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- Publisher
- Hindawi Publishing Corporation
- Copyright
- Copyright © 2021 Ali Cemal Duzgun et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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- 1176-2322
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- 1754-2103
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- 10.1155/2021/2169431
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Abstract
Hindawi Applied Bionics and Biomechanics Volume 2021, Article ID 2169431, 6 pages https://doi.org/10.1155/2021/2169431 Research Article Comparison of Two Sternal Closure Techniques Based on Risk Factors: A Prospective, Observational Study 1 2 1 Ali Cemal Duzgun , Ekin Ilkeli , and Fehmi Katircioglu Department of Cardiovascular Surgery, Ankara Training and Research Hospital, Ankara, Turkey Department of Cardiovascular Surgery, Duzce State Hospital, Duzce, Turkey Correspondence should be addressed to Ekin Ilkeli; ekinilkeli@hotmail.com Received 15 June 2021; Revised 30 August 2021; Accepted 23 September 2021; Published 8 October 2021 Academic Editor: Marco Parente Copyright © 2021 Ali Cemal Duzgun et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Stainless steel wires are still commonly used as a sternum closure technique. However, it can cause fatal complications due to rupture and dehiscence. It was anticipated that the sternal Cable System (Pioneer Surgical Technology Inc., Marquette, MI, USA) could provide a better sternal fixation and reduce the possible complications. Materials and Method. A total of 100 patients (57 male, 43 female) at high risk of dehiscence were included in this prospective observational study. Among those with EuroSCORE value of 4 and above, patients with chronic lung disease, chronic kidney disease, diabetes mellitus, obesity, smoking, body mass index, advanced age, and resurgery were operated in two separate centers. Standard steel wires (n: 51) used for sternotomy were compared with the sternal cable (n: 49). Early and late sternal dehiscence rates were compared in the study. The relationship between risk factors causing dehiscence and both methods was assessed statistically. Results. Early dehiscence rates were 6.4% in those closed with a sternal cable (n: 3) and 11.8% in those closed with a sternal wire (n:6)(p <0:05)). In risky patients, body mass index was the most determining parameter in terms of sternum dehiscence risk. Conclusion. In risky patients, we recommend the sternal cable system as a good and reliable closure technique to achieve a more stable and compact sternum. 1. Introduction The risk of developing infection after median sternot- omy is between 0.2% and 10%, and morbidity and mortality Median sternotomy still continues to be the most common rates vary between 5% and 25% in the presence of infec- tion [2]. incision type in open heart surgery as an easy, safe, fast, and inexpensive method. It is easy to access to the heart 1.1. Study Hypothesis. In this prospective study, we com- and bigger vessels with this method. Although there are dif- pared the monofilament stainless steel sternum closure wire ferent techniques and methods for sternum closure, sternal with the Sternal Cable System (Pioneer Surgical Technology closure with monofilament stainless steel wire is still the Inc., Marquette, MI, USA) in patients operated by sternot- most commonly used method because it is inexpensive [1]. omy. We tried to elaborate which factors are more predom- If adequate sternal closure could not be provided, com- inant to create a safer technique to guide surgeons. plications can be fatal especially in patients with advanced age and comorbidities. It is important because of the high 2. Materials and Method risk of sternal complications due to advanced age, chronic obstructive pulmonary disease (COPD), diabetes mellitus A total of 100 patients (57 males, 43 females) who were (DM), chronic renal failure (CRF), obesity, and osteoporosis. scheduled to be operated in two tertiary stage cardiovascular Rigid and strong fixation of the sternum also reduces the risk surgery clinics between January 2017 and September 2019 in of complications. the same session were included in the study. Both groups 2 Applied Bionics and Biomechanics included in the study were formed prospectively, two- Table 1: Demographic characteristics of the patients. centered. The same surgery team has conducted the opera- Groups tions in 2 different cardiovascular surgery centers. Exitus Variables Sternal cable Sternum wire patients and patients who could not be followed up or out n % n % of follow-up were not included in the study. The data of Gender 100 patients who were followed up regularly were evaluated. Male 30 61.2 27 52.9 The study was carried out in parallel between the two centers in patients with risk factors determined in the same date Female 19 38.8 24 47.1 range. The study was carried out on a certain number of Age patients, taking into account the sample size and the number <80 38 77.6 41 80.4 of sternal cables available. ≥80 11 22.4 10 19.6 All groups have certain risk factors such as COPD, DM, BMI CRF, advanced age, smoking, reoperation, and body mass Normal 13 27.7 17 33.3 index. BMI (body mass index) values of the patients were Overweight 22 46.8 15 29.4 evaluated according to the American Centers for Disease Control and Prevention standards in three groups which Obese 12 25.5 19 27.3 are normal, overweight, and obese [3]. Smoking The demographic characteristics of the patients (age, No 27 57.4 30 58.8 gender, smoking, etc.), operation types (coronary, valve sur- Yes 20 42.6 21 41.2 gery, etc.), and complications (dehiscence, mediastinitis, revision, etc.) were recorded. The reasons for using multifilament stainless steel cable were utilized to assess the relationship between two qualita- and monofilament standard steel wires were recorded. Stan- tive variables. Statistical significance level was set as 0.05. In the WEKA tool, logistic regression, multilayer perceptron, dard monofilament steel wires used in sternum closure were compared with multifilament stainless steel sternal cable. and J48 from classification methods were used. Since there are too many variables in the data set, the Info Gain Attri- 2.1. Approach to Patients, Surgical Method, and Follow-Up. bute Eval, Gain Ratio Attribute Eval, and Chi-Squared All patients were conducted median sternotomy. Shaving Attributed Eval methods in WEKA have been used to exam- ine the importance of the variables and variables that were and skin cleansing was done 1 day before. The left internal mammary artery (LİMA) was removed unilaterally skeleton- jointly identified as insignificant by the three methods and ized. The sternum was closed in 51 of the patients who were considered to be less important as clinical information were operated by the same surgical team using sternal steel wire excluded from the data set. and the other 49 using a sternal cable. The sternotomies in A total of 7 variables (6 independent variables and 1 dependent variable) remained in the data set. These vari- both methods were closed in an 8-shaped fashion with 5 standard stainless steel wires and 1.0 mm multifilament ables are gender, age, BMI, Lima use, smoking, comorbidity, stainless steel cable regardless of the length of the sternum. and closure method. Percentages regarding the importance The patients were followed up in terms of sternal dehis- of the variable are given according to the closing method cence in the first 6 weeks (early period) and 6 months (late which is the dependent variable. The data set was evaluated using the 10-fold crossvalidation test option. Results of the period). Sternal dehiscence grading was made according to a new classification which evaluates the anatomic changes outcome variable were given using accuracy, F-measure, and the condition of the pectoral muscle [4]. Patient data precision, and recall as the evaluation criteria. were collected and evaluated statistically. This prospective study was reviewed and approved by 3. Results the ethics committee, and informed consent was obtained from all enrolled patients. All patients were informed that The demographic data of the patients are presented in the Sternal Cable System will be use (ethics committee: Table 1. 05.11.2018-93471371-44/450-Ankara Training and Research When both sternum closure techniques are compared, Hospital). early dehiscence rates were 6.4% in cases closed with sternal cable and 11.8% in cases closed with sternal wire (p <0:05) 2.2. Statistical Analysis. WEKA 3.6 and SPSS 11.5 software (Table 2). were used to evaluate the data. As descriptive, mean ± Obesity, diabetes, age, and dehiscence were the most standard deviation and median (minimum-maximum) for common reasons for using sternum cable or sternum wire quantitative variables, the number of patients (percentage) (Table 3). for qualitative variables was used. Hospitalization durations and drainage rates were found In case of a difference between the categories of the qual- to be higher in patients who were closed with a sternal cable itative variable with more than two categories in terms of the (p <0:05) (Table 4). quantitative variable with Student t-test if normal distribu- There was no difference between the two groups in terms tion assumptions are met, if not, it was checked using the of sternum revision and sternal infection. Mediastinitis Mann–Whitney U test. Chi-square and Fisher exact tests occurred in 3 patients with sternal cable. However, this ratio Applied Bionics and Biomechanics 3 Table 2: Intraoperative and postoperative results. CABG 30 61.2 36 70.6 AVR 3 6.1 4 7.8 MVR 7 14.3 6 11.8 Surgery CABG+MVR 5 10.2 3 5.9 Aortic aneurisym dissection 2 4.1 2 3.9 CABG+AVR 2 4.1 0 0.0 No 20 42.6 24 48.0 Lima usage Yes 27 57.4 26 52.0 No 44 93.6 45 88.2 Early dehiscence Yes 3 6.4 6 11.8 No 48 98.0 49 96.1 Late dehiscence Yes 1 2.0 2 3.9 No 40 81.6 43 84.3 Str. revision Yes 9 18.4 8 15.7 No 45 91.8 47 92.2 Str. infection Yes 4 8.2 4 7.8 No 45 93.8 50 98.0 Mediastinitis Yes 3 6.2 1 2.0 Alive 46 93.9 51 100.0 Death Death 3 6.1 0 0.0 No 2 4.1 0 0.0 Str: sternal. Table 3: Sternal cable and sternum wire usage reasons. num with a single incision. It is advantageous to reach and maneuver to the entire mediastinal space with an easy and Sternal cable Sternal wire inexpensive incision such as a median sternotomy. However, Reasons n % n % it continues to carry the risk of dehiscence. Dehiscence 3 6.1 0 0.0 Preoperative risk factors for sternal dehiscence were Older age 11 22.5 10 19.6 indicated as obesity, COPD, osteoporosis, heart failure CRF 7 14.4 3 5.9 (New York Heart Association functional class III–IV), corti- costeroid, immunosuppression, diabetes mellitus, renal fail- COPD 6 12.2 10 19.6 ure, and previous sternotomy [5, 6]. Obesity-DM 11 22.4 19 37.3 If sternal healing is not achieved well after median ster- Reoper 8 16.3 9 17.6 notomy, it causes sternal separation and sternal dehiscence, Revision 1 2.0 0 0.0 resulting in severe sternal complications between 0.5% and Other 2 4.1 0 0.0 2.5% [7, 8]. Sternal dehiscence may become in mediastinitis, osteomyelitis, and unstable sternum forms, resulting in mor- tality of 10% to 40% as a result [9, 10]. Sternal stability is was not clinically significant since dehiscence and revisions very important in sternum closure. Dehiscence developing (n: 4) were closed with a sternal cable. due to unstable sternum is the main cause of sternal wound Hospitalization durations were determined as, infections. The movements caused by the inability to join the respectively, mean ± SS4:43 ± 3:16 − 2:73 ± 0:78 between bones rigidly cause tissue necrosis by damaging the sur- the sternal cable and sternum wire groups. rounding tissues, which facilitates bacterial growth. [11] The potential superiority of the Sternal Cable System was In a study comparing traditional sternum wiring and evaluated significantly in the gain chart graph of the multi- rigid sternum fixation techniques, it was stated that clinical layer perceptron method (Figure 1). stability was significantly better in subjects who underwent rigid fixation 4 weeks after the operation and bone forma- tion occurred in the osteotomy space during this period [12]. 4. Discussion Although many sternum closure techniques have been In recent years, surgeries performed in cardiac operations reported, there is no consensus on the ideal closure tech- with minimally invasive incision have provided a lot of com- nique. Multifilament Stainless Cable System (Pioneer Surgi- fort. However, it is difficult to reach to the entire mediasti- cal Technology Inc. Marquette, MI, USA) is a model 4 Applied Bionics and Biomechanics Table 4: Comparison of groups. Groups Variables Sternal cable Sternal wire n Mean ± SD Median (min.-max.) n Mean ± SD Median (min.-max.) 4:43 ± 3:16 2:73 ± 0:78 Intensive care stay 49 3.00 (1.00-17.00) 51 3.00 (2.00-6.00) 8:41 ± 4:61 7:88 ± 2:36 Hospital stay 49 7.00 (2.00-27.00) 51 7.00 (5.00-15.00) Drainage 49 1033:47 ± 527:25 900.00 (15.00-2400.00) 51 739:22 ± 244:61 750.00 (350.00-1300.00) 2:39 ± 1:15 1:98 ± 0:89 Pain killer requirement 44 2.00 (1.00-6.00) 50 2.00 (1.00-4.00) 66:55 ± 13:24 67:75 ± 9:18 Age 49 67.00 (22.00-86.00) 51 68.00 (52.00-85.00) 27:44 ± 4:04 28:69 ± 4:74 BMI 47 26.40 (21.40-36.35) 51 26.40 (22.84-37.83) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 80% 0% 10% 20% 30% 40% 50% 60% 70% 90% 100% Percentage Dependent variable: Closure technique Closure with sternal cable Closure with sternal wire Figure 1: Tree diagram of J48 method and ratios of variables. designed to be used in sternum closure. Previously, it was num wires were damaged (<0.001%) while 99.5% of the ster- reported that the failure rate of the sternum cable after nal cables continued the test without any damage. The performance of the plates is also lower than the sternal implantation was lower than the sternum wire and plates in a study comparing the sternum cable, sternum wire, and cable [14]. sternal plates used for sternum closure as form of eight Multifilament cable wiring system has been stated to [13]. According to this study, metal fatigue caused by the have about ten times stronger durability than standard steel force to separate the two halves of the sternum and the asso- wires [15]. The tensioning and compression tool used to ciated implant failure risk is significantly lower in the cable close the sternum with the sternal cable allows the cable to system compared to the wire and plate. be stretched in a controlled manner after the cable is placed As a result of this test separating the sternum from each in the sternum (the most effective application is the intercos- other repeated 7.8 million times, there are no error lines on tal placement in the form of eight). The tension of the cable the curve showing the cables, and the success rate is 100%. and thus the force applied to the sternum can be followed up Another test performed by applying opposite forces on the from the indicator on the instrument. This feature ensures vertical axis to shift the two connecting parts of the sternum that each cable placed in the sternum is covered with the is 10,000 times showed that almost all of the traditional ster- same tension and distributes the pressure homogeneously Gain Applied Bionics and Biomechanics 5 technique has been shown to be superior to standard ster- num closure. [17] No new approach has been developed for risky patient groups. One of the results of our study was to contribute to the creation of a strategy for the application of methods such as the Multifilament Stainless Cable Closure System, which is an alternative to the standard closure technique; although, there are different techniques in the sternum clo- sure process. In this manner, it was observed that the most basic invariant parameter was BMI when the data is ana- lyzed. Comorbidities have been another important deter- mining parameter. Age, Lima use, and smoking were among the other determinants. Other risks that have formed the basic parameters and the strategy were overweight, use of sternal cable in women, and over 80 years old men, obvi- ously, and seem to be more advantageous. In our experience, sternal dehiscence developed in the majority of patients while still in hospital or a few days after leaving the hospital. In our study, importantly, early dehiscence rates were found to be significantly lower in the sternal group compared to the wire group. Thus, fatal complications such as mediastini- Figure 2: Intraoperative image multifilament cable wiring system tis caused by dehiscence can be prevented in risky patient (the force applied to the sternum can be followed by the indicator groups. We think that this will contribute to the recognition on the instrument. This feature ensures that each cable placed in of risk factors and the strategy to be developed. While it the sternum is closed at the same tension and distributes the should not be used for every patient, it will be particularly pressure homogeneously over the sternum). beneficial for patients over 80 years of age, osteoporotic, smoking, and with high BMI and where Lima will be used over the sternum (Figure 2). It distributes the pressure as a graft. We think that it is essential to develop a treatment strategy with a cable in these patients. homogeneously over the sternum that occurs when the patient is breathing, coughing, or sneezing. Tightening the sternum at different points with equal strength also increases 4.1. Limitations of the Study. The main limitation of our stabilization. study is the limited number of patients in only two centers, Since there is no possibility to adjust the pressure in the because sufficient financial resources and time could not be placement of traditional sternum wires, if the sternum is provided. Therefore, multicentered, comprehensive, ran- tightened with unequal forces at different points, all the domized studies may provide better results. More compre- resulting force due to the abovementioned reasons may hensive studies are needed regarding which patients should overlap on the tightest ring and cause implant failure, the be approached with which strategy. wire to cut the bone, or sternum fractures. It is possible to develop this basal strategy and to sep- Particularly, since the bone compression procedure is arate the risk groups, add additional recommendations, or adjusted by the surgeon in the sternal cable method, the add different surgical procedures (such as minimally inva- equal and homogeneous distribution of pressure provides sive, pectoralis major flap) in patients with high dehis- decrease in complications in CRF, COPD, DM, and osteopo- cence risk. rotic patients. Multifilament Stainless Cable Closure System produced more successful results in early dehiscence rates. The differ- 5. Conclusion ence between sternal cable and sternal wire was detected as 3 6.4% and 11.8%, respectively (p <0:05). This result means We recommend multifilament stainless cables as a good and cost reduction as well as patient health. There was no statis- reliable closure technique for a more stable and compact tically significant difference between the two groups in late sternum in risky patients. BMI in particular, advanced age, dehiscence development. Lima use, being overweight, smoking, and female gender Sternal bleeding is an important cause of drainage in have attracted attention as an important baseline parameter most patients [16]. Higher drainage rates are related to in the development of strategy in patients who may have patient characteristics rather than the Sternal Cable System. sternum dehiscence risk. No clinically significant drainage was found. 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Journal
Applied Bionics and Biomechanics – Hindawi Publishing Corporation
Published: Oct 8, 2021