SWEDMAF Trial Presented at The Heart Rhythm Society Meeting May 2006 Presented by Dr. Carina Blomstrom-Lundqvist SWEDMAF Trial

SWEDMAF Trial: Background AF is present in a majority of patients undergoing mitral-valve surgery and persists in 80% to 90% of patients after surgery.AF is present in a majority of patients undergoing mitral-valve surgery and persists in 80% to 90% of patients after surgery. The goal of the trial was to evaluate mitral valve surgery with pulmonary vein isolation (PVI) using epicardial cryoablation compared with mitral valve surgery alone among patients with permanent atrial fibrillation (AF) and mitral valve disease.The goal of the trial was to evaluate mitral valve surgery with pulmonary vein isolation (PVI) using epicardial cryoablation compared with mitral valve surgery alone among patients with permanent atrial fibrillation (AF) and mitral valve disease. AF is present in a majority of patients undergoing mitral-valve surgery and persists in 80% to 90% of patients after surgery.AF is present in a majority of patients undergoing mitral-valve surgery and persists in 80% to 90% of patients after surgery. The goal of the trial was to evaluate mitral valve surgery with pulmonary vein isolation (PVI) using epicardial cryoablation compared with mitral valve surgery alone among patients with permanent atrial fibrillation (AF) and mitral valve disease.The goal of the trial was to evaluate mitral valve surgery with pulmonary vein isolation (PVI) using epicardial cryoablation compared with mitral valve surgery alone among patients with permanent atrial fibrillation (AF) and mitral valve disease. Presented at HRS 2006

SWEDMAF Trial: Study Design Presented at HRS 2006  Primary Endpoint: Sinus rhythm at 6 months  Secondary Endpoint: Sinus rhythm at 12 months; quality of life at 6 and 12 months  Primary Endpoint: Sinus rhythm at 6 months  Secondary Endpoint: Sinus rhythm at 12 months; quality of life at 6 and 12 months Mitral valve surgery with PVI using cryoablation n=30 Mitral valve surgery with PVI using cryoablation n=30 65 patients, age years, ECG documented AF for at least 3 months, clinical indication for mitral valve surgery Randomized. 22% female, mean age 65 years, mean follow-up 1 year Surgeons were un-blinded to treatment assignment but both the patient and the cardiologists remained blinded 65 patients, age years, ECG documented AF for at least 3 months, clinical indication for mitral valve surgery Randomized. 22% female, mean age 65 years, mean follow-up 1 year Surgeons were un-blinded to treatment assignment but both the patient and the cardiologists remained blinded Mitral valve surgery alone n=35 Mitral valve surgery alone n=35

SWEDMAF Trial: Intraoperative ECC Time SWEDMAF Trial: Intraoperative ECC Time Presented at HRS 2006 Intra-operative ECC time was longer in the mitral valve surgery with cryoablation group than the surgery alone group (146 min vs. 119 min, p=0.0015), driven by the 21 minute cryoablation procedure time.Intra-operative ECC time was longer in the mitral valve surgery with cryoablation group than the surgery alone group (146 min vs. 119 min, p=0.0015), driven by the 21 minute cryoablation procedure time. Intraoperative ECC Time p= Minutes

SWEDMAF Trial: Primary Endpoint Presented at HRS 2006 The primary endpoint of sinus rhythm at 6 months occurred more frequently in the mitral valve surgery with cryoablation group compared with the mitral valve surgery alone group (73% vs. 46%, p=0.024).The primary endpoint of sinus rhythm at 6 months occurred more frequently in the mitral valve surgery with cryoablation group compared with the mitral valve surgery alone group (73% vs. 46%, p=0.024). Primary endpoint of sinus rhythm at 6 months p=0.024

SWEDMAF Trial: Secondary Endpoint Presented at HRS 2006 Secondary endpoint of sinus rhythm at 12 monthswas maintained (73% vs. 49%, p=0.042)Secondary endpoint of sinus rhythm at 12 months was maintained (73% vs. 49%, p=0.042) Secondary endpoint of Sinus Rhythm at 12 Months p=0.042

SWEDMAF Trial: Adverse Events Adverse events were relatively infrequent, with no deaths in the surgery alone group and 2 deaths in the surgery with cryoablation group, one of which was due to cancer and one due to heart failure.Adverse events were relatively infrequent, with no deaths in the surgery alone group and 2 deaths in the surgery with cryoablation group, one of which was due to cancer and one due to heart failure. Bleeding requiring re-operation occurred in 1 patient in the surgery alone group and 3 patients in the cryoablation group.Bleeding requiring re-operation occurred in 1 patient in the surgery alone group and 3 patients in the cryoablation group. Presented at HRS 2006

SWEDMAF Trial: Results Among patients with permanent atrial fibrillation and mitral valve disease, mitral valve surgery with pulmonary vein isolation using cryoablation was associated with higher rates of sinus rhythm at 6 months compared with mitral valve surgery without cryoablation.Among patients with permanent atrial fibrillation and mitral valve disease, mitral valve surgery with pulmonary vein isolation using cryoablation was associated with higher rates of sinus rhythm at 6 months compared with mitral valve surgery without cryoablation. Presented at HRS 2006

SWEDMAF Trial: Summary Surgery with cryoablation restored sinus rhythm and maintained sinus rhythm more so than surgery alone, with few adverse events.Surgery with cryoablation restored sinus rhythm and maintained sinus rhythm more so than surgery alone, with few adverse events. While the present study demonstrated benefit of cryoablation with mitral valve surgery, data from the present trial do not provide information to the effect of cryoablation with coronary bypass surgery.While the present study demonstrated benefit of cryoablation with mitral valve surgery, data from the present trial do not provide information to the effect of cryoablation with coronary bypass surgery. The long-term benefit of cryoablation drying cardiac surgery for atrial fibrillation suppression remains to be evaluatedThe long-term benefit of cryoablation drying cardiac surgery for atrial fibrillation suppression remains to be evaluated Surgery with cryoablation restored sinus rhythm and maintained sinus rhythm more so than surgery alone, with few adverse events.Surgery with cryoablation restored sinus rhythm and maintained sinus rhythm more so than surgery alone, with few adverse events. While the present study demonstrated benefit of cryoablation with mitral valve surgery, data from the present trial do not provide information to the effect of cryoablation with coronary bypass surgery.While the present study demonstrated benefit of cryoablation with mitral valve surgery, data from the present trial do not provide information to the effect of cryoablation with coronary bypass surgery. The long-term benefit of cryoablation drying cardiac surgery for atrial fibrillation suppression remains to be evaluatedThe long-term benefit of cryoablation drying cardiac surgery for atrial fibrillation suppression remains to be evaluated Presented at HRS 2006