Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery

• Conditions: Efficacy and Safety of Novel Bidirectional Cannula
• Interventions: Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy)

• Registration Number: NCT04402372
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Last Update Submitted: 2020-05-22
• Study First Posted: 2020-05-26
• Last Update Posted: 2020-05-26
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient undergoing minimally invasvie aortic valve replacement 50-90 years of age

Exclusion Criteria

• previous vascular surgery of the femoral artery, emergency cardiac surgery including type A aortic dissections, internal diameter of the common femoral artery less than 7.5 mm and where the clinician felt adequate flow rates and line pressures would not be achievable with a 19F cannula, because of the patient's weight and body surface area

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Novel bidirectional cannula (BiflowTM, LivaNova, Italy)	30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F bidirectional (BiflowTM, LivaNova, Italy) for femoral artery cannulation
Group 2	Novel bidirectional cannula (BiflowTM, LivaNova, Italy)	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

Primary Outcome Measures

Name	Time	Method
Vascular complications	one moth	infection, emboli, hematoma, bleeding

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey