Abstract: SA-PO508
Effect of Baroreflex Activation Therapy on Blood Pressure: A Randomized Sham Clinical Pilot Trial on Behalf of the BAT Team
Session Information
- Hypertension and CVD: Clinical - II
November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Hypertension and CVD
- 1602 Hypertension and CVD: Clinical
Authors
- Gordin, Daniel, HUS Helsingin yliopistollisen sairaala, Helsinki, Finland
- Simonsen, Johan Rasmus, HUS Helsingin yliopistollisen sairaala, Helsinki, Uusimaa, Finland
- Vikatmaa, Pirkka, HUS Helsingin yliopistollisen sairaala, Helsinki, Uusimaa, Finland
- Tikkanen, Ilkka T., HUS Helsingin yliopistollisen sairaala, Helsinki, Finland
Group or Team Name
- On Behalf of the BAT Team.
Background
Baroreflex activation therapy (BAT) is a promising treatment option for individuals with resistant hypertension. No randomized sham controlled trials have been done thus far.
Methods
This investigator-initiated randomized, double-blinded sham-controlled pilot trial included five Finnish patients with resistant hypertension. Participants were found eligible if they were 18-70 years old with a daytime systolic ambulatory blood pressure (ABP) of ≥145 mmHg, and/or a diastolic ABP ≥95 mmHg. Patients were on ≥3 antihypertensive drugs including a diuretic. A witnessed drug intake prior to ambulatory blood pressure measurement (ABPM) was implemented. The Barostim Neo System was implanted for modulation of the autonomic nervous system by direct electrical stimulation of the carotid baroreceptors. One month after implantation, all participants were randomized to either 8 months BAT-system on or BAT-system off followed by continuous BAT for all participants (Figure). ABPM was performed per protocol. The primary outcome was defined as a change in systolic ABP after 8 months of BAT, compared to pharmacotherapy.
Results
BAT decreased mean daytime systolic blood pressure by 11.8 mmHg in three participants randomized to BAT, while in the two remaining participants randomized to continuous pharmacotherapy mean systolic daytime blood pressure increased by 8.7 mmHg. When pooling daytime systolic 24-hour ABP, BAT was associated with a 9.2 mmHg lower mean blood pressure (143.5 mmHg [95% CI:142.2-144.9] vs 152.7 mmHg [151.1-154.2], <0.0001). In linear mixed models with the BAT-system’s status as a fixed effect, daytime SBP at baseline and after 8 months of follow-up were compared between individuals on BAT and continuous pharmacotherapy. BAT was associated with a reduction in mean daytime SBP of -11.7 mmHg (P<0.0001).
Conclusion
BAT may lower systolic blood pressure in individuals with resistant hypertension. Large-scale studies are needed to support this assumption.
Funding
- Private Foundation Support