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Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography
G Model JIPH-1170; No. of Pages 5
ARTICLE IN PRESS Journal of Infection and Public Health xxx (2019) xxx–xxx
Contents lists available at ScienceDirect
Journal of Infection and Public Health journal homepage: http://www.elsevier.com/locate/jiph
Position Paper
Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography Mingbin Deng ∗ , Qi Yang Department of Cardiovascular Surgery, Affiliated Hospital of Southwest Medical University, Luzhou, 646000, Sichuan, China
a r t i c l e
i n f o
Article history: Received 3 June 2019 Received in revised form 11 August 2019 Accepted 15 August 2019 Keywords: Dacron patch Congenital heart disease complicated with infective endocarditis Echocardiography Coagulation function Renal function
a b s t r a c t To evaluate the efficacy and safety of a new domestic dacron patch in the surgical treatment of congenital heart disease (CHD) with infective endocarditis (IE), a clinical controlled trial is conducted. 48 patients with CHD complicated with IE are selected and randomly divided into two groups. 26 patients in the experimental group are treated with a new domestic dacron patch, while 22 patients in the control group are treated with an imported cardiac polyester patch. By echocardiography, collecting chest X-ray, echocardiography and laboratory examination before and after operation, the residual shunt, cardiac function, liver function, renal function, coagulation function and other related indicators are observed after operation in the two groups, and the therapeutic effect and safety of the new dacron patch are evaluated. The results showed that there is no significant difference in C/T (cardiothoracic ratio), LAD (Left atrial diameter), LVSD (left ventricular end systolic diameter) and LVDD (left ventricular end diastolic diameter) between the two groups before operation, before discharge and 1, 3 and 6 months after discharge (P > 0.05). The C/T, LAD and LVDD of the two groups decrease 6 months after operation, and the size of atrioventricle decreases significantly. There is a decreasing trend in the experimental group compared with the control group, but there is no significant difference (P > 0.05). There are no significant differences in cardiac function classification, echocardiography, electrocardiogram, patch performance evaluation and blood compatibility between the two groups before operation and 6 months after discharge. Conclusion: The new domestic dacron patch has good clinical efficacy and safety. © 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction Surgical treatment of congenital heart disease (CHD) complicated with infective endocarditis (IE) requires thorough correction of intracardiac malformations so as to reduce complications and improve surgical results [1,2]. Therefore, the key to successful cardiac septal defect surgery is to select suitable intracardiac patches [3]. There are two main sources of traditional patches for repairing intracardiac defects [4]. One is autopericardial patch, which has the advantages of tissue activity, flexibility, mechanical strength and good histocompatibility, no rejection, and is not easy to leak blood, thrombosis, hemolysis and infection [5,6]. The disadvantage is that the pericardium is inaccessible and weak [7]. The other is dacron patch, which has the advantages of thin texture, strong ten-
∗ Corresponding author at: Department of Cardiovascular Surgery, Affiliated Hospital of Southwest Medical University, No.25 Taiping Street, Jiangyang District, Luzhou, 646000, Sichuan, China. E-mail address: [email protected] (M. Deng).
sion and elasticity, easy trimming and good compatibility [8,9]. The disadvantage is that it is easy to cause complications such as anastomotic deformation, thrombosis, embolism, hemolysis and infection after repair, and the possibility of self-healing is very small [10]. Ideal tissue engineered cardiovascular patches should be of sufficient source, easy to handle, good biocompatibility, durability, no antigenicity, no adhesion with surrounding tissues, no vascular plaque and thrombosis, no complications related to them, and have a certain degree of toughness and tensile resistance. It is better to achieve the mechanical strength matching the natural tissue of the same origin, and the myocardial tissue should also have certain electrical conductivity. In addition, pericardial substitutes should also have good adherence. Blood and exudates are not easy to accumulate in the folds to produce adhesion and other characteristics [11–13]. Clinical practice has proved that echocardiographic examination of fetuses with CHD complicated with IE can diagnose their condition more accurately, help to evaluate the function and structure of their hearts, and clarify the causes of their occurrence. The new dacron patch produced by Beijing Sida Medical Device Co., Ltd. uses medical polymer materials and imported raw materials.
https://doi.org/10.1016/j.jiph.2019.08.009 1876-0341/© 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article in press as: Deng M, Yang Q. Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography. J Infect Public Health (2019), https://doi.org/10.1016/j.jiph.2019.08.009
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2 Table 1 Basic data of two groups of patients.
Table 2 Surgery performed in two groups of patients.
Type
Experimental group
Control group
P value
Operation name
Experimental group
Control group
Total
Gender (male/female) Age Weight (Kg) systolic pressure (mmHg) diastolic pressure (mmHg) Heart rate (time/min) LAD (mm) LVDD (mm) LVSD (mm) LVEF (%) LVFS (%) NYHA grading (Grade I/ Grade II) ECG (SR/AF/AVB)
16/10 20.85 ± 19.46 34.67 ± 21.23 101.47 ± 19.26 56.72 ± 12.36 94.85 ± 12.30 28.22 ± 9.55 41.27 ± 7.56 28.76 ± 5.15 62.43 ± 5.84 32.03 ± 5.17 17/9 18/5/3
11/11 19.83 ± 19.35 33.15 ± 21.35 106.43 ± 16.38 60.04 ± 11.73 92.40 ± 13.20 26.46 ± 11.25 42.47 ± 10.65 31.48 ± 7.46 60.36 ± 3.37 30.73 ± 4.15 16/6 18/3/1
0.172 0.347 0.276 0.446 0.352 0.918 0.722 0.748 0.453 0.387 0.266 0.345 0.182
ASD repair ASD repair + tricuspid valvuloplasty VSD repair ASD repair + VSD repair Total
6 4 16 0 26
7 2 10 3 22
13 6 25 3 48
Note: LAD: left atrial diameter; LVSD: left ventricular end systolic diameter; LVDD: left ventricular end diastolic diameter; LVEF: left ventricular ejection fraction; LVFS: left ventricular short axis shortening rate; ECG: electrocardiogram; SR: sinus rhythm; AF: atrial fibrillation; AVB: atrioventricular block.
It meets all the requirements for clinical trials prescribed by the State Food and Drug Administration. The safety and effectiveness of the dacron patch and echocardiography in the treatment of CHD complicated with IE will be verified in this study. Materials and methods Dacron patch The dacron patch used in this experiment is suitable for surgical repair surgery. The test results are qualified, and it has all the conditions for the clinical test as stipulated by the clinical verification of the State Food and Drug Administration (Registered Product Standards: Q/FTSD005-2011; Inspection report label of China Institute of Food and Drug Verification: NO. QZ201401253). The experimental group is made of dacron patches produced by Beijing Sida Medical Device Co., Ltd. and the control group is imported dacron patches which have been listed on the market. Patients Forty-eight CHD complicated with IE patients hospitalized by echocardiography in cardiac surgery department of Affiliated Hospital of Southwest Medical University from January 2015 to August 2018 are selected. 26 patients in the experimental group are treated with a new domestic dacron patch by echocardiography for CHD complicated with IE, while 22 patients in the control group are treated with an imported heart patch by echocardiography. The basic data and examinations of the two groups of patients are shown in Table 1. All patients involved in this study have signed the informed consent, and the study has been approved by the ethics committee of Tongde Hospital of Zhejiang Province. Echocardiography The probe frequency of the ultrasound diagnostic instrument used in the study was 2.5–3.5 MHz. The examination was carried out at quiet time of patients and at sleep after sedation for restless patients. During the examination, the patient maintained the left supine position or supine position. Routine section and subsword section examinations were carried out, and the upper sternal fossa examinations were carried out according to the specific conditions. For those with complex malformations, the examination was carried out by three-level sequential cardiac segmental method and the correct diagnosis was made.
Operative methods Both groups are operated under general anesthesia, moderate hypothermia and cardiopulmonary bypass. Cardiopulmonary bypass (CPB) is constructed by conventional intubation. All patients undergo cardiopulmonary bypass under cardiac arrest with cold crystalloid cardioplegia as myocardial protection. VSD and ASD repair are performed through the right atrial pathway. If the patient has moderate or severe tricuspid regurgitation, tricuspid valvuloplasty is also performed. The following is the successful performance of the operation. After surgical repair of the defect, the symptoms disappear without residual shunt and major complications, and general activities are not limited. Effective repair means no residual shunt on echocardiography. Evaluation criteria of therapeutic effect The main therapeutic index is effective repair. The end point of clinical study is 6 months after operation, and the end point is secondary surgery without effective repair. No residual shunt is found by echocardiography after operation. Secondary outcome indicators: The patient’s physical signs are judged by auscultation. Auscultation is divided into four grades: severe, moderate, mild and no murmur. It is acceptable if the murmur is light or there is no murmur. Other indicators: Compliance, mechanical strength during suture, suture difficulty, appearance and roughness of trimmed edge are evaluated comprehensively. The differences of each index between the experimental group and the control group are compared during the operation. Dacron patch is a kind of implantable consumables in cardiac surgery. The successful end point of clinical trial is determined by echocardiography within 2 days before operation, before discharge, 1 month after discharge and 3 months after discharge. In order to observe the efficacy and safety of the product after implantation into human body, the observation period is selected as the duration of the clinical experiment for 6 months. Therefore, echocardiogram reexamination and blood routine examination are carried out 6 months after discharge to make a comprehensive evaluation. Statistical analysis method SPSS19.0 software is used for statistical analysis. All statistical tests are conducted by bilateral test, and the test level is 0.05, that is, P < 0.05, which will be considered to have statistical significance. Metrological data were analyzed by means ± standard deviation. The counting data are described by frequency (constituent ratio). Result Early clinical situation From Table 2, it can be seen that two groups of patients need adequate auxiliary circulation after operation. After the circulation, breathing, arterial blood gas, electrolyte and other standards are met, it is necessary to stop the machine and extubate the tube, neutralize with protamine (6 mg/kg bw, twice, 6 h apart, diluted with
Please cite this article in press as: Deng M, Yang Q. Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography. J Infect Public Health (2019), https://doi.org/10.1016/j.jiph.2019.08.009
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Table 3 Comparison of follow-up indicators of cardiac size between groups.
Before operation
Before discharge
One month after discharge
Three months after discharge
Six months after discharge
C/T
LAD
LVSD
LVDD
Experimental group Control group P value Experimental group Control group P value Experimental group Control group P value Experimental group Control group P value Experimental group Control group P value
0.551 ± 0.054 0.566 ± 0.068 0.39 0.522 ± 0.053 0.531 ± 0.049 0.68 0.513 ± 0.057 0.529 ± 0.062 0.57 0.508 ± 0.056 0.513 ± 0.054 0.76 0.485 ± 0.048 0.492 ± 0.045 0.85
27.42 ± 9.14 29.45 ± 10.34 0.47 24.69 ± 9.76 24.38 ± 9.56 0.49 25.10 ± 9.25 25.26 ± 9.98 0.75 24.42 ± 8.46 25.08 ± 11.87 0.83 24.31 ± 8.37 24.76 ± 9.16 041
28.34 ± 5.68 30.35 ± 7.56 0.45 27.18 ± 6.36 30.24 ± 9.95 0.83 25.49 ± 7.35 26.63 ± 7.62 0.83 26.50 ± 6.54 29.27 ± 8.34 0.47 27.08 ± 8.87 29.19 ± 10.03 0.56
41.33 ± 7.26 42.39 ± 9.72 0.67 38.96 ± 9.32 41.28 ± 10.45 0.33 38.95 ± 8.74 41.03 ± 10.28 0.79 38.11 ± 8.39 39.92 ± 9.46 0.49 36.74 ± 9.68 39.71 ± 10.47 0.37
Note: C/T: chest X-ray cardiothoracic ratio; LAD: left atrial diameter; LVSD: left ventricular end systolic diameter; LVDD: left ventricular end diastolic diameter.
Table 4 Comparison of cardiac function between two groups.
Experimental group Control group
NYHA grading (I/II/III/IV)
LVEF (%)
LVFS (%)
ECG (SR/AF/AVB)
Before operation Six months after discharge Before operation Six months after discharge
16/10/0/0 20/6/0/0 12/10/0/0 15/7/0/0
60.98 ± 5.53 65.37 ± 4.15* 61.37 ± 3.38 63.55 ± 3.28
29.75 ± 5.26 36.16 ± 4.92* 30.88 ± 2.33 33.97 ± 2.47
18/5/3 20/4/2 18/3/1 20/1/1
Note: Compared with pre-operation. LVEF: left ventricular ejection fraction; LVFS: left ventricular short axis shortening rate; ECG: electrocardiogram; SR: sinus rhythm; AF: atrial fibrillation; AVB: atrioventricular block. * P < 0.05.
400 ml saline each time) and close the chest with hemostasis. After entering ICU, the patients continue to receive ventilator-controlled breathing, ECG monitoring, invasive blood pressure monitoring and other related treatments. The condition is basically stable and then the patients will be transferred to the general ward. There is no early death (within 30 days after operation), no serious adverse events and no early complications in the two groups. Cardiac size index Table 3 shows that there is no significant difference in C/T, LAD, LVSD and LVDD between the two groups before operation, before discharge and 1, 3 and 6 months after discharge (P > 0.05). There is a decreasing trend in the experimental group compared with the control group, but there is no significant difference (P > 0.05). The C/T, LAD, LVSD and LVDD of the two groups at 6 months after operation are significantly lower than those before operation (P < 0.05). Cardiac function indicators Cardiac function grading, color Doppler echocardiography and electrocardiogram of the two groups before operation and 6 months after discharge are shown in Table 4. Clinical performance indicators The evaluation results of patch flexibility, mechanical strength at suture, suture difficulty, appearance and roughness of the cut edge are shown in Table 5. Blood compatibility index The blood compatibility indexes of the two groups are compared before operation and 6 months after discharge. There was no significant difference between preoperative and 6 months after discharge
Table 5 Performance evaluation indexes of all patches in two groups.
Patch compliance (excellent/good/general/poor) Mechanical strength at suture (excellent/god/general/poor) Difficulty of suture (excellent/good/general/poor) Appearance and roughness of cut edges (excellent/good/general/poor)
Experimental group
Control group
16/6/4/0
15/4/3/0
18/7/1/0
17/5/0/0
14/9/3/0
15/4/3/0
17/6/3/0
16/3/3/0
(P > 0.05), and there was no significant difference between groups (P > 0.05). The results are shown in Table 6. Typical cases A 23-year-old male patient with chest tightness and palpitation after exercise is admitted to hospital from March to 25, 2017. Physical examination: clear mind, no cyanosis of lips. During auscultation, the breathing sounds of both lungs are clear, and no dry-wet rales are heard. The heart rate is 82 beats per minute, and the heart rhythm is regular. 3/6 systolic jet murmurs are detected in the third and fourth intercostals of the left sternum, and the second sound of pulmonary valve is enhanced. The abdomen is flat and soft, the liver and spleen are less than the ribs, the extremities are warm and there is no edema in both lower limbs. Outpatient echocardiography: CHD complicated with IE, non-cyanotic, interventricular septal echo interrupted 15 mm, pulmonary artery pressure estimated 95 mmHg. On March, 27, 2017, intracardiac patch repair and fenestration of ventricular septal defect are performed under general anesthesia and cardiopulmonary bypass. The patients recover smoothly after operation. Cardiac function is grade I. Ejection fraction of left ventricle is 0.66 on echocardiography, and they are cured and discharged. Fig. 1 shows echocardiography before and after repair of ventricular septal defect with intracardiac patch.
Please cite this article in press as: Deng M, Yang Q. Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography. J Infect Public Health (2019), https://doi.org/10.1016/j.jiph.2019.08.009
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Table 6 Comparison of blood compatibility between the two groups before operation and 6 months after discharge. Type
Erythrocyte count (1012 /L) hemoglobin (g/L) Platelet (109 /L) Hematocrit (%) Mean corpuscular hemoglobin (pg) Mean corpuscular hemoglobin concentration (g/L) PT (s) PTA (%) PTR INR FIB (g/L) APTT (s) TT (s)
Experimental group
Control group
Before operation
Six months after discharge
Before operation
Six months after discharge
4.84 ± 0.43 133.46 ± 32.74 239.87 ± 89.68 42.45 ± 14.25 37.45 ± 3.52 331.87 ± 10.04 11.42 ± 1.13 97.22 ± 13.63 1.026 ± 0.104 1.028 ± 0.108 2.39 ± 0.57 34.92 ± 3.48 14.52 ± 1.43
4.96 ± 1.07 128.81 ± 25.33 236.46 ± 91.37 39.05 ± 4.24 38.13 ± 2.76 341.75 ± 10.37 11.83 ± 1.04 98.35 ± 13.79 1.079 ± 0.058 1.083 ± 0.065 3.14 ± 0.69 33.58 ± 3.76 14.18 ± 1.46
4.71 ± 1.14 120.44 ± 28.38 242.25 ± 79.45 36.54 ± 9.43 28.54 ± 2.84 331.36 ± 11.39 11.78 ± 1.43 95.63 ± 16.47 1.065 ± 0.163 1.065 ± 0.152 2.32 ± 0.66 35.51 ± 3.52 15.09 ± 2.37
4.66 ± 0.98 132.15 ± 17.56 248.58 ± 56.34 35.76 ± 9.46 31.68 ± 2.37 339.43 ± 12.61 11.59 ± 0.98 98.27 ± 15.47 1.055 ± 0.068 1.048 ± 0.066 2.69 ± 0.84 30.28 ± 6.57 14.08 ± 0.76
Note: PT: prothrombin time; PTA: prothrombin activity; PTR: plasma thrombinogen ratio; INR: PT international standardized ratio; FIB: fibrinogen content; APTT: activated partial thromboplastin time; TT: thrombin time.
Fig. 1. Echocardiogram of a 23-year-old male patient with ventricular septal defect before and after repair with polyester patch. A is pre-repair echocardiography with color interventricular septal reflux velocity. B indicates that the valves are closed one month after repair of ventricular septal defect with intracardiac patch under general anesthesia and cardiopulmonary bypass.
Discussion Ventricular septal defect (VSD) is one of the common congenital heart diseases in China. The incidence of VSD is about 25%–30% [14]. Patients with congenital heart disease with large tissue defect or reconstruction of outflow tract stenosis and acquired heart disease requiring tissue repair should undergo appropriate patch repair [15,16]. The ideal heart patch must have the following characteristics: stable physical and chemical properties, firm structure, good blood compatibility, easy disinfection, etc. [17]. In this study, the clinical performance of dacron patches is evaluated comprehensively from the aspects of flexibility, mechanical strength, suture difficulty, appearance and roughness of trimmed edges. The qualified rate of the patches used in both groups is 100%. It can be concluded that the performance of the two patches is not very different. The results of this study show that 48 patients have no residual shunt, and symptoms disappear. There are no complications and general activities are not limited, that is (NYHA Cardiac Function Classification I–II), they are all effective repairs. The C/T, LAD, LVSD and LVDD of the two groups decrease in varying degrees at 6 months after operation compared with those before operation, and the difference is statistically significant (P < 0.05). Clinical practice has proved that echocardiographic examination of CHD complicated with IE can clearly reflect the anatomical structure, hemodynamic parameters and cardiac function of their hearts, so as to diagnose their condition more accurately. Foreign body hemolysis is one of the important research indicators in this
study. Because the defect is repaired in the heart cavity, the valve used for repair will continue to contact the blood [18–20]. Therefore, the requirement of blood compatibility of patch material is very high. The results of this study show that there are no significant differences in the blood compatibility indexes including red blood cell count, hemoglobin concentration, platelet concentration, hematocrit, average hemoglobin volume, average hemoglobin concentration, PT, PTA, PTR, INR, FIB, APTT and TT between the experimental group and the control group before and 6 months after discharge (P > 0.05), and they are all within the normal range. Therefore, the blood compatibility of the experimental group is good, and no adverse reactions such as hemolytic anemia occur. In conclusion, the new domestic dacron patch used in the experimental group has good therapeutic effect, good clinical performance, no related complications and serious adverse events, which meets the clinical application standards. Funding No funding sources. Competing interests None declared. Ethical approval Not required.
Please cite this article in press as: Deng M, Yang Q. Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography. J Infect Public Health (2019), https://doi.org/10.1016/j.jiph.2019.08.009
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References [1] Baumgartner H. What news in the 2010 European Society of Cardiology (ESC) guidelines for the management of grown-up congenital heart disease? J Cardiovasc Med 2013;14(2):100–3. [2] Zaidi S, Choi M, Wakimoto H, Ma L, Jiang J, Overton JD, et al. De novo mutations in histone-modifying genes in congenital heart disease. Nature 2014;498(7453):220–3. [3] Cramer JW, Ginde S, Bartz PJ, Tweddell JS, Litwin SB, Earing MG. Aortic aneurysms remain a significant source of morbidity and mortality after use of Dacron(® ) patch aortoplasty to repair coarctation of the aorta: results from a single center. Pediatr Cardiol 2013;34(2):296–301. [4] Liava’a M, Kalfa D. Surgical closure of atrial septal defects. J Thorac Dis 2018;10(Suppl 24):S2931–9. [5] Kimura S, Yamaki Y, Umesue M. Reconstruction of anterior mitral leaflet using autologous pericardial patch combined with posterior leaflet sliding for active infective endocarditis. Gen Thorac Cardiovasc Surg 2014;62(4):234–7. [6] Hazekamp MG, Koolbergen DR, Kersten J, Peper J, de Mol B, König-Jung A. Pediatric tracheal reconstruction with pericardial patch and strips of autologous cartilage. Eur J Cardiothorac Surg 2009;36(2):344–51. [7] Takiguchi M, Aoki M, Shin’oka T, Hiramatsu T, Imai Y. Autopericardial patch tracheoplasty for tracheal stenosis after arterial switch operation. J Card Surg 2010;20(3):264–6. [8] Vaideeswar PP, Mishra M. Nimbalkar, Infective endocarditis of the Dacron patch-a report of 13 cases at autopsy. Cardiovasc Pathol 2011;20(5):e169–75. [9] Skulstad H, Erikssen G, ME, Estensen HL. Lindberg, Insufficient long term follow up and risk for aneurism in patients operated with Dacron patch for coarctatio aortae. Eur Heart J 2013;34(Suppl. 1):P2117. [10] Walhout RJ, Braam RL, Schepens MA, Mulder BJ, Plokker HW. Aortic aneurysm formation following coarctation repair by Dacron patch aortoplasty. Netherlands Heart J 2010;18(8):376–7.
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[11] Wang F, Xue Y, Zhao SS, Yang TJ, Song HQ, Liu H. Suturing-free artificial dura with Dacron heart patch in decompressive craniectomy and cranioplasty. Indian J Surg 2015;77(3):1008–11. [12] Matteucci ML, Rescigno G, Capestro F, Torracca L. Aortic arch patch aortoplasty for Ortner’s syndrome in the age of endovascular stented grafts. Tex Heart Inst J 2011;39(3):401–4. [13] Koduganti SC, Maddury J, Patnaik A, Kumar R. Balloon mitral valvuloplasty by antegrade technique in a postoperative patient who underwent dacron patch closure of ASD. Indian Heart J 2006;58(1):68. [14] Qu Y, Liu X, Zhuang J, Chen G, Mai J, Guo X, et al. Incidence of congenital heart disease: the 9-year experience of the Guangdong Registry of Congenital Heart Disease, China. PLoS One 2016;11(7):e0159257. [15] Shimamoto T, Nakamura T. Successful repair of a periannular tear complicated by aortic valve replacement using a Dacron patch. J Heart Valve Dis 2009;18(4):473. [16] Masroor S, Alexander JC. Dacron patch aortoplasty of thoracic aortic pseudoaneurysm due to penetrating atherosclerotic ulcer. Innov Technol Tech Cardiothorac Vasc Surg 2007;2(2):86–8. [17] Tang D, Yang C, Geva T, Gaudette G, Del Nido PJ. Effect of patch mechanical properties on right ventricle function using MRI-based two-layer anisotropic models of human right and left ventricles. Comput Model Eng Sciences 2010;56(2):113. [18] Sun HR, Tang H, Song HB. Ball thrombus in the right atrium after patch closure of atrial septal defect. Heart Lung Circ 2014;23(6):e152–3. [19] Bezdah L, Gzara M, Allouche E, Ahmed HB, Mohamed S, Sammoud H, et al. 0397: cardiac remodeling and factors determining occurrence of atrial arrhythmia after surgical closure of atrial septal defect in adults. Arch Cardiovasc Dis 2015;7(Suppl 1):102–3. [20] Sabade S, Vagrali A, Patil S, Kalligudd P, Dhulked V, Dixit MD, et al. Anaesthetic management of a child with “cor–triatriatum” and multiple ventricular septal defects — a rare congenital anomaly. Indian J Anaesth 2010;54(3):242–5.
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ARTICLE IN PRESS Journal of Infection and Public Health xxx (2019) xxx–xxx
Contents lists available at ScienceDirect
Journal of Infection and Public Health journal homepage: http://www.elsevier.com/locate/jiph
Position Paper
Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography Mingbin Deng ∗ , Qi Yang Department of Cardiovascular Surgery, Affiliated Hospital of Southwest Medical University, Luzhou, 646000, Sichuan, China
a r t i c l e
i n f o
Article history: Received 3 June 2019 Received in revised form 11 August 2019 Accepted 15 August 2019 Keywords: Dacron patch Congenital heart disease complicated with infective endocarditis Echocardiography Coagulation function Renal function
a b s t r a c t To evaluate the efficacy and safety of a new domestic dacron patch in the surgical treatment of congenital heart disease (CHD) with infective endocarditis (IE), a clinical controlled trial is conducted. 48 patients with CHD complicated with IE are selected and randomly divided into two groups. 26 patients in the experimental group are treated with a new domestic dacron patch, while 22 patients in the control group are treated with an imported cardiac polyester patch. By echocardiography, collecting chest X-ray, echocardiography and laboratory examination before and after operation, the residual shunt, cardiac function, liver function, renal function, coagulation function and other related indicators are observed after operation in the two groups, and the therapeutic effect and safety of the new dacron patch are evaluated. The results showed that there is no significant difference in C/T (cardiothoracic ratio), LAD (Left atrial diameter), LVSD (left ventricular end systolic diameter) and LVDD (left ventricular end diastolic diameter) between the two groups before operation, before discharge and 1, 3 and 6 months after discharge (P > 0.05). The C/T, LAD and LVDD of the two groups decrease 6 months after operation, and the size of atrioventricle decreases significantly. There is a decreasing trend in the experimental group compared with the control group, but there is no significant difference (P > 0.05). There are no significant differences in cardiac function classification, echocardiography, electrocardiogram, patch performance evaluation and blood compatibility between the two groups before operation and 6 months after discharge. Conclusion: The new domestic dacron patch has good clinical efficacy and safety. © 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction Surgical treatment of congenital heart disease (CHD) complicated with infective endocarditis (IE) requires thorough correction of intracardiac malformations so as to reduce complications and improve surgical results [1,2]. Therefore, the key to successful cardiac septal defect surgery is to select suitable intracardiac patches [3]. There are two main sources of traditional patches for repairing intracardiac defects [4]. One is autopericardial patch, which has the advantages of tissue activity, flexibility, mechanical strength and good histocompatibility, no rejection, and is not easy to leak blood, thrombosis, hemolysis and infection [5,6]. The disadvantage is that the pericardium is inaccessible and weak [7]. The other is dacron patch, which has the advantages of thin texture, strong ten-
∗ Corresponding author at: Department of Cardiovascular Surgery, Affiliated Hospital of Southwest Medical University, No.25 Taiping Street, Jiangyang District, Luzhou, 646000, Sichuan, China. E-mail address: [email protected] (M. Deng).
sion and elasticity, easy trimming and good compatibility [8,9]. The disadvantage is that it is easy to cause complications such as anastomotic deformation, thrombosis, embolism, hemolysis and infection after repair, and the possibility of self-healing is very small [10]. Ideal tissue engineered cardiovascular patches should be of sufficient source, easy to handle, good biocompatibility, durability, no antigenicity, no adhesion with surrounding tissues, no vascular plaque and thrombosis, no complications related to them, and have a certain degree of toughness and tensile resistance. It is better to achieve the mechanical strength matching the natural tissue of the same origin, and the myocardial tissue should also have certain electrical conductivity. In addition, pericardial substitutes should also have good adherence. Blood and exudates are not easy to accumulate in the folds to produce adhesion and other characteristics [11–13]. Clinical practice has proved that echocardiographic examination of fetuses with CHD complicated with IE can diagnose their condition more accurately, help to evaluate the function and structure of their hearts, and clarify the causes of their occurrence. The new dacron patch produced by Beijing Sida Medical Device Co., Ltd. uses medical polymer materials and imported raw materials.
https://doi.org/10.1016/j.jiph.2019.08.009 1876-0341/© 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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2 Table 1 Basic data of two groups of patients.
Table 2 Surgery performed in two groups of patients.
Type
Experimental group
Control group
P value
Operation name
Experimental group
Control group
Total
Gender (male/female) Age Weight (Kg) systolic pressure (mmHg) diastolic pressure (mmHg) Heart rate (time/min) LAD (mm) LVDD (mm) LVSD (mm) LVEF (%) LVFS (%) NYHA grading (Grade I/ Grade II) ECG (SR/AF/AVB)
16/10 20.85 ± 19.46 34.67 ± 21.23 101.47 ± 19.26 56.72 ± 12.36 94.85 ± 12.30 28.22 ± 9.55 41.27 ± 7.56 28.76 ± 5.15 62.43 ± 5.84 32.03 ± 5.17 17/9 18/5/3
11/11 19.83 ± 19.35 33.15 ± 21.35 106.43 ± 16.38 60.04 ± 11.73 92.40 ± 13.20 26.46 ± 11.25 42.47 ± 10.65 31.48 ± 7.46 60.36 ± 3.37 30.73 ± 4.15 16/6 18/3/1
0.172 0.347 0.276 0.446 0.352 0.918 0.722 0.748 0.453 0.387 0.266 0.345 0.182
ASD repair ASD repair + tricuspid valvuloplasty VSD repair ASD repair + VSD repair Total
6 4 16 0 26
7 2 10 3 22
13 6 25 3 48
Note: LAD: left atrial diameter; LVSD: left ventricular end systolic diameter; LVDD: left ventricular end diastolic diameter; LVEF: left ventricular ejection fraction; LVFS: left ventricular short axis shortening rate; ECG: electrocardiogram; SR: sinus rhythm; AF: atrial fibrillation; AVB: atrioventricular block.
It meets all the requirements for clinical trials prescribed by the State Food and Drug Administration. The safety and effectiveness of the dacron patch and echocardiography in the treatment of CHD complicated with IE will be verified in this study. Materials and methods Dacron patch The dacron patch used in this experiment is suitable for surgical repair surgery. The test results are qualified, and it has all the conditions for the clinical test as stipulated by the clinical verification of the State Food and Drug Administration (Registered Product Standards: Q/FTSD005-2011; Inspection report label of China Institute of Food and Drug Verification: NO. QZ201401253). The experimental group is made of dacron patches produced by Beijing Sida Medical Device Co., Ltd. and the control group is imported dacron patches which have been listed on the market. Patients Forty-eight CHD complicated with IE patients hospitalized by echocardiography in cardiac surgery department of Affiliated Hospital of Southwest Medical University from January 2015 to August 2018 are selected. 26 patients in the experimental group are treated with a new domestic dacron patch by echocardiography for CHD complicated with IE, while 22 patients in the control group are treated with an imported heart patch by echocardiography. The basic data and examinations of the two groups of patients are shown in Table 1. All patients involved in this study have signed the informed consent, and the study has been approved by the ethics committee of Tongde Hospital of Zhejiang Province. Echocardiography The probe frequency of the ultrasound diagnostic instrument used in the study was 2.5–3.5 MHz. The examination was carried out at quiet time of patients and at sleep after sedation for restless patients. During the examination, the patient maintained the left supine position or supine position. Routine section and subsword section examinations were carried out, and the upper sternal fossa examinations were carried out according to the specific conditions. For those with complex malformations, the examination was carried out by three-level sequential cardiac segmental method and the correct diagnosis was made.
Operative methods Both groups are operated under general anesthesia, moderate hypothermia and cardiopulmonary bypass. Cardiopulmonary bypass (CPB) is constructed by conventional intubation. All patients undergo cardiopulmonary bypass under cardiac arrest with cold crystalloid cardioplegia as myocardial protection. VSD and ASD repair are performed through the right atrial pathway. If the patient has moderate or severe tricuspid regurgitation, tricuspid valvuloplasty is also performed. The following is the successful performance of the operation. After surgical repair of the defect, the symptoms disappear without residual shunt and major complications, and general activities are not limited. Effective repair means no residual shunt on echocardiography. Evaluation criteria of therapeutic effect The main therapeutic index is effective repair. The end point of clinical study is 6 months after operation, and the end point is secondary surgery without effective repair. No residual shunt is found by echocardiography after operation. Secondary outcome indicators: The patient’s physical signs are judged by auscultation. Auscultation is divided into four grades: severe, moderate, mild and no murmur. It is acceptable if the murmur is light or there is no murmur. Other indicators: Compliance, mechanical strength during suture, suture difficulty, appearance and roughness of trimmed edge are evaluated comprehensively. The differences of each index between the experimental group and the control group are compared during the operation. Dacron patch is a kind of implantable consumables in cardiac surgery. The successful end point of clinical trial is determined by echocardiography within 2 days before operation, before discharge, 1 month after discharge and 3 months after discharge. In order to observe the efficacy and safety of the product after implantation into human body, the observation period is selected as the duration of the clinical experiment for 6 months. Therefore, echocardiogram reexamination and blood routine examination are carried out 6 months after discharge to make a comprehensive evaluation. Statistical analysis method SPSS19.0 software is used for statistical analysis. All statistical tests are conducted by bilateral test, and the test level is 0.05, that is, P < 0.05, which will be considered to have statistical significance. Metrological data were analyzed by means ± standard deviation. The counting data are described by frequency (constituent ratio). Result Early clinical situation From Table 2, it can be seen that two groups of patients need adequate auxiliary circulation after operation. After the circulation, breathing, arterial blood gas, electrolyte and other standards are met, it is necessary to stop the machine and extubate the tube, neutralize with protamine (6 mg/kg bw, twice, 6 h apart, diluted with
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Table 3 Comparison of follow-up indicators of cardiac size between groups.
Before operation
Before discharge
One month after discharge
Three months after discharge
Six months after discharge
C/T
LAD
LVSD
LVDD
Experimental group Control group P value Experimental group Control group P value Experimental group Control group P value Experimental group Control group P value Experimental group Control group P value
0.551 ± 0.054 0.566 ± 0.068 0.39 0.522 ± 0.053 0.531 ± 0.049 0.68 0.513 ± 0.057 0.529 ± 0.062 0.57 0.508 ± 0.056 0.513 ± 0.054 0.76 0.485 ± 0.048 0.492 ± 0.045 0.85
27.42 ± 9.14 29.45 ± 10.34 0.47 24.69 ± 9.76 24.38 ± 9.56 0.49 25.10 ± 9.25 25.26 ± 9.98 0.75 24.42 ± 8.46 25.08 ± 11.87 0.83 24.31 ± 8.37 24.76 ± 9.16 041
28.34 ± 5.68 30.35 ± 7.56 0.45 27.18 ± 6.36 30.24 ± 9.95 0.83 25.49 ± 7.35 26.63 ± 7.62 0.83 26.50 ± 6.54 29.27 ± 8.34 0.47 27.08 ± 8.87 29.19 ± 10.03 0.56
41.33 ± 7.26 42.39 ± 9.72 0.67 38.96 ± 9.32 41.28 ± 10.45 0.33 38.95 ± 8.74 41.03 ± 10.28 0.79 38.11 ± 8.39 39.92 ± 9.46 0.49 36.74 ± 9.68 39.71 ± 10.47 0.37
Note: C/T: chest X-ray cardiothoracic ratio; LAD: left atrial diameter; LVSD: left ventricular end systolic diameter; LVDD: left ventricular end diastolic diameter.
Table 4 Comparison of cardiac function between two groups.
Experimental group Control group
NYHA grading (I/II/III/IV)
LVEF (%)
LVFS (%)
ECG (SR/AF/AVB)
Before operation Six months after discharge Before operation Six months after discharge
16/10/0/0 20/6/0/0 12/10/0/0 15/7/0/0
60.98 ± 5.53 65.37 ± 4.15* 61.37 ± 3.38 63.55 ± 3.28
29.75 ± 5.26 36.16 ± 4.92* 30.88 ± 2.33 33.97 ± 2.47
18/5/3 20/4/2 18/3/1 20/1/1
Note: Compared with pre-operation. LVEF: left ventricular ejection fraction; LVFS: left ventricular short axis shortening rate; ECG: electrocardiogram; SR: sinus rhythm; AF: atrial fibrillation; AVB: atrioventricular block. * P < 0.05.
400 ml saline each time) and close the chest with hemostasis. After entering ICU, the patients continue to receive ventilator-controlled breathing, ECG monitoring, invasive blood pressure monitoring and other related treatments. The condition is basically stable and then the patients will be transferred to the general ward. There is no early death (within 30 days after operation), no serious adverse events and no early complications in the two groups. Cardiac size index Table 3 shows that there is no significant difference in C/T, LAD, LVSD and LVDD between the two groups before operation, before discharge and 1, 3 and 6 months after discharge (P > 0.05). There is a decreasing trend in the experimental group compared with the control group, but there is no significant difference (P > 0.05). The C/T, LAD, LVSD and LVDD of the two groups at 6 months after operation are significantly lower than those before operation (P < 0.05). Cardiac function indicators Cardiac function grading, color Doppler echocardiography and electrocardiogram of the two groups before operation and 6 months after discharge are shown in Table 4. Clinical performance indicators The evaluation results of patch flexibility, mechanical strength at suture, suture difficulty, appearance and roughness of the cut edge are shown in Table 5. Blood compatibility index The blood compatibility indexes of the two groups are compared before operation and 6 months after discharge. There was no significant difference between preoperative and 6 months after discharge
Table 5 Performance evaluation indexes of all patches in two groups.
Patch compliance (excellent/good/general/poor) Mechanical strength at suture (excellent/god/general/poor) Difficulty of suture (excellent/good/general/poor) Appearance and roughness of cut edges (excellent/good/general/poor)
Experimental group
Control group
16/6/4/0
15/4/3/0
18/7/1/0
17/5/0/0
14/9/3/0
15/4/3/0
17/6/3/0
16/3/3/0
(P > 0.05), and there was no significant difference between groups (P > 0.05). The results are shown in Table 6. Typical cases A 23-year-old male patient with chest tightness and palpitation after exercise is admitted to hospital from March to 25, 2017. Physical examination: clear mind, no cyanosis of lips. During auscultation, the breathing sounds of both lungs are clear, and no dry-wet rales are heard. The heart rate is 82 beats per minute, and the heart rhythm is regular. 3/6 systolic jet murmurs are detected in the third and fourth intercostals of the left sternum, and the second sound of pulmonary valve is enhanced. The abdomen is flat and soft, the liver and spleen are less than the ribs, the extremities are warm and there is no edema in both lower limbs. Outpatient echocardiography: CHD complicated with IE, non-cyanotic, interventricular septal echo interrupted 15 mm, pulmonary artery pressure estimated 95 mmHg. On March, 27, 2017, intracardiac patch repair and fenestration of ventricular septal defect are performed under general anesthesia and cardiopulmonary bypass. The patients recover smoothly after operation. Cardiac function is grade I. Ejection fraction of left ventricle is 0.66 on echocardiography, and they are cured and discharged. Fig. 1 shows echocardiography before and after repair of ventricular septal defect with intracardiac patch.
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Table 6 Comparison of blood compatibility between the two groups before operation and 6 months after discharge. Type
Erythrocyte count (1012 /L) hemoglobin (g/L) Platelet (109 /L) Hematocrit (%) Mean corpuscular hemoglobin (pg) Mean corpuscular hemoglobin concentration (g/L) PT (s) PTA (%) PTR INR FIB (g/L) APTT (s) TT (s)
Experimental group
Control group
Before operation
Six months after discharge
Before operation
Six months after discharge
4.84 ± 0.43 133.46 ± 32.74 239.87 ± 89.68 42.45 ± 14.25 37.45 ± 3.52 331.87 ± 10.04 11.42 ± 1.13 97.22 ± 13.63 1.026 ± 0.104 1.028 ± 0.108 2.39 ± 0.57 34.92 ± 3.48 14.52 ± 1.43
4.96 ± 1.07 128.81 ± 25.33 236.46 ± 91.37 39.05 ± 4.24 38.13 ± 2.76 341.75 ± 10.37 11.83 ± 1.04 98.35 ± 13.79 1.079 ± 0.058 1.083 ± 0.065 3.14 ± 0.69 33.58 ± 3.76 14.18 ± 1.46
4.71 ± 1.14 120.44 ± 28.38 242.25 ± 79.45 36.54 ± 9.43 28.54 ± 2.84 331.36 ± 11.39 11.78 ± 1.43 95.63 ± 16.47 1.065 ± 0.163 1.065 ± 0.152 2.32 ± 0.66 35.51 ± 3.52 15.09 ± 2.37
4.66 ± 0.98 132.15 ± 17.56 248.58 ± 56.34 35.76 ± 9.46 31.68 ± 2.37 339.43 ± 12.61 11.59 ± 0.98 98.27 ± 15.47 1.055 ± 0.068 1.048 ± 0.066 2.69 ± 0.84 30.28 ± 6.57 14.08 ± 0.76
Note: PT: prothrombin time; PTA: prothrombin activity; PTR: plasma thrombinogen ratio; INR: PT international standardized ratio; FIB: fibrinogen content; APTT: activated partial thromboplastin time; TT: thrombin time.
Fig. 1. Echocardiogram of a 23-year-old male patient with ventricular septal defect before and after repair with polyester patch. A is pre-repair echocardiography with color interventricular septal reflux velocity. B indicates that the valves are closed one month after repair of ventricular septal defect with intracardiac patch under general anesthesia and cardiopulmonary bypass.
Discussion Ventricular septal defect (VSD) is one of the common congenital heart diseases in China. The incidence of VSD is about 25%–30% [14]. Patients with congenital heart disease with large tissue defect or reconstruction of outflow tract stenosis and acquired heart disease requiring tissue repair should undergo appropriate patch repair [15,16]. The ideal heart patch must have the following characteristics: stable physical and chemical properties, firm structure, good blood compatibility, easy disinfection, etc. [17]. In this study, the clinical performance of dacron patches is evaluated comprehensively from the aspects of flexibility, mechanical strength, suture difficulty, appearance and roughness of trimmed edges. The qualified rate of the patches used in both groups is 100%. It can be concluded that the performance of the two patches is not very different. The results of this study show that 48 patients have no residual shunt, and symptoms disappear. There are no complications and general activities are not limited, that is (NYHA Cardiac Function Classification I–II), they are all effective repairs. The C/T, LAD, LVSD and LVDD of the two groups decrease in varying degrees at 6 months after operation compared with those before operation, and the difference is statistically significant (P < 0.05). Clinical practice has proved that echocardiographic examination of CHD complicated with IE can clearly reflect the anatomical structure, hemodynamic parameters and cardiac function of their hearts, so as to diagnose their condition more accurately. Foreign body hemolysis is one of the important research indicators in this
study. Because the defect is repaired in the heart cavity, the valve used for repair will continue to contact the blood [18–20]. Therefore, the requirement of blood compatibility of patch material is very high. The results of this study show that there are no significant differences in the blood compatibility indexes including red blood cell count, hemoglobin concentration, platelet concentration, hematocrit, average hemoglobin volume, average hemoglobin concentration, PT, PTA, PTR, INR, FIB, APTT and TT between the experimental group and the control group before and 6 months after discharge (P > 0.05), and they are all within the normal range. Therefore, the blood compatibility of the experimental group is good, and no adverse reactions such as hemolytic anemia occur. In conclusion, the new domestic dacron patch used in the experimental group has good therapeutic effect, good clinical performance, no related complications and serious adverse events, which meets the clinical application standards. Funding No funding sources. Competing interests None declared. Ethical approval Not required.
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Please cite this article in press as: Deng M, Yang Q. Efficacy and safety of dacron patch in surgical treatment of congenital disease by echocardiography. J Infect Public Health (2019), https://doi.org/10.1016/j.jiph.2019.08.009