Ενδείξεις απόφραξης του ωτίου του αριστερού κόλπου. Σκεύος Σιδερής Επιμελητής Α Καρδιολογικό Τμήμα Ιπποκράτειο Νοσοκομείο Αθηνών

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1 Ενδείξεις απόφραξης του ωτίου του αριστερού κόλπου Σκεύος Σιδερής Επιμελητής Α Καρδιολογικό Τμήμα Ιπποκράτειο Νοσοκομείο Αθηνών

2 Atrial Fibrillation Atrial fibrillation is the most common sustained cardiac arrhythmia, occurring in 1.5-2% of the general population, with the average age of patients with this condition steadily rising such that it now average between 75 and 85 years. The arrhythmia is associated with a five-fold risk of stroke and threefold incidence of congestive heart failure, and higher mortality. Hospitalization of patients with AF is also very common. Social and economic aspects are all set to worsen over the coming decades. JACC 2001;237: ESC Guidelines 2012

3 Atrial Fibrillation Atrial fibrillation confers a 5-fold risk of stroke, and one in five strokes is attributed to this arrhythmia. Ischemic strokes in association with AF are often fatal, and those patients who survive are left more disabled by their stroke and more likely to suffer a recurrence than patients with other causes of stroke. In consequence, the risk of death from AF-related stroke is doubled and the cost of care is increased 1.5-fold. JAMA 1985;254:

4 Atrial Fibrillation Even short episodes of silent AF convey an increased risk for stroke. In patients 65 years or older, opportunistic screening by pulse palpation, followed by an ECG in those with an irregular pulse, is important to detect AF prior to the first stroke. Br Med J 2007;335:383 Europace 2012;2: N Engl J Med 2012;366:

5 Atrial Fibrillation Thus, this guideline strongly recommends a practice shift towards focus on identification of truly low-risk patients with AF, age<65 and lone AF who do not need any antithrombotic therapy, increased of trying to focus on identifying high-risk patients. ESC Guidelines 2012

6 J Am Coll Cardiol 2004;43: ESC Guidelines 2010

7 AF-Anticoagulants VKAs which block the formation of multiple active vitamin K-dependent coagulation factors (factors II,VII,IX, and X), these drugs block the activity of one single step in coagulation. Direct thrombin inhibitors (dabigatran) Direct factor Xa inhibitors (rivaroxaban, apixaban etc) Thromb Haemost 2010;104:49-60

Significant number of patients are difficult to anticoagulate Significant history of bleeding Elderly and frail people High HASBLED score (> 3) GI

8 Significant number of patients are difficult to anticoagulate Significant history of bleeding Elderly and frail people High HASBLED score (> 3) GI diseases (cirrhosis, angiodysplasia) Chronic renal failure Cerebral microbleeds (CMB) and cerebral amyloid angiopathy (CAA) Poor compliance to medication

9 Ηλικία-Αιμορραγία Ο ετήσιος κίνδυνος για αγγειακό εγκεφαλικό επεισόδιο σχετιζόμενο με ΚΜ αυξάνει στους ηλικιωμένους ασθενείς, ανεβαίνοντας από το 1,5% για ηλικίες ετών σε 23.5% για ηλικίες ετών. Όσο αυξάνεται ο κίνδυνος για εμβολή, αυξάνεται και ο κίνδυνος για αιμορραγικά επεισόδια. Στην εποχή των νέων αντιπηκτικών φαρμάκων μόνο το 60% των ασθενών θεραπεύονται σωστά. Stroke 1991;22: Circ Cardiovasc Qual Outcomes 2012;5:615-21

10 Stroke and left atrial appendage In patients with nonvalvular atrial fibrillation stroke comes from left atrial appendage - not 100%, but in the overwhelming majority that s the case. That s an important piece of information because it opens the door for mechanical approaches to occlude the LAA or to dramatically decrease flow in the LAA.

11 LA Appendage Closure Devices

12 LAA morphologies and risk of stroke Di Biase et al. JACC 2012

13 Left Atrial Appendage Closure Complications LAA occlusion device to warfarin, identified an early safety hazard mainly related to procedural pericardial effusion occurring in approximately 5% of patients. Prolong hospital stay and was considered a serious adverse event. JACC 2014;63:291-8

14 Amplatzer Amulet LAAO Entrapment through MV Canadian J of Cardiol 2013;29:1532

15 Late organized Left Atrial Thrombus on LAA Closure device J Cardiovasc Electrophysiol 2013

16 Late organized Left Atrial Thrombus on LAA Closure device EuroIntervention 2013;9:

17 Left Atrial Appendage Closure Complications After LAAO requires dual antiplatelet therapy for a not welldefined period. Suggested the use of dual antiplatelet therapy for 6 months followed by aspirin. However, this antiplatelet regimen also increases the risk of major bleedings. Catheter Cardiovasc Interv 2011;77:

18 Σύνοψη Κυριότερων Μελετών με Συσκευές Σύγκλεισης Μελέτη Συσκευή Τύπος Μελέτης Αντιθρομβωτική αγωγή Ομάδα Control Sievert et al 1 PLAATO Safety and Efficacy ASA (300MG)+Clopidogrel After 6 months ASA PROTECT AF 2 Watchman Randomized Warfarin. After 45 days ASA+Clopidogrel for 6 months.asa PREVAIL 3 Watchman Randomized Warfarin. After 45 days ASA+Clopidogrel for 6 months. ASA ASAP Watchman Registry ASA+Clopidogrel 1-3 months. ASA CAP 3 Watchman Registry Warfarin Warfarin Urena et al 4 Amplatzer Safety and Efficacy ASA+Clopidogrel 1-3 months. ASA ACP Amplatzer Randomized No data Dabigatran Bartus et al 5 LARIAT Safety and Efficacy Warfarin if not contraindicated. ASA 1 Sievert et al, Circulation 2002, 2 Holmes et al, Lancet Reddy et al, Circulation 2011, 4 Urena et al, JACC Bartus et al, JACC 2013

19 Primary efficacy endpoint (Stroke, Systemic Embolism, CV Death) 4-Year Data Protect AF HRS Scientific Sessions, May 2013

20 Protect AF HRS Scientific Sessions, May 2013

21 NEJM 361:1139, 2009 NEJM 365:883, 2011 NEJM 365:981, 2011 Reddy: LBCT HRS 2013 Total Mortality Reduction vs Warfarin 4 year data Protect AF

22 Budget Impact of LAAO LAAC represents an opportunity for savings to healthcare systems in the long term Europace 2014;

23 Indications for LAA closure Recurrent ischemic strokes despite adequate anticoagulation Poor compliance to anticoagulant therapy History of cerebral hemorrhage History of recurrent GI bleeding Comorbidities (uncontrolled hypertension, cerebral amyloidosis, focal cerebral hemorraghe) Coagulation disorders (low platelet count, MDS)

24 Contraindications for LAA closure Congenital heart disease Symptomatic carotid artery disease Symptomatic valvular disease Aortic arch atheromatosis Prosthetic valve ICD More than one pacemaker leads EF<35% Hypertension Hypercoagulability TEE: thrombus in LAA

25 ESC Guidelines 2012

26 Σας Ευχαριστώ για την Προσοχή σας

27 Protect AF 4-Year Superiority Ps=posterior superiority probability HRS, 2013

28 Novel oral Anticoagulants Several new anticoagulant drugs Dabigatran (RE-LY), Rivaroxaban (ROCKET-AF), and Apixaban (ARISTOTLE). The new NOACs so far tested in clinical trials have all shown non-inferiority compared with VKAs, with better safety, consistently limiting the number of ICH. Ν Engl J Med 2009;361: Ν Engl J Med 2011;365: Ν Engl J Med 2011;365:

29 ESC Guidelines 2012

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