Single-institution Cohort Study Research Articles

Magnetic seed versus skin tattoo localization of non-palpable breast lesions: a single institution cohort study.

The objective of this retrospective study was to investigate the accuracy and feasibility of magnetic seed compared to skin tattoo in preoperative localization of impalpable breast lesions in terms of accuracy of placement, re-excision and positive margins rates, and breast/surgical specimen volume ratio. We retrospectively analyzed 77 patients who underwent breast conservative surgery in our center from November 2020 to November 2021, with previous localization with skin tattoo or magnetic seed. Thirty-seven magnetic seeds were placed in 36 patients (48.6%) and 40 skin tattoos were performed in the remaining cases (51.4%). The seeds were placed correctly at the two-view mammogram acquired after the insertion in 97.6% (36/37) of cases. With both methods, 100% of the index lesions were completely removed and found in the surgical specimen. The reported re-excision rate was 0% for both groups. A significant difference was observed in the volume of breast parenchyma removed between the two groups, inferior in the seed group (p = 0.046), especially in case of voluminous breasts (p = 0.003) and small lesions (dimension < 8mm, p = 0.019). Magnetic seed is a non-radioactive localization technique, feasible to place, recommended in case of non-palpable breast lesions, saving the breast parenchyma removed compared with skin tattoo, without reducing the accuracy. Our findings contribute to the current evidence on preoperative localization techniques for non-palpable breast lesions, highlighting the efficacy of magnetic seed localization for deep and small lesions. • Magnetic seed is a non-radioactive technique for the preoperative localization of non-palpable breast lesions studied in comparison with skin tattoo. • Magnetic seed is feasible to place in terms of post-placement migration and distance from the target lesion. • Magnetic seed is recommended in case of non-palpable breast lesions, saving the breast parenchyma removed without reducing the accuracy.

Impact of radiation on immediate breast reconstruction: a retrospective single institution cohort study.

While the trend towards immediate breast reconstruction is growing, data on the long-term outcomes of patients receiving irradiation afterwards are scarce. We retrospectively reviewed the long-term complication rates in patients who received adjuvant radiation therapy after immediate breast reconstruction in our institution. We included 134 patients with breast cancer who underwent single-stage immediate breast reconstruction between January 2008 and December 2018. Sixty-eight patients received adjuvant irradiation and 66 patients did not. Autologous tissue, implant-based, and combined (implant and flap) reconstruction were performed in 40, 55, and 39 patients, respectively. Flap and implant complications data were collected. Baker's classification was used to assess capsular contracture. The average follow-up was 47 months. Both groups had similar baseline clinical characteristics and treatments received. The irradiated-group had a higher incidence of adjuvant chemotherapy (P<0.01) and a significantly higher rate of grade III/IV capsular contracture (42.1% vs. 26.9%; P=0.004) than that of the non-irradiated group. The median time to the development of capsular contracture was 37 vs. 41 months in the irradiated vs. the non-irradiated group, respectively. There were no differences in the incidence of flap complications between both groups. The only significant risk factor associated with grade III/IV capsular contracture was adjuvant post-mastectomy irradiation. The irradiated group had a higher risk of developing grade III/IV capsular contracture [odds ratio (OR), 4.35; 95% confidence interval (CI): 1.55-12.27]. Postmastectomy radiotherapy adversely affects implant-based immediate one-stage reconstruction by increasing the rate of moderate to severe capsular contracture but is not associated with flap complications.

Percutaneous CT-guided trigeminal tractotomy-nucleotomy under general anesthesia for intractable craniofacial pain.

When used to treat craniofacial pain, CT-guided trigeminal tractotomy-nucleotomy (TR-NC) is usually performed with local anesthesia. Unfortunately, local anesthesia is insufficient for patients with such severe pain that they cannot tolerate the required head positioning while awake. This study aimed to contextualize previous findings associated with TR-NC performed under general anesthesia. The authors examined clinical and operative factors that could impact postoperative pain outcomes. This is a retrospective single-institution cohort study of patients who underwent a percutaneous CT-guided TR-NC under general anesthesia at a single institution between 2012 and 2019. Outcome data were analyzed. Twenty-five patients underwent CT-guided TR-NC procedures under general anesthesia; 23 met the inclusion criteria and underwent a total of 31 procedures. The procedure success rate was 74% (23/31). Approximately 50% and 40% of procedures provided pain relief for at least 6 and 12 months, respectively. The median duration of pain relief was 153 days. Adverse events, all minor and transient, occurred following 6/31 (19%) of procedures. Patients with a body mass index > 25 were less likely to experience a successful TR-NC (p = 0.045). Higher electrode ablation temperatures (p = 0.033) and more medial entry trajectories relative to the midsagittal plane (p = 0.029) characterized successful procedures. These results suggest that CT-guided TR-NC performed under general anesthesia is safe and effective. Postoperative outcomes were found to be associated with a number of clinical and operative factors. Such associations should be further explored and evaluated in the context of future, better-powered analyses.

Patients’ perceptions of the definition of a textbook outcome following liver transplantation

BackgroundA textbook outcome (TO) describes the results of a successful liver transplantation (LT) in which all aspects of the LT and posttransplant courses were uneventful. We compared patient perceived experience of a TO with clinically defined TO. MethodsThis was a single-institution cohort study with retrospective chart review including patients who underwent LT from 2019 to 2021. Patients were asked to complete the survey at a scheduled posttransplant visit. The survey was designed to assess their viewpoints on the definition of a TO. A clinically defined TO was defined as no mortality, no severe complications, no need for reintervention, no prolonged hospital and intensive care unit stays, and no readmission. ResultsOf the 182 patients who were contacted, 132 (72.5%) completed the survey. Overall, 98 patients (74%) considered that they had experienced a TO. The clinically defined TO rate was 22.0%. Multivariate analysis showed that patients who did not experience severe complications were more likely to consider that they had a TO (P = 0.01; odds ratio: 3.2; 95% confidence interval: 1.3–7.9). ConclusionsFrom patients’ perspectives, survival and avoidance of complications were the major characteristics of a TO.

Early Urinary Catheter Removal After Colectomy for Colovesical Fistula is Not Associated With Increased Postoperative Complications.

Management of the bladder defect during colectomy for colovesical fistula (CVF) and recommendations for duration of urinary catheter drainage are inconsistent. This study aimed to determine if urinary catheter drainage duration was associated with postoperative complications. Retrospective single institution cohort study of patients undergoing resection for diverticular CVF from 2015 through 2021. Urinary catheter drainage was defined as Early (≤7days postoperative and then subdivided into 1-2days, 3-5days, 6-7days), and Late (>7days postoperative). Primary outcome was a composite measure of postoperative bladder leak, surgical site infection-III, sepsis, reoperation, and postoperative length-of-stay ≥7days. There were 73 patients-64 Early group and 9 Late group. Composite measure between groups (Early 25% vs Late 33.33%, P = .688) was not significantly different. The Late group had more patients with large bladder defects (33.3% vs 7.8%, P = .054), significantly more patients who underwent suture repair (55.6% vs 14.1%, P = .01), and significantly more patients that had an intraoperative pelvic drain (66.7% vs 15.6%, P = .003). After propensity score inverse weighting, the Late group had significantly more cystogram-detected postoperative bladder leaks (P = .002) and ileus (P = .042) than the Early group. There were no bladder leaks or ileus in those who had urinary catheter removal on postoperative days 1-2. Early urinary catheter removal was associated with no increase in bladder leaks and fewer postoperative complications after definitive management of CVF. Further investigation is required to determine if intraoperative bladder leak testing and postoperative cystograms are useful adjuncts in decision making.

Racial differences in the care of pediatric sagittal craniosynostosis: a single-institution cohort study affecting state Medicaid policy.

Although research has shown the cost-effectiveness of endoscopic versus open repair of sagittal synostosis, few studies have shown how race, insurance status, and area deprivation impact care for these patients. The authors analyzed data from children evaluated for sagittal synostosis at a single institution to assess how socioeconomic factors, race, and insurance status affect the surgical treatment of this population. They hypothesized that race and indicators of disadvantage negatively impact workup and surgical timing for craniosynostosis surgery. Medical records of patients treated for sagittal synostosis between 2010 and 2019 were reviewed. Area deprivation index (ADI) and rural-urban commuting area codes, as well as median income by zip code, were used to measure neighborhood disadvantage. Black and White patients were compared as well as patients using Medicaid versus private insurance. Fifty patients were prospectively included in the study. Thirty-one underwent open repair; 19 had endoscopic repair. All 8 (100%) Black patients had open repair, compared to 54.8% of White patients (p = 0.018). Black patients were more likely to use Medicaid compared to White patients (75.0% vs 28.6%, p = 0.019). White patients were younger at surgery (5.5 vs 10.0 months, p = 0.001), and Black patients had longer surgeries (147.5 minutes vs 110.0 minutes, p = 0.021). The median household income by zip code was similar for the two groups. Black patients were generally from areas of greater disadvantage compared to White patients, based on both state and national ADI scores (state: 7.5 vs 4.0, p = 0.013; national: 83.5 vs 60.0, p = 0.013). All (94.7%) but 1 patient undergoing endoscopic repair used private insurance compared to 14 (45.2%) patients in the open repair group (p = 0.001). Patients using Medicaid were from areas of greater disadvantage compared to those using private insurance by both state and national ADI scores (state: 6.0 vs 3.0, p = 0.001; national: 75.0 vs 52.0, p = 0.001). Because Medicaid in the geographic region of this study did not cover helmeting after endoscopic repair of sagittal synostosis, these patients usually had open repair, resulting in significant racial and socioeconomic disparities in treatment of sagittal synostosis. This research has led to a change in Alabama Medicaid policy to now cover the cost of postoperative helmeting.

Association of Body Mass Index With Outcomes Among Patients With Head and Neck Cancer Treated With Chemoradiotherapy

Combined modality therapy, such as chemoradiotherapy, often results in significant morbidity among patients with head and neck cancer. Although the role of body mass index (BMI) varies based on cancer subtypes, its association with treatment response, tumor recurrence, and survival outcomes among patients with head and neck cancer remains unclear. To evaluate the role of BMI in treatment response, tumor recurrence, and survival outcomes among patients with head and neck cancer undergoing chemoradiotherapy. This retrospective, observational, single-institution cohort study conducted at a comprehensive cancer center included 445 patients with nonmetastatic head and neck cancer who underwent chemoradiotherapy from January 1, 2005, to January 31, 2021. Normal vs overweight or obese BMI. Metabolic response after chemoradiotherapy, locoregional failure (LRF), distant failure (DF), overall survival (OS), and progression-free survival (PFS), with Bonferroni correction used to adjust for multiple comparisons and P < .025 being considered statistically significant. A total of 445 patients (373 men [83.8%]; median age, 61 years [IQR, 55-66 years]; 107 [24.0%] with normal BMI, 179 [40.2%] with overweight BMI, and 159 [35.7%] with obese BMI) were included for analysis. Median follow-up was 48.1 months (IQR, 24.7-74.9 months). On Cox proportional hazards regression multivariable analysis, only overweight BMI was associated with improved OS (5-year OS, 71.5% vs 58.4%; adjusted hazard ratio [AHR], 0.59 [95% CI, 0.39-0.91]; P = .02) and PFS (5-year PFS, 68.3% vs 50.8%; AHR, 0.51 [95% CI, 0.34-0.75]; P < .001). On logistic multivariable analysis, overweight BMI (91.6% vs 73.8%; adjusted odds ratio [AOR], 0.86 [95% CI, 0.80-0.93]; P < .001) and obese BMI (90.6% vs 73.8%; AOR, 0.89 [95% CI, 0.81-0.96]; P = .005) were associated with complete metabolic response on follow-up positron emission tomography-computed tomography after treatments. On Fine-Gray multivariable analysis, overweight BMI was associated with reduction in LRF (5-year LRF, 7.0% vs 25.9%; AHR, 0.30 [95% CI, 0.12-0.71]; P = .01), but not DF (5-year DF, 17.4% vs 21.5%; AHR, 0.92 [95% CI, 0.47-1.77]; P = .79). Obese BMI was not associated with LRF (5-year LRF, 10.4% vs 25.9%; AHR, 0.63 [95% CI, 0.29-1.37]; P = .24) or DF (5-year DF, 15.0% vs 21.5%; AHR, 0.70 [95% CI, 0.35-1.38]; P = .30). In this cohort study of patients with head and neck cancer, when compared with normal BMI, overweight BMI was an independent factor favorably associated with complete response after treatments, OS, PFS, and LRF. Further investigations are warranted to improve understanding on the role of BMI among patients with head and neck cancer.

Spinal Cord Signal Intensity Predicts Functional Outcomes in the Operative Management of Degenerative Cervical Myelopathy.

Prospective single institutional cohort study on degenerative cervical myelopathy (DCM) from 2009 to 2022. This study aims to assess the relationship among preoperative spinal cord signal change, postoperative signal change evolution, and functional outcome in patients undergoing surgery for DCM. There is conflicting evidence on whether spinal cord signal intensity influences functional outcomes in patients with DCM. This prospective study investigated 104 patients with DCM that underwent both preoperative and routine postoperative cervical spine magnetic resonance imaging (MRI) as part of a research protocol. Signal intensity/grade, modified Japanese Orthopedic Association (mJOA) scores, signal resolution, and patient demographics were assessed. Sixty-eight of the subjects were found to have abnormal T2 spinal cord signal intensity changes on their preoperative MRI. The total mean preoperative mJOA score was 13.6, increasing postoperatively to 16 (P < 0.001). The presence or absence of preoperative spinal cord signal change was not associated with the change in mJOA score or neurological recovery rate after surgery. Of the 68 patients with preoperative T2 signal change, 36 were found to have an improvement in the T2-weighted signal grade after surgery and 32 had no change in postoperative signal grade. The mean improvement in mJOA score (3.7) and neurological recovery rate (70.3%) was significantly higher in the patients with preoperative signal change whose postoperative MRI signal change grade improved by at least one point compared with those that did not (2.0, 50.5%), (P < 0.001, P < 0.003). The presence of preoperative T2-weighted signal change was associated with lower preoperative mJOA scores, but no change in mJOA after surgery or postoperative neurological recovery rate. However, improvement in T2-weighted spinal cord signal grade on postoperative MRI was significantly associated with a degree of neurological improvement after surgery.

Procedures employing interbody devices and multi-level fusion require target price adjustment to build a sustainable lumbar fusion bundled payment model

BACKGROUND CONTEXTBundled payment models require risk adjustment to ensure appropriate targets are set. While this may be standardized for many services, spine fusions demonstrate significant variability in approach, invasiveness, and use of implants, that may require further risk adjustment. PURPOSETo evaluate variability in costs of spinal fusion episodes in a private insurer bundle payment program and identify whether current procedural terminology (CPT) code modifications are necessary for sustainable implementation. STUDY DESIGN/SETTINGRetrospective single-institution cohort study. PATIENT SAMPLEA total of 542 lumbar fusion episodes in a private insurer bundled payment program from October 2018 to December 2020. OUTCOME MEASURESA total of 120-day episode of care net surplus/deficit, 90-day readmissions, discharge disposition, and length of hospital stay. METHODSA review was conducted of all lumbar fusions in a single institution's payer database. Surgical characteristics (approach [posterior lumbar decompression and fusion (PLDF), transforaminal lumbar interbody fusion (TLIF), and circumferential fusion], levels fused, and primary vs revision) were collected from manual chart review. Episode of care cost data were collected as net surplus or deficit with respect to target prices. A multivariate linear regression model was constructed to measure the independent effects of primary versus revision, levels fused, and approach on the net cost savings. RESULTSMost procedures were PLDFs (N=312, 57.6%), single-level (N=416, 76.8%) and primary fusions (N=477, 88.0%). Overall, 197 (36.3%) resulted in a deficit, and were more likely to be three levels (7.11% vs 2.03%, p=.005), revisions (18.8% vs 8.12%, p<.001), and TLIF (47.7% vs 35.1%, p<.001) or circumferential fusions (p<.001). One-level PLDFs resulted in the greatest cost savings per episode ($6,883). Across both PLDFs and TLIFs, 3-level procedures resulted in significant deficit of −$23,040 and −$18,887, respectively. For circumferential fusions, 1-level fusions resulted in deficit of −$17,169 per case which rose to −$64,485 and −$49,222 for 2- and 3-level fusions. All 2- and 3-level circumferential spinal fusions resulted in a deficit. On multivariable regression, TLIF and circumferential fusions were independently associated with a deficit of −$7,378 (p=.004) and −$42,185 (p<.001), respectively. Three-level fusions were independently associated with an additional −$26,003 deficit compared to single-level fusions (p<.001). CONCLUSIONSInterbody fusions, especially circumferential fusions, and multi-level procedures are not adequately risk adjusted by current bundled payment models. Health systems may not be able to financially support these alternative payment models with improved procedure-specific risk adjustment.

Recurrent High-Grade Squamous Intraepithelial Lesion After Loop Excision Procedure Versus Loop Procedure With Top Hat.

To evaluate single-pass loop electrosurgical excision procedure (LEEP-SP) versus LEEP with top hat (LEEP-TH) in terms of treatment failure defined as high-grade squamous intraepithelial lesion (HSIL) cytology within 2 years' follow-up. This single-institution cohort study used a prospectively collected cervical dysplasia database including all patients who underwent LEEP-SP or LEEP-TH for biopsy-proven cervical intraepithelial neoplasia between 2005 and 2019. Of 340 patients included, 178 underwent LEEP-SP and 162 LEEP-TH. The LEEP-TH patients were more likely to be older (mean age, 40.4 vs 36.5 years; p < .001) and have a positive preprocedure endocervical sampling (68.5% vs 11.8%; p < .001). Positive margins were found in 23 LEEP-SP (12.9%) and in 25 LEEP-TH (15.4%; p = .507). There was no significant difference in depth of excision between LEEP-SP (13.21 ± 23.19 mm) and LEEP-TH (17.37 ± 28.26 mm; p = .138). At 2 years, there was no difference in the rates of HSIL cytology (5.2% vs 6.3%; p = .698), any positive human papillomavirus test, or HSIL cytology (25% vs 15%; p = .284). The 57 patients undergoing repeat excision were more likely to be older (mean age, 40.95 vs 37.52 years; p = .023), have had a LEEP-TH (26.3% vs 73.7%; p < .001), and have initial cytologic HSIL (64.9% vs 35.0%; p < .001). In this single-institution study, there is no difference in the rate of recurrent HSIL in patients undergoing LEEP-SP versus LEEP-TH. A LEEP-TH may have limited additional benefit over a LEEP-SP in the treatment of cervical HSIL.

Longitudinal trends in serum calcium, parathormone and bone mineral density in breast cancer survivors on aromatase inhibitor therapy: A single institutional cohort study.

e12531 Background: Aromatase inhibitors (AIs), when used as adjuvant treatment of hormone receptor positive breast cancer, have been associated with bone density loss. However, any impact on PTH and by extension calcium (Ca) homeostasis is yet to be elucidated as no study till date has investigated longitudinal trends in parathyroid hormone (PTH) while on AI therapy. We explored these to determine if long term AI therapy was associated with hyperparathyroidism. Methods: This is a retrospective study of female breast cancer patients at the Cleveland Clinic Foundation started on AIs (anastrozole, letrozole and exemestane) from January 2015 to April 2022. Included patients had both baseline and subsequent data (after starting AI therapy), on serum Ca, PTH and lumbar spine T-scores (LsTs). These values were compared using paired t-test. Results: We identified n=9657 patients on AI therapy and included n=249 with pre and post AI PTH values. Among these, n= 209 received anastrozole, n=34 received letrozole and n=6 received exemestane. Cohort median age was 68 (IQR 62-72) years and median duration of AI therapy was 3 years. While we observed a significant positive correlation between change in Ca and change in PTH (p=0.02), the differences between baseline and treatment median serum Ca and PTH were not statistically significant. There was no significant association between changes in either serum Ca or PTH and change in LsTs (p-value: 0.69 and p-value: 0.05 respectively). Notably, 4% patients had elevated PTH and Ca after AI therapy was initiated among whom n=4 had markedly elevated PTH with low urinary Ca. Three of these four patients also had a diagnosis of chronic kidney disease (CKD) with normal vitamin D levels. Two patients with elevated PTH were on biotin supplements. There was an overall downtrend in LsTs (p-value: 0.0039) with no significant difference between the three AIs (p-value 0.0613). However, in comparison to other AIs, letrozole had the least depreciation in LsTs. Conclusions: Our findings do not suggest any correlation between AI therapy and hyperparathyroidism among breast cancer survivors. No significant increase in PTH levels occurred during AI therapy and majority of patients with clinically significant PTH elevation also had CKD, which may have contributed also to elevation of PTH level and low urinary calcium excretion.[Table: see text]

Demographic comparison of survival outcomes after bone marrow transplantation in adolescent and young adult patients: A single institution cohort study.

e18522 Background: Bone marrow transplant (BMT) has become an increasingly common treatment modality for both malignant and non-malignant conditions. However, BMT requires significant healthcare and financial resources, which can result in allocation disparities across socioeconomic, demographic, and racial/ethnic groups. The data exploring how demographic disparities impact survival after BMT is limited, particularly within the adolescent and young adult (AYA) population, defined as patients between the ages of 15 and 39 years. The goal of this study was to assess overall survival of AYA patients undergoing transplant at our institution and to gain insight into if demographic factors impact the likelihood of mortality after transplantation. Methods: Patients aged 15-39 who underwent transplant at the Wilmot Cancer Institute in Rochester, NY between 2012-2020 were identified. Information regarding demographic characteristics, indication for transplant, and mortality was collected. The primary endpoint was overall survival (OS), defined as the time from transplant to the date of death from any cause or the date of last in-person contact. Survival criteria were estimated using the Kaplan-Meier method and compared using mortality odds ratios. These analyses were stratified by indication for transplant, recorded race/ethnicity, gender, and by age. Results: 169 patients met inclusion criteria, and median OS for the entire cohort was not reached. Of 108 allogenic transplant recipients, median OS was 7.85 years (95% CI [3.3, not estimated]). Median OS for patients receiving transplant for solid tumor pathology was 3 years (95% CI [0.4 years, not estimated]), compared to other indications for transplant where survival exceeded the median. For allogenic transplant patients, median OS for Black patients was 4.8 years (95% CI [0.7 years, not estimated]), 7.8 years for Caucasian patients (95% CI [3.3 years, not estimated]), median OS was not reached for Hispanic patients, and 1.1 years for all other minorities (95% CI [0.4 years, not estimated]) (p = 0.28). There was no significant difference in mortality based on insurance type or gender for either type of transplant. There was a significant difference in mortality for allogenic transplant patients based on average median household income when compared at an average income of $60,000/ year (OR 2.6, 95% CI [1.164, 5.6] p = 0.0097). Conclusions: Overall survival for AYA patients who had a transplant for any indication at our institution was better than expected. There were no significant differences for either transplant type based on gender, racial/ethnic background, gender, age, or indication for transplant. There was a significant difference based on median household income. Larger multi-institutional studies are likely needed to accurately identify further demographic disparities.

Expression molecular subtype as a predictor of outcomes of chemoradiotherapy for esophageal cancer.

4030 Background: The standard treatment for advanced esophageal cancer is preoperative chemoradiotherapy (CRT) followed by surgery or definitive CRT (NCCN Guideline 2022 ver5). CRT has the advantage of preserving organs and functions and the prognosis for patients achieved complete response by CRT is good. However, it is currently impossible to predict the outcomes of CRT before treatment. We have performed RNA expression analysis of pre-treatment biopsy specimens of esophageal cancer and identified several intrinsic molecular subtypes, as well as E-type (high expression of squamous markers) with good prognosis for CRT and M2-type (high expression of stromal markers) with poor prognosis for CRT (US patent No 10,969,390 B2). Herein, we performed an integrated analysis to confirm the relationship between intrinsic expression molecular subtype classification and prognosis in the pooled population from two prospective cohort studies (UMIN000043637). Methods: Two cohort studies were as follows; 1) single institute prospective cohort study conducted at National Cancer Center Hospital East (n=157, UMIN-C000000459), 2) multicenter prospective cohort study conducted at 10 institutions (n=226, UMIN000016141). A total 383 cases met inclusion criteria and the Affymetrix U331Plus 2 panel (47,104 transcripts, 38,572 genes) was used to identify E-type and M2-type. The clinical course and outcome were blinded for subtype classification. Treatment was performed as usual at each institution, and treatment details and outcomes were examined by subtype. Results: Among 383 patients, 181 and 164 patients were treated by CRT and surgery, respectively. Ninety-nine percent (n=342) were squamous cell carcinoma. Stage I/II/III/IV were 13/61/86/21 and 17/63/81/3 in CRT group and surgery group, respectively. Among them, 76 (22%), 100 (29%), 169 (49%) patients were classified as E, M2 and others, respectively. Among the patients treated by CRT, CR rate of E-type and M2-type were 62.8% (95% CI, 47.8-75.7) and 33.3% (95% CI, 21.9-47.1) (p=0.006). The 5-year progression free survival (PFS) and overall survival (OS) rates of CRT group was 50.5% (95% CI, 34.7-64.4) and 59.8% (95% CI, 42.6-73.3) for E-type vs. 23.0% (95% CI, 12.0-36.2) and 29.0% (95%CI, 16.8-42.4) for M2-type, with statistically significant difference (p=0.011, p=0.003). Cox regression analysis showed that crude HR for PFS and OS of E vs M2 were 0.50 (95% CI, 0.296-0.859, p=0.012) and 0.41 (95% CI, 0.226-0750, p=0.004), respectively. In contrast, E and M2-type did not show the survival difference in surgery group. Conclusions: For the first time in the world, we confirmed that expression molecular subtype of esophageal cancer has the potential to predict the outcomes of CRT. The results may provide precision medicine in the selection of treatment for esophageal cancer.

Natural language processing identification of documented mental health symptoms associated with risk of mental health disorders in patients with cancer.

1561 Background: Delayed diagnosis and care of mental health disorders (MHD) is a significant challenge in the care for patients with cancer. The objective of this study was to use natural language processing (NLP) to identify words related to mental health documented in clinical notes surrounding the time of cancer diagnosis and assess their predictive ability of future, new MHD. Methods: This single institution cohort study consisted of patients diagnosed with cancer between January 2012 and November 2022. Cancer and MHD were identified based on ICD-10 codes obtained from deidentified electronic health record data. MHD included psychotic disorders (F20-29), mood disorders (F30-39), and anxiety disorders (F40-48). The clinical Text Analysis Knowledge Extraction System was applied to deidentified clinical notes, and symptoms mapped to SNOMED concepts relevant to mental health were identified. These mental health symptoms were aggregated in the 15 days preceding and 15 days following a first cancer diagnosis and analyzed across MHD status. Patient characteristics including sex, age, race, cancer, and insurance were also analyzed. Results: This cohort consisted of 64,010 patients with cancer who had no documented MHD prior to cancer diagnosis, with a majority being 40-64 years old (45.8%) or 65+ (43.7%) and identifying as male (53.0%) or white (60.2%). Most patients had prostate (12.5%), hematologic (10.8%), or breast (10.3%) cancer and private insurance (46.2%). 9,825 (15.3%) patients developed a newly documented MHD, with a median time of 139 days (IQR: 40-466) from cancer diagnosis. The top five most common mental health documented symptoms for all patients were normal mood (23.3%), mental state finding (17.9%), worried (10.2%), feeling content (9.9%), and cognitive function finding (6.6%). Those who had a future MHD had higher documented rates across all mental health symptoms. Multivariate cox proportional hazards model identified 18-39 years old, female, white, and Medicaid or Medicare insurance as independent factors associated with an increased risk of a future, new MHD. Prostate cancer was associated with lower risk of a future MHD. Panic (OR 2.1 [95% CI 1.8-2.4]), feeling nervous (1.9 [1.5-2.4]), feeling guilt (1.9 [1.4-2.5]), mild anxiety (1.8 [1.4-2.4]), and feeling frustrated (1.4 [1.2-1.6]) were identified as the symptoms most strongly associated with an increased risk of a future MHD. Conclusions: NLP extracted mental health symptoms documented in clinical notes correlated with an increased risk of documented MHD. Computational approaches may be tools for improving the timely diagnosis of MHD and referral to specialty services. Further work is needed to investigate potential disparities in documentation and management of care for patients with cancer who develop MHD, including delays between documentation and eventual diagnosis.

Effectiveness of an Oral Gastrografin Regimen for Complete Distal Intestinal Obstruction Syndrome.

To assess the effectiveness of oral Gastrografin treatment and outcomes in adult patients with complete distal intestinal obstruction syndrome (cDIOS). DIOS is an important gastrointestinal complication of cystic fibrosis (CF). Conservative treatment options for cDIOS are largely empirical, and the optimal management remains unclear. Surgery should be reserved for patients who have failed nonoperative treatment or have immediate indications for surgery. A retrospective single-institution cohort study was undertaken of adults with CF who had undergone lung transplantation and were admitted with an episode of cDIOS between 2004 and 2020. The outcomes of treatment in a high-volume CF transplant center with routine oral Gastrografin-based therapy were assessed. Forty-seven episodes of cDIOS were recorded in 29 (23.3%) of 124 patients who had undergone lung transplantation for CF, and mean age at cDIOS was 30.3 years (SD ±11.2). Mean follow-up post cDIOS was 75.6 months (SD ±45.5). Twelve patients had >1 cDIOS episode. One episode occurred during recovery after transplantation, and 5 patients were readmitted within 30 days posttransplant with cDIOS. A history of previous abdominal surgery was associated with the development of cDIOS (P < 0.001). Oral Gastrografin therapy was used in 95.7% of the episodes, at varying doses. Three patients (7.0%) were resistant to oral Gastrografin treatment, requiring laparotomy. There were no deaths due to DIOS. Oral Gastrografin is effective and safe for the treatment of cDIOS, with low treatment failure rates. It should be considered as a first-line treatment option for patients with CF presenting with complete distal intestinal obstruction.

KRAS Mutation Analysis Using Cell-free DNA of Pancreatic Cancer.

Detection of pancreatic cancer using small samples of the pancreas obtained by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) remains a challenge. The purpose of this study was to investigate whether the detection of KRAS mutations in cell-free DNA (cfDNA) extracted from supernatants of liquid-based fixed cytology (LBC) specimens obtained using EUS-FNA in solid pancreatic cancer can be an auxiliary test for differential diagnosis. The purpose of this study was to investigate whether the detection of KRAS mutations in cell-free DNA (cfDNA) extracted from supernatants of liquid-based fixed cytology (LBC) specimens obtained using EUS-FNA in solid pancreatic cancer can be an auxiliary test for differential diagnosis. This was a single-institution cohort study that included 50 patients with pancreatic lesions. cfDNA was isolated from the supernatant of fixed LBC samples, and KRAS mutation status was compared between cfDNA samples and FFPE small fragment tissues. Of the 50 cfDNA samples, 84% (42/50) were valid. KRAS mutations were detected in 57.1% (24/42) of the 42 valid samples. The sensitivity, specificity, and accuracy of KRAS mutation detection using cfDNA samples in the pancreatic lesions were 63.2% (24/38), 100.0% (4/4), and 66.7% (28/42), respectively. KRAS mutation status between FFPE small tissues and cfDNA samples were comparable. Gene mutation analysis using cfDNA from the supernatant of fixed LBC samples is an effective ancillary diagnostic tool for pancreatic cancer.

The role of socioeconomic factors as barriers to patient reported outcome measure completion following lumbar spine fusion

BACKGROUND CONTEXTAlthough incorporating patient reported outcomes (PROMs) into practice allows healthcare systems to evaluate the value of care provided, research and policy reflecting PROMs can only be valid if they represent all patients. Few studies have evaluated socioeconomic barriers to PROM completion, and none have done so in a spine patient population. PURPOSETo identify patient barriers to PROM completion one year following lumbar spine fusion. STUDY DESIGN/SETTINGRetrospective single-institution cohort study. PATIENT SAMPLEA total of 2,984 patients undergoing lumbar fusion between 2014 and 2020 OUTCOME MEASURESCompletion of Mental Component Score (MCS-12) and Physical Component Score (PCS-12) of Short Form-12 questionnaire 1 year postoperatively. METHODSA retrospective review was conducted of all patients undergoing 1-3-level lumbar fusion at a single urban tertiary center. PROMs were queried from our prospectively managed electronic outcomes database. Patients were considered to have complete PROMs if 1-year outcomes were available. Community-level characteristics were collected from patients’ zip codes using the Economic Innovation Group Distressed Communities Index. Bivariate analyses were performed to assess factors associated with PROM incompletion along with multivariate logistic regression to control for confounders. RESULTSA total of 1,968 (66.0%) had incomplete 1-year PROMs. Patients with incomplete PROMs were more likely to be Black (14.5% vs 9.3%, p<.001), Hispanic (2.9% vs 1.6%, p=.027), reside in a distressed community (14.7% vs 8.5%, p<.001), and be active smokers (22.4% vs 15.5%, p<.001). On multivariate regression, Black race (OR: 1.46, p=.014, Hispanic ethnicity (OR: 2.19, p=.027), distressed community status (OR: 1.47, p=.024), workers’ compensation status (OR: 2.82, p=.001), and active smoking (OR:1.31, p=.034) all were independently associated with PROM incompletion. Surgical characteristics, including primary surgeon, revision status, approach, and levels fused were not associated with PROM incompletion. CONCLUSIONSSocial determinants of health impact completion of PROMs. Patients completing PROMs are overwhelmingly White, non-Hispanic, and reside in wealthier communities. Efforts should be taken to provide better education regarding PROMs and ensure closer follow-up of certain subgroups of patients to avoid furthering disparities in PROM research.

Safety of Hyperbaric Oxygenation Treatment and Evaluation of Associated Clinical Parameters: A Single-Institutional Prospective Cohort Study

Background and Objective: Adverse events (AEs) associated with hyperbaric oxygen therapy (HBOT) are uncommon and typically not serious, being the most frequent otic/sinus barotrauma. The objective of this study is to analyze the safety of the HBOT at 1.45 atmosphere absolute (ATA) and compare it with reportsat the same and higher pressures of treatment. AE per session was 7.1% for total AE and 4.1% for overall barotrauma. AE was reported in 28.3% of patients (n=49), with barotrauma and non-barotrauma AE in 20.3% (n=35) and 8.1% (n=14). All barotrauma was recorded as subjective (100% of ear ache without eardrum damage, Teed scale=0). The frequency of total AE obtained in our study was statistically higher for 1.5, 2, and &gt;2 ATA. Non-barotrauma AE was also higher; the frequency of total AE obtained in our study was statistically significant for 1.5, 2, and &gt;2 ATA but objective barotrauma was not present, and it was significantly lower than previously reported (p &lt; 0.001). A very slow rate of pressurizations (below 1 psi/min) was associated with ear pain (OR=3.32; 95 CI%, 1.32-8.35; p &lt; 0.001). The AEs reported in this safety surveillance prospective study are minor, and no objective barotrauma was reported. HBOT at 1.45 ATA is a safe treatment, that can be performed with a portable light and a less expensive hyperbaric chamber. Methods: A total of 175 patients (68 male, 107 female) were included in this prospective study. All patients were treated with HBOT at our facility from December 2019 to August 2021. For the comparative analysis, reports from studies published from 2012 to 2021 in MEDLINE EMBASE, BIREME, Lilacs, Scielo, and the Cochrane library were used. Binary variables are described in percentages with a 95% confidence interval (95% CI). Inferential analysis was performed using a bivariate analysis by calculating odds ratio (OR) with 95% confidence intervals. Statistical analyses and sample size calculations were performed with Stata version 13.0 (College Station, TX, USA). Results: In this study, the AE per session was 7.1% for total AE and 4.1% for overall barotrauma. AE was reported in 28.3% of patients (n=49), with barotrauma and non-barotrauma AE in 20.3% (n=35) and 8.1% (n=14), respectively. All barotrauma was recorded as subjective (100% of ear ache without eardrum damage, Teed scale=0). The frequency of total AE obtained in our study was statistically higher for 1.5, 2, and &gt;2 ATA. Non-barotrauma AE was also higher, but objective barotrauma was not present and was significantly lower than previously reported (p &lt;0.001). A very slow rate of pressurizations (below 1psi/minute) was associated with ear pain (OR = 3.32; 95% CI, 1.32-8.35; p &lt;0.001). Conclusion and Implications for Translation: In this study, the AE reported in this prospective safety surveillance study are minor, and no objective barotrauma was reported. The HBOT at 1.45 ATA is a safe treatment that can be performed with a portable lighter and a less expensive hyperbaric chamber. This study supports the hypothesis that hyperbaric oxygenation therapy at 1.45 ATA is a safe treatment, allowing for the spread and application of adjuvant treatment in different pathologies. Copyright © 2023 Monge-Martínez, et al. Published by Global Health and Education Projects, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution License CC BY 4.0.

The Effect of Immediate Microsurgical Resection of Vestibular Schwannoma on Hearing Preservation.

Evaluate for differences in postoperative hearing in patients who undergo immediate versus delayed hearing preservation microsurgical resection of vestibular schwannomas (VS). Retrospective single-institution cohort study spanning November 2017 to November 2021. Single-institution tertiary care hospital. Sporadic VS in patients with American Academy of Otolaryngology-Head and Neck Surgery hearing classification A or B, with tumor size less than or equal to 2 cm and undergoing hearing preservation microsurgical resection. Delayed surgical intervention defined by time from first diagnostic MRI to date of surgery being greater than 3 months. Preoperative and postoperative audiometric performance. In total, 193 patients met inclusion criteria. Within the cohort, 70 (36%) proceeded with surgery within 3 months of diagnostic MRI with a mean observation time of 62 days, whereas 123 (63%) underwent surgery after 3 months with a mean observation time of 301 days. There was no difference in preoperative hearing between the two groups with word recognition score 99% in early intervention group and 100% in delayed intervention group (p = 0.6). However, 64% of those who proceeded with immediate surgery had successful hearing preservation, compared to a 42% of those who had delayed intervention (p < 0.01). In a multivariable logistic regression accounting for preoperative word recognition score, tumor size, and age at diagnosis, the odds of hearing preservation were lower in those who delayed surgery compared to immediate surgery (odds ratio, 0.31; 95% confidence interval, 0.15-0.61). Patients who underwent microsurgical resection within 3 months of diagnosis demonstrated a hearing preservation advantage compared to those who did not. Findings of this study highlight the counseling challenges associated with the timing of surgical treatment of VS in patients presenting with good preoperative hearing and small tumors.

Survival Outcomes in Patients With Hormone Receptor–Positive Metastatic Breast Cancer With Low or No ERBB2 Expression Treated With Targeted Therapies Plus Endocrine Therapy

Approximately 45% to 60% of hormone receptor (HR)-positive metastatic breast cancer (mBC) shows a low-level expression of ERBB2. Low ERBB2 expression is defined as ERBB2 immunohistochemical expression of 1+ or 2+ with a negative ERBB2 amplification by in situ hybridization. The efficacy of the antibody-drug conjugate trastuzumab deruxtecan in low-ERBB2, HR-positive mBC has been practice changing. However, there are conflicting data on the prognostic value of low ERBB2 expression in HR-positive mBC and whether low ERBB2 expression is a separate entity. To examine whether outcomes differ by immunohistochemical analysis for patients with HR-positive mBC with low ERBB2 expression vs those without ERBB2 expression when treated with targeted therapy (TT) plus endocrine therapy (ET). This single-institution cohort study used prospectively collected electronic data from the MD Anderson Cancer Center for patients with a diagnosis of HR-positive mBC treated with ET in combination with a TT (cyclin-dependent kinase 4/6 inhibitors [CDK4/6is], everolimus, or alpelisib) between January 1, 2010, and December 31, 2021. HR-positive mBC with either low or no ERBB2 expression. The main outcomes were median progression-free survival and overall survival. Data on demographic characteristics, estrogen and progesterone receptor status, ERBB2 status, histologic subtype, menopausal status, treatment duration, and survival status were collected. A total of 1585 women (median [range] age, 51 [24-92] years) were included in the study. Of these women, 1013 (63.9%) had mBC with low ERBB2 expression and 572 (36.1%) had mBC with no ERBB2 expression. A total of 1084 (68.4%) were treated with a CDK4/6i (912 patients were treated in the first line and 172 were treated in the second line); 475 (30.0%) received everolimus and 26 (1.6%) received alpelisib. In the patients who received a first-line CDK4/6i, 618 (67.8%) received an aromatase inhibitor as their ET backbone and 265 (29.1%) received fulvestrant. With a median follow-up time of 17.9 months (range, 1-111 months), progression-free survival and overall survival were not statistically different between the patients with low and no ERBB2 expression treated with TT plus ET. In this cohort study of patients with HR-positive mBC treated with TT plus ET, low ERBB2 expression did not have a significant association with prognosis.