Use of Loop-Suture Technique to Close a Percutaneous Access Site after Hemodialysis Graft Intervention. B. Smouse, OSP Saint Francis Medical Center, Peot"ia, II. USA • F Castaneda. j. Swischuk • T. Brady. J.D. Vrabel Scientific Session 10 Puncture Site Evaluation/ManagemenllClosure Moderator: Kevin Dickey, MD Monday, March 5, 2001 3:15 pm-4:45 pm 3:26 pm Abstract No. 74 A Comparison of Fibrin Glue and Thrombin as Agents to Fadlitate Puncture Closure Following Dialysis Graft Intervention. }. 51. George, Upslale Medical University, Syracuse, NY, USA • K.D. Murphy· OJ. Kwon CONCLUSIONS: The fibrin glue produced immediate homeostasis of 7-9Fr dialysis graft punctures despite an- ticoagulation (ACT 200-400). Thrombin soaked gelfoam was also very effective; however this required tional manual compression and the thrombinlgelfoam seal was occasionally subject to dislodgment. RF...5ULTS: The average. lime to homeostasis with topical thrombin soaked gelfoam was < lOminj however, the gelfoamllhrombin seal occasionally dislodged with arm movement or an elevated syswlic BP. Fibrin glue has an epoxy-like consistency and immediately "plugs" the tract Homeostasis was < lminute. There was no acute or delayed bleeding after applicaton of the flbrin glue. The consistency of the fibrin glue and the gOl1ex graft ply construction prevents inadvertent intraluminal administration PURPOSE: Percutaneous interventions of gonex dialysis grafts often require utilization of 6-7Fr vascular intro- ducers to accommodate a thrombectomy device or bal- loon. These sheaths produce 7.S-9Fr diameter punc- tures. Anticoagulation, platelet dysfunction, elevated blood pressure, and a large puncture can result in markedly prolonged compression times. This study evaluated the cfricacy .of both bovine thrombin and rin glue (Tissel)to facilitate puncture closure of gonex dialysis grafts MATERIALS AND METHODS.. 31 consecut;ve hemodiaiy- sis grafts with 62 loop-sutures were prospectively evalu- ated for immediate hemostasis, complication and ease of removal. There were 24 thrombolyses, 31 angioplas- ties, and S stent placements. S patients 06%) were on Coumadin, 22 patients (71%) received intravenous he- parin (mean of 2977 units), and 24 patients (77%) re- ceived Retavase (mean of 1.3 units per graft). The sheath sizes ranged from SF to 7F (mean of 6.2F). 3:37 pm Abstract No. 75 Tbe WoggJe Technique: A New Method of Suture of Hemodialysis Arteriovenous Grafts and Fistulae, 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 60 loop-sutures (97%). Two closures reqUired manual compression 00 and 16 minutes). One broken sU[ure occurred. No puncrure site bled after suture removal. 61 loop-smures (98%) were reponed as "easy" to remove. CONCLUSION: The loop-suture is very effective for im- mediate hemostasis and is easy to remove at a later date by the dialysis staff. PURPOSE To evaluate a new method of suture closure to achieve hemostasis after percutaneous inlerventions on hemodialysis access grafts and fisrulae. j\.1ATERWS AND ME1HODS: rn,e woggle technique is a modification of the purse string suture used to close a puncture site after percutaneous interventions. The woggle is a plastiC gUide wire introducer, or similar de- vice, which is placed over the ends of the purse string suture and cinched down with a hemostatLO tighcen the suture without making a knot. It is applied just before removing the sheath or catheter at che end of a proce- PURPOSE Evaluate the safery, efficacy and ease of re- moval of the loop-surure. Obtaining hemostasis after graft inrerventions is time consuming. Altbough a purse- string suture allows immediate hemostasis, its removal is difficult since it becomes imbedded in the skin. Mak- ing 4 in-and-out passes into the skin around the sheath forms a purse-string suture. Threading one end of su- ture through 2cms of plastiC wbing and forming a knot with the other end of suture creates the loop-suture. The knot is pulled tight onto the skin. This bends the tubing inw a loop exposing 2cms of suture for later snipping. The dialysis staff cuts the loop of tubing thereby releaSing the purse-string sUl1lre. Abstract No. 73 3:15 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 di- recled by the manufacturer. GOl1ex dialysis grafts sub- ject to either rhrombectomy/angioplasty or angioplasty alone were accessed with 6-7Fr introducers. Heparin was administered to achieve an ACT>200. Homeostasis of 20 graft punctures was evaluated with a 2x6cm gelfoam 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 pressure was applied and the puncrurc sites evaluated for home- ostasis in five-minute intclVals. The Tissel site was also evaluated after one and three minwes. S30
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.
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.
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
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
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
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 •
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.
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.
Retrospective Evaluation of ThrombolyticReperfusion of Occlusions: The "RETRO" Study.K. Ouriel, The Cleveland Clinic Foundation, Cleveland,
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.
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.