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TREATMENT OF IATROGENIC FEMORAL ARTERY

PSEUDOANEURYSM BY FIBRIN GLUE INJECTION: CLINICAL

EXPERIENCE

F Faresin, F Franz, S Ronsivalle

Department of Cardiovascular Disease – Vascular and Endovascular Surgery

and Angiology, Cittadella, Padua (Italy)

It is a simple, quick, safe and effective procedure in treatment of iatrogenic

pseudoaneurysm. It is a valid and useful alternative to surgical treatment.

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TREATMENT OF IATROGENIC FEMORAL ARTERY

PSEUDOANEURYSM BY FIBRIN GLUE INJECTION: CLINICAL

EXPERIENCE

ABSTRACT

PURPOSE

Pseudoaneurysms have become more frequently seen as a complication of

iatrogenic cardiovascular interventional techniques.

We report our experience in the treatment of iatrogenic pseudoaneurysms by

injecting fibrin glue into the aneurysm sac under ultrasound guidance.

TECHNIQUE

Between November 2009 to June 2011 35 patients with common femoral

artery and 1 patient with an omeral iatrogenic pseudoaneurysm were treated in

our institution.

All cases completely thrombosed within a few minutes. In two cases a 15 and

30 days echo-color-doppler ultrasound inspection revealed a pseudoaneurysm

sac refilling and were treated surgically.

In 1 case with an omeral pseudoaneurysm there was a complication of left

arm acute ischemia, but it was treated successfully with Fogarty’s

thromboembolectomy.

CONCLUSIONS

In our experience the treatment of iatrogenic pseudoaneurysms by injection of

fibrin glue into the aneurysm sac under echo-color-doppler ultrasound

guidance is a safe and effective procedure after an accurate pre operative echo

color Doppler ultrasound assessment.

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TREATMENT OF IATROGENIC FEMORAL ARTERY

PSEUDOANEURYSM BY FIBRIN GLUE INJECTION: CLINICAL

EXPERIENCE

INTRODUCTION

A pseudoaneurysm (false aneurysm) occurs when blood escapes from the

lumen of an artery through a defect in one or more layers of the arterial wall

and forms a localised pocket of blood flow either beneath the adventitia (outer

wall of the artery) or in the surrounding tissues, that is connected to the artery

by a “ neck”. The continuing extravasation of blood into the subcutaneous

tissues is contained within a pseudocapsule of fibrous tissues within the

adjacent soft tissue. This leads to a rupture causing catastrophic bleeding and

is a potential complication.

They are most commonly found as a complication of endovascular procedures

(e.g. diagnostic arteriogram, angioplasty, cardiac catheterization), vascular

trauma, or following open vascular surgery. 1,2

Once considered a rare disease in mostly post-traumatic genesis, with the

increased number of percutaneous interventions via artery cannulation, the

incidence rate of iatrogenic pseudoaneurysm has become more frequently

seen, usually in common femoral artery.

It occurs in 0.2 of diagnostic and 8% of interventional procedures but may

increase up to 16% with more complex treatments that necessitate larger

sheaths. 5-7

It is due to the characteristics of the artery wall (as atherosclerotic plaques

and loss of elasticity), lengthy procedures and investigations, using large bore

catheters, anticoagulant or antifibrinolytic therapy, insufficient compression

of the vessel at the end of the procedure.

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The diagnosis is confirmed by an echo-color-doppler ultrasound which shows

the size of the sac, the characteristics and rate of flow through communication

with the artery.

Small pseudoaneurysms usually resolve with compressive treatment.

The larger ones because of the risk of rupture, require treatment by surgery in

case of failure of the compression technique.

Open surgical repair was the gold standard for iatrogenic pseudoaneurysm

until 1991.

Fellmeth et al reported on using ultrasound scan-guided compression (UGCR)

as a nonsurgical intervention for femoral pseudoaneurysm. 7

UGCR proved to be a beneficial nonoperative technique for femoral

pseudoaneurysm; however it’s painful for the patient and time consuming.

UGCR has less success with larger pseudoaneurysms, those lasting more than

2 weeks, and those in patients who were undergoing anticoagulation therapy.

7-9

Ultrasound scan-thrombin guided injection (UGTI) was first introduced in

1986 by Cope and Zeits.

There is a reluctance in using this technique possibly because the potential

intra-arterial injection could promote a subsequent thrombosis.

We report our experience in the treatment of iatrogenic pseudoaneurysms by

injection of fibrin glue into the pseudoaneurysm sac under echo-color-doppler

ultrasound guidance.

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TECHNIQUE

Patients and methods

From November 2009 to June 2011 over 2450 patients had coronary or

peripheral angiography and angioplasty in Interventional Cardiology.

All complications related to arterial puncture sites such as bruit, hematoma,

pulsatile hematoma, or marked pain or tenderness were studied.

A color Doppler ultrasound analysis evaluated the presence of a

pseudoaneurysm or other complications, such as arteriovenous fistula.

EchocolorDoppler ultrasound confirmed the diagnosis in all cases.

Out of the 2450 procedures there were 65 pseudoaneurysms (2.6%); all were

treated with compression or ultrasound scan-guided compression. 27 patients

(41.5%) had good results but 3 patients (4.6%) with neck’s pseudoaneurysms

less than 10 mm long and/or more than 0,8 mm large, after compression or

ultrasound scan-guided compression failure, underwent surgical repair.

35patients (53.8%) with a common femoral artery iatrogenic pseudoaneurysm

and one patient (1.5%) with an omeral iatrogenic pseudoaneurysm after

compression or ultrasound scan-guided compression failure, were treated in

our Institution with fibrin glue injection inside the pseudoaneurysm sac.

Diagnostic Duplex scan was done with Siemens Acuson S2000 with 5 MHz

to 7 MHz linear array transducer.

Informer consent was obtained.

Pedal and radial pulses were assessed before and after the procedures.

The groin and the antecubital fossa were prepared and draped in the usual

sterile fashion.

With direct ultrasound scan guidance the tip of the needle 18 or 19 G was

placed within the pseudoaneurysm and the two components of fibrin glue

(fibrinogen solution and thrombin solution) were simultaneously injected into

the sac through a needle connected on a DUPLOJECT two way syringe clip.

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Back pressure was maintained at the syringe plunger to prevent clotting of the

needle.

The injection of fibrin glue was performed with ultrasound scan guidance to

confirm thrombosis of the sac.

A second injection with the same amount was required in 7 patients (19.4%).

Successful resolution was visualized within moments. During the injection a

probe echo guided pressure is made in order to close the pseudoaneurysm

neck and avoid the suction of fibrin glue inside the vessels.

At the end of a procedure, the patency of the common, superficial, profunda

femoral along with distal arteries and veins was assessed with

echocolordoppler scan evaluation.

Repeated echo-color-doppler ultrasound evaluations were performed at 24

hours and at 30 days.

Fibrin sealant

Fibrin glue (Tisseel/Tissucol; Baxter-Hyland Immuno AG, Vienna, Austria) is

a fully absorbable biological adhesive matrix without cytotoxic effects, made

of two main components: 1) a fibrinogen solution containing plasma proteins

and factor XIII; 2) a thrombin solution containing calcium chloride and

aprotinin. These components are commercially prepared from human plasma,

except for aprotinin, which is extracted from bovine lung. When mixed

together they recreate the final phase of the natural coagulation cascade

forming a structured fibrin clot similar to the physiological clot, susceptible of

fibrinolytic degradation caused by proteolytic enzymes such as plasmin.

Over the last 3 decades, fibrin glue has been used extensively by surgeons.

The required dose of sealant to cover 40 cm2 or 3.5 cm3 is about 5 ml,

however, its use in pseudoaneurysm sac embolization is an off-label

indication.

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Fibrin glue does not alter in any way MRI scanning, CT and CDU imaging.

In Italy 2 ml of Tissucol costs 180 euros, about 256 dollars. 11-14

Results

Thirty-five patients with a common femoral pseudoaneurysm and one with

omeral pseudoaneurysm developed after percutaneuous cardiac catheterism

have been treated with fibrin glue injection inside the pseudoaneurysm sac.

Sac mean diameter was 30.3 ± 11.2 mm. True lumen mean diameter was 2.3 ±

0.9 mm. Neck mean length was 15.2 ± 1.6 mm. Neck mean diameter was 0.4

± 0.2 mm.

In 12 cases (33.3%) more than one cavity were seen.

In all 35 common femoral artery pseudoaneurysm cases there was a complete

thrombosis of pseudoaneurysm sac within minutes, confirmed by echo-color-

doppler ultrasound inspection which was performed at 24 hours (Fig 1-2-3 A

and 1-2-3 B).

In 2 patients who were undergoing anticoagulation therapy, an echo-color-

doppler ultrasound inspection at 15 and 30 days respectively, revealed a

pseudoaneurysm sac refilling and were treated surgically.

One case of an omeral pseudoaneurysm had complications of acute

thrombosis of omeral, radial and ulnar ateries with left arm acute ischemia.

The patient was treated successfully with Fogarty’s thromboembolectomy.

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DISCUSSION

Fibrin glue is formed by two components that when mixed together they

recreate the final phase of the natural coagulation cascade forming a

structured fibrin clot similar to the physiological clot.

Over the last 3 decades it has been used extensively by surgeons and since

2003 we have used it successfully in prevention of EL type II with

thrombization of aneurysm sac with biomaterials during EVAR. 11-14

We have transferred our experience in aneurysm sac thrombization during

EVAR into an iatrogenic pseudoaneurysm treatment.

We believe that, compared to thrombin alone, fibrin glue is more effective in

promoting sac thrombosis and neck closure, most of all in patients who are

undergoing anticoagulation or heavy antiaggregant therapy.

Nevertheless, we point out that it is not safe to treat pseudoaneurysms with

short and wide necks that have a high risk of peripheral embolization.

In fact the case with the omeral pseudoaneurysm had a short and wide neck

(Fig 1-C and 2-C) with high blood pressure and stormy flow inside the sac

which probably caused fibrin glue suction inside the vessels and subsequently

peripheral embolization.

There were no cases of allergic or anaphylactic reactions.

We had primary success with immediate pseudoaneurysm sac thrombosis in

35 patients (97.2%), a peripheral embolization in 1 patient (2.8%) and two

cases of pseudoaneurysm refilling (5.5%). One after 15 days and the other at

30 days who both had to have surgical treatment.

As of today, our results are encouraging but more experience is necessary to

confirm validity of this method.

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CONCLUSIONS

In our experience the treatment of iatrogenic pseudoaneurysms by injection of

fibrin glue into the pseudoaneurysm sac under echo-color-doppler ultrasound

guidance is a safe, rapid, low cost, well tolerated and effective procedure.

An accurate pre-procedural echo color Doppler ultrasound assessment is

necessary in order not to treat pseudoaneurysms with anatomical features that

are at a high risk of peripheral embolization. Further studies are necessary to

assess the long term results of this procedure.

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REFERENCES

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FIGURE LEGEND

Figure 1: Typical example of a pseudoaneurysm. 1A a necked

pseudoaneurysm (PA) with flow within the aneurysm sac. 1B a post-fibrin

glue injection image, the PA is thrombosed and the cavity is now echogenic

1C the flow pattern in common femoral artery

Figure 2: Typical example of a pseudoaneurysm. 2 A a necked

pseudoaneurysm (PA) with flow within the aneurysm sac. 2B and 2 C a post-

fibrin glue injection image, the PA is thrombosed and the cavity is now

echogenic

Figure 1 and 2 C: Pseudoaneurysm with short and wide neck with high

pressure and stormy flow inside the aneurysm sac.