significant increase in KCCQ-12 summary score, from 69.1 (SD 23.7) preoperatively to 83.9 (SD 15.7) at 30 days. End-diastolic left ventricular diameters decreased from 55.19 (SD 7.10) preoperatively to 52.70 (SD 3.76) mm at 30 days, and left atrial volume decreased from 125.79 (SD 46.33) preoperatively to 91.51 (SD 37.20) ml at 30 days. Mitral regurgitation significantly reduced after the operation and up to 30-day follow-up.CONCLUSIONS: Mitral valve repair with Memo 4D is associated with good clinical and haemodynamic outcomes in the early period.
AB - OBJECTIVES: Memo 4D is a semi-rigid ring with an exclusive saddle shape and progressive increased anteroposterior diameter. This preliminary analysis reports 30-day clinical and haemodynamic outcomes of the MANTRA Memo 4D sub-study.METHODS: MANTRA is an "umbrella" prospective, multicentre, worldwide post-market study to collect real-life safety and performance data on the Corcym devices. Clinical and echocardiographic outcomes were gathered preoperatively, at discharge and each follow-up. KCCQ-12 questionnaires were collected preoperatively and at 30-days. Echocardiographic studies were performed per a predefined protocol and assessed by an independent core-lab.RESULTS: 166 patients (52, 31.3% female, mean age 60.7 ± 11.4 years) underwent mitral valve repair with Memo 4D in 17 international institutions, between July 2021 and June 2023 (enrollment is still ongoing). Primary was the most common aetiology (157, 94.6%), of which 33 cases of Barlow's disease, (19.9%); secondary mitral regurgitation was present in (6 cases, (3.6%). Thirty-day mortality was 0.6% (1). One stroke event (0.6%), one acute kidney failure (0.6%), one myocardial infarction (0.6%) and two reoperations within 30 days were reported.Surgery marked improvement in the patient's NYHA class associated with a significant increase in KCCQ-12 summary score, from 69.1 (SD 23.7) preoperatively to 83.9 (SD 15.7) at 30 days. End-diastolic left ventricular diameters decreased from 55.19 (SD 7.10) preoperatively to 52.70 (SD 3.76) mm at 30 days, and left atrial volume decreased from 125.79 (SD 46.33) preoperatively to 91.51 (SD 37.20) ml at 30 days. Mitral regurgitation significantly reduced after the operation and up to 30-day follow-up.CONCLUSIONS: Mitral valve repair with Memo 4D is associated with good clinical and haemodynamic outcomes in the early period.
U2 - 10.1093/icvts/ivae208
DO - 10.1093/icvts/ivae208
M3 - Original Article
C2 - 39666948
SN - 2753-670X
JO - Interdisciplinary Cardiovascular and Thoracic Surgery
JF - Interdisciplinary Cardiovascular and Thoracic Surgery
ER -