PRELUDE trial - Summary & Results

Jul 27, 20122 likes371 views

http://www.theheart.org/web_slides/1242353.do An analysis based on an Italian registry of 308 patients with Brugada syndrome who underwent programmed electrical stimulation (PES) studies according to one consistent protocol (unlike earlier multicenter studies that were based on varying PES protocols)

PRELUDE (Programmed Electrical
Stimulation Predictive Value in Brugada
Syndrome)

PRELUDE (Programmed Electrical Stimulation
Predictive Value in Brugada Syndrome)
C Napolitano (Fondazione Salvatore Maugeri, Pavia, Italy)
Heart Rhythm Society 2011 Scientific Sessions

• An analysis based on an Italian registry of 308 patients with Brugada syndrome
who underwent programmed electrical stimulation (PES) studies according to
one consistent protocol (unlike earlier multicenter studies that were based on
varying PES protocols)
• Background:
Brugada syndrome is a genetic disorder posing an elevated risk of syncope
and sudden death
Patients identified with the syndrome by ECG can be fitted with primary-
prevention ICDs
• Patient population:
Patients with no structural heart disease or history of cardiac arrest and either
a spontaneous or drug-therapy-induced type-1 ECG

PES: programmed electrical stimulation
ICD: implantable cardioverter-defibrillator

$PRELUDE: Results • VT/VF inducibility by PES is not a significant predictor of sudden death and therefore can't effectively be used to risk-stratify such patients for treatment with an ICD Predictors of arrhythmic events in multivariate analysis, by prognostic strength and HR (95% CI)—median 34-month follow-up Predictor Sensitivity (%) Specificity (%) NNT HR (95% CI) p VT/VF inducibility 35.7 58.8 102 1.03 (0.34–3.16) 0.96 VRP<200 vs ≥200 ms 78.6 62.9 13.2 3.9 (1.03–12.79) 0.04 Spontaneous type-1 ECG syncope 42.9 90.5 6.8 4.2 (1.38–12.79) 0.012 QRS-f 42.9 93.5 4.7 4.9 (1.54–15.8) 0.007 NNT: number needed to treat with an ICD to prevent one sudden death; VRP: ventricular refractory period; QRS-f: QRS-interval fragmentation; VT/VF: ventricular tachycardia/ventricular fibrillation$

$PRELUDE: Commentary* "We confirmed the prognostic value of a spontaneous 'type-1' electrocardiogram and a history of syncope. . . . But for the first time in a large prospective cohort, we [also] show that QRS fragmentation [QRS-f] and a ventricular refractory period [VRP] <200 ms are independent risk indicators." - Dr Carlo Napolitano "[PRELUDE] provides strong, prospective evidence that programmed stimulation is probably not going to be useful in this population." - Dr Michael Gold *All comments from PRELUDE: Inducibility in the EP lab a poor risk stratifier in Brugada syndrome (http://www.theheart.org/article/1222633.do)$

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PRELUDE trial - Summary & Results

1. PRELUDE (Programmed Electrical Stimulation Predictive Value in Brugada Syndrome)

2. PRELUDE (Programmed Electrical Stimulation Predictive Value in Brugada Syndrome) C Napolitano (Fondazione Salvatore Maugeri, Pavia, Italy) Heart Rhythm Society 2011 Scientific Sessions • An analysis based on an Italian registry of 308 patients with Brugada syndrome who underwent programmed electrical stimulation (PES) studies according to one consistent protocol (unlike earlier multicenter studies that were based on varying PES protocols) • Background: Brugada syndrome is a genetic disorder posing an elevated risk of syncope and sudden death Patients identified with the syndrome by ECG can be fitted with primary- prevention ICDs • Patient population: Patients with no structural heart disease or history of cardiac arrest and either a spontaneous or drug-therapy-induced type-1 ECG PES: programmed electrical stimulation ICD: implantable cardioverter-defibrillator

3. PRELUDE: Results • VT/VF inducibility by PES is not a significant predictor of sudden death and therefore can't effectively be used to risk-stratify such patients for treatment with an ICD Predictors of arrhythmic events in multivariate analysis, by prognostic strength and HR (95% CI)—median 34-month follow-up Predictor Sensitivity (%) Specificity (%) NNT HR (95% CI) p VT/VF inducibility 35.7 58.8 102 1.03 (0.34–3.16) 0.96 VRP<200 vs ≥200 ms 78.6 62.9 13.2 3.9 (1.03–12.79) 0.04 Spontaneous type-1 ECG syncope 42.9 90.5 6.8 4.2 (1.38–12.79) 0.012 QRS-f 42.9 93.5 4.7 4.9 (1.54–15.8) 0.007 NNT: number needed to treat with an ICD to prevent one sudden death; VRP: ventricular refractory period; QRS-f: QRS-interval fragmentation; VT/VF: ventricular tachycardia/ventricular fibrillation

4. PRELUDE: Commentary* "We confirmed the prognostic value of a spontaneous 'type-1' electrocardiogram and a history of syncope. . . . But for the first time in a large prospective cohort, we [also] show that QRS fragmentation [QRS-f] and a ventricular refractory period [VRP] <200 ms are independent risk indicators." - Dr Carlo Napolitano "[PRELUDE] provides strong, prospective evidence that programmed stimulation is probably not going to be useful in this population." - Dr Michael Gold *All comments from PRELUDE: Inducibility in the EP lab a poor risk stratifier in Brugada syndrome (http://www.theheart.org/article/1222633.do)

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PRELUDE trial - Summary & Results

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