Effect of a closure device on complication rates in high‐local‐risk patients: Results of a randomized multicenter trial

Abstract

Clinical trials have shown that coronary stenting is associated with a high level of complications at the access site. Arterial sealing devices have proven their efficacy in obtaining immediate hemostasis after sheath removal, in allowing early ambulation, and in improving patient comfort. However, there is no report showing a reduction of local complications related to their use. The purpose of this multicenter study was to compare randomly the efficacy of Angio-Seal versus compression methods of hemostasis in reducing the rate of access site complications after coronary angioplasty in 612 selected patients with higher risk of local events satisfying at least one of the following high-risk criteria: age> 70, previous puncture at the same site, history of hypertension, treatment with ticlopidine at least 2 days before the procedure, use of abciximab, 8 Fr access, prolonged heparin treatment after the angioplasty, and use of lytics if fibrinogen > 1 g/l. Group A (n = 306) had immediate sheath removal, Angio-Seal implantation, and cessation of bed rest 4 hr after the intervention. Group B (n = 306) had sheath removal according to local practice and cessation of bed rest 6-18 hr after the hemostasis procedure, also according to local practice. Clinical follow-up was done at 1 hr, 4 hr, 24 hr, discharge, and 7 days and a systematic color flow duplex sonography was performed to confirm diagnosis of access site complication. In group A, device deployment and immediate hemostasis were obtained in, respectively, 96.8% and 87% of patients. Time to hemostasis was shorter in group A: 5 vs. 52 min (P < 0.001). Cessation of bed rest was dramatically reduced in group A (438 +/- 450 min) vs. group B (952 +/- 308 min; P < 0.001). The cumulative rate of complications, using a composite primary endpoint, at 7 days was significantly different between the two groups: 5.9% of group A patients and 18% of group B patients (P < 0.001). This difference was mainly due to the dramatic reduction of prolonged bleeding in group A patients. Angio-Seal device use in high-local-risk patients allows immediate sheath removal and hemostasis with a reduction of local event rate despite a higher level of anticoagulation, compared to regular compression techniques, directly related to a dramatic decrease of prolonged bleeding.

The Use of the “Preclosure” Technique for Antegrade Aspiration Thrombectomy with Large Catheters in Acute Limb Ischemia

“…Similar procedures have a broad range of hemostatic complication rates for manual compression and VCD [10][11][12][13]. Depending on the definitions, the accuracy of follow-up protocols, and diagnostic tools used, complication rates as high as 64 % have been reported [14].…”

Novas tecnologias, novas complicações: complicações após uso de novos dispositivos de selamento e de trombectomia arterial

“…4 In another series, Chevalier et al reported, in a randomized study including 612 patients, reduction in mean homeostasis time from 52 to 5 minutes. 5 Hemorrhagic complications are the most common, with rates ranging between 5-7.4%, with 1.9% of episodes progressing with infection. There is a discussion as to whether this device could be a risk factor for infection for two reasons: excessive formation of hematomas, due to a risk known as endarteritis, and presence of a foreign body in the lumen and arterial wall, thus creating a niche for infection.…”

A Comparison of Costs and Complications of Manual Compression and Vascular Closing Devices in Femoral Cardiac Catheterization Interventions

“…We identified complications arising from either VCD or MC by using corresponding International Classification of Disease Codes (ICD). We agreed upon the following complications and ICDcodes identified by literature search and after consultation of a clinician and a coder: hematoma and bleeding [3], arteriovenous fistula (AVF) [13], pseudo aneurysm [13], retroperitoneal haemorrhage (RPH) [14], thrombosis [14], infection of access site [14] and other complications as indicated by a ICD code relating to a complication occurring from a procedure. The risk for complication was assessed binary by either having one of these complications or having no complications at all.…”