TYPE II ENDOLEAK: FROM TREATMENT OF COMPLICATION TO PREVENTION

TYPE II ENDOLEAK

FROM TREATMENT OF COMPLICATION TO PREVENTION

April 13-14, 2012

DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY

Chief: Salvatore Ronsivalle, MD

TYPE II ENDOLEAK

It’s the most common form of endoleak and arises from retrograde

filling of the sac by lumbar branches or the inferior mesenteric artery

EARLY noted at the time of EVAR, 40% spontaneously

eventually thrombose

PERSISTENT an ELII that has not spontaneously resolved

within 6 months even in the absence of aneurysm

enlargement

► Selective lumbar artery embolization through hypogastric artery

► Selective AMI embolization through an AMS artery retrograde catheterism

► Laparoscopic retroperitoneal lumbar or inferior mesenteric branches ligation

► Trans distal endograft seal zone treatment

► Translumbar CT managed sac thrombization with biomaterials

► Transabdominal echo-guided sac thrombization with biomaterials

► Surgical semi convertion

► Surgical complete convertion

TYPE II ENDOLEAK WITH SAC ENLARGEMENT

TREATMENT

TYPE II ENDOLEAK

R.V., male, 72 years old

Multiple cardiovascular disease

ASA 3

2000 Aorto-Bisiliac Stent Graft ANEURX (2213135)

2001 for type II EL with sac enlargement

lumbar arteries embolization with coils

2002 for type II EL persistence with sac enlargement

surgical semi-convertion

Follow up control angio-CT scan 2001:

EL type II

Follow up control angio-CT scan 2002:

EL type II with sac enlargement

Angiography

Selective embolization of lumbar artery

Selective lumbar artery angiography and arteries coil embolization

Selective embolization of lumbar artery

After ECD detectment of EL type II persistence with sac

enlargement, the patient underwent surgical semi-convertion

with aneurysmatic sac opening, lumbar arteries closure,

aneurysmatic sac sewing without graft removing

Follow up CT scan after semi-convertion

TYPE II ENDOLEAK

D.P.M. male, 67 years old

Multiple cardiovascular disease

ASA 3

2000 Aorto-Bisiliac Stent Graft ANEURX (2615165; 15115)

2001 for type II EL with sac enlargement

lumbar arteries embolization with coils

2002 for EL II persistence with sac enlargement

surgical convertion

Pre-surgery angio-CT scan 2000

Follow up angio-CT scan 2001: EL type II persistence and sac enlargement

Selective angiography and lumbar artery coil positioning

Selective embolization of lumbar artery

Selective angiography and lumbar artery coil positioning

Selective embolization of lumbar artery

Follow up angio-CT scan 2002: EL type II persistence and sac enlargement

After ECD detectment of EL type II persistence with sac enlargement,

the patient underwent surgical convertion with

aneurysmatic sac opening, graft removing

and substitution with byfurcated graft

Type II Endoleak

Z.A. female, 83 years old

Multiple cardiovascular disease

ASA 3

2004 Aorto-Bisiliac Stent Graft TALENT (2616155-1418105)

in follow up with ECD for type II endoleak

2011 for type II EL persistence with sac enlargement

translumbar CT managed sac thrombization with fibrin glue

Follow up angio-CT scan 2011 : type II EL persistence and sac enlargement

Follow up angio-CT scan 2011: EL type II persistence and sac enlargement

After ECD detectment of EL type II

persistence with sac enlargement,

the patient underwent

Translumbar sac thrombization with biomaterials

Step by step CT scan managed needle sac introduction

After guide and introductor positioning step by step sac

thrombization with fibrin glue

CT scan post-procedural final control

One week post procedural CT scan control

Follow up angio-CT scan 2010 : EL type II

persistence with sac refilled by a lumbar artery

One week follow up post procedural

angio-CT control scan with EL II resolution

Type II Endoleak

F.L.male, 64 years old

Multiple cardiovascular disease

ASA 3

2009 Aorto-Bisiliac Stent Graft

TALENT (3016155, 1424105)

left iliac extension BELL BOTTOM

ENDURANT (162880)

In follow up with ECD

for EL type II with sac enlargement

and lack of intra sac homogeneity

Pre surgery angio-CT scan

Follow up ECD: EL type II persistence, sac enlargement and lack of intra sac homogeneity

Follow up angio CT scan which shows sac enlargement

RMN: EL type II persistence, a lumbar artery and intra sac lack of homogeneity

2011 for EL type II persistence with sac enlargement the patient underwent

transabdominal echoguided sac thrombization with fibrin glue

followed by emergency surgical conversion after 24 hours due to sac rupture

Step by step echo-guided

transabdominal sac thrombization with fibrin glue

CT scan post-procedural final control

Emergency Surgical Conversion

after 24 hours

Emergency Surgical Conversion after 24 hours

10 cases treated in more than 10 years’ experience:

► 3 immediate complete convertion

► 4 convertion after unsuccessful lumbar trans-arterial embolization

► 1 patient in follow up for an EL II had a progressive aneurysmatic sac and proximal

neck enlargement with the main body partially slipping, developed an EL IA treated with intra-sac coils insertion plus a fibrin glue injection and proximal aortic cuff positioning

► 1 emergency convertion after unsuccessful echoguided transabdominal fibrin glue injection

► 1 successful CT managed translumbar thrombization with fibrin glue

Our experience in EL II with sac enlargement treatment

► After a EL II diagnosis many clinicians assume a ‘‘wait and see’’ approach with

regular follow- up when there is no expansion of the aneurysm sac

► The treatment of type II endoleak causing sac enlargement is always difficult,

dangerous, and almost always ends with a surgical conversion.

We propose

Aneurysm sac ‘‘thrombization’’ and stabilization in EVAR:

a technique to reduce the risk of type II endoleak

Ronsivalle S et al Aneurys sac “Thrombization” and Stabilization in EVAR : a technique to reduce the risk of Type II Endoleak.

J Endovasc. Ther. 2010; 17: 517-524

Ronsivalle S et al. Type II Endoleak: From Treatment of a Complication to prevention J Edovascular Ther 2012;19:128–130

Biomaterials

FIBRIN SEALANT is a fully absorbable biologic adhesive matrix made

of two main components

1) fibrinogen solution containing plasma coagulation proteins and

2) thrombin solution containing aprotinin (antifibrino-litic agent)

INCONEL (nickel and cobalt alloy) COILS are radiopaque, allow MRI scanning,

CT and CDU imaging

PROCEDURE

BRITE TIP introductor

between endograft

and abdominal aorta

INCONEL coils

are Inserted into

aneurysm sac

PROCEDURE

Fibrin glue injection into aneurysm sac Aneurysm sac thrombization

ANGIOGRAPHY DURING EVAR

Final angiography performed to verify sac thrombization and root occlusion of lumbar and inferior mesenteric arteries

CT SCAN

Control CT scan with evident inconel coils

September 1999 December 2010

608 patients underwent EVAR

September 1999 May 2003

228 pts: EVAR standard procedure

June 2003December 2006

131 pts: EVAR plus fibrin glue

January 2007December 2010249 pts: EVAR

plus inconel coils and fibrin glue

POPULATION

STUDY COHORT BASELINE DEMOGRAPHIC CHARATERISTICS

Armando Olivieri MD, Department of Prevention - Epidemiology Unit

(N 228) (N 317)

MALE 213 (93.4%) 285 (91.6%) §

FEMALE 15 (6.6%) 32 (8.4 %) §

AGE (YEARS) + SD 71.8 ± 8.5 72.1 ± 7.5 **

SMOKE 53 (23.2%) 53(13.9%) *

FAMILIARITY FOR AAA 2 (0.8%) 21 (5.5%) §

CHRONIC RENAL FAILURE 54 (23.7%) 100 (26.3%) §

CAROTID ARTERY DISEASE 91 (39.9%) 205 (53.9%) §

PERIFERIC ARTERY DISEASE 80 (35.1%) 64(13.8%) *

BMI > 30 47 (20.6%) 73(19.2%) §

HYPERTENSION 193 (84.6%) 356 (93.7%) *

CARDIAC DISEASE 126 (55.3%) 221 (58.2%) §

DIABETES MELLITUS 41 (18.0%) 79 (20.8%) §

HYPERLIPIDEMIA 152 (66.7%) 303 (79.7%) *§ Pearson χ2 : p>0.05

** t-test : p>0.005

GROUP II EVAR plus thrombization

GROUP I EVAR alone

INCIDENCE RATE

Armando Olivieri MD, Department of Prevention - Epidemiology Unit

cohortperson-time

(months)fai lures (num)

rates (x 1000 person-months)

EVAR alone 18845 34 1,80

EVAR plus sac thrombization 15663 12 0,77

total 34478 46 1,33

Incidence rate was 1,80 rates * 1000 person-month for EVAR alone group and 0.77 rates * 1000 person-months for EVAR plus thrombization

KAPLAN MAYER SURVIVING CURVE

Armando Olivieri MD, Department of Prevention - Epidemiology Unit

0.0

00.

25

0.5

00.

75

1.0

0

cum

ulat

ive

prob

abili

ty

379 346 272 202 132 86 67 37 10 0 0 0EVAR plus thrombization227 188 175 168 163 156 150 141 132 110 56 38EVAR alone

Number at risk

0 12 24 36 48 60 72 84 96 108 120 132 144follow up in months

EVAR alone EVAR plus sac thrombization

log-rank test p=0.0000

Kaplan–Meier Curves for the Primary End Point (endoleak type II)

RISK (HAZARD RATIO) FOR TYPE II EL

ADJUSTED FOR SURGICAL TECHNIQUE,GENDER AND OBESITY

Armando Olivieri MD, Department of Prevention - Epidemiology Unit

Hazard Ratio p I.C. 95%

surgical technique

EVAR alone 1,00

EVAR plus sac thrombization 0,19 0,000 0,10 0,37

gender

male 1,00

female 0,31 0,002 0,15 0,64

obesity

normal/overweight 1,00

BMI>30 0,18 0,018 0,04 0,73

Prevention with biomaterials

is the best strategy to manage type II endoleak

► Reduces frequency of follow up Reduces frequency of follow up

► Increases Increases EVAR successEVAR success

► SimpleSimple

► Safe Safe

► Low costLow cost

► Independent Independent of stent graft used of stent graft used

Thank you