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Improved Renal Denervation Mitigated Hypertension Induced by Angiotensin II Infusion
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Symplicity multi-electrode radiofrequency renal denervation system feasibility study.

Robert Whitbourn1, Scott A Harding, Antony Walton

  • 1St. Vincent's Hospital, Melbourne, Australia.

Eurointervention : Journal of Europcr in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
|May 19, 2015
PubMed
Summary

This study shows the Symplicity multi-electrode radiofrequency renal denervation system safely and effectively reduces blood pressure in hypertensive patients. The novel system significantly lowered systolic blood pressure (SBP) within 12 months with minimal complications.

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Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Hypertension Management

Background:

  • Renal denervation is an emerging therapy for resistant hypertension.
  • Existing systems may have longer procedure times.
  • A novel multi-electrode system aims to improve efficiency.

Purpose of the Study:

  • To evaluate the safety and performance of the Symplicity multi-electrode radiofrequency renal denervation system.
  • To assess the impact of the system on procedure time.
  • To determine the efficacy in reducing blood pressure.

Main Methods:

  • Prospective, non-randomized, open-label feasibility study.
  • Enrolled 50 subjects with hypertension.
  • Utilized a novel catheter with four electrodes for simultaneous radiofrequency energy delivery to renal artery quadrants.

Main Results:

  • Significant reduction in office systolic blood pressure (SBP) by -19.2 mmHg (p<0.001) at 12 months.
  • Significant reduction in 24-hour SBP by -7.6 mmHg (p=0.020) at 12 months.
  • Total procedure time for both renal arteries was two minutes; three minor access-site complications occurred, unrelated to energy delivery.

Conclusions:

  • The Symplicity multi-electrode system is safe and effective for renal denervation.
  • The system achieved significant blood pressure reduction.
  • The multi-electrode design reduced procedure time with minimal complications.