Presentation on theme: "Widimsky P, Tousek P, Rokyta R, et al. Charles University Prague, CZ PRAGUE-7 Study (Hot Lines presenter)"— 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)
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)
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).