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Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM

Monique E A M van Kleef1, Chandan M Devireddy2, Jan van der Heyden3

  • 1Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, the Netherlands.

JACC. Cardiovascular Interventions
|February 11, 2022
PubMed

Insights

Endovascular baroreflex amplification (EVBA) effectively lowered blood pressure in patients with resistant hypertension over 3 years. The MobiusHD device demonstrated an acceptable safety profile, warranting further investigation in randomized trials.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Hypertension Management

Background:

  • Resistant hypertension poses a significant challenge in blood pressure management.
  • Previous 6-month data showed endovascular baroreflex amplification (EVBA) effectively reduced blood pressure (BP).
  • The long-term safety and efficacy of EVBA require further evaluation.

Purpose of the Study:

  • To assess the 3-year safety and effectiveness of endovascular baroreflex amplification (EVBA).
  • To analyze data from European and American CALM-FIM cohorts for long-term outcomes.
  • To evaluate blood pressure changes and adverse events following EVBA implantation.

Main Methods:

  • Prospective, nonrandomized, first-in-human studies (CALM-FIM).
  • Inclusion of patients with resistant hypertension (BP ≥160/80 mmHg despite ≥3 medications).
  • Monitoring of adverse events, BP, heart rate, and medication up to 3 years post-implantation.

Main Results:

  • 47 patients received the MobiusHD device; 30 in Europe, 17 in the US.
  • Mean office BP decreased by 30/12 mmHg at 3 years (p<0.001).
  • Serious adverse events included hypotension, hypertension, and vascular complications; 2 strokes and 1 TIA occurred >2 years post-implantation.

Conclusions:

  • EVBA with the MobiusHD device demonstrates sustained BP reduction at 3 years.
  • The procedure appears to have an acceptable safety profile in patients with uncomplicated implantation.
  • Randomized sham-controlled trials are necessary to fully establish the risk-benefit profile of EVBA.
Abstract

Keywords:
antihypertension devicebaroreceptor modulationbaroreflexendovascular baroreflex amplificationhypertension

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