Johny Nicolas1, Paul Guedeney1,2, Bimmer E Claessen1, Julinda Mehilli3, Anna Sonia Petronio4, Samantha Sartori1, Thierry Lefèvre5, Patrizia Presbitero6, Piera Capranzano7, Alessandro Iadanza8, Davide Cao1, Mauro Chiarito1, Ridhima Goel1, Anastasios Roumeliotis1, Rishi Chandiramani1, Siyan Chen1, Gennaro Sardella9, Nicolas M Van Mieghem10, Sabato Sorrentino1, Emanuele Meliga11, Didier Tchétché12, Nicolas Dumonteil12, Chiara Fraccaro13, Daniela Trabattoni14, Ghada W Mikhail15, Maria-Cruz Ferrer-Gracia16, Christoph Naber17, Peter C Kievit18, Usman Baber1, Samin K Sharma1, Marie-Claude Morice5, George D Dangas1, Jaya Chandrasekhar1, Alaide Chieffo19, Roxana Mehran1. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. 2. Department of Cardiology, Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. 3. Department of Cardiology, Munich University Clinic, Ludwig-Maximilians University and German Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Munich, Germany. 4. Department of Cardiology, AOUP Cisanello, University Hospital, Pisa, Italy. 5. Department of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France. 6. Department of Cardiology, Instituto Clinico Humanitas, Milan, Italy. 7. Department of Cardiology, University of Catania, Catania, Italy. 8. Department of Cardiology, Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte, Siena, Italy. 9. Department of Cardiology, Policlinico Umberto I,"Sapienza" University of Rome, Rome, Italy. 10. Department of Cardiology, Erasmus Medical Center, Thoraxcenter, Rotterdam, The Netherlands. 11. Department of Cardiology, Mauriziano Umberto I Hospital, Turin, Italy. 12. Department of Cardiology, Groupe CardioVasculaire Interventional, Clinique Pasteur, Toulouse, France. 13. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy. 14. Department of Cardiology, Centro Cardiologico Monzino, IRCCS, Milano, Italy. 15. Department of Cardiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK. 16. Department of Cardiology, Hospital Universitario Miguel Servet, Zaragoza, Spain. 17. Department of Cardiology, Contilia Heart and Vascular Centre, Essen, Germany. 18. Department of Cardiology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. 19. Department of Cardiology, IRCCS San Raffael Hospital, Segrate, Italy.
Abstract
OBJECTIVES: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. BACKGROUND: Data on pacemaker insertion complicating TAVR in women are scarce. METHODS: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. RESULTS: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively). CONCLUSION: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.
OBJECTIVES: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. BACKGROUND: Data on pacemaker insertion complicating TAVR in women are scarce. METHODS: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. RESULTS: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively). CONCLUSION: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.