OBJECTIVE: The collection of fluid in the mediastinum after cardiac surgery is traditionally prevented using underwater seal drains that may be connected to low-pressure suction. High-vacuum drains (redivac drains) are a potential alternative to this arrangement and have previously been utilized in areas of general surgery, as well as in the treatment of post-sternotomy mediastinitis. There has been no study to date addressing the safety and efficacy of these drains following pediatric cardiac surgery. METHODS:Five hundred and forty-six patients were prospectively randomised to receive either the redivac drains or the conventional underwater-seal drains attached to low-pressure wall suction. We sought to test the null hypothesis that there was no difference in the incidence of residual pericardial or pleural collections requiring drainage between the 2 drainage systems. Secondary endpoints included time to drain removal, volume of drainage and drain size. Analysis was performed on an intention to treat basis. RESULTS:Two hundred and thirty-seven patients were allocated to the redivac group, while 241 were allocated to the conventional drain group. Age and gender distribution, the use of cardiopulmonary bypass, numbers of patients with univentricular morphology and number of drains utilized were similar in the 2 groups. The use of redivac drains resulted in a significantly lower incidence of residual pleural effusions requiring drainage (4 vs. 18, P=0.003). There was no difference in the incidence of pericardial effusion requiring drainage. Redivac drains drained an equivalent volume through smaller calibre tubes (12 Ch vs. 16 Ch, P<0.0001) over a shorter period of time (42h (IQR 22-45) vs. 43h (IQR 27-52), P<0.01) than the conventional drainage system. CONCLUSIONS:Redivac drains are as safe and effective as conventional drains in the pediatric setting, and resulted in a lower incidence of residual pleural effusions requiring drainage. Together with their ease of care, earlier mobilisation of patients and greater cost-effectiveness, the routine use of high-vacuum drains can be recommended following pediatric heart surgery.
RCT Entities:
OBJECTIVE: The collection of fluid in the mediastinum after cardiac surgery is traditionally prevented using underwater seal drains that may be connected to low-pressure suction. High-vacuum drains (redivac drains) are a potential alternative to this arrangement and have previously been utilized in areas of general surgery, as well as in the treatment of post-sternotomy mediastinitis. There has been no study to date addressing the safety and efficacy of these drains following pediatric cardiac surgery. METHODS: Five hundred and forty-six patients were prospectively randomised to receive either the redivac drains or the conventional underwater-seal drains attached to low-pressure wall suction. We sought to test the null hypothesis that there was no difference in the incidence of residual pericardial or pleural collections requiring drainage between the 2 drainage systems. Secondary endpoints included time to drain removal, volume of drainage and drain size. Analysis was performed on an intention to treat basis. RESULTS: Two hundred and thirty-seven patients were allocated to the redivac group, while 241 were allocated to the conventional drain group. Age and gender distribution, the use of cardiopulmonary bypass, numbers of patients with univentricular morphology and number of drains utilized were similar in the 2 groups. The use of redivac drains resulted in a significantly lower incidence of residual pleural effusions requiring drainage (4 vs. 18, P=0.003). There was no difference in the incidence of pericardial effusion requiring drainage. Redivac drains drained an equivalent volume through smaller calibre tubes (12 Ch vs. 16 Ch, P<0.0001) over a shorter period of time (42h (IQR 22-45) vs. 43h (IQR 27-52), P<0.01) than the conventional drainage system. CONCLUSIONS: Redivac drains are as safe and effective as conventional drains in the pediatric setting, and resulted in a lower incidence of residual pleural effusions requiring drainage. Together with their ease of care, earlier mobilisation of patients and greater cost-effectiveness, the routine use of high-vacuum drains can be recommended following pediatric heart surgery.
Authors: Oluwatomisin Olurotimi Obafemi; Hanjay Wang; Simar S Bajaj; Christian T O'Donnell; Stefan Elde; Jack H Boyd Journal: JTCVS Open Date: 2022-02-24