How to Increase Your Patient Volume and Screening Efficiency 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

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 Company Names ABBOTT,BSC, VOLCANO MERRIT Consulting Fees/Honoraria

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

Screening Efficiencies Improved Communication Patient Experience It is an Elective Procedure Patient is asymptomatic until it’s too late

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

Average # of Devices/Implant Attempt Devices per Case1- 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

Procedure Duration 1 WATCHMAN FDA Panel Sponsor Presentation. Oct 2014

LAAC Team Left Atrial Appendage Team Operators (EP/IC/Echo) Hospital Admin (Marketing, Coding, Finance, data support) LAA Coordinator Left Atrial Appendage Team Referral Community Imaging Surgery Anesthesiologist Dedicated Lab Staff 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

Team Approach Your Site Understand your institution Academic or Private LAA Clinical or Commercial EP, IC or Both Structural Heart Program Afib or Complex EP Program Use the resources to help build a robust program Marketing Dept Patient databases Patient outreach programs Referral Networks

Institution Criteria Positive Patient Outcomes is Top Priority 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 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

Program not a Procedure Coordinator: Navigates the system & Supports operators in all program structures Structural Heart LAAC can complement current structural program including TAVR, Mitral, ASD/PFO Complex EP / Arrhythmia Complement to existing complex left sided EP procedures Afib Center Complement or new to afib center which manages afib patients and offers all medical and device option to patients LAAC Program Offer a full suite of LAA closure options which include surgical and noninvasive LAAC can be another offering to current surgery options offered to patients

Patient Process Everyone has patients. But do you have a process? Education Educate patients and families about disease and treatment options Educate on the LAAC procedure Explanation of risks and benefits of procedure Explanation of the process from screening >> procedure >> follow up Screening Secure insurance pre-authorization for procedure Ensure patient is appropriate candidate for LAAC procedure (indication)/supporting documentation Review previous TEE (if available) or schedule new TEE to ensure patient in a good candidate (size, thrombus, etc.) Scheduling Schedule pre-procedure diagnostic studies, labs, echo, etc. Schedule procedure date for lab time, implanter, anesthesia, TEE physician, patient, company representative (LAAC team) Schedule post-procedure follow-up office visit, labs and TEE @ time of discharge (if registry req) Procedure Ensure patient has followed pre procedure instructions Ensure all key players in the LAAC team are present for procedure Post procedure ensure that patient and family understand post procedure instructions (medication, follow up TEE date, etc.) Coordinator: Understands the process and walks the patient through

Identify and Educate the Internal and External Referral Pathways Pre Procedure Procedure Post Procedure Referral to Treatment Timeline 48-72 hours Patient / MD contacted Records Pre-auth initiated 7 days TTE / TEE CTA Additional workup 10 days Presented w/ treatment plan in place Scheduled for pre-procedure visit Within 14-28 days Patient is treated

LAAO Registry Pre Procedure Procedure Post Procedure 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. 1. CHADS2 score >2 or CHA2DS2-VASc score > 3 2. Formal shared decision making (SDM) with an independent non-interventional physician 3. Suitability for short-term warfarin 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) .

Identify and Educate the Internal and External Referral Pathways Pre Procedure Procedure Post Procedure Referral to Treatment Timeline 48-72 hours Patient / MD contacted Records Pre-auth initiated 7 days TTE / TEE CTA Additional workup 10 days Presented w/ treatment plan in place Scheduled for pre-procedure visit Within 14-28 days Patient is treated

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

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

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

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

Identify and Educate the Internal and External Referral Pathways Pre Procedure Procedure Post Procedure Referral to Treatment Timeline 48-72 hours Patient / MD contacted Records Pre-auth initiated 7 days TTE / TEE CTA Additional workup 10 days Presented w/ treatment plan in place Scheduled for pre-procedure visit Within 14-28 days Patient is treated

Final Adjustments Pre Procedure Procedure Post Procedure Suggested periprocedural heparin bridging strategies for patients on chronic VKA based on patient thromboembolic and procedural bleed risk. Suggested periprocedural heparin bridging strategies for patients on chronic VKA based on patient thromboembolic and procedural bleed risk. Data from the 9th edition ACCP Guidelines: all grade 2C, except intermediate TE risk.7 *For high-bleed risk procedures: wait a full 48-72 hours before reinitiating postprocedural heparin (LMWH) bridging (especially treatment dose); stepwise increase in postprocedural heparin (LMWH) dose from prophylactic dose first 24-48 hours to intermediate/treatment dose; no postprocedural heparin (LMWH) bridging in very high bleed risk procedures (ie, major neurosurgical or cardiovascular surgeries) but use of mechanical prophylaxis. **Based on individual patient- and procedural-related risk factors for thrombosis and bleeding. Spyropoulos A C , and Douketis J D Blood 2012;120:2954-2962 ©2012 by American Society of Hematology

Identify and Educate the Internal and External Referral Pathways Pre Procedure Procedure Post Procedure Referral to Treatment Timeline 48-72 hours Patient / MD contacted Records Pre-auth initiated 7 days TTE / TEE CTA Additional workup 10 days Presented w/ treatment plan in place Scheduled for pre-procedure visit Within 14-28 days Patient is treated

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

Post Procedure Care Pre Procedure Procedure Post Procedure

Identify and Educate the Internal and External Referral Pathways Patient Volume Identify and Educate the Internal and External Referral Pathways Locate with Atrial Fibrillation LAA Program Direct Referral Primary Cardiologist Primary Care Provider Coumadin Clinic Stroke Team Non Invasive/EP

Patient Volume Source of Patients Within practice Inside the hospital Private practice (GC, GP, Geriatrics…) Patients External Referring centers (EP, IC, cards, Neuro, GI, ER) Inside the hospital (EP, IC, clin cards, Neuro, GI, ER) Within practice

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

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

What is it? Left Atrial Appendage Closure (LAAC) Device Procedure 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) General anesthesia* 1 hour procedure* 1-2 day hospital stay* * Typical to patient treatment in U.S. clinical trials

Implant Success & Warfarin Cessation Does it work? Implant Success & Warfarin Cessation p = 0.04 Implant success defined as deployment and release of the device into the left atrial appendage PREVAIL Implant Success No difference between new and experienced operators Experienced Operators n=26 96% New Operators n=24 93% Warfarin Cessation Study 45-day 12-month PROTECT AF 87% >93% CAP 96% >96% PREVAIL 92% >99% 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.

Does it work? Procedural Success ~70% new operators ~50% new operators 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

Does it work? Meta-Analysis Shows Comparable Primary Efficacy Results to Warfarin PROTECT AF 4 Yrs/PREVAIL 2 Yrs 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 0.004 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) 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

WATCHMANTM Device Reduces Ischemic Stroke Over No Therapy Does it work? WATCHMANTM Device Reduces Ischemic Stroke Over No Therapy (Events/100 Patient-Years) Ischemic Stroke Risk 79% Relative Reduction 67% 83% Baseline CHA2DS2-VASc = 3.4 Baseline CHA2DS2-VASc = 3.8 Baseline CHA2DS2-VASc = 3.9 * Imputation based on published rate with adjustment for CHA2DS2-VASc score (3.0); Olesen JB. Thromb Haemost (2011) FDA Oct 2014 Panel Sponsor Presentation. Hanzel G, et al. TCT 2014 (abstract)

Does it work? PROTECT AF/PREVAIL Pooled Analysis: Less Bleeding with WATCHMANTM Device 6 Months Post-Implant WATCHMAN Warfarin Free of Major Bleeding Event (%) HR = 0.29 p<0.001 71% Relative Reduction In Major Bleeding after cessation of anti-thrombotics Speaker Notes: An analysis of pooled data from the PROTECT AF and PREVAIL trials showed similar post-procedural bleeding rates for WATCHMAN patients who were taking concomitant anti-throbmotics and warfarin patients, up to six months. However, after discontinuing anti-thrombotics at 6 months, WATCHMAN patients had a 71% relative reduction in major bleeding compared to patients treated with warfarin.1,2 Avoidance of long-term bleeding complications, as well as efficacy and procedural risk, should be included when considering the overall benefit of LAA closure.1  1Price M et al. JACC 2014; Vol. 64, Issue 11_S 2After per protocol cessation of anti-thrombotics by WATCHMAN patients. Aspirin Warfarin +Aspirin Warfarin +Aspirin WATCHMAN Device Arm Drug Protocol Aspirin+ Clopidogrel Time (days) Time (months) Definition of bleeding: Serious bleeding event that required intervention or hospitalization according to adjudication committee 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

~50% New Operators in PREVAIL Is it Safe? Favorable Procedural Safety Profile: All Device and/or Procedure-related Serious Adverse Events within 7 Days ~50% New Operators in PREVAIL The pre-specified safety definitions across the trials differed. So they could be compared, we used a broad definition that included all procedural events in each trial. Beyond the first half of PREVAIL, safety event rates are low and comparable to other procedures performed in the LA like AF ablation Procedure complication rates continued to improve with each trial Especially important, because 50% of the operators in Prevail had no prior experience with LAA closure. N=232 N=231 N=566 N=269 N=579 N=10191 * 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

Clinical Trial Experience Post Approval Experience Is it Safe? Favorable Procedural Safety Profile: Major Procedural Complications Across WATCHMAN Studies Clinical Trial Experience Post Approval Experience CAP (N=566) CAP2 (N=579) PREVAIL (N=269) PROTECT AF (N=463) U.S. Cohort (N=3822) EWOLUTION (N=1021) * 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

WATCHMAN™ Patient Selection Who is it for? 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 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. The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. Speaker Notes: 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, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin. SH-230506-AD June15 * Please refer to product DFU for more specific details on patient selection

Who is it for? Prevalence of Antithrombotic Therapy in AF Patients: Insights from the NCDR PINNACLE Registry Oral anticoagulant therapy was defined as prescription of either warfarin sodium, dabigatran, or rivaroxaban, further stratified by warfarin (dark blue) vs dabigatran or rivaroxaban (dark brown). Other treatment strategies included prescription of aspirin only (light brown), aspirin plus a thienopyridine (light blue), or no antithrombotic therapy (light grey). Treatment with a thienopyridine was defined as prescription of clopidogrel bisulfate, ticlopidine hydrochloride, or prasugrel. Use of OACs in AF Patients peaks at ~50%, and use declines with increasing risk Hsu, J et al. JAMA Cardiol. Published online March 16, 2016. doi:10.1001/jamacardio.2015.0374

Who is it for? Patient Selection Risk Stratification: Anatomy: 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? Majority of Patients at High Stroke Risk, All Eligible for Anti-coagulation Anticoagulation Eligible1 CHA2DS2-VASc Score ≥22 93% High Risk1 PROTECT AF CAP PREVAIL CAP2 96% 100% Patients (%) CHA2DS2-VASc Score Source: Holmes, DR et al. JACC 2015. In Press. 1. AHA/ACC/HRS Guidelines (2014). SH-230506-AD June15

Who is it for? Majority of Patients in the Trial were at Moderate to High Bleeding Risk1 Patients (%) HAS BLED* Score 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; SH-230506-AD June15

It’s an Elective Procedure Everything goes hand in hand Screening Efficiencies Procedural Comfort Safe Outcomes Patient Experience More Referrals 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

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

Identify and Educate the Internal and External Referral Pathways Pre Procedure Procedure Post Procedure Referral to Treatment Timeline 48-72 hours Patient / MD contacted Records Pre-auth initiated 7 days TTE / TEE CTA Additional workup 10 days Presented w/ treatment plan in place Scheduled for pre-procedure visit Within 14-28 days Patient is treated

Is it Safe? Favorable Procedural Safety Profile: Major Procedural Complications Across WATCHMAN Studies 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%) 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%) 3 (0.078%) 12 (0.18%) Device embolization 3 (0.6%) 2 (0.7%) 9 (0.24%) 17 (0.25%) Removed percutaneously 1 3 Removed surgically 2 6 Death Procedure-related mortality 1 (0.1%) 4 (0.06%) Additional mortality within 7 days 1 (0.17%) 1 (0.026%) 5 (0.07%) * 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

Pre Procedure Procedure Post Procedure

Positive Patient Outcomes is Top Priority Physician Criteria Positive Patient Outcomes is Top Priority 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 Training programs

PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin Does it work? PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin 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 0.004 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 Efficacy comparable All stroke comparable, but balanced by more isc strokes in WM, but less hemorrhagic. After accounting for the proc strokes in the early PAF experience, no statistical difference in isch strokes CV death statistically favors WM All cause death and major bleeding are comparable between therapies, but after accounting for procedure-related bleeding events such as PEs, major bleeding rates favor WM Favors WATCHMAN   Favors warfarin Hazard Ratio (95% CI) Holmes, DR et al. J Am Coll Cardiol. 2015;65(24):2614-2623.

PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin Does it work? PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin 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 0.004 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 Efficacy comparable All stroke comparable, but balanced by more isc strokes in WM, but less hemorrhagic. After accounting for the proc strokes in the early PAF experience, no statistical difference in isch strokes CV death statistically favors WM All cause death and major bleeding are comparable between therapies, but after accounting for procedure-related bleeding events such as PEs, major bleeding rates favor WM Favors WATCHMAN   Favors warfarin Hazard Ratio (95% CI) Holmes, DR et al. J Am Coll Cardiol. 2015;65(24):2614-2623.

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