In the prospective, first-in-human study, published in JACC: Cardiovascular Interventions, Dr. Wilko Spiering of the Utrecht University, the Netherlands, and colleagues examined the long-term safety and efficacy of EVBA using the minimally invasive MobiusHD in 47 European and U.S. patients with resistant hypertension.
The self-expandable nitinol device modifies the shape of "the carotid sinus and stretches the arterial wall without impairing its pulsatility," the authors explain.
Patients in the U.S. and European CALM-FIM studies, lumped together for the current analysis, were between 18 and 80 years of age and had resistant hypertension characterized by an average office systolic blood pressure of at least 160 mmHg and an average 24-hour ambulatory blood pressure of at least 130/80 mmHg on a stable treatment regimen of three or more antihypertensive agents for 30 days or more.
Dr. Spiering and colleagues examined the incidence of serious adverse events (SAEs) and changes in blood pressure, heart rate, and prescribed antihypertensive medication at three years following implantation.
There were five SAEs within 30 days after the procedure, including hypotension (two cases), hypertension (one case), vascular-access complications (two cases), as well as two transient ischemic attacks (TIAs). Two strokes and one TIA occurred over two years following implantation.
At baseline, the average office blood pressure reading was 181/107 mmHg, but this had decreased by 25/12 mmHg at the six-month follow-up and 30/12 mmHg at the three-year follow-up. The average baseline 24-hour ambulatory blood pressure was 166/98 mmHg, but dropped by 20/11 mmHg at 6 months. The heart rate did not significantly change over three years.
"The fact that a minimally invasive procedure can reduce blood pressure substantially and persistently for 3 years is quite relevant, provided we can replicate these findings in a randomized study with a control group on optimal medical treatment," Dr. Oscar Cingolani, director of the hypertension program at Johns Hopkins Medicine, in Baltimore, Maryland, told Reuters Health by email.
Dr. Cingolani, who wasn't involved in the study, said hypertension control remains largely suboptimal, and roughly half of the hypertensive population is at risk of developing a cardiovascular event due to inadequate management. Further research is needed, he added, regarding whether the studied treatment approach could ultimately improve blood pressure and consequently reduce the risk of cardiac events in these patients.
"The next clinical trial should include a placebo group, rule out secondary causes of hypertension, and explore the effects of the EVBA on a broader population, including elderly versus young, Caucasians versus African Americans, women versus men, and obese versus lean," added Dr. Cingolani.
Dr. Mohammad H. Eslami, professor of surgery at the University of Pittsburgh School of Medicine, told Reuters Health by email that the MobiusHD device looked promising.
"Since resistant hypertension is part of constellation of cardiovascular disease, however, this device may not be advisable to patients who may have even minor carotid stenotic lesion since there is a risk of stroke during device implantation that increases by aortic arch and carotid artery calcification," he said.
"At best, this (device) should be considered experimental until further information becomes available," added Dr. Eslami. "The study is very small and although outcomes were positive, it requires much more deliberation and further studies to confirm benefit."
The study was funded by Vascular Dynamics, which makes the device. Several authors report financial ties to the company.
Dr. Spiering was not available for comment.
SOURCE: https://bit.ly/3JlOoRV JACC: Cardiovascular Interventions, online February 14, 2022.
By Brandon May
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