Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension

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Abstract

Objective:

Unlike safety data of baroreflex activation therapy device (Rheos), only few data of the currently used second device (Barostim neo) are available and little is reported about common side effects.

Methods:

We prospectively analyzed patients with resistant hypertension treated with Barostim neo. A standardized interview regarding side effects of the therapy was performed in routine follow-up visits after device implantation in 42 patients to determine adverse events staged into three degrees.

Results:

Within 6 months of baroreflex activation therapy, the office mean arterial blood pressure decreased from 169 ± 27 to 148 ± 29 mmHg systolic (P < 0.001), respectively, to 145 ± 24 mmHg after 1 year (P < 0.001), whereas the number of prescribed antihypertensive classes decreased from 6.6 ± 1.5 to 5.6 ± 1.8 (P < 0.001). Adverse events were combination of the following field depending on the severity (I° mild: local discomfort, clinical observation only, no intervention indicated; II° moderate: medically significant such as occurrence of hypertensive crisis, syncope, arrhythmias; III° severe: life-threatening events or urgent medical intervention indicated). Adverse events I° were present in almost all patients (97.6%), and occurred mainly within first 6 months after device activation. Device-related events were most frequently and could be resolved by optimization of device parameters. Most procedure-related adverse events were directly related to the incision or anesthetic procedure. Adverse events II° occurred in 28.6% patients treated with Barostim neo, whereas patients’ elevated individual risks might be potential triggers. Because of individual diversity of blood pressure response and the occurrence of adverse events, no standardization of parameters of implantable pulse generator could be found. By adapting the pulse generator settings individually, most of adverse events I° resolved without sequel.

Conclusion:

Though there are common side effects, Barostim neo significantly lowers blood pressure in resistant hypertension and provides an adequate safety profile. Regular patient visits are necessary to register side effects.

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