Clinical trial NCT02731794: On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist
Official title: Inflammatory Response and Clinical Outcome After On-pump Beating Coronary Artery Bypass Grafting Using Left Ventricular Assist Versus Biventricular Assist in Patients With Severe Left Ventricle Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Bypass
Keywords: cardiopulmonary bypass
coronary artery bypass grafting
inflammatory response
cardiac dysfunction
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.

Detailed description: Off-pump coronary artery bypass grafting (CABG) tends to have a lower incidence of postoperative complications and remarkable advantages in terms of hospital stay. However, some drawbacks include higher rates of incomplete revascularization and the hemodynamic deterioration during manipulation of the heart, more occurring in the cases of posterolateral anatomical constraints and cardiac dysfunction. It leads to urgent conversion to extracorporeal circulation (ECC) and increases the mortality. Although conventional ECC with cardioplegia arrest provides bloodless immovable field, intense systemic inflammatory response may contribute to hemodynamic unstability especially in patients already with severe cardiac dysfunction.

On-pump beating CABG, as a more comprehensive approach, not only facilitates stable hemodynamics and complete revascularization, but also supports myocardial lymphatic flow balance and decreases interstitial myocardial edema in the beating state. Especially in the high-risk patients,some findings suggested that off-pump CABG should be converted to on-pump beating CABG without hesitation, avoiding hemodynamic collapse and even catastrophic outcomes. Some investigators intentionally planned on-pump beating CABG aiming to some patients with severe left ventricle dysfunction. Furthermore, on-pump beating CABG with ECC assistance in a high-risk subgroup is also an acceptable trade-off between conventional cardioplegia and off-pump operations.

The above-mentioned ECC results about on-pump, beating-heart CABG pay much attention to the biventricular assist (BiVA). Nonetheless, much evidence also reveals that BiVA triggers an intense inflammatory response due to extracorporeal membrane lung and circuit line. Comparatively speaking, single left ventricular assist (LVA), with shorter circuit line, less priming volume and free of extracorporeal membrane lung, theoretically should reduce the inflammatory response and relative complications. As a result, aiming to the high-risk patients with severe left ventricle dysfunction, who need ECC assistance (BiVA or LVA), the investigators designed the randomized prospective study to evaluate: 1) the differences in myocardial injury as expressed by cardiac Troponin I(cTnI) and in inflammatory response by C-reactive protein (CRP), 2) the differences in the early postoperative outcomes including graft number, incidence of atrial fibrillation, in-hospital mortality and ICU stay.

Eligibility criteria: Inclusion Criteria:

* patients with severe left ventricle dysfunction with an ejection fraction (EF)≤40%, being scheduled for revascularization.

Exclusion Criteria:

* myocardial infarction within the preceding 4 weeks
* severe valve disease requiring valve replacement
* cardiac reoperations

Primary outcomes:
measure: Changes of C-reactive protein (CRP)
timeFrame: up tp 72 hours
Secondary outcomes:
measure: Incidence of atrial fibrillation
timeFrame: 10 days
measure: Durations of mechanical ventilation
timeFrame: 10 days
measure: The number for transfused packed red cells
timeFrame: up to 10 days
measure: Partial oxygen pressure/inspired oxygen fraction (P/F)
timeFrame: up tp 10 days
measure: Cardiac Troponin I (cTnI)
timeFrame: up to72 hours
measure: In-hospital mortality
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People' Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People' Hospital
name: Zhaoyun Cheng, MD
role: STUDY_DIRECTOR
References:
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