Anna S Petronio1, Jan-Malte Sinning2, Nicolas Van Mieghem3, Giulio Zucchelli4, Georg Nickenig2, Raffi Bekeredjian5, Johan Bosmans6, Francesco Bedogni7, Marian Branny8, Karl Stangl9, Jan Kovac10, Molly Schiltgen11, Stacia Kraus12, Peter de Jaegere2. 1. Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. Electronic address: as.petronio@gmail.com. 2. Department of Medicine II, Universitätsklinikum Bonn, Bonn, Germany. 3. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 4. Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. 5. Department of Cardiology, Universitätsklinikum Heidelberg, Heidelberg, Germany. 6. Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium. 7. Department of Cardiology, Istituto Clinico S. Ambrogio, Milan, Italy. 8. Department of Cardiology, Cardiocenter Hospital Podlesi, Trinec, Czech Republic. 9. Department of Cardiology and Angiology, Charite, Campus Mitte-Kardiologie, Berlin, Germany. 10. Department of Cardiology, Glenfield Hospital, Leicester, United Kingdom. 11. Department of Structural Heart Clinical Operations, Medtronic, Inc., Mounds View, Minnesota. 12. Department of Biostatistics, North American Sciences Associates, Inc., Minneapolis, Minnesota.
Abstract
OBJECTIVES: The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. BACKGROUND: Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. METHODS: The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. RESULTS: A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). CONCLUSIONS: Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870).
OBJECTIVES: The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. BACKGROUND:Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. METHODS: The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. RESULTS: A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). CONCLUSIONS: Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870).
Authors: Sabine Bleiziffer; Johan Bosmans; Stephen Brecker; Ulrich Gerckens; Peter Wenaweser; Corrado Tamburino; Axel Linke Journal: Clin Res Cardiol Date: 2017-05-08 Impact factor: 5.460