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CALM: Carotid implant lowers BP in patients with stage 2 resistant hypertension
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LAS VEGAS — A novel device implanted in the carotid artery lowered BP safely and effectively in a first-in-human study presented at VIVA 15.
Malcom T. Foster III, MD, FACC, from East Tennessee Heart Consultants, Knoxville, Tennessee, reported 180-day and 1-year results of the CALM study of the first 25 patients with stage 2 resistant hypertension to receive the device (MobiusHD, Vascular Dynamics Inc.).
All patients (mean age, 55 years) had systolic BP ≥ 160 mm Hg at baseline despite receiving at least three antihypertensive medications, one of which is a diuretic (mean number of medications, 4.2).
The MobiusHD device passively amplifies pulsatile strain and reduces BP as it increases carotid sinus baroreceptor activation and sympathoinhibition, Foster said during a press conference.
“The carotid sinus baroreceptor has a powerful impact on the central nervous system via controlled heart rate levels,” he said. “Carotid artery stenting causes decreases in BP that are transient. MobiusHD is a stent-like device placed by a percutaneous technique that is designed to exhibit chronic force and chronic stretch of the baroreceptors to impact hypertension long-term rather than just in the immediate postoperative period.”
This pathway was chosen, he said, because “the carotid artery baroreceptor is one of three major baroreceptors in the body that provides information to the brain, and the brain helps to control BP via sympathetic activation. There was an observation that if you place a stent in a carotid artery, it lowers heart rate and BP in patients, sometimes dramatically, but in a temporary fashion. The science was to develop a stent-like device that might be able to do this long-term.”
The square shape of the MobiusHD device allows it to maintain its pressure points on the baroreceptor, he said. "With every pulsatile wave that comes through, it continues to give stimulation.”
For the first-in-human study, researchers documented serious adverse events, unanticipated adverse device effects and changes in BP.
At baseline, the mean office cuff BP was 181 mm Hg systolic/106 mm Hg diastolic and 24-hour ambulatory BP was 164 mm Hg systolic/96 mm Hg diastolic.
At 180 days, patients had a mean change in office cuff BP of –23 mm Hg systolic/–10 mm Hg diastolic and a mean change in 24-hour ambulatory BP of –14 mm Hg systolic/–8 mm Hg diastolic, Foster said.
“This included patients who had failed renal sympathetic denervation,” he said.
In the nine patients for whom 1-year follow-up was available, office cuff BP was reduced by a mean of –26 mm Hg systolic/–16 mm Hg diastolic, he said.
Heart rate was not affected, he said.
Twelve serious adverse events were identified, but all were adequately managed or resolved, according to Foster.
No strokes have occurred and no evidence of carotid atherosclerosis has been observed, he said. For stroke prevention, the same precautions used in carotid stent procedures are used when implanting the novel device, and patients receive dual antiplatelet therapy for 3 months after the procedure, followed by low-dose aspirin, he noted.
“In preliminary experience, [the device] does appear to be safe … and the early BP data are promising,” he said. ˗ by Erik Swain
Reference:
Foster MT, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.
Disclosure: Cardiology Today’s Intervention could not obtain relevant financial disclosures.
Perspective
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Krishna J. Rocha-Singh, MD, FACC, FAHA, FSCAI, FSVM
The physiology behind this technology is very compelling. I do have concerns that, just like with carotid stenting, complications will be driven by doctors who are inexperienced with the procedure. If, when treating someone with hypertension with a goal of trying to reduce hard endpoints, in the procedure, you have actually caused a transient ischemic attack or a stroke, that becomes a very difficult play. Given the competitive landscape that will likely arrive with other devices, if this is to succeed, it’s going to have to fall into the hands of experts. It may be that doctors who perform this will need to be CREST-certified or CREST-2-certified. That defines a cohort of interventionalists who have the appropriate skill level. As with anything else, patient selection will be crucial.
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