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Paolo SpadaMD, Vascular Surgeon, Humanitas Research Hospital, MilanEVARplanning FounderIntroducing
Data driven innovation in chirurgia:il caso EVARplanning
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Biotecnologie orientate alle scienze medicheProdotti farmaceuticiMedicina rigenerativaMedicina personalizzataTerapia genicaImmunoterapiaProdotti nutraceutici Strumenti digitali al servizio della salutee dispositivi medicaliRilevazione parametri vitali/sintomiDispositivi terapeuticiDispositivi per la diagnostica Servizi orientati al paziente o alla sanitGestione del servizio socio-sanitarioErogazione del servizio socio-sanitarioServizio di informazione/formazione al paziente
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Aortic Aneurysm
EVAR EndoVascular Aortic Repair
Instructions for use(IFU) = limits of use
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20% endoleaks after EVAR
American College of Surgeons, January 2016
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AlgorithmdesignAppdevelopment
WebsiteFree web appRegisteredmembers
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1.285 members, 10% global EVAR surgeons, 296 plannings/month (Google Analytics)EVARplanning sessions last 12 months
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Review of 407 cases
Software for vascular imaging and sizing
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Main body
16F / 6.2 mm OD
Landing 180 mmdistal common iliacSealing 55 mm
Left leg
12F / 5 mm OD
Landing 180 mmdistal common iliacSealing 55 mmPXC121400RLT261218
Gate70 mmOverlap30 mm
Main body
16F / 6.2 mm OD
Landing 180 mmdistal common iliacSealing 55 mm
Left leg
12F / 5 mm OD
Landing 180 mmdistal common iliacSealing 55 mmPXC121400RLT261218
Oversize
Neck 18%
Bifurcation 38%
Left iliac 20%
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Francesco Migliavaccafull professor
Giancarlo Pennatifull professor
Gabriele Dubini full professor
EVARplanning development plan
Mechanical predictive analysis and machine learningPolitecnico di Milano,Laboratory of Biological Stucture MechanicsAlgorithm and 3D modeling software developmentCINECA non-profit consortium of universitiesCloud-based web platformWezen technologies
Individualmembersurgeon
CT uploadfrom CD or local driveCT viewer and automaticsizingEndograftselection and planning
Online sharing of CT and planningEndograft company specialistQuick endograft order
Case assignement to endograftcompanyHIPAA compliance for anonymization of data
The nextEVARplanning platformCE Software As a Medical Device (SAMD)Algorithm Copyright P. Spada, December 1 2014
Hospitalmember surgeonsOtherhospitals
CT uploadfrom hosp. PACSCT upload from external userCase sharing or referralCT uploadfrom CD or local driveCT viewer and automaticsizingEndograftselection and planningOnline sharing of CT and planningCase assignement to endograftcompanyQuick endograft orderCase not assigned(unlimited upload for hospital users)Endograft company specialist
IndividualmembersurgeonCT uploadfrom CD or local drive*Not-assigned cases arecancelled after 60 days.Upload limitation based on not-assigned/assigned cases ratio.Case not assigned(limited upload for individual user)*
Mechanical analysisOutcome detectionRendering algorithmConfiguration algorithm
DATA
Benefits
SurgeonsPatients
HospitalsEndograft CompaniesBenefits
Start from techsAlgorithms: yes we can
Data = EBM = Outcomes & QoL
Leverage communities
Niche is beautiful
Question time!