These publications include discussions of unapproved uses that have not been approved by FDA.  The safety and effectiveness of the medical product for the unapproved use has not been established. Users are encouraged to review the full labeling for the product, as well as all disclosures about the individual publications.

Summary

  • According to PillCam™ product labeling, the use of PillCam™ is contraindicated in patients with implanted cardiac electrical devices.
  • The publications provided here describe the use of video capsule endoscopy (VCE), such as PillCam™, in patients with these devices.
  • A pooled analysis of 735 VCE procedures in patients with cardiac devices reported no adverse cardiac events. Image loss was rare and occurred in cases when the capsule was near a left ventricular assist device or when telemetry leads were present (Tabet, 2019).
  • Clinical practice guidelines from the Canadian Association of Gastroenterology indicate that capsule endoscopy can be performed in patients with a pacemaker without special precautions (Enns, 2017).

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Articles of interest

Medtronic summary

  • Across 735 video capsules endoscopy procedures (VCE) in patients with implanted cardiac electrical devices, no adverse cardiac events or device malfunctions were reported.
  • Image transmission issues occurred in only 1.4% of cases, primarily when the capsule was near a left ventricular assist device (LVAD) or when telemetry leads were used; these did not affect completion or diagnostic yield.
  • Video capsule endoscopy remains an effective diagnostic tool in patients with implanted cardiac electrical devices.
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Tabet R, Nassani N, Karam B, Shammaa Y, Akhrass P, Deeb L. Pooled analysis of the efficacy and safety of video capsule endoscopy in patients with implantable cardiac devices. Canadian Journal of Gastroenterology and Hepatology. 2019;2019:3953807. doi: 10.1155/2019/3953807. PMID: 31236386; PMCID: PMC6545804.

Disclosures: Not applicable

Medtronic summary

  • This clinical practice guideline focuses on the use of video capsule endoscopy in adults — primarily small-bowel capsule endoscopy for patients with known or suspected Crohn’s disease, celiac disease, or gastrointestinal bleeding — and was developed using a rigorous, evidence-based process to review and recommend best practices.
  • This guideline suggests that video capsule endoscopy can be performed in patients with pacemakers without special precautions.
  • This recommendation is based on observational data showing no interference with pacemaker function or image acquisition and is classified as a conditional recommendation with very low-quality evidence. This reflects limited clinical data but consistent findings of safety in available studies.
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Enns RA, Hookey L, Armstrong D, et al. Clinical practice guidelines for the use of video capsule endoscopy. Gastroenterology. 2017;152(3):497–514. doi:10.1053/j.gastro.2016.12.032

Disclosures: 

  • Co-author Lawrence Hookey has received research or educational grants/clinical trial funding from Given Imaging, which was acquired by Medtronic.
  • Funding for the consensus meeting was provided by unrestricted, arms-length grants to the Canadian Association of Gastroenterology by Allergan Canada, Covidien Canada ULC, a Medtronic company, and Olympus Canada Inc. who had no involvement in any aspect of the guideline development.

Considerations

PillCam™ Genius SB

The PillCam™ Genius SB capsule endoscopy kit with the PillCam™ Genius SB capsule is intended for visualization of the small bowel mucosa.

  • It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
  • It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
  • It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The PillCam™ Genius SB capsule endoscopy kit may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults.

PillCam™ SB

The PillCam™ SB 3 capsule is intended for visualization of the small bowel mucosa.

  • It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
  • It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
  • It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
  • The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. 
  • The PillCam™ SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age. 

PillCam™ UGI

The PillCam™ UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age.
 

PillCam™ COLON 2

The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.
 

PillCam™ Crohn’s

The PillCam™ Crohn’s capsule is intended for visualization of the small bowel and colonic mucosa.

  • It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn’s disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn’s disease.
  • It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy.
  • The PillCam™ Crohn’s capsule may be used as a tool in the detection of abnormalities of the small bowel. It is intended for use in adults.

PillCam™ Genius SB

The PillCam™ Genius SB capsules are contraindicated for use under the following conditions:

  • In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
  • In patients with cardiac pacemakers or other implanted electromedical devices.
  • In patients with dysphagia or other swallowing disorders.
  • In patients with allergies or other known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use.

PillCam™ SB

The PillCam™ SB capsules are contraindicated for use under the following conditions:

  • In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
  • In patients with cardiac pacemakers or other implanted electromedical devices.
  • In patients with dysphagia or other swallowing disorders.
  • In patients with allergies or known contraindication to the medications and preparation agents used in the procedure as described in the relevant instructions for use.

For remote procedures, the following conditions are also contraindicated: 

  • In patients with swallowing disorders, including those patients with history of aspiration or difficulty swallowing medications.
  • In patients with cognitive or physical disabilities that may impact the safety of swallowing the capsule.
  • In patients with neurologic or muscular disorders that may affect swallowing, such as a history of stroke, or an acute central nervous system (CNS) injury.
  • In children under age 18.

PillCam™ UGI

The PillCam™ UGI capsule is contraindicated for use under the following conditions: 

  • In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or preprocedure testing and profile.
  • In patients with cardiac pacemakers or other implanted electromedical devices.
  • In patients with dysphagia or other swallowing disorders.

PillCam™ COLON/PillCam™ Crohn’s

The PillCam™ COLON/PillCam™ Crohn’s capsule is contraindicated for use under the following conditions:

  • In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
  • In patients with cardiac pacemakers or other implanted electromedical devices.
  • In patients with dysphagia or other swallowing disorders.
  • In patients with allergies or known contraindication to the medications and preparation agents used in the procedure as described in the relevant instructions for use.