Despite evidence to suggest that endoscopic clips may not be compatible with MRI in all circumstances, their in vivo behavior and real-world risks in MRI have yet to be fully determined. The current labeling standard for classifying the MRI safety of implanted medical devices such as endoscopic clips is defined by the U.S. Food and Drug Administration and includes three categories: MRI safe, MRI conditional, and MRI unsafe. The purpose of this study was to determine whether and how MRI centers across Canada screen for endoscopic clips. These discrepancies existed despite the lack of survey time constraints or restrictions on referring to outside sources while completing the survey. Eight (16%) reschedule for more than 6 weeks after endoscopy, and nine (18%) limit the field strength to 1.5 T, the safety of which is uncertain. Experiment on excised pig tissue in an MRI scanner. One year later, a secondary survey was distributed to the original participants to assess for changes made to screening policy after the initial survey and to assess awareness of any complications arising from the presence of endoscopic clips during MRI. However, there remain a few areas of potential concern in endoscopic clip screening practices. 1 —Chart shows steps used to screen for endoscopic clips at participating centers (n = 51). Commonly‐used devices and their MRI compatibility. It was possible to contact a total of 155 appropriate individuals (representing 194 MRI-equipped centers) by telephone; 103 of those responding (representing 122 centers) agreed to participate and were provided a survey access link. “Ask generally about implanted devices” was custom answer provided by four centers, so it was not presented to all participants as part of available options. Endoclips that demonstrated deflection were attached to a pig stomach and tested for detachment at a 1.5-Tesla MRI field strength. Endoscopic clipping devices are now available for treatment of GI hemorrhage and microperforations. Clips need to be reliable. Deployed into the gastrointestinal tract under endoscopic guidance, these hemostatic clips allowed safer and less invasive closure of tissue defects; control of gastrointestinal bleeding; securing of stents, catheters, and feeding tubes; and marking of internal anatomic structure for future surveillance or surgery [1]. Over the past decade, however, these assumptions about the safety of endoscopic clips in MRI have been challenged because of the unexpected behavior of the clips under magnetic fields of only 1.5 T [1] and the longer than anticipated length of retention, up to 33 weeks in some cases [3, 4]. This wording was used to capture a broad range of screening scenarios, but it does not tell us how often participants are relying on these steps during screening or under which circumstances. Conversely, 10 centers (21%) reported that no endoscopic clip models were considered MRI safe or conditional at their institutions. • Re-bleeding may occur if the clips detach within 24 hours. Endo Clip™ II 10 mm Pistol Grip Single Use Clip Applier. No MRI systems of other magnetic field strengths were reported. What MRI Sequences Produce the Highest Specific Absorption Rate (SAR), and Is There Something We Should Be Doing to Reduce the SAR During Standard Examinations? Implementation of a Point-of-Care Radiologist-Technologist Communication Tool in a Quality Assurance Program, Review. How many MRI examinations do you perform per year? Carilion Clinic; Andrew Y. Wang. We built a list of potential survey participants using online databases of MRI centers in Quebec (Quebec Health Resource Search) and the rest of Canada (Canadian Institute for Health Information, Selected Medical Imaging Equipment in Canada). DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. stentfix OTSC® - Preventing stent migration. (Yes/No/Please specify), Do you think that screening for endoclips is essential for MRI safety? Versatile Appliers for Endoscopic Procedures Appliers are engineered for security, and help eliminate clip fallout. The concern is that torqueing of a ferromagnetic hemostasis clip in a strong magnetic field could lead to bleeding or injury at the site of biopsy / polypectomy. A company who gives you the freedom to choose on your own terms, and will never lock you into a contract. (Single choice), Consent needed before proceeding with MRI, Both waiver and consent needed before proceeding with MRI, MRI not performed regardless of consent/waiver. mri any tool can be dangerous if not used properly • “overall, it is an extremly safe procedure, but like all powerful pieces of equipment, there are rules that have to be followed,” dr m nessaiver. Clips that are listed as ‘conditional’ are safe to use under conditions specified by the manufacturers, which are listed on www.mrisafety.com. [1] compared the interaction between a 1.5-T magnetic field and four common brands of endoscopic clips: Resolution Clip, TriClip, QuickClip, and Eth-icon Endo-Surgery Clip models. U.S. Food and Drug Administration website. Imagine working with company who puts all of their resources into creating the best products. They found that all clips except the Ethicon clip physically deflected when placed in a 1.5-T magnetic field. No data are available about the actual magnetic field strength at which endoclips are first deflected nor the clinical relevance of the magnetic fields on endoclips used in GI endoscopy. No centers schedule follow-up appointments with these patients after MRI. Sixteen centers (24%) did not specifically screen for endoscopic clips, five because they were not aware that endoscopic clips may not be safe for MRI. But in some instances an MRI scan may not be recommended. This survey was customized such that participants followed different paths depending on their responses. The purpose of this study was to assess endoscopic clip screening practices at Canadian MRI centers, including number of centers that screen, specific screening methods, perceived safety of endoscopic clip models, and practices for dealing with confirmed gastrointestinal endoscopic clips. Endoscopic Clip MRI Screening: A Canada-Wide Policy Survey. For example, in 2009 Gill et al. The Endo Clip™ II clip applier contains 20 ML titanium clips. First, participant bias may have existed if either screeners or nonscreeners were more likely to participate than the other or if screeners were more likely to abort their longer primary survey before completion. Fistula closure: optimized technique for treatment of GI fistulas . www.mrisafety.com/SafetyInfoFromList.asp?LSub=34, www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107708.pdf, Original Research. The purpose of this study was to assess endoscopic clip screening practices at Canadian MRI centers, including number of centers that screen, specific screening methods, perceived safety of endoscopic clip models, and practices for dealing with confirmed gastrointestinal endoscopic clips. Instinct® Endoscopic Clip This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than … The first two sections of the survey gathered data on the MRI equipment at each site (section 1) and yearly patient visits and examinations (section 2). Not all endoscopically placed clips are MRI compatible, so screening for endoscopic clips before MRI is recommended. MRI Safety and Compatibility Information Is screening for endoscopically placed (colonoscopy/gastroscopy) surgical clips (“endoclips”) a part of your pre-MRI screening protocol? Clips were selected for testing that represented the largest metallic sizes made from materials with the highest magnetic susceptibilities among 61 other similar implants. Although in the past these endoscopic clips were largely ignored during pre-MRI patient screening, many centers now routinely screen for their presence. To put these findings into perspective, approximately 150,000 patients per year may be undergoing MRI without previous endoscopic clip–specific screening, according to reports from the 16 nonscreening centers in this surveyed population alone. MRI compatibility and safety have been important issues for the aneurysm clips used in neurosurgery. Two centers provided custom response of Instinct Endoscopic Clip model (Cook Medical), which was correctly classified as MRI conditional by both centers. A follow-up reminder was sent if a response to the initial invitation was not received after 2–4 weeks. In addition, because nonscreeners were initially omitted from section 7 of the primary survey (regarding the perceived value of endoscopic clip screening), they were presented with this section in the secondary. Based on a presentation at the Canadian Association of Radiologists 2016 annual meeting, Montreal, QC, Canada. 1. Responses from 50 screeners on the primary survey and three nonscreeners on the secondary survey were combined, and these 53 centers indicated how valuable they considered endoscopic clip screening for their patients. • Although rates of occurrence are low, recurrent bleeding, ineffective clipping or endoscopic complications could result in the need for surgery. Results represent number and percentage of centers that may, at any one time, use each step to assess for endoscopic clips. Studies have also shown longer than expected endoscopic clip retention times. MRI Fact Sheets. Table 2. [Author note—Populated with selections from section 4. ‡ Clips that stay in place during surgical maneuvering while positioning the jaws around a structure have a … Magnetic resonance imaging compatibility of endoclips, American Society for Testing and Materials. Who to Call Digestive Health Center 750 University Row Madison, WI 8 am to 5 pm weekdays (608) 890-5000 or (855) 342-9900 After clinic hours, please call (608) 890-5000. Copyright © 2013-2020, American Roentgen Ray Society, ARRS, All Rights Reserved. Order Information. points to consider • the main magnetic field • time variable fields • radio frequency fields. The Ethicon Endo-surgery clip is compatible with MRI. Vesolock™ Polymer Ligation System Adhesive tape on base allows adherence to any sterile surface. All other clips showed deflection in a magnetic field, but only the TriClip demonstrated detachment from gastric tissue, and hence should be considered MRI incompatible. Although the risks of MRI to patients with endoscopic clips is unclear, the misclassification of some endoscopic clip models and inconsistent protocols for dealing with confirmed endoscopic clips call for further research and unified evidence-based endoscopic clip screening standards. Five common endoscopic clip models are the Resolution Clip (Boston Scientific), Tri-Clip (Cook Medical), QuickClip and Long-Clip (Olympus Medical Systems), and the Ethicon Endo-Surgery Clip (Ethicon Endo-Surgery) brands [1, 2]. It also can be used for hemostasis for prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. Appendix 1 is an English-language copy of the survey. ASJC Scopus subject areas … Sixty-seven MRI centers completed the survey (55% response rate). Section 3—All 51 screeners provided data about how screening is performed: 45 (88%) screened in person, 23 (45%) screened by telephone, six (12%) used screening by the referring physician, and two (4%) screened using mailed-out forms. 2 —Chart shows safety classification of six common endoscopic clip models as reported by participating centers. A Google web search was used to gather institutional telephone numbers for all 257 centers, and each was telephoned individually, in English or French as appropriate. An American College of Radiology expert panel on MRI safe practices recommends that positive identification of medical implants be made before MRI and that best efforts be made to determine their MRI compatibility [6]. As such, safety information was extrapolated from manufacturer labeling [2], previous research [1, 3, 4], and anecdotal reports from participants. Thirty-eight of the 48 (79%) answered affirmatively and subsequently categorized a list of common endoscopic clip models as either MRI safe, MRI conditional, or MRI unsafe (Fig. They need to be accurate. A total of three Delphi rounds were held, with 100% response rate for each (Fig. Copyright © 2009 American Society for Gastrointestinal Endoscopy. For example, Gill and Shellock (2012) tested metallic skin closure staples and vessel ligation clips at 3-Tesla to characterize MRI issues in order to ensure patient safety. The purpose of this memo is to provide an update on the status of pre-MRI safety screening in patients who may have had hemostasis clips placed during endoscopy or colonscopy. ENDOPATH ® ETS Compact-Flex45 Articulating, ETS-Flex45 Articulating and ETS45 Endoscopic Linear Cutter Reloads. We found similar concerns in the reported protocols for dealing with persons with gastrointestinal endoscopic clips. Sixteen of the 67 participating centers (24%, representing 149,450 estimated annual patient visits) reported not specifically screening for endoscopic clips as part of regular pre-MRI screening (i.e., were nonscreeners). The applier is designed for introduction and use through all appropriately sized trocar sleeves, or larger sized trocar sleeves with the use of an appropriate converter. One percentage does not total 100 owing to rounding. The concern is that torqueing of a ferromagnetic hemostasis clip ], We were not aware that some endoclips may not be MRI safe, We decided not to screen after review by a safety committee, Our local endoscopists use only MRI-safe clips, We tried screening for endoclips, but stopped because of limited yield/benefits. Only the Triclip demonstrated detachment from the pig gastric tissue under testing conditions. Admittedly, endoscopic clip safety is a new and developing field. The Endoscopy Suite has been recently refurbished and updated and is a state-of-the-art unit that provides comfortable single sex facilities for patients undergoing endoscopy procedures. Fifty-one of the 67 participating centers (76%, representing 210,211 estimated annual patient visits) reported screening for endoscopic clips during regular pre-MRI screening (i.e., were screeners). Of those, 32 (62%) do not perform MRI for the patient, 14 (28%) may proceed to the MRI acquisition, and four (8%) were unclear as to the performance of MRI for the patient. Survey participants were allowed multiple answers for these two sections, so added totals exceed 100%. There were means of 7992 estimated yearly visits (range, 950–23,800) and 8397 estimated yearly examinations (range, 1000–31,000) per responding center. The clip is used to stop gastrointestinal (GI) tract bleeding, which is a condition that can be challenging to treat because of the variations among bleeds. Responses were collected between June 29 and September 4, 2015. clips to stop bleeding, clips used as markers or for ligation or fasteners may be safely scanned using 1.5T and 3T MRI. For example, 16% reschedule the MRI examination for more than 6 weeks after endoscopy, despite evidence that some endoscopic clips, like the Resolution Clip model, may remain in the human gut for as long as 33 weeks [4]. The purpose of this memo is to provide an update on the status of pre-MRI safety screening in patients who may have had hemostasis clips placed during endoscopy or colonscopy. Fifty-one centers (76%) did screen for endoscopic clips. You may not be able to have an MRI while the clip is still in you. We suggest that future efforts be directed at further testing of endoscopic clip behavior in MRI and at a more systematic and objective search for possible complications. Once collection was complete, an anonymized preliminary copy of the initial results was distributed to all participants in January 2016. View PDF. If MRI were to be performed on a patient with a known gastrointestinal endoclip(s), what precautionary steps may you take (select all that apply): Approval and planning by radiologist required before scanning, Consultation with physicists before/during MRI examination, Scan only anatomical regions far away from the known clip, Limit field strength used, please specify, Avoid certain pulse sequences, please specify, Do you have routine follow-up with these patients? To determine the compatibility of different endoclips with MRI. In general, most of the endoscopic devices for deploying clips can seal openings from 0.4 inches to 0.5 inches (about 10 to 12 millimeters) across. This most commonly involved directly interviewing patients, followed closely by review of endoscopic reports and previous relevant imaging. The purpose of the secondary survey was to ask centers whether endoscopic clip screening practices had changed since the site received the primary survey results and whether they had ever encountered or heard reports of complications arising from performing MRI on persons with in situ gastrointestinal endoscopic clips. A canine study [3] showed a median of 8 weeks' retention for the Resolution Clip model. April 2009; Gastrointestinal Endoscopy 69(5) DOI: 10.1016/j.gie.2009.03.551. Where can I find more information about the MRI safety of Ethicon products? (Leave the check-boxes unchecked if a clip is MRI-unsafe) (Options include: Resolution Clip, Long Clip, QuickClip2, QuickClip2 Long, TriClip, and custom answers), If endoclips are present in the patient for which safety cannot be guaranteed (you are uncertain of clip type, or vendor does not ensure safety of clip), what are your next steps? Responses are divided into four categories: verbal interview, chart and imaging review, new imaging, and issues related to timing of MRI. Similarly, none of the 28 centers in our secondary survey, representing approximately 157,000 annual patient visits, reported any knowledge of complications from endoscopic clips in MRI. Although 11 of these were aware of potential endoscopic clip safety concerns and chose not to screen for reasons discussed previously, five were unaware that endoscopic clips may not be safe for MRI. Participants were then asked whether they specifically screen for endoscopic clips as part of their pre-MRI screening. One center did not provide a reason for forgoing endoscopic clip screening. The innovative solution for stent fixation in the digestive tract . Conclusions: The Ethicon Endo-surgery clip is compatible with MRI. Magnetic resonance imaging safety of surgical clips and staples We read McCall et al.’s letter about the magnetic resonance imaging (MRI) safety of Epilong Soft Epidu-ral Catheters (Pajunk Medizintech-nologie GmBH, Geisingen, Germany) [1] and would like to add further information for readers about the MRI compatibility of surgical clips and staples used in current surgical practice. Furthermore, in section 4, participants were asked whether they “may” use any of a series of steps to screen for endoscopic clips at their institution. Frequently Asked Questions. You will be able to rank these in the following section. FTRD® - Closing the gap between endoscopy and surgery. We operate by a higher standard. As many as 36% of screeners may perform MRI on patients with confirmed gastrointestinal endoscopic clips; 16% reschedule for more than 6 weeks after endoscopy; and 18% limit the field strength to 1.5 T, the safety of which is uncertain. Some custom responses (each reported by only a single center) included minimizing the number of sequences performed, seeking consultation with physicists before or during the MRI examination, ensuring the patient can communicate with the technologist at all times, suggesting the patient see an endoscopist immediately after MRI, and following model-specific manufacturer recommendations for MRI. Finally, this study was a survey of current screening practices, not a practical assessment of the safety of these clips in clinical use. At least 23% of screeners misclassified the safety of one or more MRI-unsafe clips. This device is not intended for the repair of GI tract lumenal perforations. Another study [4] showed a Resolution Clip device in human gut 33 weeks after placement. Twenty-eight of the 67 (42%) participating MRI sites responded to the secondary survey (24 screeners, four nonscreeners). Similarly, six centers (13% of respondents to this section) considered the Resolution Clip model safe for MRI, despite its MRI-conditional classification [2]. (select all that apply). See the MRI Fact Sheets below. The reasons provided for not screening were as follows: five (31%) were unaware that some endoscopic clips may not be safe for MRI, four (25%) stated that their local endoscopists use only MRI-safe clips, three (19%) decided not to screen after review by a safety committee, two (13%) tried screening for endoscopic clips but stopped because of limited yield or benefit, and one (6%) reported following the attending radiologist's orders in these matters on a per-case basis. (Yes/No) [Author note—An answer of “No” branched respondents directly to section 8. Published by Mosby, Inc. All rights reserved. They need to allow you the flexibility to reposition or rotate as much as is required to deliver better outcomes. A bilingual online survey was distributed to Canadian MRI centers to assess site demographics, endoscopic clip screening practices, safety considerations for different endoscopic clip models, protocols for dealing with patients with endoscopic clips, and the perceived value of screening. Section 5—Forty-eight of 51 (94%) screeners reported whether they considered any endoscopic clip models MRI safe or MRI conditional. Section 1—All 67 participating centers provided data on their MRI equipment, among which a combined total of 80 1.5-T systems and 19 3-T systems were located. If the clip is in your colon, it is important to tell your healthcare provider if you need an MRI. Only one center made changes to their screening protocol between surveys—a nonscreening site that incorporated endoscopic clips into its screening form—bringing the percentage of endoscopic clip screeners in this study to 78% of participants. Review. ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. Authors: Paul Yeaton. All commercially available endoclips are labeled as magnetic resonance imaging (MRI) incompatible. All commercially available endoclips are labeled as magnetic resonance imaging (MRI) incompatible. Section 6—Fifty screeners provided data on their protocol for dealing with patients with confirmed gastrointestinal endoscopic clips (Table 1). Endoscopic Clip MRI Screening: A Canada-Wide Policy Survey. Last, although several different safety practices were reported for when patients with endoscopic clips undergo MRI, each of these was used by only a small proportion of centers. Ethics approval was obtained from the University of Saskatchewan Research Ethics Board. Abstract Background: Endoscopic clipping devices are now available for treatment of GI hemorrhage and microperforations. The magnetic attraction was strongest for the Resolution Clip (0.7 gauss) compared with the TriClip (1.2 gauss) and the QuickClip (26.8 gauss). Similarly, 18% of centers do perform MRI, limiting field strength to 1.5 T, despite research results showing that even these weaker magnetic fields may interact with some endoscopic clip models, in some instances detaching them from the gut wall [1]. Hemoclips are not magnetic resonance imaging (MRI)-safe, and are contraindications to MRI . The radiopaque Resolution Clip is designed for hemostasis, endoscopic marking, closure and anchoring of jejunal feeding tubes. It is “MR Conditional,” a safety term which indicates that the device has been demonstrated to pose no known hazards in a specified MRI envi- ronment with specified conditions of use. Optimization of Split-Bolus CT Urography: Effect of Differences in Allocation of Contrast Medium and Prolongation of Imaging Delay. Many Canadians are undergoing MRI without screening for endoscopic clips. This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm in the upper GI tract, bleeding ulcers, arteries less than 2mm and polyps less than 1.5cm in diameter in the GI tract. Those expressing interest were sent a survey access link via e-mail. MRI Safety of Two Endoscopic Homeostasis Clips. mri • considerd to be safe • lack of ionising radiation. A secondary survey was then distributed to all original participants in July 2016. Participants who did not screen for endoscopic clips, called nonscreeners, bypassed sections 3–7 and were instead asked to complete only one further section regarding their reasons for forgoing this process (section 8). View PDF. https://doi.org/10.1016/j.gie.2009.01.024. Even among centers that did screen for endoscopic clips, we encountered a few potential concerns in the safety classification of different endoscopic clip models. Supported by the University of Saskatchewan Dean's Summer Research Program (F. Accorsi). During an endoscopy, a surgeon usually approaches the site to be clipped at a low angle, and with a short distance between the tissue and the tip of the scope, for safety. MRI of Rectal Cancer: An Overview and Update on Recent Advances. Burnout: Prevalence and Associated Factors Among Radiology Residents in New England With Comparison Against United States Resident Physicians in Other Specialties, Original Research. The development of endoscopic clips heralded a new era for endoscopic therapy. We thank all of the survey participants for completing the survey, the University of Saskatchewan College of Medicine Dean's Summer Research Program for providing the salary of one of the investigators (F. Accorsi), and the Saskatchewan Office of Francophone Affairs and the Saskatoon Population and Health Office for assistance with the French translation of survey materials.