Left Atrial Appendage Closure: The Rationale

Transcription

1 Left Atrial Appendage Closure: The Rationale JOHN D. HUMMEL, MD DIRECTOR OF CLINCAL ELECTROPHYSIOLOGY RESEARCH PROFESSOR OF CLINICAL INTERNAL MEDICINE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER 1 Disclosures Modest Advisory Board / Steering Committee Biosense-Webster Medtronic Abbot EP Research St. Jude Biosense-Webster Medtronic Biotronik Boston Scientific 1

2 The Problem: AF Increases Mortality/Morbidity: CVA Driven Odds ratio for bedridden state after CVA due to AF = 2.23 (P < ) than stroke from any other cause (No Difference Between Paroxysmal vs Persistent) AF increases RR of cognitive impairment by 40% AF increases RR for Dementia by 38% Risk of Stroke/Yr > 2% (CHADS 2 or CHA 2 DS 2 VASc 2) without systemic anticoagulation (dementia and stroke risk still increased for CHADS 0 patients) % of AF pts have HasBled Score 3: Denotes 3.74 Bleeds/100 Pt Years Kalantarian, S et al. Ann Int Med 2013; Santangeli, et. Al. Heart Rhythm, 2012; Dulli DA et al. Neuroepidemiology. 2003;22:118-23; AHA, ACC and ESC Guidelines; Camm AJ et al. Eur Heart J ; Jacobs et. Al JCE Afib and the Risk of Dementia Santangeli, et. Al. Heart Rhythm,

3 Risk of Dementia Relative to Time in Therapeutic Range 5 Atrial Fibrillation Anticoagulation 3

4 Use of OACs in AF Peaks at ~50% Use Declines with Increasing Risk Warfarin Bleeding risk Daily regimen High non-adherence rates Regular INR monitoring Food and drug interaction issues Complicates surgical procedures Novel Oral Anticoagulants Bleeding risk Daily regimen High non-adherence rates Complicates surgical procedures Lack of reversal agents High cost Red Line = OAC (DOAC + Warfarin) Hsu, J et al. JAMA Cardiol. ~30% of DOAC Patients Stop Drug at 2 Years Source: Martinez C, et al. Therapy Persistence in Newly Diagnosed Non-Valvular Atrial Fibrillation Treated with Warfarin or NOAC. A Cohort Study. Thromb Haemost Dec 22;115(1):31-9. doi: /TH

5 ACTIVE-A, ACTIVE-W Trials Outcome / year (%) ACTIVE-W: N = 6706; Warfarin superior to clopidogrel + ASA; Trial stopped early* P = Vascular event P = P = 0.53 Stroke Warfarin Major bleeding Clopidogrel + Aspirin ACTIVE-A: N = 7554 Median follow-up 3.6 yrs P = 0.01 Vascular event P < Aspirin Stroke P < Major bleeding *Due to clear evidence of superiority of oral anticoagulation therapy ACTIVE Investigators. N Engl J Med. 2009;360: ACTIVE Investigators. Lancet. 2006;367: Clinical Characteristics Comprising the HAS-BLED Bleeding Risk Score Score Bleeds Per 100 Patient Years A score 3 indicates high risk, and some caution and regular review of the patient is needed following initiation of any anticoagulant Camm AJ et al. Eur Heart J ;31:

6 The Good News: Most Thrombi Come From the Left Atrial Appendage Which Can Be Closed Approximately 90% of LA clots come from the LAA Blackshear JL, Ann Thorac Surg 1996; Alberg H Acta Med Scand 1969; Stoddard MF JACC 1995 Meta Analysis: 8 studies with 2596 patients 84% had a CHADS2 score < 2. TE risk lower in chicken wing morphology than in non-chicken wing morphology (OR 0.46; 95% CI ). Chicken wing Cactus Chicken wing vs cactus: OR 0.49; 95% CI ). Windsock Chicken wing vs windsock: OR 0.48; 95% CI Cauliflower Chicken wing vs cauliflower: OR 0.38; 95%CI Lupercio F, et. al. Heart Rhythm Jul;13(7):

7 Aegis Intrapericardial Ligation Lariat Atriclip Tiger Paw II Post-Atriclip Pouch 14 Osmancik P, Budera P, Zdarska J, Herman D, Petr R, Fojt R, Straka Z. Interact Cardiovasc Thorac Surg

8 Fluoroscopic Guidance to Assist in the Closure of the LAA 15 K Bartus et. Al. J Am Coll Cardiol 2012 WATCHMAN: Left Atrial Appendage Closure Mechanical Anticoagulation 8

9 Total Mortality Relative Reduction (vs warfarin) In Context ARISTOTLE 3 0% RE-LY 1 ROCKET-AF 2 PROTECT AF 4 % Relative Reduction in All-Cause Mortality -5% -10% -15% -20% -25% -30% P=0.13 (NS) P=0.051 P=0.15 (NS) P=0.047 Dabigatran 110 Dabigatran 150 Rivaroxaban Apixaban WATCHMAN 4 yrs -35% P= Results from different clinical trials are not intended for comparison but educational reference only 1 Connolly, S. NEJM 2009; 361: yrs f-up 2 Patel, M. NEJM 2011; 365: yrs f-up, ITT 3 Granger, C NEJM 2011; 365: yrs f-up 4 Reddy, V. LBCT HRS yrs f-up. In the US, WATCHMAN is an investigational device, limited by applicable law to investigational use only and not available for sale. CE Mark