Implanting a baroreceptor stimulation device for resistant hypertension

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

The following outcomes were reported in patients treated by implantation of a bilateral baroreceptor stimulation device:

5.1 Nerve injury with residual deficit was reported in 5% (13/265) of patients and transient nerve injury was reported in 5% (12/265) of patients in a randomised controlled trial of 265 patients (no further details given). Tongue paresis, most likely caused by intraoperative injury to the hypoglossal nerve, was reported in 1 patient in a case series of 45 patients.

5.2 Hypertension-related stroke was reported in 2% (6/265) of patients in the randomised controlled trial of 265 patients (timing and study group not reported). Perioperative stroke with minimal residual effects was reported in 1 patient in the case series of 45 patients.

5.3 Hypertensive crisis was reported in 5% (9/181) of patients treated by immediate baroreceptor stimulation and 8% (7/84) of patients treated by deferred stimulation in the randomised controlled trial of 265 patients.

5.4 Device removal before activation because of infection was reported in 7% (3/42) of patients in the case series of 45 patients. In 1 patient, the leads were left in and a new device was implanted 12 months later. Infection needing device removal was reported in 1 patient in a case series of 10 patients; the infection occurred after the 4‑month follow-up visit.

5.5 Respiratory complications (not otherwise described) after device implantation were reported in 3% (7/265) of patients in the randomised controlled trial of 265 patients.

5.6 Wound complications (not otherwise described) after device implantation were reported in 3% (7/265) of patients in the randomised controlled trial of 265 patients.

5.7 Movement of the implantable pulse generator, needing further surgery to reposition it, was reported in 1 patient in the case series of 45 patients.

The following outcomes were reported in patients treated by implantation of a unilateral baroreceptor stimulation device:

5.8 Intermittent pain lateral to the device system was reported within 30 days of device implantation in 1 patient in the case series of 30 patients; the patient recovered with no residual effects.

5.9 Device pocket haematoma 3 days after device implantation was reported in 1 patient in a case series of 30 patients; the patient recovered with no residual effects.

5.10 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers considered that the following were theoretical adverse events: traumatic injury to the carotid artery or major neck veins; bleeding; cerebral embolisation causing stroke; wound dehiscence; late damage to the carotid artery; bradycardia; bradypnoea; excessive lowering of blood pressure; orthostatic hypotension; and device failure.