Shakeel A. Qureshi MD , Matthew I. Jones MD , Kuberan Pushparajah MD , Jou-Kou Wang MD , Damien Kenny MD , Kevin Walsh MD , Younes Boudjemline MD , Worakan Promphan MD , Pimpak Prachasilchai MD , John Thomson MD , James R. Bentham MD , Felix Berger MD , Carlos A.C. Pedra MD , Marc Gewillig MD , Bryan P. Yan MD , Ziyad M. Hijazi MD
{"title":"使用自膨胀的经皮肺动脉瓣系统经导管肺动脉瓣植入术:3年的CE研究结果。","authors":"Shakeel A. Qureshi MD , Matthew I. Jones MD , Kuberan Pushparajah MD , Jou-Kou Wang MD , Damien Kenny MD , Kevin Walsh MD , Younes Boudjemline MD , Worakan Promphan MD , Pimpak Prachasilchai MD , John Thomson MD , James R. Bentham MD , Felix Berger MD , Carlos A.C. Pedra MD , Marc Gewillig MD , Bryan P. Yan MD , Ziyad M. Hijazi MD","doi":"10.1016/j.jcin.2024.12.031","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Pulmonary regurgitation is common during follow-up of patients after surgical repair of tetralogy of Fallot and other right ventricular outflow tracts (RVOTs). Many percutaneous pulmonary valves have been used but are limited to smaller RVOTs.</div></div><div><h3>Objectives</h3><div>Since August 2016, a multicenter CE (Conformité Européenne) study was initiated to evaluate a self-expandable VenusP-valve. We aimed to report the acute and 3-year follow-up results.</div></div><div><h3>Methods</h3><div>A total of 81 patients with pulmonary regurgitation were recruited for VenusP-valve implantation and assessed for a 3-year period.</div></div><div><h3>Results</h3><div>In all patients, VenusP-valves were successfully implanted. The mean age was 26.5 ± 13.3 years and the mean weight 59.5 ± 15.6 kg. There was no early procedure-related or late mortality. One patient experienced guidewire perforation of a branch pulmonary artery, causing hemoptysis, and 1 had ventricular tachycardia, at the end of the procedure. During follow-up, 1 patient developed runs of ventricular tachycardia and needed an implantable cardioverter-defibrillator and ablation of the RVOT 5 months after valve implantation. One developed endocarditis 11 months after implantation. After medical treatment, the valve has continued to function normally. One patient developed thrombus on the distal flare 3 years after implantation and was treated with anticoagulants. During 3-year follow-up, valve function has remained satisfactory and right ventricular remodeling has occurred in all patients.</div></div><div><h3>Conclusions</h3><div>We report the 3-year CE study results of percutaneous pulmonary valve implantation in patients with severe pulmonary regurgitation. The valve has shown promising safety and durability. Long-term evaluation is warranted.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 8","pages":"Pages 1045-1056"},"PeriodicalIF":11.7000,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Transcatheter Pulmonary Valve Implantation Using Self-Expandable Percutaneous Pulmonary Valve System\",\"authors\":\"Shakeel A. Qureshi MD , Matthew I. Jones MD , Kuberan Pushparajah MD , Jou-Kou Wang MD , Damien Kenny MD , Kevin Walsh MD , Younes Boudjemline MD , Worakan Promphan MD , Pimpak Prachasilchai MD , John Thomson MD , James R. Bentham MD , Felix Berger MD , Carlos A.C. Pedra MD , Marc Gewillig MD , Bryan P. Yan MD , Ziyad M. Hijazi MD\",\"doi\":\"10.1016/j.jcin.2024.12.031\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Pulmonary regurgitation is common during follow-up of patients after surgical repair of tetralogy of Fallot and other right ventricular outflow tracts (RVOTs). Many percutaneous pulmonary valves have been used but are limited to smaller RVOTs.</div></div><div><h3>Objectives</h3><div>Since August 2016, a multicenter CE (Conformité Européenne) study was initiated to evaluate a self-expandable VenusP-valve. We aimed to report the acute and 3-year follow-up results.</div></div><div><h3>Methods</h3><div>A total of 81 patients with pulmonary regurgitation were recruited for VenusP-valve implantation and assessed for a 3-year period.</div></div><div><h3>Results</h3><div>In all patients, VenusP-valves were successfully implanted. The mean age was 26.5 ± 13.3 years and the mean weight 59.5 ± 15.6 kg. There was no early procedure-related or late mortality. One patient experienced guidewire perforation of a branch pulmonary artery, causing hemoptysis, and 1 had ventricular tachycardia, at the end of the procedure. During follow-up, 1 patient developed runs of ventricular tachycardia and needed an implantable cardioverter-defibrillator and ablation of the RVOT 5 months after valve implantation. One developed endocarditis 11 months after implantation. After medical treatment, the valve has continued to function normally. One patient developed thrombus on the distal flare 3 years after implantation and was treated with anticoagulants. During 3-year follow-up, valve function has remained satisfactory and right ventricular remodeling has occurred in all patients.</div></div><div><h3>Conclusions</h3><div>We report the 3-year CE study results of percutaneous pulmonary valve implantation in patients with severe pulmonary regurgitation. The valve has shown promising safety and durability. Long-term evaluation is warranted.</div></div>\",\"PeriodicalId\":14688,\"journal\":{\"name\":\"JACC. Cardiovascular interventions\",\"volume\":\"18 8\",\"pages\":\"Pages 1045-1056\"},\"PeriodicalIF\":11.7000,\"publicationDate\":\"2025-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JACC. 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Transcatheter Pulmonary Valve Implantation Using Self-Expandable Percutaneous Pulmonary Valve System
Background
Pulmonary regurgitation is common during follow-up of patients after surgical repair of tetralogy of Fallot and other right ventricular outflow tracts (RVOTs). Many percutaneous pulmonary valves have been used but are limited to smaller RVOTs.
Objectives
Since August 2016, a multicenter CE (Conformité Européenne) study was initiated to evaluate a self-expandable VenusP-valve. We aimed to report the acute and 3-year follow-up results.
Methods
A total of 81 patients with pulmonary regurgitation were recruited for VenusP-valve implantation and assessed for a 3-year period.
Results
In all patients, VenusP-valves were successfully implanted. The mean age was 26.5 ± 13.3 years and the mean weight 59.5 ± 15.6 kg. There was no early procedure-related or late mortality. One patient experienced guidewire perforation of a branch pulmonary artery, causing hemoptysis, and 1 had ventricular tachycardia, at the end of the procedure. During follow-up, 1 patient developed runs of ventricular tachycardia and needed an implantable cardioverter-defibrillator and ablation of the RVOT 5 months after valve implantation. One developed endocarditis 11 months after implantation. After medical treatment, the valve has continued to function normally. One patient developed thrombus on the distal flare 3 years after implantation and was treated with anticoagulants. During 3-year follow-up, valve function has remained satisfactory and right ventricular remodeling has occurred in all patients.
Conclusions
We report the 3-year CE study results of percutaneous pulmonary valve implantation in patients with severe pulmonary regurgitation. The valve has shown promising safety and durability. Long-term evaluation is warranted.
期刊介绍:
JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.