Gillinov 2006, USA 26 Onorati 2011, Italy 25 Stulak 2014, USA 24
Declared objective Efficacy of treatment for paroxysmal AF with concomitant MV surgery: Cox-Maze III, PVI and PVI with connecting lesions. Outcomes of “limited” (PVI) and “extensive” (Cox-Maze IV) treatment for persistent AF with concomitant MV surgery. Outcomes in patients with surgically treated persistent/paroxysmal AF undergoing MV surgery.
Outcomes Prevalence of AF at 1, 3, 6, 12 months and yearly follow-up. Prevalence of AF at 3, 6, 12, 18, 24 months and mid-term mortality/hospitalizations. Freedom from AF at 1, 1-5 and >5-year follow-up.
General design Retrospective analysis of a single center registry 1993-2004. Cox-Maze III (n=41), PVI (n=31)/PVI + left atrial connection lesions (n=80). Standardized follow-up. Prospective. Consecutive patients (2003- 2008), concomitant PVI (n=32) and Cox-Maze IV (n=105) during MV surgery. Standardized follow-up, 24-hour ECG Holter. Retrospective analysis of a single center registry 1993-2011. Cox-Maze III (n=256) and PVI (n=68) with MV surgery as a subset of a larger cohort.
Risk of bias
Confounding Low-moderate risk. Adjustment: demographic characteristics, NYHA class, MV disease, AF duration, LV function, other cardiac comorbidity, concomitant procedures. Chrono bias and post-baseline confounding (AAD/anticoagulant use) possible. Low-moderate risk. PS baseline covariates: demographic characteristics, AF duration, LV function, atrial size, habits, diabetes and other comorbidity, previous surgery. Sextiles of PS stratification + adjustment for AF at discharge. Chrono bias and post-baseline confounding (AAD/anticoagulant use) possible. Serious risk. Declared use of a multivariable model, but no data on adjustments at all, including the subset of interest: surgical treatment of AF + MV surgery. Chrono bias and post-baseline confounding (AAD/anticoagulant use) possible.
Selection bias Low risk. Low risk. Moderate risk.
Missing data bias Low-moderate risk. Low risk. Moderate risk.
Other biases1 Low risk. Low risk. Moderate risk.
Overall risk of bias Moderate risk. Moderate risk. Serious risk.