Clinical outcomes in women and men with raphe-type bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
Uložené v:
| Názov: | Clinical outcomes in women and men with raphe-type bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement. |
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| Autori: | Gitto M; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy; Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Kim WK; Justus-Liebig University of Giessen, Department of Cardiology & Angiology, Giessen, Germany; Kerckhoff Heart Center, Bad Nauheim, Germany., Buono A; Cardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Fabris T; Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padova, Italy., De Biase C; Clinique Pasteur, Toulouse, France., Costa G; U.O.C. Cardiologia, Centro Alte Specialitá e Trapianti, P.O. G. Rodolico, A.O.U. Policlinico-V. Emanuele, Universitá di Catania, Catania, Italy., Montarello N; Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Leone PP; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy; Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Scotti A; Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA., Bellamoli M; Cardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Alfadhel M; Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom., Koren O; Department of Cardiology Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Fezzi S; Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy., Bellini B; Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy., Massussi M; Institute of Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy., Costa G; Cardiac Catheterization Laboratory, University of Pisa and Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy., Fraccaro C; Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padova, Italy., Mazzapicchi A; Cardiology Unit, Cardiac Thoracic and Vascular Department, Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Giacomin E; Cardiology Unit, Cardio-Neuro-Vascular Department, Ca' Foncello Hospital Azienda N 2 Marca Trevigiana, Treviso, Italy., Burzotta F; Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Zito A; Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Trani C; Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Gorla R; Department of Cardiology, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, San Donato Milanese, Milan, Italy., Hug K; Department of Cardiovascular Diseases, German Heart Center Munich, TUM University Hospital, Munich, Germany., Briguori C; Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy., Tartaglia F; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy., Bettari L; Cardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Colucci M; Cardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Villa E; Cardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Regazzoli D; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy., Benvenuto CP; Cardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Boiago M; Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padova, Italy., Calamita G; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy., Renker M; Kerckhoff Heart Center, Bad Nauheim, Germany., Gomez MG; Centro de Investigación biomédica en red, Division of Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Ielasi A; Division of Cardiology, Istituto di Ricovero e Cura a Carattere Scientifico Hospital Galeazzi-Sant'Ambrogio, Milan, Italy., Landes U; Edith Wolfson Medical Center, Cardiology Department, Holon, Israel; Tel-Aviv University, Tel-Aviv, Israel., Rheude T; Department of Cardiovascular Diseases, German Heart Center Munich, TUM University Hospital, Munich, Germany., Joner M; Department of Cardiovascular Diseases, German Heart Center Munich, TUM University Hospital, Munich, Germany., Testa L; Department of Cardiology, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, San Donato Milanese, Milan, Italy., Santos IA; Centro de Investigación biomédica en red, Division of Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Saia F; Cardiology Unit, Cardiac Thoracic and Vascular Department, Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Favero L; Cardiology Unit, Cardio-Neuro-Vascular Department, Ca' Foncello Hospital Azienda N 2 Marca Trevigiana, Treviso, Italy., Bai L; Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China., Chen M; Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China., Adamo M; Institute of Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy., De Carlo M; Cardiac Catheterization Laboratory, University of Pisa and Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy., Montorfano M; Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy., Makkar RR; Department of Cardiology Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Mylotte D; Department of Cardiology, University Hospitals Galway, Galway, Ireland., Blackman D; Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom., Barbanti M; U.O.C. Cardiologia, Centro Alte Specialitá e Trapianti, P.O. G. Rodolico, A.O.U. Policlinico-V. Emanuele, Universitá di Catania, Catania, Italy., De Backer O; Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Tchetche D; Clinique Pasteur, Toulouse, France., Tarantini G; Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padova, Italy., Latib A; Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA., Maffeo D; Cardiovascular Department, Interventional Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy., Mangieri A; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy. Electronic address: antonio.mangieri@gmail.com., Mehran R; Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA. |
| Zdroj: | International journal of cardiology [Int J Cardiol] 2025 Dec 15; Vol. 441, pp. 133792. Date of Electronic Publication: 2025 Aug 18. |
| Spôsob vydávania: | Journal Article; Observational Study; Multicenter Study |
| Jazyk: | English |
| Informácie o časopise: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8200291 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1874-1754 (Electronic) Linking ISSN: 01675273 NLM ISO Abbreviation: Int J Cardiol Subsets: MEDLINE |
| Imprint Name(s): | Publication: Amsterdam : Elsevier Original Publication: Amsterdam : Elsevier/North-Holland Biomedical Press, c1981- |
| Výrazy zo slovníka MeSH: | Transcatheter Aortic Valve Replacement*/trends , Transcatheter Aortic Valve Replacement*/methods , Transcatheter Aortic Valve Replacement*/adverse effects , Aortic Valve Stenosis*/surgery , Aortic Valve Stenosis*/diagnostic imaging , Aortic Valve Stenosis*/diagnosis , Bicuspid Aortic Valve Disease*/surgery , Bicuspid Aortic Valve Disease*/diagnostic imaging , Aortic Valve*/surgery , Aortic Valve*/abnormalities , Aortic Valve*/diagnostic imaging, Humans ; Female ; Male ; Retrospective Studies ; Aged ; Aged, 80 and over ; Treatment Outcome ; Registries ; Sex Factors ; Follow-Up Studies |
| Abstrakt: | Competing Interests: Declaration of competing interest WK reports personal fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, HID Imaging, Meril Life Sciences. WK received institutional grant from Boston Scientific. BB reports consultant fees from Medtronic. TR received speaker fees from Astra Zeneca, Abbott and SIS Medical and travel support from SIS Medical and Boston Scientific; not related to the current work. MM reports consultant fees from Abbott, Boston Scientific, Medtronic and Kardia. RM reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, Zoll; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity <1 % in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse). The other authors declare no conflicts of interest to disclose. Background: There is paucity of data regarding sex-related differences among patients with bicuspid aortic valve (BAV) undergoing transcatheter aortic valve replacement (TAVR). Methods: The AD-HOC was an observational, retrospective, investigator-initiated registry enrolling consecutive patients with Sievers type 1 BAV stenosis who underwent TAVR at 24 international centers from 2016 to 2023. The primary endpoint was major adverse events (MAEs), including death, neurologic events and heart failure hospitalization. Results: Of 980 included patients, 364 (37 %) were women. As compared to men, women had lower prevalence of associated comorbidities, smaller aortic dimensions and lower calcific burden on the raphe. After propensity score adjustment, Valve Academic Research Consortium-3 (VARC-3) defined technical success (93.7 % vs. 95.8 %, adjusted odds ratio [adj. OR]: 0.37, 95 % confidence intervals [CI]: 0.17-0.81) and device success (83.5 % vs. 86.6 %, adj, OR: 0.61, 95 % CI: 0.38-0.98) were lower in women, who also had more major periprocedural bleedings. There were no sex-differences in 3-year MAEs (19.7 % in women vs. 25.6 % in men, adjusted hazard ratio [adj. HR]: 0.75, 95 % CI: 0.47-1.20). Predictors of MAEs in men included diabetes, chronic obstructive pulmonary disease and severe aortic valve calcifications. Conversely, in women, chronic kidney disease was an independent predictor of MAEs and hemodynamic valve performance and higher baseline mean aortic gradients had a protective effect. Conclusions: Women undergoing TAVR for raphe-type BAV stenosis had lower technical and device success, but similar long-term clinical outcomes compared to men. Prognostic determinants differed between sexes, including clinical comorbidities in men and poor hemodynamic valve performance in women. (Copyright © 2025 Elsevier B.V. All rights reserved.) |
| Contributed Indexing: | Keywords: Bicuspid aortic valve; Sievers type 1; Transcatheter aortic valve replacement; VARC-3; Women |
| Entry Date(s): | Date Created: 20250820 Date Completed: 20250910 Latest Revision: 20250916 |
| Update Code: | 20250916 |
| DOI: | 10.1016/j.ijcard.2025.133792 |
| PMID: | 40835061 |
| Databáza: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Competing Interests: Declaration of competing interest WK reports personal fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, HID Imaging, Meril Life Sciences. WK received institutional grant from Boston Scientific. BB reports consultant fees from Medtronic. TR received speaker fees from Astra Zeneca, Abbott and SIS Medical and travel support from SIS Medical and Boston Scientific; not related to the current work. MM reports consultant fees from Abbott, Boston Scientific, Medtronic and Kardia. RM reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, Zoll; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity <1 % in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse). The other authors declare no conflicts of interest to disclose.<br />Background: There is paucity of data regarding sex-related differences among patients with bicuspid aortic valve (BAV) undergoing transcatheter aortic valve replacement (TAVR).<br />Methods: The AD-HOC was an observational, retrospective, investigator-initiated registry enrolling consecutive patients with Sievers type 1 BAV stenosis who underwent TAVR at 24 international centers from 2016 to 2023. The primary endpoint was major adverse events (MAEs), including death, neurologic events and heart failure hospitalization.<br />Results: Of 980 included patients, 364 (37 %) were women. As compared to men, women had lower prevalence of associated comorbidities, smaller aortic dimensions and lower calcific burden on the raphe. After propensity score adjustment, Valve Academic Research Consortium-3 (VARC-3) defined technical success (93.7 % vs. 95.8 %, adjusted odds ratio [adj. OR]: 0.37, 95 % confidence intervals [CI]: 0.17-0.81) and device success (83.5 % vs. 86.6 %, adj, OR: 0.61, 95 % CI: 0.38-0.98) were lower in women, who also had more major periprocedural bleedings. There were no sex-differences in 3-year MAEs (19.7 % in women vs. 25.6 % in men, adjusted hazard ratio [adj. HR]: 0.75, 95 % CI: 0.47-1.20). Predictors of MAEs in men included diabetes, chronic obstructive pulmonary disease and severe aortic valve calcifications. Conversely, in women, chronic kidney disease was an independent predictor of MAEs and hemodynamic valve performance and higher baseline mean aortic gradients had a protective effect.<br />Conclusions: Women undergoing TAVR for raphe-type BAV stenosis had lower technical and device success, but similar long-term clinical outcomes compared to men. Prognostic determinants differed between sexes, including clinical comorbidities in men and poor hemodynamic valve performance in women.<br /> (Copyright © 2025 Elsevier B.V. All rights reserved.) |
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| ISSN: | 1874-1754 |
| DOI: | 10.1016/j.ijcard.2025.133792 |