Devices to Protect Against Stroke in Atrial Fibrillation
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1 Devices to Protect Against Stroke in Atrial Fibrillation Jonathan C. Hsu, MD, MAS Associate Clinical Professor Division of Cardiology, Section of Cardiac Electrophysiology June 2, 2018
2 Disclosures Honoraria Medtronic, St. Jude Medical, Biotronik, Boston Scientific Research Grants Biosense Webster, Biotronik
3 Learning Objectives Evaluate ideal technique of closure (occlusion or ligation) of the left atrial appendage (LAA) Highlight future technologies aimed at improving LAA closure
4 Background Atrial fibrillation (AF) is the most common cardiac arrhythmia In those older than 40 years of age, an estimated 1 in 4 lifetime risk Large projected increase in prevalence by the year 2050 Lloyd-Jones DM, Wang TJ, Leip EP, et al. Circulation 2004;110: Go AS, Hylek EM, Phillips KA, et al. Jama 2001;285:
5 The Aging U.S. Population- Risk for AF Population (x 1000) 30,000 20,000 10,000 US population AF population AF Population (x 1000) 0 0 Feinberg et al. Arch Intern Med. 1995;155:471. Age (years)
6 Background The most serious, common complication of AF is arterial thromboembolism Most clinically evident embolic event is ischemic stroke
7 AF and Stroke
8 Background Antithrombotic therapy with warfarin (and now novel oral anticoagulants) has been shown to: Lower the risk of thromboembolism in patients with AF Regardless of duration Paroxysmal AF Persistent AF
9 Oral Anticoagulant Use Does Not Top 50%, Even in the Highest Stroke Risk AF Patients Hsu, et al. JAMA Cardiology 2016.
10 38-40% of patients at moderate to high risk of stroke treated with Aspirin alone Hsu, et al. JACC 2016.
11 Left Atrial Appendage Exclusion Devices for Stroke Prevention in AF A new era
12 Overview Review technique for novel treatments for ligation or occlusion of the left atrial appendage (LAA) Left atrial appendage occlusion WATCHMAN device (Boston Scientific) Left atrial appendage ligation LARIAT device (SentreHeart, Inc) Review literature on outcomes after LAA exclusion
13 Role of LAA Source of over 90% of thrombus in nonvalvular AF Kim et al. Am J Cardiol 2010; 106:
14 Left Atrial Appendage Occlusion WATCHMAN Device
15 LAA Occlusion- WATCHMAN Manufactured by Boston Scientific FDA approval 3/13/15 Left atrial appendage occlusion device Implanted with transseptal puncture and TEE guidance Goal Reduce stroke risk Comparator Warfarin anticoagulation
16 LAA Occlusion- WATCHMAN Nitinol cage covered by a layer of polyethylene terephthalate (PTFE) Deployed inside the LAA Fabric of the WATCHMAN device is permeable to blood Requires conventional thromboembolic prophylaxis with warfarin At least 45 days post-implant TEE then performed to ensure endothelialization Then treated with both aspirin 81 mg and clopidogrel 75 mg for 6 mo
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18 Watchman Device Nitinol frame Radial expansion 10 anchors 5 sizes 21, 24, 27, 30, 33 mm 160 micron membrane polyethylene terephthalate
19 Watchman Data ~1700 pts in clinical trials Implantation success 91-95% Transseptal puncture Difficult anatomy may exist Ostium diameter > LAA length Chicken wing LAA Complication rate ~3%
20 WATCHMAN Technique
21 Reddy VY, et al. Circulation. 2013;127(6):720.
22 PROTECT-AF Data Non-inferiority trial, >700 patients with nonvalvular, randomization 2:1 ratio to device or long term warfarin Inclusion criteria: paroxysmal, persistent, or permanent AF CHADS2 score 1 Device implantation was successful in 91% Reddy VY, et al. Circulation. 2013;127(6):720.
23 PROTECT-AF Data Composite primary efficacy end point: Stroke, systemic embolism, and cardiovascular death Primary safety end point: Composite of major bleeding, pericardial effusion, procedure related stroke, and device embolization Reddy VY, et al. Circulation. 2013;127(6):720.
24 Protect AF- Endpoints Reddy VY, et al. Circulation. 2013;127(6):720.
25 Primary Safety Endpoint Reddy VY, et al. Circulation. 2013;127(6):720.
26 PROTECT-AF Long Term F/U Reddy VY, et al. JAMA
27 PROTECT-AF Long Term F/U Reddy VY, et al. JAMA
28 PROTECT-AF Long Term F/U Reddy VY, et al. JAMA
29 WATCHMAN- FDA Approval Increased risk for stroke based on CHADS 2 or CHA 2 DS 2 -VASc scores and are recommended for anticoagulation therapy Are deemed by their physicians to be suitable for warfarin Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin
30 Percutaneous Left Atrial Appendage Ligation Procedures to reduce stroke risk in patients, particularly those not able to tolerate oral anticoagulation
31 LARIAT LAA Ligation Non-surgical, percutaneous device Dry epicardial puncture for epicardial access of the LAA Transseptal access for endocardial access of LAA Approved by the US FDA for soft tissue closure ( approximation ) only Particularly those who cannot take oral anticoagulation and are at high risk for stroke due to AF Electrical isolation of the LAAf
32 Subxyphoid Puncture- Appendage Ligation Access Sternum Liver RV LV
33 Subxyphoid Puncture Dry Pericardial Access
34 JACC 2012 epub 10/10/12
35 JACC 2012 epub 10/10/12
36 LARIAT
37 Summary
38 A B C D E F
39 Technique Considerations Epicardial access Micropuncture needle Buddy wire Transseptal access Low and posterior Careful suture technique 45 mm width Maximum
40 LARIAT Long-Term Followup Lakkireddy, et al. Heart Rhythm
41 LARIAT Long-Term Followup 712 consecutive LARIAT Successfully deployed in 682 patients (95.5%) Complete closure in 669 patients (98%) 13 patients (1.8%) had a trace leak (<2 mm) 1 death related to the procedure 10 patients (1.44%) had cardiac perforation necessitating open heart surgery Another 14 (2.01%) did not need surgery Risk of cardiac perforation decreased significantly after the introduction of a micropuncture needle for pericardial access
42 LARIAT Long-Term Followup Delayed complications: Pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge occurred in 34 (4.78%) patients Risk decreased significantly with the periprocedural use of colchicine Follow-up TEE (n =480) showed a leak of 2 5 mm in 6.5% and a thrombus in 2.5%
43 LARIAT and Electrical Activity Han FT, et al. Heart Rhythm May;11(5):
44 LARIAT and AF Burden Lakkireddy D, et al. Heart Rhythm
45 The Future of LARIAT Recent FDA Approval of AMAZE Trial LARIAT ligation for adjunctive treatment of AF Randomized controlled trial LARIAT + PVI ablation vs. PVI ablation alone Persistent or longstanding persistent AF Background: Only percutaneous device with potential mechanical and electrical isolation of LAA myocardium by devascularization
46 LARIAT- AMAZE TRIAL Study plan Enroll a maximum of 600 persistent or longstanding persistent AF patients Candidates for PVI catheter ablation Up to 50 center study The first stage of the AMAZE Trial will enroll up to 175 patients at 15 centers Outcome: recurrent atrial fibrillation Will use of LARIAT as adjunct to PVI decrease AF?
47 Summary AF is common and can result in stroke LAA occlusion devices, mainly Watchman in the United States, have shown equivalence compared to warfarin and will be important as a procedural option in preventing strokes in AF patients LAA ligation can be safe and effective to reduce stroke risk in patients and may have electrical benefit to reduce recurrent AF New occlusion devices will come to market
48 THANK YOU Twitter: JonHsuMD
49 Amplatzer LAA Cardiac Plug
50 Amplatzer LAA Cardiac Plug St. Jude Medical Nitinol-only cage Consists of a left atrial disk and a distal plug connected to the left atrial disk by a short waist Distal plug contains six pairs of barbs designed to increase stability within the appendage Shorter than the Watchman device May be more advantageous in individuals with variable morphology of the appendage given more flexible waist CE Mark approval in Europe, not FDA approved
51 WaveCrest Device
52 WaveCrest Device Coherex Medical Nitinol based, similar design as the Watchman However, WaveCrest is covered by a foam layer on the LAA side and PTFE on the side facing the left atrium Anchors along the LAA side Designed to be deployed at the entrance of the LAA rather deep within the structure May be alternative to Watchman if the LAA is too small to accommodate larger devices CE Mark approval in Europe, not FDA approved
53 THANK YOU Twitter: JonHsuMD
54 LAA Exclusion Contraindicated to Anticoagulation? No Yes Occlusion Device LAA Ligation Surgical exclusion
55 76 year old woman with DM, HTN, atrial fibrillation and spontaneous intracerebral hemorrhage on coumadin with INR 2.8 Discharged from hospital and now recovered, taken off of coumadin
56 Lack of Appropriate OAC
57
58
59 Inappropriate Anticoagulation
60 Inappropriate Anticoagulation
61 ASAP Trial 150 patients with nonvalvular AF and CHADS 2 1, who were considered ineligible for warfarin Primary endpoint was the combined events of ischemic / hemorrhagic stroke, and death. Mean duration of follow-up was 14.4 ± 8.6 mo Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year) Ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS 2 scores
62 Amplatzer LAA Cardiac Plug
63 Amplatzer LAA Cardiac Plug St. Jude Medical Nitinol-only cage Consists of a left atrial disk and a distal plug connected to the left atrial disk by a short waist Distal plug contains six pairs of barbs designed to increase stability within the appendage Shorter than the Watchman device May be more advantageous in individuals with variable morphology of the appendage given more flexible waist CE Mark approval in Europe, not FDA approved
64 WaveCrest Device
65 WaveCrest Device Coherex Medical Nitinol based, similar design as the Watchman However, WaveCrest is covered by a foam layer on the LAA side and PTFE on the side facing the left atrium Anchors along the LAA side Designed to be deployed at the entrance of the LAA rather deep within the structure May be alternative to Watchman if the LAA is too small to accommodate larger devices CE Mark approval in Europe, not FDA approved
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Commercial Products Percutaneous left atrial appendage closure is considered medically necessary when the criteria above is met.
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