Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention

Abstract

We assessed patient tolerance and resource utilization of using the AngioSeal closure device versus assisted manual compression using the Femostop device after percutaneous coronary intervention (PCI). Patients undergoing PCI with clean arterial access and no procedural hematoma were randomized to receive the AngioSeal or Femostop device to achieve femoral arterial hemostasis. Times from procedure end to removal from angiography table, hemostasis, ambulation, and hospital discharge were recorded. Bedside nursing/medical officer care time, vascular complications, and disposable use were also documented. Patient comfort was assessed using Present Pain Intensity and Visual Analogue scales at baseline, 4 hr, 8 hr, and the morning after the procedure. One hundred twenty-two patients were enrolled (62 AngioSeal, 60 Femostop). Patients in the AngioSeal group took longer to be removed from the angiography table (11 +/- 4 vs. 9 +/- 3 min; P = 0.002) compared with the Femostop group. Time to hemostasis (0.4 +/- 1.1 vs. 6.4 +/- 1.7 hr; P < 0.001) and ambulation (17 +/- 8 vs. 22 +/- 13 hr; P = 0.004) were less in the AngioSeal group, although time to discharge was not different. Nursing and medical officer time was no different. Disposables including device cost were higher in the AngioSeal group (209 dollars +/- 13 vs. 53 dollars +/- 9; P < 0.001). On a Visual Analogue scale, patients reported more pain at 4 hr (P < 0.001) and 8 hr (P < 0.001) in the Femostop group. The worst amount of pain at any time point was also more severe in the Femostop group (P < 0.001). Similar results were found on a Present Pain Intensity scale of pain. There were no differences in ultrasound-determined vascular complications (two each). Femoral access site closure using the AngioSeal device resulted in a small delay in leaving the angiography suite and a higher disposable cost compared to using the Femostop device. However, patients receiving the AngioSeal were able to ambulate sooner and reported less pain, which may justify the increased costs involved.

Vaso-vagal reactions during femoral arterial sheath removal after percutaneous coronary intervention and impact on cardiac events

“…Major adverse cardiac events at day 30 occurred in 5.7% of patients experiencing vaso-vagal syncope and 7.1% of those who did not ( p = 1.00) with no case of stent thrombosis in the vaso-vagal group. Whilst unpleasant for patients, we conclude that vaso-vagal syncope during sheath removal after percutaneous coronary intervention is not associated with increased adverse cardiac events in the stent era.Vaso-vagal reactions are a relatively common complication of interventional coronary procedures with a reported incidence of between 3.4% and 13.9% [1][2][3]. The presence of pain, tissue injury and strong emotional states may contribute to the development of vaso-vagal syncope [4,5], which may have serious consequences (e.g., profound asystole or infarction) for patients after percutaneous coronary intervention (PCI) [2,5].…”

“…Vaso-vagal reactions are a relatively common complication of interventional coronary procedures with a reported incidence of between 3.4% and 13.9% [1][2][3]. The presence of pain, tissue injury and strong emotional states may contribute to the development of vaso-vagal syncope [4,5], which may have serious consequences (e.g., profound asystole or infarction) for patients after percutaneous coronary intervention (PCI) [2,5].…”

Unfractionated Heparin Use After Percutaneous Coronary Intervention: Results of a Trial with a Vascular Ultrasound Endpoint

“…Consequently our results may not be applicable where sheaths are removed using closure devices or pure manual compression. Nevertheless our earlier study of 115 patients, 9 which constitutes a subset of the current study, suggested no difference in vascular events between using the Angioseal TM or Femostop TM devices to facilitate vascular closure.…”

“…Patients had been enrolled in our previously published studies comparing 6 Fr and 7 Fr sheath size on the impact of vascular complications 8 or patient tolerance and resource implications of using the Angioseal TM or Femostop TM devices to facilitate vascular closure after PCI. 9 The decision to randomise a subset of patients came after the other studies had commenced with the first patient entered into the randomised subset in November 1999. The Institutional Committee on human research of our hospital approved the studies and all patients gave written informed consent.…”

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

“…On the other hand, Biancari et al identified a significant increase in severe complications, such as groin infections, after deployment of a VCD [5]. In several cost effectiveness studies VCDs were shown to be more cost-effective than MC [6][7][8][9][10]. However, those studies were mostly single centered with only a small sample size, they only looked at one study-specific VCD and also only included highly selective populations.…”