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Observational Study
. 2016 Nov 14;9(21):2200-2209.
doi: 10.1016/j.jcin.2016.08.034.

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

Victor Mauri  1 , Andreas Reimann  1 , Daniel Stern  1 , Maximilian Scherner  2 , Elmar Kuhn  2 , Volker Rudolph  1 , Stephan Rosenkranz  1 , Kaveh Eghbalzadeh  2 , Kai Friedrichs  1 , Thorsten Wahlers  2 , Stephan Baldus  1 , Navid Madershahian  2 , Tanja K Rudolph  3
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Free article
Observational Study

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

Victor Mauri et al. JACC Cardiovasc Interv. .
Free article

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 (LVOTLC) and the area below right coronary cusp (LVOTRC) (LVOTLC median calcium 23.7 mm3 vs. 3.0 mm3; p < 0.001; LVOTRC 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, LVOTLC calcium volume >13.7 mm3, LVOTRC 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: LVOTLC and LVOTRC 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.

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