Baroreflex activation therapy safely reduces blood pressure for at least five years in a large resistant hypertension cohort
Section snippets
Background
Baroreflex activation therapy (BAT) has maintained reductions in blood pressure (BP) in a small cohort of resistant hypertension patients for at least 4 years and in a large population for over 2 years. We present the longer-term results in the large cohort to validate sustained BP reductions and better understand long-term safety.
Methods
Patients enrolled in the Rheos Pivotal Trial were seen bi-annually after completing 12 months of follow-up for endpoint collection. BP and safety data were collected.
Results
Of the 322 patients originally enrolled, 254 (79%) were confirmed responders to BAT according to FDA-mandated criteria and 216 remained active at the time of this report. BP was significantly reduced over at least 5 years of follow-up (all p < 0.001). Magnitude of BP reduction was sustained throughout the study period. Long-term impact of the carotid sinus lead appeared benign, as prevalence of significant carotid stenosis remained rare and inconsistent. Following 1 year of therapy, the rate of
Conclusion
BP and HR reductions resulting from BAT endure for at least 5 years, with important implications for improving patient outcomes. Long-term residency of system components was safe, implying a favorable risk/benefit profile.Empty Cell Baseline Δ1 Year Δ2 Years Δ3 Years Δ4 Years Δ5 Years Completed Follow-up (N) 216 209 205 207 182 40 Systolic BP (mmHg) 176.8 ± 21.2 −37.5 ± 1.9§ −34.2 ± 2.1§ −35.3 ± 2.2§ −31.3 ± 2.2§ −32.9 ± 4.5§ Diastolic BP (mmHg) 101.3 ± 14.4 −16.7 ± 1.1§ −16.2 ± 1.2§ −17.4 ± 1.2§ −16.0 ± 1.2§ −17.1 ± 2.6§ >60%
Keywords
baroreceptor; resistance; outcomes; hypertension