BACKGROUND: Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. METHODS: We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. RESULTS: Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariable analysis. CONCLUSIONS: Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.
BACKGROUND: Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. METHODS: We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. RESULTS: Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariable analysis. CONCLUSIONS: Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.
Authors: Samir R Kapadia; Martin B Leon; Raj R Makkar; E Murat Tuzcu; Lars G Svensson; Susheel Kodali; John G Webb; Michael J Mack; Pamela S Douglas; Vinod H Thourani; Vasilis C Babaliaros; Howard C Herrmann; Wilson Y Szeto; Augusto D Pichard; Mathew R Williams; Gregory P Fontana; D Craig Miller; William N Anderson; Jodi J Akin; Michael J Davidson; Craig R Smith Journal: Lancet Date: 2015-03-15 Impact factor: 79.321
Authors: Melissa A Daubert; Neil J Weissman; Rebecca T Hahn; Philippe Pibarot; Rupa Parvataneni; Michael J Mack; Lars G Svensson; Deepika Gopal; Samir Kapadia; Robert J Siegel; Susheel K Kodali; Wilson Y Szeto; Raj Makkar; Martin B Leon; Pamela S Douglas Journal: JACC Cardiovasc Imaging Date: 2016-12-08
Authors: Patrizio Lancellotti; Christophe Tribouilloy; Andreas Hagendorff; Luis Moura; Bogdan A Popescu; Eustachio Agricola; Jean-Luc Monin; Luc A Pierard; Luigi Badano; Jose L Zamorano Journal: Eur J Echocardiogr Date: 2010-04
Authors: Valérie M Collas; Christophe Dubois; Victor Legrand; Joëlle Kefer; Bernard De Bruyne; Jo Dens; Inez E Rodrigus; Paul Herijgers; Johan M Bosmans Journal: Catheter Cardiovasc Interv Date: 2015-05-11 Impact factor: 2.692
Authors: A Pieter Kappetein; Stuart J Head; Philippe Généreux; Nicolo Piazza; Nicolas M van Mieghem; Eugene H Blackstone; Thomas G Brott; David J Cohen; Donald E Cutlip; Gerrit-Anne van Es; Rebecca T Hahn; Ajay J Kirtane; Mitchell W Krucoff; Susheel Kodali; Michael J Mack; Roxana Mehran; Josep Rodés-Cabau; Pascal Vranckx; John G Webb; Stephan Windecker; Patrick W Serruys; Martin B Leon Journal: J Am Coll Cardiol Date: 2012-10-09 Impact factor: 24.094
Authors: Manel Sabaté; Sergio Cánovas; Eulogio García; Rosana Hernández Antolín; Luis Maroto; José María Hernández; Juan H Alonso Briales; Antonio J Muñoz García; Enrique Gutiérrez-Ibañes; Jorge Rodríguez-Roda Journal: Rev Esp Cardiol (Engl Ed) Date: 2013-10-04
Authors: Alec Vahanian; Ottavio Alfieri; Felicita Andreotti; Manuel J Antunes; Gonzalo Barón-Esquivias; Helmut Baumgartner; Michael Andrew Borger; Thierry P Carrel; Michele De Bonis; Arturo Evangelista; Volkmar Falk; Bernard Lung; Patrizio Lancellotti; Luc Pierard; Susanna Price; Hans-Joachim Schäfers; Gerhard Schuler; Janina Stepinska; Karl Swedberg; Johanna Takkenberg; Ulrich Otto Von Oppell; Stephan Windecker; Jose Luis Zamorano; Marian Zembala Journal: Eur J Cardiothorac Surg Date: 2012-08-25 Impact factor: 4.191
Authors: Martin B Leon; Craig R Smith; Michael J Mack; Raj R Makkar; Lars G Svensson; Susheel K Kodali; Vinod H Thourani; E Murat Tuzcu; D Craig Miller; Howard C Herrmann; Darshan Doshi; David J Cohen; Augusto D Pichard; Samir Kapadia; Todd Dewey; Vasilis Babaliaros; Wilson Y Szeto; Mathew R Williams; Dean Kereiakes; Alan Zajarias; Kevin L Greason; Brian K Whisenant; Robert W Hodson; Jeffrey W Moses; Alfredo Trento; David L Brown; William F Fearon; Philippe Pibarot; Rebecca T Hahn; Wael A Jaber; William N Anderson; Maria C Alu; John G Webb Journal: N Engl J Med Date: 2016-04-02 Impact factor: 91.245
Authors: Piotr P Buszman; Mateusz Kachel; Carlos Fernandez Ceballos; Karolina Łukasik; Wojciech Domaradzki; Maciej Pruski; Armando Tellez; Serge Rousselle; Marta Konopko; Michał Glanc; Paweł Kaźmierczak; Krzysztof P Milewski; Pawel E Buszman Journal: JACC Basic Transl Sci Date: 2022-05-11
Authors: Giuseppe Tarantini; Luca Nai Fovino; Pascal Le Prince; Olivier Darremont; Marina Urena; Antonio L Bartorelli; Flavien Vincent; Tomas Hovorka; Yasmina Alcalá Navarro; Nicolas Dumonteil; Patrick Ohlmann; Olaf Wendler Journal: Circ Cardiovasc Interv Date: 2020-06-25 Impact factor: 6.546
Authors: Marie-Isabel K Murray; Eileen Hofmann; Roberta De Rosa; Silvia Mas-Peiro; Philipp Seppelt; Thomas Walther; Andreas M Zeiher; Stephan Fichtlscherer; Mariuca Vasa-Nicotera Journal: J Interv Cardiol Date: 2019-10-01 Impact factor: 2.279
Authors: Paola Angela Maria Purita; Luisa Salido Tahoces; Chiara Fraccaro; Luca Nai Fovino; Won-Keun Kim; Cláudio Espada-Guerreiro; Ole De Backer; Morritz Seiffert; Luis Nombela-Franco; Raul Moreno Gomez; Antonio Mangieri; Anna Franzone; Francesco Bedogni; Fausto Castriota; Tiziana Attisano; Lars Søndergaard; Rosana Hernandez Antolin; Giuseppe Tarantini Journal: Int J Cardiol Heart Vasc Date: 2020-02-12