Ενδείξεις σύγκλεισης του ωτίου του αριστερού κόλπου. Σκεύος Σιδερής Διευθυντής Καρδιολογικό Τμήμα Ιπποκράτειο Νοσοκομείο Αθηνών

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1 Ενδείξεις σύγκλεισης του ωτίου του αριστερού κόλπου Σκεύος Σιδερής Διευθυντής Καρδιολογικό Τμήμα Ιπποκράτειο Νοσοκομείο Αθηνών

2 Στην Ευρώπη πάσχουν από κολπική μαρμαρυγή ~6 εκ. πληθυσμού. Κολπική μαρμαρυγή: 1%-2% του γενικού πληθυσμού Eur Heart J. 2006;27:

3 Κολπική Μαρμαρυγή Αυξάνει τον κίνδυνο ΑΕΕ ΑΕΕ: η 1 η αιτία θανάτου και η 3 η αιτία αναπηρίας σε κολπική μαρμαρυγή Οι ασθενείς με κολπική μαρμαρυγή έχουν x5 μεγαλύτερο κίνδυνο για ΑΕΕ. 20% όλων των ΑΕΕ συμβαίνουν σε ασθενείς με κολπική μαρμαρυγή. Η κλινικές εκδηλώσεις του ΑΕΕ είναι πιο σοβαρές σε ασθενείς με κολπική μαρμαρυγή (70% κίνδυνος θανάτου ή μόνιμης αναπηρίας) Το σχετιζόμενο με κολπική μαρμαρυγή ΑΕΕ συμβαίνει λόγω απόφραξης μεγαλύτερου μεγέθους εγκεφαλικών αρτηριών Η θνησιμότητα στις 30 ημέρες είναι μεγαλύτερη σε ΑΕΕ οφειλόμενα σε κολπική μαρμαρυγή έναντι των λοιπών ομάδων (25% έναντι 14%) Οι ασθενείς με κολπική μαρμαρυγή και ΑΕΕ παρουσιάζουν δυσμενέστερη πρόγνωση και υψηλότερη επανεμφάνιση ΑΕΕ στον 1 χρόνο. Stroke 1996 ;27: Lerakis S, Synetos A, Toutouzas K, Stefanadis Hellenic J Cardiol. 48: 33-36, 2008

4 Παράγοντες κινδύνου ΑΕΕ C CHA 2 DS 2 -VASc - Congestive heart failure 1 H - Hypertension 1 A D - Age > Diabetes mellitus 1 S - Stroke/TIA 2 V A Sc - Vascular disease 1 - Age Sex-category (female) 1 Maximum score 9 Ετήσιος Κίνδυνος ΑΕΕ Chest 2010;137: Eur Heart J 2010;31:

5 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

6 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:

7 Παράγοντες αιμορραγικού κινδύνου HAS-BLED H - Hypertension 1 A - Renal / liver dysfunction 1 or 2 S - Stroke 1 B - Bleeding 1 L - Labile INRs 1 E - Elderly (age > 65 yrs) 1 D - Drugs or alcohol abuse 1 or 2 Maximum score 9 Score Bleeds per 100 patient-years Eur Heart J 2010;31:

8 C CHA 2 DS 2 -VASc - Congestive heart failure 1 H - Hypertension 1 A D - Age > Diabetes mellitus 1 S - Stroke/TIA 2 V A Sc - Vascular disease 1 - Age Sex-category (female) 1 Maximum score 9 HAS-BLED H - Hypertension 1 A - Renal / liver dysfunction 1 or 2 S - Stroke 1 B - Bleeding 1 L - Labile INRs 1 E - Elderly (age > 65 yrs) 1 D - Drugs or alcohol abuse 1 or 2 Maximum score 9

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. Stroke 1991;22: Circ Cardiovasc Qual Outcomes 2012;5:615-21

10 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

11 Stroke Anticoagulant When a stroke occurs in the setting of anticoagulant therapy, mortality rates approximate 50%. In the National Electronic Injury Surveillance System project included 99,682 emergency hospitalizations, warfarin was the most commonly implicated medication constituting 33% of case. N Engl J Med 2011;365:

12 Stroke Anticoagulant Combined with the anxiety provoked by the fear of bleeding, these reasons have led to the fact that over 40% of patients with NVAF at risk for stroke do not receive warfarin, either because of absolute or relative contraindications, as perceived by patients or physicians. Circ Cardiovasc Qual Outcomes 2014;7:912-9

13 Stroke Anticoagulant The new agents have not become dominant in the field of stroke prevention for several reasons, including cost, lack of antidotes, need for twice daily dosing, and side effects. In addition, by 2 years, 21% to 33% of patients discontinued the NOAC, and the major bleeding rate per year was 2 to 3.5%, both of which are similar to that reported for conventional warfarin. N Engl J Med 2009;361:

14 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.

15 LA Appendage Closure Devices

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19 Watchman device FDA Approval FDA Approval for WATCHMAN Device. Accessed March 24, ACC/HRS/SCAI Left Atrial Appendage Occlusion Device Societal Overview. Heart Rhythm

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22 EWOLUTION Registry Left atrial appendage closure with the WATCHMAN device has a high rate in complete LAAC with low peri-procedural risk, even in population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure. Eur Heart J 2016;37:

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24 Σας Ευχαριστώ για την Προσοχή σας

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27 Transseptal sheath and needle

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

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

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

31 Left Atrial Appendage Closure Complications The majority of procedures were performed by interventional cardiologists (ICs) and each center performed an average of 10.6±11.7 (range 1 to 50) LAA procedures per year. Complication rates varied widely, but included pericardial tamponade (1% to 10%), major bleeds (0% to 8%), thromboembolism (0% to 10%), and device dislodgement (0% to 5%). The majority of the centers (65%) reported a 0% complication rate. JACC 2015;65:

32 Stroke and left atrial appendage The US Food and Drug Administration (FDA) recently approved the use of the Watchman device for reducing the risk of thromboembolism in patients with nonvalvular AF and increased risk of stroke where there is concern about the risks of long-term anticoagulant agents because of the risk of bleeding. JACC 2015;65:

33 ESC Guidelines 2012

34 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

35 Left Atrial Appendage Closure Complications Other procedural risks that occur with devices but not with initiation of pharmacologic therapy include anesthetic-related and peripheral vascular complications, as well as early embolic events Although device embolization is an obvious risk, it is extremely rare. In addition, the long-term implications of leaving a permanent implant and the risk of erosion are largely unknown. JACC 2014;46:291-8

36 Left Atrial Appendage Closure Complications Another important issue relates to the fact that some patients randomized to the device continue to also receive anticoagulant therapy longer term either for a new medical problem, such as the development of pulmonary emboli, or for a residual leak around the device at the LAA ostium, thereby making it difficult to attribute any reduction in stroke solely to the device itself. JACC 2014;63:291-8

37 Left Atrial Appendage Closure Complications In PROTECT AF, high-flow narrow leaks were not associated with increased risk of systemic thromboembolism however, the specific size of a peridevice leak that might increase complications remains unclear. JACC 2012;59:923-9

38 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:

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40 Budget Impact of LAAO LAAC represents an opportunity for savings to healthcare systems in the long term Europace 2014;europace.euu038

41 Left Atrial Appendage Closure Complications Recently published by Tzikas et al, who analyzed 1047 patients from 22 centers. These investigators reported a 97.3% success rate with a 1-year all cause mortality of 4.2%. There was a 59% risk reduction in thromboembolism and a 61% risk reduction in bleeding events Eurointervention 2015

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43 Atrial Fibrillation Atrial fibrillation is a common arrhythmia encountered in clinical practice, with a prevalence of 2 million in the US; this number is expected to increase to 16 million individuals by JAMA 2001;285:2370-5

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

45 CHA2DS2VASc score The CHA2DS2VASc score has since been validated in multiple cohorts, the accumulated evidence shows that CHA2DS2VASc is better at identifying truly low-risk patients with AF and is as good as, and possibly better than, scores such as CHADS2 in identifying patients who developed stroke and thromboembolism. Circ Arrhythm Electrophysiol 2012;5: Eur J Heart Fail 2012;14:

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