Navigation Links
New AHRQ Study Finds Mixed Evidence on Use of Radiofrequency Catheter Ablation for Treating Atrial Fibrillation
Date:7/6/2009

ROCKVILLE, Md., July 6 /PRNewswire-USNewswire/ -- A procedure that sends targeted energy into the heart through a catheter can be used to treat a common type of irregular heartbeat, but little is known about the treatment's long-term benefits and the best methods and circumstances for applying it, according to a new report funded by HHS' Agency for Healthcare Research and Quality.

The report examines the use of a procedure called radiofrequency catheter ablation to treat a type of irregular heartbeat known as atrial fibrillation. The new comparative effectiveness report found that the procedure has been shown to provide benefits in maintaining normal heart rhythm over short periods of time (up to 1 year) but found little evidence indicating whether the procedure reduces the chance that patients will experience atrial fibrillation over the long term.

The report, which compared radiofrequency catheter ablation to medication-based therapy, also found that the effect of the procedure on stroke, a major risk for patients with atrial fibrillation, is unknown. Radiofrequency catheter ablation - a procedure in which a long, thin, flexible tube is put through a blood vessel into the heart - often is used when medications do not work. In this procedure, energy pulses are delivered through the catheter to the heart, destroying small areas of heart tissue where abnormal electrical signals may cause an arrhythmia to start.

Different techniques and instruments can be used for the procedure. While there is no strong evidence to suggest that one particular technique is best for any given patient, there is general consensus concerning a basic approach to ablation procedures for atrial fibrillation. In addition, there is little evidence indicating the procedure's effectiveness when used as a first-line therapy instead of medication.

"Radiofrequency holds promise for treating atrial fibrillation, but it is clear that more research is needed to demonstrate its potential long-term benefits," said AHRQ Director Carolyn M. Clancy, M.D. "This report crystallizes the questions that researchers need to ask going forward."

Atrial fibrillation, the most common type of irregular heartbeat in adults, affects more than 2.2 million Americans, putting them at risk for heart failure, blood clots, or stroke. Patients with atria fibrillation are typically treated with medication first, but medicines only work for about half of patients for preventing recurrence of atrial fibrillation.

The report calls for more research on the effect of radiofrequency catheter ablation on quality of life. In particular, more research is needed for groups of patients for whom the research is especially lacking, such as women, the elderly, and patients who have other conditions such as heart failure or high blood pressure.

Earlier this year, HHS' Food and Drug Administration approved the first two ablation catheters indicated for use in treating atrial fibrillation, in the United States. However, physicians often use other catheters that have not been approved by the FDA for atrial fibrillation. The FDA also found that there is no conclusive evidence that people whose symptoms are reduced with ablation are less likely to have a stroke. Therefore, the FDA explicitly endorsed existing clinical guidelines that recommend that patients at risk for stroke continue to take preventive blood-thinning medications after radiofrequency catheter ablation.

As a condition of catheter approvals, the FDA mandated that the catheters' manufacturer must conduct two post approval studies (PAS) to collect long term safety data. The mandated studies apply only to FDA-approved catheters, and not to devices used off-label in clinical practice. The first PAS is a post approval registry, which will collect safety (adverse event) data and operator experience information through 7 days post-treatment with the approved ablation catheters. The study will also collect data on long term safety (adverse events) data, such as death, stroke, myocardial infarction, clinically manifested pulmonary vein stenosis, etc., at 5 years post-treatment. The second PAS is a subgroup analysis from an ongoing larger study that will look at the incidence of stroke, and compare the 3-year incidence of stroke between patients treated with the approved ablation catheters versus patients treated with medication. This study will analyze total mortality, serious bleeding and cardiac arrest.

Also, last week, the FDA approved a new medication, dronedarone, for treatment of atrial fibrillation. For more information go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170276.htm.

AHRQ's new report, Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation, is the newest analysis from the Agency's Effective Health Care program. That program, authorized by the Medicare Prescription Drug, Improvement, and Modernization Act, represents an important federal effort to compare alternative treatments for health conditions and make the findings public. The program is intended to help patients, doctors, nurses, and others choose the most effective treatments. Information, including the new report, can be found at http://www.effectivehealthcare.ahrq.gov.

Editor's Note: Use Twitter to get AHRQ news updates: www.twitter.com/ahrqnews.


'/>"/>
SOURCE Agency for Healthcare Research & Quality
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
6. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
7. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
8. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
9. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
10. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
11. Sarasotas Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... , Dec. 7, 2016  Northwest Biotherapeutics (Nasdaq: ... "Company"), a biotechnology company developing DCVax® personalized immune ... the Nasdaq Staff has not accepted the Company,s ... Rules previously reported, and the Company has notified ... Company,s common stock from listing on Nasdaq.  Upon ...
(Date:12/7/2016)... --  Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ... the ralinepag phase 2 trial.  Ralinepag is an oral, ... the treatment of pulmonary arterial hypertension (PAH). The study ... "This marks an important step in the development of ... our pipeline," said Amit Munshi , Arena,s President ...
(Date:12/7/2016)... Kan. , Dec. 7, 2016   Rx Savings ... West Virginia and its Public Employees Insurance Agency ... members access to their innovative healthcare software, ultimately saving money ... with PEIA and provide its members with access to our ... or a more effective, affordable therapy can be found," says ...
Breaking Medicine Technology:
(Date:12/8/2016)... ... 08, 2016 , ... Coppin Insurance Agency, an insurance and financial planning firm ... Cape Coral area, is embarking on a charity drive with the goal of providing ... Harry Chapin Food Bank of Southwest Florida works to provide fresh and nutritious food ...
(Date:12/7/2016)... ... December 07, 2016 , ... DrugDev again demonstrated its dedication ... one of the early adopters completing EU-U.S. Privacy Shield Certification from the U.S. Department ... on both sides of the Atlantic with a mechanism to comply with EU data ...
(Date:12/7/2016)... , ... December 07, 2016 , ... ... drug in their bodies, a researcher at the Icahn School of Medicine at ... , The study found that when young children are exposed to secondhand marijuana ...
(Date:12/7/2016)... ... December 07, 2016 , ... EnghouseSystems ... purchase price of approximately $17.4 million (net of the cash acquired), subject ... $13.2 million. Headquartered in Barcelona, Spain, Presence is a leading provider of ...
(Date:12/7/2016)... ... 2016 , ... A quote from Dr. Edward Hallowell, host of CRN International’s ... offer a rare glimpse into the mind of those people with ADHD. , Dr. ... author, has described people with ADHD as having “Ferrari engines for a brain, with ...
Breaking Medicine News(10 mins):