Use of Loop-Suture Technique to Close aPercutaneous Access Site after Hemodialysis GraftIntervention.

B. Smouse, OSP Saint Francis Medical Center, Peot"ia,

II. USA • F Castaneda. j. Swischuk • T. Brady.

J.D. Vrabel

Scientific Session 10Puncture Site Evaluation/ManagemenllClosureModerator: Kevin Dickey, MD

Monday, March 5, 20013:15 pm-4:45 pm

3:26 pm Abstract No. 74

A Comparison of Fibrin Glue and Thrombin asAgents to Fadlitate Puncture Closure FollowingDialysis Graft Intervention.}. 51.George, Upslale Medical University, Syracuse, NY,USA • K.D. Murphy· OJ. Kwon

CONCLUSIONS: The fibrin glue produced immediatehomeostasis of 7-9Fr dialysis graft punctures despite an­ticoagulation (ACT 200-400). Thrombin soaked gelfoam

was also very effective; however this required addi~

tional manual compression and the thrombinlgelfoamseal was occasionally subject to dislodgment.

RF...5ULTS: The average. lime to homeostasis with topicalthrombin soaked gelfoam was < lOminj however, thegelfoamllhrombin seal occasionally dislodged with

arm movement or an elevated syswlic BP. Fibrin gluehas an epoxy-like consistency and immediately "plugs"the tract Homeostasis was < lminute. There was noacute or delayed bleeding after applicaton of the flbringlue. The consistency of the fibrin glue and the gOl1exgraft ply construction prevents inadvertent intraluminaladministration

PURPOSE: Percutaneous interventions of gonex dialysis

grafts often require utilization of 6-7Fr vascular intro­ducers to accommodate a thrombectomy device or bal­

loon. These sheaths produce 7.S-9Fr diameter punc­

tures. Anticoagulation, platelet dysfunction, elevatedblood pressure, and a large puncture can result in

markedly prolonged compression times. This studyevaluated the cfricacy .of both bovine thrombin and fib~

rin glue (Tissel)to facilitate puncture closure of gonexdialysis grafts

MATERIALS AND METHODS.. 31 consecut;ve hemodiaiy­

sis grafts with 62 loop-sutures were prospectively evalu­ated for immediate hemostasis, complication and ease

of removal. There were 24 thrombolyses, 31 angioplas­ties, and S stent placements. S patients 06%) were onCoumadin, 22 patients (71%) received intravenous he­parin (mean of 2977 units), and 24 patients (77%) re­ceived Retavase (mean of 1.3 units per graft). Thesheath sizes ranged from SF to 7F (mean of 6.2F).

3:37 pm Abstract No. 75

Tbe WoggJe Technique: A New Method of SutureClo~'Ureof Hemodialysis Arteriovenous Grafts andFistulae, after Percutaneous Interventions.

M.E. Simons, Toronto Western Hospital, Toronlo, ON,

Canada. T w: Clark. D.K. Rajan

Rf:<.SULTS: Immediate hemostasis was achieved in 60loop-sutures (97%). Two closures reqUired manualcompression 00 and 16 minutes). One broken sU[ure

occurred. No puncrure site bled after suture removal. 61loop-smures (98%) were reponed as "easy" to remove.

CONCLUSION: The loop-suture is very effective for im­mediate hemostasis and is easy to remove at a later dateby the dialysis staff.

PURPOSE To evaluate a new method of suture closureto achieve hemostasis after percutaneous inlerventionson hemodialysis access grafts and fisrulae.

j\.1ATERWS AND ME1HODS: rn,e woggle technique is a

modification of the purse string suture used to close apuncture site after percutaneous interventions. Thewoggle is a plastiC gUide wire introducer, or similar de­

vice, which is placed over the ends of the purse stringsuture and cinched down with a hemostatLO tighcen thesuture without making a knot. It is applied just beforeremoving the sheath or catheter at che end of a proce-

PURPOSE Evaluate the safery, efficacy and ease of re­moval of the loop-surure. Obtaining hemostasis aftergraft inrerventions is time consuming. Altbough a purse­string suture allows immediate hemostasis, its removalis difficult since it becomes imbedded in the skin. Mak­ing 4 in-and-out passes into the skin around the sheathforms a purse-string suture. Threading one end of su­ture through 2cms of plastiC wbing and forming a knotwith the other end of suture creates the loop-suture.The knot is pulled tight onto the skin. This bends thetubing inw a loop exposing 2cms of suture for latersnipping. The dialysis staff cuts the loop of tubingthereby releaSing the purse-string sUl1lre.

Abstract No. 733:15 pm

MATERlALS AND METHODS· Bov;ne thrombin (Park

Davis)was reconstituted with normal saline at 20DOU/ce.Fibrin glue (TisseI/Baxtcr) 1.0ec was prepared as di­recled by the manufacturer. GOl1ex dialysis grafts sub­ject to either rhrombectomy/angioplasty or angioplastyalone were accessed with 6-7Fr introducers. Heparinwas administered to achieve an ACT>200. Homeostasisof 20 graft punctures was evaluated with a 2x6cmgelfoam soaked in 10,OOOU thrombin. An additional 20

punctures were sealed by instillation of 0.1-0.3<:c Tissel

within me subcutaneous puncture tract Light pressurewas applied and the puncrurc sites evaluated for home­ostasis in five-minute intclVals. The Tissel site was alsoevaluated after one and three minwes.

S30

Autologous Human Thrombin Injection: A NewEmbolization Treatment for Procedure-RelatedArterial Pseudoaneurysms.C. Engelke, St. Georges Hospital, London, United

Kingdom· j. W Quarmby • R.A. Morgan • A.M. Belli

PURPOSE: To assess a new embolization material forpercutaneous therapy of post-angiographic femoralpseudoaneurysms.

MATERIALS AND MEYHODS: 11 consecutive patients(41-81years, mean 65.6years, 6 female) with post angio­graphic pseudoaneurysms had 18 embolization proce­dures with direct injections of autologous thrombin intothe aneUlysmal sac. 8 pseudoaneurysms were arisingfrom the femoral artery bifurcation or the commonfemoral artery (CFA), 3 from the superficial femoral ar­tery (SFA).

dure. The suture and woggle are left for 20-60 minutes,and then the woggle is released. If hemostasis isachieved, the suture is removed, and if hemostasis isnot achieved the woggle is either retightened or the su­ture is knotted and the patient discharged. From March,1999, to September, 2000, a total of 161 suture closures,using the woggle technique, were applied in 106 pa­tient encounters, after percutaneous interventions per­formed on hemodialysis vascular access grafts and fistu­lae. Followup was via review of the dialysis records fora mean of 4 months (2 weeks to 17 months.)

RESULTS: The woggle alone was successful in achievinghemostasis in 140/161 placements (87%). In 8 /161 in­stances (5%), the suture was broken during applicationof the stitch, and manual compression was used toachieve hemostasis. In 11 cases (7%), the patient bledthrough the stitch, and manual pressure was used to aidhemostasis. In 2 applications (1%), hemostasis was notobtained prior to patient discharge, and the purse stringsuture was tied and the patient discharged. A dialysisnurse removed the suture in 2-4 days time. There wereno false aneurysms, hematomata or access thrombosesthat could be attributed to the use of this technique.

CONCLUSION: The woggle technique is simple, safe,and cuts down on the Radiologist's procedure time andremoves the need to remove the purse string suture at alater date.

Arterial Access Site Closure with the Duett™Sealing Device.I. Finch, john Muir Medical Center, Walnut Creek, CA,

USA • R. Platt • C. Wu!ff. T. Carlton

Abstract No. 773:59 pm

MATERIALS AND METHODS: Immediately following apercutaneous diagnostic or interventional endovascularprocedure 77 pts (age 64.4+/-12.3 yrs, males 71.4%) un­derwent placement of the Duett sealing device. The pri­mary efficacy endpoints included time to hemostasis(TTH), defined as the time from initiation of Duetl de­ployment until hemostasis was achieved and time toambulation (TTA), defined as the time when the pt wasable to ambulate unassisted for 110 feet without re­bleeding. The primary safety endpOint was the compos­ite incidence of major complications (vascular repair, ul­trasound-guided compression for pseudoaneurysm,access site related transfUSion, and groin infection re­quiring antibiotic therapy).

PURPOSE: Conventional management of arterial accesssites is associated with pt discomfort and may result inprolonged bed rest and local complications. As part ofthe Continued Access Registry (CAR) we evaluated thesafety and efficacy of a new vascular closure device,Duett, which is comprised of a low-profile (3F) balloondelivery catheter and a flowable procoagulant consist­ing of thrombin and collagen in a buffered suspension.

cessfully thrombosed. Four of these required repeatthrombin injections. One pseudoaneurysm displayedminimal residual perfusion and occluded cqmpletelyafter 2 weeks. Follow up (mean 2.7 months) did not re­veal any reperfusion of thrombosed aneurysms in anypatient. In 1 patient no aneurysm was demonstratedafter 3 months. 1 aneurysm decreased in size by 50%after 6 months.

CONCLUSION: Injection of autologous thrombin ap­pears safe and effective for embolization of procedure­related pseudoaneurysms. It does not carry the risk ofpotential contamination with bovine infectious agents orallergic reactions. Our early results suggest that humanautologous thrombin can substitute bovine thrombin forthis therapy. Further work is required to evaluate thelong-term results and other potential applications.

Abstract No. 763:48pm

The thrombin was isolated using 30-50ml autologouspatient blood under sterile conditions. All injectionswere made under ultrasound guidance. Increased lumi­nal echogenicity and absence of flow indicated the endof each thrombin injection. Ultrasound follow-up wasperformed on the next day, after 6 weeks and 3 monthsto detect incomplete thrombosis and size of theaneurysm sac.

RESULTS: The handling of autologous thrombin wasstraightfolward in all patients. No technical or clinicalcomplications occurred. 10 pseudoaneurysms were suc-

RESULTS: The Duet[ was successfully deployed in all 77pts (diagnostic 62/77, interventional 15/77). Sheathsizes included 5F-2, 6F-61. 7F-9, 8F-4, 9F-1. The prede­ployment ACT (interventional pts) was 253+/-64.5 secsand 6 pts (7.8%) received GP2b/3a blockers (diagnostic1.6%, interventional 33.3%). The median TTH was 6.0(interquartile range 4, 8) mins and the median TTA was189.5 (interquartile range 146, 301) mins (diagnostic171.0, interventional 421 mins). No pt experienced adevice-related major complication. However, one pt(1.3%) developed a retroperitoneal bleed requiring 831

PURPOSE: To review the use of the Perclose suture me­diated arterial closure devices.

MATERIALS AND MEmODs.· We performed prospectiveCDUS evaluation of 126 left arm arteries in twO study

transfusion which was thought 1O be due to an inadver­tem posterior anerial wall puncture during inilial shearnplacement.

The Perclose Arterial Oosure Device(s): InitialExperience.J. Ho, The University of Washington, Seattle, WA, USA •

R. Blocb • E. Hoffer. J. Borsa· A. Fontaine·IV Cohen

Abstract No. 804:32 pm

RESULTS: During the past twenty-four monrhs, we haveperformed thirty-nine (9) ulLrasound guided pseudoa­neulysm thrombin injection procedures. All of these pa­tients had recently undergone cardiac catheterizationprocedures, between three and thirty-two days earlier.Thirty-three (33) of these patients had complete and

Femoral Pseudoaneurysms: Rapid ObliterationUt.ilizing Ultrasound Guided Thrombin Injection.AM. Borowski, Prollidence Heallh Center, WClCO, TX,

USA • C. W. Hammond· IE. Olmsted· DL Parks •G.G. Vi/lQlTeal • H.N. Klaskin

RESULTS, We found LT LilA lD of <3.5mm in 13/12600.3%), average 4.09mm (range 2.9·5.4) without sign if­icam difference between two groups. In 41 volunteersaverage RJ was 0,84 (range 0.7·0.89). We found abnor­mal RJ in 8/85 (9.4%) patients, 3/8 had proXimal andS/8 distal occlusive disease of the upper extremity.There was no correlation between 10 and Rl in all set­tings. 9/85 00.6%) patients showed LilA lD of <3.5mm.In 17/85 (2lJOA,) patients with abnormal RJ or LBA ID of<3.5mm we performed diagnostic angiography using4Fr catheter. 38/68 patients (55.9%) with normal CDUSand PAOD of ileofemoral segments underwent success­ful endovascular treatment using a long 7Fr sheath withno significam access site complications.

PURPOSE· To evaluate the risks, benefits, and effective­ness of utilizing ultrasound gUided percutaneous throm­bin injection for ablation of post-eatheterization femoralpseudoaneurysms.

MATERIAlS AND ME17-l0DS: As practicing intervention­alists, we are very familiar with posr-catheterizationfemoral pseudoaneurysms. their eitiology, and treat­ment. Cunenr treatment usually consists of conservalivemanagemenr and possibly manual compression with ul­trasound guidance. This technique is very labor inten­sive, usually is associated with significant patienl mor­bidity, and can have variable success rates. We haverecently replaced this therapy wilh the use of ulua­sound guided, bovine thrombin injections for ablalionof femoral pseudoaneurysms. This technique is muchmore rapid, has much less patient morbidity, and hasdemonstrated very high initial success rates.

CONCLUSION CDUS evalua.tion in LDA access is ad­vised before diagnostic or therapeutiC endovasculartreatmem of ileofemoral segments. 7Fr sheath can be

safely used for LDA access when the brachial ID is>3.5mm. Flow abnormalities can be revealed using Rl.

groups: 41 healthy volllnteers (mean age 32) and 85 pa­tiems (mean age 6S) with peripheral arterial occlusivedisease (PAOD) of lower extremities. We evaluatedInner Diameter (ID) and Resistive Index (RO of leftLEA. We assessed RJ of radial and ulnar arteries beforeand following ahernate manuaJ occlusion. Our criteriafor the safe access were LDA TD >3.5mm and normal Ri.

Abstrdct No. 79

Abstract No. 78

4:21 pm

4dOpm

RESULTS: To date we have documented 21 complica­tions (6% complication rate). Our complication rate hasdecreased with operalOr experience. Complications in­cluded one infection requiring surgely, one femoralthrombosis, 8 device failures (faiJure to deploy correcdyor surure breakage), and 11 groin hematomas.

MATERlAlS AND METHODS.. The Perclose devices (6F

Closer, 8F and IOF Prostar, Perclose, Redwood City, CAlare suture based arterial closure devices. They providenovel opportunities for arterial access closure, espe­cially in coagulopachic and anticoagulated patients. Weplaced 34S devices in our first year of use (335 femoral,S brachial, 2 venous with 320 6F closer devices and 2SProstar devices). The patient population encompassedall patiems referred for any arterial angiography case,excluding those with preexisting infection or prior arte­

rial access in the site.

CONCLUSION This single center experience with a newvascular sealing device demonstrates its ability lO

achieve rapid hemostasis and early ambulation follow­ing diagnostic and interventional procedures with ahigh level of procedural success and a low incidence of

complications.

CONCLUSIONS: The perclose device provides a low riskmethod for closing femoral arterial access and may beused for brachial and possibly venous closure in the fu­rure. The proper use of this device and tips that mayhelp in avoiding compJications wiJI be presented.

Color-Duplex Ultrasound Assessment of Left ArmArteries for Safe Low Brachial Artery Access inEndovascular Procedures.G. Bartal, HYMC, Hadera, Israel· A. Breitgand •

A. Belenky

PURPOSE Diagnostic Angiography can be followed byan endovascular intervention during the same session,

using large sized vascular shearn. Our aim was to eval­uate anatomical and physiological Color-Duplex Ultra·sound (CDUS) parameters of left arm arteries as a stan­

dard for safe Low Brachial Artery (LBA) access.

832

Lower Extremity Arterial Thrombolysis UtilizingTwo Different Reteplase Dose Regimens.F Castaneda, OSF Saint Francis Medical Center,

Peoria, IL, USA • J.I. Swischuk • B. Smouse •T.M. Brady. K. Young· J.D. Vrabel

ber 1, 2000; with data analysis performed and com­pleted 30 days thereafter.

CONCLUSION: It is anticipated that the results of thismulticenter analysis will provide the best possible esti­mate of the comparative efficacy and true incidence ofcomplications in patie.nts treated with each of thethrombolyic agents.

total thrombosis of their pseudoaneurysm with the ini­tial procedure. Five patients had to undergo a secondembolization for complete thrombosis of their lesion,and one patient had to have a surgical repair of their le­sion. The only morbidity associated with these proce­dures was some minimal patient discomfort during nee­dle placement.

CONCLUSION: Ultrasound guided percutaneous throm­bin injection for embolization of femoral pseudoa­neurysms seems to be a very efficient, painless, and ef­fective means of therapy for this disease. Furtherevaluation is needed to better judge the potential safetyand efficacy of this procedure, but our initial impres­sions are certainly very favorable.

3:26 pm Abstract No. 82

Scientific Session 11Thrombolysis/Mechanical ThrombectomyModerator: Kenneth Wright, MD

Retrospective Evaluation of ThrombolyticReperfusion of Occlusions: The "RETRO" Study.K. Ouriel, The Cleveland Clinic Foundation, Cleveland,

OH, USA

RESULTS: A total of approximately 1000 patients willbe evaluated. Given the timeframe of the treatmentwindow, it is anticipated that similar numbers of uroki­

nase and alteplase patients and a somewhat smallernumber of reteplase patients will be available foranalysis. Data entry should be completed by Decem- 833

Abstract No. 83

RESULTS: Thrombolytic success was achieved in 92% ofthe 0.5u/hr and in 86% of the 0.25u/hr dose. The majorcomplication rate was less than half with the lower closeinfusions. The 30-day amputation free survival rate was87.5% with the higher and 100% with the lower doses.Fibrinogen levels pre-and post procedures as well aslowest during infusion were not statistically significant.No differences in total infusion times were found.

PURPOSE: To prospectively determine the technicalsuccess and complication rates of two differentReteplase regimens during catheter clirected arterialthrombolysis.

MATERIALS AND METHODS: After IRB approval,prospective data collection was obtained from 2 groupsof 25 patients that underwent lower extremity arterialthrombolysis with two different regimens of Reteplase.The doses utilized consisted of .5u/hr and 0.25u/hr. Asub therapeutic heparin dose of 500u/hr was used in allpatients. Single ancl coaxial infusion techniques wereused. All limbs were viable at presentation. Throm­bolytic success was defined as 95% thrombolysis of theoccluded artery or graft with return of antegrade flow.Thirty-day mortality and amputation rates were calcu­lated. Complications, bleeding, need of transfusions aswell as laboratory values of fibrinogen, platelets, hema­tocrit, hemoglobin, and P1T were recorded.

3:37 pm

CONCLUSION: Both closing regimens are effective inthe treatment of acute lower extremity occlusions. Nosignificant differences were found between either infu­sion regimens. However, significantly fewer major com­plications were encountered when using the lowerdose regimen.

PURPOSE: The switch from urokinase to alteplase andreteplase for peripheral thrombolysis occurred in the

Comparison of Urokinase, Alteplase and Reteplasein an In Vitro of Peripheral Arterial Thrombolysis.M. Tecuta, The Cleveland Clinic Foundation,Cleveland, OH, USA • T. Burton • R.K. Greenberg •K. Ouriel

Abstract No. 813:15 pm

Monday, March 5, 20013:15 pm-4:45 pm

PURPOSE: The unavailability of urokinase as a throm­bolytic agent for the treatment of peripheral arterial oc­clusions forced clinicians to turn to alternative agents.Streptokinase, alteplase and reteplase were availableas substitutes, yet contemporary data existed only foralteplase. Most importantly, clinicians were unsure ofthe safety of these alternate agents in comparison tothat of urokinase, specifically with respect to intracra­nial hemorrhage.

MATERiALS AND METHODS: A mulitcenter retrospectivestudy was organized to obtain an estimate of the safetyand efficacy of the various thrombolytic agents. Ap­proximately 40 centers throughout the United Stateswere chosen on the basis of a high volume of throm­bolytic cases. Institutional review board approval wasrequired at the institutions. Consecutive patients treatedwith a thrombolytic agent between January 1, 1999 andJune 30, 2000 is being entered into a internet accessibledatabase. Collected data will include demographic pa­rameters, the thrombolytic agent and dose, the durationof infusion, use of anticoagulants and antiplateJetagents, amount of thrombus dissolved and the occur­rence of bleeding or odler major complications.