For cases for 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. The timing of MR examination at 3 T or less in patients with embolization coils that are weakly ferromagnetic should be weighed on a case-by-case basis. identifier=4431. 1) Confirm MRI Readiness. 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 such patients. In patients with chronic conditions in which it makes little difference whether the scan is performed at a given time or weeks later, it may be prudent to defer MR examination until ≈6 weeks after device implantation. 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. MR technologists should be well trained on MR safety issues, because they may often represent the “last line of defense.”. The rapidly changing magnetic fields from the gradients can induce electrical currents in electrically conductive devices and may directly excite peripheral nerves. Although 1 study discussed above found that ICDs manufactured after 2000 may be more resistant to changes in function during MR examination, this finding should not be taken as a “green light” to routinely scan patients with such ICDs. It is beyond the scope of this document to provide guidelines for every cardiovascular device. Additionally, devices may undergo manufacturing modification, particularly with regard to metallic composition, while retaining the same basic name, and new devices will be introduced into the market constantly. Important Safety Information The WATCHMAN Device is a permanent implant designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. MR examination at ≤3 T in patients with peripheral stents that are nonferromagnetic can be performed immediately after implantation. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Device function may also be altered or negated as a result of interactions with the strong static magnetic fields. PI-86716-AD Extensive experience and promising results with the Watchman™ device, offering it before any other program in Northern California after FDA approval. A sterile, disk-like, device used for the non-surgical closure of cardiac defects. With all medical procedures there are risks associated with the implant procedure and the use of the device. For some weakly ferromagnetic devices, there are currently sufficient data and consensus that it can be recommended that patients with such devices can undergo MR examination any time after scanning. The higher the static magnetic field of the MR system, the greater the resultant ferromagnetic forces on weakly or overtly ferromagnetic materials. 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. Most of the stents currently used for carotid procedures are made of nitinol and are nonferromagnetic or only weakly ferromagnetic. The American Heart Association is qualified 501(c)(3) tax-exempt Do not scan a patient without first programming the MRI … 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. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. The timing of MR examination at 3 T or less in patients with cardiac closure or occluder devices that are weakly ferromagnetic should be weighed on a case-by-case basis. MR examination should not be performed in patients with known retained transvenous leads that have fractures. Furthermore, most devices have been tested under very specific circumstances (eg, magnetic field strength, radiofrequency [RF] energy levels, and type of RF transmission coils). This phenomenon may complicate monitoring of the heart rhythm during scanning, lead to inappropriate inhibition of pacemaker function, or create arrhythmia artifacts on event loop recorders. Today, peri-procedural safety rates of 2-3% are already achievable and have been shown for the Watchman device (EWOLUTION registry, Boersma et al, EHJ 2016 and the AMPLATZER: The … The MR conditions in which the device was tested should be specified in conjunction with the term “MR safe,” because a device that is safe under 1 set of conditions may not be found to be so under more extreme MR imaging conditions. Commonly used embolization coils are either nonferromagnetic or weakly ferromagnetic. 79 0 obj 2017-08-24T21:31:44Z Venous MAGNETIC RESONANCE IMAGING (MRI) SAFETY … “This nonrandomized, nonadjudicated series of nearly 4000 US patients implanted with the Watchman device, included as its primary end point safety data reported by device representatives … <> In general, if a device is a nonferromagnetic “passive” implant (ie, there is no electronically or magnetically activated component) made from a nonferromagnetic material (eg, titanium, titanium alloy, or nitinol), and if there are no concerns associated with MR-related heating, the patient with the device may undergo MR imaging immediately after implantation. (a) Photograph of the Watchman device shows the self-expanding nitinol frame and fabric covering the face of the device. Boston Scientific Corporation Less commonly, stents may be composed of or contain variable amounts of platinum, cobalt alloy, gold, tantalum, MP35N, or other materials.3 Most coronary and peripheral vascular stents exhibit nonferromagnetic or weakly ferromagnetic characteristics. To the best of our knowledge, no clinical studies have specifically addressed the risks of retained transvenous pacemaker or ICD leads. Retained transvenous pacemaker and defibrillator leads (leads left in the body after explantation of the permanent pacemaker or ICD generator) pose significant theoretical risks, including heating and cardiac excitation. Therefore, particularly in cases in which there is a relative contraindication to device examination and the examination location is distinct from the device location, consultation with a person with expertise in MR physics and MR safety is recommended. If you need an MRI (magnetic resonance imaging), it’s important to show the doctor and MRI technologist your WATCHMAN Implant Card. With the growing number of patients treated with permanent implanted or temporary cardiovascular devices, it is becoming ever more important to clarify safety issues in regard to the performance of MR examinations in patients with these devices. With all medical procedures there … Watchman device is a permanent left atrial appendage closure device, which is percutaneously implanted to prevent embolization of thrombus from the appendage into the systemic circulation in cases atrial fibrillation.It is used when there is contraindication to anticoagulation or high risk of lifelong use of anticoagulants. Recommendations It is recommended that patients register the conditions under which the implant can safely be scanned with the MedicAlert Foundation (www.medicalert.org) or an equivalent organization. null The effect of the MR examination on heating of the drug or polymer coating used in drug-eluting stents is unknown, although heating of the stent (and possible resultant effects on the drug/polymer coating) might be somewhat mitigated by flowing blood. endobj Mechanical heart valves are composed of a variety of metals, including titanium alloy, MP35N, pyrolytic carbon, Elgiloy, chromium cobalt alloy, nitinol, 316L stainless steel, and 316LVM stainless steel.3,43,48–50 Some annuloplasty rings contain no metal, whereas others may be composed in part of titanium, chromium cobalt, and other metallic materials.3,51 Sternal wires are most commonly composed of stainless steel or similar alloys. However, it is generally believed that the tissue healing process that occurs over the weeks after implantation may in some cases provide an additional degree of device anchoring, and thus, it has been advocated by some to wait ≈6 weeks before MR imaging of certain devices. Thus, a ferromagnetic object might be accelerated toward the magnet at dangerously high velocities and/or with dangerously high forces, creating a “projectile effect” that could lead to significant patient injury or damage to the MR system. In addition, a more general discussion of safety issues is also provided that uses the expertise of the writing group to synthesize the FDA labeling using the American Society for Testing and Materials terminology with the latest experimental and clinical data, as well as expert consensus opinion, to give guidance to as broad a target audience as possible for issues regarding MR safety and cardiovascular devices. Stroke prevention The Watchman device is implanted via a catheter snaked through veins into the left atrium of the heart where it is deployed like an umbrella. In patients with chronic conditions in which it makes little difference whether the scan is performed at a given time or weeks later, it may be prudent to defer MR examination until ≈6 weeks after device implantation. Hartnell et al79 reported on 51 patients with retained temporary epicardial pacing wires who underwent clinical MR examinations. A device shall be considered “MR compatible” if it is MR safe and the device, when used in the MR environment, has been demonstrated to neither significantly affect the quality of the diagnostic information nor have its operations affected by the MR system. Watchmen device … Device and procedure. Advances in magnetic resonance (MR) imaging over the past 2 decades have led to MR becoming an increasingly attractive imaging modality. 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. Given the risks associated with MR imaging of certain cardiovascular (as well as other) implants and devices, thorough and effective screening procedures for patients who are to undergo MR examinations are essential.3,17,24 Indeed, most MR examination adverse events are believed to be due to deficiencies in screening methods.3 Therefore, all patients should undergo a thorough screening procedure for cardiovascular and other implants and devices, including an interview with a healthcare worker specifically trained in MR safety and completion of a standardized screening form, which should then be thoroughly reviewed by the MR technologist or physician. To the best of our knowledge, there are no studies assessing the safety of temporary pacemakers (lead and external pulse generator). A-fib prevents the … Martin and colleagues93 reported on a series of 54 patients who underwent a total of 62 MR examinations using a 1.5-T MR system. 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. 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. Those few catheters that contain conducting wires and those few temporary transvenous pacing wires that have been tested have been labeled as “MR unsafe.”1 Patients with pulmonary artery hemodynamic monitoring/thermodilution catheters (such as the Swan-Ganz catheter) and similar catheters that have conductive wires or similar components should not undergo MR examinations because of the possible associated risks, unless in vivo testing provides labeling information or instructions for use that permit examinations to be performed safely. 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. 71-0433. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. RF energies used in the MR imaging process can also induce electrical currents in wires and leads, which could possibly induce arrhythmias. These properties of nitinol allowthe Watchman device to configure to the contours of theLAA after deployment. Expert peer review of AHA Scientific Statements is conducted at the AHA National Center. Table 1. The dosimetric term used to characterize RF energy is the specific absorption rate (SAR, measured in watts per kilogram). Watchman LAA closure device. Table 2. 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). Broader information on MR examinations is available at several well-recognized expert Web sites4–7 and in published and online documents.8–17. The issue of when patients who have been treated with weakly ferromagnetic devices may undergo MR examination has not been established definitively for every device and thus remains controversial. This has led to the unsafe examination of patients with certain devices and to the misinformed and inappropriate refusal to refer or scan patients with other devices, thus depriving the patient and treating physician of clinically useful information. 1) Confirm MRI Readiness. Most stent grafts create minimal artifacts, which allows for diagnostic visualization of the endostent lumen and for evidence of endostent leak. Find MRI guidelines and resources for radiology and other clinicians for our cardiac monitors, implantable cardiac devices, and spinal cord stimulation systems. 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. Conditional 6 More... Miscellaneous Implants and Devices More... Watchman Left Atrial Appendage Closure Device … Cardiovascular catheters, such as pulmonary artery hemodynamic monitoring/thermodilution catheters (including the Swan-Ganz catheter [Edwards Lifesciences]), and temporary transvenous cardiac pacing devices generally contain no ferromagnetic components but may incorporate nonferromagnetic, electrically conductive materials.3,78,79 The MR examination may induce sufficient voltages and currents in electrically conductive material so as to result in thermal injuries and burns to adjacent tissue (including myocardial tissue).80,81 Although the theoretical risk exists that MR examination in patients with retained temporary epicardial leads, which consist of electrically conductive material, could lead to cardiac excitation or thermal injury, such retained leads are typically relatively short in length, usually do not form large loops, and are generally not believed to pose a significant risk during MR scanning. Patients who have a pacemaker or ICD should not undergo an MR study if an alternative diagnostic test is available, and MR imaging should only be considered in cases in which the potential benefit to the patient clearly outweighs the risks to the patient. Phone: (866) 484-3268 Hours: M-F 8:00 a.m. - 5:00 p.m. Central The forces exerted on these valves and rings are less than the forces exerted by gravity and considerably less than those exerted by the beating heart and resultant pulsatile blood flow (≈7.2 N).52 A recent study using tissue samples excised during heart valve replacement surgery demonstrated that the forces required to pull a suture through a valve annulus tissue were significantly greater than magnetically induced forces at <4.7 T.53 Accordingly, patients with degenerative valvular diseases are unlikely to be at risk for valve dehiscence (loosening or unseating of the valve from its sewed-in position in the heart) during exposure to static magnetic fields up to 4.7 T. MR-related heating of prosthetic heart valves and annuloplasty rings has been assessed with ex vivo techniques. Therefore, for those drug-eluting stents tested, it is believed that MR examination may be performed immediately after implantation. endobj endobj Introduction: The Watchman device for left atrial appendage occlusion (LAAO) has proven to be effective for stroke prophylaxis in atrial fibrillation patients. Although current-generation scanners operate at levels that will not directly excite cardiomyocytes, the gradients can induce currents within electrically conductive wires and leads that could cause arrhythmias. Finally, all healthcare professionals are reminded that currently used MR scanners are typically superconducting and thus are always “on.”. MR examination of patients with sternal wires is generally considered to be safe. A second vote, on whether the product is effective in preventing clot … However, sufficient data are not available to demonstrate MRI safety and there may be potential risks (eg, device migration, vessel damage) that could be associated with force applied to the metallic components of the Zenith AAA Endovascular Graft. Acrobat Distiller 10.1.16 (Windows) For weakly ferromagnetic devices, it is theoretically possible that the forces present during an MR examination could move or dislodge such a device. Keep these conversations going! Your heart may be punctured during the procedure. The Reveal Plus ILR has been labeled as “MR conditional.”1 Patients with a Reveal Plus ILR can undergo MR examination any time after implantation, provided there is no reason to believe the device is not well implanted. The device is made of nitinol (NiTi), an alloy of … Like many other devices … application/pdf A physician with ACLS and pacemaker/ICD expertise should decide whether it is necessary to reprogram the pacemaker/ICD before the MR examination and should be in attendance for the entire study. Fractured leads may pose a particularly high risk of thermal injury. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products The recommendations in the present statement are meant to serve as a guide for physicians, MR technologists, nurses, and other healthcare professionals. 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 … The Watchman Device is a small implant placed in to the heart that can reduce the risk of stroke in patients with atrial fibrillation. A recent retrospective review of patients with myocardial infarction who underwent MR examination within 2 weeks (median 3 days) of stent implantation detected no increased incidence of clinical adverse events at 30-day and 6-month follow-up compared with those who had undergone stent implantation at more distant time points. After the nonsurgical WATCHMAN procedure, the device … 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. Over time, however, it became apparent that these terms were often applied incorrectly or used interchangeably.26 Therefore, to clarify the terminology and, more importantly, because the misuse of these terms could result in serious accidents for patients and others, the American Society for Testing and Materials International developed a new set of terms: “MR safe,” “MR conditional,” and “MR unsafe” (Table 1).27 Notably, the US FDA is not mandating retesting (and relabeling) of implants and devices that have already received approved labeling with the older terminology. <> Although formal evaluation of these devices in regard to MR safety has not been conducted, it is believed that these devices should be considered absolute contraindications to MR examination, particularly given that most hemodynamic support systems involve equipment likely to be affected by the electromagnetic fields used during MR imaging. PI-86716-AF MRI Compatibility for PI Products Additional conditions, including specific configurations of the item (eg, the routing of leads used for a neurostimulation system), may be required. Tr… h��Z�n�6��S�R*�?�H ŀ���(��v��B�iG�~\IN�G�[�G��%�Nl�M2k�&��!���|�����,��� e>�4t������;A�8q69�Ȑ��:�q69��P� g�� �~B~c�% pf�:K�5����&�3���~�A� @ܙ��x BH�g�_���;� �4/�kͽ�ϒv���GS�Qi Theframe has 10 fixation anchorsthat allow it to anchor insidethe LAA chamber.8 The meshmembrane … Find MRI guidelines and resources for radiology and other clinicians for our cardiac monitors, implantable cardiac devices, and spinal cord stimulation systems. Of those patients examined with electrocardiographic monitoring, no arrhythmias were noted, and for all patients, no symptoms suggestive of arrhythmia or other cardiac dysfunction were noted (although the anatomic region examined and the energies used in the examinations were not specifically described).79 To date, there is no report of complications related to the MR scanning of a patient with retained epicardial leads. If, during scanning, a metallic object is identified that the patient has not reported having implanted, the study should be stopped and the patient further questioned until the metallic object is identified. Scanning should only be performed at extremely experienced centers with expertise in MR imaging and electrophysiology. 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