Complications associated with the Angio-Seal arterial puncture closing device: Intra-arterial deployment and occlusion by dissected plaque
Article Outline
The Angio-Seal arterial closure device is widely used to prevent bleeding and facilitate early ambulation after arterial puncture. We had referred to us three female patients in whom this device had been used; its sponge had been unintentionally deployed in the arterial lumen. In a fourth female patient, a dissected plaque underneath the device occluded the femoral artery. Severe lower extremity ischemia occurred in each case. One intraluminal sponge was detected only after 20 days, when the patient had developed severe symptoms due to microembolization; in another patient, ischemia occurred 9 days after intraluminal deployment. In two, or possibly three, of the cases, the superficial femoral artery had been punctured. The device should not be used when the superficial femoral artery has been punctured, in which case complications are more likely to occur. Lower limb ischemia within several months after deployment of these devices should be investigated with duplex ultrasound scanning to examine the possibility that the ischemia may be caused by the device or by device-related thrombus. It is important to register the use of such devices in the procedural reports to make it possible to link their use to eventual later ischemic events.
Although meta-analyses have failed to show any advantage of arterial puncture closing devices compared with mechanical compression and despite their higher costs, they are increasingly being used to prevent bleeding and facilitate early ambulation after arterial puncture.1, 2, 3 The Angio-Seal (St Jude Medical, St Paul, Minn) arterial closure device, composed of an absorbable collagen sponge and an absorbable suture and anchor and intended for closure of puncture holes in normal arteries, has shown a trend toward performing better than other devices and having fewer complications than manual compression in a percutaneous coronary intervention (PCI) setting.3 During a 6-month period, at our hospital we treated three patients in whom this device had been used and in whom its sponge component had unintentionally been deployed in the arterial lumen. In a fourth patient, a dissected plaque underneath the device occluded the artery. All devices, three 6F and one 8F, were deployed by experienced interventionists; three were cardiologists, and one was radiologist. All devices were appropriate for the size of sheath used for vascular access. A femoral angiogram was performed before deployment of the Angio-Seal in case 2 only.
Case reports
Case 1
An 85-year-old woman underwent a PCI for the second time within 3 months because of unstable angina and three-vessel disease. Nine days after the PCI procedure, her left leg turned pale, cold, and painful, and sensibility was reduced. Pulses in the left groin were weak, and there were no audible Doppler signals at the left ankle. Acute embolization was suspected, and she was operated on under general anesthesia. There was a pronounced fibrotic reaction surrounding the groin vessels secondary to a hematoma after the PCI. An Angio-Seal suture was seen to protrude from a sealed puncture hole in the superficial femoral artery (SFA). In this patient, the division of the common femoral artery was located uncommonly proximally, perhaps explaining why the puncture site was in the SFA rather than in the common femoral artery. Upon opening the SFA, the Angio-Seal sponge with attached thrombus was found to totally occlude the SFA. The Angio-Seal sponge with adjacent thrombi was removed from the artery, which was then closed with a polyester urethane patch (Vascular-patch, B. Braun Medical AG, Tuttlingen, Germany) to avoid narrowing. The artery reoccluded 2 days later because of a dissected intima. The patient underwent successful reoperation with thromboendarterectomy 6 days after the first operation. At 1-month follow-up, she was well and had no claudication.
Case 2
A 60-year-old woman with intermittent claudication after walking 20 m and bilateral iliac arterial stenoses underwent bilateral iliac artery percutaneous angioplasty and stenting. An Angio-Seal device was used for arterial closure in the left groin. Immediately after the procedure, she developed ischemic pain in the left leg. Pulses could be palpated in the groin but not further distally on the left side. She was given fluid and low-molecular-weight heparin. Duplex ultrasound scanning (DUS) showed a nearly occlusive mass with a suture-like tail in the proximal SFA. The tail projected out through the arterial wall. The finding was suggestive of a dislodged Angio-Seal device. She was operated on under local anesthesia. The Angio-Seal device was located in the proximal part of the SFA. It was removed through a longitudinal arteriotomy placed directly over it. The patient later needed additional bilateral stenting in the common iliac arteries because of dissection at the distal ends of the first iliac stents. One month later, the ankle-brachial pressure index was 1.0 bilaterally, and the patient had no symptoms of claudication.
Case 3
A 51-year-old woman with a familial predisposition to coronary artery disease and a history of smoking underwent coronary angiography after an episode of chest pain. An Angio-Seal device was used for arterial closure. Immediately after leaving the angio suite, there were signs of ischemia in the right leg, which became pale and painful. The acute ischemia ameliorated after approximately an hour. DUS by an experienced cardiologist showed triphasic flow and normal color filling from the aortic bifurcation to the proximal leg arteries on the right side. In the following weeks, the patient developed right leg claudication after walking 200 m and had frostbite-like pain in the toes and sole of the right foot. Nineteen days after the angiography, she was admitted to our hospital with intense rest pain in the toes and sole of the right foot. The fifth toe was slightly cyanotic. On the following day, there was found to be normal capillary refilling in both feet and palpable pulses in the right dorsalis pedis and posterior tibial arteries. Duplex examination of the arteries from aortic bifurcation to crural arteries showed a mass in the right common femoral artery with a suture-like tail projecting into the SFA (Fig 1). There was intense tenderness of the sole of the foot and the toes on the right side. The acute pain was ascribed to microembolization. She was given aspirin and low-molecular-weight heparin, and the next day the pain in the right foot was markedly reduced. The mass, an Angio-Seal sponge with suture, was removed through a small arteriotomy on the common femoral artery under local anesthesia (Fig 2).
Fig 1.
In case 3, the Angio-Seal device was located in the distal common femoral artery with the resorbable suture (arrow) projecting into the superficial femoral artery. The distance marked on the figure is 0.53 cm and represents the width of the Angio-Seal sponge.
Fig 2.
Angio-Seal with thrombus and intima from case 3 after fixation in formaldehyde. A fragment of the resorbable suture is seen in the right lower corner.
Case 4
An 84-year-old woman underwent coronary angiography for suspected myocardial infarction through the right groin. When three-vessel disease was found, PCI was first considered not indicated, and an Angio-Seal device was deployed. After discussion, PCI was after all found to be indicated and was performed through the left groin. Immediately afterward, the right leg became cold and painful, and low-molecular-weight heparin was administered, whereafter the ischemia improved somewhat. The next day, the right ankle-brachial Doppler pressure index was 0.14. There were no pulses in the popliteal artery, and DUS showed occlusion of the right common femoral artery. The patient was subsequently operated on under local anesthesia. An Angio-Seal sponge was found on the wall of the common femoral artery, with the intima immediately underneath dissected off the wall, causing arterial occlusion. The sponge and dissected intima were removed. After surgery, she had no more pain in the right leg, where the circulation was clinically normalized. Apart from a wound hematoma that resolved spontaneously and slightly reduced sensitivity in the medial part of the right foot, the further course was uneventful.
Discussion
One important finding in this study is that an intraluminally deployed Angio-Seal device may be overlooked and remain undetected despite DUS when the remaining lumen is of sufficient size to allow adequate flow. In case 3, the intraluminally deployed device may have been mistaken for a plaque at the initial DUS. Only the resorbable suture is of telltale diagnostic importance. If the suture is missed on examination, the diagnosis of a misplaced hemostatic device may be overlooked. The intraluminally placed device was detected only when the patient developed severe symptoms 19 days later because of microembolization. Symptoms that occur later because of microembolization from device-associated thrombi or because of embolization of the device itself or its components may not always be ascribed to the device. It is therefore important to record the use of Angio-Seal in the procedural report to make it possible to link its use to eventual later ischemic events.
All four of our patients were women. Other studies have shown that odds for severe access complications secondary to the use of collagen-based vascular closure devices are two to eight times higher in women than in men.4, 5, 6, 7 This is thought to be related to smaller arterial diameters in women.4 Presumably, intraluminally placed Angio-Seal sponges lead to more severe stenosis in thin female arteries than in larger male ones, although large vessel size does not preclude total occlusion if any collagen is inside the lumen. Another possible explanation as to why complications, including intra-arterial deployment, are seen more frequently in women could be that the 10-mm-long anchor of the device may be more likely to be caught by a plaque when it is being retracted toward the wall in arteries with smaller luminal diameters.5 This, in our opinion, was the most likely mechanism causing dissection in case 4. Predeployment DUS might therefore be recommended to reduce complication rates selectively in women.
The four patients who had an Angio-Seal sponge removed from their arteries during the 6-month period translate to an incidence of approximately 1 per 275 devices on the basis of the number of devices used during 2005. In another study, 1 artery occlusion due to an Angio-Seal device deployed inside an artery was found after 220 deployments in 186 patients.8 In yet another study, acute femoral artery occlusion related to the use of the Angio-Seal device occurred in 5 of 742 deployments.9 Femoral angiography was, however, not recommended by the producer and was not routinely performed at that time. For comparison, acute occlusions have been found in less than 0.2% using compression techniques for sheath removal.5, 10
The suture fractured easily when the Angio-Seal was removed from the artery in case 3, 20 days after implantation. It is therefore conceivable that the suture or anchor may break off and embolize after several weeks when the degradation has weakened the resorbable suture material sufficiently.
Although it may be practically impossible to link the cause of newly developed lower limb ischemia to the implantation of an intra-arterial hemostatic device several weeks earlier, such a case has been reported by Shaw et al.11 In their report, ischemic symptoms occurred 3 months after implantation. An eccentric, almost occluding, lesion in the femoral artery dislodged to the popliteal artery during attempted balloon angioplasty. The mass was interpreted as being the anchor of the device. The mass was, however, big enough to totally occlude the popliteal artery and was similar in appearance and size to the sponges removed from our cases. Therefore, in our opinion, it most likely represented an intravascularly deployed Angio-Seal sponge.
In conclusion, as illustrated by our case 3, intra-arterial sponge deployment may remain undetected, and ischemic symptoms may occur several weeks after intra-arterial deployment of the Angio-Seal device. Every instance of lower limb ischemia within several months after deployment of such devices should be investigated with duplex ultrasonography to exclude the possibility that the ischemia may be caused by the device or by a device-related thrombus. Fluoroscopy is recommended to ensure that the puncture site is in the common femoral artery. If the SFA has been punctured, it is not advisable to use the device.
We are indebted to Torbjorn Jonung, MD, PhD, for providing case 4.
References
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Competition of interest: none.
PII: S0741-5214(06)01307-3
doi:10.1016/j.jvs.2006.07.034
© 2006 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
