Evidence map›Paper›PMID 39666948›Full record

ArticleInterdisciplinary cardiovascular and thoracic surgery2024

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 and 9 more

Registry-linked trialAbstract read
In one paragraph

Article in Interdisciplinary cardiovascular and thoracic surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05002543 (CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05002543 recruitingnot on this map

CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

Typeobservational_patient_registrySponsorCorcym S.r.lRan2021 to 2035Enrolled2,150ConditionsCardiac Valve Disease
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Omer DzemaliClinic for Cardiac Surgery, University Hospital of Zurich, Zurich, Switzerland.ORCID 0000-0001-7910-5152
Hector Rodriguez Cetina BieferClinic for Cardiac Surgery, University Hospital of Zurich, Zurich, Switzerland.
Marco Di EusanioDepartment for Cardiac Surgery, Ospedali Riuniti Ancona, Ancona, Italy.
Olivier FabreDepartment for Cardiac Surgery, Lens Hospital and Bois Bernard Private Hospital, Lens, France.
Giovanni TroiseCardiac Surgery Unit, Poliambulanza Foundation Hospital, Brescia, Italy.
Nikolaos BonarosDepartment of Cardiac Surgery, Innsbruck Medical University, Innsbruck, Austria.
Francesco GrimaldiDepartment of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy.
Yeong-Hoon ChoiDepartment of Cardiac Surgery, Kerckhoff Klinik, Bad Nauheim, Germany.
Giuseppe SantarpinoDepartment of Cardiac Surgery, Città di Lecce Hospital, Lecce, Italy.
Cristian BaezaDepartment of Cardiac Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Francesco PollariDepartment of Cardiac and Vascular Surgery, Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany.
Bertrand MarcheixDepartment of Cardiac Surgery, CHU Toulouse Rangueil University Hospital, Toulouse, France.
Davide PaciniUnit of Cardiac Surgery, Policlinico S.Orsola-Malpighi, Bologna, Italy.
Vincenzo ArganoThe Cardiac Care Group, Policlinico Paolo Giaccone, Palermo, Italy.
Max BaghaiCardiac Surgery, King's College Hospital, London, UK.
Moninder BhabraDivision of Cardiac Surgery, Queen Elizabeth Medical Centre, Birmingham, UK.
Enzo MazzaroAz. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste, Trieste, Italy.
Luigi BadanoDepartment of Cardiology, Istituto Auxologico Italiano, IRCCS, Milano, Italy.
Joerg KempfertKlinik für Herz-, Thorax- und Gefäßchirurgie Deutsches Herzzentrum der Charité, Berlin, Germany.

Funding

CORCYM S.r.l.
6 · The paper itself

Abstract

objectivesMemo 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.

methodsMANTRA 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.

resultsIn 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.

conclusionsMitral valve repair with Memo 4D is associated with good clinical and haemodynamic outcomes in the early period.MANTRA ClinicalTrials.gov number NCT05002543.

Indexed as

Annuloplasty semi-rigid ringMemo 4DMitral regurgitationOutcomesSurgical mitral valve repair

Identifiers

PMID39666948
PMCPMC11700519

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.