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January 26, 2010 — Embargoed ContentJAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases. JAMA NEWS RELEASES
Complete Table of Contents JAMA REPORT (VIDEO SCRIPT)
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED. JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ON-LINE. Go to www.jamamedia.org for more information and to apply for access. TV Note: This week's JAMA Report video is on a comparison of outcomes between using a specialized catheter or drug therapy to treat a type of atrial fibrillation. The report will be fed Tuesday, January 26, from 9:00 - 9:15 a.m. ET and 2:00 - 2:15 p.m. ET, on Galaxy 28 (C-Band), Transponder 15, downlink frequency: 4000 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA. The JAMA Report video is also now available on Pathfire every Tuesday, in VNF Provider A. Please look for the JAMA Report tab. Please Note: The FOR THE MEDIA website now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org EMBARGOED FOR RELEASE UNTIL 3:00 P.M. (CT), Tuesday, January 26, 2010
Atrial Fibrillation Treatment Using Specialized Catheter Results In Better Outcomes Compared to Drug Therapy
CHICAGO—Use of catheter ablation, in which radiofrequency energy is emitted from a catheter to eliminate the source of an irregular heartbeat, resulted in significantly better outcomes in patients with paroxysmal atrial fibrillation (intermittent cardiac rhythm disturbance) who had not responded previously to antiarrhythmic drug therapy, according to a study in the January 27 issue of JAMA. Atrial fibrillation (AF) represents an important public health problem, with patients having an increased long-term risk of stroke, heart failure and all-cause death. Although antiarrhythmic drugs are generally used as first-line therapy to treat patients with AF, they are associated with cumulative adverse effects over time and their effectiveness remains inconsistent, according to background information in the article. Catheter ablation has become an alternative therapy for AF. David J. Wilber, M.D., of Loyola University Medical Center, Maywood, Ill., and colleagues conducted a study to compare catheter ablation with antiarrhythmic drug therapy (ADT) in patients with symptomatic paroxysmal AF who previously did not respond to at least one antiarrhythmic drug. The randomized study was conducted at 19 hospitals and included 167 patients who had experienced at least three AF episodes within six months before randomization. Enrollment occurred between Oct. 2004 and Oct. 2007, with the last follow-up on January 19, 2009. Patients were randomized to catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in a 9-month follow-up period. The primary outcome the researchers focused on was time to protocol-defined failure, which included documented symptomatic paroxysmal AF during the evaluation period. The researchers found that at the end of the 9-month effectiveness evaluation period, 66 percent of patients in the catheter ablation group remained free from protocol-defined treatment failure vs. 16 percent of patients treated with ADT. "Similarly, 70 percent of patients treated by catheter ablation remained free of symptomatic recurrent atrial arrhythmia vs. 19 percent of patients treated with ADT. In addition, 63 percent of patients treated by catheter ablation were free of any recurrent atrial arrhythmia vs. 17 percent of patients treated with ADT," they write. Patients in the catheter ablation group also reported significantly better average symptom frequency and severity scores at three months on measures of quality of life. Major 30-day treatment-related adverse events occurred in 5 of 57 patients (8.8 percent) treated with ADT and 5 of 103 patients (4.9 percent) treated with catheter ablation.
"Our multicenter randomized trial demonstrates the superiority of catheter ablation over ADT in the treatment of patients with paroxysmal AF who did not respond to 1 or more drugs. Catheter ablation provided significantly better rhythm control and improved quality of life with a favorable safety profile. These findings argue for early use of catheter ablation therapy in patients with paroxysmal AF unresponsive to initial attempts with pharmacologic control," the authors conclude.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3:00 P.M. (CT), Tuesday, January 26, 2010
Intensive Insulin Therapy for Patients Treated for Septic Shock With Hydrocortisone Does Not Show Survival Benefit
CHICAGO—Treating adults with septic shock with intensive insulin therapy to counter elevated blood glucose levels associated with corticosteroid therapy did not result in a reduced risk of in-hospital death, compared to patients who received conventional insulin therapy, according to a study in the January 27 issue of JAMA. The researchers also found that adding a 2nd corticosteroid to treatment did not significantly reduce the risk of death within the hospital. Septic shock is a major complication of infectious diseases, with a mortality rate of 60 percent within a short period, according to background information in the article. Corticosteroids are used in the treatment of septic shock and may provide a survival benefit, but their use is associated with hyperglycemia. Djillali Annane, M.D., of the Hôpital Raymond Poincaré, Garches, France, and colleagues with the Corticosteroids and Intensive Insulin Therapy for Septic Shock (COIITSS) trial examined whether normalization of blood glucose levels with intensive insulin treatment would improve outcomes for adults with septic shock treated with hydrocortisone. Also, the researchers analyzed the benefit of adding the corticosteroid fludrocortisone to hydrocortisone therapy. The randomized trial, which included 509 adults with septic shock who had received hydrocortisone treatment, was conducted from Jan. 2006 to Jan. 2009 in 11 intensive care units in France. Patients were randomly assigned to 1 of 4 groups: continuous intravenous insulin infusion with hydrocortisone alone; continuous intravenous insulin infusion with hydrocortisone plus fludrocortisone; conventional insulin therapy with hydrocortisone alone; or conventional insulin therapy with intravenous hydrocortisone plus fludrocortisone. Hydrocortisone was administered every 6 hours, and fludrocortisone was administered once a day for 7 days. The researchers found that at hospital discharge, 117 of 255 patients (45.9 percent) treated with intensive insulin therapy died and 109 of 254 patients (42.9 percent) treated with conventional insulin therapy died. No significant difference existed between treatment groups for any of the secondary outcome measures, such as the median (midpoint) number of days that surviving patients spent in the ICU in the intensive insulin group (10) vs. for those in the conventional insulin group (9); the median length of stay in the hospital for the intensive insulin group (24 days) vs. those in the conventional insulin group (22 days); the median vasopressor-free (drug or other agent that is used to help raise blood pressure) days for each group was four; and the median mechanical ventilation-free days was 10 for the experimental group vs. 13 days for the control group. Patients treated with intensive insulin experienced significantly more episodes of severe hypoglycemia than those in the conventional treatment group. Regarding the outcomes of adding fludrocortisone to therapy, at hospital discharge, 42.9 percent of the patients in the fludrocortisone-treated group died and 45.8 percent of patients in the conventional insulin therapy group died. "No significant difference in overall mortality existed between the fludrocortisone-treated patients and the controls," the authors write. "Nor did significant differences exist between the two groups for the survivors' ICU and hospital lengths of stay, for the number of vasopressor-free days, and for mechanical ventilation-free days."
"The current study showed no evidence to support a strategy of intensive insulin therapy aimed at maintaining blood glucose levels in the range of 80 to 110 mg/dL for treating septic shock with corticosteroids," they write. "The current data do not support the routine use of oral fludrocortisone in addition to hydrocortisone when physicians decide to introduce corticosteroids in the management of a patient with septic shock."
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. Editorial: Should Glucocorticoid-Induced Hyperglycemia Be Treated in Patients with Septic Shock?
Greet Van den Berghe, M.D., Ph.D., of Catholic University of Leuven, Belgium, writes in an accompanying editorial that larger trials regarding the treatment of septic shock are needed.
"...syndromes such as septic shock continue to portend a grave threat to life, the provision of ICU care for these patients is exceedingly costly, and a lack of adequately robust evidence on how best to provide that care is a glaring deficiency. Rather than tolerate a climate of clinical uncertainty, it seems imperative for funding agencies and researchers invested in care of critically ill patients to conduct adequately powered trials, even if these trials might be far larger than those of the past. To ensure that such studies can be completed in a timely fashion, the cooperation of national and international trials groups, and their funding sources, will likely be necessary. Precedents for large-scale international cooperation exist in oncology and cardiology. Given the huge global burden of conditions such as septic shock, which causes hundreds of thousands of deaths in the United States alone each year, such international collaboration should and must be achievable."
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
JAMA REPORTS
VIDEO: Windows Media | Quicktime
HEATED CATHETER PROCEDURE COMPARED TO DRUGS FOR COMMON HEART RHYTHM PROBLEM
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