Feature | January 03, 2017| Anamika Kumari

Capsule Endoscopy Systems Safety in Patients With Cardiovascular Implants

Given, Pillcamp, colonoscopy, Angiodysplasias, capsule Endoscopy, LVAD interference

The Given Imaging PillCam Colon system is an example of a capsule endoscopy device the patient swallows to image the gastrointestinal track.

The capsule endoscopy systems offer a hands-free and highly accurate imaging modality for healthcare practitioners. A pill-sized capsule houses a miniature camera that captures the condition of esophageal tract lining. The technology was first introduced for commercial healthcare services in 2000. These capsule devices are now being used to help assess gastrointestinal issues related to cardiovascular devices. 

Gastrointestinal bleeding is a common side effect in patients who have a left-ventricular assist device (LVAD). Angiodysplasias, or vascular ectesias, is another form of varices in the lower colon that is closely associated with the presence of complex cardiovascular therapeutic devices. Angiodysplasias can be further aggravated with the use of anticoagulants commonly used in patients with LVADs and with some cardiovascular conditions.

The U.S. Food and Drug Administration (FDA) identifies the generic capsule endoscopic device as a prescription, single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. Recently, the use of capsule endoscopy was contraindicated for patients with cardiac implants, because of the possibility of interference during in vivo functions of both the class of devices. 

However, there is enough evidence-based research to nullify this concern. A team from the Division of Gastroenterology and Hepatology and Division of Cardiology, Mayo Clinic Arizona, found capsule endoscopy is safe in patients with implanted cardiac devices.[1] They found PillCam’s maximum transmission power is below the permitted limits for cardiac devices, so there should not be any impairment of pacemakers, implantable cardioverter defibrillators (ICD) or LVADs. However, the study found wireless telemetry can cause dysfunction of capsule endoscopy recording. 

The study looked at five patients referred to capsule endoscopy with the indication of gastrointestinal bleeding of obscure origin were included in the study. A cardiologist, assisted by an expert nurse, observed the functions of the pacemaker before and after the capsule transmission. As per their report, no adverse effects were observed on cardiovascular activities resulting from the procedure. The research team concluded that there were issues with the function of either device.[1] 
Additional Mayo Clinic study found capsule endoscopy systems do not interfere with implantable electronic devices (IEDs) function.[2] The study found capsule endoscopy did not interfere with IED function, including pacemakers, ICDs or LVADs, and pacemakers and ICDs did not interfere with the capsule imaging. However, they found LVADs might interfere with capsule images and require that capsule leads be positioned as far away as possible from the IED to assure reliable image acquisition.

While experts continue to connect the dots between angiodysplasias and cardiovascular disorders to establish indications for increased bleeding risks in patients. A study on the same topic was presented by Stephanie Mai, M.D., Loma Linda University Medical Center, Calif., at the Digestive Disease Week conference in 2016.[3] The study found there is an increased need for blood transfusions in patients with both implanted cardiovascular devices and angiodysplasias. 

The study included 87 patients who had small bowel gastrointestinal angiodysplasias. Of that group, 48 had vascular disorders, leading to a six-fold increase risk of requiring blood transfusions.
Mai was also involved in another study that found peripheral vascular disease was significantly associated with non-isolated gastrointestinal angiodysplasia.[4]

Barring capsule endoscopy system from being employed for diagnostic imaging in CVD patients will only complicate the imaging procedure. There is already clinical evidence establishing a higher probability of people with cardiovascular implants to develop colon issues. In the absence of enough evidence showing the imaging procedure has any adverse effect on cardiovascular implants, healthcare professionals are not ready to discontinue the use of practice of capsule endoscopy. 

The capsule endoscopy system market offers single-use disposable products that do not require surgical procedures or the administration of anesthesia. There are various products developed by the manufacturers in this segment, customized to function in the different parts of the gastrointestinal tract. For instance, PillCam is a range of capsule endoscopic devices manufactured by Given Imaging Ltd., including PillCam SB, PillCam Colon and PillCam ESO. 

The PillCam Colon 2 was recently approved by FDA for use in diagnostic imaging in the presence of suspected lower colon bleeding. The clearance will pave way for easy detection of colon polyps in suspected cases. 

Product developers of capsule endoscopy systems have made remarkable progress in terms of innovative hardware and software technologies. Despite the obvious challenges, they have been successful in maintaining adherence to safety standards. While some novice products await clearance from regional drug and device regulating authorities, most of them have already had a positive influence on millions of lives and resulted in better patient outcomes. 

For more information: www.alliedmarketresearch.com/capsule-endoscopy-system-market

Editor’s note: Anamika Kumari is a content writer for Allied Analytics LLP. She has a bachelor’s degree in electrical engineering and is certified in industrial automation. 

References:

1. Dirk Bandorski, Reinhard Höltgen, Dominik Stunder, et al. “Capsule endoscopy in patients with cardiac pacemakers, implantable cardioverter defibrillators and left heart assist devices.” Ann Gastroenterol. 2014; 27(1): 3–8.

2. Lucinda A. Harris, Stephanie L. Hansel, Elizabeth Rajan, et al. “Capsule Endoscopy in Patients with Implantable Electromedical Devices is Safe.” Gastroenterol Res Pract. 2013; 2013: 959234. Published online 2013 Apr 3. doi:  10.1155/2013/959234

3. Stephanie Mai. “Transfusion Rates Are Higher in Patients With Small Bowel Gastrointestinal Angiodysplasias Who Present With Melena and Vascular Disease.” May 21, 2016 presentation at Digestive Disease Week conference. Abstract Su1062.

4. Stephanie H. Mai, Christian S. Jackson, Michael D. Baek. “Su1061 Peripheral Vascular Disease Is Significantly Associated With Non-Isolated Gastrointestinal Angiodysplasia.” GIE, May 2016, Vol. 83, Issue 5, Supplement, Pages AB314–AB315DOI: http://dx.doi.org/10.1016/j.gie.2016.03.801.

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