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PREVENTIVE TREATMENT OF TYPE II ENDOLEAK

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

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  1. PREVENTIVE TREATMENT OF TYPE II ENDOLEAK A.CARDON, A.KALADJI, B.LAVIOLLE RENNES

  2. ISSUES WITH EVAR Greenhalgh et al. NEJM 2010 De Bruin et al. NEJM 2010 REINTERVENTION

  3. n>10 000 patients Schanzer et al. Circ 2010

  4. REINTERVENTIONS : Rennes, n=330 patients

  5. RENNES EXPERIENCE : NATURAL HISTORY of type II ENDOLEAK

  6. 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%)

  7. 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

  8. 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)

  9. 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

  10. 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

  11. Magellan - concentration Source: Medtronic data on file

  12. Concentration of growth factors (ELISA*) *ELISA = Enzyme-Linked ImmunoSorbent Assay Data on file

  13. Surgical technique

  14. 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

  15. 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

  16. 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

  17. Pressure Monitoring

  18. Clinical follow-up : ABSENCE OF EMBOLYSM ABSENCE OF INFECTION 1 minor respiratory decompensation 1 moderate aggravation of an existing renal insufficiency Results

  19. 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

  20. 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

  21. 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

  22. 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%°)

  23. 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

  24. 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

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