Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the angio-seal device vs. the femostop device

Amin, Fouad; Yousufuddin, Mohammed; Stables, Rod; Shamim, Waqar; Al-Nasser, Faisal; Coats, Andrew J.S.; Clague, Jonathan R.; Sigwart, Ulrich

doi:10.1016/s0167-5273(00)00386-7

Cited by 44 publications

(33 citation statements)

References 14 publications

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“…The FemoStop femoral compression system (RADI Medical Systems) has been studied primarily as part of the control arm for clinical studies on hemostasis after endovascular procedures. 28 Single-center observational studies 39,40 and a small randomized study 41 found similar or reduced rates of vascular complications with FemoStop compared with manual pressure in patients undergoing interventional procedures. In contrast, a recent randomized study of 212 patients found FemoStop use to have a higher rate of vascular complications than manual compression.…”

Section: Evidence For Passive-closure Devicesmentioning

confidence: 98%

See 1 more Smart Citation

Arteriotomy Closure Devices for Cardiovascular Procedures

Patel¹,

Jneid²,

Derdeyn³

et al. 2010

Circulation

137

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Section: Evidence For Passive-closure Devicesmentioning

confidence: 98%

“…26 Although these effects of Angio-Seal were confirmed by others, 27 some studies still favored mechanical compression with the FemoStop device (Radi Medical Systems, Inc, Wilmington, Mass) over Angio-Seal. 28 …”

Section: Collagen-mediated Devicesmentioning

confidence: 99%

Arteriotomy Closure Devices for Cardiovascular Procedures

Patel¹,

Jneid²,

Derdeyn³

et al. 2010

Circulation

137

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“…There were no differences in major vascular complications between the two groups as determined by vascular ultrasound. Previous larger studies comparing the AngioSeal device to manual compression have shown no differences in major vascular complications [6,9,13] with observed rates of complications in the AngioSeal arms of 1.1-2.8%.…”

Section: Discussionmentioning

confidence: 86%

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

Juergens

Leung

Crozier

et al. 2004

Cathet Cardio Intervent

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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.

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“…The presence of pain, tissue injury [3,4], which may have serious consequences (e.g., profound asystole or infarction) for patients after PCI [4,5]. Whilst the use of vascular closure devices may improve patient comfort [2] and decrease the time to haemostasis and ambulation [2,6], there is little evidence that they reduce the incidence of major vascular complications [7][8][9]. This, together with there cost, mean that many centres including our own remove femoral sheaths after PCI using assisted manual compression in the majority of cases.…”

Section: Introductionmentioning

confidence: 99%