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1. CRT 2017 How to Increase Your Patient Volume and Screening Efficiency Ramon Quesada, MD, FACP, FACC, FSCAI Medical Director, Structural Heart , Complex PCI & Cardiac Research Miami Cardiac & Vascular Institute, Miami, Florida Clinical Associate Professor of Medicine, Florida International University Herbert Wertheim School of Medicine

2. Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Consulting Fees/Honoraria Company Names ABBOTT,BSC, VOLCANO MERRIT

3. Patient Volume Complex anatomy – Complex procedure Increase volume for comfort and familiarity Avoid complications (pericardial effusion, air embolism, device embolization, etc )

4. It is an Elective Procedure Patient is asymptomatic until it’s too late Screening Efficiencies

5. Why do patients screen out? Something they heard Change of mind Transportation Labs Anatomy NO ONE CALLED TO TELL ME!! Screening Efficiencies

6. Average # of Devices/Implant Attempt 1 WATCHMAN FDA Panel Sponsor Presentation. Oct 2014; 2 Boersma, L.et al. EHJ ; published online Jan 2016 in press Devices per Case 1-

7. 1 WATCHMAN FDA Panel Sponsor Presentation. Oct 2014 Procedure Duration

8. LAAC Team Operators (EP/IC/Echo) Imaging Surgery Dedicated Lab Staff Anesthesiologist Hospital Admin (Marketing, Coding, Finance, data support) Referral Community LAA Coordinator Left Atrial Appendage Team Success Factors in Building a LAAC Team Coordinator who understands therapy, program and patient flow Block LAAC Days (anesthesia set time, imaging set time & consistent lab staff) Hospital and administration support Education of referral community to understand procedure as well as ensure appropriate patients Identification of a viable referral base who believes in LAA closure therapy

9. Team Approach Use the resources to help build a robust program Marketing Dept Patient databases Patient outreach programs Referral Networks Understand your institution

10. Institution Criteria Institutional Criteria: Minimum requirements (i.e. transseptal experience, TEE, surgical back-up) Access to AF patients/referral network (ability to maintain case volume) EP/IC collaboration (Heart Team): clinical experience demonstrates more successful adoption in accounts Business Qualifications: Willingness to purchase product and invest in therapy C-suite/senior Support Positive Patient Outcomes is Top Priority Key Players in Hospital Administration Administration: CEO, Directors, Department Chair Economics: Finance-Billing/Coding Team Lab Leaders: CV Service Line Directors Material Mgnt : Purchasing, Inventory, etc Marketing Team: Strategic Planning and Marketing All Onboard

11. Program not a Procedure Coordinator: Navigates the system & Supports operators in all program structures

12. Patient Process Coordinator: Understands the process and walks the patient through Everyone has patients. But do you have a process?

13. Identify and Educate the Internal and External Referral Pathways Referral to Treatment Timeline

14. NCD Criterion 2: Formal SDM interaction with an independent non-interventional physician using an evidenced-based decision tool on oral anticoagulant (OAC) in patients with NVAF prior to LAAC. This interaction must be documented. Independent non-interventional physician: Physician other than implanter CMS references primary care provider, a non-interventional cardiologist, neurologist or those who have experience caring for stroke patients (pg. 77 of decision memo) . LAAO Registry

15. Identify and Educate the Internal and External Referral Pathways Referral to Treatment Timeline

16. LAA Anatomy Assessment Wind Sock: An anatomy in which one dominant lobe of sufficient length is the primary structure Chicken Wing: An anatomy whose main feature is a sharp bend in the dominant lobe of the LAA at some distance from the perceived LAA ostium Broccoli: An anatomy whose main feature is an LAA that has limited overall length with more complex internal characteristics

17. Imaging – Why TEE? Tried and tested Team approach - Cardiologists Anticoagulation Management Anatomy Assessment

18. Imaging – Why CT? Scheduling ease Image consistency Patient comfort Anticoagulation Management Anatomy Assessment

19. Procedure Planning Proper screening imaging for planning the procedure Posterior / Inferior Anterior / Superior

20. Identify and Educate the Internal and External Referral Pathways Referral to Treatment Timeline

21. Suggested periprocedural heparin bridging strategies for patients on chronic VKA based on patient thromboembolic and procedural bleed risk. Spyropoulos A C , and Douketis J D Blood 2012;120:2954-2962 ©2012 by American Society of Hematology Final Adjustments

22. Identify and Educate the Internal and External Referral Pathways Referral to Treatment Timeline

23. Lab Efficiencies - Avoiding a Bottleneck Scheduling Capabilities Lab time Staff Surgical Backup TEE Turnover 4 + procedures per day Protocols in place Patient Communication Preop Orders

24. Post Procedure Care

25. Identify and Educate the Internal and External Referral Pathways Locate with Atrial Fibrillation Patient Volume

26. Source of Patients Patient Volume

27. Hospital Marketing Hospital Press Release Template Product Messaging Guide Hospital Newsletter Template Product Images (.jpg files) Implant animation video Patient Testimonials Patient Education Brochure Patient Volume

28. A Simple Message For the Referring Community What is it? Does it work? Is it safe? Who is it for?

29. One-time implant that does not need to be replaced Performed in a cardiac cath lab/EP suite, does not need hybrid OR Performed by a Heart Team IC/EP or IC&EP , TEE, General Anesthesia, Surgical Back- up, WATCHMAN Clinical Specialist Transfemoral Access: Catheter advanced to the LAA via the femoral vein (Does not require open heart surgery) Left Atrial Appendage Closure (LAAC) Device Procedure General anesthesia* 1 hour procedure* 1-2 day hospital stay* * Typical to patient treatment in U.S. clinical trials What is it?

30. Implant Success & Warfarin Cessation Study 45-day 12-month PROTECT AF 87% >93% CAP 96% >96% PREVAIL 92% >99% Warfarin Cessation PREVAIL Implant Success No difference between new and experienced operators Experienced Operators n=26 96% New Operators n=24 93% p = 0.28 PROTECT AF and CAP: Reddy , VY et al. Circulation. 2011;123:417-424 . PREVAIL: Holmes, DR et al. JACC 2014; 64(1):1-12. p = 0.04 Implant success defined as deployment and release of the device into the left atrial appendage Does it work?

31. Procedural Success Implant success defined as deployment and release of the device into the LAA; no leak ≥ 5 mm * The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use. 1 Boersma , L.et al. EHJ ; published online Jan 2016 in press ; 2 Reddy VY, Holmes DR, et al. JACC 2016; Article in press ~50% new operators ~70% new operators Does it work?

32. Meta-Analysis Shows Comparable Primary Efficacy Results to Warfarin PROTECT AF 4 Yrs /PREVAIL 2 Yrs Source: Holmes, J. D. R., S. K. Doshi, et al. JACC 2015; 65(24): 2614-2623 . Combined data set of all PROTECT AF and PREVAIL WATCHMAN patients versus chronic warfarin patients HR p-value Efficacy 0.79 0.22 All stroke or SE 1.02 0.94 Ischemic stroke or SE 1.95 0.05 Hemorrhagic stroke 0.22 0.004 Ischemic stroke or SE >7 days 1.56 0.21 CV/unexplained death 0.48 0.006 All-cause death 0.73 0.07 Major bleed, all 1.00 0.98 Major bleeding, non procedure-related 0.51 0.002 Favors WATCHMAN   Favors warfarin Hazard Ratio (95% CI) Does it work?

33. WATCHMAN TM Device Reduces Ischemic Stroke Over No Therapy * Imputation based on published rate with adjustment for CHA 2 DS 2 -VASc score (3.0); Olesen JB. Thromb Haemost (2011) Ischemic Stroke Risk (Events/100 Patient-Years) 79% Relative Reduction 67% Relative Reduction 83% Relative Reduction Baseline CHA 2 DS 2 -VASc = 3.4 Baseline CHA 2 DS 2 -VASc = 3.8 Baseline CHA 2 DS 2 -VASc = 3.9 FDA Oct 2014 Panel Sponsor Presentation. Hanzel G, et al. TCT 2014 (abstract) Does it work?

34. PROTECT AF/PREVAIL Pooled Analysis: Less Bleeding with WATCHMAN TM Device 6 Months Post-Implant Time (months) Free of Major Bleeding Event (%) Time (days) Warfarin +Aspirin Warfarin +Aspirin Aspirin+ Clopidogrel Aspirin WATCHMAN Warfarin Definition of bleeding: Serious bleeding event that required intervention or hospitalization according to adjudication committee 71% Relative Reduction In Major Bleeding after cessation of anti- thrombotics HR = 0.29 p<0.001 WATCHMAN Device Arm Drug Protocol Price, MJ. Avoidance of Major Bleeding with WATCHMAN Left Atrial Appendage Closure Compared with Long-Term Oral Anticoagulation : Pooled Analysis of the PROTECT-AF and PREVAIL RCTs. TCT 2014 (abstract) SH-230506-AD June15 Does it work?

35. Favorable Procedural Safety Profile: All Device and/or Procedure-related Serious Adverse Events within 7 Days N=232 N=231 N=566 N=269 N=579 N=1019 1 ~50% New Operators in PREVAIL * The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use. 1 Boersma , L.et al. EHJ ; published online Jan 2016 in press ; 2 Reddy VY, Holmes DR, et al. JACC 2016; Article in press Is it Safe?

36. Favorable Procedural Safety Profile: Major Procedural Complications Across WATCHMAN Studies Clinical Trial Experience Post Approval Experience PROTECT AF (N=463) CAP (N=566) PREVAIL (N=269) CAP2 (N=579) EWOLUTION (N=1021) U.S. Cohort (N=3822) * The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use. Source: Reddy VY, Holmes DR, et al. JACC 2016; Article in press Is it Safe?

37. WATCHMAN™ Patient Selection Indications for Use 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 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; 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. The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. * Please refer to product DFU for more specific details on patient selection SH-230506-AD June15 Who is it for?

38. Prevalence of Antithrombotic Therapy in AF Patients : Insights from the NCDR PINNACLE Registry Hsu, J et al. JAMA Cardiol . Published online March 16, 2016. doi:10.1001/jamacardio.2015.0374 Use of OACs in AF Patients peaks at ~50%, and use declines with increasing risk Who is it for?

39. Patient Selection Risk Stratification: Patients with high risk for ischemic events Patients with high risk for bleeding events Patient must be a candidate for anticoagulation Risk / Benefit of procedure outweigh that of anticoagulation Anatomy: Patients with reasonable anatomy and access Who is it for?

40. Majority of Patients at High Stroke Risk, All Eligible for Anti-coagulation PROTECT AF CHA 2 DS 2 - VASc Score ≥2 2 93% High Risk 1 CAP PREVAIL CAP2 Patients (%) CHA 2 DS 2 -VASc Score 96% 100% 100% Anticoagulation Eligible 1 Source: Holmes , DR et al. JACC 2015. In Press . 1. AHA/ACC/HRS Guidelines (2014). SH-230506-AD June15 Who is it for?

41. Majority of Patients in the Trial were at Moderate to High Bleeding Risk 1 1. Estimated HAS BLED score. Labile INR and liver function were not collected and given a score of zero Source: Holmes DR, et al. Holmes, DR et al. JACC 2015; Patients (%) HAS BLED* Score SH-230506-AD June15 Who is it for?

42. It’s an Elective Procedure Everything goes hand in hand Patient volume comes from education to the community Simplifying the steps keeps the patient engaged. A streamlined process can help more patients Share your success for increased volume

43. Responsibility to the Patient LAAC is an excellent alternative to OAC LAAC is still a new therapy It takes a Team Approach: To build the volume To increase efficiencies If we do so carefully, the patients will benefit

44. Identify and Educate the Internal and External Referral Pathways Referral to Treatment Timeline

45. PROTECT-AF PREVAIL CAP CAP2 EWOLUTION Post-FDA Approval Aggregate Data Pericardial Tamponade 20 (4.3%) 5 (1.9%) 8 (1.4%) 11 (1.9%) 3 (0.29%) 39 (1.02%) 86 (1.28%) Treated with pericardiocentesis 13 (2.8%) 4 (1.5%) 7 (1.2%) n/a 2 (0.20%) 24 (0.63%) Treated surgically 7 (1.5%) 1 (0.4%) 1 (0.2%) n/a 1 (0.10%) 12 (0.31%) Resulted in death 3 (0.78%) Pericardial effusion – no intervention 4 (0.9%) 5 (0.9%) 3 (0.5%) 4 (0.39%) 11 (0.29%) 27 (0.40%) Procedure-related stroke 5 (1.15%) 1 (0.37%) 2 (0.35%) 1 (0.10%) 3 (0.078%) 12 (0.18%) Device embolization 3 (0.6%) 2 (0.7%) 1 (0.2%) 2 (0.20%) 9 (0.24%) 17 (0.25%) Removed percutaneously 1 1 3 Removed surgically 2 2 1 1 6 Death Procedure-related mortality 1 (0.1%) 3 (0.078%) 4 (0.06%) Additional mortality within 7 days 1 (0.17%) 3 (0.29%) 1 (0.026%) 5 (0.07%) Favorable Procedural Safety Profile: Major Procedural Complications Across WATCHMAN Studies * The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use. Source: Reddy VY, Holmes DR, et al. JACC 2016; Article in press Is it Safe?

46. Physician Criteria Clinical / Implanter Qualifications : Physician skills/experience - transseptal experience, AF ablations, structural heart procedures Transseptal experience - 25 punctures in career, 10 within last 12 months (ASD/PFO not applicable) TEE echocardiography experience / skills Commitment to complete the required T raining programs Positive Patient Outcomes is Top Priority

47. HR p-value Efficacy 0.79 0.22 All stroke or SE 1.02 0.94 Ischemic stroke or SE 1.95 0.05 Hemorrhagic stroke 0.22 0.004 Ischemic stroke or SE >7 days 1.56 0.21 CV/unexplained death 0.48 0.006 All-cause death 0.73 0.07 Major bleed, all 1.00 0.98 Major bleeding, non procedure-related 0.51 0.002 Favors WATCHMAN   Favors warfarin Hazard Ratio (95% CI) PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin Holmes, DR et al. J Am Coll Cardiol . 2015;65(24):2614-2623. Does it work?

48. HR p-value Efficacy 0.79 0.22 All stroke or SE 1.02 0.94 Ischemic stroke or SE 1.95 0.05 Hemorrhagic stroke 0.22 0.004 Ischemic stroke or SE >7 days 1.56 0.21 CV/unexplained death 0.48 0.006 All-cause death 0.73 0.07 Major bleed, all 1.00 0.98 Major bleeding, non procedure-related 0.51 0.002 Favors WATCHMAN   Favors warfarin Hazard Ratio (95% CI) PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin Holmes, DR et al. J Am Coll Cardiol . 2015;65(24):2614-2623. Does it work?

49. Baseline Echo Assessment Ostial and length dimensions Largest ostium = 24.8mm Largest ostium = 27.3mm 0 degrees 45 degrees 90 degrees 135 degrees