watchman device mri safety

Instructions for obtaining permission are located at http://www.americanheart.org/presenter.jhtml? 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. Recommendations regarding the scanning of patients with permanent pacemakers and ICDs can be expected to evolve over time as more studies become available. 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. It is generally believed that additional anchoring of the stent into the vessel wall occurs over ≈6 to 8 weeks primarily due to tissue ingrowth. (bH) Frontal chest radiograph shows a Watchman device (arrow) over the expected location of the LAA. 36 0 obj application/pdf 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. The labeling approved by the FDA using the latest American Society for Testing and Materials International designation is given for each device type discussed that has been labeled with this newer terminology. Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB), Journal of the American Heart Association (JAHA), Customer Service and Ordering Information, Basic, Translational, and Clinical Research, Journal of the American Heart Association, Circulation: Arrhythmia and Electrophysiology, Circulation: Cardiovascular Interventions, Safety of Magnetic Resonance Imaging in Patients With Cardiovascular Devices, Prevalence and Evolution of Susceptibility‐Weighted Imaging Lesions in Patients With Artificial Heart Valves, Mortality After Magnetic Resonance Imaging of the Brain in Patients With Cardiovascular Implantable Devices, Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells As Regenerative Therapy for Heart Failure), Cardiac Magnetic Resonance Parameters Predict Transplantation-Free Survival in Patients With Fontan Circulation, Letter by Lederman et al Regarding Article, “MRI-Induced Stent Dislodgment Soon After Left Main Coronary Artery Stenting”, Response to Letters Regarding Article, “MRI-Induced Stent Dislodgment Soon After Left Main Coronary Artery Stenting”, Effects of External Electrical and Magnetic Fields on Pacemakers and Defibrillators, Magnetic Resonance Imaging and Implantable Devices, 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, Nonechocardiographic Imaging in Evaluation for Cardiac Resynchronization Therapy, Feasibility of Contrast-Enhanced and Nonenhanced MRI for Intraprocedural and Postprocedural Lesion Visualization in Interventional Electrophysiology, Quantitative Assessment of Artifacts on Cardiac Magnetic Resonance Imaging of Patients With Pacemakers and Implantable Cardioverter-Defibrillators, Feasibility of Real-Time MRI With a Novel Carbon Catheter for Interventional Electrophysiology, Global Impact of the 2017 ACC/AHA Hypertension Guidelines. An air embolism can cause a stroke. As a result of ferromagnetic interactions, a device may be moved, rotated, dislodged, or accelerated toward the magnet. Our patient support team is happy to help answer all your questions about living with your device. 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. Risks to the patient are likely increased in centers without highly experienced personnel in both function and programming of the device and operations/pulse sequences of the MR scanner. There are several potential risks associated with MR scanning of specific cardiovascular devices that result from these processes.3,9–12,14,16–21 Most of these risks can be understood by consideration of the areas discussed below. Venous MAGNETIC RESONANCE IMAGING (MRI) SAFETY … Since its FDA approval in March 2015, the Watchman™ left atrial appendage closure device has been implanted into nearly 50,000 patients with nonvalvular atrial fibrillation (AF) as a … 147 0 obj A relationship is considered to be “modest” if it is less than “significant” under the preceding definition. A sterile, disk-like, device used for the non-surgical closure of cardiac defects. 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. 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). This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on September 18, 2007. Most currently used clinical MR scanners are 1.5 to 3 tesla (T), which corresponds to ≈30 000 to 60 000 times the strength of the Earth’s magnetic field. An American Heart Association Scientific Statement From the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: © American Heart Association, Inc. All rights reserved. If it cannot be discerned that the patient can safely undergo MR examination, alternative imaging modalities should be used whenever possible. 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. Extensive experience and promising results with the Watchman™ device, offering it before any other program in Northern California after FDA approval. 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. Acrobat Distiller 10.1.16 (Windows) Most of the stents currently used for carotid procedures are made of nitinol and are nonferromagnetic or only weakly ferromagnetic. 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. 79 0 obj Do not scan a patient without first programming the MRI … 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. The Watchman device will be pushed through the catheter into your left atrial appendage where it will self-expand into a parachute shape with a cap. Advances in MR imaging over the last 2 decades have led to MR becoming an increasingly attractive imaging modality, one that provides excellent spatial resolution and multiplanar 3-dimensional analysis while not exposing patients to the risks associated with computerized tomography and invasive procedures. Patients with retained temporary epicardial pacing wires are believed to be able to safely undergo MR procedures, and patients do not need to be routinely screened for the presence of such wires before scanning. The device may cause a clot to form and move into your bloodstream. Your heart may be punctured during the procedure. endobj 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. Advances in magnetic resonance (MR) imaging over the past 2 decades have led to MR becoming an increasingly attractive imaging modality. Watchmen device … University of Southern California, Keck School of Medicine, Cardiac, Vascular & Thoracic Surgeons, Inc, Cincinnati, Ohio, University of Florida Health Science Center. Important Safety Information. Uniformed Services University of the Health Sciences. Therefore, it is unlikely that such implants would become moved or dislodged as a result of exposure to static magnetic fields of MR systems operating at up to 1.5 T. Studies of MR examination of both animals and humans with implanted IVC filters have thus far not reported complications or symptomatic filter displacement.63–68 Several animal studies have even used “real-time” MR for the placement of IVC filters.69,70, Most IVC filters that have been tested have been labeled as “MR safe”; the remainder of IVC filters that have been tested are classified as “MR conditional.”1 Patients who have been treated with nonferromagnetic IVC filters can undergo MR examination any time after filter implantation. 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 … 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. Numerous clinical studies have demonstrated the safety of performing MR examinations in patients with prosthetic heart valves.55,57,58 Of note, 28 patients recently underwent apparently uneventful cardiac MR imaging after percutaneous pulmonary valve implantation.59 As of this writing, we are unaware of any case of a patient incident or injury related to the presence of a heart valve prosthesis or annuloplasty ring in association with an MR examination. Older and Newer Terminology Used for Labeling Implanted Devices. Only 1 study has placed no anatomic limitations on MR procedures used for the patients studied. 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 … endobj 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. endobj a�DVv0i��];�����f�םCvB��s�.4�v?�a�{ k����`��X� Accordingly, this scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Get the #1 Ranked AFib Book on Amazon.. MRI Safety Information MR Conditional Non-clinical testing demonstrated that the LAA Exclusion System clip is MR Conditional. Furthermore, most devices have been tested under very specific circumstances (eg, magnetic field strength, radiofrequency [RF] energy levels, and type of RF transmission coils). 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. MR examination of non–pacemaker-dependent patients is discouraged and should only be considered in cases in which there is a strong clinical indication and in which the benefits clearly outweigh the risks, MR examination of pacemaker-dependent patients should not be performed unless there are highly compelling circumstances and when the benefits clearly outweigh the risks, MR examination of patients with ICDs should not be performed unless there are highly compelling circumstances and when the benefits clearly outweigh the risks. The MR imaging conditions in which the device was tested should be specified in conjunction with the term “MR compatible,” because a device that is safe under 1 set of conditions may not be found to be so under more extreme MR conditions. An item that has been demonstrated to pose no known hazards in a specified MR imaging environment with specified conditions of use. 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. The device … organization. A single reprint is available by calling 800-242-8721 (US only) or by writing the American Heart Association, Public Information, 7272 Greenville Ave, Dallas, TX 75231-4596. Your cardiologist places the WATCHMAN™ device into your heart via a minimally invasive technique using a small puncture into a vein in your groin. An example of such an interaction is the heating (and subsequent melting at the skin entry site) of a Swan-Ganz (pulmonary artery) thermodilution catheter.23 These concerns are most relevant for electrically conductive implants such as wires or leads, particularly when such wires or leads form large loops. For weakly ferromagnetic devices for which there are not currently enough data and consensus to make the recommendation that scanning can be performed safely any time after implantation, the writing group recommends that the physician weigh the risks and benefits of scanning patients with such devices on a case-by-case basis and adopt the following approach: For cases that occur in the days to weeks after device implantation in which there is a clear potential clinical benefit of scanning the patient at that time (eg, acute back pain and lower-extremity weakness after trauma), the benefits of the MR examination will likely outweigh any risks of the examination, and MR examination should generally be performed. Find MRI guidelines and resources for radiology and other clinicians for our cardiac monitors, implantable cardiac devices, and spinal cord stimulation systems. 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. Boston Scientific Corporation Over 2 million patients in the United States have implanted devices, including pacemakers and implantable cardioverter-defibrillators (ICDs). The artifact does obscure the device lumen. 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. After the nonsurgical WATCHMAN procedure, the device … MR examination at ≤3 T in patients with peripheral stents that are nonferromagnetic can be performed immediately after implantation. 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. Ask for reprint No. 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. <> For non–pacemaker-dependent patients, a physician with electrophysiological expertise should interrogate the pacemaker and reprogram as needed, For pacemaker-dependent patients, a physician with electrophysiological expertise should interrogate the pacemaker function and reprogram the pacemaker, For patients with ICDs, a physician with electrophysiological expertise should perform postscan device reprogramming and defibrillation threshold testing. 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. Expert peer review of AHA Scientific Statements is conducted at the AHA National Center. MR examination of patients with retained transvenous leads is discouraged, and MR examination should only be considered in centers with expertise in MR and electrophysiology, and only in cases in which there is a strong clinical indication. Watchman LAA closure device. <> Table 1. The present writing group believes that despite the above discussion of patients with pacemakers or ICDs who have been scanned safely, the following must be noted: (1) these studies were conducted at institutions with expertise in MR imaging and electrophysiology; (2) the number of patients who experienced adverse events that have gone unreported is unknown; (3) considerable controversy exists over safety issues regarding MR scanning of patients with pacemakers and ICDs; and (4) the presence of a pacemaker or ICD should still be considered a strong relative contraindication to routine MR examination, which is therefore discouraged. The pacemaker/ICD should be interrogated before and after the procedure. Unauthorized 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. The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. RF energies used in the MR imaging process can also induce electrical currents in wires and leads, which could possibly induce arrhythmias. Device and procedure. Acrobat Distiller 10.1.16 (Windows) The stronger the static magnetic field, the greater the magnitude of these observed perturbations. 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. The writing committee emphasizes that efforts by industry to manufacture pacemakers and ICDs that are specifically designed to be acceptable for patients undergoing MR procedures should be intensified, an approach preferable to the current “ad hoc” methods described above. 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. 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. endobj 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. MR technologists should be well trained on MR safety issues, because they may often represent the “last line of defense.”. This study is a prospective, non-randomized, multi-center observational study. The reader should be aware that local artifact remains an issue for many stents. The degree of in-stent stenosis cannot be assessed reliably in the case of coronary stents or peripheral stents, although patency of the peripheral stent can usually be inferred from a complete assessment of the MR examination. Extensive experience and promising results with the Watchman™ device, offering it before any other program in Northern California after FDA approval. 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. Customer Service <> 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. The greatest risk from the main magnetic field is attraction of a ferromagnetic object into the scanner. Therefore, for those drug-eluting stents tested, it is believed that MR examination may be performed immediately after implantation. 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. 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. Hemodynamic support devices, including intra-aortic balloon pumps, right ventricular assist devices, and left ventricular assist devices, are complex devices with variable degrees of ferromagnetic materials, moving parts, and electrical components. 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. If you need an MRI (magnetic resonance imaging), it’s important to show the doctor and MRI technologist your WATCHMAN Implant Card. After the procedure to address an adverse event Dallas, TX 75231 Customer Service 1-800-AHA-USA-1 1-800-242-8721 local Info Us. In Northern California after FDA approval device may be moved, rotated, dislodged, or accelerated toward magnet. 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