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Objective <p>This study aims to design and fabricate a leadless pacemaker (LPM) electrode loaded with rapamycin (RAPA)–poly(lactic-co-glycolic acid) (PLGA) drug sustained-release system to reduce the local fibrous tissue proliferation after LPM implantation, reduce local bioelectrical impedance, and facilitate the safe extraction of LPM after use.</p> Methods <p>We fabricated an LPM electrode loaded with the RAPA-PLGA drug-sustained-release system and carried out in vitro and in vivo experiments to verify its effect.</p> Results <p>A scanning electron microscope showed that the LPM electrode cavity was loaded with the RAPA-PLGA drug’s sustained-release system. The energy-dispersive spectrometer showed that the LPM electrode had RAPA and PLGA-related elements. The average drug loading rate of the drug sustained-release system was (51.02% ± 2.66) %, and the encapsulation rate was (85.04% ± 4.43%). The RAPA loaded in the electrode chamber was about (337.83 ± 53.66)μg. In vitro release results show that the LPM electrode loaded with RAPA–PLGA can continue to release for 44 days. In vitro cell inhibition experiments showed that the drug-loaded electrode group had an obvious inhibitory effect on fibroblasts, and the difference between the groups was significant (<i>p</i> &lt; 0.05). In vivo experiments showed that the local bioelectrical impedance of the drug-loaded electrode group is lower than that of the control group, with a difference between groups with statistical significance (<i>p</i> &lt; 0.05). The histopathological analysis of tissue sections from the site of (LPM electrode implantation revealed reduced fibrous tissue hyperplasia in the drug-loaded electrode group compared to the control group. Additionally, H&amp;E staining indicated that the implantation of drug-loaded electrodes did not induce abnormal alterations in the liver, heart, spleen, lung, or kidney tissues.</p> Conclusion <p>The LPM electrode loaded with RAPA–PLGA demonstrates significant, sustained drug release and anti-proliferative effects in vitro. This drug-loaded electrode has been deemed safe for implantation in animal models. It can effectively inhibit local fibrous tissue proliferation and reduce local bioelectrical impedance, offering a technical strategy to prolong the in vivo functionality of LPMs and enhance clinical procedures.</p>

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LPM electrode loaded with RAPA-PLGA drug sustained-release system can reduce local fibrous tissue hyperplasia and local bioelectrical impedance

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月30日

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  • Xiu Wang,
  • Wentao Du,
  • Yunyun Wang,
  • Ahsan Riaz Khan,
  • Haijun Zhang

摘要

Objective

This study aims to design and fabricate a leadless pacemaker (LPM) electrode loaded with rapamycin (RAPA)–poly(lactic-co-glycolic acid) (PLGA) drug sustained-release system to reduce the local fibrous tissue proliferation after LPM implantation, reduce local bioelectrical impedance, and facilitate the safe extraction of LPM after use.

Methods

We fabricated an LPM electrode loaded with the RAPA-PLGA drug-sustained-release system and carried out in vitro and in vivo experiments to verify its effect.

Results

A scanning electron microscope showed that the LPM electrode cavity was loaded with the RAPA-PLGA drug’s sustained-release system. The energy-dispersive spectrometer showed that the LPM electrode had RAPA and PLGA-related elements. The average drug loading rate of the drug sustained-release system was (51.02% ± 2.66) %, and the encapsulation rate was (85.04% ± 4.43%). The RAPA loaded in the electrode chamber was about (337.83 ± 53.66)μg. In vitro release results show that the LPM electrode loaded with RAPA–PLGA can continue to release for 44 days. In vitro cell inhibition experiments showed that the drug-loaded electrode group had an obvious inhibitory effect on fibroblasts, and the difference between the groups was significant (p < 0.05). In vivo experiments showed that the local bioelectrical impedance of the drug-loaded electrode group is lower than that of the control group, with a difference between groups with statistical significance (p < 0.05). The histopathological analysis of tissue sections from the site of (LPM electrode implantation revealed reduced fibrous tissue hyperplasia in the drug-loaded electrode group compared to the control group. Additionally, H&E staining indicated that the implantation of drug-loaded electrodes did not induce abnormal alterations in the liver, heart, spleen, lung, or kidney tissues.

Conclusion

The LPM electrode loaded with RAPA–PLGA demonstrates significant, sustained drug release and anti-proliferative effects in vitro. This drug-loaded electrode has been deemed safe for implantation in animal models. It can effectively inhibit local fibrous tissue proliferation and reduce local bioelectrical impedance, offering a technical strategy to prolong the in vivo functionality of LPMs and enhance clinical procedures.