Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study |
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| Institution: | 1. Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, the Netherlands;2. Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA;3. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands;4. CAMC Institute of Academic Medicine and West Virginia University, Charleston, West Virginia, USA;5. Department of Medicine, American Society of Hypertension Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, Illinois, USA;6. The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, New York, New York, USA;7. University College London Institute of Cardiovascular Science and National Institute for Health Research UCL Hospitals Biomedical Research Centre, London, United Kingdom |
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| Abstract: | ObjectivesThe aim of this study was to evaluate the long-term (3-year) safety and effectiveness of endovascular baroreflex amplification (EVBA) from both the European and American CALM-FIM cohorts.BackgroundThe CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile during 6-month follow-up.MethodsThe CALM-FIM studies were prospective, nonrandomized, first-in-human studies that enrolled patients with resistant hypertension (office systolic BP ≥160 mm Hg and mean 24-hour ambulatory BP ≥130/80 mm Hg despite a stable regimen of ≥3 antihypertensive medications, including a diuretic agent). The incidence of (serious) adverse events and changes in BP, heart rate, and prescribed antihypertensive medication up to 3 years after implantation were determined.ResultsThe Mobius device was implanted in 47 patients (30 in Europe, 17 in the United States; mean age 54 years, 23 women). Five serious adverse events (hypotension, n = 2; hypertension, n = 1; vascular access complications, n = 2) and 2 transient ischemic attacks occurred within 30 days postprocedure. Two strokes and 1 transient ischemic attack occurred more than 2 years postimplantation. Mean office BP at baseline was 181 ± 17/107 ± 16 mm Hg and decreased by 25/12 mm Hg (95% CI: 17-33/8-17 mm Hg) at 6 months and 30/12 mm Hg (95% CI: 21-38/8-17 mm Hg) at 3 years. Mean 24-hour ambulatory BP at baseline was 166 ± 16/98 ± 15 mm Hg and decreased by 20/11 mm Hg (95% CI: 14-25/8-15 mm Hg) at 6 months.ConclusionsEVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated implantation, although data from randomized sham-controlled trials are needed to further evaluate the risk-benefit profile. (Controlling and Lowering Blood Pressure With the MobiusHD? CALM-FIM_EUR], NCT01911897; Controlling and Lowering Blood Pressure With the MobiusHD? CALM-FIM_US], NCT01831895) |
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| Keywords: | antihypertension device baroreceptor modulation baroreflex endovascular baroreflex amplification hypertension BAT"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"baroreflex activation therapy BP"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"blood pressure DDD"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"daily defined dose EVBA"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"endovascular baroreflex amplification TIA"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"transient ischemic attack |
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