1. How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program
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2. Program Agenda A) Institution Evaluation B) Key Players in LAAC Team
C) Hospital Support
D) Patient Flow
E) Patient Selection
F) Identify and Educate the Internal and External Referral Pathways
G) Market Yourself as a Center of Excellence
Backup Tools & Materials
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3. A) Institution Evaluation
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4. A) Institution Evaluation
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 to 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
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5. A) Institution Evaluation
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:
Ability to commit to initial order – No consignment or rep trunk stock
Boston Scientific partnership / collaboration
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6. B) Key Players in LAAC Program
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7. 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 Backup
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
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8. 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
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9. 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
This looks good!
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10. C) Hospital Support
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11. C) Hospital Support Better Serve your Community
Improve patient outcomes compared to oral anticoagulation
Reduce oral anticoagulation burden on your patients’ QOL
Competitive Advantage
Marketing differentiator
Physician retention and recruitment
Comprehensive AF/Stroke treatment program
Hospital Opportunity
Incremental patient growth
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12. “Reimbursement” = Coding + Coverage + Payment Rates
C) Hospital Support
“Reimbursement” = Coding + Coverage + Payment Rates
Upon FDA approval, we will have Coding and Payment Rates established.
Will apply for Coverage when eligible… immediately after approval.
Key Points
Coverage gaps are routine for new novel technologies (e.g., SAPIEN, MitraClip)
BSC is proactively working with CMS and FDA with the goal of facilitating Medicare coverage as soon as possible after FDA approval
If coverage is not in place upon FDA approval, it will be necessary for clinicians/hospitals to seek coverage on a case-by-case basis by appealing denials if they occur
IN-PATIENT ONLY procedure and anticipate patient population to be primarily Medicare. Not subject to the two midnight rule.
Coverage gaps examples
SAPIEN Valve (TAVR) – approved 11/2/2011, NCD analysis initiated, final determination in May 2012
MitraClip – approved 10/24/2013, CMS opened the NCD process following FDA approval, currently awaiting coverage
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13. Hospital Reimbursement: Will I get paid?
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14. Implanting Physician Reimbursement: Will I get paid?
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15. C) Hospital Support Tools Available Download Central (click above)
WATCHMAN Comprehensive Reimbursement (coding, coverage, and payment) Guide
WATCHMAN Prior Authorization template
WATCHMAN Appeals template
WATCHMAN Economic Value Presentation (via Economic Navigator web tool)
Physician Category III Code Guide
Documentation & MS-DRG Guide
Hospital Appropriateness of Charging Guide
WATCHMAN Value Toolkit
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 labeling.
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. Providers are responsible for making appropriate decisions related to coding and reimbursement submissions. We recommend consulting your relevant manuals for appropriate coding options.
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.
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16. 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
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17. D) Patient Flow through LAAC Procedure
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18. D) 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.)

19. D) Patient Flow through LAAC Procedure
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
Add when available
iPAD Applications
Cardio teach click
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20. Screening Tools Available Patient Identification Tools
D) 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)
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21. Scheduling Tools / Best Practices
D) 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
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22. Pre Procedure Procedure Post Procedure
D) Patient Flow through LAAC Procedure
Pre Procedure
Procedure
Post Procedure
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23. D) Patient Flow through LAAC 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)
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24. Procedure Understanding Understanding of Potential Complications
D) 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
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25. D) Patient Flow through LAAC Procedure
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
Stay on same drugs until physician changes regimen
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
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26. E) Patient Selection
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27. E) 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
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28. E) Patient Selection Patients with high risk for ischemic 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
Expansion slides with anatomy and early vs later
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29. F) Identify and Educate the Internal and External Referral Pathways
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30. 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
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31. 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
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32. F) 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
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33. Referral Education and Materials
F) 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.
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34. G) Market Yourself as a Center of Excellence
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35. 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
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The WATCHMAN™ LAA Closure Device is CE Marked and is currently available For Investigational Use Only in the United States. Not for sale in the United States.

36. Hospital Marketing Resources
Hospital Press Release Template
Product Messaging Guide
Hospital Newsletter Template
Product Images (.jpg files)
Implant animation video
Patient Brochure
Patient Website
Patient Testimonials
*** Link to Resources ****
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The WATCHMAN™ LAA Closure Device is CE Marked and is currently available For Investigational Use Only in the United States. Not for sale in the United States.

37. 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
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