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1、FDA approved for MRI use The first pacing system to break the image barrier,The Revo MRI SureScan pacing system is MR Conditional designed to allow patients to undergo MRI under the specified conditions for use. A complete system, consisting of a Medtronic Revo MRI SureScan IPG implanted with two Ca
2、pSureFix MRI SureScan leads is required for use in the MRI environment.,The First and Only Pacing System FDA Approved for MRI Use,Specifically engineered for MRI safety, with reliable lead technology and a proven pacemaker platform this is state-of-the-art pacing. Now your patients get proven cardia
3、c care with MRI access.,Meeting the Need for MRI,Pacemaker Implants in an Aging Population The number of pacemakers currently implanted in the United States is approximately 1.5 million1,2,Elderly patients are the primary users of MRI: individuals over age 65 are twice as likely to need an MRI compa
4、red to younger recipients.3,Average Age of Pacemaker Patient,13% Ages 25-64,86% Age 65+,1 Kalin R, Stanton MS. PACE. 2005;28:326-328. 2 Zhan C, et al. Gen Intern Med. 2008;23:13-19. 3 Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment a global strategic business report. San Jo
5、se, CA. 2002.,Part of Comprehensive Patient Care,Now, for the first time, you can implant a state-of-the-art pacing system to provide proven cardiac care AND MRI access when your patients need it Number of Comorbidities in Pacemaker Patients,Given that 85% of all pacemaker patients have one or more
6、comorbidities, facilitating comprehensive multispecialty care is important in todays environment,Medical and Surgical Specialties Rely on MRI for Diagnosis Your choice can affect their decisions and diagnostic capabilities,15% 0 comorbidities,30% 1 comorbidity,28% 2 comorbidities,27% 3 or more comor
7、bidities,Opthalmology,Otolaryngology,Neurosurgery,Neurology,Cardiothoracic Surgery,Surgical Oncology,Nephrology,Gynecologic Oncology,Urology,Rheumatology,Oncology,Radiation Oncology,Interventional Radiology,Gastrointestinal Surgery,Orthopedic Surgery,Vascular Surgery,85%1 1 or more comorbidities,1 K
8、alin R, Stanton MS. PACE. 2005;28:326-328.,Prevalence of Common Comorbidities in the Pacemaker Patient Population,The Prevalence of Common Comorbidities Increases Rapidly Over Age 65.1-3,MRI Is the Gold Standard Diagnostic Tool for Neurologists, Oncologists, and Orthopedic Surgeons, Whose Patients A
9、re Often Over 65 Years of Age.4 MRI is unmatched in its ability to accurately visualize soft tissue It is estimated that 50 to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device5 The Most Common Reasons for MRI Referral Are Musculoskeletal and Neurologica
10、l Symptoms.6 Medicare records show that in patients 65 years of age with an implanted pacemaker: 34% have spine and intervertebral disc disease7 36% have chronic pain of wrist, foot, ankle, or elbow7 14% suffer from injury or trauma to the spine, knee, or shoulder7,1 National Cancer Institute April
11、2009. US estimated complete prevalence (including counts) by age on 1/1/2006. Based on November 2008 SEER data submission; DCCPS, Surveillance Research Program, Statistical Research and Applications Branch. 2 Lawrence RC, et al. Arthritis Rheum. 1998;41:778-799. 3 American Heart Association. Heart D
12、isease and Stroke Statistics 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: 2003-2006). 4 Magnetic Resonance Imaging (MRI) Equipment A global Strategic Business Report, Global Industry Analysts, Inc., San Jose, CA 2002. 5 Kalin R, Stanton MS. PACE. 2005;28:326-328. 6 Medic
13、al Imaging Survey, 2009. 7 Medicare Fee-for-Service Review, 2007.,Hazards and Risks of MRI with Current Pacing Systems,Since 2008, the safety and risk concerns of MRIs in cardiac device patients have been documented in 17 studies.1-17 MRI can put pacemaker patients at risk for any of the following16
14、:,1 Naehle CP, et al. Pacing Clin Electrophysiol. 2009;32:1526-1535. 2 Goldsher D, et al. Pacing Clin Electrophysiol. 2009;32:1355-1356. 3 Gimbel JR. Europace. 2009;11:1241-1242. 4 Naehle CP, et al. J Am Coll Cardiol. 2009;54:549-555. 5 Roguin A. J Am Coll Cardiol. 2009;54:556-557. 6 Mollerus M, et
15、al. Pacing Clin Electrophysiol. 2008;31:1241-1245. 7 Pulver AF, et al. Pacing Clin Electrophysiol. 2009;32:450-456. 8 Nordbeck P, et al. Magn Reson Med. 2009;61:570-578. 9 Sutton R, et al. Trials. 2008;9:68. 10 Naehle CP, et al. Radiology. 2008;249:991-1001.,11 Calcagnini G, et al. J Magn Reson Imag
16、ing. 2008;28:879-886. 12 Dyrda K, Khairy P. Expert Rev Cardiovasc Ther. 2008;6:823-832. 13 Gimbel JR. Pacing Clin Electrophysiol. 2008;31:795-801. 14 Nordbeck P, Bauer WR. Dtsch Med Wochenschr. 2008;133:624-628.Article in German. 15 Tandri H, et al. Heart Rhythm. 2008;5:462-468. 16 Roguin A, et al.
17、Circulation. 2004;110:475-482. 17 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.,MR Conditional Risk Information A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan leads is required for use i
18、n the MRI environment Any other pacing system combination may result in a hazard to the patient during an MRI scan When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing Refer to the Revo MRI Pacing System Cond
19、itions for Use located in the device manuals prior to scanning a patient. Consult Medtronics website at or call Medtronic at 1 (800) 328-2518.,Specifically Engineered for MRI Safety,Device Design Solutions Input circuits optimized Circuit design immune to interference SureScan Pacing Mode Asynchron
20、ous pacing High pacing outputs,The Revo MRI SureScan pacing system has completed clinical evaluation, regulatory review, and FDA approval; it is safe for use when used according to the MRI conditions for use as defined in the SureScan manual The implanted system must consist solely of a Medtronic Re
21、vo MRI SureScan Model RVDR01 device and two CapSureFix MRI SureScan Model 5086 MRI leads Revo MRI SureScan Pacemaker A Pacemaker Engineered with Multiple Safety Features Device verification appears on pacemaker programmer screen Automatic testing ensures only appropriate battery and impedance data a
22、re collected during MRI Dedicated programming mode provides additional security/backup for power on reset (POR) Hall sensor is immune to strong magnetic fields Easily Identifiable, Radiopaque Icon Confirms SureScan Device Implant,Specifically Engineered for MRI Safety,Lead Heating Design Solution Le
23、ad inner conductor coil design mitigates lead heating 4 filar to 2 filar increases inductance and reduces heating,Materials identical to 5076* Model 5086MRI lead flex testing Connector/body Lead body Model 5086MRI clinical implant experience starting February 2007 (928 leads implanted) *Exception of
24、 MRI Marker band and electrode coating,CapSureFix MRI SureScan Lead Model 5086 A Lead Designed for MRI Use The state-of-the-art 5086 lead is specifically designed and engineered for safety within an MRI environment The 5086 lead is based on the CapSureFix family of leads, which have been implanted i
25、n more than 1 million patients worldwide thats 2.5 million leads, with 99.5% reliability,Easily Identifiable, Radiopaque Icon Confirms SureScan Device Implant Lead Heating Model 5076 versus Model 5086 MRI,the x-axis represents 50 anatomically relevant lead paths the results demonstrate significant v
26、ariability in lead tip heating as a function of the lead path overall the 5086 MRI lead heats approximately 3 times less than the 5076 for most lead paths,Preclinical Research Demonstrates the Safety of Revo MRI Pacing System1,Testing Summary Extensive preclinical evaluation was based on clinically
27、relevant as well as worst-case scan conditions, using in vitro (bench) testing, in vivo (animal) testing, and computer simulations (modeling). MRI-Induced Lead Heating Simulations in Human Body Models Using Different Lead Combinations Human body models encompassed 2nd to 97th percentile of all human
28、 bodies, with ten different lead paths Over 400,000 different lead/body combinations were analyzed to derive a minimal probability of a 0.5 V threshold,Human Body Library,Lead Paths,1 Magnetic Resonance Imaging (MRI) Equipment a global strategic business report, Global Industry Analysts, Inc. San Jo
29、se, CA. 2002.,MRI-Induced Unintended Cardiac Stimulation (UCS) Analysis combined a prediction for the induced voltage pulse widths and amplitudes, and an in-vivo canine study to evaluate the stimulation threshold to these pulses The risk of reaching the gradient stimulation range is 1/1,000,000, whi
30、ch remains outside the capture range Results confirmed that patient risk from UCS is at an acceptable level Gradient Stimulation Strength Duration Curve,Study Design Multicenter, randomized, controlled clinical trial designed to evaluate the safety of the Revo MRI SureScan Pacing System, including a
31、ny MRI-related complications, as well as to analyze pacing capture thresholds and sensing amplitude 464 patients received a SureScan pacing system and were then randomized to elective MRI or no MRI, approximately 9-12 weeks post-implant MRI imaging intended to represent commonly used, clinically rel
32、evant scans Methods Visit Schedule,Clinical Trial Demonstrates the Safety of Revo MRI SureScan1,1 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.,Clinical Trial Demonstrates the Safety of Revo MRI SureScan1,Key Results 100% were free of MRI-
33、related complications (n = 211, P 0.001) No sustained atrial or ventricular arrhythmias, no asystole, no pacemaker output inhibition, and no electrical resets in the group receiving MRI Minimal changes in pacing capture thresholds, as shown on the following chart Primary Effectiveness End Point: Atr
34、ial and Ventricular Capture Threshold Threshold changes pre-MRI/control visit to 1-month post-MRI/control visit,1 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.,Builds Upon Medtronic Innovations,MVP Managed Ventricular Pacing Exclusive tech
35、nology that uses atrial pacing (AAIR) primarily, with DDD(R) pacing only when necessary MVP reduces unnecessary RV pacing by 99%1 ACC/AHA/HRS guidelines2 state the need to reduce unnecessary pacing as much as possible. The following studies support the guidelines: MOST3: Every incremental 1% of unne
36、cessary VP increases the risk for heart failure hospitalizations by 5.4%, and for AF, by 1%. Danish II4: Even with long AV delays, the risk of AF doubles with DDD(R) pacing compared to AAI(R) with DDD(R) backup. Gardiwal5: Patients with 72% RV pacing are at increased risk for VT/VF.,Medtronic CareLi
37、nk Network* The leading Internet-based, remote monitoring service for implanted devices6 Serving nearly 500,000 patients in 3,000 clinics in the United States * Not all devices are available on the CareLink Network,1 Gillis AM, et al. Heart Rhythm. 2005. Abstract AB21-1. 2 Epstein AE, et al. J Am Co
38、ll Cardiol. 2008;51:e1-62. 3 Sweeney MO, et al. Circulation. 2003;10:2932-2937. 4 Nielsen JC, et al. J Am Coll Cardiol. 2003;42:614-623. 5 Gardiwal A, et al. Europace. 2008;10:358-363. 6 Medtronic CareLink Metrics Database.,Revo MRI Pacing System Conditions for Use A complete SureScan pacing system
39、including a Revo MRI SureScan IPG and two SureScan leads is required for use in the MRI environment. Any other combination may result in a hazard to the patient during an MRI scan. The SureScan feature must be programmed to On prior to scanning a patient according to the specified conditions for use
40、. Cardiology requirements: Patients and their implanted systems must be screened to meet the following requirements: No previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors No broken leads or leads with intermittent electrical contact, as confirmed by l
41、ead impedance history A SureScan pacing system that has been implanted for a minimum of 6 weeks A SureScan pacing system implanted in the left or right pectoral region Pacing capture thresholds of 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms) A lead impedance value of 200 ohms () and 1,500
42、 No diaphragmatic stimulation at a pacing output of 5.0 V, and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan is on,Radiology requirements: Horizontal, cylindrical bore magnet, clinical MRI systems with a static magnetic fi
43、eld of 1.5 Tesla (T) must be used Gradient systems with maximum gradient slew rate performance per axis of 200 Teslas per meter per second (T/m/s) must be used The scanner must be operated in Normal Operating mode: The whole-bodyaveraged specific absorption rate (SAR) must be 2.0 watts per kilogram
44、(W/kg) The head SAR must be 3.2 W/kg The patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra Proper patient monitoring must be provided during the MRI scan. The methods include visual and verbal co
45、ntact with the patient, electrocardiography, and pulse oximetry (plethysmography). Training requirements: A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan feature A health professional who has completed radiology SureScan tra
46、ining must be present during the MRI scan,Brief Statement The Revo MRI SureScan pacing system is MR Conditional and as such is designed to allow patients to undergo MRI under the specified conditions for use. Indications The Revo MRI SureScan Model RVDR01 IPG is indicated for use as a system consist
47、ing of Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI SureScan 5086MRI leads. A complete system is required for use in the MRI environment. The Revo MRI SureScan Model RVDR01 IPG is indicated for the following: Rate adaptive pacing in patients who may benefit from increased pacing
48、 rates concurrent with increases in activity Accepted patient conditions warranting chronic cardiac pacing include: Symptomatic paroxysmal or permanent second- or third-degree AV block Symptomatic bilateral bundle branch block Symptomatic paroxysmal or transient sinus node dysfunctions with or witho
49、ut associated AV conduction disorders Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchron