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TTE-guided leadless pacemaker implantation shows feasibility and comparable duration to fluoroscopy in small cohortCan a heart pacemaker be implanted without any X-ray radiation?

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Key Takeaway
Consider TTE-guided leadless pacing as a radiation-free option in select patients, pending validation of long-term outcomes.

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.

Imagine getting a life-saving heart device implanted without being exposed to any X-ray radiation. That's the promise of a new technique doctors are testing for placing tiny, leadless pacemakers. Instead of using fluoroscopy (a live X-ray), they used only transthoracic echocardiography—a type of ultrasound that creates pictures of the heart using sound waves—to guide the device into place.

In this small, early study, 10 patients received the new ultrasound-guided procedure. The results were promising: the procedure was successful in all 10 patients, took about the same amount of time as the standard X-ray method, and caused no short-term safety problems. The ultrasound images were clear enough for the doctors to work with in every case.

This approach could be a game-changer for patients who are especially vulnerable to radiation or the contrast dye used in X-rays, such as people with chronic kidney disease. However, it's crucial to remember this is a very preliminary look. Only 10 patients were involved, and while the short-term results are stable, the study team is still tracking their progress at 12 and 24 months to see how the devices perform over the long haul. The findings need to be confirmed in much larger groups of patients before this could become a standard option.

What this means for you:
Early study finds ultrasound can guide pacemaker placement without X-rays, but more research is needed.

Study Details

Study typeCohort
EvidenceLevel 3
PublishedMar 2026
View Original Abstract ↓
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.
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