An implantable carotid sinus baroreflex activating system: surgical technique and short-term outcome from a multi-center feasibility trial for the treatment of resistant hypertension.
OBJECTIVE
To assess perioperative outcomes and blood pressure (BP) responses to an implantable carotid sinus baroreflex activating system being investigated for the treatment of resistant hypertension.


METHODS
We report on the first seventeen patients enrolled in a multicenter study. Bilateral perivascular carotid sinus electrodes (CSL) and a pulse generator (IPG) are permanently implanted. Optimal placement of the CSL is determined by intraoperative BP responses to test activations. Acute BP responses were tested postoperatively and during the first four months of follow-up.


RESULTS
Prior to implant, BP was 189.6+/-27.5/110.7+/-15.3 mmHg despite stable therapy (5.2+/-1.8 antihypertensive drugs). The mean procedure time was 202+/-43 minutes. No perioperative strokes or deaths occurred. System tests performed 1 or up to 3 days postoperatively resulted in significant (all p < or = 0.0001) mean maximum reduction, with standard deviations and 95% confidence limits for systolic BP, diastolic BP and heart rate of 28+/-22 (17, 39) mmHg, 16+/-11 (10, 22) mmHg and 8+/-4 (6, 11) BPM, respectively. Repeated testing during 3 months of therapeutic electrical activation demonstrated a durable response.


CONCLUSIONS
These preliminary data suggest an acceptable safety of the procedure with a low rate of adverse events and support further clinical development of baroreflex activation as a new concept to treat resistant hypertension.
Tordoir
J H M
JH
Department of Surgery, University Hospital Maastricht, Maastricht, The Netherlands. j.tordoir@surgery.azm.nl
Scheffers
I
I
Schmidli
J
J
Savolainen
H
H
Liebeskind
U
U
Hansky
B
B
Herold
U
U
Irwin
E
E
Kroon
A A
AA
de Leeuw
P
P
Peters
T K
TK
Kieval
R
R
Cody
R
R
D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001341:Autonomic Nervous System / Q000503:physiopathology*; D017704:Baroreflex; D001794:Blood Pressure; D002346:Carotid Sinus / Q000294:innervation*; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000295:instrumentation; D004567:Electrodes, Implanted; D004867:Equipment Design; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
D000959:Antihypertensive Agents