Feasibility and Safety of Transthoracic Echocardiography-Guided Transvenous Permanent Pacemaker Implantation Without Fluoroscopy.
Fluoroscopy is routinely used for transvenous permanent pacemaker implantation, but a standardized transthoracic echocardiography (TTE)-only workflow has not been prospectively evaluated.
The objective of the study was to evaluate the feasibility, acute safety, and procedural performance of fluoroscopy-free transvenous pacemaker implantation guided exclusively by TTE.
In this prospective, single-center feasibility study (RADIANCE [Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation]; NCT07458724), 52 consecutive patients referred to the Department of Structural Heart Disease were screened. Thirty-one selected patients (59.6%) with guideline-based pacing indications and adequate prespecified supine TTE acoustic windows underwent attempted TTE-only implantation. Acute procedural success required completion without fluoroscopic conversion and fulfillment of prespecified TTE-defined anatomical, electrical, and safety criteria.
TTE-only implantation was successful in 30/31 patients (96.8%; 95% CI: 83.3-99.9), with fluoroscopic conversion in 1/31 (3.2%). The mean procedure time was 55.4 ± 5.6 minutes. No major acute procedural complications occurred. During a median follow-up of 8.8 months (IQR: 6-12 months), atrial lead dislodgement requiring revision occurred in 1/21 dual-chamber recipients (4.8%; 95% CI: 0.1-23.8). Procedure time decreased with chronological case order (-0.59 minutes/case; Newey-West 95% CI: -0.68 to -0.49), an exploratory team-level association.
In selected patients with adequate supine acoustic windows, TTE-guided fluoroscopy-free pacemaker implantation was feasible with acceptable acute outcomes. The lead-position findings and exploratory case-order association require further validation in larger and more diverse populations.
The objective of the study was to evaluate the feasibility, acute safety, and procedural performance of fluoroscopy-free transvenous pacemaker implantation guided exclusively by TTE.
In this prospective, single-center feasibility study (RADIANCE [Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation]; NCT07458724), 52 consecutive patients referred to the Department of Structural Heart Disease were screened. Thirty-one selected patients (59.6%) with guideline-based pacing indications and adequate prespecified supine TTE acoustic windows underwent attempted TTE-only implantation. Acute procedural success required completion without fluoroscopic conversion and fulfillment of prespecified TTE-defined anatomical, electrical, and safety criteria.
TTE-only implantation was successful in 30/31 patients (96.8%; 95% CI: 83.3-99.9), with fluoroscopic conversion in 1/31 (3.2%). The mean procedure time was 55.4 ± 5.6 minutes. No major acute procedural complications occurred. During a median follow-up of 8.8 months (IQR: 6-12 months), atrial lead dislodgement requiring revision occurred in 1/21 dual-chamber recipients (4.8%; 95% CI: 0.1-23.8). Procedure time decreased with chronological case order (-0.59 minutes/case; Newey-West 95% CI: -0.68 to -0.49), an exploratory team-level association.
In selected patients with adequate supine acoustic windows, TTE-guided fluoroscopy-free pacemaker implantation was feasible with acceptable acute outcomes. The lead-position findings and exploratory case-order association require further validation in larger and more diverse populations.