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CASE REPORT

N e w t e ch n ologie s, n e w com plica t ion s: com plica t ion s a ft e r u se of n e w

a r t e r ia l closu r e a n d t h r om be ct om y de vice s

M a r ce lo Fe r r e ir a ; M a r ce lo M on t e ir o; Gia fa r Abu h a dba ; Lu iz La n z iot t i; Lu is Fe r n a n do Ca pot or t o*

*I nt egrat ed Ser vice of Endovascular Techniques ( SI TE) , Rio de Janeiro, RJ, Br azil.

Correspondence

J Vasc Bras. 2007; 6( 4) : 395- 8.

ABSTRACT

We describe a singular case of bot h ischem ic and t raum at ic com plicat ion, referring t o use of new devices used for endovascular approach, in t he sam e pat ient . One is a hem ost at ic closure device ( Angio- Seal® - St . Jude Medical) and t he ot her is a cat het er for percut aneous rot at ional and aspirat ion t hrom bect om y ( Rot arex® - St raub Medical) . We discuss indicat ion t o use t hese devices in sever ely ill pat ient s, w it h hem odynam ic inst abilit y, or in a st at e of hyper coagulabilit y, associat ed w it h fem or al at herosclerot ic disease, due t o it s high pot ent ial of com plicat ions.

Ke y w or ds:I schem ia, art erial occlusive disease, angioplast y, t hr om bect om y.

RESUM O

Relat am os aqui um caso singular de com plicação isquêm ica, e t am bém t r aum át ica, r efer ent e ao uso de dois novos disposit ivos par a ut ilização endovascular , am bos no m esm o pacient e. Um é um disposit ivo hem ost át ico par a selam ent o de punção ( Angio- Seal® - St . Jude Medical) e o out ro, um cat et er para t rom bect om ia rot acional aspirat iva per cut ânea ( Rot arex® - St raub Medical) .

Discut im os a indicação dest es disposit ivos em pacient es gravem ent e enfer m os, com quadr o de inst abilidade hem odinâm ica ou em est ado de hiper coagulabilidade, associado à doença

at erosclerót ica fem or al, por seu elevado pot encial de com plicações.

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I n t r odu ct ion

Follow ing a global t rend, w e live in current m edicine an age of fast and cr eat ive t echnological evolut ion, in sear ch of new , m or e pract ical solut ions t hat are easily execut ed, r educe hospit al st ay and provide out pat ient s an early r et ur n t o t heir usual act ivit ies.

The endovascular t echnique has been progressively set t ing it s foundat ion, pr oving t o be feasible and effect ive for t he t reat m ent of m ost sur gical vascular diseases, able t o offer safet y and com for t using a m inim ally invasive t echnique. How ever , due t o evolut ion and new devices t hat ar e

const ant ly being launched, w e occasionally face unexpect ed sit uat ions, com plicat ions t hat t he " new " endovascular sur geons should know and be able t o solve.

Ca se r e por t

A 73- year - old fem ale pat ient w as adm it t ed t o t he em er gency room w it h clinical st at us of acut e abdom en. Aft er abdom inal ult r asound and com put ed t om ogr aphy, t he pat ient was referred t o t he surgical cent er, w her e lapar ot om y show ed acut e m esent er ic ischem ia affect ing dist al j ej une and ileum , besides t he r ight colon, at init ial st age of ischem ic suffer ing, probably secondary t o a syndrom e of low car diac out put w it h no evidence of at her oem bolic occlusion.

Mesent er ic select ive ar t er iogr aphy w as indicat ed, follow ed by direct infusion of a solut ion of papaverine hydrochloride, 40 m g/ h, in t he superior m esent er ic art ery ( SMA) .

Te ch n iqu e

1.Ret r ogr ade punct ure of t he left com m on fem oral art ery ( CFA) w it h int r oduct ion of a 6- F sheat h m easur ing 13 cm .

2.Select ive cat het er izat ion of t he SMA using a 5- F Mikaelson cat het er ( COOK) .

3.Diagnost ic select ive angiogr aphy w as per for m ed, show ing r ar efact ion of r evascular izat ion in t he area supplied by ileal br anches and r ight colic art ery, w it h no signs of em bolism .

4.I nfusion in solut ion pum p of papaverine 0.1% , 40 m g/ h, w it h m aint enance of t he sheat h in t he left CFA.

The pat ient w as m aint ained adapt ed t o vent ilat or y pr ost hesis and r efer r ed t o t he int ensive car e unit ( I CU) in per it oneot om y for r eassessm ent in 24 hour s.

Dur ing t hat cont r ol, t here was significant im pr ovem ent in t he aspect of ileal loops, confir m ing anat om ical success show n in angiogr aphy.

The per it oneot om y w as closed and t he pat ient r et ur ned t o t he I CU, w it h m aint enance of t he sheat h in t he left CFA and papaver ine solut ion at t he sam e dose for 24 hour s.

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complete homeostasis, requiring complementation with compressive dressing. About 12 hours after removal of the sheath, there was coldness, pallor, fixed cyanosis and absence of distal pulses in the left lower limb, compatible with acute arterial occlusion. An arterial Doppler ultrasound was performed, confirming the diagnosis and showing presence of "hypoechogenic material, probably embolic, with hyperlucent halo surrounding it," compatible with the sealing biopolymer of the device (Figure 1A).

The patient was again referred to the surgical center, where she was submitted to percutaneous aspiratory rotational arterial thrombectomy using the Rotarex€ device (Straub Medical).

Te ch n iqu e

1.Retrograde puncture of the right CFA for contralateral access.

2.Control angiography showed arterial occlusion of the left CFA.

3.Introduction of a device for percutaneous aspiratory rotational arterial thrombectomy, with complete removal of the proximal thrombus.

4.A critical atherosclerotic lesion of the superficial femoral artery was also diagnosed in the Hunter channel and popliteal artery, besides an aspect suggesting multiple intraarterial thrombi.

5.The device of rotational thrombectomy was used again, until the tibiofibular trunk.

6.In the control period, there was large contrast extravasation, suggesting traumatic arterial lesion of the tibiofibular trunk (Figure 1C).

7.Temporary occlusion using a 4.0 x 60 mm angioplasty balloon (ATB – COOK Medical) was attempted, followed by a 40 x 30 mm self-expandable nitinol stent, with no success in homeostasis.

8.Direct approach of infrapatellar vessels and repair of proximal lesion at the origin of the anterior tibial artery (occluded), with its proximal ligation and terminoterminal anastomosis for

reimplantation of the tibiofibular trunk.

At the end of the procedure, the sheath was removed from the right CFA and a percutaneous arterial sealing device was used (Angio-Seal€ 6F), with reestablishment of distal pulses.

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lim b, t his t im e on t he r ight lim b, and again present ing pallor , coldness and slow capillary filling. The pat ient present ed hem odynam ically st able, dependent on low dose am ines. The punct ur e sit e was direct ly appr oached t hrough exposur e of fem oral vessels ( Figure 2) , follow ed by

t hr om boem bolect om y using a 3- F Fogart y cat het er ( Edw ar ds Lifesciences) . Ther e w as anat om ical success on angiogr aphy, associat ed w it h clinical im pr ovem ent t hat w as m aint ained for 14 days, w hen t he pat ient died due t o infect ious respirat ory insufficiency.

D iscu ssion

Art erial punct ur e sealing devices w er e developed t o replace t he m anual com pr ession m et hod and reduce perm anence t im e at post procedure rest .

Their safet y has been docum ent ed, w it h reduct ion in r isk of hem at om a form at ion, vessel occlusion, bleeding, form at ion of art eriovenous fist ulas and pseudoaneurysm s, as w ell as reduct ion in t im e t o regain w alking abilit y and hospit al dischar ge, w hen com par ed w it h t he st andard m et hod of m anual com pr ession.1 Som e st udies show ed t he safet y and efficacy of t he device rout inely used by our service, Angio- Seal® .2 , 3 We have used so far 98 devices in 76 pat ient s, w it h t w o pr evious episodes of com plicat ions sim ilar t o t hose r epor t ed herein.

Efficacy of t hese m echanism s is also confir m ed in pat ient s w ho need m assive plat elet

ant iaggr egat ion, achieving efficacious hom eost asis in m or e t han 95% of pat ient s, w it h a rat e of hem orrhagic, non- surgical com plicat ions low er t han 4% .4 I n anot her ser ies, Chevalier et al.

report ed, in a r andom ized st udy including 612 pat ient s, reduct ion in m ean hom eost asis t im e fr om 52 t o 5 m inut es.5

Hem or r hagic com plicat ions are t he m ost com m on, w it h r at es r anging bet w een 5- 7.4% , w it h 1.9% of episodes pr ogr essing w it h infect ion. Ther e is a discussion as t o w het her t his device could be a risk fact or for infect ion for t w o reasons: excessive form at ion of hem at om as, due t o a r isk know n as endart erit is, and pr esence of a for eign body in t he lum en and art erial w all, t hus creat ing a niche for infect ion.6

Occlusive com plicat ions ar e rare, w it h few report s in t he lit er at ur e.7 , 8 One hypot hesis is t hat t his is due t o m assive plat elet ant iaggr egat ion, t o w hich t hese pat ient s are usually subm it t ed.

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w it h som e st udies show ing a 61% pat ency aft er 1 year .9 Repor t ed com plicat ions ar e art erial perforat ion, at t ribut ed t o pr esence of severely calcified ar t er ies and for m at ion of ar t er iovenous fist ulas, besides dist al em bolism s, all of w hich can be convenient ly subm it t ed t o endovascular t reat m ent .1 0 , 1 1

What should be quest ioned, since t here are few available dat a, is safet y and efficiency of percut aneous ar t er ial sealer s t o be used in crit ically ill pat ient s, hypot ensive, t ending t o

hypercoagulabilit y, poor dist ribut ion of w at er , in need of vasoact ive am ines t o m aint ain ar t er ial pressure, and t hose w ho m ay need endovascular int er vent ion. All t hese fact ors ar e m uch w or sened in case t her e is obst ruct ive ar t er ial disease locat ed in t he punct ured fem or al art ery. I n addit ion, it should be quest ioned w het her it is necessar y, due t o sealer inefficiency, charact erized by act ive bleeding aft er it s use, com plem ent ar y t o m anual com pr ession and m aint enance of com pr essive dressing.

The Rot arex® device, in our pract ice, pr oved t o be efficient in cases of acut e and subacut e occlusion, but w e st ress t he risk of art erial lesion w hen used in grossly calcified or low er caliber vessels, such as infr apat ellar vessels.

Quest ioning use of t hese devices, based on pr esence of severe at her om at ous or in case of sm all-caliber veins, m akes t his a com plex t ask, since in m any series w it h a high num ber of pat ient s t her e is no m ent ion about t he im port ance of such var iables w hen t her e is st enot ic com plicat ion, usually at t ribut ed t o inadequat e use of a sealing device.

Endovascular sur geons should be alert , t her efor e, not only t o new devices t hat are launched ever y day, but also t o t heir possible com plicat ions, w hich w ill nat urally occur w hen used m or e fr equent ly and, above all, t hey should be pr epar ed t o solve t hem .

Re fe r e n ce s

1. Kor eny M, Riedm uller E, Nikfardj am M. Art erial punct ur e closing devices com par ed w it h st andar d m anual com pr ession aft er cardiac cat het er izat ion: syst em at ic r eview and m et a- analysis. JAMA. 2004; 291: 350- 7.

2. Aksoy M, Becquem in J- P, Desgr anges P, Allair e E, Kobeit er H. The safet y and efficacy of Angioseal in t herapeut ic endovascular int er vent ions. Eur J Vasc Endovasc Sur g. 2006; 32: 90- 3.

3. de la Ller a L, Andr ay JA. Deam bulación pr ecoz t r as cat et er ism o car díaco con 6 Fr Angio- Seal, un nuevo disposit ivo hem ost át ico de cier r e de la punción percut ánea. Rev Esp Cardiol. 2001; 54: 1406-10.

4. Cr em onesi A, Cast riot a F, Tar ant ino F, et al. Fem oral art erial hem ost asis using t he Angio seal fem inine syst em aft er coronary and vascular per cut aneous angioplast y and st ent ing. J I nvasive Cardiol. 1998; 10: 464- 9.

5. Chevalier B, Lancelin B, Koning R, et al. Effect of a closure device on com plicat ions r at es in high-local- risk pat ient s: result s of a r andom ized m ult icent er t rial. Cat het er Cardiovasc I nt erv.

2003; 58: 285- 91.

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7. Thalhammer C, Aschwanden M, Jeanneret C, Labs KH, J‚ger KA. Symptomatic vascular complications after vascular closure device use following diagnostic and interventional

catheterization. Vasa. 2004;33:78-81.

8. Ferreira AC, Eton D, de Marchena E. Late clinical presentation of femoral artery occlusion after

deployment of the angio-seal closure device. J Invasive Cardiol. 2002;14:689-91.

9. Duc SR, Schoch E, Pfyffer M, Jenelten R, Zollikofer CL. Recanalization of acute and subacute femoropopliteal artery occlusions with the Rotarex catheter: one year follow-up, single center

experience. Cardiovasc Intervervent Radiol. 2005; 28:603-10.

10. Berczi V, Deutschmann HA, Schedlbauer P, Tauss J, Hausegger KA. Early experience and

midterm follow-up results with a new, rotational thrombectomy catheter. Cardiovasc Intervent

Radiol. 2002;25:275-81.

11. Zeller T, Muller C, Frank U, Bƒrgelin KH, Horn B, Roskamm H. [The Straub-Rotarex

thrombectomy system: initial experiences]. Rofo. 2001;173:626-31.

Cor r e spon de n ce : Marcelo Ferreira

Rua Siqueira Campos, 59/203, Copacabana CEP 22031-070 – Rio de Janeiro, RJ, Brazil Tel.: (21) 2236.1637

Email: mmvf@uol.com.br

Referências

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