Original Cardiovascular

A Single Institution Evaluation of the Performance of Two Different Chest Drainage Systems in Pediatric Patients after Surgery for Congenital Heart Disease Vladimiro L. Vida1 Michele Gallo1 Elisa Barzon2 Veruska Olivato2 Alvise Guariento1 Massimo Padalino1 Giovanni Stellin1 1 Pediatric and Congenital Cardiac Surgery Unit, Department of

Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy 2 Cardiac Intensive Care Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy

Marco De Franceschi1

Address for correspondence Vladimiro L. Vida, MD, PhD, Pediatric and Congenital Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, Via Giustiniani, 2- 35100 Padua, Italy (e-mail: [email protected]).

Thorac Cardiovasc Surg 2015;63:404–408.

Abstract

Keywords

► congenital heart disease ► cardiac surgery ► chest drainage

received November 1, 2014 accepted after revision January 16, 2015 published online March 18, 2015

Background The study compares the efficacy and advantages of two different drainage systems in pediatric patients during surgery for congenital heart disease (CHD). Methods A total of 200 consecutive pediatric patients (< 16 years) were enrolled; in 100 patients we used a polyvinyl chloride drain (PVCD) and in the other 100 we used a silicone drain (SD). Demographics, drain’s technical data, and postoperative complications and costs were evaluated. A pain score was calculated in patients older than 6 years. Results The SDs were significantly smaller when compared with PVCDs (median of 1.63 vs. 3.09 French/kg, p ¼ 0.0006), were kept in site for a median shorter period (23 vs. 40 hours, p ¼ 0.002), drained more thoracic spaces (median of 2 vs. 1, p < 0.0001), and were associated to a lower pain score (p ¼ 0.01). The overall drain-related complication rate was lower for the SD group than for the PVCD group (3 vs. 9%, p ¼ 0.1) as well as the drainrelated adverse event required additional interventional maneuvers (0 vs. 6%, p ¼ 0.04). Patients who were treated with a PVCD reported a higher perceived pain score than patients treated with a SD, both at the time when the drain was in site (p ¼ 0.016) and during the drain’s removal (p ¼ 0.0001). Conclusion SDs can be used safely in pediatric patients during surgery for CHD. Sizes required are smaller than other conventional drains and multiple cavities can be drained with a single tube. The use of SD is associated to a lower complication rate, lower requirement of additional procedures, and lesser perceived pain from the patient, when compared with other more traditional drains.

© 2015 Georg Thieme Verlag KG Stuttgart · New York

DOI http://dx.doi.org/ 10.1055/s-0035-1546822. ISSN 0171-6425.

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Introduction Decompression and evacuation of fluid and air from the pericardial and pleural spaces is necessary after cardiac surgery to avoid cardiac tamponade and pneumothorax and it is usually achieved through the insertion of single or multiple semi-rigid tubes that are connected to a closed underwater sealed drainage system.1 First-generation drainages, which are still in use in many centers, are large-bore rigid polyvinyl chloride tubes (PVCDs; Portex chest drainages, Smiths Medical, Kent, United Kingdom) and because of their size and rigidity, their use is usually painful for patients, particularly during removal.2–4 In addition, they can trigger either atrial or ventricular arrhythmias or damage surrounding anatomical structures during suction1–5 (►Fig. 1A–C). More recently, other drainage systems (silicone drains [SD]; Blake silicone drains, Ethicon, Inc., Somerville, New Jersey, United States) have been introduced which—because of their characteristics, such as flexibility, the presence of grooves that run along the full length of the tube, and their fluted design—seem to support a better fluid drainage and cause less pain for the patient4,6–9 (►Fig. 1B–D). Recent data about their use in pediatric are encouraging and suggest that SD drains presented a fewer occurrences of effusions after cardiac surgery than standard PVCD.7 The purpose of this study is to evaluate and compare, in a randomized controlled trial, the safety, applicability, and advantages of two different drainage systems in pediatric patients requiring surgery for their congenital heart disease (CHD).

Materials and Methods Study Design Clinical Investigation Committee from the University Hospital of Padua approved the review of medical records and

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computerized hospital data, and the procedures followed were in accordance to the institutional guidelines for data collection and protection of patient confidentiality (Chairperson of the ethic committee: Prof. A.C. Frigo, protocol number: 3253, date of approval: 17/07/2014). A total of 200 pediatric patients (< 16 years of age) who underwent repair of CHD and necessitated a single chest drain after surgery were enrolled in a prospective randomized fashion. Patients were randomly assigned to receive either PVCD or SD (the two currently available drainage systems in our unit) before surgery (PVCD ¼ 100 patients and SD ¼ 100 patients). Included in the study were all patients with CHDs treated in our unit (all kinds of CHDs, including complex anomalies and single ventricular hearts). The surgical team was blinded to the allocation of the type of drain process. Patients requiring multiple chest drainages (n ¼ 15 in the PVCD group and n ¼ 4 in the SD group) were also randomized but excluded from this study to better compare the efficacy of chest drainages and to avoid confounding factors in the analysis (such as different tube diameter in the same patient, type and number of mediastinal spaces drained, and single chest tube real draining efficacy). Demographic data, the type of surgical approach (sternotomy vs. thoracotomy), drain’s technical data (diameter, number of drained spaces, need for milking, draining capability, and so on), the total drained volume during the first 24 hours, the incidence, and type of postoperative complications were considered in the analysis. Drains were routinely placed by using a separate access, secured with a 4.0 silk sutures and then connected to a low negative pressure (20 cm H2O) suction system at the time of chest closure. The amount of chest tube drainage was recorded every hour. A bleeding of less than 1 mL/kg for four consecutive hours and the absence of pleural effusions or pneumothorax at the chest X-ray were considered standard criteria for drain

Fig. 1 Chest drainages utilized in this study. (A–C) A 16-French polyvinyl chloride drain (PVCD ¼ Portex drain) (with seven round holes for fluid drainage, one at the tip and six on the side). (B–D) A 15-French silicone drain (SD ¼ Blake drain) (full-length lateral grooves for fluid drainage). Thoracic and Cardiovascular Surgeon

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Chest Drains in Pediatric Heart Surgery

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removal. All patients were treated with a standard institutional antibiotic prophylaxis with teicoplanin (20 mg/kg dose, intravenously) given in the operating room, followed by a maintenance dose (10 mg/kg dose, intravenously) every 24 hours for 2 days. Pain medications included paracetamol (15 mg/kg dose, intravenously) every 6 hours for the first 48 hours and ketoprofen (1 mg/kg dose, intravenously), if needed, in patients who underwent midline sternotomy or every 12 hours in patients who underwent a thoracotomy. The primary aim of the study was to define the overall prevalence of drain-related complications, as the presence of pericardial/pleural effusions or pneumothorax and the prevalence of drain-related adverse events requiring additional procedural maneuvers (as the need for mediastinal exploration and placement of a new chest drainage) or prolonged intensive care unit or hospital stay. A pain score (a verbal numeric scale) was also calculated, in patients older than 6 years, to quantify the perceived pain consequent to the presence of the chest drain in site and at the time of chest drain removal. The pain score ranges from 0 (no pain at all) to 10 (the worst pain you can imagine).10 Categorical variables are shown as absolute frequency and percentage. Quantitative variables were summarized as median and range. In case quantitative variables are not normally distributed (assessed by Shapiro–Wilk normality test), comparison among groups was performed by the Kruskal–Wallis test. Categorical variables were compared by the chi-square test or Fisher exact test as appropriate. All reported p-values are two sided and significant level of p ¼ 0.05 was used. Statistical analysis was performed using STATA software (Release 10.0 for Windows, StataCorp LP, Texas, United States).

Results Patient’s characteristics were well matched for age and drained volume during the first 24 hours postoperatively

between groups (►Table 1). The dimension of chest drains (indexed for patient’s body weight, as French/kg) was smaller for the SD group than the PVCD group (p ¼ 0.0006; ►Table 1). We did not experience any difference in clotting or obturation between the two drainage systems. SDs were able to drain more mediastinal spaces significantly (including pericardium and pleural spaces) than PVCDs (a median of 2 spaces, range 1–3 spaces for SD vs. a median of 1 space, range 1–2 spaces, for PVCD; p ¼ 0.0001 (►Table 1; ►Fig. 2). In addition, the need for drain’s milking during the first 24 hours postoperatively was significantly lower for the SD group (p < 0.0001) as well as the permanence of the drains in site (p ¼ 0.002; ►Table 1). We included two patients with postoperative chylothorax (one in the PVCD group and one in the SD group), both having a prolonged chest tube stay (14 and 16 days, respectively). There were 12 postoperative drain-related complications (6%), which were higher for the PVCD group when compared with the SD group (9 vs. 3%, p ¼ 0.1; ►Table 2). Six patients, all with PVCD (p ¼ 0.04), had a postoperative drain-related adverse event requiring further procedural maneuvers as the need for a new chest drainage due to a persistent pericardial/pleural effusion (n ¼ 4), the need for mediastinal exploration due to cardiac tamponade (n ¼ 1), and the need for a new chest drainage due to a pneumothorax after drain removal (n ¼ 1). All these six patients with PVCD, together with a patient of the SD group who had the occurrence of a pneumothorax after drain’s removal (SD), had a prolonged hospital stay (median of 1 day postoperatively, interquartile range 1–3, p ¼ 0.06). The author’s suggested size of silicon tube for each weight group is listed in ►Table 3. The results of the pain score evaluation are shown in ►Table 4. Patients who were treated using a PVCD reported a higher score (more perceived pain) than patients treated with a SD, both at the time when the drain was in site (p ¼ 0.016) and during the drain’s removal (p ¼ 0.0001).

Table 1 Demographics and postoperative data (n ¼ 200 patients) PVC drains (n ¼ 100)

Silicone drains (n ¼ 100)

p

Median age of patients, y (range)

0.78 y (5 d–18 y)

1.9 y (5d–18 y)

0.1

Median weight of patients, kg (range)

6.2 (2.3–72)

10.2 (1.5–73)

0.07

Time of drainage in place, h (range)

40 (5–230)

23 (18–335)

0.002

Need for drainage milking, n (%)

99 (99%)

11 (11%)

< 0.0001

Median drain Ø, F/kg (range)

3.09 (0.36–6.9)

1.63 (0.32–8.82)

0.0006

Median drained volume, mL (range)

80 (8–1,300)

75 (10–3,850)

0.69

1 space

76 (76%)

39 (39%)

2 spaces

24 (24%)

54 (54%)

3 spaces

0

7 (7%)

a

Drained mediastinal spaces , n (%)

Abbreviation: PVC, polyvinyl chloride (Portex drains). Note: Silicone drains (Blake drains); Ø, diameter. a Including pericardium and pleural spaces. Thoracic and Cardiovascular Surgeon

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Chest Drains in Pediatric Heart Surgery

they are painful for the patients, particularly during removal. In addition, because of their size and rigidity, such chest tubes can contribute in delaying postoperative recovery by limiting ambulation and deep breathing.4–6 Furthermore, different complications have been reported with the use of large PVCDs, such as arrhythmia caused by cardiac irritation, injury to the intercostal nerves, parietal pleural or lung parenchymal damage, erosion into major intrathoracic vessels, and cardiac tamponade.1–3 The introduction of SD in this setting is not new; however, there has been reluctance concerning their routine use by congenital heart surgeons because of the unknown effectiveness of the system. Preliminary reports about the use of SDs proved the noninferior performance of these smaller tubes in comparison to PVCDs.6,7 Other authors stated that SDs might be superior to conventional chest tubes in terms of patient tolerability, as well as producing less postoperative pain, and allowing an earlier ambulation.4,6,11,12 SDs are round, flexible, noncollapsing tubes with four draining channels along the

Table 2 Postoperative drainage-related complications (n ¼ 12 in 200 patients, 6%) PVC drainage n ¼ 100 patients

p

Silicone drainage n ¼ 100 patients

Overall drainage-related complications

9

3

0.1

Pericardial effusion with the drainage in site

6



0.04

Pneumothorax after drainage removal

2

3

0.9

Pleural effusion after drainage removal

1



0.9

Abbreviation: PVC, polyvinyl chloride.

Table 3 Suggested sizes of silicon tube for each weight group Silicone drains Ø, F

Weight group, kg

12

20

All patients underwent the same postoperative pain medication protocol; there were no differences between groups.

Discussion A safe and effective drainage of the pericardium and pleural spaces after cardiac surgery is essential to prevent fluid retention often leading to cardiac tamponade, to identify life-threatening bleedings, and to reduce the incidence of symptomatic effusions.1–4 Despite several attempts of miniaturizing surgical incisions with the aim of reducing patient’s surgical trauma, the chest drainage system has not changed for years and in many institutions, the drainage of mediastinal spaces after cardiac surgery is routinely achieved with rigid, large-bore PVCDs. Although these PVCDs are effective,

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sides and a solid core-center, theoretically resistant to occlusion with thrombus that has been reported to be as effective as traditional, more rigid, polyvinyl chloride tubes in thoracic drainage after cardiac procedures in both pediatric and adult patients.1,4,9 Our study was designed with the aim of comparing the safety and cost-effectiveness of the two different drainage systems, currently available at our unit, in pediatric patients requiring surgery for their CHD. We demonstrated that the performance of SDs was similar to that of larger PVCDs after cardiac surgery for congenital heart lesions. Due to their flexibility, SDs were significantly able to drain more mediastinal spaces than PVCDs, which avoids the intraoperative use of additional chest tubes. Of note, that SD can be trimmed according to surgeon’s needs by shortening the intrathoracic portion of the drain, without losing their drainage efficacy (due to the presence of long drainage channels along the axis of the tube), and without creating acute or traumatic edges at the tip of the drain consequently to the shortage (due to the softness and atraumatic characteristics of silicone). SDs were also better tolerated by our patients, because of their intrinsic characteristics of flexibility and due to the fact that they have a smaller caliber in comparison to PVCDs. This, in our opinion, can contribute for increasing Thoracic and Cardiovascular Surgeon

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Fig. 2 Postoperative chest X-ray (anterior–posterior view) showing a silicone tube (Blake drains) which drains the pericardium and both the right and left pleural spaces.

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Table 4 Pain score (in patients with age > 6 years, n ¼ 40 patients) PVC drainage (n ¼ 15)

Silicone drainage (n ¼ 25)

p

Mean pain score with the drain in site (SD)

2.46 (0.63)

1.92 (0.74)

0.016

Mean pain score at the time of drain removal (SD)

5 (0.75)

3.92 (0.62)

0.0001

Abbreviations: PVC, polyvinyl chloride; SD, standard deviation. Note: Polyvinyl chloride drains (Portex drains); Silicone drains (Blake drains).

the quality of our treatment, by further decreasing patient’s surgical insult, which is particularly important in cases of minimally invasive. In our study, postoperative drain-related complication was higher in PVCD when compared with SD, the majority of them requiring further interventional maneuvers and a prolonged hospital stay. We did not have any constrictions or leverage effects at the time of chest tube removal. We believe that our reported initial incidence of pneumothorax after drain removal, in patients with SD, was due to the fact that the technique for chest tube removal of SD is different than that for PVCD. In fact, as the drainage channels are along all the axes of the tube, the removal has to be particularly quick because an unintentional breath can lead to air intake into the chest anytime. According to our cost-analysis, the overall cost per cure was higher in patients with PVCDs as compared to SDs. Such higher cost is related to the higher incidence of drain-related complications requiring additional procedures and hospital costs for PVCDs, although the initial cost is lower. In addition, the possibility of draining more mediastinal spaces can also potentially avoid the use of additional chest tubes, thus representing a potential economic advantage of the treatment with SDs. Our study presents some limitations. The patient population is not homogeneous as we have included many different surgical procedures covering the spectrum of treatment for congenital heart defects and a wide spectrum of ages within the pediatric age group. The same surgical team treated all patients; however, certain inter-surgeon variability during the hemostatic phase may be present. In addition, there was an initial miscommunication between our staff (including residents) about the correct removal technique of SD and this could have possibly contributed to an increase in the incidence of subsequent incidence of pneumothorax after SD removal. Furthermore, the comparison of more than two drainage systems could have added more data on the identification of the ideal chest drainage system after pediatric cardiac surgery.

Conclusion

Conflict of Interest There is no conflict of interest to declare.

References 1 Ege T, Tatli E, Canbaz S, et al. The importance of intrapericardial

drain selection in cardiac surgery. Chest 2004;126(5):1559–1562 2 Moss E, Miller CS, Jensen H, et al. A randomized trial of early versus

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5 6

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In conclusion, in this study, we were able to compare the two different types of drainages, which are currently present in our unit, in a fairly large number of patients with CHD who underwent cardiac surgery. Our results confirm that the performance of SDs was similar to that of larger PVCDs after Thoracic and Cardiovascular Surgeon

cardiac surgery for congenital heart lesions. Moreover, SDs can drain more thoracic spaces, do not need tube milking, are associated with less perceived pain from the patient, and a lower complication rate and a lower requirement of additional interventional maneuvers for the occurrence of drainrelated adverse events. As a result of this study, there was a change in our clinical practice toward the exclusive use of SDs after cardiac surgery in all pediatric patients with CHD.

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delayed mediastinal drain removal after cardiac surgery using silastic and conventional tubes. Interact Cardiovasc Thorac Surg 2013;17(1):110–115 Frankel TL, Hill PC, Stamou SC, et al. Silastic drains vs conventional chest tubes after coronary artery bypass. Chest 2003;124(1):108–113 Akowuah E, Ho EC, George R, et al. Less pain with flexible fluted silicone chest drains than with conventional rigid chest tubes after cardiac surgery. J Thorac Cardiovasc Surg 2002;124(5):1027–1028 Taub PJ, Lajam F, Kim U. Erosion into the subclavian artery by a chest tube. J Trauma 1999;47(5):972–974 Roberts N, Boehm M, Bates M, Braidley PC, Cooper GJ, Spyt TJ. Twocenter prospective randomized controlled trial of Blake versus Portex drains after cardiac surgery. J Thorac Cardiovasc Surg 2006; 132(5):1042–1046 Obney JA, Barnes MJ, Lisagor PG, Cohen DJ. A method for mediastinal drainage after cardiac procedures using small silastic drains. Ann Thorac Surg 2000;70(3):1109–1110 Sakopoulos AG, Hurwitz AS, Suda RW, Goodwin JN. Efficacy of Blake drains for mediastinal and pleural drainage following cardiac operations. J Card Surg 2005;20(6):574–577 Agati S, Mignosa C, Gitto P, et al. A method for chest drainage after pediatric cardiac surgery: a prospective randomized trial. J Thorac Cardiovasc Surg 2006;131(6):1306–1309 Bailey B, Daoust R, Doyon-Trottier E, Dauphin-Pierre S, Gravel J. Validation and properties of the verbal numeric scale in children with acute pain. Pain 2010;149(2):216–221 Lancey RA, Gaca C, Vander Salm TJ. The use of smaller, more flexible chest drains following open heart surgery : an initial evaluation. Chest 2001;119(1):19–24 Gordon BM, Hasaniya NW, Newcombe JB, et al. Blake drains: a novel method of chest drainage after extracardiacfontan operation with autologous pericardium. Ann Thorac Surg 2012;94(4): 1289–1294

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A Single Institution Evaluation of the Performance of Two Different Chest Drainage Systems in Pediatric Patients after Surgery for Congenital Heart Disease.

The study compares the efficacy and advantages of two different drainage systems in pediatric patients during surgery for congenital heart disease (CH...
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