Philipp von Stein, Lukas Stolz, Jean Marc Haurand, Matthias Gröger, Felix Rudolph, Donika Mustafa, Jannik Jobst, Christoph Alexander Mues, Amir Abbas Mahabadi, Isabel A Hörbrand, Carl Schulz, Atsushi Sugiura, Tobias Ruf, Philipp Lurz, Muhammed Gerçek, Patrick Horn, Mirjam Kessler, Tienush Rassaf, Marcel Weber, Tobias Kister, Niklas Schofer, Mathias Konstandin, Florian Schindhelm, Helge Möllmann, Bernhard Unsöld, Stephan Baldus, Wolfgang Rottbauer, Volker Rudolph, Jörg Hausleiter, Roman Pfister, Victor Mauri
{"title":"二尖瓣经导管边缘到边缘修复中器械迭代的结果和影响：修复研究。","authors":"Philipp von Stein, Lukas Stolz, Jean Marc Haurand, Matthias Gröger, Felix Rudolph, Donika Mustafa, Jannik Jobst, Christoph Alexander Mues, Amir Abbas Mahabadi, Isabel A Hörbrand, Carl Schulz, Atsushi Sugiura, Tobias Ruf, Philipp Lurz, Muhammed Gerçek, Patrick Horn, Mirjam Kessler, Tienush Rassaf, Marcel Weber, Tobias Kister, Niklas Schofer, Mathias Konstandin, Florian Schindhelm, Helge Möllmann, Bernhard Unsöld, Stephan Baldus, Wolfgang Rottbauer, Volker Rudolph, Jörg Hausleiter, Roman Pfister, Victor Mauri","doi":"10.1016/j.jcin.2024.11.016","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The PASCAL P10 system for mitral valve transcatheter edge-to-edge repair has undergone iterations, including introduction of the narrower Ace implant and the Precision delivery system.</p><p><strong>Objectives: </strong>The study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations.</p><p><strong>Methods: </strong>The REPAIR (REgistry of PAscal for mltral Regurgitation) study is an investigator-initiated, multicenter registry including consecutive patients with mitral regurgitation (MR) treated from 2019 to 2024. Patients were stratified by device iteration: P10<sub>only</sub>, P10/Ace<sub>Gen1</sub> (introduction of Ace), and P10/Ace<sub>Prec</sub> (introduction of Precision). The primary endpoint was MR ≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30 days, 1 year, and 2 years).</p><p><strong>Results: </strong>A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class ≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10<sub>only</sub>, 945 P10/Ace<sub>Gen1</sub>, and 560 P10/Ace<sub>Prec</sub>. Median follow-up was 510 days (Q1-Q3: 369-874 days). Primary (47% [n = 1,019 of 2,142]) and secondary (52% [n = 1,123 of 2,142]) MR etiology did not change across device iterations (P = 0.547). Technical success was achieved in 97.0% (n = 2,099 of 2,165) with similar rates across device iterations (P = 0.290). MR ≤1+ was achieved in 72% (n = 1,397 of 2,085), improving with device iterations (P10<sub>only</sub>: 66% [n = 422 of 638], P10/Ace<sub>Gen1</sub>: 73% [n = 661 of 906], P10/Ace<sub>Prec</sub>: 77% [n = 414 of 541]; P < 0.001). MR grades of ≤1+ and ≤2+ slightly worsened at 30 days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations.</p><p><strong>Conclusions: </strong>Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation.</p>","PeriodicalId":14688,"journal":{"name":"JACC. 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Patients were stratified by device iteration: P10<sub>only</sub>, P10/Ace<sub>Gen1</sub> (introduction of Ace), and P10/Ace<sub>Prec</sub> (introduction of Precision). The primary endpoint was MR ≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30 days, 1 year, and 2 years).</p><p><strong>Results: </strong>A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class ≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10<sub>only</sub>, 945 P10/Ace<sub>Gen1</sub>, and 560 P10/Ace<sub>Prec</sub>. Median follow-up was 510 days (Q1-Q3: 369-874 days). Primary (47% [n = 1,019 of 2,142]) and secondary (52% [n = 1,123 of 2,142]) MR etiology did not change across device iterations (P = 0.547). Technical success was achieved in 97.0% (n = 2,099 of 2,165) with similar rates across device iterations (P = 0.290). MR ≤1+ was achieved in 72% (n = 1,397 of 2,085), improving with device iterations (P10<sub>only</sub>: 66% [n = 422 of 638], P10/Ace<sub>Gen1</sub>: 73% [n = 661 of 906], P10/Ace<sub>Prec</sub>: 77% [n = 414 of 541]; P < 0.001). MR grades of ≤1+ and ≤2+ slightly worsened at 30 days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations.</p><p><strong>Conclusions: </strong>Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation.</p>\",\"PeriodicalId\":14688,\"journal\":{\"name\":\"JACC. 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Cardiovascular interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jcin.2024.11.016","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Outcomes and Impact of Device Iterations in Mitral Valve Transcatheter Edge-to-Edge Repair: The REPAIR Study.
Background: The PASCAL P10 system for mitral valve transcatheter edge-to-edge repair has undergone iterations, including introduction of the narrower Ace implant and the Precision delivery system.
Objectives: The study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations.
Methods: The REPAIR (REgistry of PAscal for mltral Regurgitation) study is an investigator-initiated, multicenter registry including consecutive patients with mitral regurgitation (MR) treated from 2019 to 2024. Patients were stratified by device iteration: P10only, P10/AceGen1 (introduction of Ace), and P10/AcePrec (introduction of Precision). The primary endpoint was MR ≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30 days, 1 year, and 2 years).
Results: A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class ≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10only, 945 P10/AceGen1, and 560 P10/AcePrec. Median follow-up was 510 days (Q1-Q3: 369-874 days). Primary (47% [n = 1,019 of 2,142]) and secondary (52% [n = 1,123 of 2,142]) MR etiology did not change across device iterations (P = 0.547). Technical success was achieved in 97.0% (n = 2,099 of 2,165) with similar rates across device iterations (P = 0.290). MR ≤1+ was achieved in 72% (n = 1,397 of 2,085), improving with device iterations (P10only: 66% [n = 422 of 638], P10/AceGen1: 73% [n = 661 of 906], P10/AcePrec: 77% [n = 414 of 541]; P < 0.001). MR grades of ≤1+ and ≤2+ slightly worsened at 30 days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations.
Conclusions: Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation.
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.
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