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Mitral Valve Repair With A New Generation Ring Via Minimally Invasive Approach: Results From The International Prospective Mantra Study
Ilir Hysi1, Marco Di Eusanio
2, Yeong-Hoon Choi
3, Nikolaos Bonaros
4, Joerg Kempfert
5, Cristian Baeza
6, Giovanni Troise
7, Davide Pacini
8, Francesco Pollari
9, Giuseppe Santarpino
10, Vincenzo Argano
11, Luigi Badano
12, Omer Dzemali
13;
1Lens Hospital and Bois Bernard Private Hospital, Lens, France, Lens, France,
2Ospedali Riuniti Ancona, Ancona, Italy, Ancona, Italy,
3Kerckhoff Klinik, Bad Nauheim, Germany, Bad Nauhiem, Germany,
4Innsbruck Medical University, Innsbruck, Austria, Innsbruck, Austria,
5Klinik für Herz-, Thorax- und Gefäßchirurgie Deutsches Herzzentrum der Charité, Berlin, Germany, Berlin, Germany,
6University Hospitals Cleveland Medical Center, Cleveland, USA, Cleveland, OH, USA,
7Poliambulanza Foundation Hospital, Brescia, Italy, Brescia, Italy,
8Policlinico S.Orsola-Malpighi, Bologna, Italy, Bologna, Italy,
9Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany, Nuremberg, Germany,
10Città di Lecce Hospital. Lecce, Italy, Lecce, Italy,
11Policlinico Paolo Giaccone, Palermo, Italy, Palermo, Italy,
12Department of Cardiology, Istituto Auxologico Italiano, IRCCS, Milano, Italy and Department of Medicine and Surgery, University of Milano-Bicocca Milan, Italy, Milan, Italy,
13University Hospital of Zurich, Clinic for Cardiac Surgery, Zurich, Switzerland and City Hospital of Zurich—Triemli, Clinic for Cardiac Surgery, Zurich Switzerland., Zurich, Switzerland
BACKGROUND:The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study (ClinicalTrials.gov NCT05002543) in patients undergoing minimally invasive mitral valve repair (MI-MVr) with a new generation semi-rigid ring.
METHODS:MANTRA is an ongoing “umbrella” prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow-up. KCCQ-12 questionnaires were collected preoperatively and at 30-days. Echocardiographic studies were assessed by an independent core-lab.
RESULTS:Between July 2021 and October 2023, among the 170 subjects undergoing MVr with Corcym semi-rigid ring, 97 underwent MI-MVr in 12 International institutions through mini-thoracotomy approach. The mean age at surgery was 59.1±11.9 years with a mean EuroSCORE II of 1.3±1.3. Primary mitral regurgitation was the most common etiology (73, 75.35%), followed by Barlow’s (17, 17.5%), secondary mitral regurgitation (4, 4.1%) and other etiology (3, 3.1%). Operative and postoperative outcomes are reported in Table 1. Most surgeries were done via direct visualization (42, 43.3%), video assisted in 30 cases (30.9%), and fully endoscopic in 25 subjects (25.8%). Concomitant tricuspid valve repair was performed in 14 subjects (14.4%), atrial septal repair in 10 cases (10.3%), and atrial fibrillation treatment in 21 cases (21.6%). Thirty-day mortality was 0.0%, and only two reoperations were reported within 30 days (2.1%).Surgery resulted in a marked improvement in patients’ NYHA class, associated with a clinically significant increase in KCCQ-12 summary score (from 70.6±24.3 preoperatively to 83.1±16.5 at 30-day, p<0.0001). End-diastolic left ventricular diameters decreased from 55.06±6.86 preoperatively to 50.13±6.57 mm at 30-day follow-up, and left atrial volume decreased from 130.96±50.04 preoperatively to 89.32±39.65 ml at 30days. Mitral regurgitation decreased significantly after the operation and up to 30-day follow-up.
CONCLUSIONS:In this prospective multicenter study, MI-MVr with the new generation semi-rigid ring confirmed to be safe and effective, providing good clinical outcomes, moderate-to-large improvement of the patient’s Quality of Life at 30days, and good early hemodynamic performance with optimal reduction of the severity of MR and preservation of the left ventricular function.
Table 1_Operative and post-operative outcomes
| Overall populationN=97 |
| Minimally Invasive approach [n, (%)] | |
| Mini thoracotomy• Direct visualization• Fully endoscopic• Video assisted | 97 (100.0%)42 (43.3%)25 (25.8%)30 (30.9%) |
| Concomitant procedure [n, (%)] Tricuspid Valve Repair AF Treatment Atrial Septal Defect Repair | 14(14.4%)21 (21.6%)10 (10.3%) |
| Repair Details, N (%)- Posterior leaflet resection- Anterior leaflet resection- Cleft closure- Alfieri / edge-to-edge repair- Replacement posterior chordae- Replacement anterior chordae | 24 (24.7%)3 (3.1%)23 (23.7%)8 (8.2%)39 (40.2%)7 (7.2%) |
| Safety Early Outcome (≤ 30 days) [n, (%)] | |
| All Deaths | 0 (0.0%) |
| Re-intervention on mitral valve | 2 (1.4%) |
| Stroke | 0 (0.0%) |
| Acute Kidney Failure | 1 (0.7%) |
| Endocarditis | 0 (0.0%) |
| AV-block III | 4 (4.1%) |
| Myocardial Infarction | 1 (0.7%) |
| | Baseline | 30 days |
| KCCQ-12 Summary score [mean±SD] | n=96 | 70.6±24.3 | n=89 | 83.1±16.5 |
| Echocardiographic finding [mean±SD] | Baseline | 30 days |
| Left Ventricular End-Diastolic Diameter [mm] | n=54 | 55.06±6.86 | n=69 | 50.13±6.47 |
| Left Ventricular End-Diastolic Volume [ml] | n=50 | 167.28±53.95 | n=66 | 126.15±38.75 |
| Left Atrial Volume [ml] | n=50 | 130.96±50.04 | n=66 | 89.32±39.65 |
| Mean Mitral Pressure Gradient [mmHg] | NA | n=72 | 3.16±1.41 |
| Severe Mitral Regurgitation [N (%)] | n=77 | 47 (61.0%) | n=74 | 1 (1.4%) |
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