Vasoseal arterial closure devices may not be as safe as manual compression in percutaneous coronary intervention

摘要

Background Manual compression is routinely used to achieve haemostasis after cardiac catheterisation. When arterial closure devices were developed, it was claimed that they had equivalent safety to manual compression and the potential for greater patient comfort, ease of use, and early ambulation. However, clinical trials of the devices approved by the US FDA were underpowered to support the claim of equivalent safety. Complications related to femoral arterial puncture sites are sufficiently uncommon that an individual trial would need to be ten times larger than any of the published trials to investigate this thoroughly.Objective Nikolsky and colleagues systematically reviewed the safety of arterial closure devices versus mechanical compression for people undergoing percutaneous transfemoral coronary procedures. The primary endpoint was cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal haematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion.Method The authors searched the Cochrane Library, MED-LINE, CINAHL, EMBASE, and reference lists of identified studies for randomised, case-control, and cohort studies comparing access-related complications using closure devices versus mechanical compression published between 1991 and April 2003. Fixed and random effects models were used to pool data.