Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia? (original) (raw)
Related papers
Journal of Vascular Surgery, 2003
Background: Patients with peripheral vascular disease have been excluded from initial studies of percutaneous suturemediated closure devices (SMCD) despite representing a significant proportion of those requiring endovascular intervention. We sought to determine whether these devices could be safely used in patients with peripheral vascular disease. Methods: Patients were stratified into two groups and five subgroups on the basis of indication for arteriography, and they were prospectively randomized at the end of the procedure to receive either the SMCD or manual compression. Ankle-brachial index was determined and duplex ultrasound scanning of the accessed femoral artery was performed, before and after the procedure. Ultrasound data included peak systolic velocity, minimum intraluminal vessel diameter, and presence or absence of calcified plaque. Time to hemostasis, ambulation, and discharge were recorded, and major or minor complications were noted. Results: Of 102 patients included in the study, 52 patients were randomized to receive the SMCD. There was no difference in ankle-brachial index, minimum intraluminal vessel diameter, or peak systolic velocity in the accessed vessel after closure with SMCD or manual compression. Time to hemostasis, ambulation, and discharge was significantly less in the SMCD group (P ؍ .001). Presence of calcified plaque was not associated with complications (P ؍ .146). In the SMCD group, hemostasis was achieved with 49 of 52 devices (94.2%). There were six complications (5.9%), two of which were major and required operative intervention. All complications were hemorrhagic and not occlusive. There was no difference in overall complication rate between SMCD (7.7%) and manual compression (4.0%) groups (P ؍ .678). No infection was noted in any of the 102 patients. Conclusions: Suture-mediated percutaneous arterial closure can be safely performed in patients with peripheral vascular disease, even in the presence of calcified plaque. This closure technique enables shorter time to hemostasis, ambulation, and hospital discharge. There are observed differences in minor, but not major, complication rates for MC versus percutaneous arterial closure in patients with peripheral vascular disease, but these differences did not achieve statistical significance in this small series.
Il Giornale di chirurgia, 2006
The Authors report their experience in the management of acute lower limb ischemia following percutaneous arterial closure device application. Five patients required an emergency vascular operations for acute lower limb ischemia. The symptoms onset was < 1 hour in 1 case, 4-12 hours in 2 cases and > 24-36 hours in 2 cases. A preoperative angiography was performed in all the cases. A transfemoral embolectomy was carried out. Direct suture repair were performed in three cases, vein patch angioplasty was carried out in two cases. In one case, a common femoral artery endarterectomy was performed. No post-operative mortality and limb loss occurred. Acute lower limb ischemia due to closure devices required an extensive approach with reconstruction in high risk septic area. Angiography is mandatory for surgical strategies. We prefer direct suture repair and vein path angioplasty for vascular reconstruction.
2011
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 timeconsuming 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.
Journal of the American College of Cardiology, 2004
This review investigated the safety of arteriotomy closure devices (ACDs) versus mechanical compression in patients undergoing percutaneous transfemoral coronary procedures. The vascular complication rates were similar in diagnostic settings. In intervention settings, two ACDs had similar complication rates to mechanical compression, whereas one had higher rates. The lack of a validity assessment of the included studies limits the results. Authors' objectives To assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression in patients undergoing percutaneous transfemoral coronary surgery. Searching The Cochrane Library, MEDLINE, CINAHL and EMBASE were searched from 1991 to April 2003 for published studies; the keywords were listed. The reference lists of identified articles were also checked. Study selection Study designs of evaluations included in the review Randomised controlled trials (RCTs), cohort and case-control studies were eligible for inclusion. Some studies were excluded because they used historical controls or because there was a risk of bias in patient selection. Specific interventions included in the review Studies comparing ACD with mechanical compression (manual, by means of hand compression, sandbag, C-clamp, or Femostop) were eligible for inclusion. The authors stated that the included studies had to have a well-described protocol of intervention, but this was not defined further. The included studies assessed Angio-Seal, VasoSeal and Perclose ACDs. Participants included in the review Studies of patients undergoing percutaneous coronary intervention (PCI) with transfemoral access were eligible for inclusion. The authors stated that the included studies had to have a precise report on each of the major vascular complications, but this was not defined further. The included studies were conducted in diagnostic settings and/or PCI settings. In the included studies the proportion of men ranged from 56 to 94% and the proportion of patients with diabetes from 8 to 43%. Seventy-three per cent of studies used a >=8-F device sheath. Outcomes assessed in the review Studies that compared access-related complications were eligible for inclusion. The primary outcome measure was the cumulative incidence of major vascular complications. This was defined as: pseudo-aneurysm requiring ultrasoundguided compression or surgical repair; arterio-venous fistula; retro-peritoneal haematoma causing haemodynamic compromise, surgery, blood transfusion, prolonged hospitalisation and/or death; femoral artery thrombosis (vessel occlusion requiring surgery or thrombolysis); surgical vascular repair; access-site infection necessitating treatment with antibiotics and/or surgical drainage; and blood transfusion. How were decisions on the relevance of primary studies made? Two authors independently searched the literature and assessed the relevance of studies. Any disagreements were resolved by consensus, with arbitration by a third reviewer.
Journal of Endovascular Therapy, 2011
To assess the safety and efficacy of the StarClose device following peripheral vascular interventions employing 7-F and 8-F femoral sheaths. Methods: From May 2006 to December 2007, 226 consecutive patients (143 men; mean age 69 years, range 36-92) underwent 231 groin punctures (150 with a 7-F sheath and 81 with an 8-F sheath) that were sealed with the StarClose Vascular Closure System. All the patients underwent duplex control of the puncture site 24 hours after deployment of the device to determine the presence of vascular complications (hematoma, pseudoaneurysm, arteriovenous fistula, and arterial/venous thrombosis or stenosis). Endpoints were major vascular complications during the hospital stay, device success (hemostasis using the StarClose device alone or with ,5 minutes of adjunctive compression and freedom from major vascular complications), and procedure success (hemostasis established using any method and freedom from major vascular complications). Results: Procedural success was 96.0% (144/150) for the 7-F group and 97.5% (79/81) in the 8-F group. Device success was achieved in 91.3% (137/150) of the 7-F group and 90.1% (73/ 81) the 8-F group. Major vascular complications occurred in 4.1% (6/150) of the 7-F group: 1 patient developed massive retroperitoneal hematoma that required blood transfusion and surgical evacuation, 2 patients presented new ipsilateral lower extremity ischemia requiring revascularization, and 3 other patients developed pseudoaneurysm treated by ultrasound-guided compression or thrombin injection. In the 8-F group, only 2 (2.5%) patients had a major complication: 1 developed a high-grade stenosis of the punctured femoral artery that required angioplasty and the other developed massive retroperitoneal hematoma followed by blood transfusion and surgical evacuation. Minor complications occurred at a rate of 11.3% (17/150) in the 7-F group and 9.9% (8/81) in the 8-F group. Conclusion: Common femoral artery closure with the StarClose device following peripheral vascular procedures utilizing 7-F and 8-F sheath sizes is feasible, with few device-specific complications. A randomized trial of a larger number of patients comparing standard compression methods and StarClose is warranted.
The utility of the StarClose arterial closure device in patients with peripheral arterial disease
Annals of vascular surgery
The StarClose (Abbott Vascular, Redwood City, CA) arterial closure device utilizes an extraluminal nitinol clip to establish hemostasis. The purpose of this study was to determine the safety and efficacy of StarClose from a prospective peripheral arterial disease (PAD) registry. Over an 18-month time interval, 500 StarClose devices were used in 378 consecutive patients with symptomatic PAD after diagnostic and/or therapeutic endovascular cases. Patient demographics along with objective criteria including duplex ultrasound images, common femoral artery flow velocities, and ankle-brachial indexes (ABIs) were analyzed before and after StarClose placement. All outpatients received prophylactic antibiotic (one dose), periprocedural heparin (without protamine reversal), and antiplatelet therapy. Aspirin and clopidogrel (Plavix) was used for all patients undergoing therapeutic intervention. There were 378 patients who underwent procedures for aortoiliac or infrainguinal PAD, 99 of which we...
Annals of vascular surgery, 2002
Percutaneous arterial closure devices allow earlier mobilization and discharge of patients after arterial catheterization than with manual compression for puncture site hemostasis. We reviewed our recent experience managing the complications of femoral artery catheterization with and without these devices on the vascular surgery service at a tertiary hospital. Thirty-one patients presenting over an 18-month period with complications after femoral artery catheterization with manual compression (n = 21) or percutaneous arterial closure devices (n = 10) were retrospectively reviewed.