Balloon-assisted ExoSeal closure for inadvertent subclavian artery cannulation following central venous catheterization: A case report

Abstract

Accidental arterial puncture is a rare but significant complication associated with central venous catheterization. This report describes a case of inadvertent subclavian artery catheterization that was successfully managed with the ExoSeal vascular closure device. A female patient in her early 30s was hospitalized for severe acute pancreatitis that necessitated cannulation of the right subclavian vein. Postprocedure, infusion difficulties suggested a need for arterial catheterization, which was confirmed by imaging. The intervention resulted in prompt hemostasis and prevented further vascular injury, resulting in complication-free recovery. This case highlights the importance of rapid identification and treatment of arterial injury during central venous catheterization, and also demonstrates the effectiveness of ExoSeal in the management of vascular complications, especially in high-risk conditions.

Introduction

Central venous catheterization (CVC), involving catheter insertion into a central vein, ¹ is widely used for prolonged medical therapies, laboratory analyses, blood collection, continuous hemodynamic surveillance, blood transfusion, and fluid administration. ² The catheter enables safe and effective administration of medication, as well as the ability to monitor central venous pressure, blood gases, and electrolytes, in critically ill patients. Inadvertent puncture of the subclavian artery during catheterization is a rare but potentially life-threatening complication. ³ This report describes a case of accidental subclavian artery puncture that was successfully treated with a balloon-assisted ExoSeal vascular closure device, demonstrating the safety and efficacy of this procedure for this rare complication.

Case report

In June 2021, a female in her early 30s was admitted to the Lanzhou University Second Hospital with recurrent upper abdominal pain accompanied by nausea and vomiting. Computed tomography (CT) scans indicated acute pancreatitis, which was confirmed by measurement of blood amylase (1197 U/L) and lipase (> 2000 U/L). The patient subsequently underwent right subclavian vein cannulation on June 2021, due to her critical condition. The procedure involved the implantation of a double-lumen catheter (7Fr) deep within the vein. However, after fluid infusion, it was observed that the fluid levels fluctuated in response to the patient's heart rate, indicating incorrect insertion of the catheter into the subclavian artery. This complication may have resulted from a lack of ultrasonography guidance during catheterization.

The following day (approximately 20 hour later), the double-lumen catheter was removed. The patient was placed in the supine position and was anesthetized through local infusion of the right femoral artery. Digital subtraction angiography (DSA) showed satisfactory blood flow through the catheterization site in the right subclavian artery, with the double-lumen catheter visible within the subclavian artery (Figure 1(a)). A 6F sheath (RS*A60K10SQ, TERUMO) was introduced via the right femoral artery and was guided into the right subclavian artery using a guide wire. The location of the puncture in the subclavian artery was determined using DSA and blood pressure monitoring. A sacculus (POWERFLEX^®, Cordis; 8 mm * 6 cm) was inserted into the artery after replacement of the guide wire with a 0.018 mm guide wire. This guide wire was then introduced into the catheter in the right subclavian artery.

Figure 1.

The surgical procedure. (a) Deep vein transcatheter angiography confirmed accidental catheterization of the subclavian artery. (b) A 6F vascular sheath was guided via a guide wire into the artery. The ExoSeal device was then implanted via the vascular sheath. The sacculus was filled using a pressure pump, finger pressure on the skin helped prevent hematoma development. (c) Subclavian arterial angiography revealed no evidence of postoperative bleeding.

The catheter was removed after using the sacculus to block the right subclavian artery, and an ExoSeal vascular closure device (ExoSeal^TM, and Cordis) was then used to close the right subclavian artery. The sacculus was released after the subclavian artery was stopped for three minutes at the inferior artery puncture (Figure 1(b)). At the site of the right subclavian artery puncture, DSA indicated an absence of bleeding (Figure 1(c)). The right inguinal sheath was then removed, followed by the guide wire. The puncture site was covered with pressure, and no localized hematoma development was observed at the neck or groin.

The patient reported no significant postoperative discomfort, expressing satisfaction with the rapid diagnosis and effective management provided by the medical team. The patient and her family appreciated the timely identification and intervention of the inadvertent arterial puncture, noting that the treatment was minimally invasive and caused minimal stress.

The patient provided written informed consent for this report. The article was prepared following the CARE guidelines. ⁴

Discussion

Causes and manifestations of accidental subclavian artery puncture

Accidental catheterization of the subclavian artery can result from incorrect selection of the puncture point or overly deep puncture during deep vein catheterization. Ultrasound guidance in real-time reduces the likelihood of this complication as reliance on traditional anatomical landmarks can cause errors. Common clinical signs include difficulty in fluid administration, fluid reflux, and variations in fluid levels corresponding with the patient's heart rate. Assessment of the puncture site frequently reveals a detectable pulse, an essential diagnostic indicator. Diagnostic imaging, including color Doppler ultrasonography, can provide further evidence of the arterial puncture. ⁵

Studies indicate that mechanical complications related to central venous catheterization occur in 5% to 19% of cases, with arterial injury, the most severe complication, reported in 3.7% to 8% of procedures.^6,7 This relatively high rate highlights the importance of following instructions and having uniform training when performing catheterization procedures. Patients with arterial puncture may experience severe side effects, such as hematoma, pseudoaneurysm development, arterial bleeding, occlusion, or peripheral embolism if the cause is not identified and treated promptly. In addition to increasing morbidity, these complications can result in longer hospital stays and high medical expenses.

The application of real-time ultrasound guidance can reduce these complications by as much as 75%, highlighting its role in enhancing the safety and outcomes of the procedure. ⁸ This emphasizes the importance of incorporating ultrasound guidance as a routine practice, particularly for high-risk patients or emergencies.

Considerations for surgical access: Advantages of the femoral artery approach and limitations of the radial artery pathway

The selection of the pathway of surgical access is of critical importance in the treatment of arterial injuries. Although the radial artery could serve as an access route, this is associated with various difficulties. Insertion of a guidewire into the subclavian artery via the contralateral radial artery necessitates exceptional technical precision. The procedure can also be time-consuming, potentially extending the length of the operation and increasing perioperative risks, especially in high-risk patients. ⁹ Furthermore, use of the ipsilateral radial artery approach can interrupt the blood flow and cause arterial injury, increasing the risk of radial artery thrombosis. ¹⁰ These risks are more serious in critically ill patients who are more susceptible to ischemic damage and thrombotic events.

Access via the radial artery is associated with difficulties as the size and tortuosity of the vessel can vary significantly among patients, complicating guidewire navigation. ¹¹ Thus, irrespective of whether it is contralateral or ipsilateral, radial artery access is frequently considered unsatisfactory in complex cases.

In comparison, the femoral artery presents a more secure and easily accessible option. Its greater size and relatively simple anatomical position enable guidewire installation and minimize procedural complexity. Access via the femoral artery also reduces the risk of complications related to vascular manipulation, including thrombosis and arterial injury. ¹² It has been found that femoral artery access is associated with fewer complications and shorter procedural times relative to radial artery access, particularly in high-risk patients. ¹³ Furthermore, it has been demonstrated that ultrasound guidance further reduces the risk of complications, improving procedural safety and effectiveness. In this case, the femoral artery was selected due to these advantages to simplify the process while minimizing risks. ¹⁴

Advantages of using ExoSeal versus other methods for hemostasis

For accidental punctures of the subclavian artery, traditional methods such as manual compression are still widely used. However, as the subclavian artery is located below the clavicle, this method is often ineffective. Manual compression requires a significant amount of time and may cause discomfort to the patient, especially when the patient is in a critical condition and requires prolonged immobilization. In cases where manual compression is ineffective, additional risks may arise from surgical procedures (including vascular incision and suturing). ¹

Independent balloon compression is a minimally invasive method with a success rate of 85% to 95% in specific cases; however, its efficacy is limited in duration and depends on the operator's skill level. Complications such as thrombosis have been observed in 10% of cases. ² This condition (inadvertent subclavian artery cannulation) can also be treated by interventional surgery to place a covered stent but this method is costly, and the stent may not have adequate anchorage at the opening of the vertebral artery opening, increasing the risk of postoperative stent fracture or loosening. ¹⁵ Additionally, stent placement may be associated with complications such as postoperative infection and stenosis.^16,17

Vascular closure devices (VCDs) are commonly used for hemostasis in clinical practice, and are generally divided into two major categories, namely, intravascular and extravascular sealing devices, ¹⁸ represented by Angio-Seal and ExoSeal, respectively.

Angio-Seal is an intravascular sealing device for arterial puncture sites that employs an intraluminal anchoring mechanism. During deployment, the anchoring device attaches securely to the arterial wall at the bleeding site. This is followed by external deployment and tightening of the collagen plug at the puncture site. ¹⁹ Both the anchoring device and collagen plug are composed of biodegradable materials that are absorbed gradually over time. Angio-Seal is associated with a high procedural success rate (95%), a low device failure rate, and a low incidence of vascular complications (approximately 4.5%).^20,21 However, the use of intraluminal anchoring devices may increase the risk of infection.

Compared to Angio-Seal, the ExoSeal device uses a synthetic absorbable polyglycolideacid (PGA) embolization plug, which is externally deployed to the arterial puncture site via a contracting delivery catheter and achieves hemostasis through external compression of the vessel wall. ExoSeal can be retrieved and redeployed in cases where the initial deployment fails. ¹⁹ Compared to Angio-Seal, ExoSeal has similar rates of vascular complications and device failure (2.7%–7.2%) and a comparable surgical success rate (approximately 98%), while being easier to operate.^22,23 Due to these practical advantages, ExoSeal was selected as the vascular closure device in this case.

Limitations

The limitations include the description of a single case, which restricts the generalizability of the findings. Additionally, outcomes may depend significantly on operator experience and facility availability, suggesting potential variability in broader clinical applications. Future studies with larger sample sizes are necessary to verify the effectiveness and safety of this intervention more comprehensively.

Conclusion

Inadvertent catheterization of the subclavian artery is an uncommon but significant problem. This case study demonstrates the effective application of ExoSeal, which achieved rapid hemostasis and prevented complications. ExoSeal is a reliable, minimally invasive option, especially in high-risk scenarios.