Safety and Efficacy of Arterial Closure Devices in an Office-Based Angiosuite (original) (raw)
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Korean Journal of Radiology, 2006
Objective: This study assessed the outcomes of using vascular closure devices following percutaneous transfemoral endovascular procedures in the patients who were treated with heparin, abciximab or thrombolytics (urokinase or t-PA) during the procedures. , we conducted a prospective and randomized study in which 1,676 cases of 1,180 patients were treated with one of the two different closure devices (the collagen plug device was Angio-Seal TM ; the suture-mediated closure device was The Closer S TM ) at the femoral access site after instituting percutaneous endovascular procedures. Among the 1,676 cases, 108 cases (the drug group) were treated with heparin only (n = 94), thrombolytics only (n = 10), heparin and thrombolytics (n = 3), or abciximab and thrombolytics (n = 1) during the procedures; 1,568 cases (the no-drug group) were treated without any medication. We compared the efficacy and complications between the two groups. Of the drug group, 42 cases underwent arterial closures with the collagen plug devices and 66 cases underwent arterial closures with the suture-mediated closure devices. We also compared the efficacy and complications between these two groups.
World Journal of Surgery, 2006
Introduction: Percutaneous closure devices have been used to obtain rapid hemostasis and early mobilization of the patient after arterial catheterization. However, we observed challenging problems with the sealing procedure that require further surgical intervention. The present report is a retrospective analysis of the patterns of injury and the final outcome of four cases of femoral artery injury following the use of Angio-Seal. Methods: During the last 24 months, in a group of 175 patients (131 men, 44 women; median age 68.4 years, range 47-81 years) underwent percutaneous closure after diagnostic (n = 53) or therapeutic (n = 122) endovascular procedures. Among them we observed four patients (three men, one woman; median age 65.2 -10.8 years, range 47-75 years) who developed severe limiting claudication and required vascular repair of an iatrogenic vascular injury following deployment of the Angio-Seal. They had a femoral thrombosis due to narrowing/severe intimal dissection. Results: All patients required operative intervention with removal of the device. We performed femoropopliteal thrombectomy and common femoral endarterectomy with patch angioplasty (n = 2), resection of the femoral bifurcation and reimplantation of the deep femoral artery (n = 1), and femoral bifurcation endarterectomy with direct arterial suture (n = 1). The median hospital stay was 6.5 -3.8 days (range 4-12 days). Limb salvage was achieved in all of the surviving patients at a mean follow-up of 7 months (range 1-12 months). Conclusions: Vascular injuries are uncommon after use of the hemostasis closure device. When they occur, however, they are likely to require challenging surgical correction.
Advances in Interventional Cardiology, 2012
Background: Complications related to the femoral access substantially contribute to peri-procedural morbidity and mortality. Aim: To evaluate whether the use of a collagen plug as a vascular access closure device (AngioSeal ® , AS) influences complications related to the femoral access and duration of hospitalization for peripheral endovascular interventions. Material and methods: Two hundred and one consecutive patients (59.2% male, age 48-87 years) undergoing angioplasty/stenting of the internal carotid, common carotid, vertebral, subclavian, renal, iliac/femoral, innominate artery or cervical-subclavian bypass were randomized (1 : 1 ratio) prior to the intervention to standard manual compression (MC) or AS (6 F or 8 F device used for femoral access with 6-7 F or 8-9 F sheaths respectively). Results: Manual compression was used in 110 patients and AS in 91 patients. There was no difference in the use of 8-9 F and 6-7 F sheats between the two per treatment groups (72.5% vs. 73.6% and 27.5% vs. 26.2%, respectively). Large subcutaneous haematoma, arteriovenous fistula, pseudoaneurysm or femoral artery occlusion requiring surgery occurred in 13.8% MC vs. 4.0% AS for 6-7 F sheaths (p = 0.36) and in 19.7% MC vs. 7.6% AS for 8-9 F sheaths (p = 0.035). Total access site complication rate was 18.2% for MC and 6.6% for AS (p = 0.019). Nine patients with AS (9.9%) required an additional compression dressing (≤ 12 h). Overall, AS patients were mobilized earlier (2.9 ±2.4 h vs. 14.2 ±2.8 h, p = 0.001) and discharged home earlier after the intervention (33.6 ±14.16 h vs. 68.1 ±34.08 h, p = 0.001). Conclusions: The use of the AngioSeal ® device for femoral access closure during peripheral interventions (AngioSeal ® 8 F for 8-9 F sheath and AngioSeal ® 6 F for 6-7 F sheath) significantly reduces the access site complication rate and allows earlier patient mobilization and discharge from hospital.
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.
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.
European Journal of Vascular and Endovascular Surgery, 2011
The study aimed to evaluate vascular access site complications (ASCs) after percutaneous interventions (PIs) in our institution for changes in annual incidence and surgical management after increased usage of a vascular closure device (VCD; in all cases: Angiosealä). Material and Methods: All patients who underwent repair of arterial pseudo-aneurysms or access site stenosis/occlusion leading to leg ischaemia (LI) or new-onset disabling claudication (CI) after PIs between 2001 and 2008 were included. Annual rates of procedures and methods of repair of ASC were evaluated. Results: After a total of 58 453 PIs, 352 patients (0.6%) were operated on for: pseudo-aneurysms (n Z 300; 0.51%); and local stenosis/occlusion leading to LI/CI (n Z 52; 0.09%). Numbers increased significantly with more widespread VCD use: group A (2001e2004: 2860 VCDs; 28 284 PIs; 10.1%): n Z 132 (0.47%); and group B (2005e2008: 11,660 VCDs; 30,169 PIs; 38.6%): n Z 220 (0.73%) (p < 0.001). In contrast to similar rates of pseudo-aneurysms (group A: n Z 124; 0.44%; group B: n Z 176; 0.58%; not significant), a significant increase of operations for local stenoses/occlusions was seen with widespread VCD use: n Z 8 versus n Z 44 (p < 0.001). Conclusions: In the era of VCDs, complications are rare. However, use of these devices is not without complications, and may require complex reconstructions.
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.