Effect of baroreflex activation therapy on home blood pressure measurements after long-term treatment – a prospective, randomized crossover study

OBJECTIVE: Baroreflex activation therapy (BAT) is a treatment option for resistant hypertension. However, data from randomized trials are scarce, especially regarding long-term efficacy. METHODS: This exploratory, prospective, randomized, two-center study investigated the impact of BAT deactivation and reactivation on office and home blood pressure (BP) in patients with resistant hypertension scheduled for BAT device replacement after multiannual treatment. Patients were randomized 8 weeks before device replacement: group one was deactivated from week -8 to -4 and reactivated from week -4 until surgery, group two remained activated from week -8 to -4 and was deactivated from week -4 until surgery. Patients were not aware of assignment. BP values were monitored during outpatient visits by a blinded physician and by telemetric home measurements. Statistical analysis using paired, two-tailed t -tests was considered significant at a P value less than 0.05. RESULTS: Sixteen patients with BAT for 50 months in median (IQR: 38-77 months) were included in the study. Office BP was significantly lower under active BAT compared to preimplantation values (146 ± 27 vs. 172 ± 21 mmHg systolic, P < 0.01). Home BP with deactivated device was 5 ± 7 mmHg higher than during active BAT ( P < 0.05), office BP after 4 weeks of deactivation was 8 ± 14 mmHg higher ( P = 0.06) than at baseline. Two patients met the predefined termination criteria and were reactivated immediately. In total, nine patients (60%) were classified as BAT responders based on at least 5 mmHg BP increase or early reactivation. CONCLUSION: Deactivation of BAT increased home BP significantly, even after multiannual therapy, supporting a moderate BP-lowering effect of BAT in the long-term.