How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program

How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program

Program Agenda A) Institution Profile B) Key Players in LAAC Team
C) Hospital Support D) Reimbursement & Registry E) Patient Flow F) Patient Selection G) Identify and Educate the Internal and External Referral Pathways H) Market Yourself as a Center of Excellence

A) Institution Profile

A) Institution Profile
Your Site Academic or Private LAA Clinical or Commercial EP, IC or Both Structural Heart Program Afib or Complex EP Program Understanding Site Academic or Private: how will a LAA program successfully work (similar goals vs. competing goals) Clinical or Commercial: starting from the ground floor vs. making changes to the existing clinical structure EP, IC or Both: What specialty is leading the therapy will be key to understanding program administration Structural Heart Program: Will have a program to learn from (positive & negatives) Existing AFIB / complex EP program: Understanding of current AFIB patients and their flow

Positive Patient Outcomes is Top Priority Qualification Criteria*
A) Institution Profile Positive Patient Outcomes is Top Priority Qualification Criteria* Institutional Qualifications: 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 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 WATCHMAN training program Business Qualifications: Willingness to purchase product and invest in therapy Prioritization for accounts with established Boston Scientific partnership / collaboration Access to C-suite/senior executives * Sample of qualification criteria, not intended to be a comprehensive list

B) Key Players in LAAC Program

B) 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 Collaboration & coordination is key Coordinator who understands therapy, program and patient flow Block WATCHMAN 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

B) LAA Program Key Players
Operator: Based on operator (EP / IC / Both) will change techniques through out case LAA Coordinator: Identify the LAAC Coordinator / Champion that understands the clinical pathway, process and the procedure Imaging: Small group of physicians that are trained on views. Consistent measuring pre, during and post. Understand needs for trans septal puncture, standardized protocols, sonographer competency with check off to ensure imaging quality Anesthesia: Ability to understand LAA vs TAVR, block time with anesthesia will ensure on time cases LAAC Lab Staff: Educated staff on patient needs, procedure and flow will help with outcomes Surgery: Establish relationship and understanding of possible back up needs and alt therapies Referrals Community: Educated and bought in community that will identify optimal patients for left atrial appendage procedure Hospital Admin: Ensure buy in at all administrative levels of the procedure value for patients and hospital / Marketing / PR

B) Program Structure Options
Operators: IC and EP with the support of Echo Coordinator: Supports operators in all program structures Structural Heart Complement to existing structural heart program LAAC can complement current structural program including TAVR, Mitral, ASD/PFO Complex EP / Arrhythmia Complement to existing complex left sided EP procedures LAA can complement current complex EP program including extractions, afib and VT ablations Afib Center Complement or new to afib center which manages afib patients and offers all medical and device option to patients LAAC can be another offering to your afib patients that suffer from a variety of oral anticoagulation side effects LAA 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

C) Hospital Support

C) Hospital Support Additional Key Players in Hospital Administration
Administration: CEO, Directors, Department Chair Economics: Finance-Billing/Coding Team Lab Leaders: CV Service Line Directors Material Mgt: Purchasing, Inventory, etc Marketing Team: Strategic Planning and Marketing

C) Hospital Support 1st Step to Building Successful LAAC Program
Gain hospital support on all levels Establish and educate on clinical need for program Discuss patient benefit Improve patient outcomes compared to oral anticoagulation Reduce oral anticoagulation burden on your patients’ QOL Discuss Hospital and Program Advantage Marketing differentiator Physician retention and recruitment Comprehensive AF/Stroke treatment program Hospital Opportunity Incremental patient growth

C) Hospital Support Other Efforts to be Coordinated (if applicable):
Quality Team Ensure understanding of WATCHMAN product and support from quality team Value Analysis Team Meeting Secure date and meeting time for WATCHMAN product LAAC Credentials Define credentials are in place at time of launch Reimbursement & Economics Support of WATCHMAN procedure reimbursement process (resources available) Data Support Ability to support tracking and collecting data for study, registry and additional procedures performed on LAAC patients

D) Reimbursement & Registry

Reimbursement = Coding + Coverage + Payment
D) Reimbursement & Registry Reimbursement = Coding Coverage Payment Coding for WATCHMAN remains the same for 2016 Hospitals report ICD10 procedure code: 02L73DK (restricted to inpatient hospital site of service) Physicians report with Category III code: 0281T CPT I code available on January 1, 2017 NCD establishes uniform coverage criteria for local Medicare contractors and Medicare Advantage Plans as of February 8, 2016 Service dates prior to NCD require providers to work with payers to seek individual case consideration Continue to seek prior authorizations with private payers (leverage NCD) Payment for WATCHMAN remains unchanged for 2016 Hospital payment maps to either MS-DRG 273 or 274 Physician payment at discretion of payer – cross walking WATCHMAN to comparable CPT code recommended

Coverage and Physician payment: Category III code 0281T no longer treated as investigational and experimental by medicare, but payment is still not defined WATCHMAN Implanters must crosswalk 0281T with comparable CPT code with similar resources to ensure payment commensurate with advanced cardiovascular procedures Category III codes do not have work units (RVUs) to calculate a defined payment CPT 1 codes have work units associated with a defined physician payment rate Category III codes payment at discretion of payer AMA approved CPT 1 code for LAAC effective Jan 1, 2017 Implanters will continue reporting Category III code 0281T through 2016

CPT Crosswalk: facilitates appropriate physician payment rate for WATCHMAN Implanters would bill 0281T on claim form, describe WATCHMAN procedure and reference CPT code comparator in documentation CPT comparator dependent on time, resources, and competencies associated with performing WATCHMAN based on implanter judgment Procedure Time* (hr) 2016 Work RVUs 2016 Total RVUs 2016 National Payment SVT ablation (3D) 5 24.79 40.24 $1,442 AF ablation (3D) 6 29.81 48.43 $1,735 PFO/ ASD closure 3 21.7 34.48 $1,235 TAVR (trans aortic approach) 33.12 51.98 $1,862 TMVR 32.25 52.30 $1,874 ICD system implant 2 15.17 26.89 $ 963 *Time based on median intraoperative time from CMS 2016 Physician Work Time files

1. CHADS2 score >2 or CHA2DS2-VASc score > 3
D) Reimbursement & Registry The National Coverage Determination (NCD) outlined several criteria for coverage for percutaneous LAAC therapy NCD Criterion 1: The patient must have a CHADS2 score > 2 or CHA2DS2-VASc score > 3 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 Must be documented in medical record to assess stroke risk score and eligibility for LAAC.

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) OAC evidenced-based decision tool:* (Page 92 of decision memo) American College of Physician Foundation: AF Management Guide NICE Patient Decision Aid on AF Treatment Options ACC Cardiosmart’s AF Treatment Options *Current OAC tools do not include LAAC.

3. Suitability for short-term warfarin
D) Reimbursement & Registry NCD Criterion 3: A suitability for short-term warfarin but deemed unable to take long term OAC following the conclusion of SDM 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 A suitability for short-term warfarin: CMS’s decision is aligned with WATCHMAN FDA labeled indication (page 76 of the decision memo)

NCD Criterion 4: Multidisciplinary team (MDT) The patient (preoperatively and postoperatively) is under the care of a cohesive, multidisciplinary team of medical professionals. CMS recommends “the patient care team include pre-operative and post-operative team members and include the addition of two independent non-interventionalists that include two of the following: the patient’s primary care provider, who has the most comprehensive knowledge of the patient a non-interventional cardiologist; or a neurologist who has experience caring for stroke patients.” (pg.77 of decision analysis)

NCD Criterion 5: The procedure must be furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology program. CMS “also recommend standards in all areas, in particular: Institutional volume Procedural area Echocardiography requirements Comprehensive ancillary services with an MDT embedded in a AF and structural heart program to allow for comprehensive patient care Cardiac surgery team on site for surgical backup” (pg. 91 of decision analysis)

NCD Criterion 6: The procedure must be performed by an interventional cardiologist(s), electrophysiologist(s) or cardiovascular surgeon(s) that meet the following criteria: Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and Has performed > 25 interventional cardiac procedures that involve transseptal puncture through an intact septum; and Continues to perform > 25 interventional cardiac procedures that involve transseptal puncture through an intact septum, of which at least 12 are LAAC, over a two year period.

NCD Criterion 7: The patient is enrolled in, and the multidisciplinary team and hospital must participate in a prospective, national, audited registry that consecutively enrolls LAAC patients and tracks the following annual outcomes for each patient for a period of at least four years from the time of the LAAC Hospitals are encouraged to contact NCDR or ) to enroll in the LAAO Registry™. The LAAO data collection form is posted on the NCDR website at Once the hospital is enrolled and actively ready to enter and submit data, the hospital would then be able to retrospectively enter and submit cases. The LAAC registry has been certified as the approved registry, this information is available at

Institutional Claims Billing Instructions On institutional claims (type of bill 11X), hospitals should show: • ICD-10 procedure code of 02L73DK (Occlusion of Left Atrial Appendage with Intraluminal Device, Percutaneous Approach ) • A primary diagnosis code of one of the following: I48.0 – Paroxysmal atrial fibrillation I48.1 – Persistent atrial fibrillation I48.2 – Chronic atrial fibrillation I48.91 – Unspecified atrial fibrillation • A secondary ICD-10 diagnosis code of Z00.6 – Encounter for examination for normal comparison and control in clinical research program • Condition Code 30 (Qualifying Clinical Trial), and • Value Code D4 - Clinical Trial Number (assigned by NLM/NIH with an 8-digit clinicaltrials.gov identifier number listed on the CMS website: (CT )

Professional Claims Billing Instructions Professional claims with dates of service on or after February 8, 2016, for LAAC under CED will be paid only when billed with the following codes: • CPT 0281T • Primary ICD-10 diagnosis code (one of the following): I48.0 – Paroxysmal atrial fibrillation, I48.1 – Persistent atrial fibrillation, I48.2 – Chronic atrial fibrillation, I48.91 – Unspecified atrial fibrillation Place of Service code of 21 (inpatient hospital) • Secondary diagnosis code Z00.6 • Modifier Q0 • Clinical trial number in item 23 of the CMS-1500 form or electronic equivalent (CT )

BSC has Reimbursement Tools & Resources for the WATCHMAN™ LAAC Device
D) Reimbursement & Registry BSC has Reimbursement Tools & Resources for the WATCHMAN™ LAAC Device WATCHMAN Reimbursement Guide WATCHMAN Reimbursement Overview Presentation Pre-authorization and Appeals Templates Physician Category III Code Guide Hospital Documentation & MS-DRG Guide BSC Reimbursement Support Line at 1-800-CARDIAC and ask for reimbursement All Reimbursement resources are easily accessible at or WATCHMAN is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.

Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges, and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA- approved label. Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.

E) Patient Flow through LAAC Procedure

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 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.)

Patient Education Disease State Disease Treatment (drug vs. device) Procedure Risks & Benefits Procedure Process Tools Available Download Central (click above) Patient Material Patient Brochure Patient video / animation Device example Additional Materials WATCHMAN Patient Website click Post Implant FAQ Pre and Post Procedure samples Website(s) StopAfib.org click

Screening Tools Available Patient Identification Tools
E) Patient Flow through LAAC Procedure Patient Screening Ensure patient is appropriate candidate for LAAC procedure Secure insurance pre-authorization for procedure Review previous TEE (if available) OR schedule new TEE (Views, size, thrombus) Screening Tools Available Download Central (click above) Indication Material Echo protocols (view, size, thrombus) Patient Identification Tools EMR queries / workflow Patient database / worksheet LAAC Patient Sources (Coumadin clinics, GI clinic, ER)

Pre-procedural Instructions (found in DFU)
E) Patient Flow through LAAC Procedure Pre-procedural Instructions (found in DFU) A baseline TEE should be performed to verify that a patient’s anatomy is appropriate for a WATCHMAN® Device to be implanted. 1. Assess the following through multiple imaging planes (0°, 45°, 90° and 135° sweep): LAA size/shape, number of lobes in LAA, and location of lobes relative to the ostium. Confirm the absence of thrombus (use Color Doppler and echo contrast as necessary). 2. Record LAA ostium and LAA length measurements (0°, 45°, 90° and 135° sweep). Measure the LAA ostium at approximately these angles: at 0° measure from coronary artery marker to a point 2 cm from tip of the “limbus” at 45° measure from top of the mitral valve annulus to point 2 cm from tip of the “limbus” at 90° measure from top of the mitral valve annulus to a point 2 cm from tip of the “limbus” at 135° measure from top of the mitral valve annulus to a point 2 cm from tip of the “limbus” Measured maximum LAA ostium width must be ≥17 mm or ≤31mm to accommodate available device size

Scheduling Tools / Best Practices
E) Patient Flow through LAAC Procedure Scheduling Patients Schedule pre-procedure diagnostic studies, labs, echo, etc. Schedule procedure date (LAA day) for lab time, implanter, anesthesia, TEE physician, patient, company representative (LAAC team) Ensure discharge protocol is understood prior to procedure and re-iterated at discharge Schedule post-procedure follow-up office visit, labs and TEE Scheduling Tools / Best Practices Dedicated LAA days (operator, anesthesia, echo, lab staff) Ensure ample inventory and supplies WATCHMAN Checklist Ensure patient understands pre and post procedure expectations Standard Discharge worksheet

Pre Procedure Procedure Post Procedure
E) Patient Flow through LAAC Procedure Pre Procedure Procedure Post Procedure

Pre-Procedural Screening Understanding the indication and patient selection is key Ensure patient qualifies for a WATCHMAN Imaging requirements (size, thrombus, etc) Educate patient and family on procedure Consent patient Pre-Procedural Screening Tools / Best Practice Download Central (click above) Patient Education Material Sample Documents (WATCHMAN homework and Information Sheet)

Procedure Understanding Understanding of Potential Complications
E) Patient Flow through LAAC Procedure Procedure Understanding Download Central (click above) Procedure explanation & video (click above) Understanding of Potential Complications Pericardial Effusion Device Migration Peri-Procedural CVA Assess complication

Post Procedure Patient Post Procedure Hospital Stay 1 night overnight (in most cases) Follow Up Office Visits Follow Up Office visit 7 – 10 post procedure (or your protocol) TEE Follow Up at 45 days Drug Regimen Recommended (next page) Coordinator / Hospital Post Procedure Data collection for internal database/required registry Discharge Instructions completed by NP / Physician Follow up and TEE scheduled Update Referral MD on procedure and patient outcome SH AB June 2015

Post-Procedural Information (found in DFU)
E) Patient Flow through LAAC Procedure Post-Procedural Information (found in DFU) 1. Post-procedure warfarin therapy is required in ALL patients receiving a WATCHMAN Device. Patients should remain on mg of aspirin and warfarin should be taken post-implant (INR ). At 45 days (±15 days) post-implant, perform WATCHMAN Device assessment with TEE. Cessation of warfarin is at physician discretion provided that any peri-device flow demonstrated by TEE is ≤5 mm. If adequate seal is not demonstrated, subsequent warfarin cessation decisions are contingent on demonstrating flow ≤5 mm. At the time the patient ceases warfarin, the patient should begin clopidogrel 75 mg daily and increase aspirin dosage to mg daily. This regimen should continue until 6 months have elapsed after implantation. Patients should then remain on aspirin mg indefinitely. If a patient remains on warfarin and aspirin mg for at least 6 months after implantation, and then ceases warfarin, the patient should not require clopidogrel, but should increase to aspirin mg daily, which should be taken indefinitely. 2. At 45 days and 12 months: assess WATCHMAN Device with TEE. Confirm absence of intra-cardiac thrombus. Perform color Doppler assessment to include the device/LAA border at the following approximate TEE angles (0°, 45°, 90° and 135°). Measure any residual leak around the device if necessary. If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE. 3. Prescribe appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion

F) Patient Selection

F) 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[1] 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

PATIENT SELECTION FOR TREATMENT
F) Patient Selection PATIENT SELECTION FOR TREATMENT Selection among available treatment options must first take into account whether anticoagulation is indicated to reduce the risk of stroke based on CHADS2 or CHA2DS2-VASc scores. Next, in a patient who is deemed by their physicians to be suitable for anticoagulation with warfarin, physicians and patients should consider the rationale for implantation of the WATCHMAN Device as an alternative to long-term warfarin therapy. Specific factors may include one or more of the following: A history of major bleeding while taking therapeutic anticoagulation therapy. The patient’s prior experience with oral anticoagulation (if applicable), which may include an inability to maintain a stable therapeutic International Normalized Ratio (INR) or inability to comply with regular INR monitoring AND unavailability of an approved alternative anticoagulation agent. A medical condition, occupation, or lifestyle placing the patient at high risk of major bleeding secondary to trauma. Some studies of patients with a history of falls, or at risk for falls and head trauma, have shown that the benefits of anticoagulation therapy to reduce the risk of stroke outweigh the risk of major, life-threatening bleeding. An individualized benefit and risk assessment should be made in such patients.3, 4, 5 The presence of indication(s) for long-term warfarin use, other than non-valvular atrial fibrillation (e.g. mechanical heart valve, hypercoagulable states, recurrent deep venous thrombosis). Specific factors that need to be considered for the WATCHMAN Device and implantation procedure include the following: Overall medical status, including conditions which might preclude the safety of a percutaneous, transcatheter procedure. Suitability for percutaneous, trans-septal procedures, including considerations of: Cardiac anatomy relating to the LAA size and shape. Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity.) Ability of the patient to tolerate general or local anesthesia. Ability of the patient to undergo required imaging. Ability to comply with the recommended post-WATCHMAN Device implant pharmacologic regimen, especially for patients at high risk for bleeding, i.e., the need for warfarin plus aspirin for at least 45 days post-device implantation, clopidogrel and aspirin through 6 months post-procedure, and aspirin indefinitely.

F) Patient Selection Patients with high risk for ischemic events
Patients with high risk for bleeding events Patients with reasonable anatomy and access Patient must be a candidate for long-term anticoagulation Reasonably high risk enough for the patient to notice or comprehend the complications of anticoagulation

F) Patient Selection

G) Identify and Educate the Internal and External Referral Pathways

Referral Patterns Within implanter’s 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 implanter’s practice

Steps to Building Awareness
Begin Plan your referral strategy and educate your business partners Act Publicize through local media and build your referral base Share Accelerate adoption by deepening referring physician understanding Educate Guide patient flow through education

Locate with Atrial Fibrillation
G) 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

G) Identify and Educate the Internal and External Referral Pathways
Identify Internal & External Referral Pathways Educate Internal & External Referral Pathways Internal External Clinic (current patients) Afib Clinic (internal) + Coumadin clinic Cardiologist AHPs Geriataric ER / hospitalist (onset or AFIB / stroke) EMR Data query (existing patients) TEE Screening GI Neurologist Current external referrals (cardiologist, GPs, GI, Neurologist, etc) New referrals due to exclusive technology Internal External Grand rounds Lunch & Learns Morning conference Marketing team (website, newsletter to internal employees) Marketing team (News, media & print to external stakeholders) Dinner engagements Local society meeting

Referral to Treatment Timeline
G) Identify and Educate the Internal and External Referral Pathways Referral to Treatment Timeline 48-72 hours Patient/MD contacted Records/pre-auth initiated 7 days Consult with TTE/TEE Additional workup (Baseline additional customary pre-procedure testing) 10 days Presented w/treatment plan in place Research if appropriate Scheduled for pre-procedure visit Within days Patient is treated

Referral Education and Materials
G) Identify and Educate the Internal and External Referral Pathways Referral Education and Materials Download Central (click above) Education Tools: WATCHMAN Device Overview and WATCHMAN Economic Value Proposition Media Kit Tools: Hospital Press Release, Hospital Newsletter, Video, Images and Product messaging Tools to Engage Referring Physicians Blast Template, Letter of Introduction, Education Event Invite, Education Event Thank You letter Additional Tools Therapy Awareness Toolkit (hard copy & electronic) Implanters step-by-step instruction & easily accessible tools for how to drive awareness for their WATCHMAN program with their referring physicians.

H) Market Yourself as a Center of Excellence

Potential Marketing Opportunities
Use the WATCHMAN™ Device as a proof point for why referring physicians and their patients should seek out care at your institution by incorporating the WATCHMAN Device into: Hospital website/newsletter Newsletters for referring physicians Social media outlets Identify a patient who was enrolled in the clinical study who would be willing to share their story Consider inviting local media to your institution to coincide with an implant Use a patient story you may have identified Interview the implanting physician Issue hospital press release Engage hospital switchboard so they know who to direct patients to when asked about stroke/WATCHMAN Device

Marketing Resources from BSC
Hospital Press Release Template Product Messaging Guide Hospital Newsletter Template Product Images (.jpg files) Implant animation video Patient Testimonials Patient Education Brochure *** Link to Resources ****

Therapy Awareness by BSC
Patient Website Patient Brochure Referring Physician Website Referring Physician Brochure Implanting Physician Finder Digital and Print Ads

Summary: Starting a left atrial appendage program takes a dedicate team to support patient flow, LAAC cases and new patients Appropriate and optimal patient selection is key to success Education at all levels of the hospital: administration, operators, coordinator, lab, anesthesia, cv surgery, referral community is key to long term program success Build and educate referral pathways to ensure patient flow

ABBREVIATED STATEMENT WATCHMANTM Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Access System 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. Contraindications Do not use the WATCHMAN Device if: Intracardiac thrombus is visualized by echocardiographic imaging. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. The LAA anatomy will not accommodate a device. See Table 46 in the DFU. Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. There are contraindications to the use of warfarin, aspirin, or clopidogrel. The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section) such that the use of the WATCHMAN Device is contraindicated. Warnings Device selection should be based on accurate LAA measurements obtained using fluoro and ultrasound guidance (TEE recommended) in multiple angles (e.g., 0º, 45º, 90º, 135º). Do not release the WATCHMAN Device from the core wire if the device does not meet all release criteria. If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE. The potential for device embolization exists with cardioversion <30 days following device implantation. Verify device position post-cardioversion during this period. Administer appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion. For single use only. Do not reuse, reprocess, or resterilize. Precautions The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated. The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying the device. Use caution when introducing the WATCHMAN Access System to prevent damage to cardiac structures. Use caution when introducing the Delivery System to prevent damage to cardiac structures. To prevent damage to the Delivery Catheter or device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath. If using a power injector, the maximum pressure should not exceed 100 psi. In view of the concerns that were raised by the RE-ALIGN1 study of dabigatran in the presence of prosthetic mechanical heart valves, caution should be used when prescribing oral anticoagulants other than warfarin in patients treated with the WATCHMAN Device. The WATCHMAN Device has only been evaluated with the use of warfarin post-device implantation. ADVERSE EVENTS Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to: Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect , AV fistula , Bruising, hematoma or seroma, Cardiac perforation , Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device thrombosis, Edema, Excessive bleeding, Fever, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection / pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device / improper seal of the appendage / movement of device from appendage wall, Myocardia erosion, Nausea, Oral bleeding, Pericardial effusion / tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency / failure, Surgical removal of the device, Stroke – Ischemic , Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions There may be other potential adverse events that are unforeseen at this time. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. 1Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:

How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program

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How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program

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