title: Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry.
abstract: OBJECTIVE
  The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR).
  
  
  BACKGROUND
  Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve.
  
  
  METHODS
  The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM.
  
  
  RESULTS
  Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year.
  
  
  CONCLUSIONS
  PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894).
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Tamim M
authors.initials: TM
authors.lastname: Nazif
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: José M
authors.initials: JM
authors.lastname: Dizon
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Mikhael F
authors.initials: MF
authors.lastname: El-Chami
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: Baylor Healthcare System, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.affiliation: Stanford University School of Medicine, Stanford, California.
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.affiliation: Medstar Washington Hospital Center, Washington, DC.
authors.forename: Augusto
authors.initials: A
authors.lastname: Pichard
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Wilson Y
authors.initials: WY
authors.lastname: Szeto
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Columbia University Medical Center, New York, New York. Electronic address: skodali@columbia.edu.
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
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; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D010138:Pacemaker, Artificial; D010359:Patient Readmission; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: PARTNER; TAVR; cardiac conduction; pacemaker; transcatheter aortic valve replacement