Image: The Medtronic 53401 temporary single-chamber TVP (Photo courtesy of Medtronic).
A new study reveals that single- and dual-chamber transvenous pacemakers (TVPs) complications are quite common, affecting nearly one in six patients.
Researchers at the Cleveland Clinic (CC, OH, USA), the University of California, Los Angeles (UCLA; USA), and other institutions conducted a study to identify patients implanted with de novo dual- and single-chamber TVPs between April 2010 and March 2014. They then tracked Truven Health Analytics (Bethesda, MD, USA) MarketScan databases to uncover healthcare claims and encounters of private or Medicare supplemental insurance, and extracted relevant comorbidities and complications.
The results showed that acute complications occurred in 7.7% of single- and 9.1% of dual-chamber implants among 72,701 TVP implants; long-term complications occurred in 6.4% and 5.9%, and three-year event rates were about 15% and 16%, respectively. Considerable incidence and incremental costs of acute complications were also seen, led by thoracic trauma (3.71%), leads requiring revision (3.51%), and infection (1.15%). Long-term complications were related to the device leads, infection, and pocket contamination. The study was published on August 30, 2017, in JACC: Clinical Electrophysiology.
“Pacemakers are widely implanted across community and urban hospitals by operators of varying specialization and experience,” concluded lead author Daniel Cantillon, MD, of the Cleveland Clinic. “Claims data suggest that TVP complications are more common than previously reported, affecting nearly one in six patients by three years, and contributing to considerable incremental U.S. health care cost.”
TVP’s are used to correct profound symptomatic bradycardias that do not respond to transcutaneous pacing or drug therapy. It is achieved by threading a pacing electrode through a vein into the right atrium, right ventricle, or both. Although epicardial pacing is a temporary solution, in involves a similar level of risk of bleeding as more permanent solutions such as an implanted pacemaker. The procedure is done at the bedside, with the pacing electrode advanced under fluoroscopic and electrocardiographic guidance.
University of California, Los Angeles
Truven Health Analytics