Featured Research

from universities, journals, and other organizations

Renal denervation patient registry finds low rate of adverse events

Date:
March 31, 2014
Source:
American College of Cardiology
Summary:
Patients with uncontrolled high blood pressure treated with renal denervation had low rates of adverse events and significant lowering of blood pressure at six months, according to a registry-based study.

Patients with uncontrolled high blood pressure treated with renal denervation had low rates of adverse events and significant lowering of blood pressure at six months, according to a registry-based study presented at the American College of Cardiology's 63rd Annual Scientific Session.

The Global SYMPLICITY Registry is the first and largest dataset of patients with uncontrolled hypertension treated with renal denervation. The open-label, multicenter study was established to examine the safety and effectiveness of the procedure. Outcomes presented were for the first 1,000 consecutively enrolled patients at six months. There were five adverse events attributed to the procedure, including four vascular access site complications (0.34 percent) and one renal artery dissection that was treated. There were also nine hospitalizations for hypertensive emergency (1.0 percent), eight for atrial fibrillation (0.9 percent), eight strokes (0.9 percent), six hospitalizations for new onset heart failure (0.7 percent), five heart attacks (0.6 percent), four deaths (0.4 percent) and two cases of new onset end stage kidney disease (0.2 percent) that were considered unrelated to the procedure.

In addition, office systolic blood pressure showed a significant drop at six months of 11.9 mmHg for all patients and of 19.8 mmHg for patients with baseline office pressures greater than or equal to 160. Ambulatory systolic blood pressure -- measured by a portable machine that patients wore for 24 hours -- dropped significantly for all patients at six months, with a drop of 7.9 mmHg for all patients with blood pressure readings of 140 or higher -- and the largest reductions, 9.2 mmHg, for the subset of patients with ambulatory systolic blood pressure of 160 or higher.

"This study shows that renal denervation may be an alternative treatment for uncontrolled hypertension," said Michael Böhm, M.D., Ph.D., University of Saarland in Homburg, Germany, and lead investigator of the study. "Our study provides a significant contribution to the discussion about renal denervation when considering the procedure for high risk patients who are suffering from uncontrolled hypertension and have exhausted all other options."

Hypertension increases the risk for heart attack and stroke for more than 77 million Americans and up to one billion adults worldwide. During the Symplicity renal denervation procedure, a catheter is threaded through arteries to deliver radiofrequency energy that inactivates kidney nerves, interrupting electrical signals to and from the kidney, an organ that performs a major role in regulating blood pressure. Although renal denervation is in clinical use for uncontrolled hypertension in more than 80 countries, it is still an experimental approach in the United States.

Enrollment in the registry began in February 2012 and includes patients from 111 international sites. The registry is currently following 2,000 patients with an enrollment goal of 5,000.

Of the 1,000 patients included in this analysis, 60 percent were male and the average age was 61; 49 percent had cardiac disease, 41 percent diabetes, 30 percent chronic kidney disease and 17 percent sleep apnea. At baseline, patients were taking an average of 4.4 blood pressure medications and had an office blood pressure of 164/89. The study collected information on patients' procedures, office and ambulatory blood pressure readings, kidney function, vascular complications and other safety events.

In January 2014, Medtronic announced that it was halting its U.S. pivotal trial on renal denervation because the study had failed to reach its primary efficacy endpoint, though it did meet its primary safety endpoint. Results from this trial will also be presented at ACC.14.

Limitations of the Global Registry study include its open label design and lack of comparison group. Böhm recommends additional research to demonstrate the efficacy of renal denervation and to identify the patient populations who might benefit most from the procedure.


Story Source:

The above story is based on materials provided by American College of Cardiology. Note: Materials may be edited for content and length.


Cite This Page:

American College of Cardiology. "Renal denervation patient registry finds low rate of adverse events." ScienceDaily. ScienceDaily, 31 March 2014. <www.sciencedaily.com/releases/2014/03/140331114440.htm>.
American College of Cardiology. (2014, March 31). Renal denervation patient registry finds low rate of adverse events. ScienceDaily. Retrieved August 23, 2014 from www.sciencedaily.com/releases/2014/03/140331114440.htm
American College of Cardiology. "Renal denervation patient registry finds low rate of adverse events." ScienceDaily. www.sciencedaily.com/releases/2014/03/140331114440.htm (accessed August 23, 2014).

Share This




More Health & Medicine News

Saturday, August 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Drug Used To Treat 'Ebola's Cousin' Shows Promise

Drug Used To Treat 'Ebola's Cousin' Shows Promise

Newsy (Aug. 21, 2014) — An experimental drug used to treat Marburg virus in rhesus monkeys could give new insight into a similar treatment for Ebola. Video provided by Newsy
Powered by NewsLook.com
Two US Ebola Patients Leave Hospital Free of the Disease

Two US Ebola Patients Leave Hospital Free of the Disease

AFP (Aug. 21, 2014) — Two American missionaries who were sickened with Ebola while working in Liberia and were treated with an experimental drug are doing better and have left the hospital, doctors say on August 21, 2014. Duration: 01:05 Video provided by AFP
Powered by NewsLook.com
Cadavers, a Teen, and a Medical School Dream

Cadavers, a Teen, and a Medical School Dream

AP (Aug. 21, 2014) — Contains graphic content. He's only 17. But Johntrell Bowles has wanted to be a doctor from a young age, despite the odds against him. He was recently the youngest participant in a cadaver program at the Indiana University NW medical school. (Aug. 21) Video provided by AP
Powered by NewsLook.com
American Ebola Patients Released: What Cured Them?

American Ebola Patients Released: What Cured Them?

Newsy (Aug. 21, 2014) — It's unclear whether the American Ebola patients' recoveries can be attributed to an experimental drug or early detection and good medical care. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins