Novel endovascular baroreflex-amplifying implant lowers BP in therapy-resistant hypertension
Endovascular baroreflex amplification for resistant hypertension: a safety and proof-of-principle clinical studyLiterature - Spiering W, Williams B, Van der Heyden J, et al., CALM-FIM_EUR investigators - Lancet. 2017 Sep 1. doi: 10.1016/S0140-6736(17)32337-1
- Implantation of MobiusHD was successful in all patients, in the right internal carotid artery in 19 and in the left in 11 patients.
- Five serious adjudicated adverse events that were deemed to be possibly related to the procedure of device, occurred in four patients, but none were classified as unanticipated device effects (see original article for details and management).
- No device migrations and no significant changes in plaque formations in the carotid arteries were observed. The most frequently reported adverse event was dizziness (n=9 out of a total of 42 events), musculoskeletal pain (n=7) and hypotension (n=5).
- During the first 24 hours after implantation, a mean reduction of office BP of 38/23 mmHg (95%CI: 29-46/16-29) was seen.
- Mean reductions in office BP from baseline during follow-up were 27/14 mmHg (18-37/8-21) at 1 week, 22/10 mmHg (12-31/3-16) at 1 month, 24/11 mmHg (12-35/4-18) at 3 months, and 24/12 mmHg (13-34/6-18) at 6 months.
- Reductions in 24h mean ambulatory BPs were 15/8 mmHg (7–23/3–13) at 3 months and 21/12 mmHg (14–29/7–16) at 6 months (all p<0·002 in the overall ANOVA, and reaching p<0·0001 for SBP and DBP at 6 months).
- 22 (73%) patients met predefined criteria for clinically important BP-lowering response.
- The median number of antihypertensive medications was 0.50 lower (IQR: 1.25 – 0, P=0.0020) at 6 months and the daily defined doses was lowered by 0.42 units (2.13 to 0.09, P=0.10).
This first-in-man study of a novel endovascular baroreflex amplification device resulted in clinically important reductions in office and 24hrs ambulatory BP with acceptable safety, in patients with resistant hypertension. Most patients needed fewer medications after 6 months of follow-up.
This study has limitations inherent to a small, non-blinded set up, thus the safety profile and efficacy of the Mobius HD needs to be studied further in larger studies with longer follow-up.