Safety of Second-Generation Baroreflex Activation Therapy System

Objectives: Baroreflex activation therapy (BAT) is an established treatment of drug-resistant arterial hypertension (HT) and, more recently, heart failure (HF) patients. Implantation of first-generation devices was performed after bilateral surgical cut-down of carotid bifurcation and was associated with major adverse events. Second-generation device (Barostim neo) enables unilateral carotid exposure but requires extensive mapping of glomus caroticum to identify the hotspot - place with the best response to BAT. Purpose of this study was to evaluate the influence of surgical and anesthetic technique on the surgery course and periprocedural safety of BAT.

Methods: All Patients receiving Barostim neo at our institution between November 2013 and May 2017 were included to this study (n = 52). Surgical technique focused on exact identification of hotspot and avoiding procedural complications. Anesthetic concept evolved during the study period: first 28 patients received general anesthesia, but due to experiences of pharmacological interference with hotspot mapping the other 24 patients received a combination of a very shallow general anesthesia and ultrasound-guided peripheral cervical plexus blockade. Patients were followed-up every 3 months after implantation. Primary end-point was mortality during follow-up. Secondary end-points were influence of regional anesthesia on hotspot mapping and occurrence of periprocedural complications.

Results: Forty-two patients received BAT for HT and another 10 patients were treated due to HF. Mean surgery duration (77 ± 25 minutes) was similar in both groups (p = 0.6). The use of regional anesthesia facilitated hotspot mapping (p = 0.02) without side-effects. There were 2 BAT-related complications (3.8%): One patient developed periprocedural bleeding under NOAC which required re-exploration of device pocket. Another patient developed pocket infection, which was treated with temporary generator removal and postponed reimplantation without further adverse events. No other BAT-associated adverse events occurred. The mean follow-up duration was 13 ± 6 months. All-cause mortality during follow-up was 5.7% and was significantly higher in the HF group than HT group (20% versus 2.4%, respectively). None of the deaths was related to the BAT.

Conclusion: Second-generation BAT is a safe therapeutic approach in patients with resistant HT and advanced HF. Mid-term mortality is higher in HF patients but is not related to the BAT.