David Power1, Ulrich Schäfer2, Paul Guedeney1, Bimmer E Claessen1, Samantha Sartori1, Sabato Sorrentino1, Thierry Lefèvre3, Christian Kupatt4, Didier Tchetche5, Nicolas Dumonteil6, John G Webb7, Antonio Colombo8, Stephen Windecker9, Jurriën M Ten Berg10, David Hildick-Smith11, Peter Boekstegers12, Axel Linke13, Christophe Tron14, Eric Van Belle15, Anita W Asgar16, Raban Jeger17, Gennaro Sardella18, Ulrich Hink19, Oliver Husser20, Eberhard Grube21, Ilknur Lechthaler22, Peter Wijngaard22, Prodromos Anthopoulos22, Efthymios N Deliargyris23, Debra Bernstein23, Christian Hengstenberg24, Roxana Mehran1, George D Dangas1. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York. 2. Division of Cardiology, University Heart Center, Hamburg, Germany. 3. Department of Cardiology, Hôpital Privé Jacques Cartier, Massy, France. 4. Department of Cardiology, LMU Munich, Munich, Germany. 5. Department of Cardiology, Clinique Pasteur Toulouse, Toulouse, France. 6. Department of Cardiology, CHU Rangueil, Toulouse, France. 7. Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada. 8. Interventional Cardiology Unit, San Raffaele Hospital, Milan, Italy. 9. Department of Cardiology Bern University Hosp, Bern, Switzerland. 10. Department of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, Netherlands. 11. Department of Interventional Cardiology, Sussex Cardiac Center, Brighton, UK. 12. Helios Heart Center Siegburg, Siegburg, Germany. 13. Herzzentrum Leipzig, Leipzig, Germany. 14. Department of Cardiology, Rouen University Hospital, Rouen, France. 15. Department of Cardiology and INSERM UMR 1011, CHU Lille, Lille, France. 16. Institute de Cardiologie de Montréal, Montreal, Quebec, Canada. 17. Cardiology, University Hospital Basel, University of Basel, Switzerland. 18. Division of Cardiology, Policlinico Umberto I, Rome, Italy. 19. Department of Cardiology, Universitätsmedizin Mainz, Mainz, Germany. 20. Deutsches Herzzentrum München, Munich, Germany. 21. Universitätsklinikum Bonn, Bonn, Germany. 22. The Medicines Company, Zurich, Switzerland. 23. Science and Strategy Consulting Group, Basking Ridge, New Jersey. 24. Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria.
Abstract
BACKGROUND/ OBJECTIVE:Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PGVCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.
RCT Entities:
BACKGROUND/ OBJECTIVE:Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.
Authors: Claudio Montalto; Andrea Raffaele Munafò; Luca Arzuffi; Francesco Soriano; Antonio Mangieri; Stefano Nava; Giovanni Luigi De Maria; Francesco Burzotta; Fabrizio D'Ascenzo; Antonio Colombo; Azeem Latib; Jacopo Andrea Oreglia; Adrian P Banning; Italo Porto; Gabriele Crimi Journal: Eur Heart J Open Date: 2022-08-18
Authors: Sergio Berti; Francesco Bedogni; Arturo Giordano; Anna S Petronio; Alessandro Iadanza; Antonio L Bartorelli; Bernard Reimers; Carmen Spaccarotella; Carlo Trani; Tiziana Attisano; Angela Marella Cenname; Gennaro Sardella; Roberto Bonmassari; Massimo Medda; Fabrizio Tomai; Giuseppe Tarantini; Eliano P Navarese Journal: J Am Heart Assoc Date: 2020-10-24 Impact factor: 5.501