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PREVENTIVE TREATMENT OF TYPE II ENDOLEAK. A.CARDON, A.KALADJI, B.LAVIOLLE RENNES. ISSUES WITH EVAR. Greenhalgh et al. NEJM 2010. De Bruin et al. NEJM 2010. REINTERVENTION. n>10 000 patients. Schanzer et al. Circ 2010. REINTERVENTIONS : . Rennes, n=330 patients.
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PREVENTIVE TREATMENT OF TYPE II ENDOLEAK A.CARDON, A.KALADJI, B.LAVIOLLE RENNES
ISSUES WITH EVAR Greenhalgh et al. NEJM 2010 De Bruin et al. NEJM 2010 REINTERVENTION
n>10 000 patients Schanzer et al. Circ 2010
REINTERVENTIONS : Rennes, n=330 patients
PREVENTION : EMBOLIZATION WITH COILS • Parry et . JVS 2002 • 16 patients (no control group): Embolization with coils IMA +/- lumbar arteries • Good results on aneurysmal shrinkage • Nevala et al. JVIR 2010 • 40 patients (with a control group) : embolization IMA with coils • Reduction of type II endoleak but no more aneurysmal shrinkage+++ (22% vs 59%)
PREVENTION : COILS + THROMBIN • Muthu et al. JEVT 2007 • 70 patients (with control group) : coils in IMA + thrombin in the sac • Thrombin : Exogenous solution • No reduction of type II endoleak (14% vs 26%) • Less reintervention (p=0.03 mais no difference in km) • Pilon et al. ICTS 2009 • 20 patients (with control group) : coils (platinium)+ thrombin both in the sac • Less type II Endoleak (6% vs 30%) but p=0.05
PREVENTION : THROMBIN INJECTION • Ronsivalle et al. JEVT 2010 • 180 patients (224 control group before 2003) : thrombin injection in the sac +/- coils) • Exogenous solution : Tissucol® • Rate of type II endoleak : 2.4% vs 15.2% at 24 months (p<0.0001)
ENDGELLA STUDY • Peri-operative injection of platelet-enriched gel (PRP) associated with autologus thrombin inside the aneurysm • Why PRP gel + thrombin association? • Rapid proliferation of the coagulation process (increase of pro-coagulating zones) • High concentration of fibrin (clot + solid) • Release of metalloproteinase inhibitors
PRP Gel / Thrombine 52ml blood + 8ml anticoagulant 17 min centrifugation 6ml Platelet-enriched plasma (PRP) 2/3 in one 10ml syringe 1/3 in one 3ml syringe with coagulating factor Mix for 15sec, then, wait for 15min coagulation Fibrin clot PRP Thrombin-enriched serum Filtration 5 to 10 sec Blood used: 120ml Preparation time: 35min Leuco-platelet gel
Magellan - concentration Source: Medtronic data on file
Concentration of growth factors (ELISA*) *ELISA = Enzyme-Linked ImmunoSorbent Assay Data on file
Main evaluation criteria: Safety of the peri-operative injection procedure of the PRP + autologus thrombin Risk of infection Risk of embolization Secondary criteria Description of the course of the surgical technique Early post-procedural complications (<30 days) Endoleaks at D0, D5, D30,Y 1……… Diameter Evaluation criteria
16 patients between 05/09/2006 and 27/03/2007 Mean age: 73 (49-89) Gender: 100% male Risk factors: Hypertension: 50% (n=8) Hyper cholesterol 35% (n=5) Smoking: 50% (n=7) Diabetes: 0% (n=0) Mean procedure time: 85min (70-150min) Results
Morphological inclusion criteria Proximal aortic neck: 33mm (11-60mm) Max diameter: 55.4mm (50-80mm) Lumbar arteries: 4 lumbar arteries (2-8) Inferior mesenteric: 81% permeable Classification Results n = 16 • A 43% n=3 • B 22% n=9 • C 35% n=5 • D 0% n=0 • E 0% n=0
Clinical follow-up : ABSENCE OF EMBOLYSM ABSENCE OF INFECTION 1 minor respiratory decompensation 1 moderate aggravation of an existing renal insufficiency Results
Endoleaks during the procedure 5 patients with type II endoleaks before injection of the PRP/thrombin gel 0 endoleak at final control Endoleaks at D+5 0 endoleaks after 5 days (CT scan and doppler) Endoleaks at D+30 1 type II endoleak at the inferior mesenteric artery Max diameter decrease (from 55.4 to 54mm) No lumbar or mesenteric thrombosis Results
PRELIMINARY RESULTS • Clinical follow-up : 41.1 24.2 months • Imaging follow-up : 32.9 19.4 months • Survival : 9 (60%) • No AAA related death • Endoleaks • Type Ia : 0 • Type Ib : 1 at 3 month (reintervention) • Type II : 2 • 1 month : 1 6 month : 3 • 12 month : 318 month : 2 • 24 month : 2 36 month : 2
Endoleaks type II = 2 1 no change in diameter 1 INCREASE (3 mm) Reintervention = o diameter : 1 increase (endoleak type II) 8 no change 7 shrinkage (>5 mm) Results 2 years
RESULTS: end of follow up • Reintervention : • 1 for type Ib endoleak : iliac extension at 3 month • 1 for type II endoleak+sac enlargement : IMA embolisation at 60 months (6.5%°)
Endoleaks remain one of the main problems associated with the endovascular treatment of aortic aneurysms. Preventive treatment of endoleaks with injection of an autologus thrombin + platelet gel during the procedure Feasibility Safety: no embolization or infection Efficacy? Conclusion
Next step: Multicenter Study • Prospective, comparative, randomized, single blind, 2 parallel groups • Duration: 2 years • Power calculation: 260 patients (130 in each group) • α = 0.05 • β = 0.10