Left atrial IRAAF is associated with a small but definite risk of esophageal perforation. Unfortunately, we were unable to identify any risk factors for this life-threatening complication. A high degree of vigilance must be maintained for esophageal injury after IRAAF, particularly in patients with new neurologic deficits. Until safer methods of ablation are developed, we currently recommend against the use of IRAAF in patients undergoing cardiac surgery.

Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, 'upstream therapy') only prevent a part of this burden of disease. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these 'requirements' for outcome assessment in AF trials, further, more detailed outcome parameters are described. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF-related morbidity and mortality is desirable for any clinical trial in AF.

Objective: This report describes the early and midterm results after intraoperative radiofrequency ablation of atrial fibrillation for patients with isolated chronic atrial fibrillation or atrial fibrillation in combination with additional valvular and nonvalvular cardiac diseases.Methods: From August 1998 to March 2001, a total of 234 patients with chronic atrial fibrillation underwent isolated intraoperative radiofrequency ablation alone (n ϭ 74, 31.6%) or in combination with other cardiac procedures, such as mitral valve reconstruction (n ϭ 57, 24.4%), mitral valve replacement (n ϭ 38, 16.2%), aortic valve replacement (n ϭ 11, 5.1%), coronary artery bypass grafting (n ϭ 8, 5.0%), or a combination of the last with other cardiac procedures (n ϭ 46, 19.7%). In all cases anatomic reentrant circuits confined within the left atrium were eliminated by placing contiguous lesion lines involving the mitral anulus and the orifices of the pulmonary veins through the use of radiofrequency energy application (exposure time, 20 seconds). A median sternotomy was used in 101 cases (43.2%), and video assistance through a right lateral minithoracotomy was used in 133 cases (56.8%).Results: A total of 188 patients (83.9%) were discharged in sinus rhythm, 17 patients (7.6%) had atrial fibrillation, and 19 patients (8.5%) had atypical flutter. Pacemakers were implanted in 23 patients (9.8%). There were 10 in-hospital deaths (4.2%), and 30-day mortality was 5 patients (2.1%). In 3 cases (1.3%) an atrioesophageal fistula developed, necessitating surgical repair. Six months' follow-up was complete for 122 (61.0%) of 200 patients, with 99 patients still in stable sinus rhythm (81.1%, 95% confidence interval 73.1%-89.9%). Twelve months' follow-up was complete for 80 (90.9%) of 88 patients, with 58 patients still in sinus rhythm (72.5%, 95% confidence interval 61.3%-83.2%). Conclusions:Intraoperative radiofrequency ablation is a curative procedure for chronic atrial fibrillation. It is technically less challenging than the maze procedure and can be applied through a minimally invasive approach. Protection of the esophagus seems mandatory to avoid the deleterious complication of a left atrioesophageal fistula, such as was observed in 3 cases.

Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, 'upstream therapy') only prevent a part of this burden of disease. New treatment modalities are therefore currently under evaluation in clinical trials. Given the multifold clinical consequences of AF, controlled trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these 'requirements' for outcome assessment in AF trials, further outcome parameters are described in each outcome domain. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF-related morbidity and mortality is desirable for any clinical trial in AF.