Cardiac Failure
Conditions
Keywords
cardiac failure, thoracic surgery, cardiac pacing, artificial
Brief summary
This trial will investigate the clinical and haemodynamic effects of temporary biventricular pacing after cardiac surgery. Subjects with poor left ventricular systolic function will receive either temporary biventricular pacing or 'standard' post-operative pacing for 48 hours. The investigators hypothesis that reversal of cardiac dyssynchrony will improve tissue perfusion and cardiac haemodynamics after surgical revascularisation. This will shorten post-operative recovery in cardiac ITU.
Detailed description
Patients with poor left ventricular (LV) function are at higher risk of complications after cardiac surgery, compared to patients with preserved LV function. The higher complication rates also lead to prolonged Cardiac Intensive Care (CITU) admissions for monitoring and multi-organ support. The investigators hypothesise that BiV pacing will reverse cardiac dyssynchrony and improve target organ perfusion. This will be significantly reduced the post operative requirement for Level 3 CITU care. This study will compare 48 hours of temporary biventricular (BiV) pacing to enhance cardiac function against standard post-operative pacing, in patients with poor LV function undergoing cardiac surgery. Temporary biventricular (BiV) pacing will be achieved with the addition of a third pacing electrode attached to the left ventricle. Using a pulmonary arterial catheter the interventricular (VV) delay will be adjusted to yield the maximum cardiac output at constant heart rate- sequential BiV pacing. A pilot study conducted at the University Hospital of Wales (UHW) showed that this approach is likely to be successful. The primary endpoint of the study will be the mean duration of Level 3 CITU care required by patients after cardiac surgery. Secondary endpoints will include: haemodynamic improvement with BiV pacing; post-operative renal function; atrial fibrillation (AF)/ ventricular arrhythmias; post operative inotropic requirements and changes in biomarkers- NT Pro BNP and Troponin T.
Interventions
DEVICEBiventricular pacing
Optimised temporary biventricular pacing.
Sponsors
Cardiff and Vale University Health Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Coronary disease scheduled for surgical revascularisation. Ejection fraction \<35% (simpson's method.)
Exclusion criteria
* Permanent pacemaker or implantable defibrillator. Dialysis dependent renal failure. Permanent atrial fibrillation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government. | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.) | 30 days |
| Vascular event (stroke or myocardial infarction.) | 30 days |
| post operative arrhythmia. | 48 hours |
| Mortality | 30 days |
| Renal function and requirement for haemofiltration. | 30 days |
| Biomarkers (Troponin T and NT Pro BNP.) | 72 hours |
| Re-intubation or re-sternotomy. | 30 days |
| Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor). | 48 hours |
Countries
United Kingdom
Outcome results
None listed