Thomas Waggoner DO , Santiago Garcia MD , Tarun Chakravarty MD , Moody Makar MD , Azeem Latib MD , Robert M. Kipperman MD , Firas Zahr MD , Ivan Hanson MD , Anjan K. Sinha MD , Rahul P. Sharma MD , Jeremiah P. Depta MD , Jorge A. Castellanos MD , Susheel Kodali MD , Amar Krishnaswamy MD , Brian Whisenant MD , Daniel Menees MD , D. Scott Lim MD , Fahad Gilani MD , Carlos E. Sanchez MD , Neil Gheewala MD , Raj Makkar MD
{"title":"Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System","authors":"Thomas Waggoner DO , Santiago Garcia MD , Tarun Chakravarty MD , Moody Makar MD , Azeem Latib MD , Robert M. Kipperman MD , Firas Zahr MD , Ivan Hanson MD , Anjan K. Sinha MD , Rahul P. Sharma MD , Jeremiah P. Depta MD , Jorge A. Castellanos MD , Susheel Kodali MD , Amar Krishnaswamy MD , Brian Whisenant MD , Daniel Menees MD , D. Scott Lim MD , Fahad Gilani MD , Carlos E. Sanchez MD , Neil Gheewala MD , Raj Makkar MD","doi":"10.1016/j.jcin.2025.07.019","DOIUrl":"10.1016/j.jcin.2025.07.019","url":null,"abstract":"<div><h3>Background</h3><div>The PASCAL Precision transcatheter valve repair system provides a new option for treating prohibitive surgical risk patients with significant, symptomatic degenerative mitral regurgitation (DMR).</div></div><div><h3>Objectives</h3><div>The authors report early U.S. commercial experience with the PASCAL Precision system.</div></div><div><h3>Methods</h3><div>Patients with DMR treated with the PASCAL Precision system in the United States were analyzed from the STS/ACC TVT Registry. Procedural, clinical, echocardiographic, functional, and quality-of-life outcomes to 30 days were assessed. All outcomes, including echocardiographic assessments, were site-assessed.</div></div><div><h3>Results</h3><div>In 1,995 DMR patients, the median age was 81.6 years, and 57.0% were male. Median STS-PROM for mitral valve repair was 3.6%, and 69.4% were in NYHA functional class III/IV. Mixed etiology (DMR + other etiology) was present in 11.4%, and 66.9% had complex anatomy (annular/leaflet calcification, mitral valve area <4 cm<sup>2</sup>, bileaflet flail/prolapse/tethering, or mitral stenosis). The device was successfully implanted in 97.7%. MR reduction was significant at 30 days with 94.2% achieving ≤moderate MR and 72.6% ≤mild MR (<em>P</em> < 0.001 vs baseline). Patients experienced significant functional and quality-of-life improvements with a mean 21.0-point increase in Kansas City Cardiomyopathy Questionnaire score and 84.6% in NYHA functional class I/II (all <em>P <</em> 0.001). Mitral valve reintervention and single-leaflet device attachment rates were 0.4% and 0.5%, respectively, and all-cause mortality, cardiovascular mortality, and heart failure readmission rates were 2.2%, 1.2%, and 2.6%, respectively, at 30 days.</div></div><div><h3>Conclusions</h3><div>Early U.S. STS/ACC TVT Registry commercial experience confirms the safety and effectiveness of the novel PASCAL Precision system in the treatment of a broad population of real-world DMR patients.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 16","pages":"Pages 2036-2046"},"PeriodicalIF":11.4,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144896519","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}
Amar Krishnaswamy MD , Amr E. Abbas MD , Vasilis C. Babaliaros MD , Adam B. Greenbaum MD , Pradeep Yadav MD , Issam D. Moussa MD , Grant W. Reed MD , Roger J. Laham MD , Michael A. Morse MD , Evelio Rodriguez MD , Jeremiah P. Depta MD , James M. McCabe MD , Vinayak N. Bapat MD , Vinod H. Thourani MD , Samir R. Kapadia MD , Tsuyoshi Kaneko MD
{"title":"Mid-Term Outcomes of Balloon-Expandable Aortic Valve-in-Valve Replacement in the United States","authors":"Amar Krishnaswamy MD , Amr E. Abbas MD , Vasilis C. Babaliaros MD , Adam B. Greenbaum MD , Pradeep Yadav MD , Issam D. Moussa MD , Grant W. Reed MD , Roger J. Laham MD , Michael A. Morse MD , Evelio Rodriguez MD , Jeremiah P. Depta MD , James M. McCabe MD , Vinayak N. Bapat MD , Vinod H. Thourani MD , Samir R. Kapadia MD , Tsuyoshi Kaneko MD","doi":"10.1016/j.jcin.2025.06.039","DOIUrl":"10.1016/j.jcin.2025.06.039","url":null,"abstract":"<div><h3>Background</h3><div>Aortic valve-in-valve (AViV) replacement for is approved for patients with degenerated surgical valves at high or prohibitive surgical risk, mostly on the basis of small series with short-term follow-up.</div></div><div><h3>Objectives</h3><div>The aim of this study was to analyze the outcomes of AViV therapy using contemporary balloon-expandable valves (BEVs) in a large series with mid-term outcomes.</div></div><div><h3>Methods</h3><div>BEV AViV patients (June 2015 to December 2023) in the Society for Thoracic Surgeons (STS)/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were propensity matched to native transcatheter aortic valve replacement (TAVR) patients. Primary analysis included death and stroke at 5 years. Comparisons were also made on the basis of STS score, BEV subtype, and stented vs stentless index surgical valve type.</div></div><div><h3>Results</h3><div>In total, 14,474 AViV patients were matched to 385,556 TAVR patients (13,638 pairs). The mean age was 74 years, and the mean STS Predicted Risk of Mortality was 6.1%. Emergency cardiac surgery (0.2%) and bioprosthetic valve fracture (22%) were infrequent. Death (43.1% vs 55.2%; <em>P</em> < 0.001), stroke (10.5% vs 11.8%; <em>P</em> < 0.001), and their composite were lower for AViV compared with TAVR at 5 years with similar findings at each STS tertile. The SAPIEN 3 Ultra RESILIA device demonstrated lower discharge echo gradients for all sizes (20 mm, 19.4 mm Hg vs 23.8 mm Hg; 23 mm, 15.1 mm Hg vs 19.2 mm Hg; 26 mm, 12.1 mm Hg vs 15.1 mm Hg; and 29 mm, 8.6 mm Hg vs 12.1 mm Hg). There was no difference in death or stroke at 5 years for stentless vs stented surgical valves (42.9% vs 46.0%; <em>P</em> = 0.12).</div></div><div><h3>Conclusions</h3><div>This large, real-world analysis confirms the safety and durability of AViV compared with TAVR at all surgical risk levels at mid-term follow-up. Consideration may be given to broadening the indication for AViV.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 16","pages":"Pages 1989-2000"},"PeriodicalIF":11.4,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144895962","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}
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}
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}