Femorofemoral Bypass in Redo Cardiac Surgery

Study Overview
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Brief Summary
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Redo cardiac surgery are becoming more common with a patient population at greater risk. Sternal re-entry poses the hazard of probable injury to vital structures. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB).

Detailed Description
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Redo cardiac surgery are more frequent with a patient population at greater risk. Repeat sternal entry poses the risk of possible injury to vital structures. These include laceration of the myocardium, especially the right ventricle, injury of great vessels or crossing coronary bypass grafts as the internal mammary grafts in particular, or dislodgement of emboli from patent vein grafts. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac drain prior to sternotomy. Also, femorofemoral bypass support the hemodynamics in cases of redo emergency cardiac surgery.

Official Title
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Femorofemoral Bypass in Redo Cardiac Surgery: A Safe and Effective Operative Technique

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Procedure: Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25-65 years old Patients scheduled for repeat open heart surgery with sternotomy informed consent has been obtained Exclusion Criteria: Planned off-pump cardiac surgery Vascular disease previous operation on femoral artery under 25 years of age

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Femorofemoral bypass in redo cardiac surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with redo cardiac surgery 1<br>Procedure: the patients will undergo femorofemoral bypass | Procedure: Procedure<br>* Patients with redo cardiac surgery 1: femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac decompression prior to sternotomy. Patients with redo cardiac surgery 2: only conventional aortobicaval cannulation will be used<br>|
| Active Comparator: Patients with redo cardiac surgery 2<br>Procedure: the patients will undergo conventional Aortobicaval cannulation | Procedure: Procedure<br>* Patients with redo cardiac surgery 1: femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac decompression prior to sternotomy. Patients with redo cardiac surgery 2: only conventional aortobicaval cannulation will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive monitoring of arterial blood pressure | suitable systolic arterial blood pressure between 50 and 60 mmHg during cardiopulmonary bypass. | Baseline during operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoro-femoral bypass