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Background <p>Leadless pacemakers (LPs) avoid lead- and pocket-related issues but require large venous access, which raises safety concerns in patients with a small body surface area (BSA), particularly in Asian populations. We defined low BSA as &lt; 1.46&#xa0;m², based on validated 3D-derived anthropometric standards for Chinese adults.</p> Objective <p>To assess procedural complication rates of LP implantation in patients with low BSA.</p> Methods <p>We analyzed LP implantations from 2016 to 2025 at a single center in Thailand. Of 59 patients, 25 (42.4%) had low BSA. We conducted two comparisons: (1) low- vs. normal/high-BSA LP patients and (2) low-BSA LP patients with a 1:2 age-, sex-, and BSA-matched transvenous pacemaker (TVP) cohort. The primary outcome was major device-related complications.</p> Results <p>LP patients were elderly (median 79 years) with high comorbidity (median Charlson Comorbidity Index [CCI], 7.0). In the matched analysis, low-BSA LP patients had a significantly higher comorbidity burden than TVP controls (median CCI, 7.0 vs. 5.0; <i>P</i> = 0.002). The 3.8-year cumulative incidence of major complications did not differ between low- vs. normal/high-BSA LP patients (8.0% vs. 8.8%, <i>P</i> = 0.39) and between low-BSA LP patients vs. matched TVP controls (8.0% vs. 14.0%, <i>P</i> = 0.91). Adjusted analyses revealed no significant association between device type and complications, although the confidence intervals were wide.</p> Conclusion <p>In this exploratory analysis, patients with low-BSA showed no increased risk of major complications following LP implantation. However, given the small sample size and pronounced selection bias, these findings should be interpreted with caution.</p>

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Safety of leadless versus transvenous pacemakers in patients with low body surface area: a matched-pair analysis

  • 期刊论文

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  • 发表日期：

    2026年1月16日

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  • Sirin Apiyasawat,
  • Natcha Soontornmanokati,
  • Tachapong Ngarmukos,
  • Nilubon Methachittiphan

摘要

Background

Leadless pacemakers (LPs) avoid lead- and pocket-related issues but require large venous access, which raises safety concerns in patients with a small body surface area (BSA), particularly in Asian populations. We defined low BSA as < 1.46 m², based on validated 3D-derived anthropometric standards for Chinese adults.

Objective

To assess procedural complication rates of LP implantation in patients with low BSA.

Methods

We analyzed LP implantations from 2016 to 2025 at a single center in Thailand. Of 59 patients, 25 (42.4%) had low BSA. We conducted two comparisons: (1) low- vs. normal/high-BSA LP patients and (2) low-BSA LP patients with a 1:2 age-, sex-, and BSA-matched transvenous pacemaker (TVP) cohort. The primary outcome was major device-related complications.

Results

LP patients were elderly (median 79 years) with high comorbidity (median Charlson Comorbidity Index [CCI], 7.0). In the matched analysis, low-BSA LP patients had a significantly higher comorbidity burden than TVP controls (median CCI, 7.0 vs. 5.0; P = 0.002). The 3.8-year cumulative incidence of major complications did not differ between low- vs. normal/high-BSA LP patients (8.0% vs. 8.8%, P = 0.39) and between low-BSA LP patients vs. matched TVP controls (8.0% vs. 14.0%, P = 0.91). Adjusted analyses revealed no significant association between device type and complications, although the confidence intervals were wide.

Conclusion

In this exploratory analysis, patients with low-BSA showed no increased risk of major complications following LP implantation. However, given the small sample size and pronounced selection bias, these findings should be interpreted with caution.