UPMC Cardiovascular Experts Implanted the First Abbott Aveir™ DR Leadless Pacemaker Systems in Pennsylvania

UPMC cardiovascular experts implanted the first Abbott Aveir™ DR Leadless Pacemaker systems in Pennsylvania on Wednesday, June 22, as part of the Aveir™ Dual Chamber Leadless i2i IDE Study, a prospective, multi-center, international, single-arm, pivotal trial, in which cardiovascular experts worldwide are studying the safety and effectiveness of the pacemaker system, which is not yet commercially available.

The goal of the study, which will enroll up to 550 patients with cardiac arrythmia at up to 80 sites worldwide, is to assess the safety and effectiveness of the Aveir™ DR Leadless Pacemaker system in this patient population. Data collected from the study will be submitted to support global regulatory approvals.

Unlike traditional pacemakers, the leadless pacemaker is inserted through a minimally invasive procedure – a catheter is guided through the femoral vein to the heart, where two pacemakers are attached: one in the right atrium and one in the right ventricle.¹ No implantation of leads or a device pocket in the patient’s chest is required, possibly leading to a shorter recovery period and can eliminate common lead and device pocket-related complications associated with traditional systems. However, some complications may still arise, including the need for device repositioning and a moderate risk of cardiac perforation with subsequent pericardial effusion.¹

Sandeep Jain, MD, director, cardiac electrophysiology at UPMC Heart and Vascular Institute, implanted the first of the two leadless pacemakers at UPMC Passavant, and Andrew Voigt, MD, director, interventional electrophysiology at UPMC Shadyside, performed the second procedure. The two cardiac electrophysiology experts are eager to continue studying the pacemaker. 

“This technology has the potential to benefit a growing patient population that requires a pacemaker,” Dr. Jain said. “Our team is always searching for novel, minimally invasive treatment options that could shorten recovery and minimize complications for our patients.” 

Aveir™ DR Leadless Pacemaker is a trademark of Abbott.

Reference

1. Grippe, A. Groner. American College of Cardiology. 2019. www.acc.org/latest-in-cardiology/ten-points-to-remember/2019/06/10/13/49/the-leadless-pacemaker. Accessed on 28 June 2022.