Percutaneous closure of large-bore arterial access sites using the Perclose ProGlide suture-mediated closure device (Abbott Vascular) is associated with significantly lower rates of blood transfusions, infections, mortality and length of hospital stay, compared with surgical cutdown in a real-world setting, according to new data presented at the Vascular Interventional Advances 2017 conference (VIVA; 11–14 September, Las Vegas, USA).
Based on these findings, Darren Schneider (New York, USA) told VIVA delegates, “Perclose should be considered for large-bore closure to minimise access site complications and resource use.”
Access site closure for procedures requiring large-bore access is typically achieved using either surgical cutdown or percutaneous closure. In this case, Schneider was presenting data analysis of the percutaneous Perclose ProGlide device.
The retrospective study utilised IBM’s Explorys data from IBM Watson Health, and included longitudinal data from 55 million US patients treated since 2012. The patients included underwent transcatheter aortic valve implantation (44.9%), endovascular aneurysm repair (38.6%), thoracic endovascular aneurysm repair (21.3%), or balloon aortic valvuloplasty (3.4%).
Schneider identified 757 Perclose patients and 757 cutdown patients with mostly similar baseline characteristics. Notable differences between the groups were seen in stroke comorbidity (7.7% cutdown vs. 5% Perclose, p<0.05), use of anticoagulants (17.8% cutdown vs. 44.9% Perclose, p<0.05) and use of MRSA antibiotics (27.3% cutdown vs. 11% Perclose, p<0.05).
Matched cohort results indicated that index hospitalisation blood transfusion was higher in the cutdown group (35.7%) than in the Perclose group (9.5%; p<0.001), as were haemorrhage (3% vs. 1.8%, p=0.13) and infection (22.2% vs. 15.6%, p=0.001). At 30 days, the differences were maintained, with blood transfusion rate of 35% vs. 10.7% for cutdown (p<0.001), haemorrhage rate of 3.7% vs. 1.7% (p=0.026), and infection rate of 31.2% vs. 21.6% (p<0.001).
Schneider reported that at index procedure, Perclose patients were 80% less likely to require a blood transfusion and 41% less likely to have an infection. At 30 days, Perclose patients were 79% less likely to require a blood transfusion, 43% less likely to have an infection, and 55% less likely to have a haemorrhage.
The mortality rate was lower for Perclose patients than cutdown patients (1.1% vs. 3%, p=0.006) at 30 days, as was length of hospital stay (5.4 vs. 9 days, p<0.001). “At 30 days,” Schneider said, “Perclose patients were 70% less likely to die, while hospitalisation for Perclose patients was 43% shorter.”
Schneider stressed that the trial was retrospective rather than randomised, that some clinical characteristics that may have impacted outcomes were unavailable in the database, that patients may have been misclassified due to incomplete/inconsistent medical records, and that direct causality cannot be ascertained.
Despite these limitations, Schneider told the audience that the data were encouraging. “Future analyses should focus on quantifying the cost-savings and patient benefit from avoiding these complications,” he concluded.