Left Atrial Appendage Closure for Atrial Fibrillation 2015 UPDATE
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1 Left Atrial Appendage Closure for Atrial Fibrillation 2015 UPDATE Adam Greenbaum, MD NCVH Detroit
2 Disclosures Former proctor: SentreHEART Discussion may include the use of non-fda approved devices or off-label use of devices.
3 Objectives Review the scientific evidence that supports LAA closure as a stroke prevention strategy in patients with non-valvular atrial fibrillation Discuss the devices available in the US in 2015 Discuss the patient selection process
4 Stroke in the US 4th leading cause of death; leading cause of disability (38.6 billion in 09 ) Lifetime risk (1 in 5 women; 1 in 6 men) 87% ischemic 23.5% due to AF ( 200,000) in pts >80 y underestimated in asymptomatic AF AF increases risk of stroke 5-fold all ages; risk of AF, stroke and bleeding all increase with age Right: 76 y old with AF (increased volume, >5 branches, > 40 twigs and no fine 91-98% LAA involvement; 40% of AF pts have a structures) contraindication to anticoagulation AHA Heart Disease and Stroke Statistics 2014 Circ 2013:129:e28-e292
5 Surgical Closure of the LAA ACC/AHA A Fib Guidelines 2014 JACC March 2014.
6 Transcatheter Options For the Patient Who can Tolerate Warfarin
7 WATCHMAN First implanted in 2002 CE Mark in 2005; FDA approved 2015
8 Protect AF Trial Non-valvular AF, CHADS2 score 1, randomized 2:1 WATCHMAN or warfarin Endpoints: stroke, CV death, systemic embolism and safety (bleeding, procedural complications effusion/stroke/embolization) Warfarin 45 days, ASA + clopidogrel for 4.5 m, then aspirin only 707 pts recruited (Watchman 463, control 244) Mean f/u 18 +/- 10 pt. months Holmes, Lancet Vol 374 August 15, 2009
9 Protect AF Trial 3% vs 4.9% per year (Not Inferior) Primary Efficacy Reddy VY, et al. Circulation 2013; Vol : Jan
10 Protect AF Trial 5.5% vs 3.6% per year Primary Safety Reddy VY, et al. Circulation 2013; Vol : Jan
11 Protect AF Trial Landmark Analyses Secondary prevention Reddy VY, et al. Circulation 2013; Vol : Jan
12 PREVAIL Trial 407 pts randomized in 41 US centers CHADS 2 2 to be followed for 5 years Holmes, et al. JACC 2014:64(1):1-12
13 Device Safety Holmes, et al. JACC 2014:64(1):1-12
14 FDA Approval - Watchman March 2015 Non-valvular atrial fibrillation Increased risk of stroke based on CHADS2 or CHA2DS2VASc score Deemed by physician to be suitable for warfarin Appropriate rationale to seek alternative to warfarin taking into account the safety and efficacy of the device
15 Watchman Post Procedure Therapy Aspirin mg + warfarin (INR 2-3) x 45 days TEE at 45 days If closed (<5mm residual flow): aspirin 325mg + clopidogrel 75mg x 4.5 months then aspirin mg daily indefinitely
16 European Guidelines 2012 European Heart Journal (2012) 33,
17 Transcatheter Options For the Patient Who Cannot Tolerate Warfarin
18 LARIAT SentreHEART FDA Approved soft tissue closure 2012 Not with specific indication for stroke prevention
19 PLACE II Permanent Ligation Approximation Closure and Exclusion Non-randomized, single center, observational study Objective: assess safety and efficacy or LAA closure Patients with non-valvular AF, CHADS 2 >1 & ineligible to warfarin A poor candidate for warfarin therapy (e.g., labile INR level, non-compliant, contraindicated) and/or a warfarin failure (i.e. TIA or stroke while on warfarin therapy) Dec 2009 to Dec 2010; n=119 Bartus K, et al. JACC 2012 Sep 28; S
20 LARIAT SentreHEART 1 year 98% <1mm 2% < 2mm
21 Lariat - Literature Summary # of LARIAT cases Serious Injury to cardiac / related structure >2 PRBC in 2 days post Organ / structure requiring intervent. Fatal Pericarditis requiring hosp or surg tx Hemothorax Pneumothorax Vascular injury requiring surg treatment, hospitalization, transfusion Afzal % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 4.00% Han % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Miller % 0.00% 0.00% 0.00% 2.40% 0.00% 0.00% 0.00% Price % 8.40% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Massumi % 0.00% 5.00% 0.00% 0.00% 0.00% 0.00% 0.00% Stone % 0.00% 0.00% 0.00% 3.70% 0.00% 0.00% 0.00% Bartus % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 1.10% Bartus % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Sievert % 0.00% 0.00% 0.00% 0.00% 0.00% 0.70% 0.00% Lakkireddy % 0.00% 0.00% 0.00% 0.00% 0.00% 1.40% 1.40% Pilliarisetti % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Range 0-7.3% 0-8.4% 0-5.0% 0.00% 0-3.7% 0.00% 0-1.4% 0-4.0% Wtd Avg % 0.45% 0.27% 0.00% 0.33% 0.00% 0.11% 0.35% 3.83%
22 ASAP Trial ASA Plavix feasibility study with Watchman 150 pts with non-valvular a-fib, CHADS2 score 1, ineligible for warfarin (93% due to bleed) Multicenter, prospective, non-randomized Endpoints: stroke, CV/unexplained death, systemic embolism Clopidogrel or ticlopidine for 6 months and lifelong aspirin Mean f/u /- 8.6 months Reddy, et al JACC 2013;61:2551-6
23 ASAP Trial ASA Plavix feasibility study with Watchman 6 pts (4%) had thrombus seen by TEE (164 +/- 135 days post) Only one associated with stroke (341 days post) The 5 pts without stroke were treated conservatively (4 with 4 to 8 weeks of LMWH and 1 no treatment) Reddy, et al JACC 2013;61:2551-6
24 Patient and Device Selection ICH Life threatening bleeding Stroke off OAC Life threatening bleeding High CHADS 2 High CHADS 2 High HASBLED Alternative to OAC
25 CONCLUSIONS The data suggests that LAA closure is not inferior (and perhaps superior) to an7coagula7on Efficacy, mortality and Quality of Life benefits LAA closure is an op7on for high- risk pts with AF who have contraindica7ons/intolerance to long term an7coagula7on Long term and more safety data needed with newer devices
26 Left Atrial Appendage Closure for Atrial Fibrillation 2015 UPDATE Adam Greenbaum, MD NCVH Detroit
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