Cardiovasc Intervent Radiol (2014) 37:1352–1357 DOI 10.1007/s00270-014-0853-x
TECHNICAL NOTE
Feasibility of Vascular Access Closure in Arteries Other Than the Common Femoral Artery Using the ExoSeal Vascular Closure Device Claus Christian Pieper • Kai E. Wilhelm Hans Heinz Schild • Carsten Meyer
•
Received: 20 November 2013 / Accepted: 21 January 2014 / Published online: 14 February 2014 Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2014
Abstract Purpose To describe the feasibility of vascular access closure in arteries other than the common femoral artery (CFA) using the ExoSeal vascular closure device (VCD). Materials and Methods Between December 2011 and August 2013, 8 patients (4 males, 4 females, mean age 64 years [range 42–81]) underwent 13 extrafemoral access site closure using the ExoSeal VCD (brachial artery n = 7, venous femoropopliteal bypass n = 3, femoropopliteal segment n = 2, proximal superficial femoral artery n = 1). Patient history, procedural characteristics, and complications were recorded. Results Technical success was achieved in 12 of 13 VCD procedures. In 1 case of brachial puncture, safe plugdeployment was not possible, so manual compression was applied. In this case, angiographic and clinical control showed residual bleeding 5 min after the procedure. After additional manual compression for 5 min, the haemorrhage stopped, but a hematoma \3 cm was detectable (procedural success rate 12 of 13 closures). Overall no major complications were observed. Heparin, 5,000 IU, was administered in all cases. Six ExoSeal closures were performed under additional acetylsalicylic acid (ASS) and clopidogrel, three under additional ASS, and the remaining C. C. Pieper K. E. Wilhelm H. H. Schild C. Meyer (&) Department of Radiology, University of Bonn, Sigmund-FreudStr. 25, 53129 Bonn, Germany e-mail: [email protected] C. C. Pieper e-mail: [email protected] K. E. Wilhelm e-mail: [email protected] H. H. Schild e-mail: [email protected]
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four under heparin only. International normalized ratio and thrombocytes were within normal values in all patients. Conclusion Successful vascular access closure using the ExoSeal VCD in puncture sites other than the CFA is feasible with a low complication rate. These applications, however, remain an ‘‘off-label’’ use in selected patients. Keywords practice
Arterial intervention Artery Clinical
Introduction The most common arterial access site in interventional radiological procedures is the common femoral artery (CFA) [1]. In cases where femoral artery puncture is not feasible, other sites such as the radial, brachial, axillary, or popliteal artery, can serve as alternatives [1–3]. To achieve hemostasis after the intervention, manual compression (MC) has been the ‘‘gold standard’’ for many years, but it is time-consuming and often uncomfortable for the patient [4]. Several vascular closure devices (VCDs) have been introduced as an alternative to MC. The safety and efficacy of VCDs in general have been shown previously [5–8]. However, all VCDs currently available have only been approved for femoral access closure. Although there have been smaller studies investigating ‘‘off-label’’ VCD use in other access sites, the number of patients investigated is limited. The ExoSeal (Cordis, Miami Lakes, FL) is a completely extravascular, plug-based VCD approved for femoral access closure [9]. The aim of this article is to report our initial experiences with off-label ‘‘extrafemoral’’ vascular closure using the ExoSeal VCD in a selected patient collective.
C. C. Pieper et al.: Extrafemoral ExoSeal Closure
Materials and Methods Patient Characteristics Between December 2011 and August 2013, 8 patients (4 males, 4 females, mean age 64 years [range 42–81]) underwent 12 interventional procedures by way of 13 ‘‘extrafemoral’’ access sites with subsequent ExoSeal-closure. Interventions were performed by way of the brachial artery (n = 7), venous femoropopliteal bypass (n = 3), femoropopliteal segment (n = 2), and proximal superficial femoral artery (SFA) (n = 1). All interventions took place in daily routine practice, and informed consent, especially regarding the off-label use of an ExoSeal VCD, was obtained from each patient before intervention. Indications for the interventions and for an ‘‘extrafemoral’’ access site are listed in Table 1. Procedure and Analysis After completion of the intervention, vascular closure was performed with the ExoSeal VCD according to the manufacturer’s instructions for femoral applications. A dual visually guided deployment system (bleed-back indicator and intravascular nitinol-loop) is intended to enhance safe plug application [9]. MC was applied thereafter for 2 min. If hemostasis was successfully achieved, no compressive bandage was used. Otherwise MC was performed until hemorrhage had completely stopped followed by a compressive bandage for 6 h. All patients were admitted overnight, and the puncture site was examined hourly for 6 h after the intervention until the next morning. If a second access was available, control angiography of the ‘‘extrafemoral’’ puncture site was performed after closure. Technical success was defined as successful plug deployment without any VCD-related major complications and procedural success as ExoSeal-closure with MC of \5 min’ duration without major complications. Major adverse events were defined according to the ECLIPSE trial [10], especially including bleeding requiring surgical vascular repair, blood transfusion, or ischemia due to plug embolization. Recurrent bleeding requiring hemostatic intervention, hematoma B6 cm, or pseudoaneurysm formation were defined as minor complications. Patient history (especially medication use and laboratory findings concerning hemostasis), procedural characteristics, and complications were recorded.
Results In 12 interventions, a total of 13 ExoSeal closures (5F n = 12; 6F n = 1) were attempted. Control angiography was available by way of a second access site in 5 interventions.
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Technical success was achieved in 12 of 13 closures. Angiographic and clinical control showed residual bleeding in only 1 case of nonsuccessful plug-deployment, thus leading to a procedural success rate of 12 of 13 closures. Patient characteristics and results are listed in Table 1. In case no. 6, safe extravascular plug deployment was not possible because there was no consensus between the two visual indicators. The ExoSeal was therefore pulled out of the brachial artery and MC applied. After 5 min, control angiography by way of a remaining femoral access showed spasm of the brachial artery and residual haemorrhage. After further MC for 5 min, extravasation was no longer detectable, and the spasm had alleviated. A compressive bandage was applied for 6 h. Patient no. 1 received three extrafemoral ExoSeal closures in two interventions for acute on chronic critical limb ischemia grade II (known peripheral artery disease [PAD] IV) of the right leg. Due to open treatment of an abdominal wound extending to both groins in this critically ill patient, access by way of the left CFA was precluded altogether. On the right side only a retrograde puncture of the CFA was possible to obtain an overview angiography, which showed high-grade stenosis of the proximal SFA and multiple infragenicular stenoses (Fig. 1A, B). Because treatment by way of an antegrade access to the CFA was precluded, it was decided in the first step to dilatate the SFA stenosis by way of a retrograde femoropopliteal access. After successful dilatation, this puncture site was closed using an ExoSeal under additional fluoroscopic guidance (Fig. 1C). Control angiography showed successful hemostasis after 2 min of MC (Fig. 1D). Subsequently the infragenicular stenoses were treated by way of an antegrade SFA access that was also closed with an ExoSeal with complete hemostasis after 2 min (Fig. 1E). Recurring stenosis of the proximal SFA made a second intervention by way of a femoropopliteal access necessary after 3 months. In patient no. 2, ExoSeal application after three direct punctures (in three separate interventions; the first 2 weeks after bypass surgery) of a venous femoropopliteal bypass lead to immediate closure of the access site after only minimal MC in all three applications (Fig. 2A, B). No major complications and only one minor complication were observed. There were no intravascular plug applications. In patient no. 6, in whom ExoSeal closure was technically unsuccessful, a local hematoma B3 cm was noted on follow-up after MC without any need for further hemostatic interventions. No patient complained about any discomfort or pain after successful plug application. All interventions took place under full heparinization, which was continued for 24 h after intervention (activated partial prothrombin time 60–80 s). Six ExoSeal closures were performed during dual-antiplatelet therapy with acetylsalicylic acid (ASS) and clopidogrel, three under ASS, and four closures under heparin only. International normalized ratio (INR) was within normal parameters in all
123
123
M/62
F/68
F/67
M/71
6
7
8
R
L
L
L
L
L
PAD peripheral arterial disease
M/81
5
B
A
4
L
L
C
M/67
L
B
L
R
A
F/42
R
C
3
2
F/61
Side
R
A
1
Sex/ age (years)
B
ExoSeal closure
Patient no.
Table 1 Patient characteristics
Brachial
Brachial
Brachial
Brachial
Brachial
Brachial
Brachial
Venous bypass
Venous bypass
Venous bypass
Femoropopliteal
Proximal SFA
Femoropopliteal
Arteriel access
5F
5F
5F
5F
5F
5F
5F
5F
5F
6F
5F
5F
5F
Sheath size
Unsuccessful catheter positioning by way of CFA
Unsuccessful catheter positioning by way of CFA
Unsuccessful catheter positioning by way of CFA
Fresh surgical sutures in both groins after EVAR
Bilateral CFA occlusion
Skin infection with ulceration in both groins
Difficult access by way of antegrade femoral puncture
Open abdominal wound reaching to both groins
Indication for ‘‘extrafemoral’’ access site
Renal artery stenting in abdominal aortic dissection
MAA-test injection
Subclavian steal
Bronchial pseudoaneurysm
Mesenterial ischemia
Mesenterial ischemia
PAD IV
PAD IV
PAD IV
PAD IV
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
PAD IV PAD IV
Hypertension
Indication for intervention
1.0
1.0
1.0
1.1
1.2
1.0
1.1
1.0
1.0
1.0
1.0
1.1
INR
78
303
262
249
421
397
499
226
234
331
247
404
Thrombocytes (G/l)
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Heparin
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
ASS
No
No
No
Yes
Yes
Yes
No
No
No
No
Yes
Yes
Clopidogrel
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Technical success
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Procedural success
No
No
Hematoma \3 cm
No
No
No
No
No
No
No
No
No
No
Complications
1354 C. C. Pieper et al.: Extrafemoral ExoSeal Closure
C. C. Pieper et al.: Extrafemoral ExoSeal Closure
Fig. 1 Patient no. 1. A, B Preinterventional images showing stenoses of the proximal SFA and infragenicular arteries. C Fluoroscopic control of ExoSeal deployment in the femoropopliteal segment and D control angiography after ExoSeal deployment without contrast
Fig. 2 Venous femoropopliteal bypass A before and B after ExoSeal closure
patients (mean 1.05 [range 1–1.2]). Thrombocytes were increased in one patient. There was no case of thrombocytopenia (mean 312 G/l [range 78–499]).
Discussion Vascular access site management in general has long been restricted to MC followed by immobilization. This method
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extravasation. E Control angiography after closure of the antegrade puncture site in the proximal SFA showing successful hemostasis after 2 min of MC after dilatation of the infragenicular stenoses
can be associated with discomfort or even pain. VCDs have been developed during the last two decades as an alternative closure procedure to minimize the need for MC while maintaining safe puncture site closure [10, 11]. Several studies have shown the safety and efficacy of different VCDs in general [6–8, 12–14]. By decreasing the time to ambulation, VCDs can improve patient satisfaction and quality of life [11]. The above-mentioned studies mainly investigated closure of retrograde CFA accesses. More recently some reports have also shown feasibility of management of antegrade punctures, thereby expanding possible indications for VCD use [15, 16]. In contrast to many other VCDs, the ExoSeal is a purely extravascular closure device that involves the application of a bioabsorbable polyglycolic acid plug directly over the puncture site [9]. The efficacy and safety of this system has thus far been documented for retrograde as well as antegrade CFA closure [9, 10, 17–19]. Although the CFA is the standard access site for most vascular interventional radiological procedures, this approach can be difficult or even impossible in some cases [1]. Severe stenosis or occlusion of the CFA or iliac artery, obesity, local skin infection, previous groin surgeries, and angulated aortic bifurcation or high femoral artery bifurcation in case of antegrade access are possible reasons for a challenging femoral approach [20, 21]. For patients presenting with these problems, several alternatives have been described. The access site currently receiving the most attention apart from the radial artery is the brachial artery [2, 3] but also the axillary or popliteal artery [1, 22, 23], the SFA [21], or transpedal access seem
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to be viable alternatives with acceptable complication rates. Because no VCD specially designed for ‘‘extrafemoral’’ access sites is currently available, hemostasis is commonly achieved by MC [24]. However, especially in obese patients, MC of the popliteal artery or SFA puncture can be difficult. In recent years there have been reports of off-label VCD use in other access sites than the CFA. Because the brachial artery is of great interest to both radiologists and cardiologists, most studies have focused on this location. Overall of there have been approximately 30 patients in the literature who underwent brachial access site closure using suture-based VCD with successful closure in [90 % and a low complication rate [25–27]. A clip-based VCD showed a technical success rate of 100 % (n = 29) with complications in only two cases (one each of large hematoma and brachial artery occlusion) [28]. Preliminary reports of brachial artery puncture site closure using the AngioSeal VCD (St. Jude Medical, Minnetonka, MN) were encouraging [24, 29], Subsequently a larger study of brachial artery closure (n = 161) showed technical success in 96.9 % of patients with 3.1 % major and 7.5 % minor complications [20]. Vessel diameter should be [4 mm when using the AngioSeal to avoid thrombosis caused by the intravascular anchor [20]. This seems to be less of an issue in ExoSeal-closure due to extravascular plug application. Only recently has the feasibility of vascular access closure of antegrade punctures of the SFA using different VCDs in sheath sizes B10F been shown [30]. In this article we report our initial experiences of using the ExoSeal VCD for access sites other than the CFA, especially the brachial artery (n = 7), which to our knowledge has not been described in literature. Technical and procedural success was achieved in 12 of 13 plug deployments. In these cases, hemostasis was observed within 2 min of mild MC. In 1 case of brachial artery puncture there was no consensus between the two deployment indicators. The ExoSeal was therefore removed without deploying the plug, and MC was applied. Subsequent angiography by way of a remaining (femoral) access showed spasm of the brachial artery, which is a known problem with brachial access [24]. Technical failure might be connected to this intense spasm that decreased vessel diameter and led to inconsistency between the deployment indicators. This was the only case in which a minor hematoma could be detected. Although most of the reported cases in our study received ExoSeal closure of a brachial puncture site (7 of 13), we also included two patients treated by way of other approaches to illustrate the feasibility of ExoSeal-closure in these locations as well. In patient no. 1, a step-wise approach had to be adopted to treat all relevant stenoses. Applying this methodology
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C. C. Pieper et al.: Extrafemoral ExoSeal Closure
helped to shorten the intervention and forgoing the need of a compressive bandage enabled us to treat this critically ill patient in a single intervention. Case no. 2 serves to demonstrate that vascular closure is even feasible in a venous bypass only days after surgery, thus decreasing the need for extended MC, which can be associated with the risk of bypass thrombosis. The results of this retrospective study are certainly limited by the small patient collective available. Longer, preferably prospective studies comparing ‘‘extrafemoral’’ vascular closure with MC are needed to further assess the safety of this procedure. In summary, successful vascular access closure using the ExoSeal VCD in puncture sites other than the CFA is feasible with a low complication rate. These applications, however, remain an off-label use in selected patients, and larger studies on their safety are warranted. Conflict of interest of interest.
The authors declare that they have no conflict
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C. C. Pieper et al.: Extrafemoral ExoSeal Closure 11. Duffin DC, Muhlestein JB, Allisson SB, Horne BD, Fowles RE, Sorensen SG et al (2001) Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol 13(5):354–362 12. Kim HY, Choo SW, Roh HG, Han H, Kim SS, Lee JY et al (2006) Efficacy of femoral vascular closure devices in patients treated with anticoagulant, abciximab or thrombolytics during percutaneous endovascular procedures. Korean J Radiol 7(1): 35–40 13. Resnic FS, Blake GJ, Ohno-Machado L, Selwyn AP, Popma JJ, Rogers C (2001) Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol 88(5):493–496 14. Hieb RA, Neisen MJ, Hohenwalter EJ, Molnar JA, Rilling WS (2008) Safety and effectiveness of repeat arterial closure using the AngioSeal device in patients with hepatic malignancy. J Vasc Interv Radiol 19(12):1704–1708 15. Spiliopoulos S, Katsanos K, Karnabatidis D, Diamantopoulos A, Nikolaos C, Siablis D (2011) Safety and efficacy of the StarClose vascular closure device in more than 1000 consecutive peripheral angioplasty procedures. J Endovasc Ther 18(3):435–443 16. Lupattelli T, Tannouri F, Garaci FG, Papa G, Pangos M, Somalvico F et al (2010) Efficacy and safety of antegrade common femoral artery access closure using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in diabetic patients. J Endovasc Ther 17(3):366–375 17. Boschewitz JM, Andersson M, Naehle CP, Schild HH, Wilhelm K, Meyer C (2013) Retrospective evaluation of safety and effectiveness of the EXOSEAL vascular closure device for single vascular closure and closure after repeat puncture in diagnostic and interventional radiology: single-center experience. J Vasc Interv Radiol 24(5):698–702 18. Schmelter C, Liebl A, Poullos N, Ruppert V, Vorwerk D (2013) Suitability of ExoSeal vascular closure device for antegrade femoral artery puncture site closure. Cardiovasc Intervent Radiol 36(3):659–668 19. Maxien D, Behrends B, Eberhardt KM, Saam T, Thieme SF, Reiser MF et al (2012) Evaluation of the 6-F ExoSeal vascular
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closure device in antegrade femoral artery punctures. J Endovasc Ther 19(6):836–843 Lupattelli T, Clerissi J, Clerici G, Minnella DP, Casini A, Losa S et al (2008) The efficacy and safety of closure of brachial access using the AngioSeal closure device: experience with 161 interventions in diabetic patients with critical limb ischemia. J Vasc Surg 47(4):728–782 Kweon M, Bhamidipaty V, Holden A, Hill AA (2012) Antegrade superficial femoral artery versus common femoral artery punctures for infrainguinal occlusive disease. J Vasc Interv Radiol 23(9):1160–1164 Sangiorgi G, Lauria G, Airoldi F, Godino C, Politi L, Colombo A et al (2012) Retrograde popliteal access as bail-out strategy for challenging occlusions of the superficial femoral artery: a multicenter registry. Catheter Cardiovasc Interv 79(7):1188–1193 Ye M, Zhang H, Huang X, Shi Y, Yao Q, Zhang L et al (2013) Retrograde popliteal approach for challenging occlusions of the femoral-popliteal arteries. J Vasc Surg 58(1):84–89 Belenky A, Aranovich D, Greif F, Bachar G, Bartal G, Atar E (2007) Use of a collagen-based device for closure of low brachial artery punctures. Cardiovasc Intervent Radiol 30(2):273–275 Kulick DL, Rediker DE (1999) Use of the Perclose device in the brachial artery after coronary intervention. Catheter Cardiovasc Interv 46(1):111–112 Gliech V, Du¨bel HP, Rutsch W (2001) Suture closure of the brachial artery access site post-coronary catheterization. J Invasive Cardiol 13(1):12–14 Kim A, Fusman B, Jolly N, Feldman T (2002) Percutaneous suture closure for brachial artery puncture. J Interv Cardiol 15(4):277–280 Puggioni A, Boesmans E, Deloose K, Peeters P, Bosiers M (2008) Use of StarClose for brachial artery closure after percutaneous endovascular interventions. Vascular 16(2):85–90 Bilecen D, Bongartz G, Ostheim-Dzerowycz W (2006) Off-label use of Angio-Seal vascular closure device for brachial artery puncture closure-deployment modification and initial results after transbrachial PTA. Eur J Vasc Endovasc Surg 31(4):431–433 Gutzeit A, van Schie B, Schoch E, Hergan K, Graf N, Binkert CA (2012) Feasibility and safety of vascular closure devices in an antegrade approach to either the common femoral artery or the superficial femoral artery. Cardiovasc Intervent Radiol 35(5): 1036–1040
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TECHNICAL NOTE
Feasibility of Vascular Access Closure in Arteries Other Than the Common Femoral Artery Using the ExoSeal Vascular Closure Device Claus Christian Pieper • Kai E. Wilhelm Hans Heinz Schild • Carsten Meyer
•
Received: 20 November 2013 / Accepted: 21 January 2014 / Published online: 14 February 2014 Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2014
Abstract Purpose To describe the feasibility of vascular access closure in arteries other than the common femoral artery (CFA) using the ExoSeal vascular closure device (VCD). Materials and Methods Between December 2011 and August 2013, 8 patients (4 males, 4 females, mean age 64 years [range 42–81]) underwent 13 extrafemoral access site closure using the ExoSeal VCD (brachial artery n = 7, venous femoropopliteal bypass n = 3, femoropopliteal segment n = 2, proximal superficial femoral artery n = 1). Patient history, procedural characteristics, and complications were recorded. Results Technical success was achieved in 12 of 13 VCD procedures. In 1 case of brachial puncture, safe plugdeployment was not possible, so manual compression was applied. In this case, angiographic and clinical control showed residual bleeding 5 min after the procedure. After additional manual compression for 5 min, the haemorrhage stopped, but a hematoma \3 cm was detectable (procedural success rate 12 of 13 closures). Overall no major complications were observed. Heparin, 5,000 IU, was administered in all cases. Six ExoSeal closures were performed under additional acetylsalicylic acid (ASS) and clopidogrel, three under additional ASS, and the remaining C. C. Pieper K. E. Wilhelm H. H. Schild C. Meyer (&) Department of Radiology, University of Bonn, Sigmund-FreudStr. 25, 53129 Bonn, Germany e-mail: [email protected] C. C. Pieper e-mail: [email protected] K. E. Wilhelm e-mail: [email protected] H. H. Schild e-mail: [email protected]
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four under heparin only. International normalized ratio and thrombocytes were within normal values in all patients. Conclusion Successful vascular access closure using the ExoSeal VCD in puncture sites other than the CFA is feasible with a low complication rate. These applications, however, remain an ‘‘off-label’’ use in selected patients. Keywords practice
Arterial intervention Artery Clinical
Introduction The most common arterial access site in interventional radiological procedures is the common femoral artery (CFA) [1]. In cases where femoral artery puncture is not feasible, other sites such as the radial, brachial, axillary, or popliteal artery, can serve as alternatives [1–3]. To achieve hemostasis after the intervention, manual compression (MC) has been the ‘‘gold standard’’ for many years, but it is time-consuming and often uncomfortable for the patient [4]. Several vascular closure devices (VCDs) have been introduced as an alternative to MC. The safety and efficacy of VCDs in general have been shown previously [5–8]. However, all VCDs currently available have only been approved for femoral access closure. Although there have been smaller studies investigating ‘‘off-label’’ VCD use in other access sites, the number of patients investigated is limited. The ExoSeal (Cordis, Miami Lakes, FL) is a completely extravascular, plug-based VCD approved for femoral access closure [9]. The aim of this article is to report our initial experiences with off-label ‘‘extrafemoral’’ vascular closure using the ExoSeal VCD in a selected patient collective.
C. C. Pieper et al.: Extrafemoral ExoSeal Closure
Materials and Methods Patient Characteristics Between December 2011 and August 2013, 8 patients (4 males, 4 females, mean age 64 years [range 42–81]) underwent 12 interventional procedures by way of 13 ‘‘extrafemoral’’ access sites with subsequent ExoSeal-closure. Interventions were performed by way of the brachial artery (n = 7), venous femoropopliteal bypass (n = 3), femoropopliteal segment (n = 2), and proximal superficial femoral artery (SFA) (n = 1). All interventions took place in daily routine practice, and informed consent, especially regarding the off-label use of an ExoSeal VCD, was obtained from each patient before intervention. Indications for the interventions and for an ‘‘extrafemoral’’ access site are listed in Table 1. Procedure and Analysis After completion of the intervention, vascular closure was performed with the ExoSeal VCD according to the manufacturer’s instructions for femoral applications. A dual visually guided deployment system (bleed-back indicator and intravascular nitinol-loop) is intended to enhance safe plug application [9]. MC was applied thereafter for 2 min. If hemostasis was successfully achieved, no compressive bandage was used. Otherwise MC was performed until hemorrhage had completely stopped followed by a compressive bandage for 6 h. All patients were admitted overnight, and the puncture site was examined hourly for 6 h after the intervention until the next morning. If a second access was available, control angiography of the ‘‘extrafemoral’’ puncture site was performed after closure. Technical success was defined as successful plug deployment without any VCD-related major complications and procedural success as ExoSeal-closure with MC of \5 min’ duration without major complications. Major adverse events were defined according to the ECLIPSE trial [10], especially including bleeding requiring surgical vascular repair, blood transfusion, or ischemia due to plug embolization. Recurrent bleeding requiring hemostatic intervention, hematoma B6 cm, or pseudoaneurysm formation were defined as minor complications. Patient history (especially medication use and laboratory findings concerning hemostasis), procedural characteristics, and complications were recorded.
Results In 12 interventions, a total of 13 ExoSeal closures (5F n = 12; 6F n = 1) were attempted. Control angiography was available by way of a second access site in 5 interventions.
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Technical success was achieved in 12 of 13 closures. Angiographic and clinical control showed residual bleeding in only 1 case of nonsuccessful plug-deployment, thus leading to a procedural success rate of 12 of 13 closures. Patient characteristics and results are listed in Table 1. In case no. 6, safe extravascular plug deployment was not possible because there was no consensus between the two visual indicators. The ExoSeal was therefore pulled out of the brachial artery and MC applied. After 5 min, control angiography by way of a remaining femoral access showed spasm of the brachial artery and residual haemorrhage. After further MC for 5 min, extravasation was no longer detectable, and the spasm had alleviated. A compressive bandage was applied for 6 h. Patient no. 1 received three extrafemoral ExoSeal closures in two interventions for acute on chronic critical limb ischemia grade II (known peripheral artery disease [PAD] IV) of the right leg. Due to open treatment of an abdominal wound extending to both groins in this critically ill patient, access by way of the left CFA was precluded altogether. On the right side only a retrograde puncture of the CFA was possible to obtain an overview angiography, which showed high-grade stenosis of the proximal SFA and multiple infragenicular stenoses (Fig. 1A, B). Because treatment by way of an antegrade access to the CFA was precluded, it was decided in the first step to dilatate the SFA stenosis by way of a retrograde femoropopliteal access. After successful dilatation, this puncture site was closed using an ExoSeal under additional fluoroscopic guidance (Fig. 1C). Control angiography showed successful hemostasis after 2 min of MC (Fig. 1D). Subsequently the infragenicular stenoses were treated by way of an antegrade SFA access that was also closed with an ExoSeal with complete hemostasis after 2 min (Fig. 1E). Recurring stenosis of the proximal SFA made a second intervention by way of a femoropopliteal access necessary after 3 months. In patient no. 2, ExoSeal application after three direct punctures (in three separate interventions; the first 2 weeks after bypass surgery) of a venous femoropopliteal bypass lead to immediate closure of the access site after only minimal MC in all three applications (Fig. 2A, B). No major complications and only one minor complication were observed. There were no intravascular plug applications. In patient no. 6, in whom ExoSeal closure was technically unsuccessful, a local hematoma B3 cm was noted on follow-up after MC without any need for further hemostatic interventions. No patient complained about any discomfort or pain after successful plug application. All interventions took place under full heparinization, which was continued for 24 h after intervention (activated partial prothrombin time 60–80 s). Six ExoSeal closures were performed during dual-antiplatelet therapy with acetylsalicylic acid (ASS) and clopidogrel, three under ASS, and four closures under heparin only. International normalized ratio (INR) was within normal parameters in all
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123
M/62
F/68
F/67
M/71
6
7
8
R
L
L
L
L
L
PAD peripheral arterial disease
M/81
5
B
A
4
L
L
C
M/67
L
B
L
R
A
F/42
R
C
3
2
F/61
Side
R
A
1
Sex/ age (years)
B
ExoSeal closure
Patient no.
Table 1 Patient characteristics
Brachial
Brachial
Brachial
Brachial
Brachial
Brachial
Brachial
Venous bypass
Venous bypass
Venous bypass
Femoropopliteal
Proximal SFA
Femoropopliteal
Arteriel access
5F
5F
5F
5F
5F
5F
5F
5F
5F
6F
5F
5F
5F
Sheath size
Unsuccessful catheter positioning by way of CFA
Unsuccessful catheter positioning by way of CFA
Unsuccessful catheter positioning by way of CFA
Fresh surgical sutures in both groins after EVAR
Bilateral CFA occlusion
Skin infection with ulceration in both groins
Difficult access by way of antegrade femoral puncture
Open abdominal wound reaching to both groins
Indication for ‘‘extrafemoral’’ access site
Renal artery stenting in abdominal aortic dissection
MAA-test injection
Subclavian steal
Bronchial pseudoaneurysm
Mesenterial ischemia
Mesenterial ischemia
PAD IV
PAD IV
PAD IV
PAD IV
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
PAD IV PAD IV
Hypertension
Indication for intervention
1.0
1.0
1.0
1.1
1.2
1.0
1.1
1.0
1.0
1.0
1.0
1.1
INR
78
303
262
249
421
397
499
226
234
331
247
404
Thrombocytes (G/l)
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Heparin
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
ASS
No
No
No
Yes
Yes
Yes
No
No
No
No
Yes
Yes
Clopidogrel
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Technical success
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Procedural success
No
No
Hematoma \3 cm
No
No
No
No
No
No
No
No
No
No
Complications
1354 C. C. Pieper et al.: Extrafemoral ExoSeal Closure
C. C. Pieper et al.: Extrafemoral ExoSeal Closure
Fig. 1 Patient no. 1. A, B Preinterventional images showing stenoses of the proximal SFA and infragenicular arteries. C Fluoroscopic control of ExoSeal deployment in the femoropopliteal segment and D control angiography after ExoSeal deployment without contrast
Fig. 2 Venous femoropopliteal bypass A before and B after ExoSeal closure
patients (mean 1.05 [range 1–1.2]). Thrombocytes were increased in one patient. There was no case of thrombocytopenia (mean 312 G/l [range 78–499]).
Discussion Vascular access site management in general has long been restricted to MC followed by immobilization. This method
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extravasation. E Control angiography after closure of the antegrade puncture site in the proximal SFA showing successful hemostasis after 2 min of MC after dilatation of the infragenicular stenoses
can be associated with discomfort or even pain. VCDs have been developed during the last two decades as an alternative closure procedure to minimize the need for MC while maintaining safe puncture site closure [10, 11]. Several studies have shown the safety and efficacy of different VCDs in general [6–8, 12–14]. By decreasing the time to ambulation, VCDs can improve patient satisfaction and quality of life [11]. The above-mentioned studies mainly investigated closure of retrograde CFA accesses. More recently some reports have also shown feasibility of management of antegrade punctures, thereby expanding possible indications for VCD use [15, 16]. In contrast to many other VCDs, the ExoSeal is a purely extravascular closure device that involves the application of a bioabsorbable polyglycolic acid plug directly over the puncture site [9]. The efficacy and safety of this system has thus far been documented for retrograde as well as antegrade CFA closure [9, 10, 17–19]. Although the CFA is the standard access site for most vascular interventional radiological procedures, this approach can be difficult or even impossible in some cases [1]. Severe stenosis or occlusion of the CFA or iliac artery, obesity, local skin infection, previous groin surgeries, and angulated aortic bifurcation or high femoral artery bifurcation in case of antegrade access are possible reasons for a challenging femoral approach [20, 21]. For patients presenting with these problems, several alternatives have been described. The access site currently receiving the most attention apart from the radial artery is the brachial artery [2, 3] but also the axillary or popliteal artery [1, 22, 23], the SFA [21], or transpedal access seem
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to be viable alternatives with acceptable complication rates. Because no VCD specially designed for ‘‘extrafemoral’’ access sites is currently available, hemostasis is commonly achieved by MC [24]. However, especially in obese patients, MC of the popliteal artery or SFA puncture can be difficult. In recent years there have been reports of off-label VCD use in other access sites than the CFA. Because the brachial artery is of great interest to both radiologists and cardiologists, most studies have focused on this location. Overall of there have been approximately 30 patients in the literature who underwent brachial access site closure using suture-based VCD with successful closure in [90 % and a low complication rate [25–27]. A clip-based VCD showed a technical success rate of 100 % (n = 29) with complications in only two cases (one each of large hematoma and brachial artery occlusion) [28]. Preliminary reports of brachial artery puncture site closure using the AngioSeal VCD (St. Jude Medical, Minnetonka, MN) were encouraging [24, 29], Subsequently a larger study of brachial artery closure (n = 161) showed technical success in 96.9 % of patients with 3.1 % major and 7.5 % minor complications [20]. Vessel diameter should be [4 mm when using the AngioSeal to avoid thrombosis caused by the intravascular anchor [20]. This seems to be less of an issue in ExoSeal-closure due to extravascular plug application. Only recently has the feasibility of vascular access closure of antegrade punctures of the SFA using different VCDs in sheath sizes B10F been shown [30]. In this article we report our initial experiences of using the ExoSeal VCD for access sites other than the CFA, especially the brachial artery (n = 7), which to our knowledge has not been described in literature. Technical and procedural success was achieved in 12 of 13 plug deployments. In these cases, hemostasis was observed within 2 min of mild MC. In 1 case of brachial artery puncture there was no consensus between the two deployment indicators. The ExoSeal was therefore removed without deploying the plug, and MC was applied. Subsequent angiography by way of a remaining (femoral) access showed spasm of the brachial artery, which is a known problem with brachial access [24]. Technical failure might be connected to this intense spasm that decreased vessel diameter and led to inconsistency between the deployment indicators. This was the only case in which a minor hematoma could be detected. Although most of the reported cases in our study received ExoSeal closure of a brachial puncture site (7 of 13), we also included two patients treated by way of other approaches to illustrate the feasibility of ExoSeal-closure in these locations as well. In patient no. 1, a step-wise approach had to be adopted to treat all relevant stenoses. Applying this methodology
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C. C. Pieper et al.: Extrafemoral ExoSeal Closure
helped to shorten the intervention and forgoing the need of a compressive bandage enabled us to treat this critically ill patient in a single intervention. Case no. 2 serves to demonstrate that vascular closure is even feasible in a venous bypass only days after surgery, thus decreasing the need for extended MC, which can be associated with the risk of bypass thrombosis. The results of this retrospective study are certainly limited by the small patient collective available. Longer, preferably prospective studies comparing ‘‘extrafemoral’’ vascular closure with MC are needed to further assess the safety of this procedure. In summary, successful vascular access closure using the ExoSeal VCD in puncture sites other than the CFA is feasible with a low complication rate. These applications, however, remain an off-label use in selected patients, and larger studies on their safety are warranted. Conflict of interest of interest.
The authors declare that they have no conflict
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