Abstract
Introduction
Recent re-evaluation of the Women's Health Initiative Hormone Therapy Trials has established that hormone replacement therapy (HRT) can be beneficial for patients, if begun shortly after menopause. This study investigates the impact of a history of postmenopausal HRT on patient demographics and perioperative complications in women undergoing lumbar spinal fusion.
Methods
The National Inpatient Sample was queried from 2016 to 2020 for postmenopausal women (>55 years old or applicable diagnosis) undergoing lumbar spinal fusion for degenerative etiologies, using International Classification of Disease Tenth Revision diagnostic and procedural codes. Patient characteristics and perioperative complications were evaluated for history of HRT versus non-HRT patients undergoing lumbar spinal fusion surgery.
Results
Of the 202,945 postmenopausal patients undergoing lumbar spinal fusion, 2645 (1.3 %) had a history of receiving HRT. Analysis demonstrated that HRT was a negative predictor of acute kidney injury (OR: 0.672; p = 0.006), pneumonia (OR: 0.320; p = 0.010), and anemia (OR: 0.887; p = 0.020). It was a positive predictor of bowel/bladder dysfunction (OR: 1.371; p < 0.001).
Conclusions
The findings of this study highlight the unique demographics, comorbidities, and perioperative complications of postmenopausal women with a history of HRT undergoing lumbar spinal fusion surgery. While HRT history was associated with a favorable inpatient course, including reduced risk of acute kidney injury, pneumonia, deep venous thrombosis and myocardial infarction, these findings should be interpreted with caution due to limitations in coding accuracy and lack of long-term follow-up. HRT status may reflect broader differences in baseline health and healthcare access.
Keywords: Spine surgery, Lumbar spine, Spinal fusion, Neurosurgery, Orthopedic surgery, Hormone replacement therapy
1. Introduction
In 2002, the early stoppage of the Women's Health Initiative (WHI) randomized trial, Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women, negatively impacted support for hormone replacement therapy as a treatment for postmenopausal symptoms in women.1 Within a year of the study's termination, there was a more than 30 % decrease in hormone therapy prescriptions as well as significant cessation of advertising for these products, despite previously proven benefits in alleviating vasomotor menopausal symptoms.2 The original study cited an increased hazard ratio for breast cancer, stroke, and pulmonary embolism for healthy postmenopausal women receiving estrogen plus progestin.1
More recently, scientists and clinicians have revisited the findings from the WHI studies, drawing new conclusions that have shed positive light on the benefits of postmenopausal hormone replacement therapy (HRT). While HRT is not recommended for the prevention of cardiovascular disease, dementia, and other chronic illnesses, it is highly effective in treating vasomotor symptoms, if initiated in female patients without contraindications before 60 years of age.3
As a result of the recent WHI reinterpretations, prescriptions of postmenopausal HRT are likely to begin trending towards pre-WHI study levels. Spinal fusion surgery has seen an increase in procedural volume of 62.3 % from 2004 to 2015, with an average patient age of 59 and 56.4 % of these patients being female.4 With spine surgeons expected to encounter an increasing number of postmenopausal patients on HRT, it would be critically important to understand the potential impacts of HRT on surgical outcomes and prognosis.
The various physiological effects of estrogen on the body are well described in the literature. The hypercoagulable effects of estrogen are particularly important in the pathophysiology of surgical complications, including deep vein thrombosis (DVT), pulmonary embolism, and stroke. In the setting of surgery, where immobility and inflammation already promote a hypercoagulable state, the concern for thromboembolic events is high. Additionally, estrogen plays a significant role in maintaining bone quality, which is crucial in spinal fusion surgery, as poor bone quality is associated with increased surgical complications.5,6 With a decline in estrogen levels, postmenopausal women are more susceptible to complications of spinal fusion surgery, including non-union, delayed healing, and hardware failure.7 Given these factors, it is essential for spine surgeons to understand how HRT may impact surgical course.
This population-based cross-sectional analysis aims to explore the influence of HRT on spinal fusion surgery complications. By comprehensively synthesizing the available data, this study provides evidence-based guidance for spine surgeons in managing postmenopausal patients undergoing spinal fusion surgery to ultimately help to improve clinical decision-making and post-operative outcomes.
2. Materials and methods
2.1. Data source
The National (Nationwide) Inpatient Sample (NIS), developed for the Healthcare Cost and Utilization Project, is the largest, publicly available, inpatient healthcare database that contains de-identified information for seven million annual hospital stays in the United States. It provides data regarding patient demographics, severity and comorbidity measures, hospital characteristics, length of stay, and discharge status, among other relevant variables. Since the NIS contains de-identified patient information, this study did not require approval by an institutional review board.
2.2. Participants and setting
The NIS was queried from 2016 to 2020 using International Classification of Diseases (ICD) Tenth Revision diagnostic codes for women (>55 years old) undergoing lumbar spinal fusion for degenerative etiologies (Supplementary Table 1). Patients with a diagnosis associated with menopause were also included in the study (Supplementary Table 1). Patients with a diagnosis of traumatic fracture, vertebral/spinal cord cancer, or osteomyelitis were excluded from the study (Supplementary Table 2). Furthermore, due to coding limitations, patients with a history of hypothyroidism or premature ovarian failure were also excluded to isolate hormone replacement therapy for postmenopausal indications (Supplementary Table 2). Included patients were divided into cohorts based on history of hormone replacement therapy (HRT) (ICD10: Z79890) or no history of hormone replacement therapy (non-HRT).
2.3. Statistical method
Patients' demographics, length of stay, and total hospital charges were compared for postmenopausal patients undergoing lumbar spinal fusion with a history of HRT and patients without history of HRT (Supplementary Table 3). Chi-square analysis was used for categorical variables, while Student's t-test was used for continuous variables. Univariable chi-square analysis was then performed for perioperative complications (Supplementary Table 3). Multivariate regression analysis was conducted, while controlling for age >65, race, private insurance, diabetes, obesity, hyperlipidemia (HLD), hypertension (HTN), chronic obstructive pulmonary disease (COPD), surgical approach, multilevel procedure, and extended length of stay (>6 days; LOS). The final model was determined using the initial univariable demographic analyses and backwards stepwise p-value elimination. All reported p-values are exact 2-sided significance, alpha <0.05.
3. Results
3.1. Participants
Of the 202,945 postmenopausal patients undergoing lumbar spinal fusion, 2645 (1.3 %) had a history of receiving HRT. Patients who had HRT were predominantly white (86.2 % vs. 78.3 %; p < 0.001). These patients were also less likely to have Medicare insurance (52.4 % vs. 63.2 %; p < 0.001), less likely to have Medicaid (2.1 % vs. 3.5 %; p < 0.001), and more likely to have private insurance coverage (42.3 % vs. 29.8 %; p < 0.001). Patients in the HRT group were also more likely to be in the top 50 % of income earners (54.8 % vs. 50.1 %; p < 0.001), have shorter average LOS (3.40 days vs. 3.69 days; p < 0.001), and less likely to undergo a posterior approach fusion (68.1 % vs. 72.8 %; p < 0.001) (Table 1).
Table 1.
Demographics stratified by HRT status.
| HRT | Non-HRT | P-Value | |
|---|---|---|---|
| N | 2645 | 200,300 | |
| Average Age (years) | 65.74 | 67.27 | |
| Race | |||
| White | 86.2 % | 78.3 % | <0.001 |
| Black | 7.6 % | 9.7 % | <0.001 |
| Hispanic | 2.3 % | 5.1 % | <0.001 |
| Asian | 0.4 % | 1.6 % | <0.001 |
| Native American | 0.2 % | 0.4 % | 0.068 |
| Other | 1.3 % | 1.9 % | 0.036 |
| Insurance and Cost | |||
| Medicare | 52.4 % | 63.2 % | <0.001 |
| Medicaid | 2.1 % | 3.5 % | <0.001 |
| Private | 42.3 % | 29.8 % | <0.001 |
| Self-pay | 0.2 % | 0.5 % | 0.055 |
| No Charge | 2.8 % | 2.9 % | 0.773 |
| Other | 0.0 % | 0.0 % | |
| Top 50th Percentile Income | 54.8 % | 50.1 % | <0.001 |
| Total Charges (USD) | 165,811.23 | 163,370.32 | 0.335 |
| Surgical Characteristics | |||
| Posterior Approach | 68.1 % | 72.8 % | <0.001 |
| Multilevel Procedure | 36.3 % | 36.1 % | 0.855 |
| Length of Stay (Std. Dev.) | 3.40 (2.38) | 3.69 (2.82) | <0.001 |
3.2. Comorbidities and discharge disposition (descriptive data)
Patients in the HRT group were less likely to be obese (10.6 % vs. 14.4 %; p < 0.001), less likely to have diabetes (14.9 % vs. 22.4 %; p < 0.001), HTN (51.8 % vs. 57.0 %; p < 0.001), HLD (28.9 % vs. 33.6 %; p < 0.001), and COPD (7.6 % vs. 9.5 %; p < 0.001), compared to patients in the non-HRT group. However, patients in the HRT group were more likely to have depression (24.8 % vs. 19.7 %; p < 0.001) and anxiety (19.5 % vs. 16.1 %; p < 0.001). Patients in the HRT group were also more likely to have a diagnosis of pseudoarthrosis (5.5 % vs. 3.5 %; p < 0.001). On discharge, patients in the HRT group were more likely to have routine discharge home (64.1 % vs. 53.7 %; p < 0.001) and less likely to be transferred to a short-term hospital (0.0 % vs. 0.4 %; p < 0.001), skilled nursing facility (14.9 % vs. 22.7 %; p < 0.001) or home health care (21.0 % vs. 23.0 %; p < 0.001) (Table 2).
Table 2.
Comorbidities and discharge disposition stratified by HRT status.
| HRT | Non-HRT | P-Value | |
|---|---|---|---|
| N | 2645 | 200,300 | |
| Comorbidities | |||
| Obesity | 10.6 % | 14.4 % | <0.001 |
| Diabetes | 14.9 % | 22.4 % | <0.001 |
| HTN | 51.8 % | 57.0 % | <0.001 |
| Congestive Heart Failure | 1.1 % | 1.1 % | 0.925 |
| HLD | 28.9 % | 33.6 % | <0.001 |
| COPD | 7.6 % | 9.5 % | <0.001 |
| Osteoporosis | 8.1 % | 8.6 % | 0.383 |
| Depression | 24.8 % | 19.7 % | <0.001 |
| Anxiety | 19.5 % | 16.1 % | <0.001 |
| Smoking | 10.0 % | 9.9 % | 0.870 |
| Alcohol Use Disorder | 0.6 % | 0.6 % | 0.804 |
| Pseudoarthrosis | 5.5 % | 3.5 % | <0.001 |
| Discharge Disposition | |||
| Routine Discharge | 64.1 % | 53.7 % | <0.001 |
| Short-Term Hospital Stay | 0.0 % | 0.4 % | 0.004 |
| Skilled Nursing or Intermediate Care Facility | 14.9 % | 22.7 % | <0.001 |
| Home Health Care | 21.0 % | 23.0 % | 0.015 |
| Against Medical Advice | 0.0 % | 0.1 % | 0.181 |
| Death | 0.0 % | 0.1 % | 0.271 |
3.3. Perioperative complications (outcome data)
In univariate analysis, HRT was a negative predictor of acute kidney injury (OR: 0.672; p = 0.006), pneumonia (OR: 0.320; p = 0.010), and anemia (OR: 0.887; p = 0.020). No DVT or myocardial infarction (MI) occurred in the HRT group undergoing spinal fusion. HRT was a positive predictor bowel/bladder dysfunction (OR: 1.256; p < 0.001). After multivariate analysis – controlling for age >65, race, private insurance, diabetes, obesity, HLD, HTN, COPD, multilevel procedure, and surgical approach – HRT remained a negative predictor of pneumonia (OR: 0.370; p = 0.027). Furthermore, HRT remained a positive predictor of bowel/bladder dysfunction (OR: 1.371; p < 0.001) (Table 3).
Table 3.
Perioperative complications.
| Complication | Univariate OR (95 % CI) | P-Value | Multivariate Regression OR (95 % CI) | P-Value |
|---|---|---|---|---|
| UTI | 1.003 (0.817, 1.233) | 1.000 | ||
| AKI | 0.672 (0.507, 0.890) | 0.006 | 0.824 (0.621, 1.093) | 0.180 |
| PE | 1.404 (0.750, 2.627) | 0.341 | ||
| Pneumonia | 0.320 (0.133, 0.770) | 0.010 | 0.370 (0.153, 0.891) | 0.027 |
| MI | aNC | 0.034 | ||
| Sepsis | 0.805 (0.333, 1.945) | 0.696 | ||
| Bowel/Bladder Dysfunction | 1.256 (1.125, 1.403) | <0.001 | 1.371 (1.226, 1.535) | <0.001 |
| Delirium | 1.035 (0.781, 1.372) | 0.826 | ||
| DVT | aNC | 0.004 | ||
| Anemia | 0.887 (0.802, 0.981) | 0.020 | 0.924 (0.835, 1.024) | 0.131 |
| RBC Transfusion | 1.062 (0.895, 1.260) | 0.501 | ||
| Durotomy | 0.887 (0.714, 1.103) | 0.294 | ||
| CSF Leak | 1.042 (0.813, 1.335) | 0.747 | ||
| Aspiration Pneumonitis | 1.532 (0.818, 2.868) | 0.233 | ||
| Acute Respiratory Distress Syndrome | aNC | 1.000 | ||
| Stroke | aNC | 0.671 | ||
| SSI | aNC | 1.000 | ||
| Dehiscence | 1.457 (0.601, 3.533) | 0.404 | ||
| Hardware Failure | 1.303 (0.931, 1.824) | 0.143 | ||
| Hardware Infection | aNC | 1.000 |
NC = Not calculated (Incidence was 0 in HRT population).
4. Discussion
The current study explores the patient demographics and perioperative complications in women on postmenopausal HRT undergoing lumbar spinal fusion surgery. Through the use of the NIS database, we were able to assess a large volume of inpatient healthcare information to better identify demographic trends, variations in patient comorbidity profiles, and surgical complications of this patient population. The findings from this analysis provide unique insight into a spine surgery population that will substantially increase in size over the coming years following the reinterpretation of WHI study findings.
4.1. Demographics and comorbidities
Our study found that 1.3 % of postmenopausal women undergoing lumbar spinal fusion between 2016 and 2020 had a diagnosis of HRT. This is contrasted with other studies reporting between 3.8 and 4.7 % of postmenopausal women were receiving HRT during the same time period.8,9 One possible explanation for the discrepancy between previous studies and the current one is a lack of discussion and coding of HRT history during hospitalization for lumbar spinal fusion as well as our exclusion of patients with hypothyroid diagnoses.
Consistent with other studies, this study found the incidence of HRT use to be higher among patients of white race and those with comorbid mental health diagnoses.8 Additionally, the finding that patients on HRT were more likely to have private insurance coverage suggests that postmenopausal care access is associated with better access to healthcare overall. This conclusion is supported by multiple previous studies that demonstrated women of higher socioeconomic status are three times more likely to use HRT.10,11
Patients with a history of receiving postmenopausal HRT were less likely to have almost every comorbidity, including obesity, diabetes, HTN, HLD and COPD, indicating overall better health status. The decreased association of HRT with diabetes is consistent with previous studies showing HRT lowers risk of diabetes.12 Patients with a history of HRT were also more likely to have routine discharge home and shorter hospital stays, likely related to better baseline health characteristics. The favorable discharge disposition and lower comorbidity burden of HRT patients overall is likely related to increased longitudinal healthcare provider involvement and better preventative health maintenance in this population.
Our findings demonstrated HRT patients were more likely to have a diagnosis of pseudoarthrosis. Previous studies have shown that postmenopausal women with decreased estrogen are more likely to experience complications of spinal fusion surgery including non-union, delayed healing and hardware failure.7 Large systematic reviews have also suggested that patients with osteoporosis – a condition that is highly prevalent in postmenopausal women – benefit from preoperative bone mineral density (BMD) optimization.13 The impact of HRT on increasing BMD in the lumbar spine specifically tracks an average increase of 13.1 % in lumbar BMD; Non-treated patients experience a decrease of 4.7 % in lumbar BMD over 10 years.14 One possible explanation for this discrepancy is the limitation of ICD-10 coding and the NIS database in accurately identifying index and revision procedures. The diagnosis of pseudoarthrosis is typically provided by the consulting physician after the initial inpatient hospitalization, which makes it challenging to pinpoint when the patient was diagnosed over the course of treatment. Although HRT is primarily indicated for postmenopausal vasomotor symptoms, physicians may have been more inclined to initiate HRT for bone mineral optimization prior to revision procedures. However, there were no differences in rates of osteoporosis between groups, potentially suggesting that BMD is not the explanatory variable in the increased incidence of pseudoarthrosis in the HRT group. It is possible that subtle bone mineral density discrepancies that do not meet the threshold for clinical osteoporosis may be a contributor to pseudoarthrosis.
4.2. Postoperative complications
Patients in the history of HRT group were less likely to develop DVT and MI. One of the main contentions of the WHI trials and more recent studies evaluating HRT for the prevention of chronic disease is that HRT increases risk of cardiovascular disease and thromboembolic disease.1,12 Taken in context with the aforementioned studies, this finding suggests that although long-term risk of vascular disease might increase in certain contexts, there may be no significant increase in acute perioperative risk of these complications. This is critically important, as some surgeons may be apprehensive to perform spine surgery on HRT patients, due to the previous opinion of HRT following the WHI trials.
There is no clear explanation for the decreased risk of AKI and pneumonia for postmenopausal HRT patients undergoing spinal fusion surgery. One recent study found that women over the age of 55 years old who had received estrogen prescriptions were less likely to develop AKI during hospitalization.15 However, another previous study found that postmenopausal women receiving HRT had an increased risk of acquiring nontuberculous mycobacterial pneumonia, but the study did not examine other causes of pneumonia or hospital-acquired pneumonia.16 As discussed previously, these unexpected perioperative benefits may be related to higher baseline health status, and not necessarily the direct contribution of HRT.
We also observed a mildly increased risk of postoperative bowel/bladder dysfunction in HRT patients. There is a paucity of literature investigating the impact of hormone replacement therapy on perioperative gastrointestinal complications, such as ileus and small bowel obstruction. Some older studies have indicated that postmenopausal HRT may contribute to increased stress and urgency incontinence, but no studies describe the impact on perioperative urinary retention.17,18 Additionally, although we controlled for surgical approach, the history of HRT group was more likely to undergo anterior approach fusion, which is associated with increased risk for postoperative bowel/bladder dysfunction.19 Further research is needed to assess the impact of HRT on the bowel and bladder in the perioperative setting. For now, these findings highlight the importance of increased awareness among physicians regarding the potential for these complications in the HRT population.
4.3. Limitations
The most significant limitation of this study is patient selection though ICD-10 coding. The ICD-10 code (Z79.890) required the exclusion of patients with hypothyroidism related diagnoses, limiting generalizability to patients without hypothyroidism. Furthermore, patients over the age of 55, or those with a diagnosis of menopause or postmenopausal disorder, were included in the study, leading to the possibility that a small proportion of women who have not yet undergone menopause were included in the final analysis. Similarly, given that HRT exposure was identified through inpatient ICD-10 coding, it is likely that some patients who had received HRT were misclassified into the control group. While the large comparator group may mitigate some of the random error introduced by non-differential misclassification, it does not eliminate the bias entirely. Additionally, the diagnosis code used for HRT could not distinguish between estrogen plus progestin or estrogen-only therapy or the duration of the hormone replacement therapy. Moreover, outcomes of patients beyond their inpatient hospital stays were not measurable, limiting the ability to adequately assess pseudoarthrosis and revision procedures, which are important outcomes to evaluate in spine surgery studies.
5. Conclusions
The findings of this population-based, retrospective study highlight the unique demographics, comorbidities, and perioperative complications of postmenopausal women with a history of HRT undergoing lumbar spinal fusion surgery. The association of the HRT population with higher socioeconomic status and decreased comorbidities further strengthens the association between postmenopausal care and increased healthcare access. In addition, our study found that patients with a history of HRT may have a lower incidence of AKI, pneumonia, DVT, and MI perioperatively, offering surgeons improved clinical planning and prognostication for postmenopausal patients with a history of HRT undergoing lumbar spinal fusion surgery.
Rather than establishing causality, the value of this study lies in raising awareness of a growing and previously underexamined surgical population. With hormone replacement therapy prescriptions rising following recent reinterpretations of the Women's Health Initiative data, spine surgeons are likely to encounter more patients receiving HRT in the coming years. Understanding the demographic trends and inpatient characteristics of this group may help inform clinical decision-making, patient counseling, and risk stratification. To better evaluate the causal impact of HRT on thromboembolic and fusion-specific outcomes, future studies should utilize longitudinal datasets with available medication records, treatment duration, and perioperative medication discontinuation patterns.
Institutional review board statement (ethical approval)
Since the National Inpatient Sample (NIS) is publicly available and contains no identifiable information, approval by an institutional review board was not required for this study.
Informed consent statement
Since the NIS is publicly available and contains no identifiable information, informed consent was not required for this study.
Author contributions
M.K., Conceptualization, Writing – original draft, Writing – review & editing, Supervision, All authors have read and agreed to the published version of the manuscript. J.W., Conceptualization, Writing – original draft, Writing – review & editing, Supervision, All authors have read and agreed to the published version of the manuscript. D.M., Conceptualization, Methodology, Software, Formal analysis, Data curation, Writing – original draft, Writing – review & editing, Project administration, All authors have read and agreed to the published version of the manuscript. A.J., Formal analysis, Data curation, Writing – original draft, Writing – review & editing, Project administration, All authors have read and agreed to the published version of the manuscript. H.P., Writing – original draft, Writing – review & editing, Supervision, All authors have read and agreed to the published version of the manuscript. G.S., Writing – review & editing, All authors have read and agreed to the published version of the manuscript.Structured
Data availability statement
This study data can be requested from the corresponding author after completing the required procedures outlined by the Healthcare Cost and Utilization Project.
Funding
This research received no external funding
Acknowledgements
Not applicable.
Footnotes
Supplementary data to this article can be found online at https://doi.org/10.1016/j.jor.2025.05.057.
Appendix A. Supplementary data
The following is the Supplementary data to this article:
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
This study data can be requested from the corresponding author after completing the required procedures outlined by the Healthcare Cost and Utilization Project.