title: Impact of permanent pacemaker on mortality after transcatheter aortic valve implantation: the PRAGMATIC (Pooled Rotterdam-Milan-Toulouse in Collaboration) Pacemaker substudy.
abstract: OBJECTIVE
  We sought to evaluate the impact of permanent pacemaker (PPM) implantation on two-year mortality and one-year left ventricular ejection fraction recovery (∆LVEFR=one-year LVEF-baseline LVEF) after transcatheter aortic valve implantation (TAVI).
  
  
  RESULTS
  We pooled patient-level data from four European institutions with significant TAVI volume. Outcomes were compared between patients without PPM (no-PPM), patients with PPM prior to TAVI (old-PPM) and patients with PPM implanted after TAVI (new-PPM). Out of 1,062 patients included in the pooled data set, 783 (73.7%) were in the no-PPM group, 164 (15.4%) in the new-PPM group and 115 (10.8%) in the old-PPM group. All-cause and cardiovascular mortality at two years were similar for patients with no-PPM and new-PPM (adjusted HR 1.11, 95% CI: 0.74-1.67; p=0.62; and adjusted HR 1.16, 95% CI: 0.68-1.98; p=0.59). Conversely, old-PPM was associated with increased risk of both all-cause and cardiovascular mortality vs. no-PPM. By multivariable analysis new-PPM did not affect LVEFR, while old-PPM did. We observed a multiplicative interaction, between new-PPM and post-procedural aortic regurgitation ≥1+ on two-year mortality and one-year LVEFR, with increased risk of death and impaired LVEFR in patients with new-PPM and post-procedural aortic regurgitation (PPAR) ≥1+ (both pinteraction<0.0001).
  
  
  CONCLUSIONS
  In patients undergoing TAVI, the presence of a PPM at baseline yielded a negative effect on long-term prognosis while new-PPM did not. The combination of new-PPM with PPAR adversely impacts on survival and LV function recovery.
authors.affiliation: Department of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientiﬁc Institute, Milan, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Giustino
authors.forename: Robert M A
authors.initials: RM
authors.lastname: Van der Boon
authors.forename: Javier
authors.initials: J
authors.lastname: Molina-Martin de Nicolas
authors.forename: Nicolas
authors.initials: N
authors.lastname: Dumonteil
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.forename: Peter P T
authors.initials: PP
authors.lastname: de Jaegere
authors.forename: Didier
authors.initials: D
authors.lastname: Tchetche
authors.forename: Bertrand
authors.initials: B
authors.lastname: Marcheix
authors.forename: Damien
authors.initials: D
authors.lastname: Millischer
authors.forename: Romain
authors.initials: R
authors.lastname: Cassagneau
authors.forename: Didier
authors.initials: D
authors.lastname: Carrié
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: Van Mieghem
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000453:epidemiology; D001024:Aortic Valve Stenosis / Q000453:epidemiology / Q000503:physiopathology / Q000601:surgery*; D001145:Arrhythmias, Cardiac / Q000453:epidemiology / Q000628:therapy*; D002318:Cardiovascular Diseases / Q000401:mortality; D016022:Case-Control Studies; D002423:Cause of Death; D015897:Comorbidity; D005260:Female; D006801:Humans; D008297:Male; D009026:Mortality; D015999:Multivariate Analysis; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D011183:Postoperative Complications / Q000453:epidemiology; D012189:Retrospective Studies; D013318:Stroke Volume; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome