Eurointervention最新文献

{"title":"TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis: the Neo2 BAV Registry.","authors":"Andreas Ruck, Won-Keun Kim, Paolo Alberto Del Sole, Max Wagener, Angela McInerney, Magdi S Yacoub, Elfatih A Hasabo, Cagri Ayhan, Hesham Elzomor, Dina Neiroukh, Abdul Amir, Nawzad Saleh, Magnus Settergren, Rickard Lindler, Dinos Verouhis, Samuel Sossalla, Matthias Renker, Matteo Montorfano, Barbara Bellini, Xavier Carrillo Suarez, Victoria Vilalta Del Olmo, Federico De Marco, Matteo Biroli, Helge Mollmann, Eckel Clemens Enno, Giuseppe Tarantini, Tommaso Fabris, Alfonso Ielasi, Giuliano Costa, Marco Barbanti, Osama Soliman, Darren Mylotte","doi":"10.4244/EIJ-D-24-00869","DOIUrl":"10.4244/EIJ-D-24-00869","url":null,"abstract":"<p><strong>Background: </strong>The ACURATE neo2 is a contemporary transcatheter aortic valve implantation (TAVI) system approved for the treatment of severe aortic stenosis in Europe. The ACURATE neo2 has not been evaluated in bicuspid aortic valve (BAV) stenosis.</p><p><strong>Aims: </strong>We sought to evaluate the safety and efficacy of ACURATE neo2 in patients with BAV stenosis.</p><p><strong>Methods: </strong>We retrospectively analysed consecutive severe BAV stenosis patients undergoing TAVI with ACURATE neo2 at 10 European centres. Imaging data from preprocedural multislice computed tomography, pre- and postprocedural echocardiography, and procedural cinefluoroscopy were evaluated by a core laboratory. Valve Academic Research Consortium 3 (VARC-3)-defined 30-day procedure safety and efficacy were the primary endpoints. Adverse events were site-reported according to VARC-3 criteria.</p><p><strong>Results: </strong>Among 181 patients with BAV stenosis treated with the ACURATE neo2, the mean age was 77.5±7.2 years, 58.0% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.3% (1.6-3.7%). Most procedures were transfemoral, and predilatation was performed in all cases. A second valve was required in 4 cases (2.2%). VARC-3-defined technical success was 95.6%. The primary endpoints of device success and early safety occurred in 90.6% and 82.3%, respectively. At 30 days, cardiovascular death occurred in 2.2% (N=4) and stroke in 1.6% (N=3). Core laboratory-adjudicated echocardiography reported an effective orifice area of 2.0 (1.7-2.5) cm² and a mean transvalvular gradient of 6.5 (4.6-9.0) mmHg. Half of all cases (51.2%) had no paravalvular leak, while moderate leak occurred in 4.3%. A new permanent pacemaker was required in 11 patients (6.5%).</p><p><strong>Conclusions: </strong>The ACURATE neo2 demonstrated favourable clinical outcomes and bioprosthetic valve performance at 30 days in selected patients with severe BAV stenosis.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":"e130-e139"},"PeriodicalIF":7.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142711883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Myval transcatheter heart valve system: a new TAVI contender and remaining uncertainties.","authors":"Stephan Windecker, Daijiro Tomii","doi":"10.4244/EIJ-E-24-00067","DOIUrl":"https://doi.org/10.4244/EIJ-E-24-00067","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 2","pages":"e97-e99"},"PeriodicalIF":7.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143016581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-coated balloon angioplasty for in-stent restenosis: pros and cons.","authors":"Fernando Alfonso, Robert A Byrne, Bruno Scheller, Eric van Belle, Julinda Mehilli","doi":"10.4244/EIJ-E-24-00062","DOIUrl":"https://doi.org/10.4244/EIJ-E-24-00062","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 2","pages":"e102-e104"},"PeriodicalIF":7.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143016576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Late coronary embolisation after transcatheter aortic valve implantation.","authors":"Cristian Ene, Bert Vandeloo, Marjolein Billen, Pierre Lefesvre, Jean-François Argacha","doi":"10.4244/EIJ-D-24-00678","DOIUrl":"https://doi.org/10.4244/EIJ-D-24-00678","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 2","pages":"e140-e141"},"PeriodicalIF":7.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727694/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143016579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of the D-PACE scoring system to predict delayed high-grade conduction disturbances after transcatheter aortic valve implantation.","authors":"Francesco Bendandi, Nevio Taglieri, Leonardo Ciurlanti, Alessandro Mazzapicchi, Marco Foroni, Laura Lombardi, Francesco Palermo, Francesco Filice, Gabriele Ghetti, Antonio Giulio Bruno, Mateusz Orzalkiewicz, Giuliano Costa, Valentina Frittitta, Alessandro Comis, Sofia Sammartino, Maria Chiara Calì, Elena Dipietro, Luigi La Rosa, Corrado Tamburino, Tullio Palmerini, Marco Barbanti, Francesco Saia","doi":"10.4244/EIJ-D-24-00850","DOIUrl":"10.4244/EIJ-D-24-00850","url":null,"abstract":"<p><strong>Background: </strong>New conduction disturbances are frequent after transcatheter aortic valve implantation (TAVI). Refining our ability to predict high-grade atrioventricular block (AVB) occurring later than 24 hours after the procedure would be useful in order to select patients eligible for early discharge.</p><p><strong>Aims: </strong>This study was designed to identify predictors of high-grade AVB occurring between 24 hours and 30 days after TAVI and to develop and validate a predictive risk score.</p><p><strong>Methods: </strong>We analysed clinical, procedural, and electrocardiographic parameters of 1,290 TAVI patients. Independent predictors of delayed high-grade AVB were used to develop the predictive score, which was then externally validated in a cohort of 936 patients.</p><p><strong>Results: </strong>Implantation of self-expanding valves, greater implantation depth, longer PR interval in preprocedural electrocardiogram (ECG) and greater increase of PR duration in next-day ECG, preprocedural right bundle branch block (RBBB) and new-onset left bundle branch block or RBBB that persisted in next-day ECG were independent predictors of delayed high-grade AVB and were combined to develop the Delayed atrioventricular block Prediction for eArly disChargE (D-PACE) score. The areas under the curve of the score were 0.879 (95% confidence interval [CI]: 0.835-0.923) and 0.799 (95% CI: 0.730-0.868) in the derivation and validation cohorts, respectively. Based on the score, patients can be classified into three risk categories; low-risk patients demonstrated an incidence of delayed AVB of less than 1% and are ideal candidates for next-day discharge.</p><p><strong>Conclusions: </strong>The D-PACE score can be used to stratify TAVI patients according to their risk of delayed high-grade AVB and thereby identify those suitable for next-day discharge.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":"e119-e129"},"PeriodicalIF":7.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142683560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.","authors":"Niels van Royen, Ignacio J Amat-Santos, Martin Hudec, Matjaz Bunc, Alexander Ijsselmuiden, Peep Laanmets, Daniel Unic, Béla Merkely, Renicus S Hermanides, Vlasis Ninios, Marcin Protasiewicz, Benno J W M Rensing, Pedro L Martin, Fausto Feres, Manuel De Sousa, Eric Van Belle, Axel Linke, Alfonso Ielasi, Matteo Montorfano, Mark Webster, Konstantinos Toutouzas, Emmanuel Teiger, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angerås, Won-Keun Kim, Jürgen Rothe, Ivica Kristić, Vicente Peral, Ben J L Van den Branden, Dirk Westermann, Barbara Bellini, Mario Garcia-Gomez, Akihiro Tobe, Tsung-Ying Tsai, Scot Garg, Ashokkumar Thakkar, Udita Chandra, Marie-Claude Morice, Osama Soliman, Yoshinobu Onuma, Patrick W Serruys, Andreas Baumbach","doi":"10.4244/EIJ-D-24-00951","DOIUrl":"10.4244/EIJ-D-24-00951","url":null,"abstract":"<p><strong>Background: </strong>There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).</p><p><strong>Aims: </strong>We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.</p><p><strong>Methods: </strong>The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.</p><p><strong>Results: </strong>The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).</p><p><strong>Conclusions: </strong>The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":"e105-e118"},"PeriodicalIF":7.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11729642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142717827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The challenge of early discharge after transcatheter aortic valve implantation.","authors":"Stefan Toggweiler","doi":"10.4244/EIJ-E-24-00063","DOIUrl":"https://doi.org/10.4244/EIJ-E-24-00063","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 2","pages":"e100-e101"},"PeriodicalIF":7.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727679/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143016584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bringing order to chaos. Invasive functional assessment for all patients in the cath lab?","authors":"Frederik M Zimmermann, Ciro Pollio Benvenuto","doi":"10.4244/EIJ-E-24-00064","DOIUrl":"https://doi.org/10.4244/EIJ-E-24-00064","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 1","pages":"14-15"},"PeriodicalIF":7.6,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142958895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Managing the device-related risk of in-stent restenosis and stent thrombosis in coronary stenting.","authors":"Jens Flensted Lassen, Lisette Okkels Jensen","doi":"10.4244/EIJ-E-24-00066","DOIUrl":"https://doi.org/10.4244/EIJ-E-24-00066","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 1","pages":"16-17"},"PeriodicalIF":7.6,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142958901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polymer-free versus biodegradable-polymer drug-eluting stent in patients undergoing percutaneous coronary intervention: an assessor-blind, non-inferiority, randomised controlled trial.","authors":"Raffaele Piccolo, Paolo Calabrò, Greta Carrara, Attilio Varricchio, Cesare Baldi, Giovanni Napolitano, Ciro De Simone, Ciro Mauro, Eugenio Stabile, Gianluca Caiazzo, Tullio Tesorio, Marco Boccalatte, Bernardino Tuccillo, Plinio Cirillo, Luigi Di Serafino, Fiorenzo Simonetti, Attilio Leone, Domenico Angellotti, Giuseppe Bottiglieri, Enrico Russolillo, Gennaro Galasso, Rocco Perrotta, Arturo Cesaro, Tullio Niglio, Michele Capasso, Alessandra Spinelli, Stefano Cristiano, Antonella Faretra, Dario Bruzzese, Alaide Chieffo, Giuseppe Tarantini, Sergio Leonardi, Simone Biscaglia, Francesco Costa, Salvatore Cassese, Eugene McFadden, Dik Heg, Anna Franzone, Giulio G Stefanini, Davide Capodanno, Giovanni Esposito, For The Parthenope Investigators","doi":"10.4244/EIJ-D-24-00657","DOIUrl":"10.4244/EIJ-D-24-00657","url":null,"abstract":"<p><strong>Background: </strong>Few data are available on polymer-free drug-eluting stents in patients undergoing percutaneous coronary intervention (PCI).</p><p><strong>Aims: </strong>We aimed to determine the efficacy and safety of a polymer-free amphilimus-eluting stent (AES), using a reservoir-based technology for drug delivery, compared with a biodegradable-polymer everolimus-eluting stent (EES).</p><p><strong>Methods: </strong>This was a randomised, investigator-initiated, assessor-blind, non-inferiority trial conducted at 14 hospitals in Italy (ClinicalTrials.gov: NCT04135989). All-comer patients undergoing PCI were randomly assigned to either polymer-free AES or biodegradable-polymer EES. The primary endpoint was a device-oriented composite endpoint, including cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation at 1-year follow-up.</p><p><strong>Results: </strong>Between January 2020 and June 2022, a total of 2,107 patients with 3,042 coronary lesions were randomised to polymer-free AES (1,051 patients) or biodegradable-polymer EES (1,056 patients). At 1-year follow-up, the primary endpoint occurred in 86 (8.2%) patients randomised to polymer-free AES and 76 (7.2%) patients randomised to biodegradable-polymer EES (risk difference 1%, upper limit of the 1-sided 95% confidence interval [CI] of 2.9%; p for non-inferiority=0.041). There were no significant differences in the incidence of the components of the primary endpoint between groups. However, definite or probable stent thrombosis occurred more frequently in patients randomised to polymer-free stents (1.0% vs 0.3%; hazard ratio 3.72, 95% CI: 1.04-13.33; p=0.044) due to an increased risk of early stent thrombosis within 30 day Conclusions: In all-comer patients undergoing PCI, polymer-free AES were non-inferior to biodegradable-polymer EES at 1-year follow-up in terms of a device-oriented composite endpoint despite being associated with an increased risk of early stent thrombosis.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 1","pages":"58-72"},"PeriodicalIF":7.6,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142958902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}