PM-EU-3936A-0127-G - LAA Patient Brochure EN - Digital

Is Heart Surgery in

Your Future? Ask your doctor about reducing your risk of stroke * by eliminating your left atrial appendage

*Originated from the left atrial appendage (LAA)

Your Heart Serves Two Primary Functions

The heart pumps blood throughout your body and controls heart rate. Sometimes the heart can stop functioning normally and be managed with medications or medical procedures.

Common Heart Surgery Procedure

Coronary Artery Bypass Graft (CABG)

Mitral Valve Replacement (MVR)

Aortic Valve Replacement (AVR)

Surgical Ablation (SA)

You Are Having Heart Surgery Now What? Approximately 30% of patients having cardiac surgery have pre- operative Atrial Fibrillation. 1 Atrial fibrillation is an abnormal and irregular heartbeat, or heart rhythm. Atrial fibrillation is caused by irregular electrical signals in the heart. You might also hear atrial fibrillation called AF, or Afib.

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How Big Is the Stroke Risk?

• Patients with atrial fibrillation (AF) have a 5-fold increased risk of having a stroke and can lead to heart failure and dementia. It can also increase your risk of death. 2 • An estimated 22 percent of strokes are related to AF, a figure that has been increasing in recent years. 3

• People with AF are more likely to die from a stroke or be severely disabled than those without AF. 3

It’s important to talk to your doctor about other procedures that can take place at the same time to ensure the best long-term outcomes and improve cardiac output.

• Surgical ablation can be performed to manage atrial fibrillation.

If You Have AF, You Have • Left atrial appendage exclusion can be performed to manage clot risk. 5 x 5 x increase in stroke risk 4 increase in heart failure (HF) development 5

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Why Is the Left Atrial Appendage Important?

An abnormal heart rhythm can cause blood to form a clot in the left atrial appendage (LAA). The LAA is a small pouch located at the top of your heart. It can cause health risks for people with atrial fibrillation. Blood clots can leave the LAA and travel to another part of the body, causing harm. For example, a blood clot can travel to the brain and cause a stroke.

Left atrial appendage (LAA) of the heart

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What Does Excluding Your LAA During Surgery Mean for You?

There are two main ways a surgeon can stop the electrical signals and blood flow to the LAA during heart surgery. The doctor can close the LAA by either cutting and sewing it or closing it with a small device. If the surgeon chooses to sew the LAA closed, they use a suture or “stitches.” This procedure began in the 1930’s.

The most commonly used device is an AtriClip. This small device is placed on the outside of the LAA. The AtriClip can stop irregular heart rate signals. It also closes off blood flow to and from the LAA to the rest of the heart. Surgeons have placed hundreds of thousands of AtriClip Devices over the last 20 years.

Recommended by the European Society of Cardiology and American Societies

Talk with your heart surgeon about the best treatment options for you.

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What To Expect if the Surgeon Adds an AtriClip to Your Heart Surgery? The AtriClip will be placed at the base of the LAA to permanently close it during your surgery. The AtriClip has been specifically designed for LAA Exclusion and is covered by a special fabric which can help keep the AtriClip in place without cutting or piercing the LAA tissue . As with any heart surgery, you will be monitored during your recovery. Your doctor will determine how long you need to be in the hospital. The AtriClip does not make the stay in the hospital any longer or shorter. Your doctor will prescribe medications for your overall health condition before you leave the hospital. It is always important to tell other doctors if you have AF. It is also important for them to know if you take medications.

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AtriClip ® Device

The AtriClip has been shown to be safe and effective.

You will receive an implant card with information about the device. You will not set off the alarms at airport security. Please reference your patient implant card for information regarding MRI compatibility. Make sure to tell your doctor about any metal allergies or sensitivities you may have (e.g. nickel) to help determine which AtriClip model is best for you. Remember to talk with your doctor about potential risks and benefits of any recommended procedures.

The AtriClip Device

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Indication The AtriClip LAA Exclusion System is indicated for use in patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted. Talk to your healthcare provider if you have any questions about potential risks and benefits with this device. References 1  McCarthy, P.M. et al. (2020). Prevalence of atrial fibrillation before cardiac surgery and factors associated with concomitant ablation. J Thorac Cardiovasc Surg, 159(6):2245-2253.e15, DOI: 10.1016/j.jtcvs.2019.06.062.

2  Ong, Alexander. (2023). The Scientific Impact of Cardiac Ablation on Atrial Fibrillation. Afib Foundation. https://www.afib.org/_files/

ugd/7e5205_24040e9d2b5949aabfb5715c973a2929.pdf 3  Sridhar, A. et al. (2014). Ischemic strokes associated with atrial fibrillation -- on the rise despite major improvements in management. HRS, Abstract PO01-114.

4  Benjamin, E.J., et al. (2019). Heart Disease and Stroke Statistics — 2019 Update: A Report From the American Heart Association. Circulation, 139:e56-e528, DOI: 10.1161/CIR.0000000000000659. 5  Odutayo, A. et al. (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ; 354:i4482. 6  Joglar, J. A. et al. (2024). 2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 149(1):e1-e156. 7  Isabelle C Van Gelder, Michiel Rienstra, Karina V Bunting, Ruben Casado-Arroyo, Valeria Caso, Harry J G M Crijns, Tom J R De Potter, Jeremy Dwight, Luigina Guasti, Thorsten Hanke, et al. (2024). 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): Developed by the task force for the management of atrial fibrillation of the European Society of Cardiology (ESC), with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Endorsed by the European Stroke Organisation (ESO), European Heart Journal, ehae176

Notes

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