Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures (original) (raw)

2004, Journal of the American College of Cardiology

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.