Author + information
- Received July 21, 2016
- Revision received April 25, 2017
- Accepted May 26, 2017
- Published online November 20, 2017.
- Daniel J. Cantillon, MDa,∗ (, )
- Derek V. Exner, MD, MPHb,
- Nima Badie, PhDc,
- Kevin Davis, BSc,
- Ning Yan Gu, PhDc,
- Yelena Nabutovsky, MSc and
- Rahul Doshi, MDd
- aCleveland Clinic, Heart and Vascular Institute, Cleveland, Ohio
- bLibin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada
- cAbbott Laboratories, Abbott Park, Illinois
- dKeck Hospital of the University of Southern California, Los Angeles, California
- ↵∗Address for correspondence:
Dr. Daniel J. Cantillon, Cardiac Electrophysiology and Pacing, Cleveland Clinic, Heart and Vascular Institute, 9500 Euclid Avenue, Desk J2-2, Cleveland, Ohio 44195.
Objectives The aim of this study was to retrospectively characterize transvenous pacemaker (TVP) complications and associated health care costs in a large-scale U.S. patient cohort.
Background TVP complications have previously been shown to affect more than 1 in 10 patients but may be underestimated. Pacemakers are widely implanted across community and urban hospitals by operators of varying specialization and experience.
Methods Truven Health MarketScan databases track U.S. health care claims and encounters of private or Medicare supplemental insurance. Patients implanted with de dual- and single-chamber TVPs between April 2010 and March 2014 and over 1 year of pre-implantation MarketScan enrollment were identified. International Classification of Diseases-Ninth Revision and Current Procedural Terminology codes were used to extract relevant comorbidities and complications. Incremental adjusted cost analysis was performed for acute complications, defined as those occurring within 30 days of implantation.
Results Among 72,701 TVP implantations (mean age 75 ± 12 years, 55% men, 13% single chamber) with 1.5 ± 1.1 years of follow-up, acute complications (0 to 1 month) occurred in 7.7% of single- and 9.1% of dual-chamber TVPs and long-term complications (1 to 36 months) in 6.4% and 5.9% of single- and dual-chamber TVPs, respectively. The net 3-year event rates were approximately 15% and 16%. The incidence and incremental cost of complications are considerable. Most common acute complications include thoracic trauma (3.71%, $70,114), leads requiring revision (3.51%, $9,296), and infection (1.15%, $80,247). Long-term complications are attributed to leads (2.84%), infection (2.42%), and pocket (0.96%).
Conclusions Claims data suggest that TVP complications are more common than previously reported, affecting nearly 1 in 6 patients by 3 years and contributing to considerable incremental U.S. health care cost.
Dr. Cantillon is a consultant for Abbott, Boston Scientific, and Stryker Medical; and has received research support from Abbott, LifeWatch, and Stryker Medical. Dr. Exner is a consultant for Abbott, Medtronic, GE Healthcare, and Analytics for Life; has received fellowship support from Medtronic and Boston Scientific; has received research grants from Abbott, Medtronic, and GE Healthcare; and is an advisory board member for Analytics for Life. Dr. Badie, Mr. Davis, Dr. Gu, and Ms. Nabutovsky are employees of Abbott Laboratories. Dr. Doshi is a consultant for Abbott and Boston Scientific; and has received fellowship support from Abbott, Boston Scientific, and Medtronic.
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 July 21, 2016.
- Revision received April 25, 2017.
- Accepted May 26, 2017.
- 2017 American College of Cardiology Foundation