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The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during minimally invasive surgery
The femoral artery is a common site for peripheral cannulation in patients requiring cardiopulmonary bypass (CPB) for minimally invasive cardiac surgical procedures (MICS), redo cardiac surgical procedures, and procedures involving the thoracic aorta Limb ischemia is the most common acute and late vascular complication and has been reported in 10% to 70% of patients Traditional methods to maintain distal perfusion include the use of a downstream cannula or sewing on a side graft, but these techniques are cumbersome, time-consuming, and require additional equipment As a result, current practice is relying on the very small volume of blood that will flow around the cannula and collateral circulation to keep the leg viable, but by the time ischemia is clinically evident, irreversible cell damage may have already occurred The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during MICS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | 30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F bidirectional (BiflowTM, LivaNova, Italy) for femoral artery cannulation |
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| Group 2 | 30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F conventional (HLS, Maquet, Germany cannula with downstream line (6F) for femoral artery cannulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel bidirectional cannula (BiflowTM, LivaNova, Italy) | Device | We are going to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during minimally invasive surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular complications | infection, emboli, hematoma, bleeding | one moth |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective minimally invasive aortic valve replacement
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serdar Gunaydin, MD | Contact | 905363896521 | serdarkvc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Serdar Gunaydin, MD | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29697598 | Result | Marasco SF, Tutungi E, Vallance SA, Udy AA, Negri JC, Zimmet AD, McGiffin DC, Pellegrino VA, Moshinsky RA. A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery. Innovations (Phila). 2018 Mar/Apr;13(2):97-103. doi: 10.1097/IMI.0000000000000489. |
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