Author + information
- Received February 6, 2015
- Accepted February 12, 2015
- Published online May 1, 2015.
- Anna S. Petronio, MD∗∗ (, )
- Jan-Malte Sinning, MD†,
- Nicolas Van Mieghem, MD‡,
- Giulio Zucchelli, MD, PhD∗,
- Georg Nickenig, MD†,
- Raffi Bekeredjian, MD, PhD§,
- Johan Bosmans, MD, PhD‖,
- Francesco Bedogni, MD¶,
- Marian Branny, MD#,
- Karl Stangl, MD∗∗,
- Jan Kovac, MD††,
- Molly Schiltgen, MS‡‡,
- Stacia Kraus, MPH§§ and
- Peter de Jaegere, MD, PhD†
- ∗Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
- †Department of Medicine II, Universitätsklinikum Bonn, Bonn, Germany
- ‡Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- §Department of Cardiology, Universitätsklinikum Heidelberg, Heidelberg, Germany
- ‖Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium
- ¶Department of Cardiology, Istituto Clinico S. Ambrogio, Milan, Italy
- #Department of Cardiology, Cardiocenter Hospital Podlesi, Trinec, Czech Republic
- ∗∗Department of Cardiology and Angiology, Charite, Campus Mitte-Kardiologie, Berlin, Germany
- ††Department of Cardiology, Glenfield Hospital, Leicester, United Kingdom
- ‡‡Department of Structural Heart Clinical Operations, Medtronic, Inc., Mounds View, Minnesota
- §§Department of Biostatistics, North American Sciences Associates, Inc., Minneapolis, Minnesota
- ↵∗Reprint requests and correspondence:
Prof. Anna S. Petronio, Cardiothoracic and Vascular Department, Ospedale di Cisanello, Via Paradisa 2, 56124 Pisa, Italy.
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)
- aortic stenosis
- conduction disturbance
- permanent pacemaker implantation
- transcatheter aortic valve replacement
Medtronic Inc. funded the ADVANCE II study. Drs. Petronio, Kovac, and de Jaegere are clinical proctors and consultants for Medtronic, Inc. Dr. Sinning has received research grants from Medtronic and Edwards Lifesciences; and speaker honoraria from Medtronic, Edwards Lifesciences, Abbott, and Direct Flow Medical. Dr. Van Mieghem has received research grants from Claret Medical, Edwards Lifesciences, Boston Scientific, and Medtronic, Inc. Dr. Zucchelli is a consultant for Medtronic, Inc. Dr. Nickenig has received a research grant and consulting and speaker honoraria from Medtronic, Inc. Drs. Bosmans, Bedogni, and Branny are proctors for Medtronic, Inc. Ms. Schiltgen is an employee of Medtronic, Inc. Ms. Kraus is a contractor of Medtronic, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 6, 2015.
- Accepted February 12, 2015.
- 2015 American College of Cardiology Foundation