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Minimizing radiation exposure during Interventional Cardiology procedures Multicenter experience from Innova* IGS 520 users 1 1 Pr. Gilard, University Hospital in Brest, France and Dr. Karsenty, Clinic St Martin in Pessac, France Imagination at


  1. Minimizing radiation exposure during Interventional Cardiology procedures Multicenter experience from Innova* IGS 520 users 1 1 Pr. Gilard, University Hospital in Brest, France and Dr. Karsenty, Clinic St Martin in Pessac, France Imagination at work * Trademark of General Electric Company

  2. GE BLUEPRINT INTRODUCTION Right dose by design Improving dose management takes a strategy – what we call the GE Blueprint. It includes low-dose imaging technologies for minimally invasive procedures but also considers people and the culture and processes around them. Our dose management solutions provide healthcare organizations with insightful and comprehensive dose information and enable a proactive approach to radiation management. • Current capabilities of the Innova* IGS 520 and Innova IGS 530 include: – Dose reduction features to optimize and personalize dose settings from the tableside, while maintaining clinical details you need. – Dose awareness solutions providing insightful and comprehensive dose information to enable a proactive approach to radiation management for your healthcare organization. – Dose-efficient technologies with systems designed from the ground up to provide the image clarity you need while helping you keeping dose as low as possible. 2 * Trademark of General Electric Company

  3. GE differentiating Dose personalization provides options to help you lower dose during imaging. features that InnovaSense* system optimizes imaging geometry and helps reduce radiation minimize radiation exposure. exposure Dose Map displays an estimated peak skin dose 1 all along the exam. 1 Estimated skin dose at the modelized patient envelope 3 * Trademark of General Electric Company

  4. CURRENT CAPABILITIES TO MINIMIZE RADIATION EXPOSURE One-touch dose personalization button provides up to 98% dose reduction 1 at tableside “It is important to have a wide range of fluoro dose available on your system. The modification of the dose setting is very easy, as it can be done with the touch of a button directly from tableside.” Pr. Martine Gilard 100% 50% 24% 9% 5% 2% IQ+ IQ+ RDL+ RDL+ RDL+ RDL Normal Normal Normal Low Low Low 30fps 15fps 15fps 15fps 7.5fps 3.75fps 1 Based on Innova IGS520 Operator Manual, FOV20cm, measured in IEC 4 60601-2-43 conditions

  5. CURRENT CAPABILITIES TO MINIMIZE RADIATION EXPOSURE InnovaSense optimizes imaging geometry and helps reduce radiation exposure. InnovaSense* is an advanced patient contouring technology that uses an intelligent detector to assess movement of the gantry and select the best position for the image receptor relative to the patient. By reducing the distance from the receptor to the patient, the system optimizes imaging geometry and helps reduce radiation exposure. 5 * Trademark of General Electric Company

  6. CURRENT CAPABILITIES TO MINIMIZE RADIATION EXPOSURE With Dose Map, visualize the Dose Map peak skin dose 1 all along the exam. 6 See tutorial regarding confidentiality disclosures. Delete if not needed. 1 Estimated skin dose at the modeled patient envelope

  7. Experience from the University Hospital of Brest, France Pr. M. Gilard

  8. PATIENT DEMOGRAPHICS Retrospective analysis of 956 consecutive patients who underwent an IC procedure on the Innova IGS 520 Procedure type Access route 1200 600 520 Number of patients Number of patients 1000 500 Femoral 391 373 800 400 Radial 600 300 956 400 162 200 115 114 598 96 200 100 228 15 130 0 0 Total CA PTCA CA+PTCA Total CA PTCA CA+PTCA Procedure type Procedure type CA: diagnostic Coronaries Angiogram procedures PTCA: Therapeutic procedure of Percutaneous Transluminal Coronary Angioplasty Operators STEMI 400 500 350 CA 400 procedures Number of 300 procedures PTCA Number of 225 300 250 NON-STEMI 260 200 200 STEMI 142 150 100 214 121 100 73 27 38 0 17 50 98 OP#1 OP#2 OP#3 OP#4 Operators 0 STEMI: ST segment Elevation Myocardial Infarctus 8

  9. DOSE RATE Adequate image quality with an average fluoro dose rate at 14 mGy/min Fluoro dose rate Cine dose rate 40 600 35 500 dose rate (mGy/min) dose rate (mGy/min) 30 400 25 20 300 15 200 10 100 5 0 0 ALL N=955 BMI<25 N=344 25<BMI<30 N=399 BMI>30 N=210 ALL N=955 BMI<25 N=344 25<BMI<30 N=399 BMI>30 N=210 At an average fluoro dose rate, approximately 6 hours of fluoro would be required to reach 5Gy of cumulated AK. Even on an obese patient, approximately 3 hours, 20 minutes of fluoro would be required to reach 5Gy of CAK Each bar represents the median value of the AK measured at IRP, 15cm below isocenter, as per IEC 60601-2-43.The Error bar shows the 1st and 3rd Quartile; N is the number of 9 procedures; ALL stands for all BMI (average BMI=26.8).

  10. SYSTEM GEOMETRY OPTIMIZATION InnovaSense* helps reduce radiation exposure by up to 25% Source to image distance (SID) Fluoro dose rate 1.20 35 actual data with InnovaSense 30 1.15 simulated case without InnovaSense² 25 1.10 SID (m) 20 1.05 15 1.00 10 0.95 5 0.90 0 ALL N=955 BMI<25 N=344 25<BMI<30 N=399 BMI>30 N=210 ALL N=955 BMI<25 N=344 25<BMI<30 N=399 BMI>30 N=210 InnovaSense enables users to maintain an average SID of 105 cm 1 . Decreasing SID from 120 cm to 105 cm reduces the dose rate by 25% 1 Retrospective analysis from one-year usage (2013) of Innova IGS520 at CHU Brest ² Simulated case is simulated with the user working at max SID (120cm) instead of optimized SID obtained with InnovaSense * Trademark of General Electric Company 10

  11. CUMULATED DOSE Patient dose is lower than the values reported in multicenter reference studies, despite longer fluoro time Cumulated DAP Fluoro time 200 20 US, NEXT survey, Miller et Al, 2012 US, NEXT survey, Miller et Al, 2012 180 18 France, RAY'ACT Survey, Georges et Al, 2014 France, RAY'ACT Survey, Georges 160 et Al, 2014 16 CHU Brest, IGS520, 2013 CHU Brest, IGS520, 2013 140 14 fluoro time (minutes) DAP (Gy.cm²) 62% 120 77% 12 100 10 80 8 22% 60 6 44% 44% 40 4 20 2 0 0 CA PTCA CA+PTCA CA PTCA CA+PTCA USA: Miller et Al, 2012, based on «NEXT» national US survey; multicenter national study, data collected in 2008-2009 on 171 hospitals from 30 states, 1625 CA, 160 PTCA and 622 CA+PTCA. France: Georges et Al, 2014, based on “RAY’ACT” national French survey: multicenter national study, data collected in 2010 over 48 systems (79% equipped with Flat panel) from 44 non-academic hospital, 33937 CA, 3976 PTCA and 23847 CA+PTCA 11 Each bar represents the median value, error bar shows interquartiles.

  12. “When the case become challenging, we are too focused on the procedure and we may deliver a high dose by not changing angulation. Now that we have Dose Map we can visualize the skin dose distribution all along the procedure and get warnings when the peak skin dose becomes significant and when it may be time to think about changing the angulation. It really changed the way we work.” Pr. Martine Gilard 12

  13. DOSE MAP Peak skin dose reduction opportunity for longer, complex cases with Dose Map Number of patients > 3Gy Cumulated dose compared to estimated peak skin dose 8 1200 6.8 7 956 1000 Cumulated dose (Gy) AK (Gy) 6 5.0 estimated peak skin dose Number of patients 5 4.5 800 CAK<3Gy 3.7 4 CAK>3Gy 3.4 3.3 3.2 3.0 2.9 600 3 2.4 2.4 2.2 2 1.3 400 0.8 1 200 0 Pt#1 Pt#2 Pt#3 Pt#4 Pt#5 Pt#6 Pt#7 7 Patients 0 Working at low dose, less than 1% of cases exceeded 3Gy. On some of the patients above 3Gy, most of the dose was delivered on the same skin area and reached high peak skin dose 1 . Dose Map provides additional dose awareness that may have prevented to reach high peak skin dose 1 . 13 1 Estimated peak skin dose at the modeled patient envelope

  14. Experience from the Clinic St Martin in Pessac, France Dr. B. Karsenty

  15. DOSE REDUCTION Retrospective analysis comparing dose levels of PCI procedures before and after the installation of the new Innova IGS 520 with low-dose protocols Before (Feb – Apr 2012) After (Nov – Jan 2014) 181 PCI procedures 299 PCI procedures 29 CTO procedures 31 CTO procedures Average BMI 27.2 Average BMI 27.4 15 fps 7.5 fps Details « Normal » Details « Low » FOV 17 cm and 15 cm FOV 20 cm with collimation 15

  16. PATIENT AND OPERATOR DOSE REDUCTION Clinic St Martin has reduced patient dose by 77% and operator dose by 90% without noticeable degradation of image quality Patient dose reduction for PCI procedures Operator dose 1 reduction for PCI procedures 6 180 5.3 operator dose per procedure (µSv) 150.3 160 90% 77% 5 140 4 120 DAP (Gy.cm²) 100 3 80 2 60 34.7 40 1 0.54 20 0 0 Without low dose protocol (N=181) With low dose protocol (N=299) Without low dose protocol (N=181) With low dose protocol (N=299) Each bar represents the mean value, N is the number of procedures 1 Measurement with an electronic dosimeter on the first operator under the lead apron on the left side of the chest. 16

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