Renal Denervation Promotes Sustained Blood Pressure Reduction

An innovative bipolar energy system used for renal denervation shows a significant and sustained reduction in blood pressure.

Researchers at CardioVascular Center Frankfurt (CVC; Germany), Sankt Katharinen Hospital (Frankfurt, Germany), and 22 other centers in Europe, Australia, and New Zealand participating in the REDUCE-HTN study enrolled 146 patients to evaluating the ability of the Vessix System to reduce blood pressure at six months, compared to the pretreatment baseline blood pressure. Patients enrolled in the program were required to have a systolic blood pressure of at least 160 mmHg, despite taking three or more antihypertensive medications.

The results of an interim analysis of 139 patients showed a significant 24.6 mmHg reduction in systolic blood pressure at six months, and a sustained 29.6 mmHg reduction in systolic blood pressure in a subset of patients for whom 12-month data are available; a clinically-meaningful decrease in office systolic blood pressure at both six and 12 months in 85% of patients in the trial; and successful reduction of blood pressure in a variety of subgroups, including both men and women, patients with Type-2 diabetes, and patients age of 65 or older. The researchers reported eight procedure-related serious adverse events (5.5%).

The Vessix System, a product of Boston Scientific (Natick, MA, USA) features an intuitive push-button interface, a short 30-second treatment time and an over-the-wire, balloon-based approach familiar to cardiac and vascular specialists. The system has both European Community CE mark of approval and TGA approval, but in the United States it is an investigational device and not available for sale. The study was presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual conference, held during October 2013 in San Francisco (CA, USA).

“85% of patients treated with the Vessix System experienced a clinically-meaningful decrease in blood pressure,” said lead author and study presenter Prof. Horst Sievert, MD, PhD, of CVC, principal investigator in the REDUCE-HTN clinical program. “In my opinion, the large patient cohort and rigorous analysis of the study suggest that renal denervation using bipolar technology will be an important part of the treatment algorithm for a wide variety of patients with resistant hypertension.”

“Despite the broad availability of antihypertensive medications, high blood pressure, which puts millions of people at increased risk for major cardiovascular events including heart attack and stroke, remains a silent killer,” said Jeff Mirviss, president of peripheral interventions at Boston Scientific. "REDUCE-HTN provides the most robust dataset on multielectrode renal denervation to date and adds to the growing body of clinical evidence supporting the use of bipolar energy delivery in treating patients with resistant hypertension.”

Related Links:
CardioVascular Center
Sankt Katharinen Hospital