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Reduced Clinical Risk in Electrophysiology Procedures with Fiber Optic Shape Sensing

What is electrophysiology?

Electrophysiology (specifically, cardiac electrophysiology), or “EP”, is defined as the science of elucidating, diagnosing, and treating the electrical activities of the heart, such as an arrythmia, or irregular heartbeat. The most common arrythmia is known as atrial fibrillation (AF).  When AF requires surgical intervention, minimally invasive diagnostic and therapeutic procedures, such as cardiac mapping and ablation, are performed using catheter devices.  These procedures are generally performed by an electrophysiologist or interventional radiologist, supported by a team of medical professionals in a laboratory.

What is fluoroscopy?

The FDA describes fluoroscopy as “a type of medical imaging that shows a continuous X-ray image on a monitor, much like an X-ray movie. During a fluoroscopy procedure, an X-ray beam is passed through the body. The image is transmitted to a monitor so the movement of a body part or of an instrument or contrast agent (“X-ray dye”) through the body can be seen in detail.” In electrophysiology procedures, fluoroscopy is used as a visual navigation tool to ensure that a device is advancing properly and accurately targeting the required location within the heart.

The use of fluoroscopy in EP procedures presents a clinical risk

According to an article published in the International Journal of Cardiology, nearly 50% of the cumulative dose of radiation from imaging procedures in the US is attributed to cardiac catheterization laboratory imaging. A large portion of those procedures are electrophysiology procedures, which rely heavily on fluoroscopy for surgical guidance- often for up to or greater than 40 minutes, typically requiring a few hundred Xray shots during that time. The risk to patients, physicians and laboratory staff are those commonly associated with other forms of radiation exposure, including increased cancer risk, skin damage and lens injuries.

With the patient benefits often outweighing the risks, EP procedures continue to rise

An estimated 1.5 million EP catheterization procedures will be performed in 2021 globally, while the EP device market is projected by various market analysts to grow at a 9-12% CAGR from 2020-2024. 

One catalyst for this growth is the increasing population of patients with AF, which is estimated to be greater than 33.5 million people worldwide today. Johnson & Johnson, the current market leader in EP device sales, published a report in 2019 predicting that AF cases in the Asia Pacific region alone will  increase to 72 million by 2050.

In addition to an expanding patient population, EP device manufacturers are seeking to gain traction over antiarrhythmic drugs (AAD) as a first-line therapy.  In June 2021,  Medtronic announced it had become the first electrophysiology device manufacturer with an ablation catheter approved by the FDA to be used  as a first-line treatment in the U.S. to treat AF. This is a significant milestone, as patients can seek ablation as an initial treatment instead of having to first attempt therapy using AAD’s.

Medical device manufacturers aim to reduce the clinical risk of EP procedures by significantly reducing or eliminating fluoroscopy

The anticipated growth in the number of annual procedures presents increased concern for the safety of the patients, physicians, and laboratory staff. It comes as no surprise that EP medical device manufacturers are targeting to significantly reduce or eliminate fluoroscopy time in their new product innovations. The introduction of intracardiac echocardiography (ICE) and electromagnetic tracking solutions are examples of  technologies which help to reduce the amount of fluoroscopy required within a procedure and provide an incremental improvement. However, these technologies, even when combined, do not provide a sustainable path for the complete elimination of fluoroscopy within the procedure.   

Fiber optic shape sensing is an enabling technology for the elimination of fluoroscopy during EP procedures

Fiber optic shape sensing technology uses light to sense and then, reconstruct and display the entire length of a flexible optical fiber sensor in 3D, delivering feedback of bends, twist, and shape within a tortuous anatomy, such as within the heart or the vasculature.

To ensure positional accuracy within the anatomy, the shape sensing technology can be integrated with existing imaging modalities and overlaid with ultrasound, CT, or previously acquired MRI or Xray images.  The continuous and intuitive visualization of 3D rotatable images allows for easy navigation, thus reducing procedure risks, time and costs.  Optical fiber sensors are very small in diameter, highly flexible, and chemically inert, allowing for integration into existing electrophysiology catheter designs. Immune to electromagnetic interference, fiber optic shape sensing can be used for patients with pacemakers and other metal implants.

For more information on fiber optic shape sensing as a solution for reducing fluoroscopy in EP and other minimally invasive procedures, contact us.

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