Immediate mobilization after coronary angiography or percutaneous coronary intervention following hemostasis with the AngioSeal vascular closure device (the MOBS study)

Larsen, Ellen Nyholm; Hansen, Charlotte Bak; Thayssen, Per; Jensen, Lisette Okkels

doi:10.1177/1474515113516702

Cited by 12 publications

(20 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although this study's patients had a higher risk of bleeding due to the use of anticoagulants and thrombolytic drugs, a low incidence of minor bleeding was found, consistent with previous clinical trials and meta‐analyses, which showed that decreased periods of bed rest with immobilisation after sheath removal does not increase the frequency of bleeding involving hemodynamic instability (Augustin et al, ; Kim et al, ; Larsen, Hansen, Thayssen, & Jensen, ; Schiks et al, ; Tongsai & Thamlikitkul, ).…”

Section: Discussionsupporting

confidence: 87%

Decreasing length of limb immobilisation following nonelective transfemoral percutaneous coronary intervention: A randomised clinical trial

Santos

Melo

Assis

et al. 2019

Journal of Clinical Nursing

View full text Add to dashboard Cite

Aims and objectives:To assess the intensity and frequency of pain, use of analgesic drugs, and the incidence of paraesthesia, urinary retention and vascular complications upon decreasing affected limb immobilisation from 4-2 hrs after sheath removal in patients submitted to transfemoral percutaneous coronary intervention (PCI).Background: After sheath removal from the femoral artery following urgent or emergency PCI, patients are maintained with limb immobilisation for a mean period of 4 hr. Design:Randomised clinical trial (RCT) based on the CONSORT guidelines. Method: Randomised clinical trial was performed in patients with Acute CoronarySyndrome submitted to transfemoral PCI. The intervention group was submitted to a supine position with the head of the bed elevated (30-degree angle) with affected limb immobilisation for 2 hr after sheath removal and the control group for 4 hrs. The outcomes were pain complaints, need for analgesic drugs, incidence of paraesthesia, urinary retention and vascular complications. The outcomes were assessed immediately, 6, 12 and 24 hr after release from limb immobilisation before the patients were released from bed rest. Results:A total of 150 patients (75 in each group) participated in the study. No significant differences in outcomes were observed between the groups, except in relation to the haematoma formation that was higher in the intervention group. Conclusion:A reduced length of limb immobilisation after sheath removal following PCI does not change the frequency and intensity of pain, need of analgesic drugs, urinary retention and paraesthesia. The incidence of haematoma was higher in the intervention group, without significant clinical manifestations. | 3141 SANTOS eT Al.

show abstract

Section: Discussionsupporting

confidence: 87%

Decreasing length of limb immobilisation following nonelective transfemoral percutaneous coronary intervention: A randomised clinical trial

Santos

Melo

Assis

et al. 2019

Journal of Clinical Nursing

View full text Add to dashboard Cite

show abstract

“…AS was found to be not associated with increased bleeding risk compared with standard care with bed rest. 12 We used AS in both significant coronary and peripheral vascular diseases. Presence of significant PAD was suggested to be associated with an increased risk of complications.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Angioseal and Manual Compression in Patients Undergoing Transfemoral Coronary and Peripheral Vascular Interventional Procedures

Alshehri

Elsharawy

2015

Int J Angiol

View full text Add to dashboard Cite

Vascular closure devices (VCDs) were introduced in the early 1990s with the goal of limiting the time, labor, bed rest, and patient discomfort associated with manual compression (MC) for hemostasis after cardiovascular interventions. However, its advantage over MC has not been extensively studied after interventional procedures. The aim of this study was to do prospective, randomized study comparing the safety and efficacy of the Angio-Seal (AS) to that of MC in patients undergoing transfemoral coronary and peripheral vascular interventional procedure. A prospective, randomized trial was undertaken on consecutive series of patients admitted to King Fahd Hospital of the University for transfemoral coronary and peripheral vascular interventional procedures over 1 year. The study was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving AS with those undergoing MC. All patients were on antiplatelets and received heparin during the procedure. During the study period, 160 patients were included, 80 in each group. There was a significant difference in mean time to hemostasis in minutes (15.83 ± 1.63 minutes for MC and 0.42 ± 0.04 minutes for the AS; p < 0.001), time to ambulation in minutes (280 ± 15 for MC and 120 for AS; p = 0.04) and in minor complications (33.8% in MC vs. AS 5%; p < 0.001). However, the major complication rate did not significantly differ between the two groups (0% in AS vs. 2.5% in MC; p = 0.15). AS was found to achieve rapid closure of the femoral access site safely in patients undergoing coronary and peripheral vascular interventional procedures under antiplatelets and systemic heparinization.

show abstract

“…Recently, three studies investigated the immediate deambulation after diagnostic coronary angiography only (RISE-Study) [7] and after diagnostic and PCI procedures with femoral access (Angio-Seal™ femoral closure device allows immediate ambulation [5] and MOBS [6]). In the RISE-Study there were no deaths or major vascular complications, and the rate of minor vascular complications not requiring surgery (like hematoma >6 cm, PSA or AVF and late access site bleeding) was 1.9%.…”

Section: Comparison With Other Studies and Interpretation Of Resultsmentioning

confidence: 99%

“…VCDs provide advantages over manual compression (such as shorter time to hemostasis, more rapid patient ambulation, and the potential for cost effectiveness) and seem to be safe [3,4]. Several studies tried to substantiate current recommendations on the timing and extent of mobilization [5][6][7]. Limited data are available for stress testing after percutaneous interventions and application of VCDs.…”

Section: Introductionmentioning

confidence: 99%

Early Treadmill ECG Stress Testing After Percutaneous Coronary Intervention Following Hemostasis with the Angioseal™ Vascular Closure Device: A Prospective Single-Center Cohort Study

Albanese¹,

Stappert²,

Chondros³

et al. 2017

J Clin Trial

View full text Add to dashboard Cite

Objective: Particularly with the transfemoral access, potential complications at the puncture site with early exercise are a major concern. The purpose of this study was to compare femoral artery access site complications after percutaneous coronary interventions (PCI) in 1) patients following a standard care procedure and 2) performing treadmill electrocardiographic (ECG) stress testing within 24 h after application of the Angioseal™ vascular closure device.Methods: This is a prospective, randomised, single-center cohort study conducted in a high-volume tertiary interventional heart centre in Duisburg, Germany. 221 patients were included and 200 entered analysis. Patients were randomly assigned to treadmill testing within 24 h after transfemoral seven French (F) PCI or discharged with the recommendation of limited exercise for two weeks. Clinical examination and Duplex ultrasound (DUS) of the inguinal region was obtained within 24 h after PCI in both groups and repeated immediately after the treadmill test in the exercise group. Two-weeks clinical follow-up was obtained in both groups. Results:Early treadmill testing could be performed without any major limitations or acute complications in all assigned patients. DUS showed no new pseudoaneurysm (PSA) or arteriovenous fistula (AVF) after treadmill testing. At follow-up, there were 1) no differences regarding pain or physical limitations between the two groups and 2) four patients (4%) in the exercise group and seven patients (7%) in the standard care group developed major hematoma (>6 cm)/minor bleeding, which were clinically uneventful. Conclusions:Treadmill ECG stress testing within 24 h of PCI with the femoral access site closed by the Angioseal device was not associated with a higher complication rate compared to standard care.

show abstract

Immediate mobilization after coronary angiography or percutaneous coronary intervention following hemostasis with the AngioSeal vascular closure device (the MOBS study)

Abstract: Immediate mobilization after a coronary angiogram or PCI with the femoral access site closed by the closure device AngioSeal was not associated with increased bleeding risk compared to standard care with bed rest.

Cited by 12 publications

References 19 publications

Decreasing length of limb immobilisation following nonelective transfemoral percutaneous coronary intervention: A randomised clinical trial

Decreasing length of limb immobilisation following nonelective transfemoral percutaneous coronary intervention: A randomised clinical trial

Comparison of Angioseal and Manual Compression in Patients Undergoing Transfemoral Coronary and Peripheral Vascular Interventional Procedures

Early Treadmill ECG Stress Testing After Percutaneous Coronary Intervention Following Hemostasis with the Angioseal™ Vascular Closure Device: A Prospective Single-Center Cohort Study

Contact Info

Product

Resources

About