JetStream Atherectomy for Treating Iatrogenic Occlusion of a Stented Common Femoral Artery Following Deployment of Angio-Seal Closure Device

Abstract: We report a case of a stented common femoral artery acute occlusion following deployment of an Angio-Seal closure device treated successfully with JetStream atherectomy under distal embolic protection using a NAV6 filter. The JetStream device, with its rotational atherectomy and continuous active aspiration feature, was effective in restoring normal flow to the distal lower extremity and eliminated the subtotal occlusion. Debris was captured in the filter and was retrieved successfully. The NAV6 filter seems uniquely suited for use in conjunction with the JetStream device because its filter is detached from the wire, allowing free wire movement with atherectomy. The JetStream device with NAV6 embolic capture system appears to be an effective method in treating stented common femoral artery occlusion following Angio-Seal deployment.  

J INVASIVE CARDIOL 2013;25(9):475-477

Key words: common femoral artery, Angio-Seal, limb ischemia, 

stent, atherectomy, distal embolization, closure device

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Arterial closure devices (ACDs) are commonly used to close the arteriotomy site in the common femoral artery (CFA) following angiographic coronary or peripheral vascular procedures. One advantage of most ACDs is early ambulation and less need for compressing the CFA for a prolonged period of time to achieve hemostasis. The Angio-Seal (St Jude Medical, Inc)^1-4 is an active closure device that is widely used and has been shown in randomized trials in low-to-medium risk patients to achieve faster hemostasis, lower rates of bleeding, and overall low complication rates.¹ However, observational data from a large meta-analysis showed that ACDs may have higher complications than manual compression when high-risk patients are included.² One complication is acute closure of the CFA by inadvertently introducing collagen intravascularly. Other complications include major bleeding, infection, vascular injury such as pseudoaneurysm, and emergent vascular surgery. 

We report a case of iatrogenic closure of a stented CFA following Angio-Seal deployment treated successfully with the JetStream Navitus (2.1-3 mm; Bayer Interventional) under embolic filter protection with the NAV-6 filter (Abbott Vascular). The JetStream is a rotational atherectomy device with aspiration capacity approved by the United States Food and Drug Administration (FDA) for treatment of lower-extremity arterial obstructive disease. Its application in our case has not been reported and is off label. The rationale and potential complications of this device in this setting are discussed in this report.

Case Report

A 65-year-old female with history of hypertension, hyperlipidemia, prior smoking history, and coronary artery disease underwent successful percutaneous coronary intervention via the left CFA. The patient had prior stenting to her CFA bilaterally including a covered stent to her right CFA several months prior to this procedure. Upon completion of the procedure, a 6 Fr Angio-Seal vascular closure device was then deployed successfully with good hemostasis. The next morning, the patient complained of tingling and numbness in her left lower leg. Pulses in the pedals were markedly diminished and were very faintly appreciated with a Doppler. After informed consent, the patient was brought to the angiography laboratory for consideration of angiography and revascularization of her left lower extremity. Contralateral access from the right CFA showed a subtotal hazy occlusion of the left CFA at the site of the Angio-Seal deployment with faint flow into the left superficial femoral artery (SFA) (Figure 1).  

Our vascular service was consulted for definitive treatment while she was in the angiography laboratory. Pros and cons of treatment were discussed. The patient had a stent in her left CFA, which would complicate surgical intervention. Also, she had a recent arteriotomy in her left CFA, which would increase her risk of bleeding. Balloon angioplasty alone is suboptimal, since distal showering of the debris and thrombotic occlusion of the left SFA would likely occur. Filters would be suboptimal in the setting of balloon angioplasty alone given the size of the collagen debris in her vessel that would completely overfill and obstruct the filter. Manual or mechanical aspiration is unlikely to be effective because of the hard consistency of the collagen. With no clear optimal method on how to treat this complication, we elected to proceed with combined rotational atherectomy and aspiration using the JetStream device. The device theoretically would cut and aspirate the occlusive collagen and minimize distal embolization. Potential bleeding from the arteriotomy site could be handled with occlusive balloon angioplasty in the CFA. The device, however, has a theoretical disadvantage, particularly with blades-up, since no data exist on the interaction of the blades with the stent within the treated segment. Distal embolization may still occur with this device despite suctioning and can still lead to collagen debris downstream. 

The right CFA 6 Fr sheath was then exchanged with a 7 Fr Destination guiding catheter (Terumo Medical), which was then placed into the contralateral proximal left external iliac vessel. After the administration of 5000 units of unfractionated heparin, the lesion was crossed with a Whisper ES 0.014˝ wire (Abbott Vascular). The filter was then changed to a Spider filter (Covidien) placed into the middle SFA. The JetStream Navitus device (2.1-3 mm) was then advanced to the lesion site and 4 blade-down runs were performed. The filter did move forward with the runs. The Spider was then removed and changed to a NAV6 filter. The NAV6 was chosen because the filter is not attached on the wire and therefore provides free movement of the wire with no filter movement. Four additional blade-down runs and 4 blade-up runs were performed with stable filter position. Runs were performed at a rate of 1 mm per second. The JetStream was then removed and angiography performed, revealing less than 30% residual haziness in the left CFA. Angioplasty was then performed with a 6.0 x 40 mm EverCross balloon (Covidien) at 4 atm with 0% residual stenosis (Figure 3) and restoration of normal flow. The NAV6 was removed and small microdebris were noted. Final angiogram using digital subtraction angiography revealed excellent flow down the tibial vessels and no distal embolization. There was no compromise or debris in the profunda femoris artery (PFA). Placement of a filter in the PFA is technically not feasible with the JetStream device, since its wire will be running parallel to the SFA filter wire and will likely be damaged by the rotating blades. The right CFA sheath was then removed when the activated clotting time was less than 170 seconds and good hemostasis with manual compression was achieved. Manual compression was chosen to minimize another potential ACD complication in the right CFA at the site of a covered stent. The patient was kept on her dual-antiplatelet therapy with clopidogrel and aspirin and discharged home the following day. The patient was seen on follow-up at 1 month after the procedure and had no symptoms of claudication or groin-site complications. 

Discussion

Stenting of the CFA is uncommon and generally highly discouraged. However, bail-out stenting of the CFA may become necessary in certain exceptional situations where a major flow-limiting dissection occurs during the treatment of the CFA with balloon angioplasty or atherectomy, or in a patient with CFA embolic occlusion that fails lytic and aspiration therapy and surgery is prohibitive in the setting of thrombolysis, or in case of major bleeding from the arteriotomy site where immediate closure of the site with a covered stent becomes necessary and surgery is not an option. Review of records in this patient indicated that stenting of the right CFA was performed with a covered stent because of an arteriotomy site bleed and of the left CFA because of a flow-limiting dissection during a prior treatment.  

Several infrequent complications have been reported with ACDs, including major bleeding, acute vessel closure, groin infection, pseudoaneurysm, and arteriovenous fistula.^1-3 There are several predictors of complications with ACDs, including advanced age, complex coronary interventions, use of preprocedure anticoagulants, female gender, small CFA, and presence of peripheral arterial disease.¹ The presence of a stent in the CFA can complicate further hemostasis if the stented segment was accessed with various sheath sizes. 

It is unclear what the best strategy is in closing arteriotomy sites through stented vessels and whether this increases the risk of ACD complications. Manual compression may at least theoretically lead to long compression time of the stented segment and increase the rate of stent thrombosis. On the other hand, stents may interfere with the adequate deployment of active closure devices, such as the Angio-Seal, where the intravascular anchor may get stuck on stent struts and subsequently allow the introduction of collagen inside stented segments. There are no data on the optimal closure method of an arteriotomy site within a stented segment in the CFA for either manual compression or closure device use. 

There is no consensus on how to treat collagen-induced closure of stented CFA. Iatrogenic closure of non-stented CFA has been treated in case reports with plain old balloon angioplasty, stenting of the CFA with nitinol stents or covered stents, surgery, and atherectomy.^5-7 Treating an acute collagen occlusion within a stented segment can lead to distal embolization or major bleeding from the arteriotomy site. Collagen distal embolization may precipitate distal thrombosis and limb ischemia. An atherectomy device with continuous active suction capabilities, such as the JetStream device, may have a unique advantage in minimizing distal embolization. Despite the suction mechanism, distal embolization may still likely occur and therefore our practice has been to use a filter with the JetStream device when treating high-risk lesions, such as thrombotic occlusions or long in-stent restenotic lesions. We noted that the Spider filter has a disadvantage with the JetStream, since the filter basket is attached to its wire and therefore can move with the Jetstream’s forward motion. The uniqueness of the NAV6 is in the independent free movement of its BareWire from the filter, allowing no motion of the filter during JetStream atherectomy. In addition, the NAV6 filter has a very high capture rate preventing clinically important collagen distal embolization. In our case, the combination of the JetStream Navitus atherectomy with the NA6 filter allowed excellent results with removal of the intravascular collagen, and prevented the need for additional stenting. The filter did capture debris that was successfully retrieved and no distal to filter embolization occurred. 

To our knowledge, this is the first reported case in the literature with iatrogenic collagen occlusion of a previously stented CFA from Angio-Seal that was successfully treated with JetStream atherectomy and a NAV6 filter. In our experience, the Spider Filter is not ideal with the JetStream because of its migration with the forward advancement of the device. This method may offer an alternative effective technique to treat Angio-Seal induced closure of the CFA. More data, however, are needed to clarify the safety and effectiveness of this treatment. Data on the interaction between the JetStream device and stents in the treated vessel are also needed.

References

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