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| |  Implantable Device Improves Functional Capacity in Patients With Resistant Hypertension and Symptomatic Heart Failure: Presented at HFSA By Jenny Reising BOSTON -- September 17, 2009 -- Patients with resistant hypertension and symptomatic heart failure who were treated with the Baroreflex Activation Therapy (BAT) implantable device experienced improved functional capacity and cardiac structure, according to study data reported at the 13th Annual Scientific Meeting of the Heart Failure Society of America (HFSA). “A previous study showed that BAT was successful in improving functional capacity and cardiac structure, while reducing blood pressure in early-stage heart failure patients,” said coauthor Eric G. Lovett, PhD, senior research scientist, CVRx, Inc., Minneapolis, Minnesota, speaking at a poster presentation here on September 14. “This cohort study is part of a the European and United States Trials of the Rheos System and was designed to analyse [whether] more advanced heart patients, who had a New York Heart Association [NYHA] Class of 1 or more, could benefit from this treatment.” Patients with resistant hypertension and symptomatic heart failure with preserved ejection fraction are at a high risk to have left ventricular hypertrophy. These adverse cardiovascular changes may contribute to reduced functional capacity. Researchers implanted BAT in 21 patients who had stage II hypertension (systolic blood pressure [BP] >=160 mm Hg), NYHA Class >1, normal ejection fraction (EF) = 65 +- 5, and were taking at least 3 antihypertension drugs, including at least 1 diuretic. The device was activated a month after implantation. Patients were followed after 3 and 12 months of therapy. Patients underwent a 6-minute hall walk and were administered a short-form (SF)-12 quality-of-life questionnaire to assess functional health. Echocardiac data was collected in a subset of these patients. After 12 months of BAT, study results found that cardiac structure had improved, blood pressure was reduced, and the 6-minute hall walk also improved. There was also a trend for improved SF-12 total score (P = .06). Researchers concluded that BAT improves functional capacity and reverses left-ventricular remodelling, in addition to reducing blood pressure. “The study shows that having more advanced heart failure doesn’t impair the effectiveness of the device,” said Dr. Lovett.
“It also supports evidence for the legitimacy of a larger trial,” he added. “We now have a feasibility study underway in Europe, and are beginning one in the United States to further investigate these outcomes.” [Presentation title: Improved Functional Capacity and Cardiovascular Structure after Baroreflex Activation Therapy in Resistant Hypertension Patients With Symptomatic Heart Failure: Results From European and United States Trials of the Rheos System. Abstract 204]
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