Do not scan a patient without first programming the MRI … If there is a question as to the safety of the MR study, unless circumstances dictate otherwise and the benefits of the examination are believed to outweigh the possible risks, the examination should be deferred until it can be verified that study of the patient is safe. During MR imaging, RF energy is “pulsed” into the body to generate the MR image. <>stream MRI Safety Information MR Conditional Non-clinical testing demonstrated that the LAA Exclusion System clip is MR Conditional. Safe MR imaging involves a careful initial patient screening, accurate determination of the permanent implanted or temporary cardiovascular device and its properties, a thoughtful analysis of the risks and benefits of performing the examination at that time, and, when indicated, appropriate physician management and supervision. Our patient support team is happy to help answer all your questions about living with your device. Most devices require programming prior to MRI. Several closure devices have been evaluated at 3 T. For those tested, studies demonstrated acceptable deflection angles, torque, and MR-related heating with regard to the intended in vivo uses of these specific devices.3,62 To date, at least 1 left atrial appendage occlusion device, the Watchman left atrial appendage device (Atritech, Inc), has been tested at 3 T. Findings indicated that patients with this device can be safely scanned at 3 T (Frank Shellock, unpublished data, 2006). University of Southern California, Keck School of Medicine, Cardiac, Vascular & Thoracic Surgeons, Inc, Cincinnati, Ohio, University of Florida Health Science Center. Appropriate personnel and a “crash cart,” including defibrillator, must be available throughout the procedure to address an adverse event. On the other hand, some devices, such as many intravascular coils and stents that are firmly implanted into the vessel wall or adjacent tissues during the implantation process, may be further passively or actively anchored to the vessel wall or adjacent tissues and are subject to constant hemodynamically generated forces from the beating of the heart and resultant blood flow that are often much greater than the forces associated with the MR examination. It’s a parachute-shaped device that expands to the size of a quarter when implanted. MR examination at ≤3 T in patients with peripheral stents that are nonferromagnetic can be performed immediately after implantation. In addition to the above considerations, several other issues merit mention. The rapidly changing magnetic fields from the gradients can induce electrical currents in electrically conductive devices and may directly excite peripheral nerves. If the specific identity of a device cannot be confirmed, but it is believed for clinical reasons that the scan should be performed at that time, consideration should be given to performing the study at the lowest field strength available to reduce whatever ferromagnetic risk might be present. The majority of prosthetic heart valves and annuloplasty rings that have been tested have been labeled as “MR safe”; the remainder of heart valves and rings that have been tested have been labeled as “MR conditional.”1 On the basis of the above studies and findings, the presence of a prosthetic heart valve or annuloplasty ring that has been formally evaluated for MR safety should not be considered a contraindication to an MR examination at 3 T or less (and possibly even 4.7 T in some cases) any time after implantation. The magnified image (insert) shows a close-up of the Watchman device. The majority of endovascular aortic stent grafts, but not all, are made from nonferromagnetic or weakly ferromagnetic materials. The Watchman LAA closure device has a self-expanding nitinol cage with a permeable polyester fabric on the surface and fixation barbs surrounding the perimeter. An item that is known to pose hazards in all MR environments. Ex vivo evaluation of the Reveal Plus ILR did not suggest significant risk of device movement or dislodgment.76 Clinical MR study of 10 patients with these loop recorders demonstrated no subjective symptoms experienced by patients, no adverse clinical events, and no damage to the devices, although rhythm monitoring was not performed during these examinations. The Watchman Device is a small implant placed in to the heart that can reduce the risk of stroke in patients with atrial fibrillation. The Left Atrial Appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium. MR will increasingly be used in the population as a whole and in many cases may be the best imaging modality available for the increasing number of patients with permanently implanted and temporary cardiovascular devices. Most important to the issue of patient safety during MR examination is the “do no harm” approach. A patient with this device can be scanned safely in an MR system immediately … Conditional 6 More... Miscellaneous Implants and Devices More... Watchman Left Atrial Appendage Closure Device … uuid:3f5aa78a-66d5-4388-b6af-c09c072cc194 The location of the device relative to the anatomy to be studied is also an important consideration in assessing the risk-benefit ratio of the study. The implant is designed to prevent blood clots caused by atrial fibrillation (A-fib) from getting into the bloodstream. Team approach to reducing atrial fibrillation-related … When doubt remains as to the safety of performing an MR examination, the reader is urged to consult a more detailed source of information, such as dedicated Web sites, reference manuals, or, especially, the manufacturer’s product information when available. Hartnell et al79 reported on 51 patients with retained temporary epicardial pacing wires who underwent clinical MR examinations. Like many other devices … One ex vivo study of temporary transvenous pacing leads reported temperature increases of up to 63.1°C.82 Preliminary results of a recent study confirmed that even unconnected temporary transvenous pacing (as well as permanent pacing) leads can undergo high temperature increases at 1.5 T.83 In a chronic-pacemaker animal model undergoing MR examination at 1.5 T, temperature increases of up to 20°C were measured, although pathological and histological examination did not demonstrate heat-induced damage of the myocardium.84 The MR imaging conditions that generated such elevated lead temperatures included use of the body RF coil to transmit RF energy over the area of the lead (eg, an MR examination of the chest/thorax). The timing of MR examination at ≤3 T in patients with peripheral stents that are weakly ferromagnetic should be determined on a case-by-case basis. The timing of MR examination at 3 T or less in patients with aortic stent grafts that are weakly ferromagnetic should be weighed on a case-by-case basis. In 1 study, ex vivo testing at 1.5 T on 19 different coronary stents revealed 2 to be nonferromagnetic and the remaining 17 to be at worst “minimally” ferromagnetic.28 Other ex vivo studies of various coronary stents also led to the conclusions that MR examination with those stents tested would be safe.29–32 Studies of peripherally implanted stents yielded generally similar results, with the exception of a stainless steel Zenith/Cook iliac stent (Cook), which at 3 T was found to have ferromagnetic properties.3,33,34 Studies conducted thus far have not suggested any increased risk of stent subacute or late thrombosis after MR examination.32,35–38, More recently, ex vivo study has been conducted on several of the more commonly used coronary drug-eluting stents, including 2005 to 2006 versions of the Cypher (Johnson & Johnson/Cordis), Taxus Express (Boston Scientific), Taxus Liberte (Boston Scientific), and Endeavor (Medtronic) stents.3,39–41 These ex vivo studies demonstrated a lack of ferromagnetic interactions at 3 T that would pose a risk for stent migration. Thus, scanning should only be performed at extremely experienced centers with expertise in MR imaging and electrophysiology. Our patient support team is happy to help answer all your questions about living with your device. Furthermore, many of the reported cases of MR-related injuries and most of the few fatalities that have occurred have been the result of failure to follow established safety guidelines or the use of outdated information related to the safety aspects of biomedical implants and devices. To look up your patient’s system, use the Product Search tool to determine whether your patient’s device and leads are safe for an MRI. Most, but importantly not all, currently implanted cardiovascular devices are either nonferromagnetic or weakly ferromagnetic. Most studies of IVC filters have generally been conducted at 1.5 T or less, although many IVC filters have now been evaluated at 3 T and deemed acceptable for MR examination.1,3. If a device … Finally, all healthcare professionals are reminded that currently used MR scanners are typically superconducting and thus are always “on.”. 1) Confirm MRI Readiness. Phone: (866) 484-3268 Hours: M-F 8:00 a.m. - 5:00 p.m. Central Although temporary transvenous lead heating might be minimized or avoided by scanning anatomic regions above (eg, head/brain) or below (eg, lower extremities) cardiac pacing leads, scanning of patients with temporary transvenous pacing leads (without the generator) is not recommended. This site uses cookies. middlett An item that poses no known hazards in any MR environment. An ex vivo study of the Guglielmi detachable coil (Boston Scientific) found that there were no magnetic field interactions and that the temperature increase was minimal during extreme MR imaging conditions.71 Subsequently, >100 patients with Guglielmi detachable coils have reportedly undergone MR imaging without incident.72 Other embolization coils made from nitinol, platinum, or platinum and iridium with similar configurations have been evaluated and found to be safe for patients undergoing MR procedures performed in studies at 3 T or less.3,18,72–75 To date, there have been no reports of adverse events associated with MR examinations conducted on patients with platinum coils implanted in the neurovasculature. The approved manufacturer’s labeling for the Zenith AAA endovascular graft states in part, “Adverse events have not been reported clinically in patients who have undergone MRI. With all medical procedures there … A second vote, on whether the product is effective in preventing clot … MR imaging has thus developed into a broadly applied diagnostic tool for patients with cardiovascular and other disease states, and the number of patients undergoing scanning each year is increasing. 2017-08-24T21:31:44Z For cases in which there is a clear potential clinical benefit of scanning in the days to weeks after implantation, the benefits of the MR examination will likely outweigh the risks of the examination, and MR examination should generally be performed. Commonly used embolization coils are either nonferromagnetic or weakly ferromagnetic. Your cardiologist places the WATCHMAN™ device into your heart via a minimally invasive technique using a small puncture into a vein in your groin. endobj The patient’s heart rhythm and vital signs should be monitored throughout the MR procedure. Theframe has 10 fixation anchorsthat allow it to anchor insidethe LAA chamber.8 The meshmembrane … Deaths associated with MR examination of patients with pacemakers/ICDs have been reported.91–95 As best as can be determined, all of these deaths occurred in the setting of MR examinations that were not supervised or monitored by a physician. Therefore, a careful assessment of these potential risks and the potential benefits to the patient should be completed before use of MR imaging.”46 The writing group agrees with this approach. In addition, it may have been necessary to evaluate the functional or operational aspects of an implant or device relative to specific MR imaging conditions. <> This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on September 18, 2007. After the nonsurgical WATCHMAN procedure, the device … Therefore, for those drug-eluting stents tested, it is believed that MR examination may be performed immediately after implantation. There are few current data on the performance of MR examination of pacemaker-dependent patients, and MR examination of pacemaker-dependent patients should not be performed unless there are highly compelling circumstances in which the benefits clearly outweigh the risks and then according to the criteria listed in the text and Table 2. Accordingly, this scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. (bH) Frontal chest radiograph shows a Watchman device (arrow) over the expected location of the LAA. 75 0 obj Therefore, the reader should be aware that there may be confusion with regard to the labeling of certain biomedical implants. Patients with tested coils1,3 may undergo MR examination at up to 3 T, according to the conditions under which they were tested. Advances in magnetic resonance (MR) imaging over the past 2 decades have led to MR becoming an increasingly attractive imaging modality. Those pacemakers that have been tested have been labeled as “MR unsafe.”1 At present, MR examination of non–pacemaker-dependent patients is discouraged and should only be considered in cases in which there is a strong clinical indication, in which the benefits clearly outweigh the risks, and then according to the criteria listed in the text and Table 2. The higher the static magnetic field of the MR system, the greater the resultant ferromagnetic forces on weakly or overtly ferromagnetic materials. At the end of the day, the panel voted unanimously that the Watchman device was safe for the indicated patient group. Watchman in the Real World: Reports on Use in High-Risk Patients and Overall Safety. 2017-08-24T21:31:44Z There is 1 report in the literature of a Swan-Ganz thermodilution catheter that “melted” at the skin entry site in a patient undergoing MR examination.23 It was postulated that the RF fields transmitted by the MR system caused heating of the copper wires within the catheter. MRI Compatibility for PI Products With all medical procedures there … If such scanning is performed, the risks of MR scanning should be discussed specifically and clearly with the patient, and the written informed consent should specifically list risks, including (1) pacemaker/ICD dysfunction, (2) pacemaker/ICD damage, (3) arrhythmia, and (4) death. What MRI safety information does the labeling contain? Although patients with the Endologix AAA or Lifepath AAA stents may undergo MR imaging, because of the artifacts created by these stents, MR examination is not recommended as the modality of choice for examinations specifically targeted toward evaluation of the stent grafts. Coils composed of stainless steel may create local artifact, which limits the usefulness of the MR examination if the coil is in the region of interest. Of note, interrogation of the devices after MR revealed tachyarrhythmias and bradyarrhythmias recorded during the examinations that were believed to be artifacts.77. Device and procedure. For the purposes of this statement, the term “ferromagnetic” is used to denote a substance that experiences an attractive force in the presence of a magnetic field. Customer Service For example, some MR imaging studies of the brain may theoretically produce maximal dB/dt values over a cardiac pulse generator and leads implanted in the upper thorax. Background. Many inferior vena cava (IVC) filters are made of nonferromagnetic materials, whereas some others are composed of weakly ferromagnetic materials.3 Devices such as IVC filters are attached with hooks. Extensive, although not complete, ex vivo, animal, and clinical data are available from which to generate recommendations regarding the safe performance of MR examination in patients with cardiovascular devices, as well as to ascertain caveats and contraindications regarding MR examination for patients with certain cardiovascular devices. The primary Effectiveness Endpoint is the occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up.The primary safety … Unlike permanent devices, temporary pacemakers use unfixed leads that are more prone to movement, longer leads that may be more prone to induction of lead currents, and a less sophisticated pulse generator, which makes them likely more susceptible to electromagnetic interference. Unauthorized Although this latter phenomenon may have led to recommendations that MR scanning be deferred for 6 to 8 weeks in patients treated with nonferromagnetic coronary stents, there are no good clinical data or rationale to support this recommended delay. “MR unsafe” items include magnetic items such as a pair of ferromagnetic scissors. Pacemaker-dependent patients were excluded from the study, and heart rhythm was monitored during the examination. Keep these conversations going! No matter what treatment pathways you and your team decide to follow, the conversations you have together now and in the future are essential for protecting your health and ensuring you are feeling well and able to enjoy your life. MR examination should not be performed in patients with known retained transvenous leads that have fractures. The device is made of nitinol (NiTi), an alloy of … 79 0 obj Patients with atrial fibrillation are at increased risk of stroke, … Your cardiologist places the WATCHMAN™ device into your heart via a minimally invasive technique using a small puncture into a vein in your groin. The Watchman implant is a permanent heart device. However, 3 stent grafts (Zenith AAA endovascular graft [Cook], Endologix AAA stent [Endologix], and Lifepath AAA stent [Edwards Lifesciences Corp]) have been reported to show severe susceptibility artifact that makes evaluation of the endostent lumen or surrounding tissues problematic.47. 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