Author + information
- Received June 16, 2014
- Revision received July 24, 2014
- Accepted July 31, 2014
- Published online January 1, 2015.
- Tamim M. Nazif, MD∗,
- José M. Dizon, MD∗,
- Rebecca T. Hahn, MD∗,
- Ke Xu, PhD†,
- Vasilis Babaliaros, MD‡,
- Pamela S. Douglas, MD§,
- Mikhael F. El-Chami, MD‡,
- Howard C. Herrmann, MD‖,
- Michael Mack, MD¶,
- Raj R. Makkar, MD#,
- D. Craig Miller, MD∗∗,
- Augusto Pichard, MD††,
- E. Murat Tuzcu, MD‡‡,
- Wilson Y. Szeto, MD‖,
- John G. Webb, MD§§,
- Jeffrey W. Moses, MD∗,
- Craig R. Smith, MD∗,
- Mathew R. Williams, MD∗,
- Martin B. Leon, MD∗,
- Susheel K. Kodali, MD∗∗ (, )
- PARTNER Publications Office
- ∗Columbia University Medical Center, New York, New York
- †Cardiovascular Research Foundation, New York, New York
- ‡Emory University School of Medicine, Atlanta, Georgia
- §Duke Clinical Research Institute, Durham, North Carolina
- ‖Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- ¶Baylor Healthcare System, Plano, Texas
- #Cedars Sinai Medical Center, Los Angeles, California
- ∗∗Stanford University School of Medicine, Stanford, California
- ††Medstar Washington Hospital Center, Washington, DC
- ‡‡Cleveland Clinic, Cleveland, Ohio
- §§St. Paul’s Hospital, Vancouver, British Columbia, Canada
- ↵∗Reprint requests and correspondence:
Dr. Susheel Kodali, Columbia University Medical Center/New York Presbyterian Hospital, 177 Ft. Washington Avenue, Room 501, New York, New York 10032.
Objectives The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR).
Background Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve.
Methods The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM.
Results Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year.
Conclusions PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894)
The PARTNER trial was funded by Edwards Lifesciences, and the protocol was developed jointly by the sponsor and the steering committee. The current analysis was designed and completed by the authors through the PARTNER Publications Office, which is colocated at Columbia University Medical Center/The Cardiovascular Research Foundation and The Cleveland Clinic. The PARTNER Publications Office is supported by an unrestricted grant from Edwards Lifesciences, administered by Medstar Health Research Institute. The sponsor had no involvement in the design or analysis of this substudy or in the decision to publish the results. Drs. Nazif, Pichard, Webb, and Kodali are consultants for Edwards Lifesciences. Dr. Hahn is a consultant for Edwards Lifesciences and has received research grant support from Phillips Healthcare. Dr. Babaliaros is a consultant for Direct Flow Medical, Bard Medical, and Intervalve; and is an investigator for Edwards Lifesciences. Dr. Douglas' institution has received research grant support from Edwards Lifesciences. Dr. El-Chami is a consultant to Boston Scientific; and has received a research grant from Medtronic. Dr. Herrmann has received grant support from Abbott Vascular, Boston Scientific Corporation, Edwards Lifesciences, Medtronic, Siemens, St. Jude Medical, and W.L. Gore and Associates; and is a consultant for Edwards Lifesciences, St. Jude Medical, and Siemens. Drs. Mack, Miller, Tuzcu, Smith, and Leon have received travel reimbursements from Edwards Lifesciences related to their activities as a member of the PARTNER Trial Executive Committee. Dr. Makkar has received grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, and St. Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; is a proctor for Edwards Lifesciences; and holds equity in Entourage Medical. Dr. Miller is supported by an R01 research grant from the National Heart, Lung, and Blood Institute (#HL67025); and has received consulting fees/honoraria from Abbott Vascular, St. Jude Medical, and Medtronic. Dr. Pichard is a proctor for Edwards Lifesciences. Dr. Szeto is a consultant for MicroInterventional Devices; and is an investigator for Edwards Lifesciences. Dr. Moses has served on the executive committee of the PARTNER trial. Dr. Williams is a consultant for Edwards Lifesciences and Medtronic. Dr. Kodali is a consultant to Meril; serves on the Scientific Advisory Board of and has equity in Thubrikar Aortic Valve, Inc.; is a principal investigator for and received research support from Claret Medical; and has received research and grant support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 16, 2014.
- Revision received July 24, 2014.
- Accepted July 31, 2014.
- 2015 American College of Cardiology Foundation