Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study.
OBJECTIVE
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.
Scheffers
Ingrid J M
IJ
University Hospital Maastricht and Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.
Kroon
Abraham A
AA
Schmidli
Jürg
J
Jordan
Jens
J
Tordoir
Jan J M
JJ
Mohaupt
Markus G
MG
Luft
Friedrich C
FC
Haller
Hermann
H
Menne
Jan
J
Engeli
Stefan
S
Ceral
Jiri
J
Eckert
Siegfried
S
Erglis
Andrejs
A
Narkiewicz
Krzysztof
K
Philipp
Thomas
T
de Leeuw
Peter W
PW
D000328:Adult; D017704:Baroreflex / Q000502:physiology*; D004599:Electric Stimulation Therapy / Q000295:instrumentation* / Q000379:methods; D005060:Europe / Q000453:epidemiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000453:epidemiology / Q000503:physiopathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome