Widimsky P, Tousek P, Rokyta R, et al. Charles University Prague, CZ PRAGUE-7 Study (Hot Lines presenter)

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Presentation transcript:

Widimsky P, Tousek P, Rokyta R, et al. Charles University Prague, CZ PRAGUE-7 Study (Hot Lines presenter)

Background. Surgical atrial ablation procedure (MAZE) may restore sinus rhythm (SR) in pts with atrial fibrillation (AF) undergoing cardiac surgery. Hypothesis (formulated by cardiac surgeons): (1)MAZE restores SR after surgery (2)without increasing perioperative complications (3)SR presence may improve long term outcomes.

Methods Prospective randomized open multicenter study Primary efficacy outcome: SR presence (without any AF episode) during 24-hours ECG after 1 year. Primary safety outcome at 30 days: death / myocardial infarction / stroke / renal failure. Main secondary outcome: composite of death, major bleeding, stroke or hospitalization for heart failure after 1 and 5 years.

Patients Inclusion criteria: Heart team indication for cardiac surgery AF documented at least twice in last six months - paroxysmal or (long standing) persistent signed informed consent age over 18 years. Exclusion criteria: Emergent surgery 224 pts with AF scheduled for valvular and/or coronary surgery MAZE group (left atrial surgical ablation, n=117) Non-MAZE group (no ablation, n=107)

Baseline characteristic n (%)MAZE (n = 117)Non-MAZE (n = 107) Age (years)69.9 ± ± 7.9 Paroxysmal AF26 (22.2)33 (30.8) Persistent AF30 (25.6)25 (23.4) Longstanding persistent AF61 (52.1)49 (45.8) Atrial fibrillation just prior surgery91 (77.8)70 (65.4) Left atrial diameter (mm)48.7 ± ± 7.1 Mean NYHA functional class2.3 ± ± 0.7 Prior stroke / TIA13 (11.1)15 (14.0) Diabetes41 (35.0)40 (37.4) Prior major bleeding4 (3.4)6 (5.6) Ejection fraction (%)52.6 ± ± 12.5 Logistic EuroSCORE5.8 ( )6.8 ( )

Surgical procedure Cryomaze (ATS) in 97% pts, radiofrequency in 3% pts. Ablation time for each lesion 90 seconds. Lesion set: pulmonary veins ablation, left atrial appendage exclusion and three interconnecting lesions Epicardially or endocardially (based on whether LA is opened during the main surgical procedure)

Procedure types (all-comers with AF)

Sinus rhythm after 1 year (primary efficacy end-point, Holter 24-hour ECG) p = 0,002 p = p = 0,194 p< 0,001

Evolution of sinus rhytm during 1 year (12-lead ECGs)

Perioperative complications Primary safety outcome (death / myocardial infarction / stroke / renal failure at 30 days) p = 0,411

Long-term adverse events (Death/ major bleeding/ stroke/ hospitalization for heart failure after 1 year) p = 0,785 p = 0,800 p = 0,654 p = 0,319 p = 0,680

Secondary outcomes at 1 year p=0,825 p=0,887 p=0,174

Conclusions (1) Surgical ablation improves the likelihood of SR presence up to 1 year postoperatively (2) Without perioperative complications (3) No impact on 1-year clinical outcomes Most significant rhythm benefit in pts with longstanding persistent AF (no benefit seen in paroxysmal AF).