Hans-Josef Feistritzer MD, PhD , Oliver Dumpies MD , Liesbeth Rosseel MD, PhD , Darren Mylotte MD , Toby Rogers MD , Daniel J. Blackman MD , Fadi Sawaya MD , Thomas Modine MD , Tullio Palmerini MD , Holger Thiele MD , Axel Unbehaun MD , Kendra J. Grubb MD, MHA, MSc , Ole de Backer MD, PhD , Mohamed Abdel-Wahab MD
{"title":"Alternative Access for TAVR","authors":"Hans-Josef Feistritzer MD, PhD , Oliver Dumpies MD , Liesbeth Rosseel MD, PhD , Darren Mylotte MD , Toby Rogers MD , Daniel J. Blackman MD , Fadi Sawaya MD , Thomas Modine MD , Tullio Palmerini MD , Holger Thiele MD , Axel Unbehaun MD , Kendra J. Grubb MD, MHA, MSc , Ole de Backer MD, PhD , Mohamed Abdel-Wahab MD","doi":"10.1016/j.jcin.2025.08.029","DOIUrl":"10.1016/j.jcin.2025.08.029","url":null,"abstract":"<div><div>Current guideline recommendations for transcatheter aortic valve replacement are largely confined to procedures performed via transfemoral (TF) access. Major advances in preprocedural planning, delivery system technology, and procedural technique have led to substantial growth in TF access, even in complex vascular anatomies. However, determining the threshold beyond which TF access is either not feasible or carries unacceptable risk remains controversial. Furthermore, although alternative transvascular access routes have largely replaced surgical transthoracic approaches in patients unsuitable for TF access, the optimal alternative access route is still debated. Herein, the authors provide a state-of-the-art review of alternative access for TAVR, including the decision-making process between TF and non-TF approaches and the key elements of alternative access site selection and execution.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 19","pages":"Pages 2309-2325"},"PeriodicalIF":11.4,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278395","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}
Raj Makkar MD , Firas Zahr MD , Tarun Chakravarty MD , Scott Chadderdon MD , Moody Makar MD , Tobias Friedrich Ruf MD , Robert M. Kipperman MD , Andrew N. Rassi MD , Jörg Hausleiter MD , Robert L. Smith MD , Molly Szerlip MD , Scott Goldman MD , D. Scott Lim MD , Ignacio Inglessis-Azuaje MD , Pradeep Yadav MD , Philipp Lurz MD, PhD , Tobias Kister MD , Charles J. Davidson MD , Mubashir Mumtaz MD , Hemal Gada MD , Ralph Stephan von Bardeleben MD, PhD
{"title":"CLASP IID Trial and Registry","authors":"Raj Makkar MD , Firas Zahr MD , Tarun Chakravarty MD , Scott Chadderdon MD , Moody Makar MD , Tobias Friedrich Ruf MD , Robert M. Kipperman MD , Andrew N. Rassi MD , Jörg Hausleiter MD , Robert L. Smith MD , Molly Szerlip MD , Scott Goldman MD , D. Scott Lim MD , Ignacio Inglessis-Azuaje MD , Pradeep Yadav MD , Philipp Lurz MD, PhD , Tobias Kister MD , Charles J. Davidson MD , Mubashir Mumtaz MD , Hemal Gada MD , Ralph Stephan von Bardeleben MD, PhD","doi":"10.1016/j.jcin.2025.07.014","DOIUrl":"10.1016/j.jcin.2025.07.014","url":null,"abstract":"<div><h3>Background</h3><div>One-year outcomes from the CLASP IID Trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial; <span><span>NCT03706833</span><svg><path></path></svg></span>) and Registry established the PASCAL transcatheter valve repair system as a safe and effective treatment for prohibitive-risk degenerative mitral regurgitation (DMR). Longer-term follow-up is ongoing.</div></div><div><h3>Objectives</h3><div>This paper reports the CLASP IID Trial and Registry 2-year outcomes.</div></div><div><h3>Methods</h3><div>In the CLASP IID Trial, prohibitive-risk patients with 3+/4+ DMR, deemed suitable for both the PASCAL and MitraClip systems, were randomized 2:1 (PASCAL: n = 204; MitraClip: n = 96). Patients with complex anatomy deemed ineligible for randomization were enrolled in the CLASP IID Registry (N = 98) and treated with the PASCAL system.</div></div><div><h3>Results</h3><div>In the randomized cohort, significant and sustained MR reduction was achieved at 2 years. MR ≤2+ rate was 95.0% (96/101) in the PASCAL group vs 91.5% (54/59) in the MitraClip group (<em>P</em> = 0.500), and MR ≤1+ rate was 77.2% (78/101) vs 67.8% (40/59) (<em>P</em> = 0.198), respectively. Kaplan-Meier estimates for freedom from all-cause mortality, cardiovascular mortality, heart failure hospitalization, and nonelective mitral valve reinterventions were 80.8% vs 86.2% (<em>P</em> = 0.216), 88.6% vs 90.4% (<em>P</em> = 0.666), 86.4% vs 94.3% (<em>P</em> = 0.058), and 97.9% vs 97.9% (<em>P</em> = 0.962), respectively. In the registry cohort, 91.9% (34/37) achieved MR ≤2+ and 64.9% (24/37) achieved MR ≤1+. Kaplan-Meier estimates for freedom from all-cause mortality, cardiovascular mortality, heart failure hospitalization, and nonelective mitral valve reinterventions were 77.2%, 84.0%, 85.1%, and 99.0%, respectively. Significant improvements in functional status and quality of life were observed in both cohorts.</div></div><div><h3>Conclusions</h3><div>Two-year outcomes from the CLASP IID Trial and Registry show favorable survival, and significant and sustained MR reduction with functional and quality-of-life improvements, confirming sustained safety and effectiveness of the PASCAL system in treating a broad population of DMR patients.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 19","pages":"Pages 2392-2404"},"PeriodicalIF":11.4,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278398","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}
{"title":"Refining Bleeding Risk Stratification After TAVR","authors":"Shinnosuke Kikuchi MD , Antonin Trimaille MD, PhD , Adrien Carmona MD , Amandine Granier MD , Dinh Phi Truong MD , Kensuke Matsushita MD, PhD , Benjamin Marchandot MD , Manh Cuong Vu MD , Marion Kibler MD , Franck Zheng MD , Zoe Heyberger MD , Julien Tse Sik Sun MD , Florian Loizon MD , Paul Knellwolf MD , Dorian Recht MD , Baudouin Koenig MD , Kiyoshi Hibi MD, PhD , Pierre Leddet MD , Fabien De Poli MD , Laurence Jesel MD, PhD , Olivier Morel MD, PhD","doi":"10.1016/j.jcin.2025.08.011","DOIUrl":"10.1016/j.jcin.2025.08.011","url":null,"abstract":"<div><h3>Background</h3><div>Acquired von Willebrand factor deficiency is a key contributor to bleeding after transcatheter aortic valve replacement (TAVR).</div></div><div><h3>Objectives</h3><div>The aim of this study was to evaluate whether assessing primary hemostatic disorder using closure time of adenosine diphosphate (CT-ADP), a marker of von Willebrand factor dysfunction, enhances bleeding risk stratification in TAVR patients at high bleeding risk (HBR).</div></div><div><h3>Methods</h3><div>A total of 884 patients from a prospective TAVR registry were analyzed. The primary endpoint was 2-year major bleeding. HBR was defined using the Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) criteria. Primary hemostatic disorder was defined as CT-ADP >180 seconds, measured before and 24 hours post-TAVR.</div></div><div><h3>Results</h3><div>VARC-HBR criteria were met in 614 patients (69%). CT-ADP significantly decreased from pre-TAVR to 24 hours postprocedure (170 seconds [124-300 seconds] vs 125 seconds [97-180 seconds]; <em>P</em> < 0.0001). Postprocedural CT-ADP >180 seconds was observed in 220 patients (25%). Patients meeting the VARC-HBR criteria had a higher incidence of 2-year major bleeding than those without (21.7% vs 10.5%; log-rank <em>P</em> < 0.0001). Among patients meeting VARC-HBR criteria, those with postprocedural CT-ADP >180 seconds had a higher 2-year bleeding rate (37.0% vs 16.4%; log-rank <em>P</em> < 0.0001). Adding postprocedural CT-ADP >180 seconds to VARC-HBR score significantly improved predictive accuracy for 2-year bleeding (from 0.65 to 0.69; <em>P</em> = 0.00012). Landmark analysis showed that although meeting the VARC-HBR criteria predicted periprocedural bleeding, it did not predict late bleeding. However, postprocedural CT-ADP >180 seconds identified patients at increased risk for late bleeding among those meeting VARC-HBR criteria (11.4% vs 2.4%; log-rank <em>P</em> < 0.0001).</div></div><div><h3>Conclusions</h3><div>Postprocedural CT-ADP assessment enhances bleeding risk stratification beyond VARC-HBR criteria and may support individualized management strategies in high-risk TAVR patients.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 19","pages":"Pages 2371-2388"},"PeriodicalIF":11.4,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144954684","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}
Rick H.J.A. Volleberg MD, Doosup Shin MD, Simone Saitta PhD, Richard A. Shlofmitz MD, Evan Shlofmitz DO, Allen Jeremias MD, MSc, Ruben G.A. van der Waerden MSc, Jos Thannhauser PhD, Niels van Royen MD, PhD , Ziad A. Ali MD, DPhil
{"title":"Deep Learning–Derived Plaque Burden for Intracoronary Optical Coherence Tomography","authors":"Rick H.J.A. Volleberg MD, Doosup Shin MD, Simone Saitta PhD, Richard A. Shlofmitz MD, Evan Shlofmitz DO, Allen Jeremias MD, MSc, Ruben G.A. van der Waerden MSc, Jos Thannhauser PhD, Niels van Royen MD, PhD , Ziad A. Ali MD, DPhil","doi":"10.1016/j.jcin.2025.07.021","DOIUrl":"10.1016/j.jcin.2025.07.021","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 19","pages":"Pages 2432-2434"},"PeriodicalIF":11.4,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144954734","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}