ArticleJournal of cardiothoracic surgery2024
Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study.
Article in Journal of cardiothoracic 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. Cited by 3 papers, 1 of them a synthesis that pooled it.
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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.
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.
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Use of Perceval Valves in Older Patients: A Systematic Review.Reviews in cardiovascular medicine · 2025Pooled it
- Transcatheter Versus Sutureless Aortic Valve Replacement: A Propensity-Matched Single-Center Cohort Study.Medicina (Kaunas, Lithuania) · 2026Article
- Isolated Rapid Deployment Aortic Valve Replacement in Patients with Aortic Stenosis: Single-Center Retrospective Study.Journal of cardiovascular development and disease · 2025Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve.
methodsMANTRA 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 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days.
resultsA total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported.
conclusionsPreliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS.
trial registrationThe MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).
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