A comparative study on the efficacy of the Cox-Maze IV procedure versus pulmonary vein ablation for atrial fibrillation in concomitantly cardiac surgery: a multicenter, randomized and controlled clinical trial

Abstract

BACKGROUND: Atrial fibrillation is the most prevalent arrhythmia which has consequences that have an impact on the morbidity and mortality of the elderly people. The worst associated prognosis is the generation of strokes and other thromboembolic events. For the management of this pathology there are several options such as pharmacology therapy, ablation, cardioversion or surgery. The main limitation is the ineffectiveness of these procedures. However, surgery is the one that has seen less recurrence of fibrillation. Thus, a technique called Cox-Maze IV has appeared, which is like an ablation of pulmonary veins but more complex and with more ablative lines, and therefore, with a greater capacity of success. OBJECTIVE: The main objective of this study is to evaluate whether is it more effective the Cox-Maze IV procedure in order to reduce the atrial fibrillation recurrence at 1 year compared with an isolated pulmonary vein ablation in concomitant surgeries with patients who, apart from this arrhythmia, suffer from valve disease or myocardial ischemia. Other secondary objectives are the investigation of the same outcome regardless the type of atrial fibrillation, including paroxysmal, persistent, long-standing persistent and permanent, and assess if the effectiveness could last both in a short time (6 months) and in a long time (5 years). Finally, the last aim is evaluating if exist a reduction of stroke risk associated, along with mortality. METHODS: This protocol is designed as a multicenter, longitudinal, prospective, single blinded, randomized and controlled clinical trial. The study will be carried out in Hospital Universitari Dr. Josep Trueta, Hospital Clínic i Provincial de Barcelona and Hospital General Universitario Gregorio Marañón. Patients will be randomly assigned into 2 groups with a ratio 1:1. Both groups will undergo cardiac surgery with the difference of the intervention for AF: the control group will take an isolated pulmonary vein ablation and, the group experimental will be undergoing a Cox-Maze IV. The recruitment of patients will last 12 months with a subsequent follow-up of 5 years