Costanza Pellegrini1, MD; Philippe Garot2, MD; Marie-Claude Morice2, MD; Corrado Tamburino3, MD, PhD; Sabine Bleiziffer4, MD; Holger Thiele5, MD; Smita Scholtz6, MD; René Schramm4, MD, PhD; James Cockburn7, MD; Michael Cunnington8, MD; Alexander Wolf9, MD; Marco Barbanti10, MD; Didier Tchétché11, MD; Paolo Pagnotta12, MD; Martine Gilard13, MD, PhD; Francesco Bedogni14, MD; Eric Van Belle15, MD; Mariuca Vasa-Nicotera16, MD; Alaide Chieffo17, MD; Kris Bogaerts18, PhD; Christian Hengstenberg19, MD; Davide Capodanno3, MD, PhD; Michael Joner1,20, MD
1. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany; 2. Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France; 3. Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico “G.Rodolico – S. Marco” - University of Catania, Catania, Italy; 4. Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, University Hospital, Ruhr-University Bochum, Bad Oeynhausen, Germany; 5. Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; 6. Department of Interventional Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany; 7. Department of Cardiology, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK; 8. Department of Cardiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 9. Department of Interventional Cardiology, Elisabeth Hospital Essen, Essen, Germany; 10. Department of Cardio-Thoracic-Vascular diseases and transplantation, Azienda Ospedaliero-Universitaria Policlinico “G. Rodolico-San Marco”, Catania, Italy; 11. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France; 12. Department of Cardiovascular Medicine, Humanitas Clinical and Research Center, Milano, Italy; 13. Department of Cardiology, Brest University Hospital, Brest, France; 14. Cardiology Department, IRCCS Policlinico San Donato, Milano, Italy; 15. Department of Cardiology, University Hospital, Lille, France; 16. Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany; 17. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; 18. KU Leuven, Faculty of Medicine, I-BioStat, Leuven, Belgium and UHasselt, I-BioStat, Hasselt, Belgium; 19. Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria; 20. Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany
Background: No detailed data on left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) exist from randomised clinical trials comparing the ACURATE neo and CoreValve Evolut devices.
Aims: Our aim was to assess the incidence and impact of new LBBB and PPI with self-expanding prostheses from a powered randomised comparison.
Methods: From the SCOPE 2 trial, 648 patients with no previous pacemaker were analysed for PPI at 30 days, and 426 patients without previous LBBB were adopted for analysis of LBBB at 30 days.
Results: At 30 days, 16.5% of patients required PPI; rates were higher in CoreValve Evolut compared to ACURATE neo recipients (21.0% vs 12.3%; p=0.004). Previous right bundle branch block (odds ratio [OR] 6.11, 95% confidence interval [CI]: 3.19-11.73; p<0.001) was associated with an increased risk of PPI at 30 days, whereas the use of the ACURATE neo (OR 0.50, 95% CI: 0.31-0.81; p=0.005) was associated with a decreased risk. One-year mortality was similar in patients with and without new PPI. A total of 9.4% of patients developed persistent LBBB at 30 days, with higher incidences in CoreValve Evolut recipients (13.4% vs 5.5%; p=0.007). New LBBB at 30 days was associated with lower ejection fraction at 1 year (65.7%±11.0 vs 69.1%±7.6; p=0.041).
Conclusions: New LBBB and PPI rates were lower in ACURATE neo compared to CoreValve Evolut recipients. The ACURATE neo valve was associated with a lower risk of PPI at 30 days. No effect on 1-year mortality was determined for PPI at 30 days, while LBBB at 30 days was associated with reduced ejection fraction at 1 year.
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