Contribution This systematic review found that radiofrequency ablation after a failed drug course maintained sinus rhythm more often than continuation of drug therapy alone .
The benefits of maintaining sinus rhythm with antiarrhythmic drugs appeared to be offset by the serious adverse effects of the drugs .
Context Is radiofrequency catheter ablation a better alternative than medical therapy for patients with atrial fibrillation ?
The Editors Atrial fibrillation is the most common sustained arrhythmia in clinical practice ( 1 ) .
Its prevalence increases with age , from 0.1 % in people younger than 55 years to more than 9 % by 80 years of age ( 2 ) .
The heavy burden of atrial fibrillation on morbidity , mortality , and health care re sources creates a pressing need for novel approaches to management .
In some patients , adequate pharmacologic slowing of the ventricular response rate ( a rate-control strategy ) is sufficient to control symptoms .
However , many patients remain symptomatic from the lack of organized atrial contraction and the persistent irregularity of the ventricular response in atrial fibrillation .
In such patients , the appropriate treatment is restoration of normal sinus rhythm , achieved electrically or chemically ( a rhythm-control strategy ) ( 2 ) .
Radiofrequency catheter ablation is a promising approach that offers the benefits of maintaining sinus rhythm without the adverse effects of antiarrhythmic drugs .
Catheter ablation for atrial fibrillation is based on the underst and ing that electrical activity emanating from the pulmonary veins frequently serves as a trigger for atrial fibrillation .
In the late 1990s , Hassaguerre and colleagues ( 5 ) observed that elimination of local electrograms at these foci with radiofrequency energy reduced the risk for recurrence of atrial fibrillation .
Currently , the foundation of most atrial fibrillation ablation procedures is to target and electrically isolate the pulmonary veins ( 6 ) .
This may be achieved by delivering lesions immediately outside the ostia of the pulmonary veins or along a wider area in the left atrium encircling the veins .
Additional lesion sets have been used to ablate nonpulmonary vein triggers of atrial fibrillation and to target atrial areas thought to be responsible for maintaining atrial fibrillation ( 6 ) .
These linear lesions may be created in the posterior left atrium , the roof of the left atrium , the interatrial septum , and the isthmus formed between the mitral annulus and the pulmonary vein or left atrial appendage .
At present , the Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation , put forth by the Heart Rhythm Society and endorsed by several professional organizations , states that the foundation of most atrial fibrillation ablation procedures is to target the pulmonary veins , pulmonary vein antra , or both ( 6 ) .
The panel advised us that 8-mmtip and irrigated-tip catheters are now the catheters of choice for radiofrequency ablation of atrial fibrillation in the United States .
The conventional 4-mmtip catheter is rapidly being phased out of use for this indication .
The following 3 key questions were formulated : 1 .
What is the effect of radiofrequency catheter ablation on short-term ( 6 to 12 months ) and long-term ( > 12 months ) rhythm control ; rates of congestive heart failure ; changes in the size of the left atrium and ventricle ; rates of stroke ; quality of life ; avoiding anticoagulation ; and readmissions for paroxysmal , persistent , and long-st and ing persistent ( chronic ) atrial fibrillation ?
2 .
How does the effect of radiofrequency ablation  on rhythm control differ among the various techniques used ?
3 .
What are the short- and long-term complications and harms associated with radiofrequency ablation ?
Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials.
CONTEXT Medical evidence may be biased over time if completion and publication of r and omized efficacy trials are delayed when results are not statistically significant . OBJECTIVE To evaluate whether the time to completion and the time to publication of r and omized phase 2 and phase 3 trials are affected by the statistical significance of results and to describe the natural history of such trials . DESIGN Prospect i ve cohort of r and omized efficacy trials conducted by 2 trialist groups from 1986 to 1996 . SETTING Multicenter trial groups in human immunodeficiency virus infection sponsored by the National Institutes of Health . PATIENTS A total of 109 efficacy trials ( total enrollment , 43708 patients ) . MAIN OUTCOME MEASURES Time from start of enrollment to completion of follow-up and time from completion of follow-up to peer- review ed publication assessed with survival analysis . RESULTS The median time from start of enrollment to publication was 5.5 years and was substantially longer for negative trials than for results favoring an experimental arm ( 6.5 vs 4.3 years , respectively ; P<.001 ; hazard ratio for time to publication for positive vs negative trials , 3.7 ; 95 % confidence interval [ CI ] , 1.8 - 7.7 ) . This difference was mostly attributable to differences in the time from completion to publication ( median , 3.0 vs 1.7 years for negative vs positive trials ; P<.001 ) . On average , trials with significant results favoring any arm completed follow-up slightly earlier than trials with nonsignificant results ( median , 2.3 vs 2.5 years ; P=.045 ) , but long-protracted trials often had low event rates and failed to reach statistical significance , while trials that were terminated early had significant results . Positive trials were su bmi tted for publication significantly more rapidly after completion than were negative trials ( median , 1.0 vs 1.6 years ; P=.001 ) and were published more rapidly after su bmi ssion ( median , 0.8 vs 1.1 years ; P=.04 ) . CONCLUSION Among r and omized efficacy trials , there is a time lag in the publication of negative findings that occurs mostly after the completion of the trial follow-up
Contribution This systematic review found that radiofrequency ablation after a failed drug course maintained sinus rhythm more often than continuation of drug therapy alone .
The benefits of maintaining sinus rhythm with antiarrhythmic drugs appeared to be offset by the serious adverse effects of the drugs .
Context Is radiofrequency catheter ablation a better alternative than medical therapy for patients with atrial fibrillation ?
The Editors Atrial fibrillation is the most common sustained arrhythmia in clinical practice ( 1 ) .
Its prevalence increases with age , from 0.1 % in people younger than 55 years to more than 9 % by 80 years of age ( 2 ) .
The heavy burden of atrial fibrillation on morbidity , mortality , and health care re sources creates a pressing need for novel approaches to management .
In some patients , adequate pharmacologic slowing of the ventricular response rate ( a rate-control strategy ) is sufficient to control symptoms .
However , many patients remain symptomatic from the lack of organized atrial contraction and the persistent irregularity of the ventricular response in atrial fibrillation .
In such patients , the appropriate treatment is restoration of normal sinus rhythm , achieved electrically or chemically ( a rhythm-control strategy ) ( 2 ) .
Radiofrequency catheter ablation is a promising approach that offers the benefits of maintaining sinus rhythm without the adverse effects of antiarrhythmic drugs .
Catheter ablation for atrial fibrillation is based on the underst and ing that electrical activity emanating from the pulmonary veins frequently serves as a trigger for atrial fibrillation .
In the late 1990s , Hassaguerre and colleagues ( 5 ) observed that elimination of local electrograms at these foci with radiofrequency energy reduced the risk for recurrence of atrial fibrillation .
Currently , the foundation of most atrial fibrillation ablation procedures is to target and electrically isolate the pulmonary veins ( 6 ) .
This may be achieved by delivering lesions immediately outside the ostia of the pulmonary veins or along a wider area in the left atrium encircling the veins .
Additional lesion sets have been used to ablate nonpulmonary vein triggers of atrial fibrillation and to target atrial areas thought to be responsible for maintaining atrial fibrillation ( 6 ) .
These linear lesions may be created in the posterior left atrium , the roof of the left atrium , the interatrial septum , and the isthmus formed between the mitral annulus and the pulmonary vein or left atrial appendage .
At present , the Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation , put forth by the Heart Rhythm Society and endorsed by several professional organizations , states that the foundation of most atrial fibrillation ablation procedures is to target the pulmonary veins , pulmonary vein antra , or both ( 6 ) .
The panel advised us that 8-mmtip and irrigated-tip catheters are now the catheters of choice for radiofrequency ablation of atrial fibrillation in the United States .
The conventional 4-mmtip catheter is rapidly being phased out of use for this indication .
The following 3 key questions were formulated : 1 .
What is the effect of radiofrequency catheter ablation on short-term ( 6 to 12 months ) and long-term ( > 12 months ) rhythm control ; rates of congestive heart failure ; changes in the size of the left atrium and ventricle ; rates of stroke ; quality of life ; avoiding anticoagulation ; and readmissions for paroxysmal , persistent , and long-st and ing persistent ( chronic ) atrial fibrillation ?
2 .
How does the effect of radiofrequency ablation  on rhythm control differ among the various techniques used ?
3 .
What are the short- and long-term complications and harms associated with radiofrequency ablation ?