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ESC-2015 Univ.-Prof. Dr. Wilhelm Haverkamp Stellvertretender Klinikdirektor Charité - Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Kardiologie
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ALBATROSS
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EPHESUS EPHESUS, Therapiebeginn im Mittel 7 Tage nach Myokardinfarkt mit linksventrikulärer Dysfunktion (EF<40%) und HerzinsuffizienzPitt et al., 2003
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ALBATROSS Study Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up
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ALBATROSS: Design
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ALBATROSS: Primary endpoint
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ALBATROSS: Death
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ALBATROSS: Conslusions
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CIRCUS
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Does Cyclosporine ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients ? (the CIRCUS study) Michel OVIZE, MD, PhD Louis Pradel Hospital and Claude Bernard University, Lyon, France
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CIRCUS: Design
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Secondary outcomes at 1 year Cyclosporine (n=395) Control (n=396) Odds Ratio (95% CI) P value Death: all-cause7.1 %6.6 %1.09 [0.63 ; 1.90] 0.76 Death: cardiovascular 6.1 % 1.01 [0.56 ; 1.81] 0.98 HF worsening or re-hospitalization for HF 22.8 %22.7 %1.01 [0.72 ; 1.41] 0.97 Re-hospitalization for HF 10.6 %10.4 %1.03 [0.65 ; 1.63] 0.65
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Conclusion In anterior STEMI, cyclosporine did not reduce the risk of the composite primary outcome –One out of four patients died or experienced heart failure despite receiving state-of-the-art medical care. –Despite the results of CIRCUS, reperfusion injury is clinically important. The impact on clinical outcomes of recent encouraging phase II trials remains to be determined.
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UNDER-ATP EAST-AF
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Pulmonalvenenisolation Verma et al, 2015
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AF-Ablation: Persistierendes VHF Verma et al, 2015
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UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate Atsushi Kobori, Koichi Inoue, Kazuaki Kaitani, Yuko Nakazawa, Toshiya Kurotobi, Itsuro Morishima, Fumiharu Miura, Takeshi Morimoto, Takeshi Kimura, and Satoshi Shizuta
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Background Adenosine (triphosphate) has been reported to provoke dormant electrical conduction between the left atrium and Pulmonary Veins (PV) after an initially successful PV isolation (PVI). Adenosine triphosphate (ATP) guided PVI has been shown to improve the outcomes of AF ablation. Hachiya H, et al. J Cardiovasc Electrophysiol. 2007;18(4):392. Matsuo S, et al. J Cardiovasc Electrophysiol. 2007;18(7):704. Kumagai K, et al. J Cardiovasc Electrophysiol. 2010;21(5):494. Macle L, et al. Lancet 2015;386,9994:672.
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Aim The aim of this large-scale (>2,000) multicenter prospective randomized controlled trial was to evaluate the efficacy of ATP-guided PVI as compared with conventional PVI in patients undergoing AF ablation.
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Endpoint Primary endpoint Recurrent atrial tachyarrhythmias* at 1-year with a blanking period of 90 days post ablation.
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Event-free Survival from the Primary Endpoint Freedom from Atrial Tachyarrhythmias (%) 10 0 80 60 40 20 0 0 90 180 270 365 465 Days After First Ablation ATP-Guided PVI Conventionaal PVI 68.7% 67.1 % Log-rank P=0.19 Adjusted HR 0.89, 95% CI 0.74-1.09, P=0.25 Intervall0d90d180 d 270d365 d 450d ATP-Guided PVI; N at risk 11121111896800625 Conventional PVI; N at risk 1001999787701533
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Clinical Follow-up Periodical visits: @ 3-, 6-, and 12-month (ECG, blood samples etc.) 2-week ambulatory electrogram recording: @ hospital- discharge, 6-month and 12-month 24-hour Holter monitoring : @ 6- and 12-month Additional symptom driven ECG-monitoring
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LEADLESS 2
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Reddy et al, 2015
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Leadless PM Reddy et al, 2015
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Leadless PM Reddy et al, 2015
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Leadless II Reddy et al, 2015
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LEADLESS II: Procedural characteristics Reddy et al, 2015
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LEADLESS II: Serious adverse events Reddy et al, 2015
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AEGEAN
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AEGEAN: Assessment of an Education and Guidance program for Eliquis Adherence in Non-valvular AF Primary Objective: –To assess the impact of an educational program on implementation phase adherence in patients taking apixaban for SPAF. Assessed at 24 weeks after initiation using an EMD, Helping Hand® Secondary Objectives: –To assess the impact of an educational program on persistence at 24 weeks inpatients taking apixaban
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AEGEAN: Discussant review Importance –First large prospective RCT of an educational intervention on adherence and persistence to NOACs –High rate of adherence and persistence overall on apixaban –No additional value of a proactive educational program on adherence in the first 6 months of treatment, in a selected trial population Limitations –Patient selection, which may not fully represent real life patients Measuring adherence increases adherence [the patient is ‘aware’] Comorbidities and regular healthcare professional contact may influence adherence and persistence –Not powered for efficacy and safety endpoints –Long term adherence and persistence (beyond 6 months) may decrease over time
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