Complications and Health Care Costs Associated With Transvenous Cardiac Pacemakers in a Nationwide Assessment.

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.