Author + information
- Received February 28, 2018
- Revision received June 29, 2018
- Accepted June 29, 2018
- Published online September 17, 2018.
- Omair K. Yousuf, MDa,b,c,d,∗ (, )
- Robbert Zusterzeel, MD, PhD, MPHb,
- William Sanders, MD, JD, MBAb,
- Daniel Caños, MPH, PhDb,
- Carmen Dekmezian, BSe,
- Henry Silverman, BSe,
- Hugh Calkins, MDf,
- Ronald Berger, MD, PhDf,
- Harikrishna Tandri, MDf,
- Saman Nazarian, MD, PhDf,g and
- David G. Strauss, MD, PhDb
- aDepartment of Cardiology, Johns Hopkins University, School of Medicine, Baltimore, Maryland
- bU.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, Maryland
- cSaint Luke’s Mid America Heart Institute, Kansas City, Missouri
- dUniversity of Missouri-Kansas City, School of Medicine, Kansas City, Missouri
- eAcumen, LLC, Burlingame, California
- fDepartment of Medicine, Division of Cardiology, Johns Hopkins University, School of Medicine, Baltimore, Maryland
- gUniversity of Pennsylvania, School of Medicine, Philadelphia, Pennsylvania
- ↵∗Address for correspondence:
Dr. Omair K. Yousuf, St Luke’s Mid America Heart Institute, 4330 Wornall Road, Suite 2000, Kansas City, Missouri 64111.
Objectives This study examined the trend in growth of catheter ablation for ventricular tachycardia (VT) performed in the United States with analysis of rates and predictors of major adverse events.
Background Sustained VT is a significant cause of sudden death, heart failure (HF), and recurrent shocks in implantable cardioverter-defibrillator (ICD) recipients. Catheter ablation for VT reduces arrhythmia recurrence. Limited data are available regarding the use, safety, and long-term outcomes after VT ablation.
Methods Using the U.S. Medicare database linked to the Social Security Death Index, we examined the annual use of VT ablation in 21,073 patients over 12 years, with 30-day risk of mortality, nonfatal major adverse events (MAEs), 1-year risk of mortality, re-hospitalization, repeat ablation, and factors associated with adverse outcomes.
Results Among 21,073 patients (age 70 ± 9 years; 77% men; 90% white), there were 1,581 (7.5%) non-fatal MAEs within 30 days. There were 963 (4.6%) vascular complications, 485 (2.3%) pericardial complications, and 201 (1%) strokes and/or transient ischemic attacks. Mechanical circulatory support use was infrequent (2.3%). The 30-day and 1-year mortality rates were 4.2% and 15.0%, respectively. The 1-year incidence of repeat ablation was 10.2 per 100 person-years and re-hospitalization for HF or VT was 15.4 per 100 person-years and 18 per 100 person-years, respectively. Patients with an ICD had increased 30-day (4.9% vs. 0.86%) and 1-year mortality (17.5% vs. 2.54% [22.9 per 100 person-years vs. 3.1 per 100 person-years]; hazard ratio [HR]: 2.93; 95% confidence interval [CI]: 2.21 to 3.88). Rates of hospitalization for HF (18 per 100 person-years vs. 1.8 per 100 person-years; HR: 4.00; 95% CI: 2.78 to 5.78) or VT recurrence (22.7 per 100 person-years vs. 2.1 per 100 person-years; HR: 5.70; 95% CI: 4.09 to 7.96) were also higher at 1 year. Between 2000 and 2012, annual VT ablation volumes increased >4-fold.
Conclusions Catheter ablation for VT is frequently performed. Short-term MAEs and 1-year mortality is significant and is highest in patients with an ICD. These findings may provide greater insight of outcomes in an unselected real-world population undergoing VT ablation.
This project was supported by the SafeRx Project, a joint initiative of the CMS (Baltimore, Maryland), USFDA (Silver Spring, Maryland), and the U.S. Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation and by a research fellowship from the Oak Ridge Institute for Science and Education (Oak Ridge, Tennessee) through an interagency agreement between the U.S. Department of Energy and the USFDA. Acumen LLC is a contractor to CMS.
The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the U.S. Department of Health and Human Services. Dr. Yousuf has been a consultant for Abbott; Dr. Calkins has received research grants from Boston Scientific and St Jude Medical; and has been a consultant for Medtronic, St. Jude Medical, and Atricure. Dr. Berger has received educational grants from St. Jude Medical, Medtronic, Boston Scientific, and Johnson & Johnson; and has been a consultant for Zoll Corp. and Boston Scientific. Dr. Tandri has been a consultant for Abbot. Dr. Nazarian has received a research grant from Biosense Webster; and has been a consultant for Biosense Webster, Medtronic, and CardioSolv. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All 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 February 28, 2018.
- Revision received June 29, 2018.
- Accepted June 29, 2018.
- 2018 American College of Cardiology Foundation
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