Abstract
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.
Highlights
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Pedal artery pseudoaneurysm (PSA) related to access complicating transpedal access (TPA) catheterization is reported.
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PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access.
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It is easily treatable by ultrasound guided thrombin injection without complications.
1
Introduction
Percutaneous vascular intervention is a popular initial approach taken to treat symptomatic peripheral arterial disease (PAD) over surgical intervention . 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 . A substantial proportion of these complication were related to the femoral artery access which was the initial approach taken by the operators . For coronary intervention, there was a rise in the radial artery approach as it was associated with a significant reduction in these complications . Of all the vascular related complication, post catheterization PSA is a rare one, it is seen in the range of about 0.05–6% in transfemoral approach and <0.1% in transradial approach . 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 . 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 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 > 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 . 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 , success and complication rates were evaluated. The Institutional review board approved this study and all patients signed an informed consent prior the procedure.
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 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 > 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 . 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 , 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. 2 A ), 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. 2 B). Repeat ultrasound one month after the diagnosis in these cases showed no PSA and patency of the vessel.
