Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study.

ABSTRACT:

Background

Transvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices. Mechanical TLE tools, including rotational sheaths, are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools.

Objective

To prospectively investigate the safety and effectiveness of mechanical TLE in real-world usage.

Methods

Patients were enrolled at 10 sites in the United States and Europe to evaluate the use of mechanical TLE devices. Clinical success, complete procedural success, and complications were evaluated through follow-up (median, 29 days). Patient data were source verified

SUBMITTER: Sharma S 

PROVIDER: S-EPMC8183877 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature