Mitral valve repair with the semi-rigid Memo 4D annuloplasty ring: early clinical and echocardiographic outcomes from the MANTRA study

Omer Dzemali; Hector Rodriguez Cetina Biefer; Marco Di Eusanio; Olivier Fabre; Giovanni Troise; Nikolaos Bonaros; Francesco Grimaldi; Yeong-Hoon Choi; Giuseppe Santarpino; Cristian Baeza; Francesco Pollari; Bertrand Marcheix; Davide Pacini; Vincenzo Argano; Max Baghai; Moninder Bhabra; Enzo Mazzaro; Luigi Badano; Joerg Kempfert

doi:10.1093/icvts/ivae208

Mitral valve repair with the semi-rigid Memo 4D annuloplasty ring: early clinical and echocardiographic outcomes from the MANTRA study

Interdiscip Cardiovasc Thorac Surg. 2024 Dec 25;40(1):ivae208. doi: 10.1093/icvts/ivae208.

Authors

Omer Dzemali^{1

2}, Hector Rodriguez Cetina Biefer^{1

2}, Marco Di Eusanio³, Olivier Fabre⁴, Giovanni Troise⁵, Nikolaos Bonaros⁶, Francesco Grimaldi⁷, Yeong-Hoon Choi⁸, Giuseppe Santarpino⁹, Cristian Baeza¹⁰, Francesco Pollari¹¹, Bertrand Marcheix¹², Davide Pacini¹³, Vincenzo Argano¹⁴, Max Baghai¹⁵, Moninder Bhabra¹⁶, Enzo Mazzaro¹⁷, Luigi Badano^{18

19}, Joerg Kempfert²⁰

Affiliations

¹ Clinic for Cardiac Surgery, University Hospital of Zurich, Zurich, Switzerland.
² Clinic for Cardiac Surgery, City Hospital of Zurich-Triemli, Zurich, Switzerland.
³ Department for Cardiac Surgery, Ospedali Riuniti Ancona, Ancona, Italy.
⁴ Department for Cardiac Surgery, Lens Hospital and Bois Bernard Private Hospital, Lens, France.
⁵ Cardiac Surgery Unit, Poliambulanza Foundation Hospital, Brescia, Italy.
⁶ Department of Cardiac Surgery, Innsbruck Medical University, Innsbruck, Austria.
⁷ Department of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy.
⁸ Department of Cardiac Surgery, Kerckhoff Klinik, Bad Nauheim, Germany.
⁹ Department of Cardiac Surgery, Città di Lecce Hospital, Lecce, Italy.
¹⁰ Department of Cardiac Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
¹¹ Department of Cardiac and Vascular Surgery, Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany.
¹² Department of Cardiac Surgery, CHU Toulouse Rangueil University Hospital, Toulouse, France.
¹³ Unit of Cardiac Surgery, Policlinico S.Orsola-Malpighi, Bologna, Italy.
¹⁴ The Cardiac Care Group, Policlinico Paolo Giaccone, Palermo, Italy.
¹⁵ Cardiac Surgery, King's College Hospital, London, UK.
¹⁶ Division of Cardiac Surgery, Queen Elizabeth Medical Centre, Birmingham, UK.
¹⁷ Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste, Trieste, Italy.
¹⁸ Department of Cardiology, Istituto Auxologico Italiano, IRCCS, Milano, Italy.
¹⁹ Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
²⁰ Klinik für Herz-, Thorax- und Gefäßchirurgie Deutsches Herzzentrum der Charité, Berlin, Germany.

Abstract

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 laboratory.

Results: In total, 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 (enrolment 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 six 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.MANTRA ClinicalTrials.gov number NCT05002543.

Keywords: Annuloplasty semi-rigid ring; Memo 4D; Mitral regurgitation; Outcomes; Surgical mitral valve repair.

Associated data

ClinicalTrials.gov/NCT05002543

Grants and funding

CORCYM S.r.l.