title: Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study.
abstract: OBJECTIVE
  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.affiliation: Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. Electronic address: as.petronio@gmail.com.
authors.forename: Anna S
authors.initials: AS
authors.lastname: Petronio
authors.affiliation: Department of Medicine II, Universitätsklinikum Bonn, Bonn, Germany.
authors.forename: Jan-Malte
authors.initials: JM
authors.lastname: Sinning
authors.affiliation: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Van Mieghem
authors.affiliation: Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Zucchelli
authors.affiliation: Department of Medicine II, Universitätsklinikum Bonn, Bonn, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Department of Cardiology, Universitätsklinikum Heidelberg, Heidelberg, Germany.
authors.forename: Raffi
authors.initials: R
authors.lastname: Bekeredjian
authors.affiliation: Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Bosmans
authors.affiliation: Department of Cardiology, Istituto Clinico S. Ambrogio, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.affiliation: Department of Cardiology, Cardiocenter Hospital Podlesi, Trinec, Czech Republic.
authors.forename: Marian
authors.initials: M
authors.lastname: Branny
authors.affiliation: Department of Cardiology and Angiology, Charite, Campus Mitte-Kardiologie, Berlin, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Stangl
authors.affiliation: Department of Cardiology, Glenfield Hospital, Leicester, United Kingdom.
authors.forename: Jan
authors.initials: J
authors.lastname: Kovac
authors.affiliation: Department of Structural Heart Clinical Operations, Medtronic, Inc., Mounds View, Minnesota.
authors.forename: Molly
authors.initials: M
authors.lastname: Schiltgen
authors.affiliation: Department of Biostatistics, North American Sciences Associates, Inc., Minneapolis, Minnesota.
authors.forename: Stacia
authors.initials: S
authors.lastname: Kraus
authors.affiliation: Department of Medicine II, Universitätsklinikum Bonn, Bonn, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: de Jaegere
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000401:mortality / Q000592:standards; D005060:Europe; D005260:Female; D019983:Guideline Adherence / Q000592:standards; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D017410:Practice Guidelines as Topic / Q000592:standards; D010818:Practice Patterns, Physicians' / Q000592:standards; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: aortic stenosis; conduction disturbance; permanent pacemaker implantation; transcatheter aortic valve replacement