Michał Kuzemczak MD, PhD, MSc, Mohammad Alkhalil DPhil, Janusz Lipiecki MD, PhD
{"title":"Many Devices in the Toolbox…But Which One Performs Best in Treating Calcified Lesions?","authors":"Michał Kuzemczak MD, PhD, MSc, Mohammad Alkhalil DPhil, Janusz Lipiecki MD, PhD","doi":"10.1016/j.jcin.2025.04.032","DOIUrl":"10.1016/j.jcin.2025.04.032","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 16","pages":"Page 2073"},"PeriodicalIF":11.4,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144794480","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}
Alessandro Giaj Levra, Francesco Tartaglia, Costanza Lisi, Giovanni La Canna, Ottavia Cozzi, Orges Hoxha, Giorgio Scarpini, Giulio Stefanini, Lucia Torracca, Bernhard Reimers, Antonio Mangieri, Damiano Regazzoli
{"title":"Pulling the Plug and Rolling With the Leak: Occluder Removal and Tootsie Roll to Prevent Interaction.","authors":"Alessandro Giaj Levra, Francesco Tartaglia, Costanza Lisi, Giovanni La Canna, Ottavia Cozzi, Orges Hoxha, Giorgio Scarpini, Giulio Stefanini, Lucia Torracca, Bernhard Reimers, Antonio Mangieri, Damiano Regazzoli","doi":"10.1016/j.jcin.2025.07.013","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.07.013","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.4,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144954776","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}
Stephen G Worthley, Arturo Giordano, Nicola Corcione, Luis Nombela-Franco, Federico De Marco, Antony Walton, Francesco Bedogni, Helge Möllmann, Ole De Backer, Lionel Leroux, Ganesh Manoharan, Didier Tchétché, Maurizio Taramasso, Lihua Li, Hai-Chien Kuo, Nicolas M Van Mieghem
{"title":"Thirty-Day And One-Year Outcomes Of Navitor Transcatheter Aortic Valve In Low- or Intermediate-Risk Patients.","authors":"Stephen G Worthley, Arturo Giordano, Nicola Corcione, Luis Nombela-Franco, Federico De Marco, Antony Walton, Francesco Bedogni, Helge Möllmann, Ole De Backer, Lionel Leroux, Ganesh Manoharan, Didier Tchétché, Maurizio Taramasso, Lihua Li, Hai-Chien Kuo, Nicolas M Van Mieghem","doi":"10.1016/j.jcin.2025.08.021","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.08.021","url":null,"abstract":"<p><strong>Background: </strong>The Navitor transcatheter aortic valve is a self-expanding, intra-annular valve indicated for patients with severe aortic stenosis (AS) at high or extreme surgical risk.</p><p><strong>Objectives: </strong>To assess the safety and effectiveness of the Navitor valve in severe AS patients at low or intermediate surgical risk.</p><p><strong>Methods: </strong>VANTAGE is a prospective, single-arm, multicenter study. The primary effectiveness endpoint was moderate or greater paravalvular leakage (PVL) at 30 days; the primary safety endpoint was all-cause mortality or fatal stroke/stroke with disability at 12 months. Both endpoints were assessed against a performance goal (PG) when the sample size requirements were met. Clinical events and imaging assessments were evaluated by an independent committee and a core laboratory, respectively.</p><p><strong>Results: </strong>A total of 434 patients (203 low-risk, 231 intermediate-risk) underwent Navitor implantation between July 2021 and November 2024 across 36 sites in Europe, Australia, and Israel. The mean STS-PROM scores were 1.5% and 2.6% for the low- and intermediate-risk groups. Technical success was 97.0%, with no procedural mortality. At 30 days, no patients had moderate or greater PVL (0%), which was significantly below the PG of 6.6% (p<0.0001). In the first 262 patients with 12-month follow-up completed, the rate for all-cause mortality or fatal stroke/stroke with disability was 2.3%, also significantly below the PG of 11.3% (p<0.0001). Sustained hemodynamic performance (mean gradient 8.0 mmHg, effective orifice area 1.8 cm<sup>2</sup>) was seen through 12 months.</p><p><strong>Conclusion: </strong>Navitor demonstrated favorable safety and performance outcomes at 12 months, supporting its expansion to low- and intermediate-risk populations.</p>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.4,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144954761","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}
Jennifer von Stein, Nina C Wunderlich, Maria Isabel Körber, Stephan Baldus, Juan F Granada, Roman Pfister, Philipp von Stein, Christos Iliadis
{"title":"Acute Effect of Tricuspid Valve Transcatheter Edge-to-Edge Repair on 3-Dimensional Tricuspid Annular Dimensions.","authors":"Jennifer von Stein, Nina C Wunderlich, Maria Isabel Körber, Stephan Baldus, Juan F Granada, Roman Pfister, Philipp von Stein, Christos Iliadis","doi":"10.1016/j.jcin.2025.07.009","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.07.009","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.4,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144954753","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}
Sunny Goel MD, Sahil Khera MD, MPH, Parasuram Krishnamoorthy MD, Amit Hooda MD, Stamatios Lerakis MD, PhD, Lucy M. Safi DO, Annapoorna S. Kini MD, Samin K. Sharma MD, George D. Dangas MD, PhD, Gilbert H.L. Tang MD, MSc, MBA
{"title":"Sentinel Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement","authors":"Sunny Goel MD, Sahil Khera MD, MPH, Parasuram Krishnamoorthy MD, Amit Hooda MD, Stamatios Lerakis MD, PhD, Lucy M. Safi DO, Annapoorna S. Kini MD, Samin K. Sharma MD, George D. Dangas MD, PhD, Gilbert H.L. Tang MD, MSc, MBA","doi":"10.1016/j.jcin.2025.06.019","DOIUrl":"10.1016/j.jcin.2025.06.019","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 15","pages":"Pages 1948-1950"},"PeriodicalIF":11.4,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144528019","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}
Utkarsh Ojha MBBS, BSc , Muhammad Mohsin BSc , Krzysztof Macierzanka BSc , Fiyyaz Ahmed-Jushuf MBBS, BSc , Christopher A. Rajkumar MBBS, BSc , Shayna Chotai MBBS, BSc , Florentina A. Simader MD , Matthew J. Shun-Shin MA, BMBCh, PhD , Michael J. Foley MBBS, BSc , Rasha K. Al-Lamee MA, MBBS, PhD
{"title":"Safety, Efficacy, and Effectiveness of Coronary Sinus Reducer Implantation in Refractory Angina","authors":"Utkarsh Ojha MBBS, BSc , Muhammad Mohsin BSc , Krzysztof Macierzanka BSc , Fiyyaz Ahmed-Jushuf MBBS, BSc , Christopher A. Rajkumar MBBS, BSc , Shayna Chotai MBBS, BSc , Florentina A. Simader MD , Matthew J. Shun-Shin MA, BMBCh, PhD , Michael J. Foley MBBS, BSc , Rasha K. Al-Lamee MA, MBBS, PhD","doi":"10.1016/j.jcin.2025.06.012","DOIUrl":"10.1016/j.jcin.2025.06.012","url":null,"abstract":"<div><h3>Background</h3><div>Previous coronary sinus reducer (CSR) meta-analyses in refractory angina (RA) focused on single-arm studies, capturing observed effectiveness—comprising the physical effect of CSR, contextual effects (eg, placebo), and non-treatment-related phenomena (eg, confounding). Efficacy evaluation requires comparative estimates from randomized controlled trials (RCTs), ideally double blind and placebo controlled, to isolate the physical effect.</div></div><div><h3>Objectives</h3><div>The aims of this study were to evaluate the safety and efficacy of CSR in RA and to compare its efficacy with observed effectiveness.</div></div><div><h3>Methods</h3><div>The study was preregistered with the International Prospective Register of Systematic Reviews (<span><span>CRD42023399099</span><svg><path></path></svg></span>). Electronic databases were searched until April 2024. Random-effects models separately pooled single-arm, isolated RCT intervention-arm, and RCT placebo-controlled estimates. Therapeutic outcomes included improvements in Canadian Cardiovascular Society classification, Seattle Angina Questionnaire scores, and treadmill exercise time. Safety outcomes, summarized descriptively, comprised procedural success and adverse events.</div></div><div><h3>Results</h3><div>Three double-blind, placebo-controlled RCTs (n = 180) and 13 single-arm studies (n = 668) were analyzed. The overall unweighted procedural success rate was 98.3% (95% CI: 97.0%-99.1%). Single-arm studies and RCT intervention arms demonstrated statistically significant improvements across therapeutic outcomes. For Canadian Cardiovascular Society classification, placebo-controlled rates were 26% (95% CI: 11%-38%; <em>P</em> < 0.001) for ≥1-class improvement and 17% (95% CI: 2%-37%; <em>P</em> = 0.02) for ≥2-class improvement, representing approximately one-third of single-arm improvement rates. Seattle Angina Questionnaire domain analyses demonstrated insufficient placebo-controlled evidence of benefit. Placebo-controlled exercise time change was 49.62 seconds (95% CI: 1.84-97.40 seconds; <em>P</em> = 0.04).</div></div><div><h3>Conclusions</h3><div>CSR implantation is safe and feasible and demonstrates promising antianginal efficacy in patients with RA. However, uncertainty in current efficacy findings and susceptibility of effectiveness data to nonphysical influences preclude definitive conclusions about clinical utility, warranting larger placebo-controlled trials.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 15","pages":"Pages 1864-1877"},"PeriodicalIF":11.4,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144827413","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}