Leadless vs. transvenous pacemakers after TAVR: Tracking complications, costs and survival
When patients require a permanent pacemaker (PPM) after transcatheter aortic valve replacement (TAVR), should care teams turn to a transvenous or leadless device? According to a new analysis published in JACC: Cardiovascular Interventions, leadless pacemakers are linked to improved outcomes both in the hospital and up to two years after treatment.[1]
“A leadless pacemaker is a small, capsule-like device implanted in the right ventricular apex,” wrote corresponding author Toshiki Kuno MD, PhD, with the cardiology division at Montefiore Medical Center in New York City, and colleagues. “By design, it reduces the risk of complications associated with transvenous pacing leads or subcutaneous pockets, a common complication of a traditional transvenous pacing system. These advantages may be especially relevant for patients experiencing bradyarrhythmic complications of TAVR because the majority of such individuals are elderly, frail, and burdened with multiple comorbidities, rendering them at risk of complications from transvenous pacemakers. Moreover, a notable proportion of conduction disturbances following TAVR are reported to resolve during follow-up, making leadless pacemakers an appealing choice as a temporary pacing system to navigate through the acute phase of tenuous conduction disease without incurring long-term consequences. However, the rate of adoption for such an approach remains unclear.”
To learn more about pacemaker utilization after TAVR, Kuno et al. explored data from more than 165,000 Medicare patients treated from 2017 to 2020. Nearly 12,000 of those patients required a PPM implantation; after exclusions, final cohort included 10,338 TAVR patients aged 65 years old or older.
Overall, 730 patients received a leadless pacemaker and the remaining 9,608 patients received a transvenous pacemaker. The utilization of leadless pacemakers after TAVR jumped significantly as the study went on, increasing by more than three times from 2017 to 2020.
Leadless pacemaker patients were linked to lower rates of in-hospital complications (7.2% vs. 10.1%) and device-related complications (0.7% vs. 2.1%). Total healthcare spending—defined as the sum of the Medicare payment, primary payer payment, beneficiary expenses for cost sharing and provider payments—were similar for the two device options.
Up to two years after treatment, meanwhile, leadless pacemakers were still associated with a lower complication rate. There were no significant differences when it came to heart failure hospitalizations or infective endocarditis, however.
Reviewing these findings, the authors determined that leadless pacemakers “may be an attractive alternative” when treating patients who are especially vulnerable after undergoing TAVR.
“Complications arising from transvenous pacemakers, such as pneumothorax, pocket hematoma, lead fracture/dislodgement, lead-related vascular occlusion, valvular injury, and infection, are common, affecting nearly one in six patients,” the authors wrote. “These issues pose a significant burden on both quality of life and healthcare costs. Our study revealed that leadless pacemakers had fewer in-hospital complications and midterm device-related complications than transvenous pacemakers in patients with bradyarrhythmic complications of TAVR. This finding is consistent with existing research in the non-TAVR population.”
Leadless pacemakers, the group added, “may offer an optimal strategy” when conduction disorders follow TAVR because they “support the acute phase” of the issue “without imposing the risk of long-term complications associated with transvenous pacemakers or the need for extraction.”
Read the full analysis here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.