This document summarizes a study on using fibrin glue to induce thrombosis of aneurysm sacs during endovascular aneurysm repair (EVAR). The study included 84 patients who underwent EVAR with additional injection of fibrin glue into the aneurysm sac. Follow-up for up to two years found thrombosis of fibrin glue-treated aneurysm sacs in 97.6% of cases. The authors conclude that intraoperative fibrin glue injection is an effective preventive strategy for type II endoleaks and may be considered for routine prevention of type II endoleaks during EVAR.

1. MODULAR EXTENSION INTO
EXTERNAL ILIAC ARTERY
+
HYPOGASTRIC ARTERY
EMBOLIZATION
PHOENIX 2005–FIRST OFFICIAL PRESENTATION AT
INTERNATIONAL CONGRESS XVIII

2. Department of Cardiovascular DiseaseDepartment of Cardiovascular Disease
Civic Hospital, Cittadella (PD), ItalyCivic Hospital, Cittadella (PD), Italy
S Ronsivalle, F Faresin, F Pettenuzzo, M Riggi, R Lipari, L PedonS Ronsivalle, F Faresin, F Pettenuzzo, M Riggi, R Lipari, L Pedon
M. ZanchettaM. Zanchetta
XVIII International CongressXVIII International Congress
Endovascular InterventionEndovascular Intervention
Phoenix Feb 16 2005
Preventive treatment of type IIPreventive treatment of type II
endoleak using fibrin glue in patientsendoleak using fibrin glue in patients
undergoing endovascular treatmentundergoing endovascular treatment
for abdominal aortic aneurysmsfor abdominal aortic aneurysms

3. MODULAR EXTENSION INTO
EXTERNAL ILIAC ARTERY
+
HYPOGASTRIC ARTERY
EMBOLIZATION
PHOENIX 2006 – PRESENTATION AT INTERNATIONAL CONGRESS XIX

4. M. ZanchettaM. Zanchetta
Dipartimento di Malattie CardiovascolariDipartimento di Malattie Cardiovascolari
Ospedale Civile Cittadella (PD)Ospedale Civile Cittadella (PD)
1919thth
INTERNATIONAL CONGRESSINTERNATIONAL CONGRESS
ENDOVASCULAR INTERVENTIONSENDOVASCULAR INTERVENTIONS
Phoenix February 15 2006
Preventive treatment of type II endoleakPreventive treatment of type II endoleak
by using the fibrin glue at the time ofby using the fibrin glue at the time of
endografting: two years’ experienceendografting: two years’ experience

5. Background:Background:
Management of type II endoleakManagement of type II endoleak
Preoperative coil embolization (IMA, LA)Preoperative coil embolization (IMA, LA)
Intriguing thrombogenic sponge at theIntriguing thrombogenic sponge at the
time of aortomonoiliac endograftingtime of aortomonoiliac endografting
Embotherapy: - transarterial (vascular coils)Embotherapy: - transarterial (vascular coils)
- translumbar (liquid embolic- translumbar (liquid embolic
agent)agent)
Laparoscopic retroperitoneal branch ligationLaparoscopic retroperitoneal branch ligation
Conservative or surgical approachesConservative or surgical approaches
Choke E. J Cardiovasc Surg 2004;45:349-66Choke E. J Cardiovasc Surg 2004;45:349-66

6. Aim of the studyAim of the study
To report the two years’ experience of theTo report the two years’ experience of the
intraoperative fibrin glue ( Tissucolintraoperative fibrin glue ( Tissucol®®
)) aneurysmaneurysm
sac embolization in order to primarily preventsac embolization in order to primarily prevent
reperfusion type II endoleakreperfusion type II endoleak
TTo describe the technical details and mid-termo describe the technical details and mid-term
clinical results of this new techniqueclinical results of this new technique

7. Baseline characteristics of patientsBaseline characteristics of patients
(June 2003 - December 2005)(June 2003 - December 2005)
Characteristic N° = 84 patients
■ Male sex (N°, %) 94%
■ Age (yr) 73.8 ± 7.8
■ Body-mass index 26.6 ± 4.1
■ IMA (N°) 10
■ LA per patient (paired) 1-3
■ Comorbidity
- Diabetes mellitus 9.6 %
- Tabacco use 55.1 %
- Hypertension 54.5 %
- Hyperlipidemia 52.6 %
- Carotid artery disease 15.2 %
- Cardiac disease 46.6 %
- Renal disease 8.4 %
- Pulmonary disease 27.7 %

8. Infrarenal AAA morphologic characteristicsInfrarenal AAA morphologic characteristics
Angiography and contrast-enhancedAngiography and contrast-enhanced
computed tomographycomputed tomography
3-D sagittal view3-D sagittal view2-D axial view2-D axial viewCoronal viewCoronal view

9. Aorto-bifurcated stent graftAorto-bifurcated stent graft
Device
(marked)
Main body
diameter (mm)
Profile
(F)
Fixation
site
Patient
n°
 Talent
(Medtronic)
24-34 22-24 Suprarenal 69
 AneuRx
(Medtronic)
22-28 21 Infrarenal 14
 Excluder
(WL Gore)
23-28.5 Infrarenal 1
33 iliac extensions were deployed by using the bell-bottom
technique (24 Talent and 9 AneuRx extensions)

10. Fibrin glue injection technique toFibrin glue injection technique to
induce aneurysm sac embolizationinduce aneurysm sac embolization
Zanchetta M . J Endovasc Ther 2005;12:579-82Zanchetta M . J Endovasc Ther 2005;12:579-82
Step 1Step 1 Step 2Step 2

11. Target side-branchTarget side-branch
occlusion monitoringocclusion monitoring
 Angiography (OEC 9800, GE Healthcare, MI, FL)
 IVUS (AcuNav, Siemens, Mountain View, CA)
to demonstrate
1. pre-fibrin glue injecton patency and direction of
flow into the aneurysm sac
2. post-fibrin glue injection embolization of aneurysm
sac and thrombosis of type II endoleak

12. Complex type II leakComplex type II leak Lacking outflow vesselsLacking outflow vessels
Direct angiographic monitoring ofDirect angiographic monitoring of
aneurysm sac embolizationaneurysm sac embolization
Angiography of aneurysm sacAngiography of aneurysm sac
Pre-FG injection Post-FG injection

13. Indirect ultrasound monitoring ofIndirect ultrasound monitoring of
aneurysm sac embolizationaneurysm sac embolization
IVUS of aneurysm sacIVUS of aneurysm sac
Pre-FG injection Post-FG injectionBaseline IVUS
Empty
aneurysm sac
Intrasac flow velocity
from inflow vessels
Type II endoleak
thrombosis

14. Two year follow-up
At discharge, 3, 6, 12, 18, 24 months and annually
thereafter:
■ Clinical examination
■ Serum creatinine
■ Abdominal x-ray
■ CT-scan
■ Echo-color Doppler
N°patients
Mean follow-up:
14.4 ± 8.7 months
0
20
40
60
80
100
0 3 6 12 18 24
Months

15. 60
70
80
90
100
0 3 6 12 18 24
Cumulativemajoradverse
eventsfreesurvival(%)
No. of patients 84 76 65 50 44
31
Time after stent grafting (months)
    



  91.3%
98.8%
Primary
Assisted
Kaplan-Meier curve
Reporting standards for endovascular
AAA repair outcomes
Chaikof EL. J Vasc Surg 2005;35:1048-60

16. Reporting standards for endovascular
AAA repair complications
Classification N° (%) Grading
■ Deployment-related
- failed deployment
- arterial rupture
2 (2.4%)
1 (1.2%)
1 (1.2%)
2, conversion
2, iliac repair
■ Implanted-related
- postop graft migration
- postop limb
obstruction
2 (2.4%)
1 (1.2%)
1 (1.2%)
2, aortic cuff
3, fem-fem bypass
■ Systemic
- renal insufficiency
- small bowel ischemia
3 (3.6%)
2 (2.4%)
1 (1.2%)
1, no dialisis (PTA)
3, bowel resection
Chaikof EL. J Vasc Surg 2005;35:1048-60
Only 1 fibrin glue aneurysm sac embolization failure

17. TemporalTemporal
characterizationcharacterization
PatientsPatients
NoNo
MonthsMonths
6 12 156 12 15
■ Operative deathsOperative deaths
- procedure-related- procedure-related
- device-related- device-related
1 *1 *
00
■ Late deathsLate deaths
- aneurysm-related- aneurysm-related
- non aneurysm-related- non aneurysm-related
00
4 **4 ** 2 1 12 1 1
Chaikof EL. J Vasc Surg 2005;35:1048-60Chaikof EL. J Vasc Surg 2005;35:1048-60
* Symptomatic contained rupture; ** verified
Reporting standards for endovascularReporting standards for endovascular
AAA repair deathsAAA repair deaths

18. Type No (%) Cause of perigraft flow
■ Type I 1 (1.2%) Inadequate proximal seal
■ Type II 2 (2.4%) Flow from lumbar arteries
■ Type III 0 -
■ Type IV 0 -
Reporting standards for endovascularstandards for endovascular
AAA repair endoleakAAA repair endoleak
Chaikof EL. J Vasc Surg 2005;35:1048-60

19. Change in
AAA size
1-6 months
N° (%)
6-12 months
N° (%)
12-24 months
N° (%)
Increase
(>5mm)
1 1.6% 1 2.0% 1 3.2%
No change 33 52.4% 26 53.1% 16 51.6%
Decrease
(>5mm)
29 46.0% 22 44.9% 14 45.2%
Change in AAA size diameter
by interval



Aneurysm sac remodeling

20. 20
30
40
50
60
70
0 3 6 9 12 15 18 21 24
AAA size and change in diameter
by interval
SERIAL CHANGE OF TRANSVERSE ANEUSYSM DIAMETER
Time after stent grafting (months)
Aneurysmdiameter(mm)
No. of patients 84 76 65 50 44 31
p=0.051 p=0.001
REMODELING INDEX
0.92 0.97 0.98 0.97 0.98

21. Study conclusionsStudy conclusions
Intraoperative fibrin glue aortic aneurysm sac
embolization appears to be a suitable procedure
This “ad hoc” preventive strategy provides easy,
effective and durable aortic side-branch occlusion
Our two year follow-up confirms thrombosis of
fibrin glue-treated aneurysm sacs in 97.6% of cases
This approach may be considered a strategy for
routine preventive treatment of type II endoleaks

22. Fibrin glue injection technique toFibrin glue injection technique to
induce aneurysm sac thrombosisinduce aneurysm sac thrombosis
■ The access to the excluded aortic sac was obtained by leaving
the guidewire between the prosthesis and the native aorta during
the endovascular procedure
■ A 23 mm long 5F brite tip introducer sheath was advanced over
the guidewire and 5 ml of fibrin glue (Tissucol) was injected by
means of dedicated double-lumen catheter (Duplocat®
)
Zanchetta M . J Endovasc Ther 2005;12:579-82Zanchetta M . J Endovasc Ther 2005;12:579-82