Limb occlusion Limb Occlusion. JP Becquemin Henri Mondor Hospital, University Paris XII Creteil France

Transcription

1 Limb occlusion Limb Occlusion JP Becquemin Henri Mondor Hospital, University Paris XII Creteil France

2 Limb Graft Occlusion Laura van Zeggeren et al., J Vasc Surg 2013;-:1-9.

3 Stent Graft Improvements Lower profile Better flexibility Larger and smaller iliac limbs Better anchoring Better component fixation Blood tight fabric

4 Endurant Medtronic

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9 Limb Occlusion What is the incidence? Are they any the predictive factors? Can we prevent it?

10 Disclosure none related to this talk

11 ENGAGE Global Registry Study Sponsor - Medtronic Largest Contemporary EVAR Registry with single manufacturer s stent graft 1263 Patients 30 Countries 6 Continents Real world patients: Limited Inclusion/exclusion criteria Real world practice: Limited procedural specifications - Standard follow-up

12 Engage Limb Occlusion Analysis Aim of the study o Incidence and predictive factors of iliac limb occlusion at 2 years o Predictor index of limb occlusion

13 Engage POST MARKET Global Registry The Endurant Stent Graft System 1143 patients with bifurcated grafts 2286 limbs Occlusion occured in 39 patients ( 3,4%) 42 limbs ( 1.8% )

14 Freedom from Stent-graft Occlusion 30 Days 99.4% 6 Months 98.6% 1 Year 98.2% 2 Year 97.9% 70% within 6 th Month

15 Engage Registry Data analysis Statistical analysis: Comparison of occluded vs. non occluded grafts Univariate and multivariate logistic regression model

16 Engage Occlusion Sub-analysis Statistical Methods Classification And Regression Tree ( CART ) method Strong tool for predictive modeling with a large number of covariates or higher order of interactions Recursive partitioning is a statistical method to construct binary decision trees. Steyerberg E. W. (2009), Clinical Prediction Models. Springer, New York. Beriman L. (1984), Classification and regression trees. Belmont, CA: Wadsworth International Group. Liang, K. Y. and Zeger, S. L. (1986), Longitudinal Data Analysis Using Generalized Linear Models, Biometrika, 73, 13 22

17 Variables Demographics Anatomic charateristics Intra op events

18 Proper sizing

19 Engage Occlusion Sub-analysis Study Results 47* Potential Predictors for Modeling Key factors Demographic Medical Conditions Vessel Characteristics Stent-graft Events Index Procedure 6 Predictors G 2 % of Contribution Stent graft landing into the external iliac artery Cumulative Contribution % 23.3% Access vessel < 10 mm % 40.1% aneurysm diameter < 59 mm % 53.0% Stent-graft kinking % 65.3% Endoleak corrected % 70.9% Ipsilateral or contralateral side % 72.3% *Model on Medtronic

20 Predictors Chart based on weighted value of key predictors High risk High risk Y Y EIA landing < 10 mm KINK Y N Access Diameter > 10 mm N Intra op correction Small AAA N Low risk

21 High versus low risk observed 38 events out of 42 were in the high risk group

22 Analysis of Stent-graft Limb Occlusion Stratified by Iliac Artery Condition (High vs. Low Risk group) p<0.0001

23 Engage Occlusion Sub-analysis Study Results High Risk Patient Group vs. Low Risk Patient Group The odds of occlusion in high risk patients was 14.6 times greater than that of patients with low risk iliac arteries

24 Summary : Limb occlusion 3.4% / patient 1.8 % per limb 0.4% in the low risk group

25 Summary EIA landing, small access vessels, small AAA, kink and adjunct procedures Higher risk of occlusion

26 Summary Endurant graft offers very satisfying results Flexibility per se is not a cause of occlusion Smaller profile and flexible stents permit the treatment of very challenging cases

27 Engage Participating Sites Teijink (NET), Catharina Hospital Kritpracha (THA), Songklanagarind Hospital Lawlor (CAN), Victoria Hospital Punt (SAF), St Georges Hospital van Sterkenburg (NET), Alysis Zorggroep, Rijnstate Ziekenhuis Kiskinis (GRC), Papageorgiou Hospital Welten (NET), Atrium Hospital Novotny (CZE), Institut Klin a experimentalni mediciny Peeters (BEL), Imelda Hospital Rose (GBR), Freeman Hospital Boeckler (DEU), Universitätsklinikum Heidelberg Albuquerque e Castro (POR), Centro Hosp de Lisboa Mwipatayi (AUS), Royal Perth Hospital Choukroun FRA), Hop Cardiologique du HautLeveque Papazoglou (GRC), Kianous Stavros Clinic Gutowski (POL), Samodzielny Publ Szpital Kliniczny Staszkiewicz (POL), Szpital Bielanski Haggart (NZL), Waikato DHB Verhagen (NET), Erasmus Medical Centre Numan (TUR), Memorial Hospital Goktay (TUR), Dokuz Eylül University Cheng (HKG), Queen Mary Hosp Riambau (ESP), Hospital Clinic i Provincial de Barcelona De La Torra (ESP), Hosp Univ Central de Asturias Vermassen (BEL), Universitair Ziekenhuis Gent Delle (SWE), Sodersjukhuset Rand (AUT), Krankenhaus Hietzing Dubenec (AUS), Royal Prince Alfred Hospital Bosiers (BEL), Sint Blasius Hospital Bilkis (LIT), Vilnius University Hospital Torsello (DEU), St Franziskus Hospital GmbH De Vries (NET), St. Antonius Hospital Vaquero Puerta (ESP), Hosp Clinico y Universitario de Valladolid Grigg (AUS), Box Hill Hospital Wolf (ISR), Sourasky Medical Center Grigg (AUS), Epworth HealthcareEastern Fitridge (AUS), Queen Elizabeth Hospital Hayes (GBR), Addenbrookes Hospital Salmeron (ESP), Hospital Clinico Universitario San Cecilio Hoffmann (DEU), Klinikum Solingen Van Marle (SAF), Unitas Hospital Midy (FRA), Hosp Pellegrin Do/Schmidli (CHE), Inselspital, Universitatsspital Bern Palones (ESP), Hospital Universitario Dr. Peset Hendriks (BEL), UZ Antwerpen Mc Wiliams (GBR), Royal Liverpool Univ Hosp Oguskurt (TUR), Adana Baskent University Hospital Boyne (AUS), Royal Brisbane and Womens Hosp Becquemin (FRA), Hospital Henri Mondor Matley (SAF), Kingsbury Hosp Hill (NZL), Auckland City Hospital Mwipatayi (AUS), Hollywood Private Hospital

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