United States

Background 
Patients with severe aplastic anemia (SAA) develop high-risk infections. Prior data suggest efficacy and safety of granulocyte transfusion (GT) as an infection management tool in this population. A multicenter randomized control trial of GT in patients with severe neutropenia of varying etiologies did not reveal a significant difference in overall survival (OS) or microbial response but was limited by low enrollment and variable granulocyte dose. In this study of SAA patients who received GTs at our institution, we characterize patients’ clinical and survival outcomes and the role of GTs as a bridge to curative therapy. 

Methods 
SAA patients treated with immunosuppressive therapy who received GTs between 2011 and 2020 are included in our analysis. The primary outcomes are survival from first GT, including OS, and number of patients surviving to discharge and HSCT in patients awaiting HSCT. Secondary outcomes include evaluation of response at 30 days after initiation of GTs based on clinical, microbiological, and radiographical criteria. Cox proportional-hazards model was utilized to determine impact of neutrophil response and infection type on survival. Kaplan-Meier was used to assess OS. 

Results 
Twenty-eight SAA patients of median age 20 years (range 6-65 years) underwent 30 GT courses of median 8 products per course (range 1-39 products), over median 23.5 days (range 3-103 days), with a per-dose median 1.28 x 10^9 granulocyte cells/kg (range 0.45-4.52 x 10^9). Infection type included bacterial (n=15), fungal (n=12), and mixed (n=3). OS from initial GT was 50% with a median length of follow up at 550.5 days (range 2-4213 days). 18 of 28 (64.3%) patients survived to hospital discharge. Of the 21 patients awaiting HSCT during granulocyte therapy, 18 (85.7%) received HSCT. Patients achieving complete, partial or stable response at 30 days had significantly improved OS compared to non-responders (p=0.00004). Sex, type of infection, or % of days with ANC &gt;200 cells/mcL during the granulocyte course, were not predictive of survival (p=0.52, p=0.7, p=0.28 respectively). 

Conclusion 
GTs of adequate dose and course duration are a valuable adjunctive therapy to manage severe infections in SAA patients and may be particularly valuable as a bridge to undergoing curative treatment with HSCT.

2022 AMA Research Challenge

The Clinical Role of Granulocyte Transfusions in Severe Aplastic Anemia

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Ricardo Correa, MD, EdD
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Jessica Li, MD/PhD Candidate
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Charles Lopresto, DO

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Welcome to the largest national, multi-specialty research event featuring research from 750 medical students, residents and fellows, and international medical graduates.


Background 
Patients with severe aplastic anemia (SAA) develop high-risk infections. Prior data suggest efficacy and safety of granulocyte transfusion (GT) as an infection management tool in this population. A multicenter randomized control trial of GT in patients with severe neutropenia of varying etiologies did not reveal a significant difference in overall survival (OS) or microbial response but was limited by low enrollment and variable granulocyte dose. In this study of SAA patients who received GTs at our institution, we characterize patients’ clinical and survival outcomes and the role of GTs as a bridge to curative therapy. 

Methods 
SAA patients treated with immunosuppressive therapy who received GTs between 2011 and 2020 are included in our analysis. The primary outcomes are survival from first GT, including OS, and number of patients surviving to discharge and HSCT in patients awaiting HSCT. Secondary outcomes include evaluation of response at 30 days after initiation of GTs based on clinical, microbiological, and radiographical criteria. Cox proportional-hazards model was utilized to determine impact of neutrophil response and infection type on survival. Kaplan-Meier was used to assess OS. 

Results 
Twenty-eight SAA patients of median age 20 years (range 6-65 years) underwent 30 GT courses of median 8 products per course (range 1-39 products), over median 23.5 days (range 3-103 days), with a per-dose median 1.28 x 10^9 granulocyte cells/kg (range 0.45-4.52 x 10^9). Infection type included bacterial (n=15), fungal (n=12), and mixed (n=3). OS from initial GT was 50% with a median length of follow up at 550.5 days (range 2-4213 days). 18 of 28 (64.3%) patients survived to hospital discharge. Of the 21 patients awaiting HSCT during granulocyte therapy, 18 (85.7%) received HSCT. Patients achieving complete, partial or stable response at 30 days had significantly improved OS compared to non-responders (p=0.00004). Sex, type of infection, or % of days with ANC >200 cells/mcL during the granulocyte course, were not predictive of survival (p=0.52, p=0.7, p=0.28 respectively). 

Conclusion 
GTs of adequate dose and course duration are a valuable adjunctive therapy to manage severe infections in SAA patients and may be particularly valuable as a bridge to undergoing curative treatment with HSCT.

technical paper

Strabismus is a visible disability that impacts one's ability to make eye contact. In this study, we evaluate the impact that strabismus has on quality of life in adults and explore how strabismus surgery can be effective in improving quality of life.

The impact of strabismus on quality of life in adults

Introduction: The Rotterdam CT (RCT) score is a prognostic metric used to predict mortality in patients with traumatic brain injury (TBI) using injury characteristics observed on initial CT. Withdrawal of life-sustaining therapies (WLST) following trauma may be related to certain patient factors such as age and injury severity, but its relationship to RCT remains unknown. 

Objectives: The present study aims to determine whether the RCT score can be used as a reliable predictor of WLST in patients with TBI and to validate previous studies demonstrating that the RCT score can reliably predict mortality in patients with TBI. 

Methods: All patients ≥ 18 years old with TBI were identified from the MetroHealth TBI Database, a registry of patients admitted to MetroHealth Medical Center (Cleveland, OH) with TBI between 2018-2021. We collected factors related to RCT score, baseline demographic data, clinical presentation, neurosurgical intervention, and do not attempt resuscitation (DNAR) orders. The primary outcome measure was WLST, and the secondary outcome measure was mortality. Binary logistic regression models were created to determine factors independently associated with WLST and mortality. 

Results: A total of 1110 patients were identified. The median age was 61 years old and 69.3% (770/1110) were male. In this cohort, 11.3% (n = 125) of patients underwent WLST. A bivariate logistic regression model revealed that RCT score (continuous) (odds-ratio (OR) 1.6 [95% confidence-interval (95%-CI) 1.2-2.2]), Glasgow Coma Scale (continuous; GCS) (OR 0.84 [95%-CI 0.78-0.91]), Injury Severity Scale score (continuous; ISS) (OR 1.04 [95%-CI 1.01-1.07]), ventricular drain (OR 4.7 [95%-CI 1.1-19.6]), and DNAR (OR 47.8 [23.8-95.6]) were all independently associated with WLST. An additional bivariate logistic regression model revealed that RCT score (OR 2.08 [95%-CI 1.49-2.91]), ISS (OR 1.06 [95%-CI 1.03-1.10]), GCS (OR 0.81 [95%-CI 0.74-0.88]), undergoing a craniectomy (OR 0.28 [95%-CI 0.09-0.83]), and DNAR (OR 73.3 [95%-CI 34.8-145.7]) were all independently associated with mortality. These models demonstrated excellent accuracy and discrimination ability for both WLST and mortality as endpoints, as demonstrated by concordance statistics of 0.97.

Conclusion: In adult TBI patients, the RCT score can be accurately used to independently predict both WLST and mortality with high predictive validity.

The Predictive Validity of the Rotterdam Computed Tomography Score on Withdrawal of Life-Sustaining Therapies in Patients with Traumatic Brain Injury

Objective: 
The primary purpose of this study was to determine if treating endometriosis with optimal excision surgery leads to lower rates of repeat surgery as compared to historical rates of repeat surgery by ablation. A secondary outcome was to examine whether the use of hormonal suppression differed before surgery, depending on the stage of endometriosis found at surgery.
Study design: 
We performed a prospective cohort study (Canadian Task Force class II-3).
Materials and methods: 
Preoperative data, operative data, and follow-up postoperative data were collected prospectively (IRB 20900) at the Saint Louis University Center for Endometriosis, a referral center for the surgical management of endometriosis specializing in the optimal excision of endometriosis, from time frame 2012-2019. Optimal excision was defined as completely excising all areas of abnormal peritoneum, wherever found in the pelvis, having looked systematically with near contact laparoscopy. All surgeries were performed by a single surgeon specializing in optimal excision. Follow-up data was collected from annual questionnaires sent postoperatively to patients.
Results: 
Of the 756 patients in the database who underwent surgery for endometriosis, 620 patients had histological confirmation of endometriosis in any location excised, yielding a rate of finding tissue-proven endometriosis to be 82%. The mean follow-up time period in months was 32 months (range 5-136 months). Of the 620 patients with tissue-proven endometriosis, 570 women had optimal excision (OE) surgery for endometriosis (91.9%) of which 14 patients underwent repeat surgery (2.5%). Of the 620 patients, 366 women (60%) were on hormonal suppression specifically: 96.4% of the 366 women on hormonal contraceptives, 29.5% on GnRH agonists/antagonists/chemical menopause, and 14.6% on progesterone-secreting IUDs with a median length of suppression of 36 months. At surgery, 62.9% of patients were categorized as endometriosis stage 1 or 2, 11.8% for stage 3, and 25.3% for stage 4. There was also no significant association between hormonal suppression before endometriosis excision surgery with the stage of endometriosis found at surgery. 
Conclusion: 
The rate of repeat surgery is an important clinical factor when looking at surgical outcomes. The rate of repeat surgery after optimal excision surgery for endometriosis was remarkably low (2.5%) as compared to historical rates of repeat surgery by ablation (40-60% in 1-2 years following initial procedure ). Additionally, the lack of significant evidence between hormonal suppression use and progression of stage of endometriosis provides implicit evidence that hormonal suppression does not prevent progression of the disease. Further controlled studies are needed to verify these findings.


The Rate of Repeat Surgery After Optimal Excision Surgery of Endometriosis at a Single Tertiary Referral Center

BACKGROUND: Otitis Media (OM) is one of the most prevalent pediatric infectious diseases often comprising two common diagnoses: acute otitis media (AOM) and otitis media with effusion (OME). The current guidelines on managing OM have emphasized the need to accurately diagnose fluid presence in the ear, and the latest methods for OM diagnosis are often inaccurate or under-utilized. This frequently results in over-usage of antibiotics for AOM or misdiagnosis of middle ear effusion in OME. Emerging technologies including leveraging artificial intelligence (AI) and automation to improve OM diagnosis are likely to play a significant role for clinicians into the future. As a specific example, optical coherence tomography (OCT), capable of imaging body cavities and tissue, has recently been introduced as a promising technology for the accurate diagnosis of OM. This study was conducted to capture the current state of advances in automation and technological innovations in OM diagnosis.
METHODS: A qualitative systematic review of PubMed, Scopus, and Google Scholar was conducted to analyze the role of AI and automation in the diagnosis and management of OM. Articles were reviewed for eligibility and 41 studies met inclusion criteria.
RESULTS: Across studies, use of AI has shown promising progress toward more accurate diagnosis of AOM. Clinicians can use AI and obtain reliable imaging focused on AOM and OME, aiding in both management and diagnosis. Applications of OCT have provided for high- quality detection, diagnostics, and monitoring prognosis of OM. Smartphone attachments employing acoustic reflectance have recently demonstrated great potential for cost-effective and remote OM diagnosis. Although smartphone otoscopes are available for remote use by parents, there remains risk for discrepancies when compared to data acquired by physicians.
CONCLUSION: Through the development of an automated diagnostic algorithm for OM, AI and automation technologies would provide several benefits to OM patients worldwide. This cost-effective approach can account for early detection of OM in pediatric patients, assist parents in deciding whether their children need professional help, and aid clinicians in managing OM with potentially more reliability than current technologies.

The Role of Artificial Intelligence and Automation in the Diagnosis and Management of Otitis Media

Abstract Title: Time to Hemorrhage Response After Implementation of an Obstetric
Hemorrhage Bundle
Background: Obstetric hemorrhage (OBH) is a leading cause of maternal mortality on day of birth. Alarmingly, but not surprisingly, maternal mortality tracks closely with racial disparities, with patients from underserved backgrounds at a greater risk for death during pregnancy and childbirth. Despite several effective uterotonic interventions available for postpartum bleeding, the rate of OBH per 10,000 births has seen a sharp increase, from 4.3 in 1993 to 21.1 in 2014. OBH “bundles” that standardize hemorrhage recognition and response have been shown to reduce OBH rates, however the mechanisms for reduction in morbidity are unclear. Imprecise estimate of blood loss leading to delayed provider response to hemorrhage has been theorized as a contributing factor for the rise in hemorrhage rates. This is the first study to compare the time delay of uterotonic interventions for OBH before and after the implementation of an OBH bundle.
Methods: We performed a retrospective study of 7276 deliveries before and after
implementation of an OBH bundle which includes risk assessment tools and quantitative blood loss measurement. A random sample of deliveries from January to December 2016 was selected for the pre-intervention group. All deliveries from January 2018 to December 2019 were included in the post-intervention group. The primary outcome was time from delivery to first dose of oxytocin; secondary outcome was the number of uterotonic interventions utilized. Groups were compared using Student’s t-tests and chisquared tests.
Results: Of the 7276 deliveries, 1944 (27%) occurred pre-intervention and 5332 (73%) occurred post-intervention. After bundle implementation, average oxytocin time delay decreased from 8.3 minutes to 5.9 minutes (p <0.01). The frequency of second line uterotonic interventions increased from 16% to 18% post-intervention (p <0.05).
Conclusion: This is the first study to investigate how implementation of standard OBH treatment drives clinical decision making such as medication administration. Implementation of this OBH bundle was associated with more prompt delivery of uterotonic interventions. Future studies should explore the effect of OBH bundle protocols on hemorrhage-related outcomes.

Time to Hemorrhage Response After Implementation of a Obstetric Hemorrhage Bundle

Abstract Title: Tissue Anchoring Nanomedicine Alleviates Osteoarthritis Knee Model in Mice

Background 
Osteoarthritis (OA) is the most common joint disorder in the United States. The CDC estimates more than 32.5 million US adults suffer from clinical OA. According to the AAOS evidence-based guidelines, intraarticular anti-inflammatory therapy is the first line treatment for knee OA. Currently available therapies have critical shortcomings, primarily the inability to modify pathophysiological disease progression limiting treatment solely to palliative care. Further, rapid clearance of these drugs from the joint space limits therapeutic potential and results in systemic side effects. Given the established anti-inflammatory potential and readily modifiable structure of nanoparticle fullerene (C60), we attempt to develop a more precise treatment for knee OA.
Methods
We have previously developed a targeted C60 nanoparticle composed of a C60 cage with a conjugated cFLFLF peptide (cFLFLF-C60) that binds specifically to formyl peptide receptor-1, a receptor abundantly expressed on activated macrophages. Using Raw 264.7 macrophages, Lipopolysaccharide, and the Cy5 fluorophore integrated in the cFLFLF peptide, the nanoparticle’s preferential binding was evaluated, and anti-inflammatory efficacy analyzed by PCR. Ten to 12-week-old Balb/c mice underwent destabilization of middle meniscus (DMM) surgery to induce OA, with seven mice receiving a cFLFLF-C60 injection and six serving as control (injected with saline). IVIS imaging was then used to evaluate the functionalized-C60’s distribution 2 weeks post-injection. After 6 weeks, the mice were sacrificed, and the knee joints scanned and analyzed by microCT as well as sectioned and stained for histological analysis.
Results
The cFLFLF-C60 demonstrated preferential binding to LPS-stimulated macrophages versus non-inflammed macrophages. IVIS imaging revealed significant retention within the injured knee joint compared to fluorophore-labeled saline. MicroCT analysis revealed that compared to control mice joints, cFLFLF-C60 effectively attenuated OA morphological changes (subchondral sclerosis, osteophyte formation) and restored trabeculae morphological parameters back to those of sham group (trabeculae number, spacing, and connectivity density). Histologic analysis revealed improved OARSI grading and tidemark measurements in the cFLFLF-C60 cohort.
Conclusion
cFLFLF-C60 preferentially anchors to activated macrophages, leading to significantly increased joint space retention. The pathophysiological changes that define OA were attenuated by intra-articular injection of cFLFLF-C60 as confirmed by microCT and histological analysis.


Tissue Anchoring Nanomedicine Alleviates Osteoarthritis Knee Model in Mice

Background: There have been a few recent studies that attempt to describe the insertional anatomy of the triceps brachii muscle onto the tip of the olecranon process of the ulna. Despite the findings from these studies, the detailed complexity of this insertional footprint continues to challenge surgeons as evidenced by continued reports of triceps-associated complications following elbow procedures including tendon rupture and triceps insufficiency. The purpose of this study is to provide a more detailed understanding of the three-dimensional footprint of the triceps brachii at its olecranon insertion at the elbow.
Methods: To perform this basic science study, 22 cadaveric elbows were dissected leaving only the distal insertion of the triceps intact. The insertion was defined and probed with a three-dimensional digitizer to create a digital three-dimensional footprint allowing width, height, and surface area of the footprint to be recorded relative to the bare area. Additionally, the insertional soft tissues of tendon versus muscle along with the shape of the footprints were qualitatively described. An alpha of 0.05 was used for all statistical analysis.
Results: We found the mean width and surface area of the lateral segment to be greater in males than in females (30.07 mm vs. 24.37 mm, p=0.0339 and 282.1 mm vs. 211. 56 mm, p= 0.0181, respectively). No other statistically significant differences between the sexes were noted. In all specimens, the triceps insertional footprint was “crescent-shaped” and consisted of three regions: central tendon, medial muscular extension, and lateral muscular extension.
Conclusion: The distinction between muscles and tendons is particularly important for surgical decision making. These findings better detailing the complexity of the insertional anatomy of the triceps brachii muscle help explain the importance of avoiding these muscular structures during triceps-off approaches and provides the framework for future clinical studies.


Triceps Brachii Insertional Footprint: Under-estimated Complexity

*Purpose: The rate of living donor kidney transplants (LDKTs) performed has declined overall regardless of race. Studies show that web-based tools increase access to living organ donation (LOD). Kidney transplant candidates (KTCs) may be reluctant to ask potential donors directly. Donor app was designed to help KTCs identify potential living donors by creating social media postings about their need for transplant. The purpose of this study is to evaluate the feasibility of using Donor app in improving awareness about LOD and rates of LDKT.
*Methods: Single-center prospective pilot study of 53 adult KTCs without potential donors was conducted using Donor app. KTCs were required to have access to social media account(s) including Facebook, Messenger, Email and/or Twitter. Based on KTC preference, postings were shared on as many platforms as desired. KTCs were allowed to have donor Champion(s) that will post their own story on social media about their relationship with KTC to advocate for donation. Demographics, clinical characteristics, donor referrals and transplant outcomes were compared between KTCs who used the Donor app with 1:1 matched historic controls from our waitlist.
*Results: 47 KTCs posted their stories using the Donor app. Median age 48 yrs (Interquartile range [IQR]: 41.5-58.5 yrs); median time on waitlist 511 days (IQR: 107-777 days), with 54% AA (n=25). Total views on all platforms and patients were 8501. 67 donor referrals came on behalf of 21/47 KTCs (44%) with a median of 6 days (IQR: 1-23 days) from posting to 1st donor inquiry; 6/21 (28%) had at least 1 donor Champion. KTCs with at least 1 donor referral were also likely to have at least 1 donor Champion (p=0.009), use of multiple social media outlets for posting their story (p=0.02), and had significantly higher views vs. ones with no referrals (487 vs. 71 views/KTC respectively; p=0.003). To date, 2 underwent transplants (1 LDKT; 1 deceased direct donation) and 4 have approved living donors pending the scheduling of transplant. Another 4 KTC’s have living donors still in evaluation. None of the matched controls had any living donor referrals (p=0.01).
*Conclusions: The Donor app can significantly increase awareness & rate of LOD, including in AA. Transplant programs should consider this technology as adjunct support for KTCs who otherwise have no prospects for potential living kidney donation.

Using social media to increase live organ donation for kidney transplant candidates: Single-center study using Donor App

Background:
Boston Medical Center (BMC) is a safety net hospital that serves a diverse patient population with various socio-demographic backgrounds. It is crucial to understand whether such factors serve as barriers to care. Previous studies have investigated disparities among specific populations, such as African Americans, and have used the accounts of cancer survivors or oncologists, but few studies have addressed barriers that encompass multiple minority populations in a safety net hospital. This study investigates disparities in care regarding clinical trial discussion and enrollment in lung cancer patients. 

Methods:
1,121 patients with a diagnosis of lung cancer between January 2015 to December 2020 at BMC were included in this study. Electronic medical records were searched for keywords “clinical trial” or “enroll”, or by filtering oncology notes for “research encounter.” Each chart was reviewed for one of three categories: 1) clinical trial discussed and patient enrolled, 2) clinical trial discussed but patient not enrolled, 3) clinical trial not discussed. Socio-demographic variables such as age, gender, race, ethnicity, city, primary language, median household income, insurance, and education level were also collected. SPSS version 26.0 was used for chi-squared and t-test statistical analysis. 

Results: 
Of 1,121 patients, 50.4% were of minority race, 16.9% did not speak English, 8% were Hispanic, 70.6% had an education of high school or below, and 70.6% belonged to a lower median house-hold income (<$84,000). Clinical trial was discussed in 141 patients (12.6%) and of those, 22 (15.6%) were enrolled. Although clinical trial enrollement has been historically low at BMC, we enrolled more African American patients (50%). When looking at age, clinical trial discussions were conducted more with younger patients (68.19 vs 71.37, p=0.001). There was no significant difference in clinical trial discussion or enrollment between gender, race, ethnicity, primary language, median household income, insurance, or education level. 

Conclusion:
Overall, BMC’s clinical trial discussion and enrollment rate were found to be similar across various socio-demographic factors. The only difference identified was clinical trials were discussed more with younger populations. This indicates that patients presenting with lung cancer to BMC experience minimal disparities in care regarding clinical trial discussion and enrollment.

Disparities in Lung Cancer Clinical Trial Discussion and Enrollment at a Safety Net Hospital

Background
Syphilis, colloquially termed “the Great Imitator,” is a sexually transmitted infection caused by the spirochete treponema pallidum. Syphilis occurs in multiple stages. Tertiary syphilis occurs years after inoculation, presents with chronic granulomas, cardiovascular, and neurologic manifestations. Syphilitic hepatitis is a rare and often missed diagnosis in patients who have syphilis and who are often co-infected with HIV or hepatitis B.
Case Presentation 
The diagnosis is made by both clinical presentations and positive serological markers, characteristic transaminitis, with no other alternative cause of hepatobiliary injury identified. Here, we highlight a case of an undomiciled 40-year-old male with HIV (on Genvoya) and chronic hepatitis B, who presented with tachycardia to 107. Physical examination was remarkable for a diffusely spread rash with erythema on the bilateral lower extremities, a small purulent boil on the right shin, left index finger and dry, itchy, distinct raised purple lesions on the scalp, eyebrows, upper and lower extremities, back, and shoulders. Laboratory findings were remarkable for a severely elevated alkaline phosphatase, mild transaminitis, and elevated total bilirubin, with negative pertinent imaging including a right upper quadrant sonogram, CT scan of the abdomen, and MRCP. Extensive additional work-up revealed elevated VDRL titers. Both a skin and liver biopsy were completed. Immunohistochemical stain of shave biopsy of a verrucous plaque on the scalp vertex and an excoriated papule of the left neck highlighted numerous spirochetes. Liver biopsy revealed hepatocellular necrosis with moderate mixed inflammation involving the portal tract and periportal hepatocytes, with immunohistochemical marker for spirochetes negative for organisms. However, given the patient’s clinical history of secondary syphilis involving the skin and lab abnormalities, it raised the differential diagnosis of syphilitic hepatitis.
Diagnosis
With our case report and extensive research of the literature, we hope to shed light on the importance of certain infections, even those in decline, on the differential. Additionally, contemplation of coexisting infections often helps to contribute to diagnoses not otherwise common. Because of how rarely seen syphilitic hepatitis is, it is often a missed diagnosis, but we are hopeful our case report helps physicians with patients with similar presentations, especially patients with otherwise unexplained high alkaline phosphatase levels.


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The Clinical Role of Granulocyte Transfusions in Severe Aplastic Anemia

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