LAA Occluders: The Right Device for the Right Patient ACC/SHA MEETING OCTOBER 31 ST 2015 JEDDAH, KSA OMER A. M. ELAMIN, MD, FACC

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1 LAA Occluders: The Right Device for the Right Patient ACC/SHA MEETING OCTOBER 31 ST 2015 JEDDAH, KSA OMER A. M. ELAMIN, MD, FACC INTERVENTIONAL CARDIOLOGIST DIRECTOR, ADULT CARDIOLOGY FELLOWSHIP TRAINING PROGRAM KING FAISAL SPECIALIST HOSPITAL AND RESEARCH CENTER, JEDDAH

2 When to implant an LAA closure device? Which device to implant?

3 Rationale for Percutaneous LAA Occlusion

4 AF Treatment Options AF Ablation* Pacing Drugs for Rhythm/Rate Control AND/OR Embolic Management Interventions Drugs (warfarin) Drugs (dabigatran, rivaroxaban, apixaban) Surgical Ligation LAA Clips Endovascular LAA

5 Stroke Risk in AF Patients Non-rheumatic AF pts: Thrombus present in 12.6% of patients. 90% of the thrombi were found in the LAA Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg 1996;61:755 9.

6 Comparison of Various Modalities for Stroke Prophylaxis Pharmacological Management with VKA Effective: 67% stroke risk reduction Management of narrow therapeutic window Major complication: bleeding Surgical Excision of LAA (Appendectomy) Residual shunt: 10% Inconsistent outcomes due to incomplete exclusion Can create pouch with stagnant blood flow High invasiveness Transcatheter Device Closure Minimally invasive nature Designed for percutaneous closure of the LAA An alternative therapy for reducing risk of stroke

7 NOACs vs Coumadin Efficacy Non-inferior to more efficacious Less overall mortality (as a group) Safety Generally safer (less major bleeding and ICH, but more GI bleeding) Concerns No antidote for emergencies Contraindications End-stage renal disease

8 Gaps in Oral Anticoagulant Therapy Thrombus incidence reduced, but not zero Bleeding Patients with ESRD Compliance

9 ESC Guidelines Interventional percutaneous LAA closure may be considered in patients with very high stroke risk and contraindications for long-term anticoagulation.

10 ACC/AHA Guidelines: Cardiac Surgery LAA Occlusion/Excision Recommendation COR LOE Surgical excision of the LAA may be considered in patients undergoing cardiac surgery. IIb C

11 Conditions to Consider Percutaneous LAAO Condition Recurrent ischemic stroke despite well-controlled therapeutic OAC Detail May be considered after exclusion of other sources of embolism Previous ICH Recurrent GI bleeding Co-morbidities Coagulopathies Intolerance to new OAC drugs May be considered as an alternative to the use of novel anticoagulants, acknowledging individual patient factors, and bleeding etiology Bleeding from unknown origin or intestinal angiodysplasia despite endoscopic therapy. Lesions that are not accessible for endoscopic therapy Uncontrolled hypertension, cerebral microbleeds, cerebral amyloid angiopathy Low platelet counts, myelodysplastic syndrome GI intolerance, severe liver and kidney dysfunction. Vitamin K antagonists are the first option to consider, percutaneous LAA occlusion may be considered as a secondary alternative

12 Which device should the patient receive?

Geometry of left atrial appendage assessed with multidetector-row

13 LAA Anatomy Morphologies of the LAA: Windsock (A), chicken wing (B), cauliflower (C) or swan (D) EuroIntervention 2014;10: Geometry of left atrial appendage assessed with multidetector-row computed tomography: implications for transcatheter closure devices

14 Types of LAA Occlusion Devices

15 LAA Occluders PLAATO WATCHMAN AMPLATZER Cardiac Plug

16 LAA Occluders Lariat (SentreHeart) Wavecrest (Coherex) LAmbre (Lifetech)

WATCHMAN Device WATCHMAN is a self-expanding nitinol frame with fixation anchors and a permeable fabric cover Five sizes of device (21, 24, 27, 30 and 33 mm) It is implanted via a

17 WATCHMAN Device WATCHMAN is a self-expanding nitinol frame with fixation anchors and a permeable fabric cover Five sizes of device (21, 24, 27, 30 and 33 mm) It is implanted via a transseptal approach by use of a catheter-based delivery system The delivery catheter is capable of recapturing the device if necessary Received CE mark in 2005 and USFDA approval in 2015

WATCHMAN : Device endothelialization Canine

18 WATCHMAN : Device endothelialization Canine Model 30 Day Canine Model 45 Day Human Pathology - 9 Months Post-implant (Non-device related death) Images on file at Boston Scientific Corporation. Results in animal models may not necessarily be indicative of clinical outcomes.

19 WATCHMAN Device Only device with large number of patients enrolled in prospective randomized trials Implantation success rates 95% Efficacy At 4yrs WATCHMAN was superior to warfarin in primary efficacy, allcause mortality, and cardiovascular death (PROTECT-AF) Safety All procedure-related events (up to 7 days post implant): %

20 FDA indications of WATCHMAN LAA Closure Device The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: - Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy - Are deemed by their physicians to be suitable for warfarin; and Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin

21 WATCHMAN: Pros and Cons Advantages Superior to warfarin at 4 yrs Reduced all-cause mortality compared to warfarin Largest body of evidence Disadvantages Potential for device embolization Depth equals diameter, hence shallow appendages may be a challenge Requires anticoagulation for 6 weeks then antiplatelets for a combined total of 6 months

ACP/Amulet Device Lobe Positioned inside the LAA neck Designed to conform to different sizes and shapes of LAA anatomy Disc Designed to completely seal the LAA at the orifice

22 ACP/Amulet Device Lobe Positioned inside the LAA neck Designed to conform to different sizes and shapes of LAA anatomy Disc Designed to completely seal the LAA at the orifice Stabilizing Wires Engage with the wall of the LAA Help hold the device in place Waist Maintains tension between lobe and disc Flexible connection allows device to self-orient

23 ACP/Amulet Device A Orifice B Landing Zone C Depth

Measurements and Sizing: Device Size Selection Maximum Landing Zone Width (mm) Amulet Device Size Lobe Length (mm) Minimum LAA Depth (mm) Disc Diameter (mm) 11.0-13.0 16 7.5 10 22 13.0-15.

24 Measurements and Sizing: Device Size Selection Maximum Landing Zone Width (mm) Amulet Device Size Lobe Length (mm) Minimum LAA Depth (mm) Disc Diameter (mm) Sheath Diameter 12F or 14F with adaptor 14F

25 ACP/Amulet Device Implantation success rates 95 97% Efficacy 63% RRR in stroke vs expected 60% RRR in bleeding vs expected Safety Periprocedural complications (Stroke/TIA, embolization, tamponade) %

26 ACP/Amulet: Pros and Cons Advantages Widest range of LAA coverage by: size morphology Comparable to Watchman device in efficacy and safety Disadvantages No prospective randomized trial data Potential for device embolization Dual antiplatelet therapy for 6 months

27 LARIAT Device

28 Evidence for Efficacy Implantation success rate 13% of patients had inappropriate anatomy Another 3% had pericardial adhesions, procedure aborted Eventually attempted in 75% of eligible patients 96% successful implantation rate in those attempted Efficacy ~82% (18% developed leaks up to 1 year post procedure) Safety 3.3% (single center; 7.7% complication rate in epicardial ablations)

29 LARIAT: Pros and Cons Advantages No risk of device embolization Allows for immediate postprocedure cessation of anticoagulant or antiplatelet agents Disadvantages Requires both transeptal puncture and pericardial access, with theoretically more patient risk Limited by LAA anatomy (need CT scan) Limited by patient profiles Not FDA approved for LAA closure Late recanalization/leaks

30 Inappropriate Patients for LARIAT Patient Profiles History of pericarditis History of cardiac surgery Pectus excavatum Recent myocardial infarction within 3 months History of thoracic radiation Anatomic Profiles LAA width >40 mm Superiorly oriented LAA with the LAA apex directed behind the pulmonary trunk Bilobed LAA or multilobed LAA in which lobes are oriented in different planes exceeding 40 mm Posteriorly rotated heart

31 Recent FDA statement on LARIAT We identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the LARIAT Suture Delivery Device and/or its associated devices. Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery. Warning to physicians: Be aware that the safety and effectiveness of the LARIAT Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established

32 Which device to implant?

left atrial appendage assessed with multidetector-row

33 Feasibility of endovascular device implantation based on MDCT imaging EuroIntervention 2014;10: Geometry of left atrial appendage assessed with multidetector-row computed tomography: implications for transcatheter closure devices

34 WATCHMAN vs ACP/Amulet WATCHMAN ACP/Amulet US FDA approved Yes No CE marked Yes Yes Prospective randomized clinical studies Implantation success rates 95% 95 97% Complication rates % % Need for anticoagulation First 45 days No Yes No Need for antiplatelets 45 days to 6 months 6 months Range of LA orifice diameters mm mm Minimum LA depth needed >21 mm >10 mm

35 Remember!! When not to implant Valvular AF (MS; prosthetic MV; MV repair) Presence of intracardiac thrombus. Active endocarditis or other infections producing bacteremia. Where placement of the device would interfere with any intracardiac or intravascular structures.

36 Guideline-Based Management Approach Assess need for stroke prophylaxis Assess bleeding risk Assess patient profile Discuss options with patient

37 Summary Most patients will still be treated with OAC For those unable to use OAC, who failed treatment with OAC or have a high risk of bleeding, percutaneous LAA occlusion is a great alternative for stroke prophylaxis Procedural risks and benefits should be outlined to the patient Device choice should be based on LAA size, morphology and patient profile Amongst currently available devices, the LARIAT carries additional risks of pericardial space access, has lower rates of implantation success and an incidence of late recanalization Amongst the intraluminal obliterating devices, the WATCHMAN has the largest body of clinical data, with superiority compared to Warfarin and reduction in all-cause mortality The ACP/Amulet has the largest range of possible anatomical coverage with established safety and efficacy, but lacks randomized clinical data

38 Thank you!

Devices to Protect Against Stroke in Atrial Fibrillation

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 Disclosures Honoraria