Femorofemoral Bypass in Redo Cardiac Surgery

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03624738
• Other study ID #: Cardiac surgery
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: March 30, 2019

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: Mohamed mahmoud ahmed, Doctor
• Phone: 01008332462
• Email: mohamedmahmoudclinic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 30, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Procedure:
• Procedure
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Agrifoglio M, Gennari M, Kassem S, Polvani G. Saphenous vein cannulation in re-redo cardiac surgery. J Card Surg. 2012 Nov;27(6):676-7. doi: 10.1111/jocs.12004. Epub 2012 Oct 15. — View Citation

Kaneko T, Vassileva CM, Englum B, Kim S, Yammine M, Brennan M, Suri RM, Thourani VH, Jacobs JP, Aranki S. Contemporary Outcomes of Repeat Aortic Valve Replacement: A Benchmark for Transcatheter Valve-in-Valve Procedures. Ann Thorac Surg. 2015 Oct;100(4):1298-304; discussion 1304. doi: 10.1016/j.athoracsur.2015.04.062. Epub 2015 Jul 21. — View Citation

Knight JL, Cohn LH. Left thoracotomy and femoro-femoral bypass for reoperative revascularization of the posterior coronary circulation. J Card Surg. 1987 Sep;2(3):343-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	invasive monitoring of arterial blood pressure	suitable systolic arterial blood pressure between 50 and 60 mmHg during cardiopulmonary bypass.	Baseline during operation