THE DATA EXPLOSION: HOW CAN WE ACHIEVE INTEROPERABILITY F.David Rollo M.D., PhD., FACC, FACNP Chief Medical Officer Philips Medical Systems

DIAGNOSTIC IMAGING ISSUES MedPac report - Escalating utilization of diagnostic imaging - Diagnostic imaging a major cause of increase in healthcare costs - No evidence diagnostic imaging improves clinical outcomes - Major cause for increased utilization due to lack of standardization: protocols, training and certification - No evidence diagnostic imaging reduces or eliminates unnecessary or inappropriate procedures - Increased utilization also related to new operating venues: - Physician offices - Stand alone clinics - Shared services

FOCUS ON INTEROPERABILITY MedPac report - Escalating utilization of diagnostic imaging - Diagnostic imaging a major cause of increase in healthcare costs - No evidence diagnostic imaging improves clinical outcomes - Major cause for increased utilization due to lack of standardization: protocols, training and certification - No evidence diagnostic imaging reduces or eliminates unnecessary or inappropriate procedures - Increased utilization also related to new operating venues: - Physician offices - Stand alone clinics - Shared services

INTEROPERABILITY ISSUES Lack of standardization examples: Acquisition protocols Clinical validation of post acquisition processing (Reconstruction) Guidelines for applying post acquisition processing Recommendations on how to optimize image quality and diagnostic content for devices which vary in performance - Between manufacturers - New vs older technology (Same vendor)

LACK OF STANDARDIZATION Device Examples PET: - Variations in patient preparation protocols - Variations in acquisition/processing: 2D/2D; 2D,3D; 3D,3D - Device design and performance variation 7 different detector types 8 different reconstruction alternatives Spatial resolution variance: mm NEC variance: clinical dose MRI - Variations in acquisition protocol - Variations in post acquisition processing - Device design and performance variation Open vs closed design O.25- 7T field strength Fixed vs variable magnets

GOAL FOR INTEROPERABILITY Consistency in image quality and reproducibility of diagnostic content resulting in: - Increased diagnostic accuracy - Increased confidence in physicians interpretation - Improved decisions regarding most appropriate therapy, WITH, Repeatability of diagnostic decisions for most appropriate therapy independent of the geographical location, vendor or site for service ( access to care)

IMPROVED DECISIONS FOR THERAPY GOAL: Clinically validate the impact of AC on MPI in terms of: sensitivity/specificity; confidence in interpretation; and appropriateness of referrals to cardiac cath STUDY DESIGN: -250 patients from 3 facilities with MPI with and without AC and cardiac cath results - 10 experienced physicians participated in blinded study to score AC and non AC images in random order for presence of ischemia (1-5), confidence in interpretation and recommendations for cath RESULTS: Sensitivity/ Specificity with and w/o AC:92%, 84%: 88%,82% Confidence with and w/o AC: 89%,37% Cardiac cath referral with and w/o AC: 8%, 32% ASNC GUIDELINE: All MPI studies should utilize AC

IMPROVED IMAGE QUALITY AND DIAGNOSTIC CONTENT GOAL: Collaborate with MI Pharma to improve image quality and diagnostic content through development of optimized reconstruction software STUDY DESIGN: -Pharma provided 10 raw data image sets -Device manufacturer developed software optimized for target specific imaging which included :OSEM-3D Recon, Resolution Recovery, Scatter Correction, CT AC and CT for anatomical localization RESULTS: System Spatial resolution improved from 8 mm to 5mm Improved accuracy of lesion detection allows SPECT/CT data to be exported to RTP for IMRT therapy vs Brachytherapy

Slice #55 ~12,573 counts/slice PATIENT STUDY 76 yr old white male post prostatectomy in 1998 & recent increased PSA

Slice #55 ~12,573 counts/slice Original CT Transformed Fused attenuation map CT & SPECT image 3D FBP OS-EM, 2 it. OS-EM, 3 it. OS-EM, 5 it. w/o correction w/ CDR correction w/ CDR, attenuation w/ CDR, attenuation Butterworth, n=8, fc=0.15/p correction correction & scatter correction PATIENT STUDY 76 yr old white male post prostatectomy in 1998 & recent increased PSA SPECT images show asymmetric radiotracer focus at the left common iliac suspicious for lymph node involvement

RECCOMENDATIONS FOR IMPROVED INTEROPERABILITY ACROSS MODALITIES Cross license clinically validated software solutions to all vendors to standardize protocols and to optimize image quality and diagnostic content for all devices at all points of care Establish NIH/NCIF data base for all modalities and require that all new reconstruction software be clinically validated and certified in terms of diagnostic accuracy for intended applications Encourage Professional Medical Societies to establish guidelines for: - clinical indications for performing studies - recommended acquisition and processing protocols - training and certification requirements for staff - accreditation requirements for facility