Author + information
- Received November 12, 2019
- Revision received January 24, 2020
- Accepted January 29, 2020
- Published online June 15, 2020.
- Daniel J. Friedman, MDa,∗ (, )
- Sean D. Pokorney, MD, MBAb,c,
- Amer Ghanem, PhDd,
- Stephen Marcello, MDe,
- Iftekhar Kalsekar, PhDd,
- Sashi Yadalam, PhDd,
- Joseph G. Akar, MD, PhDa,
- James V. Freeman, MD, MPH, MSa,
- Laura Goldstein, MPHf,
- Rahul Khanna, MBA, PhDd and
- Jonathan P. Piccini, MD, MHSb,c
- aSection of Cardiac Electrophysiology, Yale School of Medicine, New Haven, Connecticut
- bDuke Clinical Research Institute, Durham, North Carolina, cElectrophysiology Section, Duke University Hospital, Durham, North Carolina
- cElectrophysiology Section, Duke University Hospital, Durham, North Carolina
- dJohnson and Johnson, Medical Device Epidemiology, New Brunswick, New Jersey
- eJohnson and Johnson, Medical Safety, New Brunswick, New Jersey
- fJohnson and Johnson, Franchise Health Economics and Market Access, Irvine, California
- ↵∗Address for correspondence:
Dr. Daniel J. Friedman, Section of Cardiac Electrophysiology, Yale School of Medicine, Courier P.O. Box 208017, New Haven, Connecticut 06520-8017.
Objectives This study identified factors associated with risk for cardiac perforation in the setting of atrial fibrillation (AF) ablation in contemporary clinical practice.
Background Cardiac perforation is an uncommon but potentially fatal complication of AF ablation. An improved understanding of factors associated with cardiac perforation could facilitate improvements in procedural safety.
Methods Logistic regression models were used to assess predictors of cardiac perforation among Medicare beneficiaries who underwent AF ablation from July 1, 2013 and December 31, 2017. Cardiac perforation was defined as a diagnosis of hemopericardium, cardiac tamponade, or pericardiocentesis, within 30 days of AF ablation.
Results Of 102,398 patients who underwent AF ablation, 0.61% (n = 623) experienced cardiac perforation as a procedural complication. Rates of cardiac perforation decreased over time. In adjusted analyses of the overall population, female sex (odds ratio [OR]: 1.34; 95% confidence interval [CI]: 1.14 to 1.58; p = 0.0004), obesity (OR: 1.35; 95% CI: 1.09 to 1.68; p = 0.0050), and absence of intracardiac echocardiography (ICE) (OR: 4.85; 95% CI: 4.11 to 5.71; p < 0.0001) were associated with increased risk for cardiac perforation, whereas previous cardiac surgery (OR: 0.14; 95% CI: 0.07 to 0.26; p < 0.0001) was associated with a lower risk for perforation. Patient risk factors for cardiac perforation were identical in the subset of patients in whom ICE was used (n = 76,134). A risk score was generated with the following point assignments: female sex (1 point); obesity (1 point); nonuse of ICE (5 points); and previous cardiac surgery (−6 points).
Conclusions Cardiac perforation is a rare complication of AF ablation; incidence has decreased over time. One of the strongest predictors of cardiac perforation in the contemporary era is a modifiable factor, use of intraprocedural ICE.
This study was funded by Johnson and Johnson. Dr. Friedman has received research support from Boston Scientific, Biosense Webster, and Abbott; has received educational grants from Boston Scientific, Medtronic, Abbott, and Biotronik; and has received consulting fees from Abbott and AtriCure. Dr. Pokorney has received research support from Bristol-Myers Squibb, Pfizer, Janssen Pharmaceuticals, the Food and Drug Administration, Gilead, and Boston Scientific; has received consulting/advisory board support from Medtronic, Boston Scientific, Philips, Janssen Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Portola, and Zoll; and has received DSMB support from Medpace. Dr. Kalsekar holds stock in Johnson and Johnson. Dr. Freeman has received fees from Janssen Pharmaceuticals, Medtronic, Boston Scientific, and Biosense Webster; has received research support from the American College of Cardiology. Dr. Khanna holds stock in Johnson and Johnson. Dr. Piccini has received grants for clinical research from Abbott, American Heart Association, Boston Scientific, Gilead, Janssen Pharmaceuticals, National Heart, Lung, and Blood Institute, and Philips; and has served as a consultant to Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, Johnson & Johnson, LivaNova, Medtronic, Milestone, Oliver Wyman Health, Sanofi, Philips, and Up-to-Date. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received November 12, 2019.
- Revision received January 24, 2020.
- Accepted January 29, 2020.
- 2020 The Authors