This study assessed the safety and efficacy of a novel implantable device therapy in resistant hypertension patients.
Background
Despite the availability of potent antihypertensive drugs, a substantial proportion of patients remain hypertensive. A new implantable device (Rheos system, CVRx, Inc., Minneapolis, Minnesota) that activates the carotid baroreflex may help these patients.
Methods
Forty-five subjects with systolic blood pressure ≥160 mm Hg or diastolic ≥90 mm Hg despite at least 3 antihypertensive drugs were enrolled in a prospective, nonrandomized feasibility study to assess whether Rheos therapy could safely lower blood pressure. Subjects were followed up for as long as 2 years. An external programmer was used to optimize and individualize efficacy.
Results
Baseline mean blood pressure was 179/105 mm Hg and heart rate was 80 beats/min, with a median of 5 antihypertensive drugs. After 3 months of device therapy, mean blood pressure was reduced by 21/12 mm Hg. This result was sustained in 17 subjects who completed 2 years of follow-up, with a mean reduction of 33/22 mm Hg. The device exhibited a favorable safety profile.
Conclusions
The Rheos device sustainably reduces blood pressure in resistant hypertensive subjects with multiple comorbidities receiving numerous medications. This unique therapy offers a safe individualized treatment option for these high-risk subjects. This novel approach holds promise for patients with resistant hypertension and is currently under evaluation in a prospective, placebo-controlled clinical trial.
Key Words
baroreflex
device
feasibility
hypertension
treatment
Abbreviations and Acronyms
BP
blood pressure
SAE
serious adverse event
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This study was funded by CVRx, Inc., Minneapolis, Minnesota. CVRx was involved in the study design and data collection, but there was no involvement in analysis, interpretation of data, writing of the report, and decision to submit the paper for publication. Drs. Scheffers and de Leeuw have received a research grant from CVRx. Dr. Jordan participated in the DEBuT HT trial which was funded by CVRx. All other authors report that they have no relationships to disclose.