Costanza Pellegrini1, MD; Philippe Garot2, MD; Marie-Claude Morice2, MD; Corrado Tamburino3, MD, PhD; Sabine Bleiziffer4, MD; Holger Thiele5, MD; Smita Scholtz6, MD; Rene 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.
No account yet?
Sign up for free!
Create my pcr account
Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases
from PCRonline.com
aortic stenosisatrio-ventricular blockfemoral
Interventions for valvular diseaseTAVI
Read next article
A first-in-human study of transjugular transcatheter tricuspid valve replacement with the LuX-Valve Plus system