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. |