Left Atrial Appendage Closure Techniques: 2015

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1 Left Atrial Appendage Closure Techniques: 2015 Ramon Quesada, MD, FACP, FACC, FSCAI Medical Director, Interventional Cardiology & Cardiac Research Medical Director, Structural Heart and TAVR Program Baptist Cardiac & Vascular Institute, Miami, Florida Clinical Associate Professor of Medicine, Florida International University Herbert Wertheim School of Medicine

2 Ramon Quesada, MD, FACP, FACC,FSCAI, FCCP Speakers Bureau: Medtronic, Abbott, BSC Consultant/Advisory Board: Abbott

3 Atrial Fibrillation A major source of cardiogenic embolismrelated stroke 500,000 strokes per year AHA estimates that 15 20% of strokes/year are related to AF 90% of thrombus originate in LAA Source: Neurology, 1978; Stroke, 1985; European Heart Journal, 1987; Lancet, 1987

embolism lodges itself in the blood vessels of the brain, restricting blood flow and causing a stroke Thrombus in the

4 Fibrillation causes blood to stagnate in the LAA The stagnant blood becomes an ideal environment for a thrombus or blood clot to form The blood clot, or portion of it, dislodges from the LAA and travels through arterial system The embolism lodges itself in the blood vessels of the brain, restricting blood flow and causing a stroke Thrombus in the LAA Images on file at Boston Scientific Corporation 1 Blackshear JL. Odell JA., Annals of Thoracic Surgery. 1996;61:

CHA 2 DS 2 VASc is a newer scoring system Risk of Stroke CHA 2 DS 2 VASc, developed by Lip et al, is a refinement of the older CHADS 2 Score which includes additional stroke risk factors and puts

disease 1 A Age 65-74 years 1 Sc Sex (female gender) 1 European Society of Cardiology Guidelines 2 CHA 2 DS 2 -VASc Score Treatment 18% 15% 12% 9% 6% 3% 0% 0 No treatment 1 Aspirin or warfarin or

5 CHA 2 DS 2 VASc is a newer scoring system Risk of Stroke CHA 2 DS 2 VASc, developed by Lip et al, is a refinement of the older CHADS 2 Score which includes additional stroke risk factors and puts greater emphasis on age as a risk factor 1 Condition/Risk Factor Points C Congestive heart failure 1 H Hypertension 1 A Age 75 years 2 D Diabetes mellitus 1 S 2 Previous stroke or TIA 2 V Vascular disease 1 A Age years 1 Sc Sex (female gender) 1 European Society of Cardiology Guidelines 2 CHA 2 DS 2 -VASc Score Treatment 18% 15% 12% 9% 6% 3% 0% 0 No treatment 1 Aspirin or warfarin or dabigatran 2 Warfarin or dabigatran 1. Lip GY et al, Chest. 2010;137(2): Camm AJ et al, Eur Heart J. 2010;31: Annual Risk of Stroke 9.8% 9.6% 6.7% 6.7% 3.2% 4.0% 1.3% 2.2% 0.0% 15.2% CHA 2 DS 2 VASc Score

6 An Alternative to Medical Therapy: Percutaneous Closure of Left Atrial Appendage for Stroke Prevention in Non-Valvular Afib Patients

Interventions with the LAA: Clinical Studies Today Ligation, Clips, and Endovascular Options LAA Clip Surgical Ligation EXCLUDE Trial (completed) AtriClip Device was FDA approved

gov identifier: NCT00779857 LAA Closure (LAAC) Devices Currently No FDA approved LAAC device O PLAATO First LAAC device (2001) Device no longer available WATCHMAN Safety and

WATCHMAN LARIAT currently does not have a specific indication for LAA Closure or Stroke Reduction 2 Completed Trials: PROTECT AF Trial PREVAIL Trial ClinicalTrials.

7 Interventions with the LAA: Clinical Studies Today Ligation, Clips, and Endovascular Options LAA Clip Surgical Ligation EXCLUDE Trial (completed) AtriClip Device was FDA approved in 2010 for LAA closure No specific indication for Stroke Reduction ClinicalTrials.gov identifier: NCT LAA Closure (LAAC) Devices Currently No FDA approved LAAC device O PLAATO First LAAC device (2001) Device no longer available WATCHMAN Safety and Efficacy of Left Atrial Appendage Occlusion Devices Observational Study (retrospective) To compare LARIAT vs. WATCHMAN LARIAT currently does not have a specific indication for LAA Closure or Stroke Reduction 2 Completed Trials: PROTECT AF Trial PREVAIL Trial ClinicalTrials.gov identifiers: NCT (PROTECT AF) NCT (PREVAIL) ClinicalTrials.gov identifier: NCT ACP First trial begun in 2013 AMPLATZER C ardiac Plug Clinical Trial ClinicalTrials.gov identifier: NCT Caution: In the US, WATCHMAN is an investigational device, limited by applicable law to investigational use only and not available for sale. CE Mark 2005

LAA tissue Barbs Contour shape accommodates most LAA anatomy Threaded Insert Fabric Cap: (PET) Fabric

8 Threaded Insert Experience with WATCHMAN LAA Closure Device PET fabric Frame: Nitinol structure Available sizes: 21, 24, 27, 30, 33 mm (diameter) 10 Fixation barbs around device perimeter engage LAA tissue Barbs Contour shape accommodates most LAA anatomy Threaded Insert Fabric Cap: (PET) Fabric Polyethyl terephthalate Prevents harmful emboli from exiting during the healing process Barbs 160 micron filter

9 Overview: WATCHMAN Implantation Procedure

WATCHMAN Evidence-Based Medicine 2002 Pilot Endpoints: Feasibility and Safety Comparison: nonrandomzed Incl/Excl: CHADS 2 1, able to tolerate warfarin 2008 CAP Registry Endpoints: Collect additional

10 WATCHMAN Evidence-Based Medicine 2002 Pilot Endpoints: Feasibility and Safety Comparison: nonrandomzed Incl/Excl: CHADS 2 1, able to tolerate warfarin 2008 CAP Registry Endpoints: Collect additional safety and efficacy data to be pooled with PROTECT AF Incl/Excl: same as PROTECT AF 2010 PREVAIL Endpoint: Safety and Efficacy Comparison: warfarin Incl/Excl: CHADS 2 2, some exceptions for CHADS 2 =1 no clopidegrel 7 days prior to procedure 2012: ESC Guidelines & Expanded Indication 2009 ASAP Endpoint: Efficacy 2005 PROTECT AF Comparison: CHADS 2 score expected stroke rate Endpoints: Safety and Efficacy Incl/Excl: intolerant or contra-indicated for warfarin Comparison: warfarin Incl/Excl: CHADS 2 1, able to tolerate warfarin 2013 EMEA Registry* Endpoint: Additional information in a real-world setting Incl/Excl: All comers SH AA

11 WATCHMAN Clinical Study Experience STUDY PATIENTS SITES COMMENTS Pilot 66 8 PROTECT AF Continued Access Registry (CAP) ASAP* patient years of follow-up 30 patients with 5+ years of follow-up 1,500 patient years of follow-up 27 months average follow-up per patient Significantly improved safety results Treat patients contraindicated for warfarin EVOLVE* 37 3 Evaluate next generation WATCHMAN Total 1,563 PREVAIL Same endpoints as PROTECT AF Revised inclusion/exclusion criteria Initiate enrollment November 2010 *European enrollment sites only

12 PROTECT AF 4 Year Follow Up: Primary Efficacy Endpoint SH AA

13 Rate per 100 patient years PROTECT AF Long Term (4 Year Follow-up) Events in PROTECT AF trial at 2,621 patient years % lower 60% lower 34% lower P S = Primary Efficacy P= CV or Unexplained Death P= All-Cause Death WATCHMAN Group N=463 Warfarin Group N=244 Ps = Posterior Probability for Superiority All three endpoints met statistical superiority SH AA

14 Cohort Data from PROTECT AF Intent-to-Treat: Primary Safety Results Reflects the risks of the Intervention WATCHMAN Rate (95% CI) Control Rate (95% CI) Rel. Risk (95% CI) 600 pt-yrs , , , pt-yrs , , , pt-yrs , , , pt-yrs , , , pt-yrs , , , 2.70 Higher upfront risk associated with the procedure Higher relative risk in terms of safety

15 Primary Safety Kaplan-Meier Estimates Event Free Probability Watchman Control Control Watchman Days from Randomization Cohort 1 Year Event Rate (95% CI) 2 Year Event Rate (95% CI) 3 Year Event Rate (95% CI) WATCHMAN 10.1 (7.4, 12.9) 10.4 (7.6, 13.2) 13.6 (9.9, 17.4) Control 4.3 (1.7, 6.9) 6.7 (3.4, 10.0) 8.9.(4.8, 12.9) 1500 Patient-year Analysis

16 What Are these Events and Why are they Happening? Procedure Related Pericardial Effusion / Tamponade Procedure-related stroke Device embolization Bleeding events (mostly associated with Control Group) Intracranial or GI bleeding requiring transfusions 1 bleeding event on device arm while patient was on Coumadin post implant

17 Next Step: Registry More Safety Data from Enrollment in CAP Registry 26 centers continued enrolling in non-randomized CAP registry Gained more experience with procedure Safety data demonstrates the learning curve associated with the procedure Data shows that risks of the procedure have been mitigated

18 Procedure & Implant Success Rates PROTECT AF vs. CAP Procedure Time (Mean ± SD) PROTEC T AF PROTECT AF Early Late CAP p- value* p- value± 62±34 67±36 58±33 50±21 <0.001 <0.001 Implant Success 485/542 (89.5%) 239/271 (88.2%) 246/271 (90.8%) 437/460 (95%) *From tests comparing the PROTECT AF cohort with CAP ±From tests for differences across three groups (early PROTECT AF, late PROTECT AF, and CAP) Implant success defined as attempted case resulting in successful implantation

19 Safety Event Rates in PROTECT AF and CAP PROTECT AF PROTECT AF Early Late CAP p-value* p-value± Proc/Device Rel. Safety AE w/in 7 days 42/542 (7.7%) 27/271 (10%) 15/271 (5.5%) 17/460 (3.7%) Serious pericardial effusion w/in 7 days 27/542 (5%) 17/271 (6.3%) 10/271 (3.7%) 10/460 (2.2%) Proc. Rel. Stroke 5/542 (0.9%) 3/271 (1.1%) 2/271 (0.7%) 0/460 (0%) *From tests comparing the PROTECT AF cohort with CAP ±From tests for differences across three groups (early PROTECT AF, late PROTECT AF, and CAP) The 5 procedure related strokes were air embolisms during procedure Reduced to 0% in CAP from improved air management techniques

20 Primary Safety Kaplan-Meier Estimates CAP PROTECT AF Late PROTECT AF Early

21 Demographics: Device Patients Characteristic Age, years PROTECT AF N= ± 8.8 (463) (46.0, 95.0) CAP N= ± 8.3 (566) (44.0, 94.0) PREVAIL N= ± 7.4 (269) (50.0, 94.0) P value <0.001 Gender (Male) 326/463 (70.4%) 371/566 (65.5%) 182/269 (67.7%) CHADS 2 Score (Continuous) CHADS 2 Risk Factors 2.2 ± 1.2 (1.0, 6.0) 2.5 ± 1.2 (1.0, 6.0) 2.6 ± 1.0 (1.0, 6.0) CHF 124/463 (26.8%) 108/566 (19.1%) 63/269 (23.4%) Hypertension 415/463 (89.6%) 503/566 (88.9%) 238/269 (88.5%) Age /463 (41.0%) 293/566 (51.8%) 140/269 (52.0%) Diabetes 113/463 (24.4%) 141/566 (24.9%) 91/269 (33.8%) Stroke/TIA 82/463 (17.7%) 172/566 (30.4%) 74/269 (27.5%) Most notable differences: Age, Diabetes, and Prior Stroke/TIA <0.001 SH AA PROTECT AF and CAP data from Reddy, VY et al. Circulation. 2011;123:

22 PREVAIL Trial: Co-Primary Endpoints One-sided 95% upper CI bound for success 2.2% 2.67% 2.618% 95% upper CI bound for non-inferiority % upper CI bound for non-inferiority % 2.5% 3.0% Percent of patients experiencing an event Acute (7-day) occurrence of death, ischemic stroke, systemic embolism and procedure or device related complications requiring major cardiovascular or endovascular intervention month Rate Ratio 2.0 Comparison of composite of stroke, systemic embolism, and cardiovascular/unexplained death Similar 18-month event rates in both control and device groups = month Rate Difference Comparison of ischemic stroke or systemic embolism occurring >7 days post randomization Endpoint success in the presence of an over performing control group Endpoint Success; 6 events in device group = 2.2% (6/269) Results are preliminary; final validation not yet complete PREVAIL Results from David Holmes, MD

23 PREVAIL Control (Warfarin) Group Performance In spite of the high average CHADS 2 score of 2.6 in the control group, the observed rate of stroke in the PREVAIL Control group was lower than in other published warfarin studies PREVAIL control group rate = 0.7 (95% CI 0.1, 5.1) Wide confidence bounds due to small number of patients with 18-months of follow-up Trial Control (Warfarin) Group Stroke, Systemic Embolism Rate (Per 100 PY) PROTECT AF RE-LY (Dabigatran) ARISTOTLE (Apixaban) ROCKET AF (Rivaroxaban) PREVAIL 0.7 Results are preliminary; final validation not yet complete PROTECT AF from Reddy, VY et al. Circulation. 2011;123: PREVAIL Results from David Holmes, MD 1 Ischemic stroke rate from Holmes et al. Lancet 2009; 374: Connolly et al. N Engl J Med 2009; 361: Granger et al. N Engl J Med 2011; 365: Patel et al. N Engl J Med 2011; 365:883-91

0% Study Implant Success 95% N= 26 Experienced Operators 96.2% N= 24 New Operators 93.

24 Despite implantation in higher risk patients the WATCHMAN device was safely implanted by new operators PROTECT AF Implant Success CAP Implant Success PREVAIL Implant Success 90.9% 94.3% 95.0% p = 0.01 % of Successful Implants 90.0% 92.0% 94.0% 96.0% 98.0% Study Implant Success 95% N= 26 Experienced Operators 96.2% N= 24 New Operators 93.2% Implant success defined as deployment and release of the device into the left atrial appendage p = SH AA PROTECT AF and CAP data from Reddy, VY et al. Circulation. 2011;123:

7% p = 0.005 8.0% 7.0% 6.0% 5.0% 4.1% 4.4% 4.0% 3.0% n=39 n=23 n=12 2.0% 1.0% 0.

25 % of Patients PREVAIL: 7 Day Serious Procedure/Device Related Complications Composite of vascular complications includes cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications % 9.0% 8.7% p = % 7.0% 6.0% 5.0% 4.1% 4.4% 4.0% 3.0% n=39 n=23 n=12 2.0% 1.0% 0.0% PROTECT AF CAP PREVAIL No procedure-related deaths reported in any of the trials PROTECT AF and CAP data from Reddy, VY et al. Circulation. 2011;123: PREVAIL Results from David Holmes, MD

0 Reduction of ~50% in pericardial effusion rates between studies Procedure-related stroke reduced to 0 Of patients

26 % Patients Procedure related safety events Rates of safety events within 7 days of procedure in PROTECT AF and CAP registry Reduction of ~50% in pericardial effusion rates between studies Procedure-related stroke reduced to 0 Of patients experiencing pericardial effusion in CAP, 90% were treated with pericardiocentesis and 10% required surgical intervention PROTECT-AF CAP Reddy VY et al. Circulation. 2011;123:

27 % of Patients % of Patients PREVAIL 4.0% 3.0% Pericardial Effusions and Stroke p = P = PROTECT AF CAP PREVAIL 2.4% 2.0% 1.0% 0.0% 3.0% 2.0% 1.0% 0.0% 1.6% n=7 0.2% 0.4% n=1 n=1 Cardiac perforation requiring surgical repair p = PROTECT AF CAP PREVAIL 1.1% n=5 0.0% 0.4% n=0 n=1 Procedure/Device Related Strokes 1.2% n=11 n=7 1.5% n=4 Pericardial effusion with cardiac tamponade requiring pericardiocentesis or window PROTECT AF and CAP data from Reddy, VY et al. Circulation. 2011;123: PREVAIL Results from David Holmes, MD

28 PREVAIL: Conclusions Despite implantation in higher risk patients the WATCHMAN device was safely implanted by new operators 2 of 3 primary endpoints were met even in the presence of an over performing control group Results of the PREVAIL trial add to the wealth of previously published data on WATCHMAN PREVAIL Results from David Holmes, MD

29 Procedural Risks: We know what they are and we ve learned techniques to reduce their incidence Cardiac Perforation Transeptal crossing Advancement into LAA Device deployment and recapture Periprocedural Stroke Inappropriate Device Placement Poor Seal of LAA Device Embolization

made shorter, reducing the need to cannulate as deep into

30 Modifications to Device: Have prevented complications or reduced severity of events Technical Improvements Device made shorter, reducing the need to cannulate as deep into LAA New sheath developed Softer tip Markers for guidance into appendage

31 Standardization of Procedure Techniques: Have prevented complications or reduced severity of events Optimized Transeptal access Strict use of pigtail catheter for cannulation of LAA Proper device manipulation Patient Management Reduced ACT levels during procedure Discontinued use of post procedure LMWH

TEE in most cases ICE if that is the operator s comfort level Mid to

32 Avoiding Cardiac Perforation from Transeptal Crossing Use available imaging tools for safe crossing. TEE in most cases ICE if that is the operator s comfort level Mid to inferior and posterior stick for best approach into LAA Getting across difficult septums RF energy for crossing

33 Avoiding Cardiac Perforation While Accessing the LAA Use of the Pigtail catheter Start contrast injection at ostium for full visualization of LAA

34 Angiographic Assessment in Two Views RAO Caudal and Cranial Use multiple imaging planes to understand the anatomy and plan the approach Distinguish separate lobes to determine optimal placement Using only one view may have them overlap on Cine

35 Deployment Knob Avoiding Cardiac Perforation: Device Manipulation Core Wire Hemostasis Valve Constrained Device Distal Marker Band Careful deployment by not advancing into LAA Watch distal tip of device during deployment and recapture

36 Additional Avoidable Risks: Improper seal of LAA Device embolization Avoiding these scenarios requires understanding of LAA and device imaging During baseline screening After device deployment and prior to release

37 Avoiding Device Placement Complications Requires Understanding the Anatomy

38 Identify an Improper Position Before Releasing: Avoid Leaks, Avoid Embolization Example of inadequate position in posterior lobe Final device placement in anterior lobe Off axis position En face view of device Long axis view of device Face at ostium Canted position Barbs disengaged! Stable position Proper seal

39 Understanding Proper Position Before Releasing: Avoid Leaks, Avoid Embolization Device in improper position Final, stable position and good seal Significant Shoulder Much of device is in the left atrium High angle showing proper orientation at ostium Canted position Coaxial Position

Use All Imaging Tools to Confirm Release Criteria Inappropriate Placement Tines compressed distally Rapid filling of contrast into LAA through

40 Use All Imaging Tools to Confirm Release Criteria Inappropriate Placement Tines compressed distally Rapid filling of contrast into LAA through gaps Inferior shoulder protrusion Final Device Placement Device opened up allowing barbs to make contact Slow filling of contrast through filter cap

41 Benefit of Device Therapy: Localized, single intervention, long term solution to stroke prevention Data shows that the therapy is effective Avoids Risks Associated with Anticoagulants: Continual bleeding risk from drugs Systemic effects of medication Patient compliance issues Difficulties with anticoagulation reversal when needed Long term, these problems continue to increase

42 Patient History 79 YR old female with a history of Chronic Atrial Fibrillation with a high risk for anticoagulation due to two episodes of GI bleeding, one episode while on coumadin and the 2 nd episode on Pradaxa. Most recent hospitalization for lower GI bleeding. PMH: previous embolic CVA with no major sequelae HTN, no Diabetes, non-smoker

43 Planned Therapy Patient was referred for LAA occlusion vs exclusion Patient did not qualify for the PREVAIL study (currently in randomization ~ coumadin vs Watchman device) Therefore patient was offered LAA exclusion with the Lariet device

44 Transeptal catheter in place Lariet delivery sheath advanced over the wire transpericardially

45 Magnet wire is advanced to the tip of the left atrial appendage

46 Magnet wire is advanced to the tip of the left atrial appendage and over the wire the balloon marker is advanced to the neck of the appendage.

47 The two magnets are engaged to position for procedure

48 The Lariet device is advanced over the left atrial appendage

49 The snare is closed excluding the left atrial appendage

50 Final result: Complete exclusion of left atrial appendage

51 ATRIAL SEPTAL OCCLUDER FOR LAA CLOSURE Approval Status: First FDA approved for ASD Closure

52 Patient Hx 77 yr old male with hx of embolic CVA, TIAs, CABG, chronic atrial fibrillation, admitted with a grand mal seizure but is at very high risk for anticoagulation. Eval for Watchman device but was not approved. The patient was not a candidate for the Lariet device because of the previous CABG with no intact pericardium. CHADS score of 4.

53 Trans Septal Access

54 LAA Closure: Pre Angio and Guide Engagement

55 LAA Guide Deep Engagement

56 Device ASO Deployment

57 Device Stability Testing

58 LAA Post Release

59 TEE Post Release

60 What We ve Learned About the Risks of Stroke Prevention There are risks involved with the LAA closure procedure The risks we have seen occur under a controlled environment and can be minimized or prevented There are risks and long term complications with anticoagulation LAA occlusion must be seen as an ALTERNATIVE solution for stroke prevention in AF patients Procedure risks need to be considered under the context of the patient s other options

61 Thank You!

Appendage Closure. Jason Rogers, MD. Director, Interventional Cardiology UC Davis Medical Center Sacramento, California

Appendage Closure. Jason Rogers, MD. Director, Interventional Cardiology UC Davis Medical Center Sacramento, California Appendage Closure Jason Rogers, MD Director, Interventional Cardiology UC Davis Medical Center Sacramento, California Left Atrium: Atrial Fibrillation Left Atrial Appendage Left Atrium Incidence of Atrial