AtriCure PM-US-1500B-0830-G EPi-Sense Guided Coagulation System Instructions

AtriCure PM-US-1500B-0830-G EPi-Sense Guided Coagulation

Product Information

Media Interview Guide

The Media Interview Guide is a tool that helps users plan and deliver quality information to media outlets during interviews. The guide specifically focuses on explaining the Hybrid AFTM Therapy and its impact on patients. The guide provides tips on knowing key points, delivering messages quickly and clearly, and creating strong leads into key points. It also includes suggested talking points for users to consider.

Product Usage Instructions

1. Know Your Key Points: Prior to the interview, create a simple and concise outline of the key points you want to convey. Consider who is interviewing you and their audience. Keep in mind that interviews often last only a few minutes, so it’s important to know your message and deliver it quickly and clearly.
   Practicing your points beforehand with a colleague can also be helpful.

2. Give Added Weight to Your Points: Begin your statements with phrases such as “What we’re focused on…” and “The most important factor is…” to create a strong lead into your key points.

3. Use Suggested Talking Points: The guide provides suggested talking points that users can consider when planning for an interview. These talking points include information on the link between heart failure and AF, the increase in stroke risk, and the different symptoms for early stage and advanced stage AF.

4. Deliver Your Message Clearly: During the interview, focus on delivering your key points quickly and clearly. Remember to use the phrases mentioned in step 2 to add weight to your points and create a strong lead. Additionally, be sure to speak clearly and confidently.

5. Follow Up: After the interview, follow up with the interviewer if necessary. This can help clarify any points that were not addressed during the interview or provide additional information.

Media Interview Guide

Conducting a media interview can be intimidating, but with a little planning you can deliver quality information to media outlets. Review the information below to help you plan for an interview explaining the Hybrid AF™ Therapy and its impact on patients.

Know Your Key Points
Create a simple and concise outline of the key points you want to convey in the interview. Consider who is interviewing you and who their audience is. Why do they care about Hybrid AF Therapy? Interviews often last only a few minutes. Know your message and deliver it quickly and clearly. It can help to practice your points beforehand with a colleague. (See the Key Points, p. 2.)

Give Added Weight to Your Points
Begin statements with phrases such as “What we’re focused on …” and “The most important factor is …” to create a strong lead into your key points.

Bring the Conversation Back
An interviewer may not ask questions directly related to your key points, but you still need to convey your message with the short time you have. Use this as an opportunity to answer the question in a way that brings you back to one of your key points.

• Reporter: “My aunt has heart failure. Should she get checked for Afib?”
• Interviewee: “Even though your aunt may have never felt symptoms of Afib, we often see a strong link between heart failure and AF. She should talk to her doctor about it, since we know 1 in 4 people over the age of 40 will develop AF during their lifetime.”1

Navigate Tough Questions

• The interviewer is tasked with telling the whole story, not just putting a positive spotlight on your hospital or treatment, and s/he might ask difficult questions of safety and efficacy. Be prepared for these types of questions. In your response, be sure to politely answer the question with your perspective and bring it back to your key messages whenever possible, ending on a positive note.
• Consider everything you say before, during and after an interview to be “on the record.”

Suggested Talking Points

What Is Hybrid AF Therapy?

• The first ever prospective, multi-center, randomized, controlled trial to focus on treating advanced atrial fibrillation (AF) with a hybrid therapy approach. This is the highest level of evidence.

• People may have heard of endocardial catheter ablation, which treats the inside of the heart.
  The Hybrid AF CONVERGE RCT trial demonstrated the clinical effects of combining the endocardial ablation (inside of the heart) with epicardial ablation (treating the outside of the heart).

• In this way Hybrid AF Therapy targets two key trigger areas where atrial fibrillation usually begins: the pulmonary veins inside the heart and the back wall on the outside of the heart.

Millions of People Need Treatment

• Key Point #1: 1 in 4 adults over age 40 will develop AF in their lifetime1 which causes a 5x increase in stroke risk.2
• Key Point #2: AF affects about 33 million people worldwide3 and 8 million people in the U.S4. More than 3.5 million of those people in the U.S. have advanced AF called long-standing persistent AF.4

This Treatment Is More Effective

• Key Point #3: For people with advanced stages of AF, catheter ablation alone often does not work, even with repeat ablations.5 The Hybrid AF Therapy, which combines ablation on both sides of the heart wall, can be a lasting solution for patients with long-standing persistent AF.6
• Key Point #4: These are some of the 18-month findings with Hybrid AF Therapy:6,7 (compared to catheter ablation alone)
• It was 2x more effective at stopping AF—among patients who didn’t get extra rhythm control medication.
• Patients were more than twice as likely to no longer need AF medications.
• Most people spend at least 90% less time in atrial fibrillation at 1 year.
• Key Point #5: People in the Hybrid AF Arm of the trial report feeling better, both physically and emotionally.7
  Data based on the post-hoc analysis of long-standing persistent AF sub-groups (N=65)

Who Would Benefit from This Therapy?

• People who have long-standing persistent AF. These people have had atrial fibrillation that has lasted for over a year without stopping.
• It is important to note that AF progresses from mild to more severe forms. Without effective treatment, a case of mild, or paroxysmal AF can eventually become long-standing persistent AF.
• Historically, people with this more severe form of atrial fibrillation had few options to stop their AF. That’s why this new Hybrid AF Therapy is so important.

Treating AF Is Always Very Important Because

• It’s a progressive disease.
• Atrial fibrillation puts a person at 5x higher risk of stroke2 and 5x greater risk of heart failure8.
• It is also associated with being less active and a diminished quality of life.9

What Patients Should Know
The symptoms for early stage and advanced stage AF are different. Symptoms for advanced AF:9,10

• Shortness of breath
• Lightheadedness
• Fainting
• Weakness
• Lack of energy
• Chest pain or angina

What Patients Should Do

• Talk to their doctor to find out what treatment is best for them.
• If a patient has had treatment for AF and symptoms continue, there is now a new therapy to consider, the Hybrid AF Therapy. It is important to speak to their doctor about treatment.
• It’s important for each person to find an effective treatment that can stop atrial fibrillation, so that it doesn’t progress and become worse.

EPi-Sense® Coagulation System/EPi-Sense ST™ Coagulation Device
U.S. Indications: The EPi-Sense Guided Coagulation System is intended for the treatment of symptomatic long-standing persistent atrial fibrillation (continuous atrial fibrillation greater than 12 months duration) when augmented in a hybrid procedure with an endocardial catheter listed in the instructions for use, in patients (1) who are refractory or intolerant to at least one Class I and/or III antiarrhythmic drug (AAD); and (2) in whom the expected benefit from rhythm control outweighs the potential known risks associated with a hybrid procedure such as delayed post-procedure inflammatory pericardial effusions. Contraindications include patients with Barrett’s Esophagitis, left atrial thrombus, a systemic infection, active endocarditis, or a localized infection at the surgical site at the time of surgery. Adverse Events: Reported adverse events associated with epicardial ablation procedure may include, but are not limited to, the following: pericardial effusion/cardiac tamponade, pericarditis, excessive bleeding, phrenic nerve injury, stroke/TIA/neurologic complication. Please review the Instructions for Use for a complete listing of contraindications, warnings, precautions and potential adverse events located at the following AtriCure web address: https://www.AtriCure.com/EPi-Sense-Coagulation- Device.
Warnings: Physicians should consider post-operative anti-inflammatory medication to decrease the potential for post-operative pericarditis. and/or delayed post-procedure inflammatory pericardial effusions. Physicians should consider post-procedural imaging (i.e. 1-3 weeks post-procedure) for detection of post-procedure inflammatory pericardial effusions. Precautions: Precautionary measures should be taken prior to considering treatment of patients: (1) Deemed to be high risk and who may not tolerate a potential delayed post-procedure inflammatory pericardial effusion. (2) Who may not be compliant with needed follow-ups to identify potential safety risks. To ensure patients undergoing treatment with the EPi-Sense device are well informed, the benefits, potential risks and procedural outcomes associated with the EPi- Sense Hybrid Convergent procedure should be discussed with the patient. Physicians should document accordingly in the medical record. Qualified operators are physicians authorized by their institution to perform surgical sub-xyphoid pericardial access. The coagulation devices should be used by physicians trained in the techniques of minimally invasive endoscopic surgical procedures and in the specific approach to be used. Operators should undergo training on the use of EPi-Sense device before performing the procedure. Safety and effectiveness of concomitant left atrial appendage closure was not evaluated in the CONVERGE study. Follow-up should be conducted at approximately 30 days post-procedure to monitor for signs of delayed onset pericarditis or pericardial effusion.Rx Only

Sources

1. Lloyd-Jones, D.M., et al. (2004). Lifetime risk for development of atrial fibrillation. Circulation, 110, 1042-1046. doi: 10.1161/01.CIR.0000140263.20897.42

2. Benjamin, E.J., et al. (2019). Heart Disease and Stroke Statistics — 2019 Update: A Report From the American Heart Association. Circulation, 139m e56-e528, DOI: 10.1161/CIR.0000000000000659

3. Rahman, F., et al. (2014). Global epidemiology of atrial fibrillation. Nature reviews cardiology, 11, 639-654.
   https://doi.org/10.1038/nrcardio.2014.118

4. Colilla, S. et al. (2013). Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. American journal of cardiology, 112(8), 1142-1147.

5. Zembala, M., et al. (2017). Staged hybrid ablation for persistent and longstanding persistent atrial fibrillation effectively restores sinus rhythm in long-term observation. Archives of medical science : AMS, 13(1), 109–117. https://doi.org/10.5114/aoms.2015.53960

6. DeLurgio, D.B., et al. (2021). Hybrid epicardial-endocardial RF ablation vs. endocardial catheter ablation for long-standing persistent atrial fibrillation treatment: Results from CONVERGE randomized controlled trial. International AF Symposium.

7. AtriCure. (2020). PMA P200002 FDA Instructions For Use: Epi-Sense® Guided Coagulation System.

8. Odutayo, A. et al. (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ, 354, i4482.

9. Calkins, H. et al. (2018). 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation. Heart rhythm, 14(10):e275-444.

10. Barbarossa, A., et al. (2014). Silent atrial fibrillation: a critical review. Journal of atrial fibrillation, 7(3), 1138.
    http://www.jafib.com/PMC/XML/Inprogress/1138/1138pdf_federico_guerra.pdf.

References

• Global epidemiology of atrial fibrillation | Nature Reviews Cardiology
• Staged hybrid ablation for persistent and longstanding persistent atrial fibrillation effectively restores sinus rhythm in long-term observation
• EPi-Sense System | AtriCure

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