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Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease
Cardiovascular Revascularization Medicine xxx (2016) xxx–xxx
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease☆,☆☆ Apurva Patel a, Roosha Parikh a, Yili Huang a,b, Michael Liou a,b, Justin Ratcliffe a, Olivier F. Bertrand c, Joseph Puma a, Tak W. Kwan a,b,⁎ a b c
Mount Sinai Beth Israel Medical Center, New York, United States of America Chinatown Cardiology, P.C., New York, NY Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
a r t i c l e
i n f o
Article history: Received 24 August 2016 Received in revised form 8 October 2016 Accepted 11 October 2016 Available online xxxx Keywords: Transpedal arterial access Pseudoaneurysm Vascular complication Peripheral arterial disease
a b s t r a c t Background: There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. Objective: Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. Methods: We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2 h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. Results: The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. Conclusions: PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection. © 2016 Elsevier Inc. All rights reserved.
1. Introduction Percutaneous vascular intervention is a popular initial approach taken to treat symptomatic peripheral arterial disease (PAD) over surgical intervention [1–2]. However this treatment options has its own set of risk, mainly vascular complication related to the access site like bleeding, hematoma, retroperitoneal bleed, pseudoaneurysm (PSA) and arteriovenous fistula amongst others [3–4]. A substantial proportion of these complication were related to the femoral artery access which was the initial approach taken by the operators [1–4]. For coronary intervention, there was a rise in the radial artery approach as it was associated with a significant reduction in these complications [2,5–7]. Of all the vascular related complication, post catheterization Abbreviations: TPA, Transpedal arterial access; TFA, Transfemoral approach; PAD, Peripheral arterial disease; PSA, Pseudoaneurysm; DPA, Dorsalis pedis artery; ATA, Anterior tibial artery; PTA, Posterior tibial artery; PA, Peroneal artery. ☆ Authorship Declaration: All authors listed meet authorship criteria. They have read and are in agreement with the manuscript. ☆☆ Disclosures: None ⁎ Corresponding author at: Chinatown Cardiology, P.C., 139 Centre St., Rm 307, New York, NY, 10013. Tel.: +1 212 334 3507; fax: +1 212 334 4728. E-mail address: [email protected] (T.W. Kwan).
PSA is a rare one, it is seen in the range of about 0.05–6% in transfemoral approach and b0.1% in transradial approach [3,7–13]. There has a been an increasing trend towards the use of transpedal/tibial artery (TPA) approach for evaluation and treatment of PAD as it has shown to be feasible and expected to be associated with better patient comfort, less recovery time and possibly less access site complications [1,2]. However there are no reports on any access site complications mainly PSA associated with the TPA. Here we report a case series of pedal/tibial artery PSA related to access site complicating diagnostic and/or intervention catheterization from the TPA. 2. Methods We performed a retrospective analysis of a prospectively collected database of consecutive patients, referred for symptomatic peripheral arterial disease between June 2014 and January 2016 who underwent diagnostic peripheral angiography and/or peripheral intervention via pedal/tibial artery access. Pedal/tibial artery access included access via dorsalis pedis artery (DPA)/anterior tibial artery (ATA), posterior tibial artery (PTA) and/or peroneal artery (PA). Pedal/tibial artery access was chosen as the first approach in these cases, as per institutional protocol. Under ultrasound guidance, the flow in the DPA/ATA, PTA
http://dx.doi.org/10.1016/j.carrev.2016.10.003 1553-8389/© 2016 Elsevier Inc. All rights reserved.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
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A. Patel et al. / Cardiovascular Revascularization Medicine xxx (2016) xxx–xxx
and/or PA was demonstrated by Doppler in the long-axis and short-axis views. Access was obtained with a 21 × 19 tapered gauge echogenic tip needle (Terumo Corporation, Somerset, NJ) with an anterior wall puncture technique followed by a 4 Fr Pinnacle Precision (Terumo Corporation, Somerset, NJ). Systemic heparin was given to maintain activated clotting time N 250 s. An antispasmodic cocktail of 100mcg of nitroglycerine and 2.5 mg verapamil was injected intra-arterial. If a significant lesion was identified, intervention was performed via the 4 Fr sheath (Terumo Corporation, Somerset, NJ) or upsized to a 6 Fr Glidesheath Slender (Terumo Corporation, Somerset, NJ), which employs a smaller outer diameter that is equivalent to a standard 5 Fr sheath, from the retrograde approach. Hemostasis is an integral part of all vascular procedures in order to avoid bleeding or artery occlusion. Recent experiences from transradial studies suggest that patent hemostasis is the best practice to prevent access vessel occlusion [14]. We extrapolated this experience from radial access to pedal access which is also a small caliber vessel. Manual compression with minimal pressure may not be adequate and several compression devices have been developed in an attempt to maximize operator and staff efficiency. After the procedure, a large TR Band™ (Terumo Corporation, Somerset, NJ) or a Vasostat™ (Forge Medical, Inc., Bethlehem, PA, USA) was placed at the access site for 2 h using the patent hemostasis technique with certain modifications. In brief, the TR Band™ was inflated at the site of pedal puncture and the sheath removed. The TR Band™ was deflated slowly until the appearance of blood flow; an extra 1 cm 3 of air was then added, which confirmed occlusion at the puncture site. TR Band™ was used for PA access as well. There is always a concern about absence of bony support beneath, however with the pressure from the TR Band™ transmitted to the tissue beneath which will eventually be transmitted to the underlying vessel, the main purpose is patent hemostasis and not complete occlusion which can be achieved by this technique. In the Vasostat™ device, a central plunger is ratcheted to apply sufficient compression to the puncture site in the skin and the underlying entry point in the pedal/tibial artery, the device is secured by adhesive pads and the sheath is removed. The patient was discharged home after 2 h of monitoring. A clinical assessment was performed prior to the discharge and at follow-up visits 1-week post intervention. At 1-month after the intervention, a lower extremity duplex ultrasound was performed to assess patency of the arteries and the access sites. Patients diagnosed with PSA related to the access site were identified clinically (swelling, pain and/or tenderness at the access site) and confirmed with an arterial duplex ultrasound. Demographics and clinical variables for these patients were obtained from electronic medical records. The ultrasound images of the PSA were analyzed, the morphological features, treatment method [15], success and complication rates were evaluated. The Institutional review board approved this study and all patients signed an informed consent prior the procedure. 3. Results A total of 2236 peripheral diagnostic and/or interventional procedures were performed in 1460 patients (Table 1) between June 2014 and January 2016 at our center. Amongst them, 609 procedures were diagnostic only and 1629 were interventional. DPA/ATA was accessed during 1777 procedures, PTA was accessed during 301 procedures, and PA was accessed during 158 procedures. The incidence of PSA per procedure related to access site was 0.002% (4/2236 procedures), while the incidence of PSA per patient related to access site was 0.003% (4/1460 patients). The incidence of PSA per punctured vessel for PTA was 0.01% (4/301 PTA access), there were no PSA seen in the DPA/ATA or PA. Also, no PSA was seen after a diagnostic procedure, all cases were seen after an interventional procedure (0.002%, 4/1629 procedures) (Fig. 1). Patient demographics, morphological characteristics of the PSA (Fig. 2A), treatment modalities are depicted in Table 2.
All patient failed initial attempt of manual compression – after a PSA was identified, manual compression was tried for 15–30 min followed by TR Band™ application for up to 2 h. Repeat Doppler ultrasound examination was performed in all these patients without any resolution of PSA, after which they were successfully treated by ultrasound guided thrombin injection. Using ultrasound guidance, PSA of the PTA was located. Bovine thrombin (5000 U; King Pharmaceuticals, Inc.) was reconstituted in normal saline as 100 U/ml. A 3-way stopcock was used to perform injections with attachments of thrombin and saline. While withdrawing the saline syringe, a 21 gauge needle was inserted into the PSA chamber. Once blood returned into the saline syringe, saline was then injected into the chamber to confirm placement into the PSA. Color duplex imaging allows confirmation of needle placement on visualization of a “color flash” in the PSA chamber with injection of saline. The tip of the needle can often be clearly visualized after saline injection. While observing the ultrasound images, a total of up to 5 ml of thrombin (up to 500 U) was injected until the PSA cavity thrombosed. After thrombus formation was visualized, success of the thrombin injection was confirmed by demonstrating an absence of color flow and an absence of Doppler flow through the tract. Patient was placed on bed rest for 2 h after the injection and then discharged. There was resolution of symptoms and no residual complications in all the patients (Fig. 2B). Repeat ultrasound one month after the diagnosis in these cases showed no PSA and patency of the vessel.
3.1. Case 1 An 80-year-old male underwent a lower extremity catheterization from the right PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe calcified lesions in the right superficial femoral artery, right PTA and completely occluded PA, The lesions in SFA and PTA were treated with atherectomy and balloon angioplasty. Post procedure, patient was discharged on aspirin and clopidogrel. Two week later, patient presented to the office with complains of a large right lower extremity swelling with severe pain at the previous access site. On ultrasound, it was confirmed to be a PSA measuring 1.0 cm × 1.3 cm, neck of 1.9 mm. It was successfully treated by ultrasound guided thrombin injection (100 U), confirmed by demonstrating an absence of color flow and Doppler flow through the tract.
Table 1 Baseline patient characteristics. N = 1460 Age (years) Male, % H/o Hypertension, % H/o Hyperlipidemia, % H/o Atrial fibrillation, % Current smoker, % Former smoker, % H/o Coronary artery disease, % H/o Myocardial infarction, % H/o Cerebrovascular accident, % H/o IDDM, % H/o NIDDM, % H/o Prior PVD intervention, % Rutherford classification, % II III IV V VI
72.6 ± 27.4 52.1 84.1 77 11.7 13.5 30.5 73.2 2.2 3.2 4.8 40.6 13.1 8.3 57 32.2 2.3 0.1
Data given as mean ± standard deviation or number (percentage). H/o – History of; IDDM – Insulin dependent diabetes mellitus; NIDDM – Non-insulin dependent diabetes mellitus; PVD – Peripheral vascular disease.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
A. Patel et al. / Cardiovascular Revascularization Medicine xxx (2016) xxx–xxx
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Fig. 1. Incidence of Pseudoaneurysm.
3.2. Case 2 A 77-year-old female underwent a lower extremity catheterization from the left PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe left PTA calcified lesion and a moderate lesion in the left SFA. The lesion in the PTA was treated with atherectomy and balloon angioplasty. Post procedure, patient was discharged on clopidogrel. Four days later, patient complained of worsening left foot swelling and pain near the access site. On ultrasound it was confirmed to be a PSA measuring 1.4 cm × 1.6 cm, neck of 1.5 mm. It was successfully treated by ultrasound guided thrombin injection (300 U), confirmed by demonstrating an absence of color flow and Doppler flow through the tract. 3.3. Case 3 A 78-year-old male underwent a lower extremity catheterization from the right PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe right ATA, PTA, tibioperoneal trunk calcified lesions. The lesions in the TP trunk and PTA were treated with atherectomy and balloon angioplasty. Post procedure, patient was discharged on apixaban (Atrial fibrillation) and aspirin. Four days later, patient complained of worsening left foot swelling and pain near the access site. On ultrasound it was confirmed to be a PSA measuring 1.0 cm × 1.5 cm, neck of 1.2 mm. It was successfully treated by ultrasound guided thrombin injection (200 U), confirmed by demonstrating an absence of color flow and Doppler flow through the tract. 3.4. Case 4 An 86-year-old male underwent a lower extremity catheterization from the right PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe right ATA and PA calcified lesions. The lesion in the ATA and PA were treated with atherectomy and balloon angioplasty.
Post procedure, patient was discharged on warfarin (Atrial fibrillation). Ten days later, patient complained of worsening left foot swelling and pain near the access site. On ultrasound it was confirmed to be a PSA measuring 1.6 cm × 1.1 cm, neck of 1.6 mm. It was successfully treated by ultrasound guided thrombin injection (100 U), confirmed by demonstrating an absence of color and Doppler flow through the tract.
4. Discussion This is the first case series described reporting the rate of PSA related to the access site in TPA for endovascular treatment of PAD. In our study of 2236 peripheral vascular procedures we observed a very low rate of PSA (0.002%), only related to PTA access (0.01%), after an interventional procedure (0.002%). All the cases were treated successfully with ultrasound guided thrombin injection with no incidence of thromboembolism, local ischemia or rupture. All of them had a patent PTA at 1 month follow up. PSA is a rare complication after arterial puncture for endovascular intervention. It is characterized by localized rupture of the arterial wall leading to blood extravasation, which is then walled off by the surrounding layers of connective tissue but maintains its communication with the arterial lumen through a neck [3,7,8,11]. The incidence after transfemoral catheterization ranges from 0.05% to 6% while it is reported at b0.1% after transradial catheterization [3,7–13]. The common factors associated with it are multiple punctures, anticoagulation, larger sheath size, female sex, obesity, and calcified arteries amongst other [7,9,16]. Walker et al. reported two cases of PSA after transpedal approach, however it was unclear if they were related to access site [17]. In our study, we report for the first time, the incidence of PSA related to vascular access of the pedal/tibial artery. It was 0.002% which is very rare in comparison to the incidences reported for the transfemoral and transradial approach. It also supports the statement from The Society of Cardiovascular and Interventional Radiology that an acceptable
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
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A. Patel et al. / Cardiovascular Revascularization Medicine xxx (2016) xxx–xxx
Fig. 2. A Pseudoaneurysm of the posterior tibial artery. B Resolution of pseudoaneurysm in the posterior tibial artery after thrombin injection PSA: Pseudoaneurysm, PTA: Posterior tibial artery.
rate of symptomatic PSA and/or arteriovenous fistula rate should be ≤0.2% after endovascular procedures [18]. In our study, we observed that all the PSA related to PTA access, however none seen in the ATA/DPA or the PA, and only after an interventional procedure. The incidence was so low it is difficult to analyze the predictors; however we feel that it was likely related to anatomical course of the PTA, possible sheath size, malapposition/failure of hemostasis device and/or the duration of hemostasis. While applying a hemostasis device after sheath removal in the PTA, because of the depressed fossa beneath the medial malleolus where the PTA runs, it was felt that it doesn't provide sufficient bony support for the hemostasis device to compress the artery. As a result of which we felt
that the duration for which the hemostasis device was applied (~ 2 h) was inadequate, particularly for PTA access. This problem was not encountered with the DPA, ATA and PA. We also feel that the extra need of anticoagulation, burden of disease and use of atherectomy device may be some factors which would differentiate the interventional procedures from the diagnostic procedures in the occurrence of PSA. In this series, all the 4 patients presented with painful pulsatile swelling at access site. All the PSA were easily accessible, and were treated successfully with an ultrasound guided thrombin injection with no resultant complication. None of the cases required surgical treatment, hence avoiding the morbidity associated with it. At 1 month follow up, the PTA in these patients was patent.
Table 2 Clinical characteristics, pseudoaneurysm morphology, and treatment modality. No
Age, Sex
Clinical Characteristics
Rutherford Class
Access site
Hemostasis method
PSA morphology
1 2 3 4
80 `Male 77 Female 77 Male 87 Male
HTN, smoker HTN, HLD, CAD HTN, HLD, DM, smoker, CAD, A. Fib HTN, A. Fib, CAD, DM, smoker
3 3 3 4
L. PTA L. PTA R. PTA R. PTA
RACD RACD RACD RACD
1.0 1.4 1.0 1.6
× × × ×
1.3 1.6 1.5 1.1
cm, neck 1.9 cm, neck 1.5 cm, neck 1.2 cm, neck 1.6
Treatment mm mm mm mm
UGTI UGTI UGTI UGTI
HTN: Hypertension, HLD: Hyperlipidaemia, CAD: Coronary artery disease, DM: diabetes mellitus, A. Fib: Atrial fibrillation, L: Left, R: Right, PTA: Posterior tibial artery, RACD: Radial artery compression device, UGTI: ultrasound guided thrombin injection.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
A. Patel et al. / Cardiovascular Revascularization Medicine xxx (2016) xxx–xxx
5. Limitations This was a single center observational cohort study, so it has its related biases. The transpedal technique was done at a center with large volume transradial operators, the results may not be extrapolated to centers with operators who are not familiar with similar equipment, puncture technique and patent hemostasis techniques. Data on the vascular complication related to transradial access for treatment of PAD is not available to compare with the transpedal access. Our study did not have any cases where we used manual compression for hemostasis, hence we are not able to provide data for comparison versus device compression. One of the factors which influence the incidence of PSA is anticoagulation status, during all the procedures, the ACT was maintained at N300 s, however we do not have specific ACT level to report for individual cases. All the patients were followed at 1 month – clinically and Doppler ultrasound examination was performed, however there is a possibility that a clinical/subclinical PSA may have developed after 1 month, however we are not aware of any such cases. 6. Conclusion PSA is an extremely rare access site complication following transpedal approach for treatment of peripheral arterial disease. It is easily treatable by thrombin injection without any resultant complication. References [1] Amoroso NS, Shah S, Liou M, Ratcliffe J, Lala M, Diwan R, et al. Superficial femoral artery intervention by single transpedal arterial access. J Invasive Cardiol 2015;27: E236–41. [2] Kwan TW, Shah S, Amoroso N, Diwan R, Makker P, Ratcliffe JA, et al. Feasibility and safety of routine transpedal arterial access for treatment of peripheral artery disease. J Invasive Cardiol 2015;27:327–30.
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[3] Ortiz D, Jahangir A, Singh M, Allaqaband S, Bajwa TK, Mewissen MW. Access site complications after peripheral vascular interventions: incidence, predictors, and outcomes. Circ Cardiovasc Interv 2014;7:821–8. [4] Dencker D, Pedersen F, Engstrom T, Køber L, Hojberg S, Nielsen MB, et al. Major femoral vascular access complications after coronary diagnostic and interventional procedures: a Danish register study. Int J Cardiol 2016;202:604–8. [5] Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011;377:1409–20. [6] Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol 1997;29:1269–75. [7] Kanei Y, Kwan T, Nakra NC, Liou M, Huang Y, Vales LL, et al. Transradial cardiac catheterization: a review of access site complications. Catheter Cardiovasc Interv 2011;78:840–6. [8] Liou M, Tung F, Kanei Y, Kwan T. Treatment of radial artery pseudoaneurysm using a novel compression device. J Invasive Cardiol 2010;22:293–5. [9] Ates M, Sahin S, Konuralp C, Gullu U, Cimen S, Kizilay M, et al. Evaluation of risk factors associated with femoral pseudoaneurysms after cardiac catheterization. J Vasc Surg 2006;43:520–4. [10] Collins N, Wainstein R, Ward M, Bhagwandeen R, Dzavik V. Pseudoaneurysm after transradial cardiac catheterization: case series and review of the literature. Catheter Cardiovasc Interv 2012;80:283–7. [11] Stone PA, Campbell JE, AbuRahma AF. Femoral pseudoaneurysms after percutaneous access. J Vasc Surg 2014;60:1359–66. [12] Webber GW, Jang J, Gustavson S, Olin JW. Contemporary management of postcatheterization pseudoaneurysms. Circulation 2007;115:2666–74. [13] White CJ, Gray WA. Endovascular therapies for peripheral arterial disease: an evidence-based review. Circulation 2007;116:2203–15. [14] Pancholy S, Coppola J, Patel T, Roke-Thomas M. Prevention of radial artery occlusionpatent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Catheter Cardiovasc Interv 2008;72:335–40. [15] Dzijan-Horn M, Langwieser N, Groha P, Bradaric C, Linhardt M, Böttiger C, et al. Safety and efficacy of a potential treatment algorithm by using manual compression repair and ultrasound-guided thrombin injection for the management of iatrogenic femoral artery pseudoaneurysm in a large patient cohort. Circ Cardiovasc Interv 2014;7:207–15. [16] Hackl G, Gary T, Belaj K, Hafner F, Eller P, Brodmann M. Risk factors for puncture site complications after endovascular procedures in patients with peripheral arterial disease. Vasc Endovascular Surg 2015;49:160–5. [17] Walker C. Pedal access in critical limb ischemia. J Cardiovasc Surg (Torino) 2014;55: 225–7. [18] Hessel SJ, Adams DF, Abrams HL. Complications of angiography. Radiology 1981; 138:273–81.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease☆,☆☆ Apurva Patel a, Roosha Parikh a, Yili Huang a,b, Michael Liou a,b, Justin Ratcliffe a, Olivier F. Bertrand c, Joseph Puma a, Tak W. Kwan a,b,⁎ a b c
Mount Sinai Beth Israel Medical Center, New York, United States of America Chinatown Cardiology, P.C., New York, NY Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
a r t i c l e
i n f o
Article history: Received 24 August 2016 Received in revised form 8 October 2016 Accepted 11 October 2016 Available online xxxx Keywords: Transpedal arterial access Pseudoaneurysm Vascular complication Peripheral arterial disease
a b s t r a c t Background: There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. Objective: Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. Methods: We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2 h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. Results: The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. Conclusions: PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection. © 2016 Elsevier Inc. All rights reserved.
1. Introduction Percutaneous vascular intervention is a popular initial approach taken to treat symptomatic peripheral arterial disease (PAD) over surgical intervention [1–2]. However this treatment options has its own set of risk, mainly vascular complication related to the access site like bleeding, hematoma, retroperitoneal bleed, pseudoaneurysm (PSA) and arteriovenous fistula amongst others [3–4]. A substantial proportion of these complication were related to the femoral artery access which was the initial approach taken by the operators [1–4]. For coronary intervention, there was a rise in the radial artery approach as it was associated with a significant reduction in these complications [2,5–7]. Of all the vascular related complication, post catheterization Abbreviations: TPA, Transpedal arterial access; TFA, Transfemoral approach; PAD, Peripheral arterial disease; PSA, Pseudoaneurysm; DPA, Dorsalis pedis artery; ATA, Anterior tibial artery; PTA, Posterior tibial artery; PA, Peroneal artery. ☆ Authorship Declaration: All authors listed meet authorship criteria. They have read and are in agreement with the manuscript. ☆☆ Disclosures: None ⁎ Corresponding author at: Chinatown Cardiology, P.C., 139 Centre St., Rm 307, New York, NY, 10013. Tel.: +1 212 334 3507; fax: +1 212 334 4728. E-mail address: [email protected] (T.W. Kwan).
PSA is a rare one, it is seen in the range of about 0.05–6% in transfemoral approach and b0.1% in transradial approach [3,7–13]. There has a been an increasing trend towards the use of transpedal/tibial artery (TPA) approach for evaluation and treatment of PAD as it has shown to be feasible and expected to be associated with better patient comfort, less recovery time and possibly less access site complications [1,2]. However there are no reports on any access site complications mainly PSA associated with the TPA. Here we report a case series of pedal/tibial artery PSA related to access site complicating diagnostic and/or intervention catheterization from the TPA. 2. Methods We performed a retrospective analysis of a prospectively collected database of consecutive patients, referred for symptomatic peripheral arterial disease between June 2014 and January 2016 who underwent diagnostic peripheral angiography and/or peripheral intervention via pedal/tibial artery access. Pedal/tibial artery access included access via dorsalis pedis artery (DPA)/anterior tibial artery (ATA), posterior tibial artery (PTA) and/or peroneal artery (PA). Pedal/tibial artery access was chosen as the first approach in these cases, as per institutional protocol. Under ultrasound guidance, the flow in the DPA/ATA, PTA
http://dx.doi.org/10.1016/j.carrev.2016.10.003 1553-8389/© 2016 Elsevier Inc. All rights reserved.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
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and/or PA was demonstrated by Doppler in the long-axis and short-axis views. Access was obtained with a 21 × 19 tapered gauge echogenic tip needle (Terumo Corporation, Somerset, NJ) with an anterior wall puncture technique followed by a 4 Fr Pinnacle Precision (Terumo Corporation, Somerset, NJ). Systemic heparin was given to maintain activated clotting time N 250 s. An antispasmodic cocktail of 100mcg of nitroglycerine and 2.5 mg verapamil was injected intra-arterial. If a significant lesion was identified, intervention was performed via the 4 Fr sheath (Terumo Corporation, Somerset, NJ) or upsized to a 6 Fr Glidesheath Slender (Terumo Corporation, Somerset, NJ), which employs a smaller outer diameter that is equivalent to a standard 5 Fr sheath, from the retrograde approach. Hemostasis is an integral part of all vascular procedures in order to avoid bleeding or artery occlusion. Recent experiences from transradial studies suggest that patent hemostasis is the best practice to prevent access vessel occlusion [14]. We extrapolated this experience from radial access to pedal access which is also a small caliber vessel. Manual compression with minimal pressure may not be adequate and several compression devices have been developed in an attempt to maximize operator and staff efficiency. After the procedure, a large TR Band™ (Terumo Corporation, Somerset, NJ) or a Vasostat™ (Forge Medical, Inc., Bethlehem, PA, USA) was placed at the access site for 2 h using the patent hemostasis technique with certain modifications. In brief, the TR Band™ was inflated at the site of pedal puncture and the sheath removed. The TR Band™ was deflated slowly until the appearance of blood flow; an extra 1 cm 3 of air was then added, which confirmed occlusion at the puncture site. TR Band™ was used for PA access as well. There is always a concern about absence of bony support beneath, however with the pressure from the TR Band™ transmitted to the tissue beneath which will eventually be transmitted to the underlying vessel, the main purpose is patent hemostasis and not complete occlusion which can be achieved by this technique. In the Vasostat™ device, a central plunger is ratcheted to apply sufficient compression to the puncture site in the skin and the underlying entry point in the pedal/tibial artery, the device is secured by adhesive pads and the sheath is removed. The patient was discharged home after 2 h of monitoring. A clinical assessment was performed prior to the discharge and at follow-up visits 1-week post intervention. At 1-month after the intervention, a lower extremity duplex ultrasound was performed to assess patency of the arteries and the access sites. Patients diagnosed with PSA related to the access site were identified clinically (swelling, pain and/or tenderness at the access site) and confirmed with an arterial duplex ultrasound. Demographics and clinical variables for these patients were obtained from electronic medical records. The ultrasound images of the PSA were analyzed, the morphological features, treatment method [15], success and complication rates were evaluated. The Institutional review board approved this study and all patients signed an informed consent prior the procedure. 3. Results A total of 2236 peripheral diagnostic and/or interventional procedures were performed in 1460 patients (Table 1) between June 2014 and January 2016 at our center. Amongst them, 609 procedures were diagnostic only and 1629 were interventional. DPA/ATA was accessed during 1777 procedures, PTA was accessed during 301 procedures, and PA was accessed during 158 procedures. The incidence of PSA per procedure related to access site was 0.002% (4/2236 procedures), while the incidence of PSA per patient related to access site was 0.003% (4/1460 patients). The incidence of PSA per punctured vessel for PTA was 0.01% (4/301 PTA access), there were no PSA seen in the DPA/ATA or PA. Also, no PSA was seen after a diagnostic procedure, all cases were seen after an interventional procedure (0.002%, 4/1629 procedures) (Fig. 1). Patient demographics, morphological characteristics of the PSA (Fig. 2A), treatment modalities are depicted in Table 2.
All patient failed initial attempt of manual compression – after a PSA was identified, manual compression was tried for 15–30 min followed by TR Band™ application for up to 2 h. Repeat Doppler ultrasound examination was performed in all these patients without any resolution of PSA, after which they were successfully treated by ultrasound guided thrombin injection. Using ultrasound guidance, PSA of the PTA was located. Bovine thrombin (5000 U; King Pharmaceuticals, Inc.) was reconstituted in normal saline as 100 U/ml. A 3-way stopcock was used to perform injections with attachments of thrombin and saline. While withdrawing the saline syringe, a 21 gauge needle was inserted into the PSA chamber. Once blood returned into the saline syringe, saline was then injected into the chamber to confirm placement into the PSA. Color duplex imaging allows confirmation of needle placement on visualization of a “color flash” in the PSA chamber with injection of saline. The tip of the needle can often be clearly visualized after saline injection. While observing the ultrasound images, a total of up to 5 ml of thrombin (up to 500 U) was injected until the PSA cavity thrombosed. After thrombus formation was visualized, success of the thrombin injection was confirmed by demonstrating an absence of color flow and an absence of Doppler flow through the tract. Patient was placed on bed rest for 2 h after the injection and then discharged. There was resolution of symptoms and no residual complications in all the patients (Fig. 2B). Repeat ultrasound one month after the diagnosis in these cases showed no PSA and patency of the vessel.
3.1. Case 1 An 80-year-old male underwent a lower extremity catheterization from the right PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe calcified lesions in the right superficial femoral artery, right PTA and completely occluded PA, The lesions in SFA and PTA were treated with atherectomy and balloon angioplasty. Post procedure, patient was discharged on aspirin and clopidogrel. Two week later, patient presented to the office with complains of a large right lower extremity swelling with severe pain at the previous access site. On ultrasound, it was confirmed to be a PSA measuring 1.0 cm × 1.3 cm, neck of 1.9 mm. It was successfully treated by ultrasound guided thrombin injection (100 U), confirmed by demonstrating an absence of color flow and Doppler flow through the tract.
Table 1 Baseline patient characteristics. N = 1460 Age (years) Male, % H/o Hypertension, % H/o Hyperlipidemia, % H/o Atrial fibrillation, % Current smoker, % Former smoker, % H/o Coronary artery disease, % H/o Myocardial infarction, % H/o Cerebrovascular accident, % H/o IDDM, % H/o NIDDM, % H/o Prior PVD intervention, % Rutherford classification, % II III IV V VI
72.6 ± 27.4 52.1 84.1 77 11.7 13.5 30.5 73.2 2.2 3.2 4.8 40.6 13.1 8.3 57 32.2 2.3 0.1
Data given as mean ± standard deviation or number (percentage). H/o – History of; IDDM – Insulin dependent diabetes mellitus; NIDDM – Non-insulin dependent diabetes mellitus; PVD – Peripheral vascular disease.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
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Fig. 1. Incidence of Pseudoaneurysm.
3.2. Case 2 A 77-year-old female underwent a lower extremity catheterization from the left PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe left PTA calcified lesion and a moderate lesion in the left SFA. The lesion in the PTA was treated with atherectomy and balloon angioplasty. Post procedure, patient was discharged on clopidogrel. Four days later, patient complained of worsening left foot swelling and pain near the access site. On ultrasound it was confirmed to be a PSA measuring 1.4 cm × 1.6 cm, neck of 1.5 mm. It was successfully treated by ultrasound guided thrombin injection (300 U), confirmed by demonstrating an absence of color flow and Doppler flow through the tract. 3.3. Case 3 A 78-year-old male underwent a lower extremity catheterization from the right PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe right ATA, PTA, tibioperoneal trunk calcified lesions. The lesions in the TP trunk and PTA were treated with atherectomy and balloon angioplasty. Post procedure, patient was discharged on apixaban (Atrial fibrillation) and aspirin. Four days later, patient complained of worsening left foot swelling and pain near the access site. On ultrasound it was confirmed to be a PSA measuring 1.0 cm × 1.5 cm, neck of 1.2 mm. It was successfully treated by ultrasound guided thrombin injection (200 U), confirmed by demonstrating an absence of color flow and Doppler flow through the tract. 3.4. Case 4 An 86-year-old male underwent a lower extremity catheterization from the right PTA using a 10 cm 4Fr Terumo sheath. Diagnostic angiography revealed severe right ATA and PA calcified lesions. The lesion in the ATA and PA were treated with atherectomy and balloon angioplasty.
Post procedure, patient was discharged on warfarin (Atrial fibrillation). Ten days later, patient complained of worsening left foot swelling and pain near the access site. On ultrasound it was confirmed to be a PSA measuring 1.6 cm × 1.1 cm, neck of 1.6 mm. It was successfully treated by ultrasound guided thrombin injection (100 U), confirmed by demonstrating an absence of color and Doppler flow through the tract.
4. Discussion This is the first case series described reporting the rate of PSA related to the access site in TPA for endovascular treatment of PAD. In our study of 2236 peripheral vascular procedures we observed a very low rate of PSA (0.002%), only related to PTA access (0.01%), after an interventional procedure (0.002%). All the cases were treated successfully with ultrasound guided thrombin injection with no incidence of thromboembolism, local ischemia or rupture. All of them had a patent PTA at 1 month follow up. PSA is a rare complication after arterial puncture for endovascular intervention. It is characterized by localized rupture of the arterial wall leading to blood extravasation, which is then walled off by the surrounding layers of connective tissue but maintains its communication with the arterial lumen through a neck [3,7,8,11]. The incidence after transfemoral catheterization ranges from 0.05% to 6% while it is reported at b0.1% after transradial catheterization [3,7–13]. The common factors associated with it are multiple punctures, anticoagulation, larger sheath size, female sex, obesity, and calcified arteries amongst other [7,9,16]. Walker et al. reported two cases of PSA after transpedal approach, however it was unclear if they were related to access site [17]. In our study, we report for the first time, the incidence of PSA related to vascular access of the pedal/tibial artery. It was 0.002% which is very rare in comparison to the incidences reported for the transfemoral and transradial approach. It also supports the statement from The Society of Cardiovascular and Interventional Radiology that an acceptable
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
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A. Patel et al. / Cardiovascular Revascularization Medicine xxx (2016) xxx–xxx
Fig. 2. A Pseudoaneurysm of the posterior tibial artery. B Resolution of pseudoaneurysm in the posterior tibial artery after thrombin injection PSA: Pseudoaneurysm, PTA: Posterior tibial artery.
rate of symptomatic PSA and/or arteriovenous fistula rate should be ≤0.2% after endovascular procedures [18]. In our study, we observed that all the PSA related to PTA access, however none seen in the ATA/DPA or the PA, and only after an interventional procedure. The incidence was so low it is difficult to analyze the predictors; however we feel that it was likely related to anatomical course of the PTA, possible sheath size, malapposition/failure of hemostasis device and/or the duration of hemostasis. While applying a hemostasis device after sheath removal in the PTA, because of the depressed fossa beneath the medial malleolus where the PTA runs, it was felt that it doesn't provide sufficient bony support for the hemostasis device to compress the artery. As a result of which we felt
that the duration for which the hemostasis device was applied (~ 2 h) was inadequate, particularly for PTA access. This problem was not encountered with the DPA, ATA and PA. We also feel that the extra need of anticoagulation, burden of disease and use of atherectomy device may be some factors which would differentiate the interventional procedures from the diagnostic procedures in the occurrence of PSA. In this series, all the 4 patients presented with painful pulsatile swelling at access site. All the PSA were easily accessible, and were treated successfully with an ultrasound guided thrombin injection with no resultant complication. None of the cases required surgical treatment, hence avoiding the morbidity associated with it. At 1 month follow up, the PTA in these patients was patent.
Table 2 Clinical characteristics, pseudoaneurysm morphology, and treatment modality. No
Age, Sex
Clinical Characteristics
Rutherford Class
Access site
Hemostasis method
PSA morphology
1 2 3 4
80 `Male 77 Female 77 Male 87 Male
HTN, smoker HTN, HLD, CAD HTN, HLD, DM, smoker, CAD, A. Fib HTN, A. Fib, CAD, DM, smoker
3 3 3 4
L. PTA L. PTA R. PTA R. PTA
RACD RACD RACD RACD
1.0 1.4 1.0 1.6
× × × ×
1.3 1.6 1.5 1.1
cm, neck 1.9 cm, neck 1.5 cm, neck 1.2 cm, neck 1.6
Treatment mm mm mm mm
UGTI UGTI UGTI UGTI
HTN: Hypertension, HLD: Hyperlipidaemia, CAD: Coronary artery disease, DM: diabetes mellitus, A. Fib: Atrial fibrillation, L: Left, R: Right, PTA: Posterior tibial artery, RACD: Radial artery compression device, UGTI: ultrasound guided thrombin injection.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003
A. Patel et al. / Cardiovascular Revascularization Medicine xxx (2016) xxx–xxx
5. Limitations This was a single center observational cohort study, so it has its related biases. The transpedal technique was done at a center with large volume transradial operators, the results may not be extrapolated to centers with operators who are not familiar with similar equipment, puncture technique and patent hemostasis techniques. Data on the vascular complication related to transradial access for treatment of PAD is not available to compare with the transpedal access. Our study did not have any cases where we used manual compression for hemostasis, hence we are not able to provide data for comparison versus device compression. One of the factors which influence the incidence of PSA is anticoagulation status, during all the procedures, the ACT was maintained at N300 s, however we do not have specific ACT level to report for individual cases. All the patients were followed at 1 month – clinically and Doppler ultrasound examination was performed, however there is a possibility that a clinical/subclinical PSA may have developed after 1 month, however we are not aware of any such cases. 6. Conclusion PSA is an extremely rare access site complication following transpedal approach for treatment of peripheral arterial disease. It is easily treatable by thrombin injection without any resultant complication. References [1] Amoroso NS, Shah S, Liou M, Ratcliffe J, Lala M, Diwan R, et al. Superficial femoral artery intervention by single transpedal arterial access. J Invasive Cardiol 2015;27: E236–41. [2] Kwan TW, Shah S, Amoroso N, Diwan R, Makker P, Ratcliffe JA, et al. Feasibility and safety of routine transpedal arterial access for treatment of peripheral artery disease. J Invasive Cardiol 2015;27:327–30.
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[3] Ortiz D, Jahangir A, Singh M, Allaqaband S, Bajwa TK, Mewissen MW. Access site complications after peripheral vascular interventions: incidence, predictors, and outcomes. Circ Cardiovasc Interv 2014;7:821–8. [4] Dencker D, Pedersen F, Engstrom T, Køber L, Hojberg S, Nielsen MB, et al. Major femoral vascular access complications after coronary diagnostic and interventional procedures: a Danish register study. Int J Cardiol 2016;202:604–8. [5] Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011;377:1409–20. [6] Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol 1997;29:1269–75. [7] Kanei Y, Kwan T, Nakra NC, Liou M, Huang Y, Vales LL, et al. Transradial cardiac catheterization: a review of access site complications. Catheter Cardiovasc Interv 2011;78:840–6. [8] Liou M, Tung F, Kanei Y, Kwan T. Treatment of radial artery pseudoaneurysm using a novel compression device. J Invasive Cardiol 2010;22:293–5. [9] Ates M, Sahin S, Konuralp C, Gullu U, Cimen S, Kizilay M, et al. Evaluation of risk factors associated with femoral pseudoaneurysms after cardiac catheterization. J Vasc Surg 2006;43:520–4. [10] Collins N, Wainstein R, Ward M, Bhagwandeen R, Dzavik V. Pseudoaneurysm after transradial cardiac catheterization: case series and review of the literature. Catheter Cardiovasc Interv 2012;80:283–7. [11] Stone PA, Campbell JE, AbuRahma AF. Femoral pseudoaneurysms after percutaneous access. J Vasc Surg 2014;60:1359–66. [12] Webber GW, Jang J, Gustavson S, Olin JW. Contemporary management of postcatheterization pseudoaneurysms. Circulation 2007;115:2666–74. [13] White CJ, Gray WA. Endovascular therapies for peripheral arterial disease: an evidence-based review. Circulation 2007;116:2203–15. [14] Pancholy S, Coppola J, Patel T, Roke-Thomas M. Prevention of radial artery occlusionpatent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Catheter Cardiovasc Interv 2008;72:335–40. [15] Dzijan-Horn M, Langwieser N, Groha P, Bradaric C, Linhardt M, Böttiger C, et al. Safety and efficacy of a potential treatment algorithm by using manual compression repair and ultrasound-guided thrombin injection for the management of iatrogenic femoral artery pseudoaneurysm in a large patient cohort. Circ Cardiovasc Interv 2014;7:207–15. [16] Hackl G, Gary T, Belaj K, Hafner F, Eller P, Brodmann M. Risk factors for puncture site complications after endovascular procedures in patients with peripheral arterial disease. Vasc Endovascular Surg 2015;49:160–5. [17] Walker C. Pedal access in critical limb ischemia. J Cardiovasc Surg (Torino) 2014;55: 225–7. [18] Hessel SJ, Adams DF, Abrams HL. Complications of angiography. Radiology 1981; 138:273–81.
Please cite this article as: Patel A, et al, Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease, Cardiovasc Revasc Med (2016), http://dx.doi.org/10.1016/j.carrev.2016.10.003