SWEDMAF TrialSWEDMAF TrialSWEDMAF TrialSWEDMAF Trial

Presented atPresented atThe Heart Rhythm Society Meeting The Heart Rhythm Society Meeting

May 2006May 2006

Presented by Dr. Carina Blomstrom-Lundqvist Presented by Dr. Carina Blomstrom-Lundqvist

SWEDMAF TrialSWEDMAF TrialSWEDMAF TrialSWEDMAF Trial

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SWEDMAF Trial: BackgroundSWEDMAF Trial: BackgroundSWEDMAF Trial: BackgroundSWEDMAF Trial: Background

• AF is present in a majority of patients AF is present in a majority of patients undergoing mitral-valve surgery and persists undergoing mitral-valve surgery and persists in 80% to 90% of patients after surgery. in 80% to 90% of patients after surgery.

• The goal of the trial was to evaluate mitral The goal of the trial was to evaluate mitral valve surgery with pulmonary vein isolation valve surgery with pulmonary vein isolation (PVI) using epicardial cryoablation compared (PVI) using epicardial cryoablation compared with mitral valve surgery alone among patients with mitral valve surgery alone among patients with permanent atrial fibrillation (AF) and with permanent atrial fibrillation (AF) and mitral valve disease.mitral valve disease.

• AF is present in a majority of patients AF is present in a majority of patients undergoing mitral-valve surgery and persists undergoing mitral-valve surgery and persists in 80% to 90% of patients after surgery. in 80% to 90% of patients after surgery.

• The goal of the trial was to evaluate mitral The goal of the trial was to evaluate mitral valve surgery with pulmonary vein isolation valve surgery with pulmonary vein isolation (PVI) using epicardial cryoablation compared (PVI) using epicardial cryoablation compared with mitral valve surgery alone among patients with mitral valve surgery alone among patients with permanent atrial fibrillation (AF) and with permanent atrial fibrillation (AF) and mitral valve disease.mitral valve disease.

Presented at HRS 2006Presented at HRS 2006

www.Clinicaltrialresults.org

SWEDMAF Trial: Study DesignSWEDMAF Trial: Study DesignSWEDMAF Trial: Study DesignSWEDMAF Trial: Study Design

Presented at HRS 2006Presented at HRS 2006

Primary Endpoint: Sinus rhythm at 6 monthsPrimary Endpoint: Sinus rhythm at 6 months Secondary Endpoint: Sinus rhythm at 12 months; quality of life at 6 and 12 Secondary Endpoint: Sinus rhythm at 12 months; quality of life at 6 and 12

monthsmonths

Primary Endpoint: Sinus rhythm at 6 monthsPrimary Endpoint: Sinus rhythm at 6 months Secondary Endpoint: Sinus rhythm at 12 months; quality of life at 6 and 12 Secondary Endpoint: Sinus rhythm at 12 months; quality of life at 6 and 12

monthsmonths

Mitral valve surgery with PVI using cryoablation

n=30

Mitral valve surgery with PVI using cryoablation

n=30

65 patients, age 18-80 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 18-80 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

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SWEDMAF Trial: Intraoperative ECC TimeSWEDMAF Trial: Intraoperative ECC Time SWEDMAF Trial: Intraoperative ECC TimeSWEDMAF Trial: Intraoperative ECC Time

Presented at HRS 2006Presented at HRS 2006

• Intra-operative ECC Intra-operative ECC time was longer in time was longer in the mitral valve the mitral valve surgery with surgery with cryoablation group cryoablation group than the surgery than the surgery alone group (146 alone group (146 min vs. 119 min, min vs. 119 min, p=0.0015), driven by p=0.0015), driven by the 21 minute the 21 minute cryoablation cryoablation procedure time. procedure time.

146

119

0

30

60

90

120

150

Mitral Valve withCryoablation

Mitral ValveSurgery Alone

146

119

0

30

60

90

120

150

Mitral Valve withCryoablation

Mitral ValveSurgery Alone

Intraoperative ECC Time p=0.0015

Min

utes

Min

utes

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SWEDMAF Trial: Primary EndpointSWEDMAF Trial: Primary EndpointSWEDMAF Trial: Primary EndpointSWEDMAF Trial: Primary Endpoint

Presented at HRS 2006Presented at HRS 2006

• The primary The primary endpoint of sinus endpoint of sinus rhythm at 6 rhythm at 6 months occurred months occurred more frequently in more frequently in the mitral valve the mitral valve surgery with surgery with cryoablation cryoablation group compared group compared with the mitral with the mitral valve surgery valve surgery alone group (73% alone group (73% vs. 46%, p=0.024).vs. 46%, p=0.024).

73%

46%

0%

25%

50%

75%

Mitral ValveSurgery withCryoablation

Mitral ValveSurgery Alone

73%

46%

0%

25%

50%

75%

Mitral ValveSurgery withCryoablation

Mitral ValveSurgery Alone

Primary endpoint of sinus rhythm at 6 monthsp=0.024

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SWEDMAF Trial: Secondary EndpointSWEDMAF Trial: Secondary EndpointSWEDMAF Trial: Secondary EndpointSWEDMAF Trial: Secondary Endpoint

Presented at HRS 2006Presented at HRS 2006

• Secondary Secondary endpoint of endpoint of sinus sinus rhythm at 12 rhythm at 12 monthsmonths was was maintained maintained (73% vs. (73% vs. 49%, 49%, p=0.042)p=0.042)

73%

49%

0%

25%

50%

75%

Mitral ValveSurgery withCryoablation

Mitral ValveSurgery Alone

73%

49%

0%

25%

50%

75%

Mitral ValveSurgery withCryoablation

Mitral ValveSurgery Alone

Secondary endpoint of Sinus Rhythm at 12 Months p=0.042

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SWEDMAF Trial: Adverse EventsSWEDMAF Trial: Adverse EventsSWEDMAF Trial: Adverse EventsSWEDMAF Trial: Adverse Events

•Adverse events were relatively infrequent, Adverse events were relatively infrequent, with no deaths in the surgery alone group and with no deaths in the surgery alone group and 2 deaths in the surgery with cryoablation 2 deaths in the surgery with cryoablation group, one of which was due to cancer and one group, one of which was due to cancer and one due to heart failure.due to heart failure.

•Bleeding requiring re-operation occurred in 1 Bleeding requiring re-operation occurred in 1 patient in the surgery alone group and 3 patient in the surgery alone group and 3 patients in the cryoablation group. patients in the cryoablation group.

Presented at HRS 2006Presented at HRS 2006

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SWEDMAF Trial: ResultsSWEDMAF Trial: ResultsSWEDMAF Trial: ResultsSWEDMAF Trial: Results

• Among patients with permanent atrial fibrillation and Among patients with permanent atrial fibrillation and mitral valve disease, mitral valve surgery with mitral valve disease, mitral valve surgery with pulmonary vein isolation using cryoablation was pulmonary vein isolation using cryoablation was associated with higher rates of sinus rhythm at 6 associated with higher rates of sinus rhythm at 6 months compared with mitral valve surgery without months compared with mitral valve surgery without cryoablation.cryoablation.

• Among patients with permanent atrial fibrillation and Among patients with permanent atrial fibrillation and mitral valve disease, mitral valve surgery with mitral valve disease, mitral valve surgery with pulmonary vein isolation using cryoablation was pulmonary vein isolation using cryoablation was associated with higher rates of sinus rhythm at 6 associated with higher rates of sinus rhythm at 6 months compared with mitral valve surgery without months compared with mitral valve surgery without cryoablation.cryoablation.

Presented at HRS 2006Presented at HRS 2006

www.Clinicaltrialresults.org

SWEDMAF Trial: SummarySWEDMAF Trial: SummarySWEDMAF Trial: SummarySWEDMAF Trial: Summary

• Surgery with cryoablation restored sinus rhythm and Surgery with cryoablation restored sinus rhythm and maintained sinus rhythm more so than surgery alone, maintained sinus rhythm more so than surgery alone, with few adverse events.with few adverse events.

• While the present study demonstrated benefit of While the present study demonstrated benefit of cryoablation with mitral valve surgery, data from the cryoablation with mitral valve surgery, data from the present trial do not provide information to the effect of present trial do not provide information to the effect of cryoablation with coronary bypass surgery. cryoablation with coronary bypass surgery.

• The long-term benefit of cryoablation drying cardiac The long-term benefit of cryoablation drying cardiac surgery for atrial fibrillation suppression remains to be surgery for atrial fibrillation suppression remains to be evaluatedevaluated

• Surgery with cryoablation restored sinus rhythm and Surgery with cryoablation restored sinus rhythm and maintained sinus rhythm more so than surgery alone, maintained sinus rhythm more so than surgery alone, with few adverse events.with few adverse events.

• While the present study demonstrated benefit of While the present study demonstrated benefit of cryoablation with mitral valve surgery, data from the cryoablation with mitral valve surgery, data from the present trial do not provide information to the effect of present trial do not provide information to the effect of cryoablation with coronary bypass surgery. cryoablation with coronary bypass surgery.

• The long-term benefit of cryoablation drying cardiac The long-term benefit of cryoablation drying cardiac surgery for atrial fibrillation suppression remains to be surgery for atrial fibrillation suppression remains to be evaluatedevaluated

Presented at HRS 2006Presented at HRS 2006