Pub Date : 2024-11-25DOI: 10.1016/j.jcin.2024.08.034
Iván Sánchez-Sánchez MD , Enrico Cerrato MD, PhD , Mario Bollati MD , Carolina Espejo-Paeres MD , Luis Nombela-Franco MD, PhD , Emilio Alfonso-Rodríguez MD , Santiago J. Camacho-Freire MD, PhD , Pedro A. Villablanca MD , Ignacio J. Amat-Santos MD, PhD , José M. De la Torre Hernández MD, PhD , Isaac Pascual MD, PhD , Christoph Liebetrau MD, PhD , Benjamín Camacho MD , Marco Pavani MD , Juan Albistur MD , Roberto Adriano Latini MD , Ferdinando Varbella MD , Víctor Alfonso Jiménez Díaz MD , Davide Piraino MD , Massimo Mancone MD, PhD , Iván J. Núñez-Gil MD, PhD
Background
Limited data are available to guide the management of coronary artery aneurysms (CAAs).
Objectives
The authors sought to define the clinical characteristics, identify variables that predict outcomes, and provide long-term data on CAAs.
Methods
We describe outcomes from 1,729 consecutive patients with CAAs included in an ambispective international registry (CAAR [Coronary Artery Aneurysm Registry]; NCT02563626) involving 33 hospitals across 9 countries in America and Europe.
Results
Patients were predominantly male (78.6%; 1,359/1,729) with a mean age of 66 years. Classic cardiovascular risk factors were common, as well as coronary artery disease (85.8%; 1,484/1,729), peripheral vascular disease (10.9%; 188/1,729), and chronic kidney disease (8.0%; 138/1,729). The median number of aneurysms per patient was 1.0 (Q1-Q3: 1.0-1.0), with the most affected territory being the left anterior descending artery (49.6%; 857/1,729). The majority underwent any revascularization procedure (68.5%; 1,184/1,729), mainly percutaneous coronary intervention (50.7%; 877/1,729), and were discharged on dual antiplatelet therapy (65.6%; 1,134/1,729). After a median follow-up of 44.8 months (Q1-Q3: 14.9-88.1), 379 died (21.9%), and 641 (37.1%) developed a major adverse cardiovascular event (MACE) (all-cause death, heart failure, unstable angina, and reinfarction). In a multivariable analysis, age (HR: 1.03; 95% CI: 1.02-1.04; P < 0.001), diabetes mellitus (HR: 1.47; 95% CI: 1.23-1.75; P < 0.001), renal insufficiency (HR: 1.53; 95% CI: 1.19-1.96; P = 0.010), peripheral vessel disease (HR: 1.43; 95% CI: 1.13-1.82; P = 0.003), reduced left ventricular ejection fraction (HR: 0.98; 95% CI: 0.98-0.99; P < 0.001), acute indication for the index coronary angiography (HR: 1.30; 95% CI: 1.08-1.55; P = 0.005), and the number of coronary vessels presenting severe stenosis (HR: 1.11; 95% CI: 1.02-1.20; P = 0.015) were independent predictors of MACEs. Remarkably, only 37 patients presented with local aneurysm complications during follow-up.
Conclusions
The long-term prognosis of CAAs is not favorable, with MACEs associated with the underlying risk factor profile for atherosclerotic heart disease.
{"title":"Long-Term Prognosis of Coronary Aneurysms","authors":"Iván Sánchez-Sánchez MD , Enrico Cerrato MD, PhD , Mario Bollati MD , Carolina Espejo-Paeres MD , Luis Nombela-Franco MD, PhD , Emilio Alfonso-Rodríguez MD , Santiago J. Camacho-Freire MD, PhD , Pedro A. Villablanca MD , Ignacio J. Amat-Santos MD, PhD , José M. De la Torre Hernández MD, PhD , Isaac Pascual MD, PhD , Christoph Liebetrau MD, PhD , Benjamín Camacho MD , Marco Pavani MD , Juan Albistur MD , Roberto Adriano Latini MD , Ferdinando Varbella MD , Víctor Alfonso Jiménez Díaz MD , Davide Piraino MD , Massimo Mancone MD, PhD , Iván J. Núñez-Gil MD, PhD","doi":"10.1016/j.jcin.2024.08.034","DOIUrl":"10.1016/j.jcin.2024.08.034","url":null,"abstract":"<div><h3>Background</h3><div>Limited data are available to guide the management of coronary artery aneurysms (CAAs).</div></div><div><h3>Objectives</h3><div>The authors sought to define the clinical characteristics, identify variables that predict outcomes, and provide long-term data on CAAs.</div></div><div><h3>Methods</h3><div>We describe outcomes from 1,729 consecutive patients with CAAs included in an ambispective international registry (CAAR [Coronary Artery Aneurysm Registry]; <span><span>NCT02563626</span><svg><path></path></svg></span>) involving 33 hospitals across 9 countries in America and Europe.</div></div><div><h3>Results</h3><div>Patients were predominantly male (78.6%; 1,359/1,729) with a mean age of 66 years. Classic cardiovascular risk factors were common, as well as coronary artery disease (85.8%; 1,484/1,729), peripheral vascular disease (10.9%; 188/1,729), and chronic kidney disease (8.0%; 138/1,729). The median number of aneurysms per patient was 1.0 (Q1-Q3: 1.0-1.0), with the most affected territory being the left anterior descending artery (49.6%; 857/1,729). The majority underwent any revascularization procedure (68.5%; 1,184/1,729), mainly percutaneous coronary intervention (50.7%; 877/1,729), and were discharged on dual antiplatelet therapy (65.6%; 1,134/1,729). After a median follow-up of 44.8 months (Q1-Q3: 14.9-88.1), 379 died (21.9%), and 641 (37.1%) developed a major adverse cardiovascular event (MACE) (all-cause death, heart failure, unstable angina, and reinfarction). In a multivariable analysis, age (HR: 1.03; 95% CI: 1.02-1.04; <em>P</em> < 0.001), diabetes mellitus (HR: 1.47; 95% CI: 1.23-1.75; <em>P</em> < 0.001), renal insufficiency (HR: 1.53; 95% CI: 1.19-1.96; <em>P</em> = 0.010), peripheral vessel disease (HR: 1.43; 95% CI: 1.13-1.82; <em>P</em> = 0.003), reduced left ventricular ejection fraction (HR: 0.98; 95% CI: 0.98-0.99; <em>P</em> < 0.001), acute indication for the index coronary angiography (HR: 1.30; 95% CI: 1.08-1.55; <em>P</em> = 0.005), and the number of coronary vessels presenting severe stenosis (HR: 1.11; 95% CI: 1.02-1.20; <em>P</em> = 0.015) were independent predictors of MACEs. Remarkably, only 37 patients presented with local aneurysm complications during follow-up.</div></div><div><h3>Conclusions</h3><div>The long-term prognosis of CAAs is not favorable, with MACEs associated with the underlying risk factor profile for atherosclerotic heart disease.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"17 22","pages":"Pages 2681-2691"},"PeriodicalIF":11.7,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-25DOI: 10.1016/j.jcin.2024.09.053
Nicolas M. Van Mieghem MD, PhD
{"title":"The Era of Head-to-Head Comparisons of Transcatheter Heart Valves Has Begun","authors":"Nicolas M. Van Mieghem MD, PhD","doi":"10.1016/j.jcin.2024.09.053","DOIUrl":"10.1016/j.jcin.2024.09.053","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"17 22","pages":"Pages 2623-2625"},"PeriodicalIF":11.7,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-25DOI: 10.1016/j.jcin.2024.11.016
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
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.
{"title":"Outcomes and Impact of Device Iterations in Mitral Valve Transcatheter Edge-to-Edge Repair: The REPAIR Study.","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":"https://doi.org/10.1016/j.jcin.2024.11.016","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. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}