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DOI: 10.1055/s-0041-1725850
Baroreflex Activation Therapy for Resistant Hypertension: Results from Midterm Prospective Ambulatory Blood Pressure Registry
Objectives: First generation baroreflex activation therapy (BAT) devices showed clinical efficacy in patients with drug-resistant arterial hypertension (AHT), but the safety profile was insufficient with up to 20% complications. Data regarding efficacy of second-generation devices were generated mostly from office blood pressure measurements or short-term 24-hour ambulatory blood pressure (ABP) registries. We present a mid-term prospective registry to evaluate the efficacy and safety of recent BAT devices.
Methods: All patients receiving BAT for resistant AHT at our institution between November 2013 and June 2019 were prospectively included into this study. ABPM was performed at baseline, in 3-month intervals in the first year after BAT implantation and in 6-month intervals afterwards for up to 42 months. The primary efficacy end-points were changes in systolic and diastolic blood pressure and number of antihypertensive medications. The primary safety end point was the number of BAT-related complications.
Result: Sixty-four patients (mean age: 63 years, 67% males) were included. Overall, mean systolic ABP decreased over the 3.5-years period from 168 ± 17 mm Hg to 149 ± 19 mm Hg (mean change −18.8 mm Hg; 95% confidence interval [CI]: −29.32 to −8.36; p < 0.0007). Mean diastolic ABP decreased from 97 ± 16 to 85 ± 12 mm Hg (mean change -11.7 mm Hg; 95% CI: −19.2 to −4.2; p < 0.0021). Mean number of antihypertensive drugs was reduced from 6.9 ± 1.3 to 5.2 ± 1.5 (mean change −1.7; 95% CI: −0.8 to −0.27; p < 0.0009). Freedom from overall BAT-related adverse events was 93.5%. Four perioperative complications (one pocket bleeding, one pocket infection, one n. hypoglossus palsy, one hoarseness) resolved without residual deficits. No adverse events associated with BAT were observed after the perioperative period.
Conclusion: Systolic and diastolic ABP and number of antihypertensive drugs decreased significantly during 3.5-year follow-up after BAT implantation in 64 consecutive patients. The safety profile of second generation BAT devices is significantly improved compared with the first generation.
Publication History
Article published online:
19 February 2021
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