Early Silent Graft Failure in Off-pump Coronary Artery Bypass Grafting: A Computed Tomography Analysis

Aortocoronary bypass surgery is one of the most common operations in the western world. The goal of the surgeon is to perform a complete revascularization of the coronary arteries with the best, available bypass material.

Aortocoronary bypass surgery can be performed with (on-pump) or without (off-pump) the heart lung machine. If the operation is performed without the heart lung machine, the heart is continuously beating while the surgeon sews the bypass to the diseased coronary artery. In randomized trials, the benefits of the off-pump technique in the hands of experienced surgeons in terms of shorter operating times, less transfusions and less pulmonary and renal complications were proven. A criticism of the off-pump technique is the reduced number of distal anastomoses, which means that fewer coronary arteries may be connected with bypass grafts because of the technically sophisticated situation. A worse quality of the connection (anastomosis) between coronary artery and bypass is often discussed, leading to a bypass occlusion already in the early stage after surgery resulting in more re-interventions on the coronary vessels. So-called silent bypass failure without clinical correlation has been examined in three relevant studies including both, the on- and the off-pump technique, with inhomogenous results. In addition to the technique, other parameters such as the degree of narrowing (stenosis) of the diseased coronary artery and collateralization of a closed coronary artery may play a role in early occlusion.

All bypass patients after off-pump surgery receive routinely a computed tomographic examination of the heart. With this method, silent bypass occlusions without clinical correlation, i.e. cardiac infarction, elevated cardiac laboratory parameters or ECG changes, can be detected easily. In case of an occlusion of a relevant bypass, an intervention before discharge can be planned and performed.

We would like to investigate the occlusion rate of this retrospective patient cohort after off-pump surgery and the potential risk factors, that may influence on early graft failure. We hypothesize, that early graft failure depends not only on the choice of the graft material, but also on the local grade of coronary stenosis, the collateralisation of occluded coronary vessels and the intraoperative flow results, as well as on the region of the target vessel.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Graft Failure; Bypass Complication
• Intervention / Treatment: Diagnostic test: Cardiac computed tomography

• Study Type: Observational
• Enrollment (Actual): 192

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients after off-pump coronary artery bypass grafting from January 2017 till April 2018, who received a postoperative computed tomography for the evaluation of the bypass patency before discharge

Description

Inclusion Criteria:

• patients after off-pump coronary artery bypass grafting
• postoperative computed tomography for the evaluation of the bypass patency before discharge

Exclusion Criteria:

• Operation with a heart-lung machine
• Combined interventions
• Postoperative emergency coronary angiography
• There is a documented rejection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bypass graft failure; Patients with at least one detected graft failure after routine cardiac computed tomography before discharge	Diagnostic test: Cardiac computed tomography; Routine computed tomography of the heart before discharge
No bypass graft failure; Patients without occluded bypass grafts after routine cardiac computed tomography before discharge	Diagnostic test: Cardiac computed tomography; Routine computed tomography of the heart before discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early postoperative graft failure	Assessment of graft failure by computed tomography in all patients after isolated off-pump surgery	first week after aortocoronary bypass grafting

Collaborators and Investigators

• Sponsor: Triemli Hospital
• Investigators: Principal Investigator: Alicja Zientara, Dr, Triemli Hospital Zurich

Publications and helpful links

General Publications

• Zientara A, Rings L, Bruijnen H, Dzemali O, Odavic D, Haussler A, Gruszczynski M, Genoni M. Early silent graft failure in off-pump coronary artery bypass grafting: a computed tomography analysisdagger. Eur J Cardiothorac Surg. 2019 Nov 1;56(5):919-925. doi: 10.1093/ejcts/ezz112.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 2, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: KEK-ID 2017-02315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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