Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial
| Autor: | Jens C. Ritter, Jos C. van den Berg, Klaus A. Hausegger, Olivier Regnard, Marianne Brodmann, Johannes B. Dahm, Pascal Desgranges, Ludovic Berger, Shirley Jansen, Eric Steinmetz, Koen Deloose, Bibombe P. Mwipatayi |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Access-site complication medicine.medical_specialty Psychological intervention 610 Medicine & health 030204 cardiovascular system & hematology Peripheral vascular intervention 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Femoral access medicine Clinical endpoint Humans Radiology Nuclear Medicine and imaging Vascular closure device Clinical Investigation Prospective Studies Endovascular treatment Adverse effect 4F Aged Groin business.industry Hemostatic Techniques Ambulatory treatment Endovascular Procedures Correction Equipment Design Surgery Femoral Artery medicine.anatomical_structure Treatment Outcome Ambulatory Female Cardiology and Cardiovascular Medicine business Vascular Closure Devices |
| Zdroj: | Cardiovasc Intervent Radiol Cardiovascular and Interventional Radiology Brodmann, Marianne; Deloose, Koen; Steinmetz, Eric; Regnard, Olivier; Ritter, Jens C; Berger, Ludovic; Dahm, Johannes B; Jansen, Shirley; Mwipatayi, Bibombe P; Desgranges, Pascal; Hausegger, Klaus; van den Berg, Jos C. (2021). Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial. Cardiovascular and interventional radiology, 44(5), pp. 689-697. Springer 10.1007/s00270-020-02738-5 |
| ISSN: | 1432-086X |
| DOI: | 10.1007/s00270-020-02738-5 |
| Popis: | Purpose Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed. Materials and Methods BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days. Results The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p p Conclusions Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices. |
| Databáze: | OpenAIRE |
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