Data Sheet 1_Safety and efficacy of completely transthoracic echocardiography guided leadless pacemaker implantation assisted by Panna guide wire: initial clinical experience.pdf

Background and objectiveConventional 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.
MethodsThis 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.
ResultsAll 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.
ConclusionsThis 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.

研究背景与研究目的
传统无导线起搏器（leadless pacemaker, LP）植入术依赖透视成像，会使患者与术者暴露于电离辐射及造影相关风险中。经胸超声心动图（transthoracic echocardiography, TTE）是无辐射的替代方案，但由于介入器械的超声显影效果不佳，完全经TTE引导的LP植入仍颇具挑战。本研究旨在评估超声优化型Panna导丝辅助下完全经TTE引导的LP植入术的短期安全性、技术可行性与操作效率。

研究方法
本研究针对TTE引导队列采用前瞻性方案设计的单臂研究方案，并与历史透视引导对照组开展回顾性对比分析。所有安全性与有效性终点均在患者入组前正式预先设定。本研究周期为2024年7月至2025年7月，共筛查符合LP植入指征的连续病例32例，最终10例合格患者接受了Panna导丝辅助的无透视/无造影TTE引导LP植入术。术前完成TTE超声窗分级，术中采用标准化操作流程（半定量“鹅颈征”评估、TTE引导牵拉试验）。本研究纳入2020年1月至2023年12月期间的44例透视引导LP植入患者作为历史对照组，采用倾向得分重叠加权法开展对比统计分析，以平衡基线协变量并评估组间差异。术中及随访阶段均对操作可行性、短期安全性、起搏参数与皮肤至皮肤的操作时长进行评估。

研究结果
10例患者的TTE超声窗均为最优分级（1级）。手术成功率达100%，未发生不良事件（中位随访时间4.7个月），器械性能稳定。敏感性分析显示，TTE引导技术的有效性不受术者经验水平影响。与44例经倾向得分加权后的对照组相比，TTE引导组的操作时长略长但无统计学差异（62.78±13.05 vs. 60.5±19.1 min，P>0.05），且手术效率相当，可为高危患者（如慢性肾脏病（chronic kidney disease, CKD）、辐射敏感人群）规避辐射与造影相关风险。长期随访（12/24个月）正按计划推进中。

研究结论
本初步研究结果证实，Panna导丝辅助下完全经TTE引导的LP植入术具备短期安全性与技术可行性，可在不劣于透视引导术操作效率的前提下，规避辐射与造影相关风险。本研究作为一项产生假说的概念验证性研究（样本量较小、长期随访数据尚不完整），其结论需在样本量≥50例且随访时长≥24个月的大型多中心注册研究中进一步验证，以确认其长期安全性与推广应用价值。