JACC: CARDIOVASCULAR IMAGING

VOL. 10, NO. 10, 2017ª 2017 PUBLISHED BY ELSEVIER ON BEHALF OF THE

ISSN 1936-878X/$36.00

AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

http://dx.doi.org/10.1016/j.jcmg.2016.11.020

A Highly Predictive Risk Model forPacemaker Implantation After TAVR
Yoshio Maeno, MD, PHD, Yigal Abramowitz, MD, Hiroyuki Kawamori, MD, Yoshio Kazuno, MD, Shunsuke Kubo, MD,Nobuyuki Takahashi, MD, Geeteshwar Mangat, MD, Kazuaki Okuyama, MD, Mohammad Kashif, MD,Tarun Chakravarty, MD, Mamoo Nakamura, MD, Wen Cheng, MD, John Friedman, MD, Daniel Berman, MD,Raj R. Makkar, MD, Hasan Jilaihawi, MD

ABSTRACTOBJECTIVES This study sought to develop a robust and deﬁnitive risk model for new permanent pacemaker
implantation (PPMI) after SAPIEN 3 (third generation balloon expandable valve) (Edwards Lifesciences, Irvine, California)
transcatheter aortic valve replacement (third generation balloon expandable valve TAVR), including calciﬁcation in theaortic-valvular complex (AVC).
BACKGROUND The association between calcium in the AVC and need for PPMI is poorly delineated after third
generation balloon expandable valve TAVR.
METHODS At Cedars-Sinai Heart Institute in Los Angeles, California, a total of 240 patients with severe aortic stenosis
underwent third generation balloon expandable valve TAVR and had contrast computed tomography. AVC wascharacterized precisely by leaﬂet sector and region.
RESULTS The total new PPMI rate was 14.6%. On multivariate analysis for predictors of PPMI, pre-procedure third
generation balloon expandable valve TAVR, right bundle branch block (RBBB), shorter membranous septum (MS) length,
and noncoronary cusp device-landing zone calcium volume (NCC-DLZ CA) were included. Predictive probabilities weregenerated using this logistic regression model. If 3 pre-procedural risk factors were present, the c-statistic of the modelfor PPMI was area under the curve of 0.88, sensitivity of 77.1%, and speciﬁcity of 87.1%; this risk model had highnegative predictive value (95.7%). The addition of the procedural factor of device depth to the model, with theparameter of difference between implantation depth and MS length, combined with RBBB and NCC-DLZ CA increased thec-statistic to 0.92, sensitivity to 94.3%, speciﬁcity to 83.8%, and negative predictive value to 98.8%
CONCLUSIONS By using a precise characterization of distribution of calciﬁcation in the AVC in a single-center,retrospective study, NCC-DLZ CA was found to be an independent predictor of new PPMI post–third generation balloon
expandable valve TAVR. The ﬁndings also reinforce the importance of short MS length, pre-existing RBBB, andventricular implantation depth as important synergistic PPMI risk factors. This risk model will need validation by future
prospective multicenter studies. (J Am Coll Cardiol Img 2017;10:1139–47) © 2017 Published by Elsevier on behalf of theAmerican College of Cardiology Foundation.

Transcatheter aortic valve replacement (TAVR)

an important complication of TAVR that has been

is a well-established alternative to surgicalassociated in some studies with increased mort-aortic valve replacement for intermediateality and rehospitalization rates (2). The exact fre-and high-risk patients with severe aortic valve

quency of new PPMI varies according to the valvestenosis (1). Cardiac conduction disturbance requiring

design used and was previously noted to be signiﬁ-

new permanent pacemaker implantation (PPMI) is

cantly lower with balloon-expandable (BE) TAVR

From the Cedars-Sinai Heart Institute, Los Angeles, California. Dr. Jilaihawi is a consultant for Edwards Lifesciences, St. Jude
Medical, and Venus MedTech. Dr. Makkar has received grant support from Edwards Lifesciences and St. Jude Medical; is aconsultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. All other authors have reportedthat they have no relationships relevant to the contents of this paper to disclose.
Manuscript received May 24, 2016; revised manuscript received October 28, 2016, accepted November 10, 2016.