Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement With the SAPIEN 3

Victor Mauri; Andreas Reimann; Daniel Stern; Maximilian Scherner; Elmar Kuhn; Volker Rudolph; Stephan Rosenkranz; Kaveh Eghbalzadeh; Kai Friedrichs; Thorsten Wahlers; Stephan Baldus; Navid Madershahian; Tanja K Rudolph

doi:10.1016/j.jcin.2016.08.034

Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement With the SAPIEN 3

JACC Cardiovasc Interv. 2016 Nov 14;9(21):2200-2209. doi: 10.1016/j.jcin.2016.08.034.

Affiliations

¹ Department of Cardiology, Heart Center, University of Cologne, Cologne, Germany.
² Department of Cardiothoracic Surgery, Heart Center, University of Cologne, Cologne, Germany.
³ Department of Cardiology, Heart Center, University of Cologne, Cologne, Germany. Electronic address: tanja.rudolph@uk-koeln.de.

PMID: 27832845
DOI: 10.1016/j.jcin.2016.08.034

Abstract

Objectives: The aim of this study was to identify predictors of permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter valve (Edwards SAPIEN 3).

Background: New-onset conduction disturbances requiring PPMI remain a major concern following TAVR. Predictors are not yet well defined.

Methods: The influence of angiographic implantation depth, device landing zone calcium volume, oversizing, pre- and post-dilation, and baseline conduction disturbances on PPMI rate was analyzed in 229 patients undergoing TAVR with the SAPIEN 3 device.

Results: PPMI was performed in 14.4% of patients. Patients requiring PPMI had higher left ventricular outflow tract (LVOT) calcium volume in the area below the left coronary cusp (LVOT_LC) and the area below right coronary cusp (LVOT_RC) (LVOT_LC median calcium 23.7 mm³ vs. 3.0 mm³; p < 0.001; LVOT_RC median calcium 6.6 mm³ vs. 0.3 mm³; p = 0.014), a higher prevalence of pre-existing right bundle branch block (15% vs. 2%, p = 0.004), and lower implantation depth (ventricular portion of the stent frame 29 ± 12% vs. 21 ± 5%; p < 0.001). On multivariate regression analysis, LVOT_LC calcium volume >13.7 mm³, LVOT_RC calcium volume >4.8 mm³, pre-existing right bundle branch block, and implantation depth >25.5% emerged as independent predictors of PPMI. Upon modification of the implantation technique, aiming at a high final valve position, implantation depth decreased from 24% ventricular portion to 21% (p = 0.012), accompanied by a decrease in PPMI rate (19.2% vs. 9.2%; p = 0.038).

Conclusions: LVOT_LC and LVOT_RC calcium load, baseline right bundle branch block, and implantation depth were identified as independent predictors of the need for PPMI post-TAVR. Patient groups with different PPMI risk could be stratified using these 4 predictors. A slightly higher valve implantation site may prevent excessive PPMI rates.

Keywords: SAPIEN 3; calcium distribution; permanent pacemaker implantation; transcatheter aortic valve replacement.

Publication types

Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Aortic Valve / diagnostic imaging
Aortic Valve / physiopathology
Aortic Valve / surgery*
Aortic Valve Stenosis / diagnostic imaging
Aortic Valve Stenosis / physiopathology
Aortic Valve Stenosis / surgery*
Arrhythmias, Cardiac / diagnosis
Arrhythmias, Cardiac / etiology
Arrhythmias, Cardiac / physiopathology
Arrhythmias, Cardiac / therapy*
Balloon Valvuloplasty
Cardiac Pacing, Artificial* / adverse effects
Female
Heart Valve Prosthesis*
Humans
Male
Multidetector Computed Tomography
Pacemaker, Artificial*
Prosthesis Design
Risk Factors
Severity of Illness Index
Time Factors
Transcatheter Aortic Valve Replacement / adverse effects
Transcatheter Aortic Valve Replacement / instrumentation*
Treatment Outcome