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

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Presentation on theme: "A.CARDON, A.KALADJI, B.LAVIOLLE RENNES PREVENTIVE TREATMENT OF TYPE II ENDOLEAK."— Presentation transcript:

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

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

3 Schanzer et al. Circ 2010 n> patients

4 REINTERVENTIONS : Rennes, n=330 patients

5 RENNES EXPERIENCE : NATURAL HISTORY OF TYPE II ENDOLEAK

6 PREVENTION : EMBOLIZATION WITH COILS Parry et. JVS patients (no control group): Embolization with coils IMA +/- lumbar arteries Good results on aneurysmal shrinkage Nevala et al. JVIR 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 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 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 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 52ml blood + 8ml anticoagulant 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 Filtration Fibrin clot Thrombin-enriched serum 5 to 10 sec Leuco-platelet gel PRP Gel / Thrombine Blood used: 120ml Preparation time: 35min 17 min centrifugation PRP

11 Magellan - concentration mean ± S.D.; n = 19blood(60 mL) PRP (6 mL) mult PLT (x 1000/µL) ± ± ± 0.73 WBC (x 1000/µL) 5.49 ± ± ± 0.90 Hct (%) ± ± 1.59N/A Source: Medtronic data on file

12 Concentration of growth factors (ELISA*) Mean ± S.D.; n = 9 ( † n = 4) Initial Blood (60 mL) PRP (6 mL) PDGF-AB (ng/mL) 10.2 ± ± 28.8 PDGF-AA (ng/mL) 2.7 ± ± 4.2 PDGF-BB (ng/mL) 5.8 ± ± 36.6 TGF- ß 1 (ng/mL) 41.8 ± ± 49.1 VEGF (pg/mL) 83.1 ± ± bFGF † (pg/mL) 10.7 ± ± 25.0 EGF (pg/mL) 12.9 ± ± 49.4 *ELISA = Enzyme-Linked ImmunoSorbent Assay Data on file

13 Surgical technique

14 Evaluation criteria 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 D 0, D 5, D 30,Y 1……… Diameter

15 Results 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)

16 Results n = 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 A 43% n=3 B 22% n=9 C 35% n=5 D 0% n=0 E 0% n=0

17 Pressure Monitoring

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

19 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

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21 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

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23 Results 2 years 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)

24 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%°)

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26 Conclusion 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?

27 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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