Srivastava 2008, India 23 Albrecht 2009, Brazil 22 CTSN 2015/2019, USA 13,21
General design Single-center, open-label, enrollment 2000-2005, 5-year follow-up with 3-month intervals; 4 treatment arms including Cox-Maze IV and PVI. Single-center, open-label, enrollment 1999-2004, 5-year follow-up with 6-month intervals; 3 treatment arms including Cox-Maze III and PVI. Multicentric, assessor-blind, enrollment 2010-2013, 12-month follow-up with 3-month intervals; 3 treatment arms including Cox-Maze IV and PVI.
Patients Age 12-60 years, undergoing MV surgery, no active CAD, no antiarrhythmics, LA ≤6 cm. Age 18-79, LVEF >20%, undergoing MV surgery , no previous surgeries. Age ≥18 years, undergoing MV surgery, no previous ablations, no thyroid disease, life expectancy >1 year.
Postoperatively If NSR not achieved: DC or amiodarone. If NSR not achieved: DC or amiodarone; anticoagulation as per indication. AAD first 3 months after surgery. Further ablation when needed. All patients anticoagulated over 12-month period.
Declared endpoints Conversion to NSR, AF free survival at 1-year follow-up. Not explicitly stated. Primary: AF after 6 and 12 months (3-day Holter ECG). Secondary: composite of death, stroke, HF hospitalization, NYHA class worsening and mitral valve reintervention; mortality; need for rhythm-related interventions.
Patient evaluation Clinical symptoms, ECG, echo. Clinical symptoms, ECG, echo, treadmill. Transtelephonic monitoring.
Risk of bias
Randomization Some concern. Some concern. Low risk.
Treatment deviations Some concern. Some concern. Low risk.
Missing outcome data Low risk. Low risk. Low risk.
Other RoB2 biases1 Low risk. Low risk. Low risk.
Overall risk of bias Some concerns. Some concerns. Low risk.