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

Abstract

Objectives: The aim of this study was to evaluate the long-term (3-year) safety and effectiveness of endovascular baroreflex amplification (EVBA) from both the European and American CALM-FIM cohorts.

Background: The CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile during 6-month follow-up.

Methods: The CALM-FIM studies were prospective, nonrandomized, first-in-human studies that enrolled patients with resistant hypertension (office systolic BP ≥160 mm Hg and mean 24-hour ambulatory BP ≥130/80 mm Hg despite a stable regimen of ≥3 antihypertensive medications, including a diuretic agent). The incidence of (serious) adverse events and changes in BP, heart rate, and prescribed antihypertensive medication up to 3 years after implantation were determined.

Results: The Mobius device was implanted in 47 patients (30 in Europe, 17 in the United States; mean age 54 years, 23 women). Five serious adverse events (hypotension, n = 2; hypertension, n = 1; vascular access complications, n = 2) and 2 transient ischemic attacks occurred within 30 days postprocedure. Two strokes and 1 transient ischemic attack occurred more than 2 years postimplantation. Mean office BP at baseline was 181 ± 17/107 ± 16 mm Hg and decreased by 25/12 mm Hg (95% CI: 17-33/8-17 mm Hg) at 6 months and 30/12 mm Hg (95% CI: 21-38/8-17 mm Hg) at 3 years. Mean 24-hour ambulatory BP at baseline was 166 ± 16/98 ± 15 mm Hg and decreased by 20/11 mm Hg (95% CI: 14-25/8-15 mm Hg) at 6 months.

Conclusions: EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated implantation, although data from randomized sham-controlled trials are needed to further evaluate the risk-benefit profile. (Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_EUR], NCT01911897; Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_US], NCT01831895).

Keywords: antihypertension device; baroreceptor modulation; baroreflex; endovascular baroreflex amplification; hypertension.

Conflict of interest statement

Funding Support and Author Disclosures This work was supported by Vascular Dynamics, Inc. The study sponsor was involved in study design, data monitoring, and central storage of the data. Data analysis was performed by an external statistician who was hired by the study sponsor and performed the analysis according to the methods as requested by the authors. The authors determined the analytical methodology and data interpretation and prepared the manuscript. The sponsor had no role in data interpretation or manuscript preparation. The authors had final responsibility for the decision to submit the paper for publication. Dr van Kleef is paid through a research grant from Vascular Dynamics. Dr Devireddy is a consultant for Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical. Dr Van der Heyden is a paid proctor for Vascular Dynamics. Dr Bates is a consultant for CeloNova BioSciences, Vascular Dynamics, and W.L. Gore. Dr Bakris is a consultant for Merck, Janssen, Bayer, and Vascular Dynamics; and has received grant or clinical trials research support from Janssen, Bayer, Vascular Dynamics, Vifor, Novo Nordisk, Ionis, and Alnylam. Dr Stone has received speaker or other honoraria from Terumo and Cook; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Reva, Matrizyme, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity or options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, the MedFocus family of funds. Dr Williams is a consultant for Vascular Dynamics. Dr Spiering is a consultant for Vascular Dynamics; and has received a research grant from Vascular Dynamics.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.