WHAT IF YOU COULD MINIMIZE RADIATION EXPOSURE WHILE ACHIEVING CLINICAL AND QUALITY SUCCESS? 1-4
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1 WHAT IF YOU COULD MINIMIZE RADIATION EXPOSURE WHILE ACHIEVING CLINICAL AND QUALITY SUCCESS? 1-4 The reduction of live X-ray in medical procedures performed in Europe is a clear goal set by the EU institutions, as well as among physicians and other health care professionals. This poses no greater challenge (or opportunity) than in the area of cardiovascular medicine. By working with industry partners that can provide innovative technology solutions to the health care provider community, our X-ray occupational, public and medical exposure may be minimized.
2 CVD BURDEN RADIATION RISKS Cardiovascular Disease Medical Radiation Exposure CVD BURDEN Each year cardiovascular disease (CVD) causes more than 4 million deaths in Europe representing 47% of all deaths. 5 The prevalence of CVD is increasing, presenting substantial health and economic burdens. Treatment for CVD often involves medical imaging-assisted interventions, such as cardiac ablation and rhythm management. The increased use of medical imaging for CVD management has resulted in increased medical radiation exposure for both health care providers and patients. Along with this increased exposure comes higher risk for radiation-related illnesses, such as cancer, and ocular cataracts/lens opacities Though rare in Europe, mandatory regulations exist for recording or reporting radiation dosing; clinical measures and guidance that regulatory agencies endorse suggest a societal need for facilities and care providers to minimize radiation exposure as much as reasonably possible.
3 CVD BURDEN RADIATION RISKS Cardiovascular Disease Medical Radiation Exposure THE BURDEN OF CARDIOVASCULAR DISEASE $ $ $ 47% CURRENTLY, 47% OF ALL DEATHS IN EUROPE are caused by some form of CVD 5 The costs associated with treatment are estimated TO COST THE EU ECONOMY ALMOST 196 BILLION A YEAR. 5 The high burden of CVD in Europe has led to the use of a substantial number of imaging-assisted interventions for disease treatment. However, radiation exposure from medical imaging procedures and tests has become the largest man-made source of human radiation exposure, 2 and it is expected that the use of medical imaging for CVD management will continue to rise. 11 This will create work-related risks for interventional cardiologists and electrophysiologists, as well as other health care professionals.
4 CVD BURDEN RADIATION RISKS Cardiovascular Disease Medical Radiation Exposure THE BURDEN OF MEDICAL RADIATION EXPOSURE Interventional radiology imaging uses ionizing radiation, such as X-ray and fluoroscopy. 5 % 4 % 12 % 14 % 79 % FREQUENCY OF EXAMINATION IN CARDIOLOGY 48 % TOTAL COLLECTIVE DOSE (smv=4, 150) 21 % 17 % Conventional Radiology Nuclear Medicine Computed Tomography Interventional Radiology Figure 1. In the United States, interventional radiology is responsible for only 12% of cardiology exams, but represents 48% of the total radiation exposure related to medical imaging, more than any other single source of medical radiation. 12
5 Professional & Patient Risk RADIATION RISKS While patients and providers are both exposed to radiation due to medical imaging procedures, medical personnel may be at the greatest risk because of the high number of procedures performed each year. 13 Unlike many other mutagens, X-ray beams can access all internal organs, meaning that even a single electron set into motion by an X-ray photon may cause permanent molecular damage. 14 This radiation causes DNA damage to human cells. 15 Research shows that even low levels of radiation exposure from X-ray examinations can lead to chromosomal damage. 16,17
6 Professional & Patient Risk HEALTH CARE PROFESSIONAL RISK Research supports the hypothesis that increased brain cancer in practitioners who perform fluoroscopic procedures may be linked to radiation exposure. 7,15,18 Other radiation-associated conditions observed in interventional cardiologists include lens opacity and posterior subcapsular cataract PROCEDURE AND FLUOROSCOPY TIMES BY YEAR These risks are compounded by the added risk of chronic orthopedic injury from traditional lead aprons, aggravated by conditions common to the EP lab (e.g., improper table height, fluoroscopy monitor height and position, and on-table control panel position). Traditional lead aprons weigh approximately 15 pounds, and can place up to 300 pounds of pressure per square inch on a physician s intervertebral discs. 19, PROCEDURE TIME (P<0.0005) FLUOROSCOPY TIME (P<0.0005) Figure 2. Changes in Atrial Fibrillation Ablation Procedure/Fluoroscopy Time Over 7 Years (Single Hospital Center Data) 27 Interventional cardiologists and electrophysiologists, in particular, are at the highest risk for radiation exposure. 17,21 Invasive and interventional cardiologists often receive radiation through fluoroscopy (Figure 2), 22 which can cumulatively cause a non-negligible lifetime attributable risk of cancer. 13 Specifically, high radiation exposure, and associated increased risk for cancer, has been identified in clinicians who regularly perform interventional procedures involving fluoroscopy SCROLL PATIENT RISK Patient risk for radiation exposure is highest for individuals who require multiple imaging tests. 4 Although exposure guidelines are in place for patients. 28,29 individual patient differences may lead to differences in risk related to exposure. Specifically, the cumulative effective dose of radiation administered increases with age, and is higher in children, women and obese patients. SCROLL Fluoroscopic imaging is a fixture in modern electrophysiology and catheterization labs, and may expose both patients and practitioners to radiation due to scatter from the incident beam. 7,30 These doses are rarely measured, 14 and it is difficult to determine how much radiation internal organs absorb. 31 Complex procedures generally require longer fluoroscopy times, resulting in increased radiation exposure. 10,30,32 Besides cancer risks related to radiation exposure, other risks associated with fluoroscopic imaging include radiation-induced cataracts and skin burns. 33
7 LONG-TERM FINANCIAL IMPACT REGULATORY RESPONSES LIVE X-RAY REDUCTION LONG-TERM FINANCIAL IMPACT In the long-term, illness related to radiation exposure may jeopardize cardiologists ability to maintain a full workload, and the hospital may be responsible for treatment costs, as well as insurance or other liability associated with key staff developing radiation-induced illness. A SURVEY REVEALED 1 IN 5 CARDIOLOGISTS purposely remove their dosimeter to avoid exceeding a radiation limit An international survey conducted by the Society of Cardiovascular Angiography and Interventions (SCAI) revealed that nearly 1 in 5 cardiologists have purposely not worn a dosimeter to avoid exceeding a radiation limit. 34 As cardiologists increasingly move from contract positions toward full-time hospital employment, 35 hospitals will be responsible for their benefits and Workers Compensation claims. Efforts taken now to reduce radiation exposure and develop a radiation-safe hospital environment can help preserve both hospital revenue and the safety of staff members.
8 LONG-TERM FINANCIAL IMPACT REGULATORY RESPONSES LIVE X-RAY REDUCTION REGULATORY RESPONSES The current core European principle now governing the use of ionizing medical radiation is known as ALARA As Low As Reasonably Achievable. 10 Additionally, the EU developed a regulatory framework specifically related to medical radiation exposure. 36 Regulatory measures have been proposed by the European Commission to help protect health care professionals and patients from excess medical radiation exposure. The EU institutions agree that radiation exposure from medical imaging is potentially dangerous and should be minimized. 11,37,38
9 MediGuide Technology MediGuide Enabled Devices Imaging Concerns Hospital Economics LIVE X-RAY REDUCTION MediGuide Technology is the first and only solution to enable navigation of devices on pre-recorded X-ray images allowing the physician to reduce the duration of live X-ray during a procedure. MediGuide Technology applies 3-D visualization and precise navigation to pre-recorded 2-D X-ray images; the physician can use these images to perform complex electrophysiology procedures and CRT implants.
10 MediGuide Technology MediGuide Enabled Devices Imaging Concerns Hospital Economics MEDIGUIDE TECHNOLOGY MediGuide Technology is analogous to a global positioning system (GPS) in that it uses a low-powered electromagnetic field to locate device-based sensors in three-dimensional space. The system uses this location information to overlay MediGuide Enabled devices on the corresponding pre-recorded X-ray image, which allows the physician to reduce the duration of live X-ray during a procedure (Figure 3). With the use of pre-recorded X-ray images, MediGuide Technology creates a real-time clinical environment that: Figure 3. Live X-ray (left) and pre-recorded X-ray (right) using MediGuide Technology n adjusts automatically for changes in heart rate, respiratory motion and patient movement; n accurately tracks catheter position and orientation within 1 mm and 1 degree; n provides biplane visualization with uniplane equipment; and n adds additional perspective and improves workflow during catheter navigation. CLINICAL RESEARCH Animal and human data consistently show that MediGuide Technology can accurately track diagnostic and ablation catheters with decreased fluoroscopic exposure and procedure time. 1,39-42 Animal (swine) data have confirmed the accuracy of the technology during pacing, radiofrequency energy delivery and subject movement. 39 Human data on the use of MediGuide Technology have shown consistent, positive outcomes in both tracking accuracy and reduction in duration of live X-ray. 1,40-42
11 MediGuide Technology MediGuide Enabled Devices Imaging Concerns Hospital Economics MediGuide Transmitters Installed in fluoroscopy detector MediGuide CathConnect Connection between MediGuide Enabled devices and the MediGuide Connect MediGuide Enabled Devices Contain position and orientation sensor MEDIGUIDE ENABLED DEVICES FOR EP AND CRT PROCEDURES The system consists of hardware and software elements that can be installed in conjunction with existing fluoroscopy imaging systems in catheterization or EP laboratories (Figure 4). MediGuide Connect Connects bedside components to the MediGuide Console Figure 4. Main Components of the MediGuide System
12 MediGuide Technology MediGuide Enabled Devices Imaging Concerns Hospital Economics ADDRESSING MEDICAL IMAGING CONCERNS The use of medical imaging has increased substantially over the past 20 years, 43 leading to concerns that physicians and patients are being exposed to increased and possibly excessive levels of radiation. Fluoroscopy, used for interventional radiology, is associated with the highest levels of radiation exposure. Current fluoroscopic navigational systems that interventional cardiology departments now deploy may lead to substantial radiation exposure for physicians, patients and hospital staff. The use of MediGuide Technology in the electrophysiology lab improves procedure planning and guidance, while reducing the duration of live X-ray. 42 The use of MediGuide Technology has been shown to reduce the duration of live X-ray by 50% to 86%. 42 MediGuide Technology is the only 3-D cardiovascular navigation and visualization platform available to reduce live X-ray usage in the EP lab. This technology offers the potential to increase EP lab capacity and safety, as well as provide institutions with substantial benefit that may improve a hospital s competitive marketplace position. 86 % REDUCED MEDICAL RADIATION EXPOSURE 50 %
13 MediGuide Technology MediGuide Enabled Devices Imaging Concerns Hospital Economics WHAT CAN MEDIGUIDE TECHNOLOGY DO TO HELP HOSPITAL ECONOMICS? 86% REDUCED MEDICAL RADIATION EXPOSURE 42,44 40% PROCEDURE TIME REDUCTION 44 SCROLL SCROLL >18 min 46 Average fluoro time for flutter or simple cases >61 min 46 Average fluoro time for a complex case WHAT ARE THE RELATIVE RATES OF EXPOSURE IN CARDIAC IMAGING PROCEDURES? Comparison of Typical Effective Doses (msv) from Medical Imaging Modalities and Body Area examined 47 Dental X-ray (Intraoral) 0.01 Chest X-ray (posteroanterior) 0.02 Chest X-ray (posteroanterior and lateral) 0.1 Breast X-ray (mammography) 0.4 Head CT scan 2 Coronary angiography CT scan (prospectively gated) 7 Diagnostic coronary angiography (Invasive Imaging) 7 Coronary angiography CT scan (tube current modulation) 13 Coronary angiography CT scan (helical) TI-99mTc dual isotope (130/1000 MBq) (Cardiac Nuclear Stress test) 24 Reported Values of Effective Dose Estimates (msv) 48 Round trip flight, New York to New Orleans 0.02 Posteroanterior and Lateral Study of Chest 0.1 Annual Background Radiation to Public 0.1 CT Calcium Scoring 3 Myocardial Pefusion Imaging: Rubidium Diagnostic Coronary Angiography 5 Myocardial Pefusion Imaging: Sestamibi stress/rest (single day) 9 CT Chest for Pulmonary Embolism 14 PCI or RF Ablation 15 CT Coronary Angiography 16 Average Annual Occupation Dose Limit* 20 Myocardial Pefusion Imaging: Thallium stress/rest 41 MediGuide Enabled tools include both EP and CRT devices. MEDIGUIDE TECHNOLOGY ABLATION PROCEDURES SIMPLE TO COMPLEX CARDIAC RESYNCHRONIZATION THERAPY (CRT) PROCEDURES *Averaged over 5 years. Maximal permissible in a year =50mSv.
14 SCROLL 1. Rolf S, Sommer P, Gaspar T, et al. Ablation of atrial fibrillation using novel 4D catheter tracking within autoregistered LA angiograms. Circ Arrhythm Electrophysiol. 2012;5(4): Picano E. Sustainability of medical imaging. BMJ. 2004;328(7439): Picano E, Vano E. The radiation issue in cardiology: the time for action is now. Cardiovasc Ultrasound. 2011;9: Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics 2012 update. Circulation. 2012;125(1):e2-e European Cardiovascular Disease Statistics Matanoski GM, Seltser R, Sartwell PE, et al. The current mortality rates of radiologists and other physician specialists: specific causes of death. Am J Epidemiol. 1975;101(3): Finkelstein MM. Is brain cancer an occupational disease of cardiologists? Can J Cardiol. 1998;14(11): Vano E, Kleiman NJ, Duran A, et al. Radiation cataract risk in interventional cardiology personnel. Radiat Res. 2010;174(4): Ciraj-Bjelac O, Rehani MM, Sim KH, et al. Risk for radiation-induced cataract for staff in interventional cardiology: is there reason for concern? Catheter Cardiovasc Interv. 2010;76(6): Hirshfeld JW, Jr., Balter S, Brinker JA, et al. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005;111(4): Picano E. Economic and biological costs of cardiac imaging. Cardiovasc Ultrasound. 2005;3:13; National Cancer Institute and The Society of Interventional Radiology. Interventional fluoroscopy: Reducing radiation risks for patients and staff causes/radiation/interventionalfluoroscopy/page4. Accessed April 9, Bedetti G, Botto N, Andreassi MG, et al. Cumulative patient effective dose in cardiology. Br J Radiol. 2008;81(969): Hirshfeld JW, Jr. Radiation exposure in cardiovascular medicine: How do we protect our patients and ourselves? Circ Cardiovasc Interv. 2011;4(3): Gofman JW. Executive Summary. Radiation from Medical Procedures in the Pathogenesis of Cancer and Ischemic Heart Disease: Dose-Response Studies with Physicians per 100,000 Population. San Francisco: Committee for Nuclear Responsibility; radiation/cnr/rmp/chp1f.html. Accessed April 9, Roguin A, Goldstein J, Bar O. Brain tumours among interventional cardiologists: A cause for alarm? Report of four new cases from two cities and a review of the literature. EuroIntervention. 2012;7(9): Bhatti P, Doody MM, Preston DL, et al. Increased frequency of chromosome translocations associated with diagnostic x-ray examinations. Radiat Res. 2008;170(2): Zakeri F, Hirobe T, Akbari Noghabi K. Biological effects of low-dose ionizing radiation exposure on interventional cardiologists. Occup Med (Lond). 2010;60(6): DeAngelis LM. Brain tumors. N Engl J Med. 2001;344(2): ; Hardell L, Mild KH, Pahlson A, Hallquist A. Ionizing radiation, cellular telephones and the risk for brain tumours. Eur J Cancer Prev. 2001;10(6): Pelz DM. Low back pain, lead aprons, and the angiographer. Am J Neurorad. 1999;21: Klein LW, Miller DL, Balter S, et al. Occupational health hazards in the interventional laboratory: Time for a safer environment. J Vasc Interv Radiol. 2009;20(2): Andreassi MG. The biological effects of diagnostic cardiac imaging on chronically exposed physicians: The importance of being non-ionizing. Cardiovasc Ultrasound. 2004;2: Limacher MC, Douglas PS, Germano G, et al. ACC expert consensus document. Radiation safety in the practice of cardiology. J Am Coll Cardiol. 1998;31(4): Vano E, Gonzalez L, Guibelalde E, Fernandez JM, Ten JI. Radiation exposure to medical staff in interventional and cardiac radiology. Br J Radiol. 1998;71(849): Cousins C, Sharp C. Medical interventional procedures-reducing the radiation risks. Clin Radiol. 2004;59(6): Tsapaki V, Kottou S, Vano E, et al. Correlation of patient and staff doses in interventional cardiology. Radiat Prot Dosimetry. 2005;117(1-3): Venneri L, Rossi F, Botto N, et al. Cancer risk from professional exposure in staff working in cardiac catheterization laboratory: Insights from the National Research Council s Biological Effects of Ionizing Radiation VII Report. Am Heart J. 2009;157(1): Winkle RA, et al. Trends in atrial fibrillation ablation: have we maximized the current paradigms? J Interv Card Electrophysiol. 2011; s European Commission Directorate-General for Energy and Transport. Technical recommendations for monitoring individuals occupationally exposed to external radiation. Radiation Protection No doc/publication/160.pdf. Accessed April 9, U.S. Nuclear Regulatory Commission.10 CFR Occupational Dose Limits for Adults Accessed April 9, U.S. Department of Health and Human Services. White paper: Initiative to Reduce Unnecessary Exposure from Medical Imaging EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm htm. Accessed April 9, National Council on Radiation Protection and Measurements. Exposure of the U.S. population from diagnostic medical radiation. Bethesda, MD Efstathopoulos EP, Pantos I, Andreou M, et al. Occupational radiation doses to the extremities and the eyes in interventional radiology and cardiology procedures. Br J Radiol. 2011;84(997): U.S. Food and Drug Administration. Consumer Health Information. Reducing Radiation from Medical x-rays UCM pdf. Accessed April 9, Best PJ, et al. SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel. Catheter Cardiovasc Interv. 2011;77: Neal T. More Heart Docs Working for Hospitals Cardiology/Prevention/ Accessed April 9, Medical Devices Regulation (2012/0266(COD)), Basic Safety Standards Council Directive (2013/59/EURATOM). 37. The National Academy of Sciences, 2006; International Atomic Energy Agency. Measures to strengthen international co-operation in nuclear, radiation, transport and waste safety Accessed April 9, 2014; 38. Miller DL, Balter S, Dixon RG, et al. Quality improvement guidelines for recording patient radiation dose in the medical record for fluoroscopically guided procedures. J Vasc Interv Radiol. 2012;23(1): Sih H, Hegrenes J, Rollmann T, et al. MediGuide Technology Robustly and Accurately Tracks Catheter Location. Heart Rhythm rd Annual Scientific Sessions. Boston, MA Richter S, Doering M, Gaspar T, et al. CRT Implant Using a New Sensor-based Navigation System: Results from the First Human Use Study. Heart Rhythm rd Annual Scientific Sessions. Boston, MA Rolf S, Sommer P, Gaspar T, et al. Catheter Ablation of Ventricular Tachycardia Using a New Non-fluoroscopic Sensor-guided 4D Navigation Tool: MediGuide. Heart Rhythm rd Annual Scientific Sessions. Boston, MA Sommer P, Wojdyla-Hordynska A, Rolf S, et al. Initial experience in ablation of typical atrial flutter using a novel three-dimensional catheter tracking system. Europace. 2013;15(4): The Joint Commission Sentinel Event Alert. Radiation Risks of Diagnostic Imaging Accessed April 9, Sommer P, Wojdyla-Hordynska A, Rolf S, et al. Initial experience in ablation of typical atrial flutter using a novel three-dimensional catheter tracking system. Europace. 2013;15(4): Thibault B, Andrade J G, Dubuc M, et al. Reducing Radiation Exposure during CRT Implant Procedures: Early Experience with a Sensor-Based Navigation System. doi: / pace Pappone C, Vicedomini G, Santinelli V, et al. The Role of 3D Mapping Technology and Fluoro Reduction in the Electrophysiology World. Journal of Atrial Fibrillation 2013; Dyrda K, Guerra P.G, Macle L, et al. Radiation Exposure in the Cardiovascular Space. Journal of Atrial Fibrillation 2013; Sharma A, Reddy M, Vallakati A, et al. Specific Risks to Patients and Medical Professionals from Radiation Exposure. Journal of Atrial Fibrillation 2013; SCROLL
15 St. Jude Medical Inc. Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota USA Fax St. Jude Medical International Division One Lillehei Plaza St. Paul, Minnesota USA Fax St. Jude Medical S.C., Inc. Americas Division 6300 Bee Cave Road Bldg. Two, Suite 100 Austin, TX USA Fax SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-1935 Zaventem, Belgium Fax St. Jude Medical Brasil Ltda. Rua Itapeva, 538 5º ao 8º andares São Paulo SP Brazil Fax St. Jude Medical (Hong Kong) Ltd. Suite 1608, 16/F Exchange Tower 33 Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR Fax St. Jude Medical Japan Co., Ltd. Shiodome City Center 15F Higashi Shinbashi, Minato-ku Tokyo Japan Fax St. Jude Medical Australia Pty, Ltd. 17 Orion Road Lane Cove, NSW 2066 Australia Fax SJMprofessional.com Rx only : Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. MediGuide Technology is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled diagnostic or therapeutic invasive devices used in vascular or cardiac interventions in the Cath Lab environment, on both live and pre-recorded fluoroscopy. The System is indicated for use as an adjunct to fluoroscopy. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved. SJM-MDG This document is for international use only.
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