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P UBLIS HED B  E L S EVIER I N C .                                                                                                                       h ttp:/ /dx.do i.org/ 10.1016 / j.jacc.2 0 1 4 .04.03 3

 

 

Predictors of  Permanent Pacemaker Implantation in Patients With Severe Aortic Stenosis Undergoing TAVR

 

A Meta-Analysis

 

Georgee C. M. Siontis, MD,* Peter Jüni, MD,y Thomas Pilgrim, MD,* Stefan Stortecky, MD,* Lutz Büllesfeld, MD,* Bernhard Meier, MD,* Peter Wenaweser, MD,* Stephan Windecker, MD*

 

 

 

ABSTRACT

 

 

BACKGROUND Atrioventricular (AV) conduction disturbances requiring  permanent pacemaker (PPM) implantation may complicate transcatheter aortic  valve  replacement (TAVR). Available evidence on predictors of PPM is sparse and  derived  from  small  studies.

OBJECTIVES The objective of this  study  was to provide  summary  effect estimates for clinically useful  predictors of PPM implantation after  TAVR.

 

MMETHODS We performed a systematic search  for studies that reported the  incidence of PPM implantation after  TAVR and  that provided raw data  for the  predictors of interest. Data on study,  patient, and  procedural characteristics were abstracted. Crude risk ratios  (RRs) and  95%  confidence intervals for each  predictor were  calculated by use of random effects models. Stratified analyses by type  of implanted valve  were  performed.

 

RESULTS We obtained data  from  41 studies that included 11,210TAVR patients, of whom  17% required PPM implan- tation after  intervention. The rate  of PPM ranged from  2% to  51% in individual  studies (with  a median  of 28%  for the Medtronic  CoreValve Revalving  System  [MCRS] and  6%  for the  Edwards  SAPIEN valve  [ESV]). The summary  estimates indicated increased risk of PPM after  TAVR for men (RR: 1.23; p < 0.01); for patients with first-degree AV block (RR: 1.52; p < 0.01), left  anterior hemiblock  (RR: 1.62; p < 0.01), or right  bundle branch  block (RR: 2.89; p < 0.01) at baseline; and  for patients with  intraprocedural AV block  (RR: 3.49;  p < 0.01). These  variables  remained significant predictors when  only patients treated with  the  MCRS bioprosthesis were  considered. The data  for ESV were  limited.  Unadjusted estimates indicated a 2.5-fold higher  risk for PPM implantation for patients who  received  the  MCRS than  for those who received the  ESV.

 

CONCLUUSIONS Male sex, baseline conduction disturbances, and intraprocedural AV block emerged as predictors of PPM implantation after  TAVR. This study  provides useful  tools  to identify  high-risk  patients and to guide clinical decision making before and after  intervention.  (J Am Coll Cardiol 2014;64:129–40) © 2014 by the American College of Cardiology Foundation.

 

______________________________________

From the *Department of  Cardiology, Bern  University Hospital, Bern, Switzerland; and the yDepartment  of  Clinical Research, Clinical Trials  Unit, Bern, Switzerland. Dr.  Jüni is  an  unpaid steering committee member or  statistical executive committee member of  trials funded by  Abbott Vascular, Biosensors International, Medtronic, and Johnson & Johnson. Dr. Büllesfeld is a consultant for Abbott, Edwards Lifesciences, Medtronic, and Mitralign. Prof.  Meier has  received educational and research support in  the form of  research grants to  the institution  from Abbott, Cordis, Boston Scientific, Edwards Lifesciences, Medtronic, and St. Jude. Prof. Wenaweser has  received honoraria and lecture fees  from Medtronic and Edwards Lifesciences. Prof. Windecker has received research contracts to  the institution from Biotronik and St Jude; and lecture fees  from Abbott, Biosensors, Biotronik, Boston Scientic, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no  relationships relevant to  the contents of this paper to  disclose.

Manuscript received December 6, 2013; revised manuscript received February 10, 2014,  accepted April  3, 2014.


 

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