Sternal closure with sandwiched three-piece bioresorbable mesh reduces postoperative hemorrhage: a retrospective study

doi:10.21203/rs.3.rs-2709664/v1

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Sternal closure with sandwiched three-piece bioresorbable mesh reduces postoperative hemorrhage: a retrospective study

https://doi.org/10.21203/rs.3.rs-2709664/v1

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Background: Median sternotomy is the most performed procedure in cardiac surgery; however, sternal bleeding remains a problem. This study aimed to investigate whether sternal reconstruction using a sandwiched three-piece bioresorbable mesh plate can prevent postoperative bleeding more than a bioresorbable pin.

Methods: Patients (n = 218) who underwent median sternotomy were classified according to whether a sandwiched three-piece bioresorbable mesh plate and wire cerclage (group M, n = 109) or a bioresorbable pin and wire cerclage (group P, n = 109) was used during sternal reconstruction. The causes of postoperative bleeding and computed tomography data were analyzed and compared between the groups.

Results: The preoperative patient characteristics did not significantly differ between the groups. However, the amount of bleeding at 6 h postoperatively was lower in group M than in group P (235 ± 147 vs. 284 ± 175 mL, p = 0.0275). Chest reopening, intubation time, and length of intensive care unit and hospital stays did not differ between the groups. Evaluation for sternal and substernal hematoma on postoperative day 5 using computed tomography showed sternal displacement in 4 (4%) and 22 (20%) patients, and substernal hematoma in 9 (8%) and 22 (20%) patients in groups M and P, respectively; the difference was significant. The four-grade evaluation of substernal hematoma based on computed tomography yielded a significantly lower grade for group M than for group P, revealing that the mesh plate was an independent predictor of substernal hematoma prevention.

Conclusion: Sternal fixation with a three-piece bioresorbable mesh plate could prevent postoperative bleeding and substernal hematoma more than sternal fixation with a pin.

median sternotomy

bioresorbable mesh plate

postoperative hemorrhage

Median sternotomy is the most common surgical procedure in cardiac surgery. The incidence of complications, such as sternal dehiscence and infections, ranges from 0.3–8% [1, 2]. Sternal wound complications increase the mortality rate from 10–40% [3]. Furthermore, 6–25% of cases of thoracic sternal infection are associated with a reopened chest due to postoperative hemorrhage, indicating a causal relationship between hemorrhage and infection [4]. Therefore, preventing postoperative hemorrhage is one of the most crucial goals in cardiac surgery. Stainless steel wiring is the standard method for sternal closure after median sternotomy. Recently, Super FIXSORB MX40 mesh plates (Teijin Medical Technologies CO. Ltd., Osaka, Japan), which are made of poly-L-lactide, have been applied in addition to conventional stainless-steel wiring. The mesh plate is resorbed after approximately 6 years through osteoconduction [5] and has already been used for fixing rib fractures and flail chest repair [6, 7]. Furthermore, postoperative respiratory conditions are more stable when a mesh plate is used for median sternotomy after congenital cardiac surgery and coronary artery bypass grafting [8, 9]. Therefore, we devised a method to close the sternum by external fixation using a three-piece mesh plate (Fig. 1). Fixation was found to be stronger with this technique, and it was inferred that prevention of sternal displacement would reduce the incidence of postoperative bleeding. We hypothesized that chest closure with the mesh method would reduce the incidence of postoperative sternal hemorrhage. We further compared conventional chest closure using pins to that using mesh plates.

Study population

This retrospective study included 249 consecutive patients who underwent cardiac surgery at Toda Chuo General Hospital between April 2017 and December 2019. The following patients were excluded: 2 patients who underwent minimally invasive cardiac surgery, 1 with chest closure using SternaLock Blu (Biomet Microfixation CO. Ltd., Jacksonville, FL), 26 with chest closure using Fixsorb wave (Teijin Medical Technologies CO. Ltd., Osaka, Japan), and 2 who could not be withdrawn from cardiopulmonary bypass. Ultimately, the study included 218 patients.

For basic sternal fixation, conventional wire cerclage was used. Between July 2018 and December 2019, we used a three-piece mesh plate for full sternotomy (group M, n = 109). For comparison, group P (n = 109) included patients who underwent chest closure using a pin between April 2017 and February 2019. Data on the postoperative course, bleeding, infection, and computed tomography (CT) were compared between the groups. This study was approved by the Institutional Review Board of Toda Chuo General Hospital (approval number: 0517; received on November 29, 2021).

Surgical Procedure

All patients underwent sternal closure with conventional wire cerclage without bone wax that was performed by a single surgeon. Six simple single wires were used; two transsternal and four parasternal wires were placed at the manubrium and sternal body, respectively. The mesh plate and all corners of each plate were cut with scissors (Fig. 1A). The schema of the mesh plate implantation method is shown in Fig. 1B. The mesh plate was fixed by passing two transsternal and parasternal wires (first and third) through the holes on the mesh plate. Subsequently, each wire was tied, and two mesh plates were implanted on the posterior surface of the sternum. The sternum was closed using three mesh plates; two on the posterior surface and one on the anterior surface. Figure 2 shows the procedure for sternal closure with a three-piece mesh plate. From deep to superficial, the pectoral fascia was closed with 0 Vicryl sutures in a continuous pattern. The subcutaneous tissue was closed with 2 − 0 Vicryl sutures in a continuous pattern after placement of a 10-Fr subcutaneous drain, and the skin was closed with 5 − 0 polydioxanone clear sutures in a continuous pattern. In group P, the above procedure was also performed except that instead of a mesh, one pin each was inserted into the sternal manubrium and body. All patients received prophylactic antibiotic treatment with cefazolin (dosage based on individual patient weight) for 48 h postoperatively.

Postoperative Management

Once admitted to the postoperative intensive care unit (ICU), activated clotting time was measured hourly and maintained at < 120 s by administering protamine as needed. Postoperative blood glucose levels were measured hourly and maintained at < 180 mg/dL by continuous intravenous insulin administration. Drains were placed in the pericardial and thoracic cavities as well as retrosternally. The effluent volume was measured hourly with milking of the drainage as needed. Sedation was discontinued when the drainage rate was < 30 mL/h, and the patient was extubated from the ventilator when he was fully conscious and oriented. The criterion for leaving the ICU was having a hemodynamically stable condition and being able to walk 50 m. All patients underwent chest CT on postoperative day 5 to assess the sternum and check for substernal hematoma.

Definitions And Endpoints

The primary endpoint was the total volume of postoperative bleeding. The secondary endpoints included the length of ICU and hospital stays, rate of deep sternal wound infection, degree of substernal hematoma (Fig. 3), sternal healing, and dehiscence using CT data on postoperative day. To evaluate sternal healing, we adopted methods from previous studies [10, 11]. Deep sternal wound infection was defined according to the following criteria: 1) bacteria could be isolated from cultures of mediastinal tissue or fluid; 2) evidence of mediastinitis was observed during surgery; and 3) presence of chest pain, sternal instability, or fever (> 38℃) with either purulent mediastinal discharge or bacterial isolation from a blood culture of drainage fluid originating from the mediastinal area [12].

Statistical Analyses

Continuous and normally distributed data are presented as means ± standard deviations, while categorical data are expressed as percentages. All analyses were performed using JMP Pro version 15 (SAS Institute, Cary, NC, USA). Statistical significance was set at p < 0.05. Between-group differences were evaluated using the Chi-square test for categorical variables and the t-test or Mann–Whitney U test for continuous variables. We compared the baseline characteristics, operative data, and postoperative complications of groups P and M using the Pearson 2 test for categorical variables, the t-test for continuous variables, and the Mann–Whitney U test for continuous skewed data. Ordered logistic regression analysis was performed to evaluate independent predictors of substernal hematoma prevention using the four-grade evaluation of substernal hematoma on CT.

The preoperative patient characteristics are listed in Table 1. No significant differences were noted between the two groups. Preoperative drug prescriptions, including aspirin, clopidogrel, warfarin, or novel oral anticoagulants, were not significantly different between the groups. Additionally, both groups did not significantly differ in the preoperative diagnoses, including ischemic heart disease, aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation, aortic aneurysm, and aortic dissection.

Table 1

Patient characteristics
	M (n = 109)	P (n = 109)	p-value
Age (years)
Under 60	16 (15%)	22 (20%)	0.4125
60–69	21 (19%)	26 (24%)
70–79	43 (39%)	40 (37%)
Over 80	29 (27%)	21 (19%)
Sex (men), n (%)	67 (61.5%)	75 (68.8%)	0.2555
Body mass index (kg/m²)	23.1 ± 3.6	22.9 ± 3.7	0.6833
Hypertension, n (%)	80 (73.4%)	71 (65.1)	0.1865
Dyslipidemia, n (%)	53 (48.6%)	46 (42.2%)	0.3410
DM, n (%)	29 (26.6%)	20 (18.3%)	0.1442
Smoking history, n (%)	59 (54.1%)	59 (54.1%)	1.0000
HD, n (%)	2 (1.8%)	6 (5.5%)	0.1496
History of stroke, n (%)	9 (8.3%)	10 (9.2%)	0.8102
Orthopedic disease, n (%)	22 (20.2%)	16 (14.7%)	0.2841
Hb (g/dL)	12.7 ± 2.0	13.0 ± 1.9	0.1888
Platelet	20.7 ± 6.5	20.3 ± 5.6	0.6192
Alb	3.9 ± 0.5	4.0 ± 0.5	0.2320
eGFR	57.9 ± 19.5	60.7 ± 22.6	0.3376
BNP	238.4 ± 553.1	246.7 ± 491.4	0.9136
HbA1c	6.0 ± 1.0	5.9 ± 0.7	0.4071
Ejection fraction (%)	63.2 ± 12.7	62.3 ± 14.4	0.6304
Preoperative drugs
Aspirin	23 (21.1%)	27 (24.7%)	0.5191
Clopidogrel	10 (9.2%)	11 (10.1%)	0.8184
Warfarin	3 (2.8%)	6 (5.5%)	0.3071
NOAC	17 (15.6%)	13 (11.9%)	0.4316
Diagnosis
Ischemic	21 (46%)	25 (54%)	0.8254
Aortic Stenosis	21 (55%)	17 (45%)
Aortic Regurgitation	11 (48%)	12 (52%)
Mitral Stenosis	1 (25%)	3 (75%)
Mitral Regurgitation	23 (51%)	22 (49%)
Aneurysm	19 (58%)	14 (42%)
Dissection	10 (50%)	10 (50%)
Others	3 (33%)	6 (66%)
Pre-operative SPPB	11.3 ± 1.4	11.3 ± 1.3	0.8575
Euro Score (%)	6.7 ± 9.7	5.7 ± 6.8	0.3904
DM, diabetes mellitus; HD, hemodialysis; Hb, hemoglobin; alb, albumin; eGFR, estimated glomerular filtration rate; BNP, brain natriuretic peptide; HbA1c, hemoglobin A1c; NOAC, novel oral anticoagulant; SPPB, short physical performance battery

Operative data, such as the procedure (rates of coronary artery bypass grafting, valve, aorta, concomitant, and congenital surgeries), rate of emergency, amount of bleeding, volume of blood transfused, and operative, perfusion, cross-clamp, and upper and lower circulatory arrest times were not significantly different between the groups. These details are presented in Table 2.

Table 2

Operative results
	M (n = 109)	P (n = 109)	p-value
CABG, n (%)	18 (17)	21 (19)	0.4625
Valve, n (%)	44 (40)	41 (38)
Aorta, n (%)	16 (15)	21 (19)
Concomitant, n (%)	26 (24)	22 (20)
Congenital, n (%)	0	2 (2)
Others, n (%)	5 (5)	2 (2)
Emergency, n (%)	19 (17%)	24 (22%)	0.4967
Amount of bleeding (mL)	891 ± 693	774 ± 948	0.4362
Amount transfused (mL)	2743 ± 1194	2814 ± 1390	0.1965
Blood transfusion, n (%)	105 (96%)	108 (99%)	0.1747
Amount of blood transfused (mL)	849 ± 723	1,042 ± 1,069	0.1136
Operation time (min)	300 ± 96	298 ± 107	0.6980
Perfusion time (min)	151 ± 58	146 ± 48	0.3541
Cross-clamp time (min)	113 ± 48	110 ± 44	0.1122
Upper circulatory arrest time (min)	7.7 ± 4.3	8.6 ± 4.4	0.4854
Lower circulatory arrest time (min)	47.7 ± 17.2	49.4 ± 19.2	0.7389
CABG, coronary artery bypass grafting

The postoperative course is summarized in Table 3. The total volume of blood loss from all drains (284 ± 175 vs. 235 ± 147 mL, p = 0.0275) and the number of patients with > 400 mL blood loss (22 [20%] vs. 8 [7%], p = 0.0059) at 6 h postoperatively significantly differed between groups P and M, respectively. No significant difference was found between the groups regarding the rates of chest reopening for bleeding, thoracocentesis, sternal infection, intubation time, and lengths of ICU and hospital stays.

Table 3

Postoperative course
	M (n = 109)	P (n = 109)	p-value
6 h total amount of bleeding (mL)	235 ± 147	284 ± 175	0.0275
Over 400 mL/6h bleeding, n (%)	8 (7%)	22 (20%)	0.0059
Reopen chest for bleeding, n (%)	0	2 (1.8%)	0.1554
Thoracocentesis, n (%)	1 (0.9%)	0	0.3162
Intubation time (min)	412 (145–7,935)	465 (195–46,080)	0.2692
Over 48 h intubation time, n (%)	7 (6%)	6 (6%)	0.7749
ICU stay (days)	2.0 ± 2.6	2.8 ± 5.0	0.1575
Over 2 days ICU stay, n (%)	32 (29%)	41 (38%)	0.1965
First day of sitting (days)	1.5 ± 1.9	1.2 ± 0.7	0.1346
First day of standing (days)	2.0 ± 4.9	1.3 ± 0.9	0.1567
First day of walking (days)	1.9 ± 3.7	1.8 ± 1.5	0.8046
Able to walk 50 m (days)	1.9 ± 4.9	2.2 ± 2.6	0.6095
Able to walk 100 m (days)	2.8 ± 1.5	3.2 ± 2.7	0.2008
Able to walk 200 m (days)	5.2 ± 5.0	4.6 ± 3.3	0.3533
Able to walk 300 m (days)	5.6 ± 5.2	5.1 ± 2.4	0.3970
Hospital stay (days)	14.3 ± 9.7	13.8 ± 12.0	0.7467
Sternal infection, n (%)	1 (0.9%)	0	0.3162
ICU, intensive care unit

The postoperative CT findings are listed in Table 4. No significant differences were observed in the sternal step-off in the coronal section or sternal gap, dehiscence, and cutting. However, the sternal step-off in and substernal hematoma in axial images were significantly lower in patients from group M than in those from group P. Furthermore, the four-grade evaluation of substernal hematoma on CT yielded Grade 1, 2, 3, and 4 values of 92 (85%) vs. 68 (62%), 8 (7%) vs. 19 (17%), 8 (7%) vs. 21 (19%), and 1 (1%) vs. 1 (1%) in groups M and P, respectively (p = 0.003). Ordered logistic regression analysis using the four-grade evaluation of substernal hematoma on CT showed that the use of a mesh plate was an independent predictor of substernal hematoma prevention (Table 5).

Table 4

Postoperative computed tomography findings
	M (n = 109)	P (n = 109)	p-value
Sternum step-off of axial section	4 (4%)	22 (20%)	0.0002
Sternum step-off of coronal section	0	0	1
Gap of sternum	3 (2%)	2 (2%)	0.6510
Dehiscence of sternum	0	0	1
Cutting of sternum	0	0	1
Substernal hematoma	9 (8%)	22 (20%)	0.0117
Postoperative hematoma grade
Grade 1	92 (85%)	68 (62%)	0.0030
Grade 2	8 (7%)	19 (17%)
Grade 3	8 (7%)	21 (19%)
Grade 4	1 (1%)	1 (1%)

Table 5

Multivariate predictors for the four-grade evaluation of substernal hematoma on postoperative computed tomography
	Univariate		Multivariate
	OR (95% CI)	p-value	OR (95% CI)	p-value
Age (years)	0.99 (0.97–1.02)	0.7301	0.98 (0.95–1.01)	0.3439
Sex (men) Yes = 1	0.91 (0.67–1.24)	0.5475	0.88 (0.62–1.25)	0.4766
HD Yes = 1	1.02 (0.38–2.15)	0.9572	0.93 (0.34–2.08)	0.8638
Orthopedic disease Yes = 1	0.87 (0.57–1.28)	0.4829	0.82 (0.52–1.26)	0.4039
Platelet count	0.98 (0.94–1.03)	0.5345	0.98 (0.93–1.03)	0.3954
Anticoagulant medication Yes = 1	1.17 (0.78–1.71)	0.4295	1.03 (0.66–1.55)	0.9018
Euro Score (%)	1.00 (0.97–1.04)	0.8007	1.01 (0.96–1.07)	0.6391
Emergency Yes = 1	1.14 (0.79–1.63)	0.4612	1.13 (0.70–1.78)	0.6027
Intraoperative bleeding (mL)	0.99 (0.99–1.00)	0.9176	1.00 (0.99–1.00)	0.8236
Operation time (min)	0.99 (0.99–1.00)	0.7430	0.99 (0.99–1.00)	0.7160
Perfusion time (min)	1.00 (0.99–1.01)	0.1431
Cross-clamp time (min)	1.00 (0.99–1.02)	0.0634
Mesh Yes = 1	0.55 (0.40–0.76)	0.0003	0.55 (0.39–0.76)	0.0005
OR, odds ratio; CI, confidence interval; HD, hemodialysis

Of the two patients who could not be withdrawn from cardiopulmonary bypass, one underwent autopsy in whom the mesh plate on the posterior sternal surface was tightly bound to the back of the sternum wherein hematoma occurred. In this case, despite the presence of a percutaneous cardiopulmonary support, the patient had good hemostasis and minimal blood loss, with a total blood loss volume of 430 mL after 6 h. The autopsy confirmed that the sternum was not displaced because it was sandwiched between three plates, and that the posterior plate acted as a hemostatic despite the presence of a hematoma (Fig. 4).

Sternal closure using three pieces of a bioresorbable mesh plate that sandwiches sternal halves could reduce the incidence of postoperative bleeding and substernal hematoma when compared to sternal closure with a bioresorbable pin. In our study, sternal closure using mesh plates reduced the incidence of bleeding in the postoperative period, which may prevent postoperative infection and improve wound healing.

There have been eight reports of sternal closure using bioresorbable plates. Tanaka et al. reported that postoperative respiratory and hemodynamic conditions were more stable with Super FIXSORB MX40 mesh plates for median sternotomy after congenital cardiac surgery [8]. Sakashita et al. confirmed that fixation sternotomy with Super FIXSORB MX40 mesh plates promoted bone stability and decreased postsurgical pain [13]. Additionally, Tamura et al. reported that fixation with Super FIXSORB MX40 mesh plates resulted in increased sternal stability, decreased postoperative pain, and improved postoperative respiratory function [9]. As shown in Fig. 1, we devised this method assuming that sandwiching the sternum between the plates would prevent sternal displacement and postoperative bleeding by tightly aligning the sternal bone marrow. Axial CT evaluation on postoperative day 5 showed a significantly less sternal step-off and less postoperative substernal hematoma formation in group M than in group P (Table 4), which was similar to the study by Watanuki et al. who reported less anteroposterior sternal displacement [14]. In our multivariate analysis of postoperative CT data for substernal hematoma, the mesh plate was an independent predictor of substernal hematoma prevention.

Our closure method does not require preoperative bone marrow width measurement; however, our method requires a wire to be placed between the ribs of the sternal body to implant the mesh retrosternally. As a result, depending on its size, the wire penetrating the sternum may be less than the width of the mesh and could interfere with sternal closure. In contrast, preoperative bone marrow sizing is required prior to pinning. Additionally, the bone marrow width does not correlate with sternal body size, and reports state that the bone marrow size should be measured preoperatively. The study concluded that the pin size in the bone marrow should be measured by preoperative CT [15]. Since the mesh is an external fixator, preoperative measurements are unnecessary compared to when using pins, which are internal fixators. The mesh is expected to provide better fixation than pins for patients with a sparse sternal marrow, such as in older women with osteoporosis. Two mesh pieces are placed posteriorly because there is less muscle and connective tissue on the posterior surface of the sternum than on the anterior surface, and the tight fit and crimping may prevent bleeding. Meanwhile, we used a narrower mesh on the anterior surface so as not to interfere with the closure of the muscles and connective tissue. Imanishi et al. treated a sternal fracture with a mesh plate sandwiched between the front and back of the sternum for fixation [16].

At the time of reoperation, which was 2 years after the initial surgery, the chest was opened with a sternal saw (Fig. 5). The mesh plate was not an obstacle during the reoperation as it could be cut similar to the Super FIXSORB MX40, which is a bioresorbable mesh plate composed of unsintered or uncalcined hydroxyapatite and poly-l-lactic acid. Although this sheet is resorbed in the body after approximately 6 years [17, 18], no reports have indicated that Super FIXSORB MX40 mesh plate increases the risk of inflammation or infections. In the present study, the incidence of mediastinitis was similar between both groups, suggesting that there are no disadvantages to using a mesh plate.

This study had some limitations. First, our study was retrospective. Second, this was a single-center study; therefore, it was limited by the relatively small number of included patients. Third, unmeasured confounding factors may have influenced the results. Therefore, further prospective studies with a large cohort are required.

Sternal closure with a three-piece bioresorbable plate sandwiching the sternum is a safe method for sternal closure and could reduce the incidence of postoperative bleeding and substernal hematoma formation in comparison to sternal closure using a bioresorbable pin.

Ethics approval and consent to participate

Written informed consent was obtained from all participants. This study was approved by the Institutional Review Board of the Toda Chuo General Hospital (approval number: 0517; November 29, 2021).

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interest

The authors declare that they have no competing interests.

Funding

None

Author contributions

Manuscript writing: Y.Y.

Operator & assistant: Y.Y., T.Y., T.O., J.L., Y.S., S.D., A.A.

Data collection: Y.Y., Y.M.

Statistical analysis: Y.Y., D.E., M.T.

All authors critically revised it for intellectual content, read and approved the final version, and agreed to be accountable for this work.

Acknowledgments

The authors want to thank Editage for the English language review.

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No competing interests reported.

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Sternal closure with sandwiched three-piece bioresorbable mesh reduces postoperative hemorrhage: a retrospective study

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