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. |