TTE-guided leadless pacemaker implantation shows feasibility and comparable duration to fluoroscopy in small cohort
This was a prospectively protocolized single-arm cohort study with retrospective comparative analysis against a historical control group. It evaluated completely transthoracic echocardiography (TTE)-guided leadless pacemaker implantation assisted by the ultrasound-optimized Panna guidewire in 10 eligible patients, compared to 44 historical patients who underwent standard fluoroscopy-guided implantation. The primary outcome was not explicitly reported; secondary outcomes included procedural feasibility, short-term safety, pacing parameters, and procedural duration.
All 10 patients in the TTE-guided cohort had optimal (Grade 1) acoustic windows. Procedural success was achieved in 10/10 patients (100%). The skin-to-skin procedural duration was comparable between groups: 62.78 ± 13.05 minutes for TTE-guided versus 60.5 ± 19.1 minutes for fluoroscopy-guided (P > 0.05). The study reported no adverse events and stable device performance during a median follow-up of 4.7 months, with long-term follow-up (12/24 months) ongoing.
Key limitations include the small sample size of 10 patients, incomplete long-term follow-up, and the study's design as a hypothesis-generating proof-of-concept. The findings are preliminary and require validation in larger multicenter registries (n ≥ 50) with ≥24-month follow-up. The practice relevance centers on the potential to eliminate radiation and contrast-related risks for high-risk patients (e.g., those with chronic kidney disease or radiation sensitivity) while matching the procedural efficiency of fluoroscopy-guided implantation, though generalizability is not yet confirmed.