LAA and Stroke Prevention
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1 LAA and Stroke Prevention Samuel J. Asirvatham, MD Professor of Medicine, Professor of Pediatrics Program Director Cardiac Electrophysiology; Vice Chair Innovations Mayo Clinic Turin, October 26, MFMER
2 Disclosure I receive royalties for work licensed through Mayo Clinic to a privately held company for contributions related to the use of nerve signal modulation to treat central, autonomic, and peripheral nervous system disorders, including pain. Mayo Clinic receives royalties and owns equity in this company. The company does not currently license or manufacture any drug or device in the medical field. Co-patent holder for technique to minimize coagulum formation during radiofrequency ablation Products or techniques related to the above disclosures are not being discussed in this presentation. Pertains to inventions/startup companies that include Nevro, Aegis, and the Phoenix Corp. Honoraria/Speakers: Abiomed Biotronik Blackwell Futura Boston Scientific Medtronic Sanofi-aventis Spectranetics St. Jude Consulting: Sanofi Stereotaxis 2012 MFMER
3 Appendage Ligation and AF Ablation Do they work? Additional risk Additional Benefit Approach dependence Electrophysiology Additional procedures 2012 MFMER
4 AF and Stroke Risk of stroke 5 times greater in patients with AF than those without 1 When AF occurs in association with stroke Higher mortality Greater disability Lower discharge rate home 15% risk of stroke recurrence within 1 year, if untreated 1 Wolf PA et al. Stroke 1991;22: Lip GYH, Edwards SJ. Thromb Res 2006;118: MFMER
5 Stroke Prevention in Non-Rheumatic AF Aspirin Compared with Placebo Relative risk reduction (95% CI) AFASAK I 432 SPAF I 57 EAFT 403 ESPS II 404 LASAF 447 UK-TIA 46 Adjusted-Dose Warfarin Compared with Placebo Relative risk reduction (95% CI) AFASAK I 432 SPAF I 57 BAATAF 428 CAFA 436 SPINAF 437 EAFT 403 All trials (n=6) All trials (n=6) Aspirin better 19% reduction Nondisabling > disabling More effective with HTN/DM 0-50 Aspirin worse Warfarin better 0-50 Warfarin worse 80% reduction MFMER
6 Annual Rates of Major Hemorrhage During Anticoagulation 4 Major Bleeding Rate (%/Year) Average = 1.2%/yr. 0 AFASAK SPAF BAATAF CAFA SPINAF Fuster V et al.j Am Coll Cardiol 2011;57:e101-e MFMER
7 2012 MFMER
8 White CJ et al J Am Coll Cardiol 2011;58: MFMER
9 Since the AF risk factors also cause atherosclerosis, how important is the LAA for stroke in AF? 2012 MFMER
10 Stroke: TEE findings for source of Embolism 25 % LAA SEC LAA Th Ao Athero PFO AS Aneur unselected Strokes 108 Cardioembol Strandberg et al JNNP 2002;73:29 Sorescu et al Am J Med Sci 2003;326: MFMER
11 Association Between AF and Stroke Mechanism AF Vascular inflammation + fibrosis Diminished LAA contraction Atrial myopathy LAA thrombus Implications AF precedes CVA Control of AF may prevent CVA LAA closure prevents CVA AF (marker of disease burden) Mechanical dysfunction/ thrombus AF burden predicts risk No temporal association between AF and stroke Role of LAA depends on which tissue affected 2012 MFMER
12 Ischemic area Embolus blocks blood flow LAA-Dependent and LAA-Independent Stroke in AF LAA independentarch, carotid, intracerebral Aspirin sensitive Fibrillation in LA LAA dependent Warfarin/ anticoagulant sensitive Thrombus 2012 MFMER
13 Figure 3 A. surface Duration: 7 sec surface B. atrial ventricular ventricular Atrial rate: 270 bpm markers C. atrial markers * * Atrial rate: 350 bpm ventricular 2012 MFMER
14 ASSERT: Subclinical AF and Stroke Subclinical atrial tachyarrythmias (SAT) detected in 10.1% at 3 mos SATs independently associated with 2.5- fold increased risk of ischemic stroke/se after adjustment (p=0.008) Risk independent of other risk factors for stroke and of presence of clinical AF p = p <0.001 Healey JS et al. N Eng J Med 2012;366: MFMER
15 Temporal Relationship Between AF and Stroke AT/AF burden (hours/day) Daoud et al: HRJ 2011; 8: CHADS 2 Baseline Antithrombotic Patient # score therapy 1 2 Therapy 2 3 ASA 3 6 None 4 5 ASA 5 1 OAC 6 4 ASA 7 2 ASA 8 1 OAC/ASA 9 1 OAC 10 3 ASA 11 4 OAC/ASA 12 5 ASA 13 2 None 14 2 None 15 3 ASA 16 3 None 17 3 OAC/ASA 18 4 OAC/ASA 19 2 ASA 20 2 None Months from CVE The majority of CVE/SE did not occur proximate to AT/AF episodes 2012 MFMER
16 2012 MFMER
17 What have we learned from TEE? We do not see often a clot When we see a clot it is in the LAA LAA has a strange shape prone to clots LAA low velocity predisposes to clots What do we do about it? 2012 MFMER
18 LAA Occlusion Devices **DR Holmes JR. ACC March 2009 Catheter and Cardiovascular Interventions, Oct MFMER
19 2012 MFMER
20 A D B E C F Friedman, Holmes JCE MFMER
21 Device Therapy Targeting the Appendage Endovascular appendage occlusion WATCHMAN Device Other approaches Surgical appendage ligation Surgical appendage removal Minimally invasive bronchoscopic approaches Percutaneous subxiphoid approaches Pericardial appendage obliteration 2012 MFMER
22 Device Evidence that Warfarin Prevent stroke via LAA dependent mechanisms Intent-to-Treat All Stroke Event-free probability patient-year analysis WATCHMAN Control Days Randomization allocation (2 device:1 control) Key Implication: Confirms Role of LAA in CVA Holmes et all Lancet MFMER
23 PROTECT AF Clinical Trial Design Prospective, randomized study of WATCHMAN LAA Device vs. Long-term Warfarin Therapy 2:1 allocation ratio device to control 800 Patients enrolled from Feb 2005 to Jun 2008 Device Group (463) Control Group (244) Roll-in Group (93) 59 Enrolling Centers (U.S. & Europe) Follow-up Requirements TEE follow-up at 45 days, 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin Enrollment continues in Continued Access Registry 2012 MFMER
24 Intent-to-Treat Primary Safety Results Randomization allocation (2 device : 1 control) Device Control Events Total Rate Events Total Rate Rel. Risk Cohort (no.) pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) 900 pt-yr (6.4, 11.3) (2.2, 6.7) (1.18, 4.13) 1.0 Event-free probability 0.9 WATCHMAN Control ,095 Days **DR Holmes JR. ACC March MFMER
25 Intent-to-Treat Primary Safety Results Randomization allocation (2 device : 1 control) Device Control Events Total Rate Events Total Rate Rel. Risk Cohort (no.) pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) 900 pt-yr (6.4, 11.3) (2.2, 6.7) (1.18, 4.13) Event-free probability WATCHMAN ,095 Days Control Effusion Bleeding Double Jeopardy Since must be On coumadin **DR Holmes JR. ACC March MFMER
26 2012 MFMER
27 2012 MFMER
28 2012 MFMER
29 2012 MFMER
30 2012 MFMER
31 2012 MFMER
32 2012 MFMER
33 Ideal Approach No need for anticoagulation No need to enter the left atrium Simple to deploy Rapid recovery No need for post operative bed rest 2012 MFMER
34 Normal Heart External Topography Aorta Ao RA RV RV LV R Ant Oblique L Ant Oblique 2012 MFMER
35 Epicardial Approach Epicardial approach shown to be feasible for VT ablation in patients with CAD. Complication seen in 4/53 patients in form of RV perforation and tamponade. Also effective for other arrhythmias (VT with & without SHD, WPW, RVOT VT, AT) especially when endocardial ablation unsuccessful. No complications seen. Eduardo Sosa, JACC 2000 Schweikert et al. Circulation. 2003;108: MFMER
36 Asirvatham SJ: Innovation Focus: the Patient with Arrhythmia. Journal of Cardiovascular Translational Research 2008; 1: MFMER
37 2012 MFMER
38 Electrical Navigation to Move Within the Closed Pericardial Space 2012 MFMER
39 2012 MFMER
40 Hollow Suture Concept 2012 MFMER
41 Closing Hollow Suture Around LAA 2012 MFMER
42 No Occlusion High Jet Flow During Occlusion No Flow Across Ostium Complete Occlusion MFMER
43 Chronic LAA ligation LAA Closure Site Mitral Valve 2012 MFMER
44 2012 MFMER
45 Utility of ICE With LAA Closure Device Deployment Transseptal access facilitation Identification of left atrial appendage ostium Exclusion of left atrial or left atrial appendage thrombus Identification of unusual left atrial appendage morphology Easy discernment from ostium of left-sided pulmonary vein Accurate sizing of ostium of the appendage Identification of accurate positioning at the mouth of the LAA Identification of blood flow around inappropriately-sized device and assessment of stability 2012 MFMER
46 2012 MFMER
47 2012 MFMER
48 Appendage Ligation and AF Ablation Do they work? Additional risk Additional Benefit Approach dependence Electrophysiology Additional procedures 2012 MFMER
49 AF and Thrombo-embolism Atrial fibrillation Atria quiver Blood clots form in atrial appendage Common cause of throbmoembolism CP MFMER
50 2012 MFMER
51 Survival After Stroke AF Effect 100 Survival (%) No AF Persistent AF n= n=21 0 Petty GW et al: Neurology 1998; 50: Years after first cerebral infarction CP MFMER
52 Atrial Fibrillation is Heterogeneous LAA Right Atrium Left Atrium Modified from:seet, Friedman, Rabinstein Circ MFMER
53 Event Reporting Results of AF Surgery Freedom from permanent AF Freedom from surgical failure Prevalence of AF Freedom from stroke Freedom from pacemaker Gillinov: Surg Atrial Fib, 2002 Depiction Time-related event depiction Time zero = 6 months after date of surgery Time-related event depiction Time zero = 6 months after date of surgery Prevalence vs time Time zero = date of surgery Time-related event depiction Time zero = date of surgery Time-related event depection Time zero = date of surgery CP MFMER
54 2012 MFMER
55 2012 MFMER
56 LSPV LAA LV 2012 MFMER
57 2012 MFMER
58 2012 MFMER
59 Appendage Ligation and AF Ablation Do they work? Additional risk Additional Benefit Approach dependence Electrophysiology Additional procedures 2012 MFMER
60 2012 MFMER
61 2012 MFMER
62 2012 MFMER
63
64 Appendage Ligation and AF Ablation Do they work? Additional risk Additional Benefit Approach dependence Electrophysiology Additional procedures 2012 MFMER
65 2012 MFMER
66 External Cardiac Anatomy Cardiac Chambers Desc Thor Ao LA SVC RA RAA Asc Ao PA LAA LV RV Superior View 2012 MFMER
67 Epicardial Access via RAA 2012 MFMER
68 One lead to pace LV and defibrillate Deflection/flexibility could be added to distal screw/tip to facilitate LV placement 2012 MFMER
69 Clips for thoracotomy 2012 MFMER
70 LAA and Stroke Prevention Samuel J. Asirvatham, MD Professor of Medicine, Professor of Pediatrics Program Director Cardiac Electrophysiology; Vice Chair Innovations Mayo Clinic Turin, October 26, MFMER
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