Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery

Comparative Clinical Efficacy of Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery

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

Study Overview

• Status: Unknown
• Conditions: Efficacy and Safety of Novel Bidirectional Cannula
• Intervention / Treatment: Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy)

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Ankara City Hospital
    • Contact: Kanat Ozisik, MD; Phone Number: 90-5052901885; Email: sozisik2002@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective minimally invasive aortic valve replacement

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy); 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
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	Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular complications	infection, emboli, hematoma, bleeding	one moth

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Serdar Gunaydin, MD, Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): June 15, 2020
• Study Completion (Anticipated): June 15, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; cannula; bidirectional
• Other Study ID Numbers: 2020-1994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No