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Safety and efficacy of completely transthoracic echocardiography guided leadless pacemaker implantation assisted by Panna guide wire: initial clinical experience
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Background and objective
Conventional leadless pacemaker (LP) implantation relies on fluoroscopy, exposing patients and operators to ionizing radiation and contrast-related risks. Transthoracic echocardiography (TTE) is a radiation-free alternative, but complete TTE-guided LP implantation remains challenging due to poor ultrasound visibility of interventional devices. This study evaluated the short-term safety, technical feasibility, and procedural efficiency of completely TTE-guided LP implantation assisted by the ultrasound-optimized Panna guidewire.
Methods
This study utilized a prospectively protocolized, single-arm design for the TTE-guided cohort, with a retrospective comparative analysis against a historical fluoroscopy-guided control group. All safety and efficacy endpoints were formally predefined prior to patient enrollment. A total of 32 consecutive patients with LP implantation indications were screened during the study period (July 2024–July 2025), and 10 eligible patients underwent fluoroscopy/contrast-free, TTE-guided LP implantation using the Panna guidewire. Preoperative TTE acoustic window grading was performed, and standardized protocols (semi-quantitative “gooseneck” sign assessment, TTE-guided tug test) were applied during the procedure. A historical control group of 44 fluoroscopy-guided LP patients (January 2020–December 2023) was included, with propensity score overlap weighting-based comparative statistical analyses performed to balance baseline covariates and assess between-group differences. Procedural feasibility, short-term safety, pacing parameters, and skin-to-skin procedural duration were evaluated intraoperatively and during follow-up.
Results
All 10 patients had optimal TTE acoustic windows (Grade 1). Procedural success was 100%, with no adverse events (median follow-up: 4.7 months) and stable device performance. Sensitivity analysis showed the TTE technique's effectiveness was not affected by operator experience. Compared with 44 propensity score-weighted controls, TTE-guided implantation had slightly longer but comparable procedural duration (62.78 ± 13.05 vs. 60.5 ± 19.1 min,
P
> 0.05) and comparable efficiency, eliminating radiation/contrast-related risks for high-risk patients (e.g., CKD, radiation sensitivity). Long-term follow-up (12/24 months) is ongoing per schedule.
Conclusions
This preliminary experience demonstrates the short-term safety and technical feasibility of completely TTE-guided LP implantation assisted by the Panna guidewire, which eliminates radiation/contrast risks while matching fluoroscopy-guided efficiency. As a hypothesis-generating proof-of-concept study (small sample, incomplete long-term follow-up), these findings require validation in larger multicenter registries (
n
≥ 50) with ≥24-month follow-up to confirm long-term safety and generalizability.
Frontiers Media SA
Title: Safety and efficacy of completely transthoracic echocardiography guided leadless pacemaker implantation assisted by Panna guide wire: initial clinical experience
Description:
Background and objective
Conventional leadless pacemaker (LP) implantation relies on fluoroscopy, exposing patients and operators to ionizing radiation and contrast-related risks.
Transthoracic echocardiography (TTE) is a radiation-free alternative, but complete TTE-guided LP implantation remains challenging due to poor ultrasound visibility of interventional devices.
This study evaluated the short-term safety, technical feasibility, and procedural efficiency of completely TTE-guided LP implantation assisted by the ultrasound-optimized Panna guidewire.
Methods
This study utilized a prospectively protocolized, single-arm design for the TTE-guided cohort, with a retrospective comparative analysis against a historical fluoroscopy-guided control group.
All safety and efficacy endpoints were formally predefined prior to patient enrollment.
A total of 32 consecutive patients with LP implantation indications were screened during the study period (July 2024–July 2025), and 10 eligible patients underwent fluoroscopy/contrast-free, TTE-guided LP implantation using the Panna guidewire.
Preoperative TTE acoustic window grading was performed, and standardized protocols (semi-quantitative “gooseneck” sign assessment, TTE-guided tug test) were applied during the procedure.
A historical control group of 44 fluoroscopy-guided LP patients (January 2020–December 2023) was included, with propensity score overlap weighting-based comparative statistical analyses performed to balance baseline covariates and assess between-group differences.
Procedural feasibility, short-term safety, pacing parameters, and skin-to-skin procedural duration were evaluated intraoperatively and during follow-up.
Results
All 10 patients had optimal TTE acoustic windows (Grade 1).
Procedural success was 100%, with no adverse events (median follow-up: 4.
7 months) and stable device performance.
Sensitivity analysis showed the TTE technique's effectiveness was not affected by operator experience.
Compared with 44 propensity score-weighted controls, TTE-guided implantation had slightly longer but comparable procedural duration (62.
78 ± 13.
05 vs.
60.
5 ± 19.
1 min,
P
> 0.
05) and comparable efficiency, eliminating radiation/contrast-related risks for high-risk patients (e.
g.
, CKD, radiation sensitivity).
Long-term follow-up (12/24 months) is ongoing per schedule.
Conclusions
This preliminary experience demonstrates the short-term safety and technical feasibility of completely TTE-guided LP implantation assisted by the Panna guidewire, which eliminates radiation/contrast risks while matching fluoroscopy-guided efficiency.
As a hypothesis-generating proof-of-concept study (small sample, incomplete long-term follow-up), these findings require validation in larger multicenter registries (
n
≥ 50) with ≥24-month follow-up to confirm long-term safety and generalizability.
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