Closure

Scientific Session 10 Puncture Site Evaluation/ManagemenllClosure

Abstract No. 74

Moderator: Kevin Dickey, MD

Use of Loop-Suture Technique to Close a Percutaneous Access Site after Hemodialysis Graft Intervention.

Monday, March 5, 2001 3:15 pm-4:45 pm

B. Smouse, OSP Saint Francis Medical Center, Peot"ia, II. USA • F Castaneda. j. Swischuk • T. Brady.

3:15 pm

J.D. Vrabel

Abstract No. 73

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

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, elevated blood pressure, and a large puncture can result in

markedly prolonged compression times. This study evaluated the cfricacy .of both bovine thrombin and fib~ rin glue (Tissel)to facilitate puncture closure of gonex dialysis grafts

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 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 homeostasis in five-minute intclVals. The Tissel site was also evaluated after one and three minwes.

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

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was also very effective; however this required addi~ tional manual compression and the thrombinlgelfoam seal was occasionally subject to dislodgment.

PURPOSE Evaluate the safery, efficacy and ease of removal of the loop-surure. Obtaining hemostasis after graft inrerventions is time consuming. Altbough a pursestring suture allows immediate hemostasis, its removal is difficult since it becomes imbedded in the skin. Making 4 in-and-out passes into the skin around the sheath forms a purse-string suture. Threading one end of suture 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.

MATERIALS AND METHODS.. 31 consecut;ve hemodiaiysis 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 on Coumadin, 22 patients (71%) received intravenous heparin (mean of 2977 units), and 24 patients (77%) received Retavase (mean of 1.3 units per graft). The sheath sizes ranged from SF to 7F (mean of 6.2F). 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 immediate hemostasis and is easy to remove at a later date by the dialysis staff.

3:37 pm

Abstract No. 75

Tbe WoggJe Technique: A New Method of Suture Clo~'Ure of Hemodialysis Arteriovenous Grafts and Fistulae, after Percutaneous Interventions. M.E. Simons, Toronto Western Hospital, Toronlo, ON, Canada. T

w: Clark. D.K. Rajan

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 device, 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-

dure. The suture and woggle are left for 20-60 minutes, and then the woggle is released. If hemostasis is achieved, the suture is removed, and if hemostasis is not 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 for a mean of 4 months (2 weeks to 17 months.) RESULTS: The woggle alone was successful in achieving

hemostasis in 140/161 placements (87%). In 8 /161 instances (5%), the suture was broken during application of the stitch, and manual compression was used to achieve hemostasis. In 11 cases (7%), the patient bled through the stitch, and manual pressure was used to aid hemostasis. In 2 applications (1%), hemostasis was not obtained prior to patient discharge, and the purse string suture was tied and the patient discharged. A dialysis nurse removed the suture in 2-4 days time. There were no false aneurysms, hematomata or access thromboses that 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 and removes the need to remove the purse string suture at a later date.

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Abstract No. 76

Autologous Human Thrombin Injection: A New Embolization Treatment for Procedure-Related Arterial 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 for

percutaneous therapy of post-angiographic femoral pseudoaneurysms. 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 into the aneUlysmal sac. 8 pseudoaneurysms were arising from the femoral artery bifurcation or the common femoral artery (CFA), 3 from the superficial femoral artery (SFA).

The thrombin was isolated using 30-50ml autologous patient blood under sterile conditions. All injections were made under ultrasound guidance. Increased luminal echogenicity and absence of flow indicated the end of each thrombin injection. Ultrasound follow-up was performed on the next day, after 6 weeks and 3 months to detect incomplete thrombosis and size of the aneurysm sac. RESULTS: The handling of autologous thrombin was straightfolward in all patients. No technical or clinical complications occurred. 10 pseudoaneurysms were suc-

cessfully thrombosed. Four of these required repeat thrombin injections. One pseudoaneurysm displayed minimal residual perfusion and occluded cqmpletely after 2 weeks. Follow up (mean 2.7 months) did not reveal any reperfusion of thrombosed aneurysms in any patient. In 1 patient no aneurysm was demonstrated after 3 months. 1 aneurysm decreased in size by 50% after 6 months. CONCLUSION: Injection of autologous thrombin ap-

pears safe and effective for embolization of procedurerelated pseudoaneurysms. It does not carry the risk of potential contamination with bovine infectious agents or allergic reactions. Our early results suggest that human autologous thrombin can substitute bovine thrombin for this therapy. Further work is required to evaluate the long-term results and other potential applications.

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Abstract No. 77

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 PURPOSE: Conventional management of arterial access sites is associated with pt discomfort and may result in prolonged bed rest and local complications. As part of the Continued Access Registry (CAR) we evaluated the safety and efficacy of a new vascular closure device, Duett, which is comprised of a low-profile (3F) balloon delivery catheter and a flowable procoagulant consisting of thrombin and collagen in a buffered suspension. MATERIALS AND METHODS: Immediately following a

percutaneous diagnostic or interventional endovascular procedure 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 to ambulation (TTA), defined as the time when the pt was able 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). RESULTS: The Duet[ was successfully deployed in all 77

pts (diagnostic 62/77, interventional 15/77). Sheath sizes included 5F-2, 6F-61. 7F-9, 8F-4, 9F-1. The predeployment ACT (interventional pts) was 253+/-64.5 secs and 6 pts (7.8%) received GP2b/3a blockers (diagnostic 1.6%, interventional 33.3%). The median TTH was 6.0 (interquartile range 4, 8) mins and the median TTA was 189.5 (interquartile range 146, 301) mins (diagnostic 171.0, interventional 421 mins). No pt experienced a device-related major complication. However, one pt (1.3%) developed a retroperitoneal bleed requiring

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transfusion which was thought 1O be due to an inadvertem posterior anerial wall puncture during inilial shearn placement. CONCLUSION This single center experience with a new vascular sealing device demonstrates its ability lO achieve rapid hemostasis and early ambulation following diagnostic and interventional procedures with a high level of procedural success and a low incidence of complications.

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Abstract No. 78

The Perclose Arterial Oosure Device(s): Initial Experience. J. Ho, The University of Washington, Seattle, WA, USA • R. Blocb • E. Hoffer. J. Borsa· A. Fontaine· IV Cohen PURPOSE: To review the use of the Perclose suture mediated arterial closure devices.

MATERlAlS AND METHODS.. The Perclose devices (6F Closer, 8F and IOF Prostar, Perclose, Redwood City, CAl are suture based arterial closure devices. They provide novel opportunities for arterial access closure, especially in coagulopachic and anticoagulated patients. We placed 34S devices in our first year of use (335 femoral, S brachial, 2 venous with 320 6F closer devices and 2S Prostar devices). The patient population encompassed all patiems referred for any arterial angiography case, excluding those with preexisting infection or prior arterial access in the site. RESULTS: To date we have documented 21 complications (6% complication rate). Our complication rate has decreased with operalOr experience. Complications included one infection requiring surgely, one femoral thrombosis, 8 device failures (faiJure to deploy correcdy or surure breakage), and 11 groin hematomas. CONCLUSIONS: The perclose device provides a low risk method for closing femoral arterial access and may be used for brachial and possibly venous closure in the furure. The proper use of this device and tips that may help in avoiding compJications wiJI be presented.

4:21 pm

Abstrdct No. 79

Color-Duplex Ultrasound Assessment of Left Arm Arteries for Safe Low Brachial Artery Access in Endovascular Procedures. G. Bartal, HYMC, Hadera, Israel· A. Breitgand • A. Belenky PURPOSE Diagnostic Angiography can be followed by an endovascular intervention during the same session, using large sized vascular shearn. Our aim was to evaluate anatomical and physiological Color-Duplex Ultra· sound (CD US) parameters of left arm arteries as a standard for safe Low Brachial Artery (LBA) access.

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

groups: 41 healthy volllnteers (mean age 32) and 85 patiems (mean age 6S) with peripheral arterial occlusive disease (PAOD) of lower extremities. We evaluated Inner Diameter (ID) and Resistive Index (RO of left LEA. We assessed RJ of radial and ulnar arteries before and following ahernate manuaJ occlusion. Our criteria for the safe access were LDA TD >3.5mm and normal Ri. RESULTS, We found LT LilA lD of <3.5mm in 13/126 00.3%), average 4.09mm (range 2.9·5.4) without sign ificam difference between two groups. In 41 volunteers average RJ was 0,84 (range 0.7·0.89). We found abnormal RJ in 8/85 (9.4%) patients, 3/8 had proXimal and S/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 using 4Fr catheter. 38/68 patients (55.9%) with normal CDUS and PAOD of ileofemoral segments underwent successful endovascular treatment using a long 7Fr sheath with no significam access site complications. CONCLUSION CDUS evalua.tion in LDA access is advised before diagnostic or therapeutiC endovascular treatmem 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.

4:32 pm

Abstract No. 80

Femoral Pseudoaneurysms: Rapid Obliteration Ut.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 PURPOSE· To evaluate the risks, benefits, and effectiveness of utilizing ultrasound gUided percutaneous thrombin injection for ablation of post-eatheterization femoral pseudoaneurysms.

MATERIAlS AND ME17-l0DS: As practicing interventionalists, we are very familiar with posr-catheterization femoral pseudoaneurysms. their eitiology, and treatment. Cunenr treatment usually consists of conservalive managemenr 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 have recently replaced this therapy wilh the use of uluasound guided, bovine thrombin injections for ablalion of femoral pseudoaneurysms. This technique is much more rapid, has much less patient morbidity, and has demonstrated very high initial success rates.

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

total thrombosis of their pseudoaneurysm with the initial procedure. Five patients had to undergo a second embolization 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. Further evaluation is needed to better judge the potential safety and efficacy of this procedure, but our initial impressions are certainly very favorable.

Scientific Session 11 Thrombolysis/Mechanical Thrombectomy Moderator: Kenneth Wright, MD

Monday, March 5, 2001 3:15 pm-4:45 pm 3:15 pm

Abstract No. 81

Retrospective Evaluation of Thrombolytic Reperfusion of Occlusions: The "RETRO" Study. K. Ouriel, The Cleveland Clinic Foundation, Cleveland, OH, USA 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 available as substitutes, yet contemporary data existed only for alteplase. Most importantly, clinicians were unsure of the safety of these alternate agents in comparison to that of urokinase, specifically with respect to intracranial hemorrhage. MATERiALS AND METHODS: A mulitcenter retrospective study was organized to obtain an estimate of the safety and efficacy of the various thrombolytic agents. Approximately 40 centers throughout the United States were chosen on the basis of a high volume of thrombolytic cases. Institutional review board approval was required at the institutions. Consecutive patients treated with a thrombolytic agent between January 1, 1999 and June 30, 2000 is being entered into a internet accessible database. Collected data will include demographic parameters, the thrombolytic agent and dose, the duration of infusion, use of anticoagulants and antiplateJet agents, amount of thrombus dissolved and the occurrence of bleeding or odler major complications. RESULTS: A total of approximately 1000 patients will be evaluated. Given the timeframe of the treatment window, it is anticipated that similar numbers of urokinase and alteplase patients and a somewhat smaller number of reteplase patients will be available for analysis. Data entry should be completed by Decem-

ber 1, 2000; with data analysis performed and completed 30 days thereafter. CONCLUSION: It is anticipated that the results of this multicenter analysis will provide the best possible estimate of the comparative efficacy and true incidence of complications in patie.nts treated with each of the thrombolyic agents.

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Abstract No. 82

Lower Extremity Arterial Thrombolysis Utilizing Two 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 PURPOSE: To prospectively determine the technical success and complication rates of two different Reteplase regimens during catheter clirected arterial thrombolysis. MATERIALS AND METHODS: After IRB approval, prospective data collection was obtained from 2 groups of 25 patients that underwent lower extremity arterial thrombolysis with two different regimens of Reteplase. The doses utilized consisted of .5u/hr and 0.25u/hr. A sub therapeutic heparin dose of 500u/hr was used in all patients. Single ancl coaxial infusion techniques were used. All limbs were viable at presentation. Thrombolytic success was defined as 95% thrombolysis of the occluded artery or graft with return of antegrade flow. Thirty-day mortality and amputation rates were calculated. Complications, bleeding, need of transfusions as well as laboratory values of fibrinogen, platelets, hematocrit, hemoglobin, and P1T were recorded. RESULTS: Thrombolytic success was achieved in 92% of the 0.5u/hr and in 86% of the 0.25u/hr dose. The major complication rate was less than half with the lower close infusions. The 30-day amputation free survival rate was 87.5% with the higher and 100% with the lower doses. Fibrinogen levels pre-and post procedures as well as lowest during infusion were not statistically significant. No differences in total infusion times were found. CONCLUSION: Both closing regimens are effective in the treatment of acute lower extremity occlusions. No significant differences were found between either infusion regimens. However, significantly fewer major complications were encountered when using the lower dose regimen.

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Abstract No. 83

Comparison of Urokinase, Alteplase and Reteplase in an In Vitro of Peripheral Arterial Thrombolysis. M. Tecuta, The Cleveland Clinic Foundation, Cleveland, OH, USA • T. Burton • R.K. Greenberg • K. Ouriel PURPOSE: The switch from urokinase to alteplase and reteplase for peripheral thrombolysis occurred in the

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