Understanding How an AFib Heart Implant Is Used at Saint Joseph Health System

Understanding How an AFib Heart Implant Is Used at Saint Joseph Health System

When it comes to preventing strokes, improving your heart health is important. For example, patients with atrial fibrillation (AFib), a common heart condition, has a significantly higher risk of stroke. To help AFib patients reduce their risk, a special purpose heart device implant is used for certain patients. This device provides the same level of protection against a stroke caused by AFIB, like taking a blood thinner, but without the adverse effects of bleeding, anemia, pain, gastritis associated with regular use of blood thinners.

The heart's regular rhythm ensures the smooth flow of blood, but when this rhythm is disrupted, as in the case of AFib, it can lead to the formation of blood clots in a naturally existing pouch called Left Atrial Appendage (LAA) in the upper left chamber of the heart. Clot formation in this pouch is responsible for more than 90% of cases of AFIB associated stroke due to this clot dislodging from the pouch and travailing to the brain from the heart. 

Blood thinners have traditionally been used to mitigate this risk, but they come with their own set of complications. Because of this many patients are unable to tolerate long-term anticoagulation therapy. LAAC procedure is a unique one-time implant which offers an innovative and a permanent solution for stroke prevention by giving our patients a life free of blood thinners while offering the same level of protection against stroke by providing an alternative that targets the root cause directly.

What is the AFib Implant?

The AFib implant is a small, mushroom or an umbrella-like device that prevents stroke in people with non-valvular AFib. This device is placed in the left atrial appendage (LAA) of the heart, a small sac where blood clots often form in AFib patients. By sealing off the LAA, the device prevents clots from entering the bloodstream and causing a stroke. Unlike blood thinners, which reduce clotting throughout the body, the device specifically targets the LAA, offering a localized and effective solution.

The AFib implant is about the size of a quarter and is made from materials that are well-tolerated by the body. The device’s design allows it to expand and fit snugly into the LAA, effectively sealing it off. Over time, heart tissue grows over the implant, permanently closing off the appendage. This targeted approach means that the risk of stroke is greatly reduced without the ongoing need for medication to thin the blood.

The device also offers several advantages over traditional methods. Nearly 99.7% of patients who receive the implant can often discontinue blood thinners, which reduces the risk of bleeding—a common side effect of these medications. Moreover, the AFib implant has been shown in clinical trials to be as effective as blood thinners in preventing stroke, providing a reliable alternative for patients seeking a different treatment option.

How does the AFib Implant work?

The AFib implant procedure is minimally invasive. Generally, patients can expect three things when receiving the implant.

1. Pre-Procedure Preparation: Patients undergo few simple tests to ensure they are suitable candidates for the AFib implant. These tests may include imaging studies to assess the heart’s anatomy and overall health. Doctors may use transesophageal echocardiograms (TEE) and rarely a computed tomography (CT) scan may be required to assess for suitability for the closures to get detailed images of the heart and the LAA. Some patients may require 30 days ECG monitor to assess for AFIB burden of the heart.
2. Implantation Process: The procedure is minimally invasive and is performed under general anesthesia with an expert ultrasound imaging guidance. A catheter is inserted through a small hold of the size of a pencil in the groin and guided to the heart. The device is then deployed in the LAA, where it expands and seals off the appendage. The entire process takes about one to two hours, depending on the complexity of the patient’s heart anatomy. The catheter-based approach ensures that the procedure is less invasive than open-heart surgery.
3. Post-Procedure Care: After the procedure, patients typically stay in the hospital overnight for monitoring and is discharged home the following day. Post-procedural limitations are similar to any routine cardiac angiogram procedure. The patient will have a nurse check the surgical site at 5 to 7 days and perform a trans-esophageal echocardiogram to evaluate the device seal of the LAA at 45 days. At 45 days, the device integrates with the heart tissue, forming a barrier that prevents blood clots from forming inside the LAA pouch and also from escaping out from the pouch. Patients may need to continue taking blood thinners temporarily until the device is fully integrated and once the device is integrated they can discontinue the blood thinner for good. 

By eliminating the need for long-term anticoagulants, patients reduce their risk of bleeding, which can be particularly dangerous in older adults or those with a history of gastrointestinal issues, bleeding strokes and mechanical falls due to gait and balance issues. Additionally, the procedure’s minimally invasive nature means a shorter recovery time and less discomfort compared to traditional surgical methods.

However, like any medical procedure, the AFib implant has potential risks and side effects. These can include complications from the catheter insertion, such as bleeding or infection, and issues with device placement, such as incomplete closure of the LAA. Long-term risks might include the potential for the device to move or cause irritation to the surrounding heart tissue. However, with improved implant technology, the large registry study suggested that the overall composite complication rate was less than 0.3% with LAAC procedure making it one of the safest procedures in the arena of cardiovascular interventional procedures.

Who is a candidate for the AFib Implant?

The AFib implant is designed for patients with non-valvular AFib who are at high risk for stroke and cannot tolerate long-term anticoagulant therapy. Candidates are typically those who have had complications from blood thinners or have conditions that make blood thinners unsuitable. At Saint Joseph, a thorough assessment is conducted to determine each patient’s eligibility.

To determine if a patient is a good candidate for the AFib implant, Saint Joseph physicians evaluate several factors, including:

• Medical history: Patients with a history of bleeding complications from blood thinners, such as gastrointestinal bleeding or hemorrhagic stroke, are prime candidates for the device. Additionally, those with conditions that predispose them to falls, which increase the risk of bleeding, may also benefit.
• Lifestyle considerations: For patients who lead active lifestyles or are involved in activities that carry a higher risk of injury, the AFib implant can provide peace of mind by eliminating the need for blood thinners, which increase the risk of severe bleeding from even minor injuries.
• Anatomical suitability: Imaging studies help doctors assess the size and shape of the LAA to ensure the device can be effectively implanted. Patients must have a suitable LAA anatomy for the device to work properly. More than 99% patients are usually found suitable anatomically for this implant.
• Overall health: Patients need to be healthy enough to undergo a procedure involving general anesthesia and catheterization. Those with severe heart conditions or other serious health issues may require additional evaluations.

At Saint Joseph, the assessment process includes a multidisciplinary approach involving cardiologists, electrophysiologists, and cardiac imaging specialists to ensure a comprehensive evaluation and optimal patient outcomes.

AFib Implant at Saint Joseph Health System

Saint Joseph is a leader in cardiac care and was the first hospital in the state of Indiana to perform over 100 successful AFib implant procedures. To date, the hospital has successfully implanted the device in nearly 400 patients. The cardiology team, including structural heart disease experts like Dr. Harsha Santheshivara Nagarajarao and Dr. Praveen Pratap, brings extensive experience and skill to each procedure.

Patients benefit from the latest technology and state-of-the-art facilities, ensuring the highest standards of care. The team’s expertise and the hospital’s commitment to cardiac health make Saint Joseph a premier choice for patients considering the AFib implant.