Recommendations for the Performance of MR Examinations in Patients With Pacemakers or ICDs. PI-86716-AF MRI Compatibility for PI Products 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. Due to the wide prevalence of cardiovascular diseases, a significant proportion of patients who would ideally be referred for MR examinations will have permanent cardiac pacemakers or implantable cardioverter defibrillators (ICDs). With all of this information, its likely you have at least started discussing treatment options available for managing your Afib symptoms and for reducing your stroke risk. To purchase additional reprints, call 843-216-2533 or e-mail [email protected]. “MR unsafe” items include magnetic items such as a pair of ferromagnetic scissors. 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has been tested at 3 T. Findings indicated that patients with this device can be safely scanned at 3 T (Frank Shellock, unpublished data, 2006). 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. Do not scan a patient without first programming the MRI … The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition. 2017-08-24T20:54:34Z The majority of cardiac closure and occluder devices that have been tested have been labeled as “MR safe”; several that have been tested are labeled as “MR conditional.”1 Patients with nonferromagnetic cardiac closure and occluder devices may undergo MR procedures at any time after implantation. The reader should be aware that local artifact remains an issue for many stents. Pacing threshold changes were noted in 40 of 107 leads, of which 10 were judged to be significant, 2 of which required a change in programmed output. 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. 79 0 obj Concentration of RF energy is frequency dependent and therefore changes for a given device in a different field strength. 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. 1) Confirm MRI Readiness. PI-86716-AF MRI Compatibility for PI Products The Watchman Device is a small implant placed in to the heart that can reduce the risk of stroke in patients with atrial fibrillation. Older and Newer Terminology Used for Labeling Implanted Devices. 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. 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. If it cannot be discerned that the patient can safely undergo MR examination, alternative imaging modalities should be used whenever possible. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition. 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. A catheter delivers the device to your LAA under x-ray … PScript5.dll Version 5.2.2 What are the risks of the Watchman implant? Of note, interrogation of the devices after MR revealed tachyarrhythmias and bradyarrhythmias recorded during the examinations that were believed to be artifacts.77. Extensive experience and promising results with the Watchman™ device, offering it before any other program in Northern California after FDA approval. The pacemaker/ICD should be interrogated before and after the procedure. A catheter delivers the device to your LAA under x-ray … 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. Components. 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. 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. 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. SAR increases with the square of the field strength.22 Certain metallic devices (such as leads) can act as an “antenna” and concentrate this RF energy, which leads to excessive local heating, especially at the tip of these 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 … ����[�h���u��0T:�!���I��73�C�B� iQE`��)qF � �$B�!t*�� ��U%�[9 �G~C͍$�dN��rۓ\�yq��{���+[W�ZL=��Ou�j�����۶�R8�J#@ګ:Ύ��R�t������ѫ"�'uR�Q�k��m��[�aC�kU�/S����V��SQ>ם��\܊2�V+�~Ks�'ꍧ"_�7�~���]6T��^, Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products, PI-86716-AE AUG2015 stents magnetic resonance imaging MRI compatibility, PI-86716-AF MRI Compatibility for PI Products. 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 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. 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. A sterile, disk-like, device used for the non-surgical closure of cardiac defects. The multiparametric nature of this risk results in the seemingly paradoxical situation of being able to identify implants/wires that test as being safe at a given field strength/frequency yet are unsafe at a higher or lower one. 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. The Reveal Plus ILR contains no lead wires; however, the electromagnetic fields produced during MR imaging may adversely affect the data stored by the Reveal Plus ILR. uuid:25e82b54-76d6-4425-96a5-e3733fe0351f Team approach to reducing atrial fibrillation-related … 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. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No Device … 2017-08-24T21:31:44Z 36 0 obj No episodes of pacing above the upper rate limit or arrhythmias were noted.93 A small series of patients with ICDs who were undergoing neurological MR examination found that none of the 8 patients scanned experienced significant adverse clinical events; in 1 patient, a change in programming was noted.96 One study involving ex vivo device testing and in vivo animal testing found that ICDs manufactured after 2000 may be more resistant to changes in function during MR examination.97 Several other small series have reported on the results of MR scanning in patients with pacemakers or ICDs,98–103 and it is believed that at least several hundred patients with these devices have undergone examination.104,105 Recent studies of patients with pacemakers or ICDs have confirmed the findings of these earlier studies, and these study investigators, among others, have proposed strategies and protocols for safe pacemaker/ICD scanning.106,107 No deaths have been reported in studies in which patients were deliberately scanned and properly monitored, although cases of changes in pacing threshold, programming changes, need for device reprogramming, and possibly battery depletion have been noted. A sterile, disk-like, device used for the non-surgical closure of cardiac defects. Contact Us. The WATCHMAN device has been implanted in more than 80,000 patients worldwide and the latest-generation WATCHMAN FLX device received CE Mark in March 2019. endobj After the procedure, your heart tissue will gradually … endobj 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. Patients with atrial fibrillation are at increased risk of stroke, … endobj MRI exams are safe for some devices. In addition, nonmetallic fabrics and other materials are often used for these devices.1,3,60–62 In tests for magnetic field interactions conducted at 1.5 T, devices made from 304V stainless steel displayed weakly ferromagnetic qualities, whereas those made from nitinol, titanium, titanium alloy, and MP35N were nonferromagnetic.3,60,61. 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. patients should not be considered for the WATCHMAN Implant if they are doing well and anticipate continuing to do well with anticoagulant medications. <>stream MR examination should not be performed in patients with known retained transvenous leads that have fractures. It is made up ofa metallic frame that is covered by a polyester mesh membrane.8 The metallic frame is made from nitinol, which is analloy of nickel and titanium that has unique memory andsuperelastic properties. Therefore, for those drug-eluting stents tested, it is believed that MR examination may be performed immediately after implantation. RF energies used in the MR imaging process can also induce electrical currents in wires and leads, which could possibly induce arrhythmias. Furthermore, because the harsh electromagnetic environment associated with the MR system can alter the operation of an external pulse generator or damage it, it may not be possible to reliably pace the patient during the MR examination, which makes the issue of scanning a patient with a temporary transvenous lead irrelevant in most cases. It’s a parachute-shaped device that expands to the size of a quarter when implanted. The earliest embolization coils were stainless steel; more recently developed coils are often made from platinum or other alloys. Introduction: The Watchman device for left atrial appendage occlusion (LAAO) has proven to be effective for stroke prophylaxis in atrial fibrillation patients. Tr… A physician with pacemaker/ICD expertise should be in attendance during scanning, and a “crash cart,” including a defibrillator, must be available throughout the procedure to address any adverse events. 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. Acrobat Distiller 10.1.16 (Windows) 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. The greatest risk from the main magnetic field is attraction of a ferromagnetic object into the scanner. %PDF-1.5 %���� The Watchman device has been advertised heavily, both to the public, in medical journals, and at medical conferences. 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Additional conditions, including specific configurations of the item (eg, the routing of leads used for a neurostimulation system), may be required. With all of this information, its likely you have at least started discussing treatment options available for managing your Afib symptoms and for reducing your stroke risk. The patient’s heart rhythm and vital signs should be monitored throughout the MR examination. identifier=4431. In addition to the above considerations, several other issues merit mention. The Left Atrial Appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium. Broader information on MR examinations is available at several well-recognized expert Web sites4–7 and in published and online documents.8–17. Because this device contains ferromagnetic components, the strong magnetic fields associated with the MR system can create sufficient magnetic field interactions for the Reveal Plus ILR such that the patient may feel slight movement of this device.76 Although this does not represent a safety hazard, the patient should be informed of this possibility to avoid undue concern. WATCHMAN is “MRI conditional,” which means you can safely have … Most, but importantly not all, currently implanted cardiovascular devices are either nonferromagnetic or weakly ferromagnetic. 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. Inpatients should be examined for the presence of temporary devices (eg, pulmonary artery catheters or temporary pacing leads). endobj Although there is a theoretical possibility of an electromagnetic interaction with a heart valve that contains metal in the disk or leaflet that could inhibit opening and closing of the mechanical heart valve prosthesis (referred to as the Lenz effect), this has never been demonstrated experimentally or reported clinically.56 Those valves and rings that have undergone testing thus far at 3 T have not demonstrated clinically significant magnetic field interaction or MR-related heating and thus have been found to be safe for clinical MR examinations.3,43. An ex vivo study of stent grafts at 3.0 T found that most exhibited nonferromagnetic or weakly ferromagnetic properties, with the exception of several EndoFit stent grafts and extenders (Endomed Inc).43 Thus far, there have been several published studies of MR examinations in patients with aortic stent grafts that have not noted any adverse clinical events related to the MR examinations.44,45 The MR characteristics of the Zenith AAA endovascular graft (Cook) have been evaluated through bench testing in MR systems with static fields of ≤1.5 T, and this stent graft was found to exhibit significant deflection and torque of the stainless steel metallic component of the endovascular graft and therefore did not meet standard “MR safe” bench test criteria.46, A practical consideration in MR examinations of endovascular stents relates to the potential magnetic susceptibility effects (artifacts) induced by the metallic components of the stent grafts. PI-86716-AE AUG2015 stents magnetic resonance imaging MRI compatibility Phone: (866) 484-3268 Hours: M-F 8:00 a.m. - 5:00 p.m. Central Local Info Watchmen device … The device is made of nitinol (NiTi), an alloy of … 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 … 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. For devices in which the ferromagnetism of the device is a significant safety concern, consideration should be given to performing the study at the lowest field strength available to reduce whatever ferromagnetic risk might be present. https://doi.org/10.1161/CIRCULATIONAHA.107.187256, National Center The Watchman is inserted during an outpatient procedure through a catheter in your groin that is then fed up into your heart. In patients who have been treated with a weakly ferromagnetic IVC filter (Gianturco bird nest IVC filter [Cook], stainless steel Greenfield vena cava filter [Boston Scientific]), it is advised that the patient wait at least 6 weeks before undergoing an MR examination (because these older devices initially may not be anchored as firmly in place as other devices discussed in the present report), unless there is a strong clinical indication to perform the MR examination sooner after implantation, and as long as there is no reason to suspect that the device is not positioned properly or that it is not firmly in place. At the end of the day, the panel voted unanimously that the Watchman device was safe for the indicated patient group. They go on to state that “while FDA recognizes that there are pacemaker and ICD patients for whom, on a case-by-case basis, the diagnostic benefit from MR imaging outweighs the presumed risks, we believe that those risks have not yet been characterized and mitigated sufficiently to justify the routine use of MR examination in those populations.” Faris and Shein recently reiterated their position in an updated editorial.108. 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. <> 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. Blood collects there and can form clots in the LAA and atria. 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 Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer … An understanding of the risks involved in such study requires an expert understanding of the physics involved in MR scanning. Retained fractured leads may pose a particularly high risk of thermal injury. Findings from three Cleveland Clinic real-world studies suggest a wider range of patients stand to benefit from the left atrial appendage closure device. 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. MRI (magnetic resonance imaging) uses a large, circular magnet and radio waves to produce clear computer images of the body. “The Watchman device, which has been implanted in more than 90,000 patients globally, continues to demonstrate a reduced risk of stroke and has shown reduced bleeding post-procedure … Team approach to reducing atrial fibrillation-related … 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 scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. The recommendations in the present statement are meant to serve as a guide for physicians, MR technologists, nurses, and other healthcare professionals. organization. A relationship is considered to be “significant” if (1) the person receives $10 000 or more during any 12-month period, or 5% or more of the person’s gross income; or (2) the person owns 5% or more of the voting stock or share of the entity, or owns $10 000 or more of the fair market value of the entity. After the nonsurgical WATCHMAN procedure, the device … An item that is known to pose hazards in all MR environments. Like many other devices … endobj 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. Like many other devices … 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. Terminology applied to implants and devices relative to the MR environment has evolved over the years. Scanning should only be performed at extremely experienced centers with expertise in MR imaging and electrophysiology. Venous MAGNETIC RESONANCE IMAGING (MRI) SAFETY … 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. Finally, all healthcare professionals are reminded that currently used MR scanners are typically superconducting and thus are always “on.”. 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. Visit http: //www.americanheart.org/presenter.jhtml? identifier=3023366 devices ( eg, pulmonary artery catheters or temporary pacing leads ) accelerated the! Recently developed coils are often made from a variety of watchman device mri safety blood collects there can. They are doing well and anticipate continuing to browse this site uses cookies in... 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