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65 (); 8-14
doi:
10.1016/j.jor.2024.11.027

Ensuring safety and optimization in total joint arthroplasty of cancer patients: A comprehensive analysis of complication risks and modifiable risk factors

LSUHSC School of Medicine, New Orleans, LA, USA
LSUHSC Department of Orthopaedic Surgery, New Orleans, LA, USA
Ochsner Sports Medicine Institute, Ochsner Clinic Foundation, New Orleans, LA, USA
Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 6823 Saint Charles Ave, New Orleans, LA, 70118, USA
Research, Analytics, and Development Core, Baylor Scott & White Research Institute, Dallas, TX, USA
Biostatistics Program, School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA, USA

⁎Corresponding author: Tara Korbal. tmakar@lsuhsc.edu

Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

The primary objective of this study is to determine whether an active cancer diagnosis results in an increased risk of perioperative TJA complications and postoperative mortality. The secondary objective is to analyze the effects of demographic factors on perioperative complication rates in cancer patients undergoing TJA.

Patients with active cancer diagnoses undergoing total joint arthroplasty from 2014 to 2020 were included in this retrospective analysis. Patient data was obtained through ReachNet, which consisted of data from the University Medical Center, Tulane University Medical Center, Ochsner Health System, and Baylor Scott & White Health. ICD-9/10 codes were tagged for active cancer diagnoses within 365 days before surgery or 30 days after surgery to establish our active cancer population. Acute surgical complications within 30 days were identified by ICD codes.

Patient demographics included predominantly male (51.5 %), white (83 %), and non-Hispanic (96.5 %) patients followed by black individuals (15.9 %) with 47.5 % of patients being smokers. Cancer patients did have a higher acute complication rate (2.6 % vs 1.7 %), but this difference was not significant (p = .139). This difference was higher but also not significant after adjustment (aOR = 1.32, 95 % CI = 0.71–2.43, p = .377). After adjustment, increased Charlson Comorbidity Index (CCI), white race and non-elective surgery were significant contributors to complication risk. Complication rates decreased significantly with year. Nonelective surgeries were also associated with higher complication rates (8.2 % vs. 1.8 %, p = .014).

Patients with active cancer diagnoses demonstrated higher unadjusted rates of TJA acute surgical complications and increased adjusted CCI when compared to non-cancer patients. Identifying risk factors and demographics correlated with increased perioperative complications may provide physicians with necessary information to avoid negative TJA outcomes in cancer patients.

1

1 Introduction

Osteoarthritis (OA) of the knee and hip is one of the most common causes of disability in adults and can be characterized as articular cartilage degeneration and bone remodeling resulting in joint pain and dysfunction.1–3 The etiology of OA is often described as multifactorial, involving a complex interplay of genetic, biomechanical, and environmental factors.4 However, one of the most common causes of osteoarthritis is increased age.4,5 With around 23 % of the United States population projected to be older than 65 by the year 2060, the management of degenerative diseases, such as osteoarthritis, will continue to remain a primary concern.6

Managing osteoarthritis involves a blend of pharmaceutical interventions and efforts to prevent the progression of the disease.7,8 While preventative measures such as losing weight and minimizing joint damage may prevent the development of osteoarthritis, total joint arthroplasty (TJA) is an effective treatment option for managing end-stage joint osteoarthritis in patients with failed conservative treatment.8–11 Total joint arthroplasty (TJA) has the potential to provide substantial pain alleviation and enhance the functionality of the affected joint. Nevertheless, it is crucial to carefully consider potential complications associated with these procedures, particularly in high-risk patient populations.12–14

Previous evidence has demonstrated that patients undergoing TJA with risk factors such as rheumatoid arthritis, diabetes mellitus, obesity, and cancer may be predisposed to dislocation, periprosthetic joint infection, and other systemic complications.15–18 Furthermore, an active cancer diagnosis in TJA patients has been associated with increased postoperative mortality and in-hospital complications.18 As the incidence of cancer has been predicted to increase due to a previously mentioned ageing population, it is imperative to understand the relationship between total joint arthroplasty and cancer diagnosis in order to mitigate negative surgical outcomes.19,20

The lack of conclusive evidence regarding the correlation between cancer diagnoses and TJA outcomes makes it challenging to ascertain the extent of surgical risk within this population. We hypothesize that patients with an active cancer diagnosis will have an increased risk of perioperative TJA complications and postoperative mortality. Hence, we assessed the rates of acute complications and postoperative mortality in a subgroup of cancer patients undergoing total joint arthroplasty procedures. As a secondary objective, we compared the effects of factors such as race, sex, insurance type, and other variables on acute complication rates in cancer patients who undergo TJA.

2

2 Methods

2.1

2.1 Study design

2.1.1

2.1.1 Population

This retrospective study analyzed 9798 patients who underwent TJA from 2014 to 2020 via ReachNet, which consisted of data from the University Medical Center New Orleans, Tulane University Medical Center, Ochsner Health System, and Baylor Scott & White Health. Clinical characteristics (Charleston comorbidity index (CCI), smoking status, active cancer treatment, insurance type, and elective surgery status), patient demographics (race, age, and sex), and postoperative outcomes (acute complications and mortality rates within 30 days) were analyzed. The computation of the Charlson Comorbidity Index (CCI) was carried out by applying the scoring system previously established by Charlson et al.21 Approval for this study was granted by the Institutional Review Board of the Louisiana State University Health Sciences Center and the research was conducted in compliance with the guidelines outlined.

2.1.2

2.1.2 Outcomes

ICD-9/10 codes were tagged for active cancer diagnoses within 365 days before surgery or 30 days after surgery to establish our active cancer population. Acute surgical complications within 30 days were identified by ICD codes. Complications included mortality, urinary tract infection, blood transfusion, cerebrovascular event, respiratory failure, renal failure, deep vein thrombosis, pneumonia, sepsis, and periprosthetic joint infection (Supplemental Table 1).

2.1.3

2.1.3 Statistical analysis

Charlson Comorbidity Index (CCI) was calculated without including cancer in equation. R statistical software version 4.3.0 was utilized for statistical analysis. Fisher exact tests and Wilcoxon rank-sum tests were used to determine whether different patient factors were associated with acute complication. Multivariable logistic regression with multiple imputation for missing variables was used to determine whether cancer increased acute complication rates after adjustment. Odds ratios (OR) with 95 % confidence intervals (CI) were used to report the multivariate regression analysis results. Average treatment effects (ATE) were computed by averaging the predicted probabilities of acute complication with and without each explanatory variable included in the model for each patient, then subtracting the averages of these values. Statistical significance was determined when the two-tailed p-value ≤0.05. R statistical software version 4.3.0 was utilized for all statistical testing.

3

3 Results

3.1

3.1 Descriptive characteristics

Table 1 delineates the descriptive population statistics of patients with and without active cancer diagnoses that are pertinent to this study. A comparative analysis was conducted between patients diagnosed with active cancer (n = 456) and those without any history of cancer (n = 9342) (Table 1). Patient demographics included predominantly female (55.5 %), white (81.4 %), and non-Hispanic (96.4 %) patients followed by black individuals (16.9 %) with 43.7 % of patients being smokers (Table 1). Patients with private insurance had lower active cancer diagnoses (3.4 % vs 4.8 %, p = .024), as did females (4.1 % vs 5.4 %, p = .002) and elective surgery recipients (4.3 % vs 8.6 %, p < .001) (Table 1). Cancer patients had higher adjusted CCI (1.45 vs 1.02, p < .001), lower BMI (28.77 vs 30.08, p < .001), and higher age (68.23 vs 64.83, p < .001) (Table 1). They did not have a differential length of stay (1.73 vs 1.71, p = .753) (Table 1). Cancer patients did have a higher complication rate (2.6 % vs 1.7 %), but this difference was not significant (p = .139) (Table 1).

Table 1 Demographic information and descriptive characteristics for patients with active cancer diagnoses compared to those without cancer.
Variables All Patients (9798) Active Cancer Diagnosis (456) No Active Cancer Diagnosis (9342) P-values % Active Cancer
RACE
Black 1628 (16.9, 138) 72 (15.9, 3) 1556 (16.9, 135) 0.497 4.4
Other 170 (1.8, 138) 5 (1.1, 3) 165 (1.8, 135) 2.9
White 7862 (81.4, 138) 376 (83, 3) 7486 (81.3, 135) 4.8
HISP
No 9282 (96.4, 169) 435 (96.5, 5) 8847 (96.4, 164) 1 4.7
Yes 347 (3.6, 169) 16 (3.5, 5) 331 (3.6, 164) 4.6
Alcohol
No 9627 (98.3) 450 (98.7) 9177 (98.2) 0.584 4.7
Yes 171 (1.7) 6 (1.3) 165 (1.8) 3.5
Smoking
No 5520 (56.3) 240 (52.6) 5280 (56.5) 0.111 4.3
Yes 4278 (43.7) 216 (47.4) 4062 (43.5) 5
Private Insurance
No 7468 (84.6, 973) 358 (88.6, 52) 7110 (84.4, 921) 0.024 4.8
Yes 1357 (15.4, 973) 46 (11.4, 52) 1311 (15.6, 921) 3.4
Surgical Revision
No 9401 (95.9) 434 (95.2) 8967 (96) 0.393 4.6
Yes 397 (4.1) 22 (4.8) 375 (4) 5.5
Nonelective Surgery
No 9086 (92.7) 395 (86.6) 8691 (93) <0.001 4.3
Yes 712 (7.3) 61 (13.4) 651 (7) 8.6
Hospital System
A 3314 (33.8) 175 (38.4) 3139 (33.6) 0.063 5.3
B 6215 (63.4) 273 (59.9) 5942 (63.6) 4.4
C 269 (2.7) 8 (1.8) 261 (2.8) 3
Sex
Female 5435 (55.5) 221 (48.5) 5214 (55.8) 0.002 4.1
Male 4363 (44.5) 235 (51.5) 4128 (44.2) 5.4
Any Complication
No 9628 (98.3) 444 (97.4) 9184 (98.3) 0.139 4.6
Yes 170 (1.7) 12 (2.6) 158 (1.7) 7.1
CCI 1.04 (1.48) 1.45 (1.68) 1.02 (1.46) <0.001
BMI 30.02 (6.37) 28.77 (5.88) 30.08 (6.38) <0.001
Time from Surgery to Death (Years) 2.44 (1.91, 9545) 1.72 (1.58, 423) 2.55 (1.93, 9122) 0.019
Time from Surgery to Last Follow up (Years) 2.41 (2.09) 2.38 (2) 2.41 (2.09) 0.681
Age 64.99 (11.74) 68.23 (10.76) 64.83 (11.76) <0.001
Year of Surgery 2017.05 (2.07) 2017.18 (2.03) 2017.05 (2.07) 0.169
Length of Stay 1.72 (1.8, 1) 1.73 (1.76, 0) 1.71 (1.8, 1) 0.753

Demographics and descriptive characteristics of patients with active cancer diagnosis suffering from acute surgical complications are demonstrated in Table 2. Out of 456 patients with an active cancer diagnosis, 12 patients (2.6 %) suffered from acute complications (Table 2). Cancer patients suffering from complications had higher CCI values (2.5 vs. 1.42, p = .074) (Table 2). Nonelective surgeries were also associated with higher acute complication rates (8.2 % vs. 1.8 %, p = .014) (Table 2). Black patients had higher acute complication rates than white patients (4.2 % vs. 2.4 %), and patients undergoing active cancer treatment were at higher risk for surgical complication (4.4 % vs. 2.2 %); however, these differences were not significant (p = .503, p = .265) (Table 2). Complication rates decreased significantly with year (Table 2).

Table 2 Demographic information and descriptive characteristics for patients suffering from acute complications limited to a subgroup of patients with active cancer diagnosis.
Variables Cancer patients (456) Complication (12) No Complication (444) P-values % Complication
Year
2014 44 (9.6) 2 (16.7) 42 (9.5) 0.644 4.5
2015 75 (16.4) 2 (16.7) 73 (16.4) 2.7
2016 71 (15.6) 3 (25) 68 (15.3) 4.2
2017 70 (15.4) 1 (8.3) 69 (15.5) 1.4
2018 48 (10.5) 1 (8.3) 47 (10.6) 2.1
2019 67 (14.7) 3 (25) 64 (14.4) 4.5
2020 69 (15.1) 0 (0) 69 (15.5) 0
2021 12 (2.6) 0 (0) 12 (2.7) 0
Race
Black 72 (15.9, 3) 3 (25, 0) 69 (15.6, 3) 0.503 4.2
Other 5 (1.1, 3) 0 (0, 0) 5 (1.1, 3) 0
White 376 (83, 3) 9 (75, 0) 367 (83.2, 3) 2.4
Hispanic
No 435 (96.5, 5) 11 (100, 1) 424 (96.4, 4) 1 2.5
Yes 16 (3.5, 5) 0 (0, 1) 16 (3.6, 4) 0
Alcohol
No 450 (98.7) 12 (100) 438 (98.6) 1 2.7
Yes 6 (1.3) 0 (0) 6 (1.4) 0
Smoking
0 240 (52.6) 3 (25) 237 (53.4) 0.076 1.3
1 216 (47.4) 9 (75) 207 (46.6) 4.2
Private insurance
No 358 (88.6, 52) 10 (100, 2) 348 (88.3, 50) 0.612 2.8
Yes 46 (11.4, 52) 0 (0, 2) 46 (11.7, 50) 0
Surgical Revision
No 434 (95.2) 9 (75) 425 (95.7) 0.016 2.1
Yes 22 (4.8) 3 (25) 19 (4.3) 13.6
Nonelective Surgery
No 395 (86.6) 7 (58.3) 388 (87.4) 0.014 1.8
Yes 61 (13.4) 5 (41.7) 56 (12.6) 8.2
SYSTEM
A 175 (38.4) 3 (25) 172 (38.7) 0.154 1.7
B 273 (59.9) 8 (66.7) 265 (59.7) 2.9
C 8 (1.8) 1 (8.3) 7 (1.6) 12.5
SEX
F 221 (48.5) 4 (33.3) 217 (48.9) 0.384 1.8
M 235 (51.5) 8 (66.7) 227 (51.1) 3.4
Cancer Treatment Prescription
No 390 (85.5) 10 (83.3) 380 (85.6) 0.688 2.6
Yes 66 (14.5) 2 (16.7) 64 (14.4) 3
Cancer Treatment Procedure
No 409 (89.7) 9 (75) 400 (90.1) 0.116 2.2
Yes 47 (10.3) 3 (25) 44 (9.9) 6.4
Active Cancer Treatment
No 366 (80.3) 8 (66.7) 358 (80.6) 0.265 2.2
Yes 90 (19.7) 4 (33.3) 86 (19.4) 4.4
Public Insurance
No 176 (43.6, 52) 4 (40, 2) 172 (43.7, 50) 1 2.3
Yes 228 (56.4, 52) 6 (60, 2) 222 (56.3, 50) 2.6
CCI 1.45 (1.68) 2.5 (2.24) 1.42 (1.65) 0.074
BMI 28.77 (5.88) 28.08 (4.22) 28.79 (5.92) 0.672
Time from Surgery to Death (Years) 1.72 (1.58, 423) 0.08 (NA, 11) 1.77 (1.58, 412) 0.242
Time from Surgery to Last Follow up (Year) 2.38 (2) 2.74 (2.53) 2.37 (1.98) 0.724
Age 68.23 (10.76) 71.5 (9.78) 68.14 (10.79) 0.233
Year of Surgery 2017.18 (2.03) 2016.5 (1.88) 2017.2 (2.04) 0.233
Length of Stay 1.73 (1.76) 1.67 (1.97) 1.73 (1.76) 0.671
3.2

3.2 Logistic regression

Following adjustment, cancer patients still had a higher acute complication rate than those without cancer, but this difference was also not significant (aOR = 1.32, 95 % CI = 0.71–2.43, p = .377) (Fig. 1). Additionally, increased CCI (aOR = 1.44, 95 % CI = 1.34–1.55, p < .001), white race (aOR = 1.62, 95 % CI = 1.03–2.56, p = .038), and non-elective surgery (aOR = 2.07, 95 % CI = 1.33–3.21, p = .001) were significant contributors to complication risk after adjustment (Fig. 1). Increased surgery year was associated with a decrease in acute complication rate (aOR = 0.73, 95 % CI = 0.67–0.80, p < .001) (Fig. 1).

Multivariable Logistic regression results predicting acute complication in cancer and non-cancer patients.
Fig. 1 Multivariable Logistic regression results predicting acute complication in cancer and non-cancer patients.

Cancer patients (HR = 2.4, 95 % CI = 1.66–3.48) and patients undergoing non-elective surgery (HR = 2.14, 95 % CI = 1.52–3, p=<0.001) were at higher risk for mortality. (Fig. 2). The estimated 5 year survival probability from Kaplan-Meieter analyses was 95.4 % (94.7%–96.1 %) for non-cancer patients and 86.6 % (95 % CI = 81.8%–91.6 %) for active cancer patients. Smoking history (HR = 1.6, 95 % CI = 1.24–2.06, p < .001), increased CCI (HR = 1.34, 95 % CI = 1.26–1.42, p < .001), private insurance (HR = 1.62, 95 % CI = 1.07–2.46, p = .037), and older age (HR = 1.05, 95 % CI = 1.03–1.06, p < .001) were also significant risk factors for mortality in all patients (Fig. 2). Additionally, risk factors for increased morality in a subgroup of patients with active cancer diagnosis included private insurance status (HR = 3.01, 95 % CI = 1.14–7.99, p = .061) and non-elective surgery (HR = 3.09, 95 % CI = 1.34–7.15, p = .009) (Fig. 3).

Multivariable Cox regression results predicting survival rate in cancer and non-cancer patients.
Fig. 2 Multivariable Cox regression results predicting survival rate in cancer and non-cancer patients.
Multivariable Cox regression results predicting survival rate limited to patients with an active cancer diagnosis.
Fig. 3 Multivariable Cox regression results predicting survival rate limited to patients with an active cancer diagnosis.
4

4 Discussion

4.1

4.1 Key results

Our study aimed to investigate the rates of acute complications and postoperative mortality in a specific subgroup of patients undergoing total joint arthroplasty procedures—those with a history of cancer. Understanding the impact of cancer on surgical outcomes is crucial for informing clinical decision-making and improving patient care. In this manuscript, we offer a comprehensive examination of patient demographics, acute complication rates, and mortality risk factors within this population. Our findings present compelling evidence opposing the notion of precluding these patients from undergoing elective TJA based solely on a cancer diagnosis.

The demographic profile is essential for contextualizing our findings and recognizing potential disparities in surgical outcomes. Comparative analyses revealed that patients with public insurance, males, and those undergoing nonelective surgery had higher rates of active cancer diagnoses (Table 1). Notably, cancer patients exhibited distinct features, including a higher adjusted Charlson Comorbidity Index (CCI), lower BMI, and advanced age, all of which contribute to the complexity of their surgical management (Table 1). However, while cancer patients had higher adjusted CCI, our study did not find a differential length of stay or statistically significant higher acute complication rate among cancer patients when compared to those without cancer, highlighting the potential feasibility of these procedures within the cancer population (Table 1).

A significant decrease in 30-day complication rates over the study period was also observed, underscoring the importance of ongoing advancements in surgical techniques, perioperative care, and patient management (Table 2). Additionally, while cancer patients undergoing active cancer treatment were found to be at an increased risk for acute surgical complications (Table 2), it is crucial to dispel the historic stereotype surrounding chemotherapy. Modern cancer medications, tailored to specific cancer subtypes with minimized side effects, can be safely navigated during elective surgeries.22,23 Surgeons should consider the refined landscape of contemporary cancer treatments, enabling informed decisions to proceed with elective procedures for patients undergoing active cancer treatment, thus improving overall care and outcomes.

Logistic regression analysis revealed that increased CCI, white race, and non-elective surgery were significant contributors to complication risk in all patients (Fig. 1). The association between cancer and acute complication rates was not statistically significant (Fig. 1). These findings highlight the importance of carefully considering patient comorbidity, racial disparities, and surgical urgency when assessing and managing complication risks in diverse populations.

Increased mortality risk was identified in cancer patients, and in all patients undergoing non-elective surgery (Figs. 2 and 3). Furthermore, cancer patients with private insurance status demonstrated higher mortality rates (Fig. 3). This data emphasizes the need for careful consideration and operative planning, rather than increasing selection bias against these patient populations (Fig. 2). Smoking history, increased CCI, and older age were also significant risk factors for mortality in the overall patient population (Fig. 2). Surgeons routinely encounter patients with modifiable risk factors such as smoking, as demonstrated by a substantial proportion of our patient population (43.7 %) being tobacco users. This level of adaptability in approaching cases should also be applied to patients with active cancer diagnoses, underlining the need for a nuanced and inclusive perspective in surgical decision-making.

Current literature demonstrates that postoperative complications and mortality following total joint arthroplasty (TJA) are common in patients with a diagnosis of cancer. Patients with an active diagnosis or history or cancer have increased morbidity and mortality following TJA.18 Furthermore, our study revealed elevated mortality rates among patients with an active cancer diagnosis. However, the observed increase in complication rates in this group did not reach statistical significance, suggesting that surgeons can safely perform operations on these individuals. These findings contribute to the growing body of knowledge guiding personalized care strategies for this vulnerable patient population and may help to prevent the stigma of decreased joint replacement utility in patients with lower life expectancy.

Preoperative patient optimization, with the goal of improved outcomes and financial performance, is a common phenomenon in the world of arthroplasty. However, patient optimization can often result in selection bias against patients with modifiable risk factors such as diabetes, smoking, increased BMI, blood pressure and cancer who are not capable of achieving maximal optimization due to health disparities or low socioeconomic status.24 Optimizing cancer patients for TJA may involve perioperative plans similar to other high-risk patients with additional considerations beyond standard protocols. Emphasis should be placed on evaluating kidney and liver function, as these are often impacted by cancer treatments. Additionally, it is important to address nutritional deficiencies and potential immunosuppression by ensuring adequate protein levels and appropriate absolute neutrophil counts. Close collaboration with the patient's oncologist is essential, including obtaining a clearance letter to guide individual treatment plans. This partnership enables any concerns from the orthopedic surgeon to be thoroughly assessed and resolved in coordination with the oncologist, ensuring a comprehensive, patient-specific approach to optimization.

4.2

4.2 Limitations & strength

Our study is not without limitations. Most importantly, this investigation was potentially limited by its retrospective nature. While supported by a large sample size and patients from four different institutions, all patients are from the southern region of the United States and this data gathered from this patient population may not extrapolate to other regions. Additionally, this study was limited by its reliance on database ICD coding, which may result in inaccurate identification of patient characteristics, including cancer diagnoses and the presence of complications. However, the study team took significant steps to mitigate this limitation, spending months meticulously reviewing and refining ICD codes to ensure inclusivity and accurate identification of relevant patient data. Further, our definition of “active cancer” being specific ICD codes tagged within 365 days before surgery or 30 days after surgery may not encompass potential influences on surgical outcomes such as specific cancer stages, cancer types, or treatment modalities. This study may not have fully accounted for other confounding factors, including socioeconomic status, comorbidities, and functional status, which may also impact both cancer diagnoses and surgical outcomes. While our study offers significant insights, further research is needed to validate our findings and explore extended follow-up periods. Additionally, assessing long-term outcomes—such as functional recovery, quality of life, long-term complications, and postoperative mortality—would provide a more comprehensive evaluation of total joint arthroplasty in cancer patients.

5

5 Conclusion

While cancer patients have slightly higher CCI, their complication risk for elective surgery is not significantly different from other groups. In addition, they can be optimized, just like any other patient with modifiable risk factors, such as diabetes, smoking, or increased BMI. Identifying risk factors and patient demographics associated with increased risk of perioperative complications within this group can aid in addressing health inequities and equip physicians with essential insights to proactively manage and improve TJA outcomes in cancer patients.

CRediT authorship contribution statement

Tara Korbal: Conceptualization, Data curation, Writing – original draft, Investigation. Robert Branstetter IV: Data curation, Writing – original draft. Matthew Cable: Visualization, Investigation, Supervision. Deryk Jones: Visualization. Lizheng Shi: Supervision. Lauren Hall: Supervision. Andrew Chapple: Writing – review & editing, Data curation, Investigation, Formal analysis.

Ethical approval and patient consent

Ethical approval was waived by the local Ethics Committee of Louisiana State University Health Science Center New Orleans in view of the retrospective nature of the study and all the procedures being performed were part of the routine care.

Due to the retrospective nature of the study, informed consent of the patients was not required because the study analyzed anonymous clinical data of the patients.

Ethical statement

Ethical approval was waived by the local Ethics Committee of Louisiana State University Health Science Center New Orleans in view of the retrospective nature of the study and all the procedures being performed were part of the routine care.

Funding statement

There was no funding for this project.

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