INTRODUCINGWATCHMAN

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

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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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A) Institution Evaluation

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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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A) Institution EvaluationInstitutional 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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B) Key Players in LAAC Program

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B) LAAC Team

Operators (EP/IC/Echo)

Imaging

Surgery Backup

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- 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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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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B) Program Structure Options

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

Operators: IC and EP with the support of EchoCoordinator: Supports operators in all program structures

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C) Hospital Support

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C) Hospital SupportBetter 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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C) Hospital Support

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.

“Reimbursement” = Coding + Coverage + Payment RatesUpon FDA approval, we will have Coding and Payment Rates established.

Will apply for Coverage when eligible… immediately after approval.

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Hospital Reimbursement: Will I get paid?

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Implanting Physician Reimbursement: Will I get paid?

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C) Hospital Support

Tools AvailableDownload 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. SH-303719-AA

C) Hospital SupportOther 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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D) Patient Flow through LAAC Procedure

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D) Patient Flow through LAAC Procedure

Educatio

n

• 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

Screenin

g

• 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)

Procedur

e

• 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.)

D) Patient Flow through LAAC Procedure

Patient Education1) Disease State2) Disease Treatment (drug vs. device)3) Procedure4) Risks & Benefits5) Procedure Process

Tools AvailableDownload 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

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Pre Info Post Info

D) Patient Flow through LAAC Procedure

Patient Screening1) Ensure patient is appropriate candidate for LAAC procedure 2) Secure insurance pre-authorization for procedure3) 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)

Name: DOB: Referring 1:Phone: Referring 2:SS/Chart #:

Afib: No Ablation: No Chf: No Htn: No 0CAD: No Htn: No Bleed: No 0

Moderate/Severe Rheumatic Mitral Stenosis No Cardioversion: No Age: 0 Labile INR: No 0Mechanical heart valve No TEE: No Diabetes: No Drugs: No 0Previous Mitral Valve Surgical Repair No Date of TEE: Stroke/TIA: No Renal: No 0

CT: No Vascular dz: No Liver: No 0Pervious CABG No Date of CT: Sex/Gender: Male Stroke/Tia: No 0

Previous Echo: No 0 Alcohol: No 0Date of Echo: 1.9% 0

0 1.1%0.0%

1 62 73 84 95 10

Insurance:Pre-auth:

Surgical date:

Warafin Eligible: No

Action & Next Steps

Afib History Physical History (CHADS Vasc / HASBLED)

NOT LEFT ATRIAL APPENDAGE CANIDATE

Current MedsCHADS2 VASC2 annual risk:

CHADS2 annual risk:

Screening appointment:Coordinator meeting:

Referring Physician Follow-up:

CHADS2 Score:

CHADS2 VASC2 Score:Hasbled score:

Annual Bleed risk:

Comments:

Misc Notes:

Tools to Save, Print & PDF

Where Pati ent Heard About Procedure:Address:

No AFIB

Type

Left Atrial Appendage Closure Evaluation

Demographics: Update List of LAA Patients

Create PDF File

Email Report

Clear Form

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D) Patient Flow through LAAC Procedure

Scheduling Patients1) Schedule pre-procedure diagnostic studies, labs, echo, etc.2) Schedule procedure date (LAA day) for lab time, implanter, anesthesia, TEE physician, patient, company representative

(LAAC team)3) Ensure discharge protocol is understood prior to procedure and re-iterated at discharge4) 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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Day Prior

D) Patient Flow through LAAC Procedure

Pre Procedure Procedure Post

Procedure

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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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Homework

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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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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E) Patient Selection

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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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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

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F) Identify and Educate the Internal and External

Referral Pathways

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Referral Patterns

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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Steps to Building Awareness

BeginPlan your referral strategy and educate your business

partners

ActPublicize through local media and build your referral base

ShareAccelerate adoption by deepening referring physician

understanding

Educate Guide patient flow through education

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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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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- Email 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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G) Market Yourself as a Center of Excellence

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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 DeviceThe WATCHMAN™ LAA Closure Device is CE Marked and is currently available For Investigational Use Only in the United States. Not for sale in the

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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 ****

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.

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• 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

Summary:

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