Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study

The 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. MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market...

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Published in:Journal of cardiothoracic surgery 2024-06, Vol.19 (1), p.340-10, Article 340
Main Authors: Micovic, Slobodan, Nobre, Angelo, Choi, Jae Woong, Solinas, Marco, Shehada, Sharaf-Eldin, Torella, Michele, Baeza, Cristian, Parrino, Eugene, Pollari, Francesco, Troise, Giovanni, Kappert, Utz, Mellert, Friedrich, Je, Hyung Gon, Argano, Vincenzo, Lam, Ka Yan, Rinaldi, Mauro, Gutermann, Herbert, Meuris, Bart
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Aorta
Aortic valve
Aortic Valve - surgery
Aortic valve replacement
Aortic Valve Stenosis - surgery
Catheters
Disease
Female
Heart
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation - methods
Heart valves
Hemodynamics
Hemodynamics - physiology
Humans
Male
Middle Aged
Mineralization
Mortality
Ostomy
Patients
Perceval plus
Prospective Studies
Prostheses
Prosthesis Design
Quality of Life
Questionnaires
Real-life data
Recovery (Medical)
Surgeons
Surgery
Sutureless Surgical Procedures - methods
Sutureless valve
Treatment Outcome
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container_end_page 10
container_issue 1
container_start_page 340
container_title Journal of cardiothoracic surgery
container_volume 19
creator Micovic, Slobodan
Nobre, Angelo
Choi, Jae Woong
Solinas, Marco
Shehada, Sharaf-Eldin
Torella, Michele
Baeza, Cristian
Parrino, Eugene
Pollari, Francesco
Troise, Giovanni
Kappert, Utz
Mellert, Friedrich
Je, Hyung Gon
Argano, Vincenzo
Lam, Ka Yan
Rinaldi, Mauro
Gutermann, Herbert
Meuris, Bart
description The 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. 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 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. A 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 
doi_str_mv 10.1186/s13019-024-02861-1
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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 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. A 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 &lt; 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p &lt; 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. Preliminary 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. 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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 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. A 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 &lt; 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p &lt; 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. Preliminary 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. The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>38902742</pmid><doi>10.1186/s13019-024-02861-1</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Aged, 80 and over
Aorta
Aortic valve
Aortic Valve - surgery
Aortic valve replacement
Aortic Valve Stenosis - surgery
Catheters
Disease
Female
Heart
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation - methods
Heart valves
Hemodynamics
Hemodynamics - physiology
Humans
Male
Middle Aged
Mineralization
Mortality
Ostomy
Patients
Perceval plus
Prospective Studies
Prostheses
Prosthesis Design
Quality of Life
Questionnaires
Real-life data
Recovery (Medical)
Surgeons
Surgery
Sutureless Surgical Procedures - methods
Sutureless valve
Treatment Outcome
title Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-27T05%3A46%3A04IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Early%20outcomes%20of%20aortic%20valve%20replacement%20with%20Perceval%20PLUS%20sutureless%20valve:%20results%20of%20the%20prospective%20multicentric%20MANTRA%20study&rft.jtitle=Journal%20of%20cardiothoracic%20surgery&rft.au=Micovic,%20Slobodan&rft.aucorp=MANTRA%20Investigators&rft.date=2024-06-21&rft.volume=19&rft.issue=1&rft.spage=340&rft.epage=10&rft.pages=340-10&rft.artnum=340&rft.issn=1749-8090&rft.eissn=1749-8090&rft_id=info:doi/10.1186/s13019-024-02861-1&rft_dat=%3Cgale_doaj_%3EA798501173%3C/gale_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c445t-4ea3b107dcb4f70d02de940d138b69ae215f663073d48c9d07fe50137f03f9033%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=3079251993&rft_id=info:pmid/38902742&rft_galeid=A798501173&rfr_iscdi=true