ICE 2012 Ioannina,

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1 ICE 2012 Ioannina, Case presentation Left Atrial Appendage Occlusion therapy for Stroke Prevention in Atrial Fibrillation Apostolos Tzikas MD, PhD, FESC Interventional Cardiology Congenital & Structural Heart Disease Inter-Balkan Medical Center, Thessaloniki, Greece

2 Disclosures Consultant, Proctor & Lecturer - St. Jude Medical

3 Atrial Fibrillation AF increases 5 fold the risk of embolic stroke Up to 20% strokes are related to AF AF strokes tend to be especially severe and disabling De Vos et al. J Am Coll Cardiol Wolf et al. Stroke Wolf et al. Stroke. 1994

4 % of Patients Atrial Fibrillation Effect of first ischemic stroke in patients with AF (n=597) 60% 50% 40% 30% 20% 10% 0% Disabling Fatal Gladstone et al. Stroke. 2009

5 Risk for Stroke CHADS 2 Score CHA 2 DS 2 VASc Score CHF 1 CHF or LVEF <40% 1 HTA 1 HTA 1 Age > 75 1 Age 75 2 Diabetes 1 Diabetes 1 Stroke or TIA 2 Stroke or TIA 2 Vascular Disease 1 Age Female 1

6 Risk of Bleeding Bleeding Risk Score

1. Patient selection Antiplatelet therapy with aspirin + clopidogrel, or - less effectively - aspirin only, should be considered in patients who refuse any OAC, or cannot tolerate

7 1. Patient selection Antiplatelet therapy with aspirin + clopidogrel, or - less effectively - aspirin only, should be considered in patients who refuse any OAC, or cannot tolerate anticoagulants for reasons unrelated to bleeding If there are contraindications to OAC or antiplatelet therapy, left atrial appendage occlusion, closure or excision may be considered

8 1. Patient selection

9 AF Cost analysis Cost in $ Aspirin Aspirin and Clopidogrel Warfarin (not including INR monitoring) Dabigatran 10 / year 1857 / year 180 / year 3240 / year Cost of INR 26 / visit Moderate to severe Iscemic Neurological Event (admission) Moderate to severe Iscemic Neurological Event (long-term) 5400 / month Major bleeding without residua 4400 Hemorrhagic stroke (admission) Hemorragic stroke (long-term) 5700 / month Shah et al. Circulation. 2011

10 OAC Drugs Dabigatran

12 Where is the thrombus located?

13 Where is the thrombus located? Location of Thrombus in Non-Rheumatic AF 91% (201/222) of Left Atrial Thrombus Localized to the LAA Setting N Appendage % LA Body % Reference TEE Stoddard; JACC, 1995 TEE Manning; Circ, 1994 Autopsy Aberg; Acta Med Scan, 1969 TEE Tsai; JFMA, 1990 TEE Klein; Int J Card Image, 1993 TEE & Operation Manning; Circ, 1994 SPAF III TEE Klein; Circ, 1994 TEE Leung; JACC, 1994 TEE Hart; Stroke, 1994 Total Thrombus Blackshear et al. Ann Thorac Surg.1996

14 LAA Anatomy 11.1 mm 10.7 mm Su et al. Heart. 2008

15 Aorta Anatomy of LAA LUPV Superior Wall of the LAA Cresta 10 mm Lt. Cx artery

16 Is it possible to close the LAA percutaneously?

17 LAA Closure Devices PLAATO Soccer ball WATCHMAN 1/2 Rugby ball AMPLATZER CARDIAC PLUG Puck & Disc

18 LAA Closure Trans-septal puncture AP view Lateral view 1-3 cm

19 LAA Closure Devices Related Studies

20 PLAATO study Multicentric and Prospective 111 patients on aspirin with formal contraindication to OAC drugs Patients with CHADS 2 1 Device successfully implanted in 108 (97.3%) N=111 Major or minor stroke 2 Myocardial Infarction 0 Surgery related to device implantation 1 Cardiac or Neurologic death 4 Major Adverse Events 7 (in 5 patients) Ostermayer et al. J Am Coll Cardiol. 2005

21 PROTECT AF Study WATCHMAN DEVICE

22 PROTECT AF Study WATCHMAN device vs. Long-term Warfarin First and only available randomized trial Non-Inferiority design Allocation 2:1 (device:control) 800 patients Device (463) Control (244) Holmes et al. Lancet. 2009

23 PROTECT AF Study Primary End Point: CV death, Stroke or Systemic Embolization Holmes et al. Lancet. 2009

24 PROTECT AF Study All cause Stroke Holmes et al. Lancet. 2009

25 PROTECT AF Study Hemorrhagic Stroke Holmes et al. Lancet. 2009

26 PROTECT AF Study Adverse Events Adverse events Any pericardial effusion - Requiring drainage Procedural-related stroke - Air emboli Watchman N= (6.5%) 22 (4.8%) 5 (1.1%) 4 (0.9%) Warfarin N=244 0% 0% 0% 0% Device embolization 3 (0.6%) 0% Major bleeding 16 (3.5%) 10 (4.1%) Hemorrhagic stroke 1 (0.2%) 6 (2.5%) Others (arrhythmia, espoph tear) 2 (0.4%) 0% CV surgery from procedural complications 10 (2.2%) 0% Holmes et al. Lancet. 2009

27 PROTECT AF Study Adverse Events Pericardial effusions most common safety issue Throughout PROTECT AF Trial, procedural modifications and training enhancements were implemented Site implant group Any Serious No. % No. % Early patients (1-3) 13/ / Late patients ( 4) 27/ / Total 40/ / Holmes et al. Lancet. 2009

28 PROTECT AF Study Conclusions The WATCHMAN LAA Technology offers a safe and effective alternative to warfarin in patients with non-valvular AF at risk for stroke who are eligible for warfarin therapy Substantial learning curve effect Second randomized trial ongoing Holmes et al. Lancet. 2009

The Amplatzer Cardiac Plug Self-expanding device made from a nitinol mesh and polyester patch 8 different sizes: 16-30 mm

29 The Amplatzer Cardiac Plug Self-expanding device made from a nitinol mesh and polyester patch 8 different sizes: mm Easy deployment with microscrew Retrievable + repositionable Reliable Occlusion CE Mark Dec 2008 > 3500 implants worldwide

30 The Amplatzer Cardiac Plug PV Ridge Lt. Circumflex artery Mechanism of Action

31 LAA Closure Devices - ACP

32 LAA Closure Devices - ACP Angiography

33 LAA Closure Devices - ACP Lobe

34 LAA Closure Devices - ACP Disc

35 LAA Closure Devices - ACP Release

36 LAA Closure Devices - ACP LAA closure

37 LAA Closure Devices - ACP European N= 143 Asia-Pacific N=20 Brasil N=86 Procedural Success 132 (96%) 19 (95%) 85 (99%) Stroke during hospitalization 3 (2.1%) 0 (0%) 2 (2.3%) Pericardial effusion 5 (3.5%) 0 (0%) 1 (1.1%) Cardiac Tamponade 5 (2.8%) 0(0%) 1(1.1%) Device Embolization 3 (2.1%) 0 (0%) 2 (2.3%) Follow-up 13 months 12 months Stroke during FU - 0 (0%) 0 (0%) Park et al. CCI. 2010; Lam et al. CCI. 2012; Guérios et al. Arq Bras Cardiol. 2012

LAA Closure Devices ACP MHI 25 patients Montreal unable Heart to Institute take Warfarin for AF From November 2009 to September 2011 CHADS 2 score: 3.

38 LAA Closure Devices ACP MHI 25 patients Montreal unable Heart to Institute take Warfarin for AF From November 2009 to September 2011 CHADS 2 score: 3.24 ± 1.09 Indications Intracranial Bleeding: 9 (36%) Gastro-Intestinal Bleeding: 6 (24%) Non Gastro-Intestinal Bleeding: 8 (32%) Other reasons: 2 (8%)

39 LAA Closure Devices - ACP European Asia-Pacific Brasil MHI N= 143 N=20 N=86 N=25 Procedural Success 132 (96%) 19 (95%) 85 (99%) 25 (100%) Stroke during hospitalization 3 (2.1%) 0 (0%) 2 (2.3%) 0 (0%) Pericardial effusion 5 (3.5%) 0 (0%) 1 (1.1%) 0 (0%) Cardiac Tamponade 5 (2.8%) 0(0%) 1(1.1%) 0 (0%) Device Embolization 3 (2.1%) 0 (0%) 2 (2.3%) 0 (0%) Follow-up 13 months 12 months 16 months Stroke during FU - 0 (0%) 0 (0%) 1 (4%)

40 LAA Closure Devices - ACP

41 LAA Closure Devices - ACP

42 LAA Closure Devices - ACP

43 LAA Closure Devices - ACP

44 LAA Closure Devices Future Perspectives PLAATO withdrawn from the market due to financial reasons WATCHMAN second generation device abandoned ongoing randomized clinical trial New devices Percutaneous endocardial (Occlutech, Coherex, Gore, etc) Epicardial (Epitek, AtriCure, SentreHeart, Medtronic, etc)

45 LAA Closure Devices Future Perspectives ACP ongoing randomized clinical trial pooled retrospective multicenter study second generation device Amulet FIM July 2012 (Montreal) CE mark expected early 2013

and stiffness Increased waist length End-screw

46 ACP 2 Amulet Increased lobe length Increased disc diameter Stabilizing wires: increased in number and stiffness Increased waist length End-screw recessed Larger sizes ( 34mm) Flexible delivery cable

47 Conclusions Take Home Message LAA device closure is a safe and effective alternative in patients with non-valvular AF and a formal contraindication for OAC drugs requires specific technical skills and has a significant learning curve More randomized studies are needed, especially in the era of new OAC drugs

48 Thank you!

50 LAA Thrombus Migration of LAA thrombus caught on TEE Parekh A et al. Circulation 2006

51 Control Device PROTECT AF Study Day 0 Day 2-14 Day 45 postimplant Ongoing to 5 years Preimplant interval Device subject takes warfarin Device subject has ceased warfarin Device subject gets implant Randomize Control subject takes warfarin Day 0 Ongoing to 5 years Holmes et al. Lancet. 2009

52 P Design differences: ACP vs WATCHMAN ACP WATCHMAN The roof of the LA PV PV MV MV MV MV

53 PROTECT AF Study 87% of implanted subjects were able to cease warfarin at 45 days and the rate further increased at later time points Visit Watchman N/Total (%) 45 day 349/401 (87.0) 6 month 347/375 (92.5) 12 month 261/280 (93.2) 24 month 95/101 (94.1) Reasons for remaining on warfarin therapy after 45-days Observation of flow in the LAA (n = 30) Physician Order (n = 13) Other (n = 9) Holmes et al. Lancet. 2009

54 CCS AF Guidelines CHADS 2 = 0 Aspirin mg/day CHADS 2 = 1 Aspirin or OAC (Coumadin or Dabigatran) OAC preferred over aspirin CHADS 2 2 OAC (Coumadin or Dabigatran) CCS AF Guidelines. 2010

LAA Surgical Closure Success of different techniques for LAA closure Type of Closure n Patent LAA Remnant LAA Excluded LAA with Persistent Flow Successful LAA Closure Excision 52 0 14 (27%) 0

55 LAA Surgical Closure Success of different techniques for LAA closure Type of Closure n Patent LAA Remnant LAA Excluded LAA with Persistent Flow Successful LAA Closure Excision (27%) 0 38(73%) Suture exclusion 73 6 (8%) 6 (8%) 44 (61%) 17 (23%) Stapler exclusion 12 2 (17%) 7 (58%) 3 (25%) 0 (0%) Total (6%) 27 (20%) 47 (34%) 55 (40%) Kanderian et al. J Am Coll Cardiol.2008

LAA Surgical Closure Elimination of the LAA may impede thirst in hypovolemia, deteriorate hemodynamic As patients responses age and to often volume develop or pressure atrial fibrillation, overload,

56 LAA Surgical Closure Elimination of the LAA may impede thirst in hypovolemia, deteriorate hemodynamic As patients responses age and to often volume develop or pressure atrial fibrillation, overload, prophylactic decrease cardiac output appendage and promote removal heart whenever failure. the Instead chest of is open preventing is suggested strokes, as the consequences a method of to LAA prevent elimination future strokes. may thus In chronic create new AF patients, risk factors for stroke. appendicectomy In general, elimination can be done of the with LAA a mini-thorascopic might induce more approach. harm than benefit Futher to patients studies with are atrial planned fibrillation. to demonstrated As long as the the role effectiveness of the LAA is not of appendicetomy fully understodd in preventing it should strokes not be in the eliminated. chronic fibrillating patients. Johnson et al. European Journal of Cardiothoracic Surgery.2000

57 OAC Drugs Coumadin Coumadin has several disadvantages Slow onset/offset of action Unpredictabe response Resistance Routine monitoring Frequent dose adjustements Numerous food-drug interactions Narrow therapeutic window (INR 2-3)

58 Events / 1000 patient years OAC Drugs Coumadin 80 Target INR ( ) Ischemic stroke (70% more if INR <2) Intracranial haemorrhage (100% more if INR >3) 20 0 < >4.5 Hylek et al. N Eng J Med. 2003

59 New OAC Drugs Characteristic Apixaban Rivaroxaban Dabigatran Target Factor Xa Factor Xa Thrombin Prodrug No No Yes Bioavailability 60% 80% 6% Dosing Fixed, b.i.d. Fixed, o.d. Fixed, o.d or bid Half life 12 hours 7 to 11 hours hours Renal clearance 25% 35% 80% Monitoring No No No Drug interactions Potent CYP3A4 & P-gp inhibitors Potent CYP3A4 & P-gp inhibitors Potent P-gp inhibitors

60 New OAC Drugs Bleeding Major bleeding 4.00 RR 0.93 (95% CI: ) RRR 20% 3.32 p=0.32 (sup) D110 mg BID D150 mg BID Warfarin 342 / 6, / 6, / 6,022 Connolly et al. N Eng J Med. 2009

61 Feature ACP Amulet Sizes (mm) Disc Ø Lobe + 4mm Lobe + 6mm Lobe + 6mm Lobe + 7mm Lobe Length 6.5mm 7.5mm 10mm Waist Length 4mm 5.5mm 8mm SW Ø # SW Pairs Oversizing mm 3-5mm 3-6mm Sheath (Fr) Disc End Screw Protruding Recessed PKG Partially pre-loaded Fully pre-loaded

Atrial Fibrillation RIA: Prevalence of atrial fibrillation increases th age Prevalence of AF 12 10 8 lence ) 6 4 2 0 <55 55-59

62 Atrial Fibrillation RIA: Prevalence of atrial fibrillation increases th age Prevalence of AF lence ) < Age (years) Women (n = 7801) Men (n = 10,173) Go AS et al. JAMA. 2001;285: Go et al. JAMA. 2001

63 Anatomy of LAA - Variability MSCT

Watchman a Stroke Prevention Technology for Patients with Atrial Fibrillation

Watchman a Stroke Prevention Technology for Patients with Atrial Fibrillation Scripps hospital,la Jolla, CA Atrial fibrillation is a major source of cardiogenic embolic related stroke 500,000 strokes per