Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia?

PURPOSE: Mechanical closure devices for arterial hemostasis after angiography, such as the Perclose suture-mediated closure system, are designed to decrease time to ambulation and improve patient comfort. Although these devices are safe and efficacious, to date there has been little reported about use of the Perclose device in a cohort consisting exclusively of patients with lower extremity peripheral vascular disease. The purpose of this study was to determine the safety and efficacy of routine use of the Perclose system in patients with documented peripheral vascular disease undergoing angiography to treat chronic lower extremity ischemia. METHODS: The Perclose device was placed for arterial closure after femoral artery access in 500 consecutive patients with documented peripheral vascular disease (ankle-brachial index, <0.8) who underwent diagnostic angiography or percutaneous intervention because of chronic lower extremity ischemia. These 500 patients composed 91% of all patients who underwent angiography because of chronic lower extremity ischemia between January 1, 2001, and April 1, 2002. All complications associated with the Perclose device were identified and reviewed. RESULTS: Of the 500 arteries, 54% were accessed for diagnostic angiography and 46% for intervention. Perclose device placement was successful in 475 attempts (95%). Overall major complication rate was 1.4% (7 of 500 arteries). Complications included one death from retroperitoneal hemorrhage; three episodes of limb ischemia, two requiring operation and one requiring lytic therapy; two pseudoaneurysms; and one hematoma, which prolonged hospitalization. The hematoma was the only complication in the 25 patients with failed Perclose device placement. There were no infections requiring admission or operation. CONCLUSION: The Perclose suture-mediated closure device is efficacious and can be used safely in selected patients with documented peripheral vascular disease. Complications associated with this device tend to be more severe than those historically reported for manual compression. Substantial experience with use of this device is required to achieve excellent results in patients with difficult anatomy.     

Complications associated with the Angio-Seal arterial puncture closing device: intra-arterial deployment and occlusion by dissected plaque

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.     

Management of acute lower limb ischemia associated with the Angio-Seal arterial puncture closing device

Arterial percutaneous closure devices (APCD) could lead to severe vascular complications, like acute lower limb ischemia. The aim of this study was to evaluate retrospectively our personal series of acute lower limb ischemia following the use of APCD. From January 2004 to June 2009 the Angio-Seal percutaneous closure devices was deployed in 198 patients. Eight (4%) acute lower limb ischemia required urgent surgical repair. The device was removed in all cases. A thromboembolectomy was performed in five patients (62.5%) and in three (37.5%) an endarterectomy with patch closure was carried out (two saphenous vein and one Dacron). Limb salvage rate was 87.5%. We compared Angio-Seal complications group (A) with the 190 patients in which the Angio-Seal was successfully used without complications (group B) by means of Student's t-test. At 36-month follow-up with color-coded duplex ultrasounds, no chronic limb ischemia or other complications requiring surgical repair occurred. Diabetes, obesity, severe femoral atherosclerotic involvement, use of sheath size >7 Fr and time-consuming procedures were significant risk factors for ischemic APCD complications. Despite vascular injuries being uncommon after APCD deployment, generally a complex surgical repair is necessary. A more careful patient selection would be advisable.     

Infectious and Ischemic Complications from Percutaneous Closure Devices Used after Vascular Access

The introduction of percutaneous closure devices (PCDs) to seal arteriotomy sites following percutaneous vascular access (PVA) can lead to greater complications than those with manual compression. The aim of this study was to compare complications and outcome between patients requiring surgery after receiving a PCD and those undergoing standard manual compression. This retrospective study evaluated 56 patients (mean age, 63 years) requiring surgical intervention from January 1, 1998 to April 30, 2002, following complications of PVA. Operative indications were pseudoaneurysm, hemorrhage, infectious complications, and limb ischemia. Patients were divided into two groups for comparison: group I (n = 15, PCD) and group II (n = 41, no PCD). In group 1 patients there were 18 limbs in which 20 Perclose devices were used and 1 limb in which a Duett device was used. From the outcomes in these two groups we concluded that patients undergoing surgical intervention following complications of PVA are at a significantly increased risk for infectious and ischemic complications and require more complex vascular repair when percutaneous closure devices are used.     

Histologic and duplex comparison of the perclose and angio-seal percutaneous closure devices

The intravascular and extravascular effects of percutaneous closure devices have not been well studied. We assessed the performance and healing characteristics in dogs of two devices approved by the US Food and Drug Administration. Nine adult male dogs were anesthesized prior to percutaneous access of both femoral arteries with a 6F sheath. All dogs were systemically heparinized to an activated clotting time (ACT) > 250 seconds. Duplex sonography was performed preoperatively to measure vessel diameter and flow velocity. In each dog, one of two devices (Perclose, Abbot Laboratories, Abbott Park, IL or Angio-Seal, St. Jude Medical, St. Paul, MN) was randomly deployed into one of the two femoral arteries. The other device was deployed on the opposite side. Duplex sonography was repeated immediately after deployment and 28 days later to measure changes in vessel diameter and flow velocity. At 28 days, angiography was performed on both femoral arteries before they were removed for histologic evaluation. The time required to excise each vessel reflected the degree of scarring. Hemostasis time for the Angio-Seal device far surpassed the Perclose device (39 +/- 7 vs 0 minutes; p < .05). Vessel narrowing was observed only at 28 days after deployment of the Angio-Seal device (p < .05). Extensive extravascular scarring was observed with the Angio-Seal device, which resulted in a longer femoral artery dissection time and greater periadventitial scar thickness compared with the Perclose device (p < .05). When compared with the Perclose suture closure device, the Angio-Seal collagen plug closure device prolonged hemostasis time and produced greater vessel narrowing and periadventitial inflammation (extravascular scarring) in a canine model at 4 weeks.     

Canadian experience with percutaneous endovascular aneurysm repair: short-term outcomes

Background

To decrease the morbidity associated with cut-downs during endovascular aneurysm repair, some authors have suggested the totally percutaneous endovascular repair (PEVAR). The goal of this report is to evaluate and describe our centre’s experience with the total percutaneous endovascular aneurysm repair (PEVAR) for aortic abdominal aneurysm (AAA).

Methods

We performed a retrospective analysis of 15 consecutive patients with AAA, including 1 with right common iliac artery aneurysm.

Results

There were 12 men and 3 women with a mean age of 74 (standard deviation [SD] 2) years who underwent PEVAR with a Perclose ProGlide suture-mediated closure system between July 2007 and July 2008. All surgeries were elective. Forty percent of patients had a history of smoking, 73% were hypertensive, 33% were diabetic, 20% had chronic obstructive pulmonary disease and 40% had coronary artery disease. Fourteen patients had bilateral deployment for bifurcated devices (7 bifurcated Gore Excluder, 7 bifurcated Cook Zenith grafts), and 1 patient had unilateral deployment for a Cook Zenith device. The outer diameter of the sheaths used for puncture sites was on average 18.1-Fr (SD 0.6), with main bodies being 21.1-Fr (SD 0.3) and contralateral sides 15-Fr (SD 0.3). Procedural success was 93%, with 1 patient requiring a femoral artery cut-down because of failure of the Perclose device to deploy in the groin. Another patient had persistent venous bleeding in 1 puncture site that stopped with skin suturing. Endovascular aneurysm repair was 100% with no conversion to open surgery and no type-I endoleaks. The mean length of stay in hospital was 2.2 (SD 0.4) days. There were no long-term groin complications at 6 (SD 1) months’ follow-up.

Conclusion

To our knowledge, this is the first Canadian report of experience with PEVAR using the Perclose device. The technique is safe, reliable and allows discharge of patients soon after surgery.     

Lower limb ischemic complications after the use of arterial puncture closure devices.

We report three cases of lower limb ischemia occurring after the use of arterial puncture closure devices (APCDs). In two patients, who have undergone percutaneous angioplasty of lower limb arteries, the Angio-Seal APCD led to thrombosis of the common femoral artery. In another patient who has undergone coronary angiography, this device has led to dissection of the common femoral artery. Since these observations seem to not be merely sporadic, radiologists and cardiologists as well as vascular surgeons should be aware of their possible occurrence in order to avoid these complications and to provide promptly an adequate treatment.     

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??Comparation between blood vessel suture instrument and traditional surgical suture in EVAR surgery for abdominal aortic aneurysm: An analysis of 130 cases ZHANG Zheng, CHEN Zhong, TANG Xiao-bin, et al. Beijing Anzhen Hospital ??Capital Medical University, Beijing 100029, China
Corresponding author??CHEN Zhong, E-mail??chenzhong8658@vip.sina.com
Abstract Objective To investigate the application of the Perclose Proglide vascular closure devices in the endovascular abdominal aortic aneurysm repairing operation and its significance. Methods The clinical data of 130 cases of endovascular abdominal aortic aneurysm repairing operation performed between March 2013 and February 2015 in Department of Vascular Surgery??Beijing Anzhen Hospital of Capital Medical University were analyzed retrospectively. Among them, 69 cases were treated with Perclose Proglide vascular closure devices to suture the puncture site of the femoral arteries and 61 cases were treated with the traditional surgical suture to close the puncture site of the femoral arteries. The relationship between the two groups and various clinicopathological factors of patients with abdominal aortic aneurysm were analyzed by Chi-square using statistical software SPSS17.0. The clinicopathological factors include operation successful rate??operation time??intraoperative blood loss??hospital stay??cost of operation??wound healing??lower limb ischemia and so on. Results Analysis using chi-square showed that Perclose Proglide vascular closure devices group was obviously better than the other group in operative time, intraoperative blood loss and hospital stay (P<0.05). Conclusion Comparing with the traditional surgical suture method??Perclose Proglide vascular closure devices are safe and effective. The patients have less injury and can recover more quickly??The Perclose Proglide vascular closure devices are worthy of clinical popularization??     

Percutaneous endovascular repair of infrarenal abdominal aortic aneurysms: a feasibility study

BACKGROUND: Endovascular grafting has markedly reduced the invasiveness of the treatment of abdominal aortic aneurysms. By using a modification of technique for available closure devices, we have been able to achieve percutaneous repair of aneurysms. This study reviewed our initial experience with this technique. METHODS: Demographics and background data from patients undergoing endovascular repair of abdominal aortic aneurysms were reviewed from prospectively collected registry data. Operative notes and angiographic and computed tomography scan data were retrospectively reviewed to assess the success of the percutaneous approach. RESULTS: Fourteen patients have undergone percutaneous placement of the AneuRx (Medtronic, Sunnyvale, Calif) endovascular graft, with a modification of the technique for the Prostar (Perclose, Redwood City, Calif) device for access site closure. Main graft body introduction with a 22F sheath proved successful in nine of 12 (75%) deployments. Contralateral limb deployment through a 16F sheath was successful in 10 of 14 deployments (71.4%). Reasons for conversion to open groin incisions include inadequate percutaneous hemostasis (six cases), iliofemoral dissection (four cases), device failure (one case), and compromised distal flow (one case). Percutaneous deployment success appears to be improved with larger iliac artery dimensions, decreased calcification, and limited tortuosity, because of the limitation of complications related to delivering a larger diameter sheath. Of the 13 percutaneous endograft insertions that were attempted, six (46.2%) were completely successful. CONCLUSION: Percutaneous deployment of available devices is technically feasible by using modifications of technique with percutaneous closure devices, despite large introducer sizes. Further experience with this technique offers the potential for identifying patients in whom this will prove successful and for even further reducing hospital stay and recovery times for aneurysm repair.     

Iatrogenic vascular injuries from percutaneous vascular suturing devices

OBJECTIVE: The purpose of this study was to examine the patterns of injury and the strategies of surgical repair of iatrogenic vascular injuries from a percutaneous vascular suturing device after arterial cannulation. METHODS: We retrospectively reviewed the clinical experience from an academic vascular surgical practice over a 2-year period. The subjects were patients undergoing vascular repair of iatrogenic vascular injury after deployment of a percutaneous vascular suturing device. Interventions were direct repair of arterial injury (with or without device extraction) or arterial thrombectomy and repair. The main outcome variables included patterns of arterial injury, magnitude of arterial repair, limb salvage, hospital stay, and perioperative mortality and morbidity rates. RESULTS: From August 1998 through August 2000, eight patients (4 men, 4 women; median age, 55 years; range, 44-80 years) required vascular operations for complications of percutaneous suturing devices after diagnostic (2) or therapeutic (6) arteriograms through a transfemoral approach. Complications included four pseudoaneurysms (1 infected) due to arterial tear from suture pull through, two entrapped closure devices due to device malfunction, and two arterial thromboses due to narrowing/severe intimal dissection. All patients required operative intervention. Direct suture repair with or without device removal was performed in five patients, arterial debridement with vein patch angioplasty in one patient, and arterial thrombectomy and vein patch angioplasty in two patients. There were no perioperative deaths. The median hospital stay was 5 days (range, 2-33). Limbs were salvaged in all patients with a mean follow-up of 4.8 months (range, 1-13). CONCLUSIONS: Although abbreviated postangiography recovery periods and early ambulation have motivated the widespread use of percutaneous suturing devices, the infrequent occurrence of vascular injuries produced by these devices can be significantly more challenging than simple acute pseudoaneurysms or hemorrhage. In addition, thrombotic complications have a small but finite risk of limb loss.     

Infectious complications resulting from use of hemostatic puncture closure devices

BACKGROUND: Femoral access site complications have increased as the fields of invasive cardiology, radiology, and endovascular surgery have emerged. In order to address one of these complications, hemorrhage, the hemostatic puncture closure devices were developed. METHODS: Retrospective review of cardiac catheterizations performed at a single institution to investigate infectious groin complications related to use of the Perclose Prostar and Techstar devices. RESULTS: Infectious groin complications were significantly higher in the Perclose group as compared with manual compression. Three patients had clinical and laboratory evidence of arterial infection whereas 2 had soft tissue infections. All 5 required operative intervention ranging from incision and drainage to arterial reconstruction. Hemorrhagic complications were not significantly different between the two groups. CONCLUSIONS: The Perclose devices provide hemostasis after femoral artery catheterization similar to manual compression. However, infectious groin complications appear to be more common with these devices.     

Complications associated with percutaneous closure devices.

BACKGROUND: In an effort to reduce time to hemostasis after angiography, several closure devices have been marketed. We report some of their complications. METHODS: A retrospective review was conducted. RESULTS: Over an 8-month study period, 2,181 diagnostic and interventional procedures were performed. Closure devices were used in 408 (19%) of these patients. The Angio-Seal closure device is composed of a collagen sponge and an absorbable polymer anchor that compresses the hole in the arteriotomy. The ProstarXL sealing device consists of a rotating barrel that deploys 4 needles through the arteriotomy, and then individual knots are extracorporeally tied. The Duett device consists of a balloon occluding catheter and injectable collagen and thrombin. Ten of the patients developed a complication from the closure device (2.5%). Four of these were subcutaneous abscesses. Two of these patients had expanding pseudaneurysms, 2 had lower extremity ischemia, and 1 patient had an acute bleed. These complications were all managed surgically. Another patient developed a retroperitoneal bleed that was managed nonoperatively. CONCLUSIONS: As the use of these devices increase, these complications will become more common.     

腹主动脉瘤腔内修复术中血管缝合器与手术切开缝合临床应用对比研究

目的 探讨Perclose Proglide血管缝合器在腹主动脉瘤腔内修复手术中的应用及意义。方法 回顾性分析2013年3月至2015年2月,首都医科大学附属安贞医院血管外科临床确诊腹主动脉瘤并实施腔内修复术的130例病人资料。术中采用穿刺股动脉方法建立入路并使用Perclose Proglide 血管缝合器缝合69例（A组）,手术切开股动脉并缝合61例（B组）。分析两组在缝合成功率、手术时间、术中出血量、住院时间、手术费用、伤口愈合情况、有无下肢缺血等因素,探讨Perclose Proglide 血管缝合器在腹主动脉瘤腔内修复手术中的应用效果。结果 在130例病人中,与手术切开组（B组）相比,使用缝合器组（A组）手术时间更短、术中出血量少、且住院时间较短,且差异均有统计学意义（P<0.05）。结论 在腹主动脉瘤腔内修复手术中,经皮穿刺建立股动脉入路并使用Perclose Proglide 血管缝合器处理穿刺点,该方法安全有效,且创伤小,病人术后恢复更快,值得推广使用。     

Management of infected femoral closure devices

An increase in infectious complications has been noted with the introduction of percutaneous femoral artery closure devices. We report five cases of infected groins and/or femoral arteries following angiographic procedures that were completed using the Perclose Suture Mediated Closure Device (Perclose). Each patient required drainage of the abscess and removal of the Perclose suture. Most patients required more extensive vascular reconstructive procedures. When these complications arise, we recommend expeditious drainage of the abscess, removal of the suture, and adequate exposure of the femoral artery to facilitate repair of the vessel.     

Surgical treatment of complications associated with the Angio-Seal vascular closure device

Vascular closure devices are used to provide quick hemostasis and early ambulation after percutaneous interventions. The Angio-Seal (AS) vascular closure device forms a mechanical seal by closing the puncture site located between a bioabsorbable anchor within the lumen and a collagen sponge on the adventitia. Although morbidities associated with AS are reportedly infrequent, even the slightest inaccuracy in device implantation may result in displacement of these device components, leading to sudden and severe complications. We report the surgical treatment of complications associated with the use of AS in four patients, including acute limb ischemia, pseudoaneurysm formation, significant hemorrhage, and hypovolemic shock. A common factor in all these cases was that the components of the AS device were displaced from their original site of implantation, stressing the importance of proper device placement. All patients underwent successful surgical vascular repair. Our report highlights the need for exercising extreme care during device implantation, and also the requirement for vigilant inspection for any associated vascular complications commencing immediately after device implantation. It is vital that these device components are actively looked for and removed during surgical exploration so as to prevent future complications.     

Embolisation of Angio-Seal™ device: an unusual case of post-cardiac catheterisation limb ischaemia

We present the case of a 67-year-old male presenting with critical limb ischaemia following cardiac catheterisation. Immediately after deployment of an arterial closure device, the patient reported severe lower limb pain with impalpable pulses. Magnetic resonance angiography revealed an abrupt disruption of flow in the tibioperoneal trunk. Subsequent surgery revealed embolisation of the arterial closure device. The patient went on to make an unremarkable recovery.     

Entrapment of a cerebral embolic protection device--a case report

Cerebral protection devices have significantly reduced the incidence of embolic events in patients undergoing carotid stenting. With the increasing availability of such devices an awareness of the potential complications associated with their deployment is essential. Here we report a patient with entrapment of a filter device within a carotid stent that required surgical removal. The mechanisms underlying this complication and measures to prevent its occurrence are discussed.     

Femoral artery infections associated with percutaneous arterial closure devices

Hemostasis obtained by manual compression after femoral artery catheterization results in consistently low rates of major complications. A rare complication of femoral artery catheterization is arterial infection. Its occurrence after diagnostic angiography using manual compression has not been reported. We report two cases of femoral arterial infection after uneventful diagnostic catheterization in nonimmunocompromised patients using the Perclose percutaneous arterial closure device. Our cases are representative of Perclose associated infections, with delayed presentation of a staphylococcal arterial infection requiring arterial debridement and reconstruction. This article indicates that Perclose use carries a risk of severe arterial infection. Surgeons should be aware of the potential infectious complications associated with Perclose use and the need for aggressive treatment.     

Ischemic complications after endovascular abdominal aortic aneurysm repair

OBJECTIVES: Limb and pelvic ischemia are known complications after endovascular abdominal aortic aneurysm repair (EVAR). The objective of this paper is to present our experience with the incidence, presentation, and management of such complications. METHODS: Over 9 years 311 patients with aortic aneurysms underwent EVAR. A retrospective review identified 28 patients (9.0%) with ischemic complications. RESULTS: Among 28 patients with ischemic complications, 21 had lower extremity ischemia and 7 had pelvic ischemia: colon (n = 4), buttock (n = 2), and spinal cord (n = 2). Of the 21 patients with lower extremity ischemia, 15 had limb occlusions (71.4%), 3 due to embolization (14.7%) and 3 the result of common femoral artery thromboses (14.7%). Limb occlusions were manifested as severe acute arterial ischemia (n = 6), rest pain (n = 3), intermittent claudication (n = 5), and decreased femoral pulse (n = 1). Limb occlusions were managed with thrombectomy and stent placement (n = 4), femorofemoral bypass (n = 7), eventual explantation because of persistent endoleak (n = 1), and expectant management (n = 3). The 3 patients with occlusions managed expectantly all had intermittent claudication, which has subsequently improved. In the 6 patients with lower extremity ischemia due to embolization or common femoral artery injury presentation was acute, and embolectomy was performed, followed by femoral artery endarterectomy and patch angioplasty or placement of an interposition graft. One patient who had a prolonged postoperative course including cardiac arrest subsequently required distal bypass and ultimately above- knee amputation. Among the 7 patients with pelvic ischemia, 2 patients had unilateral hypogastric artery embolization before the original surgery. Among the patients with colonic ischemia, 3 were seen immediately postoperatively, and required colectomy and colostomy. Two patients who required urgent colectomy subsequently had multiple organ failure, and died in the perioperative period. One patient had abdominal pain 1 week after surgery, which was managed with bowel rest, with subsequent improvement. In 2 patients spinal cord ischemia developed immediately after surgery, which resulted in persistent paraplegia. Buttock ischemia developed in 2 patients, 1 of whom required fasciotomy because of gluteal compartment syndrome, and had transient renal failure. CONCLUSIONS: Ischemic complications are not uncommon after EVAR, and may exceed the incidence with open surgical repair. Limb ischemia is most often a result of limb occlusion, and can be successfully managed with standard interventions. Pelvic ischemia often results from atheroembolization despite preservation of hypogastric arterial circulation. Colonic and spinal ischemia are associated with the highest morbidity and mortality.     

Closure of major diabetic foot wounds and defects with external fixation

Amputation may become unavoidable in certain cases of severe ischemia, infection, or lower extremity ulcerations. When limb salvage procedures are indicated and available in diabetic patients, they will strongly support patient quality of life and prevent further complications when patients are educated appropriately. The authors describe their technique for limb salvage procedures based on a combination of an MRI-guided debridement of necrotic tissues, application of an antibiotic-impregnated bone cement, and closure of the soft tissue and bone defects with the use of an external fixation device.