Objective: Complications following percutaneous femoral access are a significant source of morbidity and cost in patients undergoing peripheral vascular interventions. Our purpose in this study is to determine if access complications could be reduced by the use of a standardized protocol.
Methods: We studied prospectively 210 consecutive patients in our vascular surgery practice undergoing peripheral arterial interventions via percutaneous retrograde femoral access. First, we prospectively collected data to determine current outcomes during a 4-month observation phase. Based on these experiences, we designed and implemented a uniform arterial closure protocol, with closure device use guided by sheath size, arterial calcification, and previous groin scarring. Our main outcome measures were major complications (need for operation) or minor complications (access site bleeding or hematoma). Outcomes were compared between the two phases using chi-squared analysis and analysis of variance (ANOVA).
Results: In the observation phase, 119 patients underwent 140 arterial punctures, and in the postprotocol phase, we performed 112 punctures in 91 patients. Between the observation and postprotocol phases, patient demographics were similar; average sheath size was unchanged (sheaths over 6F 6% vs 8%, respectively, P = .55), and percentage of patients receiving heparin did not change significantly (76% vs, 86%, P = .08). No major complications occurred in either the observation or the postprotocol phases. While 24 minor complications occurred in the observation phase, only seven minor complications occurred in the postprotocol phase (17% vs 7%, P < .02). Closure device use decreased with protocol implementation (57% to 32%, P < .01), but closure device failures also decreased from 23% to 7% (P < .01).
Conclusions: Process improvement, achieved by instituting a standardized percutaneous arterial closure protocol based on selective closure device use guided by sheath size, arterial calcification, and previous access scarring. Implementation of our protocol resulted in a decrease in the incidence of minor complications at the access site and refined patient selection for closure device use.