SMASH-VT TrialSMASH-VT TrialSMASH-VT TrialSMASH-VT Trial

Presented atPresented atThe Heart Rhythm Society MeetingThe Heart Rhythm Society Meeting

May 2006May 2006

Presented by Dr. Vivek ReddyPresented by Dr. Vivek Reddy

Substrate Substrate MappingMapping and Ablation in Sinus Rhythm and Ablation in Sinus Rhythm to Halt Ventricular Tachycardia Trialto Halt Ventricular Tachycardia Trial

Substrate Substrate MappingMapping and Ablation in Sinus Rhythm and Ablation in Sinus Rhythm to Halt Ventricular Tachycardia Trialto Halt Ventricular Tachycardia Trial

www.Clinicaltrialresults.org

SMASH-VT Trial: BackgroundSMASH-VT Trial: BackgroundSMASH-VT Trial: BackgroundSMASH-VT Trial: Background

• The goal of the trial was to evaluate treatment with The goal of the trial was to evaluate treatment with ICD implantation with catheter ablation compared ICD implantation with catheter ablation compared with ICD alone among post myocardial infarction (MI) with ICD alone among post myocardial infarction (MI) patients with sustained ventricular tachycardia (VT)/ patients with sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)ventricular fibrillation (VF)

• The goal of the trial was to evaluate treatment with The goal of the trial was to evaluate treatment with ICD implantation with catheter ablation compared ICD implantation with catheter ablation compared with ICD alone among post myocardial infarction (MI) with ICD alone among post myocardial infarction (MI) patients with sustained ventricular tachycardia (VT)/ patients with sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)ventricular fibrillation (VF)

Presented at HRS 2006Presented at HRS 2006

www.Clinicaltrialresults.org

SMASH-VT Trial: Study DesignSMASH-VT Trial: Study DesignSMASH-VT Trial: Study DesignSMASH-VT Trial: Study Design

Presented at HRS 2006Presented at HRS 2006

Primary Endpoint: Appropriate ICD therapiesPrimary Endpoint: Appropriate ICD therapies Primary Endpoint: Appropriate ICD therapiesPrimary Endpoint: Appropriate ICD therapies

ICD implantation with ICD implantation with substrate-based catheter substrate-based catheter

ablation ablation n=62n=62

ICD implantation with ICD implantation with substrate-based catheter substrate-based catheter

ablation ablation n=62n=62

ICD aloneICD alone

n=64n=64

ICD aloneICD alone

n=64n=64

126 patients not using class l or lll antiarrhythmic drugs, prior MI, and either VF arrest, unstable VT, or prior ICD and single appropriate shock

Randomized.13% female, mean age 66 years, mean follow-up 2 years71% NYHA Class ll, 18% NYHA Class lll, Mean EF 31.7%

18% had VF arrest, 52% had unstable VT, 21% had syncope and inducible VT and 9% had prior ICD and single appropriate shock, 96% received beta-blockers and 91% received ACE-inhibitors, index MI was anterior in 41% of

patients and 67% had prior revascularization

126 patients not using class l or lll antiarrhythmic drugs, prior MI, and either VF arrest, unstable VT, or prior ICD and single appropriate shock

Randomized.13% female, mean age 66 years, mean follow-up 2 years71% NYHA Class ll, 18% NYHA Class lll, Mean EF 31.7%

18% had VF arrest, 52% had unstable VT, 21% had syncope and inducible VT and 9% had prior ICD and single appropriate shock, 96% received beta-blockers and 91% received ACE-inhibitors, index MI was anterior in 41% of

patients and 67% had prior revascularization

Ablation was performed with electroanatomic mapping to delineate the Ablation was performed with electroanatomic mapping to delineate the endocardial infarct marginsendocardial infarct margins

The radiofrequency ablation catheter used either a standard 4mm (n=10) or an The radiofrequency ablation catheter used either a standard 4mm (n=10) or an irrigated 3.5 mm tip (n=52)irrigated 3.5 mm tip (n=52)

Ablation was performed with electroanatomic mapping to delineate the Ablation was performed with electroanatomic mapping to delineate the endocardial infarct marginsendocardial infarct margins

The radiofrequency ablation catheter used either a standard 4mm (n=10) or an The radiofrequency ablation catheter used either a standard 4mm (n=10) or an irrigated 3.5 mm tip (n=52)irrigated 3.5 mm tip (n=52)

www.Clinicaltrialresults.org

SMASH-VT Trial: Primary EndpointSMASH-VT Trial: Primary EndpointSMASH-VT Trial: Primary EndpointSMASH-VT Trial: Primary Endpoint

Presented at HRS 2006Presented at HRS 2006

15%

33%

0%

10%

20%

30%

Ablation Group Control Group

15%

33%

0%

10%

20%

30%

Ablation Group Control Group

Primary endpoint of appropriate ICD therapy (%)

p<0.05

Incidence of appropriate ICD shock (%)p<0.05

• The primary endpoint of appropriate ICD therapy occurred less The primary endpoint of appropriate ICD therapy occurred less frequently in the ablation group compared with the control group frequently in the ablation group compared with the control group (15% vs. 33% p=<0.05), as did appropriate ICD shock (10% vs. 33%, (15% vs. 33% p=<0.05), as did appropriate ICD shock (10% vs. 33%, p=<0.05).p=<0.05).

10%

31%

0%

10%

20%

30%

Ablation Group Control Group

10%

31%

0%

10%

20%

30%

Ablation Group Control Group

www.Clinicaltrialresults.org

SMASH-VT Trial: Adverse EventsSMASH-VT Trial: Adverse Events SMASH-VT Trial: Adverse EventsSMASH-VT Trial: Adverse Events

Presented at HRS 2006Presented at HRS 2006

• Mortality occurred in Mortality occurred in 7% of the ablation 7% of the ablation group and 17% of the group and 17% of the control group control group (p=0.073).(p=0.073).

• Among the adverse Among the adverse events in the ablation events in the ablation group, there was one group, there was one pericardial effusion pericardial effusion without tamponade, without tamponade, one deep vein one deep vein thrombosis, and one thrombosis, and one CHF exacerbation.CHF exacerbation.

7%

17%

0%

5%

10%

15%

20%

AblationGroup

ControlGroup

7%

17%

0%

5%

10%

15%

20%

AblationGroup

ControlGroup

Mortality among both patient groups (%) p=0.073

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SMASH-VT Trial: SummarySMASH-VT Trial: SummarySMASH-VT Trial: SummarySMASH-VT Trial: Summary

• Among post-MI patients with sustained VT/VF, ICD Among post-MI patients with sustained VT/VF, ICD implantation with substrate-based catheter ablation was implantation with substrate-based catheter ablation was associated with a reduction in appropriate ICD therapy associated with a reduction in appropriate ICD therapy through two years compared with ICD therapy alone.through two years compared with ICD therapy alone.

• The present trial suggests that the procedure can also be The present trial suggests that the procedure can also be effective in reducing ICD shocks in the post-MI setting, effective in reducing ICD shocks in the post-MI setting, although it should be noted that the procedure is difficult although it should be noted that the procedure is difficult to perform and extremely technical, so use for to perform and extremely technical, so use for prophylactic therapy should be undertaken with caution prophylactic therapy should be undertaken with caution and only in experienced centers.and only in experienced centers.

• Among post-MI patients with sustained VT/VF, ICD Among post-MI patients with sustained VT/VF, ICD implantation with substrate-based catheter ablation was implantation with substrate-based catheter ablation was associated with a reduction in appropriate ICD therapy associated with a reduction in appropriate ICD therapy through two years compared with ICD therapy alone.through two years compared with ICD therapy alone.

• The present trial suggests that the procedure can also be The present trial suggests that the procedure can also be effective in reducing ICD shocks in the post-MI setting, effective in reducing ICD shocks in the post-MI setting, although it should be noted that the procedure is difficult although it should be noted that the procedure is difficult to perform and extremely technical, so use for to perform and extremely technical, so use for prophylactic therapy should be undertaken with caution prophylactic therapy should be undertaken with caution and only in experienced centers.and only in experienced centers.

Presented at HRS 2006Presented at HRS 2006