Publications by authors named "Shalin Shah"

98 Publications

A Study of Neuromyelitis Optica Spectrum Disorders (NMOSD): Disease Pattern Based on Antibody Status.

Neurol India 2022 May-Jun;70(3):1131-1136

Department of Neurology, V.S. General Hospital, Ahmedabad, Gujarat, India.

Introduction: Neuromyelitis optica (NMO) is a central demyelinating disorder, predominantly affecting the optic nerves and spinal cord and autoimmune basis. We aimed to analyze the clinical, laboratory, and imaging features associated with NMO spectrum disorders (NMOSD) according to the aquaporin 4 antibody (AQP4-Ab) serology status.

Methods: The inclusion of the patients was based on the Wingerchuk criteria (2006) for NMO, known antibody status and has minimum 1-year follow-up. We analyzed and compared 46 patients with known antibody status.

Results: AQP4-Ab positivity was 56.5%. The male to female ratio in the seropositive group was 1:7.7 and 1:1.2 in the seronegative group. The mean age of onset in seropositive patients was 36.8 years (vs 28.8 years in seronegative NMOSD patients). Clinical feature, cerebrospinal fluid (CSF) and magnetic resonance imaging (MRI) features were also different, but data from two subsets did not reach statistical significance. The relapse rate was higher in AQP4 positive NMOSD (84.6% vs 55% in the seronegative group). The recovery rate for AQP4 positive patients was poor (15%).

Summary: We found differences in age, gender, and prognosis between the two groups. Antibody status may be a guiding factor in deciding the treatment approach during the first attack of NMOSD.
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http://dx.doi.org/10.4103/0028-3886.349679DOI Listing
July 2022

Correlating the patterns of diabetic macular edema, optical coherence tomography biomarkers and grade of diabetic retinopathy with stage of renal disease.

Int Ophthalmol 2022 May 28. Epub 2022 May 28.

Bio-statistical department, Dr. Shroff's Charity Eye Hospital, New Delhi, 110002, India.

Purpose: To correlate optical coherence tomography (OCT)-based morphological patterns of diabetic macular edema (DME), biomarkers and grade of diabetic retinopathy (DR) in patients with various stages of chronic kidney disease (CKD) secondary to diabetes.

Design: Multicentric retrospective cross-sectional study was conducted at seven centers across India.

Methods: Data from medical records of patients with DME and CKD were entered in a common excel sheet across all seven centers. Staging of CKD was based on estimated glomerular filtration rate (eGFR).

Results: The most common morphological pattern of DME was cystoid pattern (42%) followed by the mixed pattern (31%). The proportion of different morphological patterns did not significantly vary across various CKD stages (p = 0.836). The presence of external limiting membrane-ellipsoid zone (ELM-EZ) defects (p < 0.001) and foveal sub-field thickness (p = 0.024) showed a direct correlation with the stage of CKD which was statistically significant. The presence of hyperreflective dots (HRD) and disorganization of inner retinal layers (DRIL) showed no significant correlation with the stage of CKD. Sight threatening DR was found to increase from 70% in CKD stage 3 to 82% in stages 4 and 5 of CKD, and this was statistically significant (p = 0.03).

Conclusion: Cystoid morphological pattern followed by mixed type was the most common pattern of DME on OCT found in patients suffering from stage 3 to 5 of CKD. However, the morphological patterns of DME did not significantly vary across various CKD stages. ELM-EZ defects may be considered as an important OCT biomarker for advanced stage of CKD.
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http://dx.doi.org/10.1007/s10792-022-02332-3DOI Listing
May 2022

Can Cervical and Lumbar Epidural Blood Patches Help Avoid Revision Surgery for Symptomatic Postoperative Dural Tears?

World Neurosurg 2022 Aug 20;164:e877-e883. Epub 2022 May 20.

University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. Electronic address:

Background: Incidental durotomies resulting in symptomatic postoperative cerebrospinal fluid (CSF) leaks can be treated with bedrest, subarachnoid lumbar drain, and surgical re-exploration. Another option is an epidural blood patch, which forms a clot over the dural tear in a minimally invasive manner. Our objective was to describe our center's outcomes and complications following epidural blood patches for symptomatic postoperative durotomies.

Methods: Patients undergoing spine surgeries at one institution from 2012-2020 were included. Patient charts were reviewed for demographic information, surgical data, rate of dural tear, type of repair, and use of blood patches postoperatively.

Results: A total of 1392 patients (726 male, 666 female, average age: 56.3 ± 15.4 years), including 436 cervical and 956 posterior thoracolumbar/lumbar spine surgeries were screened. There were 6 (1.4%) cervical, 64 (6.7%) lumbar, and a total of 70 (5.0%) patients with incidental dural tears/blebs. Of these patients, we identified 2 cervical and 8 lumbar spine patients with persistent CSF leaks who received epidural blood patches postoperatively. Nine of 10 (90%) had resolution of symptoms. One lumbar patient failed both an initial blood patch and subsequent surgical re-exploration, but had successful relief after a second blood patch.

Conclusions: The incidence of dural tears/blebs was 1.4% in cervical, 6.7% in lumbar, and 5.0% in all spine surgeries. Of the 10 patients with symptomatic CSF leaks, 9 were successfully treated with blood patches. Targeted epidural blood patch is effective in treating symptomatic CSF leaks and minimizes the morbidity of surgical re-exploration.
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http://dx.doi.org/10.1016/j.wneu.2022.05.060DOI Listing
August 2022

Thyroid-Associated Peripapillary Vascular Remodelling - A Novel Area for Research? [Letter].

Clin Ophthalmol 2022 12;16:1475-1476. Epub 2022 May 12.

Department of Ophthalmology (Guru Nanak Eye Centre), Maulana Azad Medical College, New Delhi, India.

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http://dx.doi.org/10.2147/OPTH.S372789DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9113653PMC
May 2022

Outcome of transcanalicular laser dacryocystorhinostomy with endonasal augmentation in acute versus post-acute dacryocystitis.

Eye (Lond) 2022 May 19. Epub 2022 May 19.

Department of Ophthalmology, Guru Nanak Eye Centre (Associated with Maulana Azad Medical College), New Delhi, India.

Objective: To study the outcomes of transcanalicular laser dacryocystorhinostomy (TCL-DCR) with endonasal augmentation in acute versus post-acute dacryocystitis and compare it with external DCR in post-acute settings.

Methods: A prospective, randomised study was conducted in 90 adult cases of Acute dacryocystitis. All the patients were started on systemic antibiotics and a 4 mm × 4 mm osteotomy was created using TCL-DCR. The osteotomy was enlarged to 8 mm × 8 mm by endonasal augmentation at the same sitting in group 1, after 10 days in group 2 and after 10 days with external DCR in group 3. The cases were assessed for symptomatic relief and complications. Success was defined as functional and anatomical patency at 36 months.

Results: The mean age was 45.33 ± 15.06 years and the male: female ratio was 1:2. The presenting complaints were painful swelling (100%), epiphora or discharge (88.8%), fistula (33%) and fever (6%). The average number of acute episodes was 2.96. The intra-group pain reduction from day 1 to day 4, was significant in all three groups (p = 0.000). Intra-operative (p = 0.015, χ = 8.37) and post-operative complications (p = 0.002, χ = 0.002) were higher in group. Anatomical success was achieved in all the three groups, however, the functional success in Group 3, Group 2 and Group 1 was 100%, 86.7% and 66.7% respectively (p = 0.002, χ = 12.86).

Conclusions: The creation of osteotomy using TCL-DCR provides early relief in symptoms. Single-stage surgery in inflamed tissues is associated with higher complication rates. External DCR in post-acute settings gives the best outcomes with minimal complications, endoscopic augmentation requires a close follow-up.
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http://dx.doi.org/10.1038/s41433-022-02104-4DOI Listing
May 2022

Early DNR in Older Adults Hospitalized with SARS-CoV-2 Infection During Initial Pandemic Surge.

Am J Hosp Palliat Care 2022 May 5:10499091221084653. Epub 2022 May 5.

Division of Hospital Medicine, Department of Medicine, 5799Northwell Health, Manhasset, NY, USA.

The role of early Do Not Resuscitate (DNR) in hospitalized older adults (OAs) with SARS-CoV-2 infection is unknown. The objective of the study was to identify characteristics and outcomes associated with early DNR in hospitalized OAs with SARS-CoV-2. We conducted a retrospective chart review of older adults (65+) hospitalized with COVID-19 in New York, USA, between March 1, 2020, and April 20, 2020. Patient characteristics and hospital outcomes were collected. Early DNR (within 24 hours of admission) was compared to non-early DNR (late DNR, after 24 hours of admission, or no DNR). Outcomes included hospital morbidity and mortality. Of 4961 patients, early DNR prevalence was 5.7% (n = 283). Compared to non-early DNR, the early DNR group was older (85.0 vs 76.8,  < .001), women (51.2% vs 43.6%,  = .012), with higher comorbidity index (3.88 vs 3.36,  < .001), facility-based (49.1% vs 19.1%, 001), with dementia (13.3% vs 4.6%,  < .001), and severely ill on presentation (57.9% vs 32.3%,  < .001). In multivariable analyses, the early DNR group had higher mortality risk (OR: 2.94, 95% CI: 2.10-4.11), less hospital delirium (OR: 0.55, 95% CI: 0.40-.77), lower use of invasive mechanical ventilation (IMV, OR: 0.37, 95% CI: .21-.67), and shorter length of stay (LOS, 4.8 vs 10.3 days,  < .001), compared to non-early DNR. Regarding early vs late DNR, while there was no difference in mortality (OR: 1.12, 95% CI: 0.85-1.62), the early DNR group experienced less delirium (OR: 0.55, 95% CI: .40-.75), IMV (OR: 0.53, 95% CI: 0.29-.96), and shorter LOS (4.82 vs 10.63 days, OR: 0.35, 95% CI: 0.30-.41). In conclusion, early DNR prevalence in hospitalized OAs with COVID-19 was low, and compared to non-early DNR is associated with higher mortality but lower morbidity.
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http://dx.doi.org/10.1177/10499091221084653DOI Listing
May 2022

Demographic Profile and Prescribing Patterns of Anti-epileptic Drugs in Indian Epilepsy Patients: Electronic Medical Record-Based Nation-Wide Retrospective Cohort Study.

Cureus 2022 Mar 31;14(3):e23676. Epub 2022 Mar 31.

Insights, HealthPlix Technologies, Bengaluru, IND.

The aim of this study was to provide real-world data on clinical characteristics, risk factors, and treatment patterns in Indian patients with epilepsy. Electronic medical record (EMR) data of patients diagnosed with epilepsy between January 2001 and December 2019, which included demographics, diagnosis, anti-epileptic drug usage, and underlying risk factors were evaluated. The majority of patients were between the age group of 18 and 55 years (n=3,186), with males accounting for 62% and the remaining 38% being females. Further, the most common comorbidity was hypertension (23.3%, n=1,470), followed by diabetes mellitus (10.8%, n=683) and depression (9.4%, n=597). The most prevalent form of epilepsy was focal epilepsy (n=5,141 81.4%), followed by generalized epilepsy (n=601). Focal epilepsy was most prevalent in males (62%, n=3,167) and most common in the age group of 18-55 years (50.3%, n=2588). Anti-epileptic drug (AED) usage data from 6,318 patients showed that the most commonly prescribed AED alone or in combination for both focal and generalized epilepsy was levetiracetam (41.8%, n= 2645). Data collected from this study are aligned but do not completely agree with the Guidelines for the Management of Epilepsy in India (GEMIND). This affirms treatment initiation with AED monotherapy; however, the treatment choices do not necessarily follow the recommended guidelines to select conventional AEDs, at low strengths, at initiation.
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http://dx.doi.org/10.7759/cureus.23676DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9055561PMC
March 2022

Noninflammatory thyroid eye disease in Indian subcontinent: Is it a departure from Rundle's curve?

Indian J Ophthalmol 2022 05;70(5):1866-1867

Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.

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http://dx.doi.org/10.4103/ijo.IJO_2680_21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9333009PMC
May 2022

Ocular sequelae in severe COVID-19 recovered patients of second wave.

Indian J Ophthalmol 2022 05;70(5):1780-1786

Society for Health Education and Allied Research, New Delhi, India.

Purpose: To evaluate the retinal microvascular changes in patients, recovered from severe COVID-19 during the second wave of the pandemic in North India.

Methods: In this observational cross-sectional study, 70 eyes of 35 patients who recovered from severe COVID-19 during the second wave underwent detailed ophthalmic evaluation 4-6 weeks after discharge. Twelve controls were also enrolled, and the difference in the findings between the case and control groups on optical coherence tomography (OCTA) were studied.

Result: The ages of study participants ranged from 27 to 60 years with the male:female ratio being 1.05:1. The fundus changes suggestive of ischemia in the form of cotton wool spots and vascular tortuosity were seen in 25 eyes (35.71%). Increased venous tortuosity was the most common finding seen in 23 eyes (32.85%), of which 10 eyes (28.57%) had concurrent hypertensive retinopathy (HTR) changes. There was a significant reduction in the mean vascular density (VD) and perfusion density (PD) for both the superficial capillary plexus (SCP) and deep capillary plexus (DCP) at inner, outer ring, and whole (P < 0.05). Foveal avascular zone was significantly enlarged in both the SCP (P = 0.01) and the DCP (P = 0.03). The mean ganglion cell-inner plexiform layer (GC-IPL) was significantly reduced in comparison to controls (P < 0.001).

Conclusion: Severe COVID-19 can result in microvascular changes at the macula in the form of reduction in vascular and perfusion density, which can be evaluated using OCTA. As structural changes precede functional changes, a close watch is recommended in patients showing compromise in retinal microvasculature.
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http://dx.doi.org/10.4103/ijo.IJO_2882_21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9332963PMC
May 2022

Challenges in the Management of Upper Lid Keloid.

Case Rep Ophthalmol Med 2022 25;2022:3032246. Epub 2022 Mar 25.

Pathology, Govind Ballabh Pant Hospital, New Delhi, India.

A middle-aged lady presented with a firm, nontender mass on the left upper lid and area behind the left ear following lid reconstruction with postauricular graft for cicatricial ectropion 11 months prior. She had a similar mass on the right shin. She was diagnosed as a case of multiple keloids. Intralesional injection of triamcinolone acetonide suspension and 5-Fluorouracil (5-FU) in the upper lid keloid resulted in ulceration of its surface. Surgical excision, injection of 5-FU in the keloid bed with temporal forehead flap reconstruction, was performed. Occurrence of inadvertent postoperative wound infection with was treated with local dressing with colistimethate sodium. Adjuvant therapy with topical imiquimod cream 5% was given subsequently for 24 weeks with no recurrence of the lid keloid after 16 months. The patient was managed using a combination of conservative and surgical therapy and multidisciplinary team work and kept on a long term follow-up.
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http://dx.doi.org/10.1155/2022/3032246DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8975687PMC
March 2022

Ganglion cell layer thickness - a marker for early dysthyroid optic neuropathy.

Eye (Lond) 2022 Mar 28. Epub 2022 Mar 28.

Department of Ophthalmology (Guru Nanak Eye Centre), Maulana Azad Medical College, New Delhi, India.

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http://dx.doi.org/10.1038/s41433-022-02035-0DOI Listing
March 2022

Hip Spica Stroller: A Technical Note.

Indian J Orthop 2022 Apr 18;56(4):634-638. Epub 2021 Nov 18.

Consultant Pediatric Orthopedic Surgeon, Orthokids Clinic, 7th Floor, Golden Icon, Near Shivranjani Flyover, 132 feet Ring road, Satellite, Ahmedabad, Gujarat 380015 India.

Background: Care of the child after hip-spica application is the most challenging issue faced by parents. Reduced mobility and recumbency can cause respiratory problems, skin irritation and discomfort for the child. Parents need to lift the child in a spica to make him upright and to mobilize. To improve the comfort of the family in post spica care, we have designed a 'Hip Spica Stroller' which is low profile, comfortable, easy to construct and relatively inexpensive. This manuscript discusses our early experience with this hip-spica stroller use.

Methods: A sturdy, relatively lightweight and portable stroller was designed in collaboration with local mechanical engineering team. The stroller allowed safe upright placement of the child with spica and their easy mobility. From the second post-operative day, children were mobilised in the stroller. We looked for development of any complications related to the stroller such as spica breakage, skin irritation or excoriation development. Parents were also inquired about their feedback and satisfaction with the device upon spica removal.

Results: We used the spica stroller in nine patients after Developmental Dysplasia Hip (DDH) treatment and in eight patients post shaft femur fracture treatment. None of the patients experienced any stroller-related complications. All the patients maintained the joint reduction and the fractured bone fragment alignment. High satisfaction rates were reported by parents.

Conclusion: Hip Spica Stroller is an innovative and easy-to-make device which would enhance the post spica care. It can aid alleviating the fear of parents for their child's hip-spica treatment.

Supplementary Information: The online version contains supplementary material available at 10.1007/s43465-021-00568-2.
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http://dx.doi.org/10.1007/s43465-021-00568-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8921444PMC
April 2022

Modified Velpeau Sling Application for the Treatment of Fractures Around Shoulder in Infants.

J Pediatr Orthop 2022 Jul 14;42(6):e596-e600. Epub 2022 Mar 14.

Neokids Hospital, Jaipur, Rajasthan, India.

Background: Fractures around the shoulder region in infants are treated by arm-chest bandaging, adhesive strapping, or sling application. These conventional treatment methods are associated with issues like skin irritation, excoriation, movement of bone fragments causing muscle spasm, and difficulty in nursing care. We describe the technique of modified Velpeau sling application and reviewed its efficacy at a long-term follow-up.

Methods: A retrospective study was conducted with 19 infants who presented between 2009 and 2018 to a tertiary care center in western India with either clavicle or humerus fracture. Inclusion criteria was any infant with humerus or clavicle fracture that underwent modified Velpeau sling application and had a minimum follow-up of 2 years. Patients were followed at weekly intervals until sling discontinuation based on the fracture healing. At further follow-up, children were assessed for the presence of angular or rotational malalignment and limb length discrepancy. Functional outcome was measured by the Paediatric Adolescent Shoulder Survey at the final follow-up.

Results: Seven clavicle and 12 humerus fractures were treated with this technique. The mean age at presentation was 50 days (range, 1 d to 7 mo). The average follow-up was 6 years (range, 2 to 10 y). Two infants had underlying osteogenesis imperfecta. Infants without underlying pathology had no angular/rotational malalignment or limb length discrepancy, while both infants with underlying osteogenesis imperfecta had a varus alignment and shortening of the humerus. Infants without underlying pathology demonstrated good functional outcomes measured by the Paediatric Adolescent Shoulder Survey questionnaire, while those with pathology had functional limitations.

Conclusions: The modified Velpeau method is an effective way of treating fractures around the shoulder region in infants without underlying pathology. Several advantages such as accessibility of sling material, easy application, inexpensive material, and absence of skin-related complications make this an effective treatment.

Level Of Evidence: Level IV-therapeutic study.
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http://dx.doi.org/10.1097/BPO.0000000000002144DOI Listing
July 2022

Distal Anterior Choroidal Artery Dissecting Aneurysm Presenting as Ischemic Stroke- Imaging and Management.

Ann Indian Acad Neurol 2021 Sep-Oct;24(5):794-797. Epub 2021 Mar 5.

Director - Neurointerventional Surgery and Co-Director Stroke Artemis Agrims Institute of Neuroscience, Gurgaon, India.

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http://dx.doi.org/10.4103/aian.AIAN_1202_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8680883PMC
March 2021

Clinico-Radiological-Pathological Correlation of Visual Loss in COVID-Associated Rhino-Orbito-Cerebral Mucormycosis.

Ophthalmic Plast Reconstr Surg 2022 May-Jun 01;38(3):242-249. Epub 2022 May 11.

Department of Radiodiagnosis, Maulana Azad Medical College, New Delhi, India.

Purpose: To correlate the clinical, radiological, and histopathological features in Covid-associated Rhino-orbito-cerebral mucormycosis cases presenting with acute visual loss.

Design: Cross-sectional study.

Methods: Covid-associated Rhino-orbito-cerebral mucormycosis cases with unilateral visual loss, planned for exenteration, underwent orbital and ophthalmological ocular examination. The available radiological sequences, doppler ultrasonography and histopathology findings were correlated with clinical manifestations.

Results: The median age was 51 years and the male: female ratio was 3:1. All except one presented with unilateral ophthalmoplegia. The ocular media were hazy in 2 eyes. In 8 eyes, retinal changes were suggestive of occlusion of CRA (6), combined occlusion of CRA and central retinal vein (1), and myopic degeneration with hypertensive retinopathy (1). The contralateral eye showed retinal ischemic changes in one patient. Radiological imaging showed orbital apex involvement in the 10 affected eyes and one contralateral eye. Ipsilateral cavernous sinus thrombosis, diffusion restriction on MRI of optic nerve, internal carotid artery narrowing/thrombosis, and cortical watershed infarcts were seen in 8, 4, 4, and 2 cases, respectively. The blood flow in CRA and ophthalmic artery was absent or reduced in all the 10 affected eyes and in 1 contralateral eye. On histopathology, orbital fat necrosis, fungal hyphae, acute inflammation, granuloma formation, ischemic thrombosis of ophthalmic artery was observed in 10 specimens. CRA was patent in 9 and thrombosed in 1 eye. Optic nerve was ischemic in 8 and viable in 2 eyes.

Conclusion: Acute visual loss in ROCM cases is associated with orbital apex involvement and thrombotic ischemia of ophthalmic artery. Cessation of flow in CRA possibly occurs secondary to ophthalmic artery thrombosis.
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http://dx.doi.org/10.1097/IOP.0000000000002112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9093237PMC
May 2022

Double Crush Syndrome of the Upper Extremity.

JBJS Rev 2021 12 15;9(12). Epub 2021 Dec 15.

University of Rochester School of Medicine and Dentistry, Rochester, New York.

»: The double crush hypothesis originally proposed that compression of a peripheral nerve at a proximal site increases its susceptibility to additional distal lesions.

»: The etiology of double crush syndrome is likely multifactorial as mechanical, systemic, pharmacologic, or environmental factors may increase a patient's susceptibility to this syndrome.

»: To date, there remains no standardized definition of double crush syndrome, and there is no consensus on its exact pathophysiology or diagnostic criteria.

»: Patients with double crush syndrome should be counseled that surgical repair may produce inferior outcomes compared with those who are treated for isolated entrapment neuropathies.
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http://dx.doi.org/10.2106/JBJS.RVW.21.00082DOI Listing
December 2021

Fusarium Causing Recalcitrant Post-operative endophthalmitis-Report of a Case with Review of Literature.

Ocul Immunol Inflamm 2021 Oct 12:1-3. Epub 2021 Oct 12.

Optometry Department, Dr. Shroff's Charity Eye Hospital, New Delhi, India.

Purpose: To study the clinical profile and management of a case of fungal postoperative endophthalmitis caused by .

Case Report: A 40-year-old male underwent an uneventful cataract surgery developed postoperative endophthalmitis. The infection was fulminant and was treated aggressively with pars plana vitrectomy with intravitreal and oral antifungals. The microbiology culture of vitreous sample showed . There was a late recurrence in the form of a fungal ball behind the iris after 6 months of the initial episode. This fungal ball was then managed by transscleral cryotherapy. The eye became hypotonus due to chronic inflammation and silicone oil was instilled to salvage the eye.

Conclusion: Fusarium endophthalmitis needs an aggressive management. Due to late recurrence regular follow-up is mandatory. Early vitrectomy with oral and intravitreal voriconazole is the treatment of choice. Transscleral cryotherapy is a useful option to treat fungal balls behind the iris tissue.
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http://dx.doi.org/10.1080/09273948.2020.1830124DOI Listing
October 2021

The Systems Biology Simulation Core Library.

Bioinformatics 2021 Sep 23. Epub 2021 Sep 23.

Dept. of Computer Science, University of Tübingen, 72076 Tübingen, DE.

Summary: Studying biological systems generally relies on computational modelling and simulation, e.g., model-driven discovery and hypothesis testing. Progress in standardisation efforts led to the development of interrelated file formats to exchange and reuse models in systems biology, such as SBML, the Simulation Experiment Description Markup Language (SED-ML), or the Open Modeling EXchange format (OMEX). Conducting simulation experiments based on these formats requires efficient and reusable implementations to make them accessible to the broader scientific community and to ensure the reproducibility of the results. The Systems Biology Simulation Core Library (SBSCL) provides interpreters and solvers for these standards as a versatile open-source API in JavaTM. The library simulates even complex bio-models and supports deterministic Ordinary Differential Equations (ODEs); Stochastic Differential Equations (SDEs); constraint-based analyses; recent SBML and SED-ML versions; exchange of results, and visualisation of in silico experiments; open modelling exchange formats (COMBINE archives); hierarchically structured models; and compatibility with standard testing systems, including the Systems Biology Test Suite and published models from the BioModels and BiGG databases.

Availability: SBSCL is freely available at https://draeger-lab.github.io/SBSCL/ and via Maven Central.

Supplementary Information: The material available at Bioinformatics online provides details on resources and availability, implementation, support of the SBML Test Suite, BioModels, and BiGG simulations with benchmark comparisons, and comparison to other simulators with SBML support.
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http://dx.doi.org/10.1093/bioinformatics/btab669DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8756180PMC
September 2021

Rhino-Orbito-Cerebral-Mucormycosis During the COVID-19 Second Wave in 2021 - A Preliminary Report from a Single Hospital.

Clin Ophthalmol 2021 17;15:3505-3514. Epub 2021 Aug 17.

Society for Health Education and Allied Research, New Delhi, India.

Purpose: To list the clinico-epidemiological profile and possible risk factors of COVID-19 associated rhino-orbital-cerebral mucormycosis (CA-ROCM) patients presenting to a COVID dedicated hospital during the second wave of COVID-19 in India.

Patients And Methods: A cross-sectional, single-center study was done on 60 cases of probable CA-ROCM based on clinical features and supportive diagnostic nasal endoscopic findings and/or radiologic findings. Patients with recent or active COVID-19 were included. The demographic profile, clinical features, possible risk factors and diagnostic workup (microbiological, pathological and radiological) were analysed to identify the triggering factors for CA-ROCM.

Results: The age of patients ranged from 29 to 75 years and male-female ratio was 3:1. The duration between the first positive COVID report and onset of CA-ROCM was 0 to 47 days. Forty-nine (81.66%) patients had a recent COVID infection and 11 (18.33%) had active COVID infection at presentation. Thirty-five patients (58%) had ocular/orbital involvement at presentation. In the affected eye, 10 had no perception of light and in the rest visual acuity ranged from log MAR 0 to +1.5. Ocular manifestations were ptosis (29), ophthalmoplegia (23), periocular tenderness and edema (33), proptosis (14), black discoloration of eyelids (3), facial palsy (3), endophthalmitis (4), retinal artery occlusion (8), disc edema (4) and disc pallor (5). Twenty-two (25%) patients had neither received steroids nor oxygen. Thirty patients (50%) were managed with oxygen while 38 patients (63.3%) with systemic steroids. The most common risk factor was diabetes in 59 patients. The average glycosylated hemoglobin (HbA1c) was 10.31 ± 2.59%. Systemic Amphotericin B was started in all the patients. Radical surgical debridement was performed in 12 patients and the remaining were planned.

Conclusion: SARS-CoV-2 variant with accompanying glycaemic dysregulation was found to be the triggering factor for the epidemic of CA-ROCM.
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http://dx.doi.org/10.2147/OPTH.S324977DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8380130PMC
August 2021

Comparative evaluation of dacryocystorhinostomy with retrograde intubation and conjunctivo-dacryocystorhinostomy.

Can J Ophthalmol 2021 Aug 7. Epub 2021 Aug 7.

Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India.

Objective: To compare the surgical outcomes of dacryocystorhinostomy with retrograde intubation and conjunctivo-dacryocystorhinostomy for the management of proximal mid-bicanalicular lacrimal obstruction.

Design: Randomized, controlled trial.

Methods: The study was conducted in 50 eyes of 50 adult patients with bicanalicular obstruction ≤ 6 mm from the punctum. The etiology, duration of symptoms, and Munk scores were recorded. Group A underwent dacryocystorhinostomy with retrograde intubation, and in group B, conjunctivo-dacryocystorhinostomy was performed. Success was defined as anatomic patency on syringing, a negative fluorescein dye disappearance test, and a Munk score < 2 twelve months postoperatively.

Results: There were 23 males and 27 females, 18-66 years of age, with a 6-month to 20-year duration of epiphora. The etiologies were idiopathic, trauma, and allergic conjunctivitis and ocular surface inflammation. In group A, the pseudopunctum was located medial to the diagnosed level of canalicular block by 1.28 ± 0.54 mm and 1.04 ± 0.88 mm in upper and lower canaliculi, respectively. Four post-traumatic cases required intervention following closure of the pseudopunctum, all being located ≥ 7 mm from the true punctum (p = 0.001). The complication rate was higher in group B than in group A (p = 0.001). At 12 months, the success rate was 100% in group A and 88% in group B (22 of 25; p = 0.74), with reduction in Munk scores from preoperative levels in both groups (p = 0.001).

Conclusion: Dacryocystorhinostomy with retrograde intubation and conjunctivo-dacryocystorhinostomy have comparable success rates in the management of proximal mid-bicanalicular obstructions. Dacryocystorhinostomy with retrograde intubation has lower complication rates and does not require long-term maintenance of the bypass tube, unlike conjunctivo-dacryocystorhinostomy.
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http://dx.doi.org/10.1016/j.jcjo.2021.07.002DOI Listing
August 2021

Work Outcomes after Intensity-Modulated Proton Therapy (IMPT) versus Intensity-Modulated Photon Therapy (IMRT) for Oropharyngeal Cancer.

Int J Part Ther 2021 25;8(1):319-327. Epub 2021 Jun 25.

Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Purpose: We compared work outcomes in patients with oropharyngeal cancer (OPC), randomized to intensity-modulated proton (IMPT) versus intensity-modulated photon therapy (IMRT) for chemoradiation therapy (CRT).

Patients And Methods: In 147 patients with stage II-IVB squamous cell OPC participating in patient-reported outcomes assessments, a prespecified secondary aim of a randomized phase II/III trial of IMPT (n = 69) versus IMRT (n = 78), we compared absenteeism, presenteeism (i.e., the extent to which an employee is not fully functional at work), and work productivity losses. We used the work productivity and activity impairment questionnaire at baseline (pre-CRT), at the end of CRT, and at 6 months, 1 year, and 2 years. A one-sided Cochran-Armitage test was used to analyze within-arm temporal trends, and a χ test was used to compare between-arm differences. Among working patients, at each follow-up point, a 1-sided Wilcoxon rank-sum test was used to compare work-productivity scores.

Results: Patient characteristics in IMPT versus IMRT arms were similar. In the IMPT arm, within-arm analysis demonstrated that an increasing proportion of patients resumed working after IMPT, from 60% (40 of 67) pre-CRT and 71% (30 of 42) at 1 year to 78% (18 of 23) at 2 years ( = 0.025). In the IMRT arm, the proportion remained stable, with 57% (43 of 76) pre-CRT, 54% (21 of 39) at 1 year, and 52% (13 of 25) working at 2 years ( = 0.47). By 2 years after CRT, the between-arm difference between patients who had IMPT and those who had IMRT trended toward significance ( = 0.06). Regardless of treatment arm, among working patients, the most severe work impairments occurred from treatment initiation to the end of CRT, with significant recovery from absenteeism, presenteeism, and productivity impairments by the 2-year follow-up ( < 0.001 for all). Higher magnitudes of recovery from absenteeism (at 1 year,  = 0.05; and at 2 years,  = 0.04) and composite work impairment scores (at 1 year,  = 0.04; and at 2 years,  = 0.04) were seen in patients treated with IMPT versus those treated with IMRT.

Conclusion: In patients with OPC receiving curative CRT, patients randomized to IMPT demonstrated increasing work and productivity recovery trends. Studies are needed to identify mechanisms underlying head and neck CRT treatment causing work disability and impairment.
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http://dx.doi.org/10.14338/IJPT-20-00067.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8270077PMC
June 2021

Proton Therapy for Major Salivary Gland Cancer: Clinical Outcomes.

Int J Part Ther 2021 25;8(1):261-272. Epub 2021 Jun 25.

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Purpose: To report clinical outcomes in terms of disease control and toxicity in patients with major salivary gland cancers (SGCs) treated with proton beam therapy.

Materials And Methods: Clinical and dosimetric characteristics of patients with SGCs treated from August 2011 to February 2020 on an observational, prospective, single-institution protocol were abstracted. Local control and overall survival were calculated by the Kaplan-Meier method. During radiation, weekly assessments of toxicity were obtained, and for patients with ≥ 90 days of follow-up, late toxicity was assessed.

Results: Seventy-two patients were identified. Median age was 54 years (range, 23-87 years). Sixty-three patients (88%) received postoperative therapy, and nine patients (12%) were treated definitively. Twenty-six patients (36%) received concurrent chemotherapy. Nine patients (12%) had received prior radiation. All (99%) but one patient received unilateral treatment with a median dose of 64 GyRBE (relative biological effectiveness) (interquartile range [IQR], 60-66), and 53 patients (74%) received intensity-modulated proton therapy with either single-field or multifield optimization. The median follow-up time was 30 months. Two-year local control and overall survival rates were 96% (95% confidence interval [CI] 85%-99%) and 89% (95% CI 76%-95%], respectively. Radiation dermatitis was the predominant grade-3 toxicity (seen in 21% [n = 15] of the patients), and grade ≥ 2 mucositis was rare (14%; n = 10 patients). No late-grade ≥ 3 toxicities were reported.

Conclusion: Proton beam therapy for treatment of major SGCs manifests in low rates of acute mucosal toxicity. In addition, the current data suggest a high rate of local control and minimal late toxicity.
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http://dx.doi.org/10.14338/IJPT-20-00044.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8270094PMC
June 2021

Proton Therapy for Head and Neck Cancer: A 12-Year, Single-Institution Experience.

Int J Part Ther 2021 25;8(1):108-118. Epub 2021 Jun 25.

Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Purpose: To characterize our experience and the disease control and toxicity of proton therapy (PT) for patients with head and neck cancer (HNC).

Patients And Methods: Clinical outcomes for patients with HNC treated with PT at our institution were prospectively collected in 2 institutional review board-approved prospective studies. Descriptive statistics were used to summarize patient characteristics and outcomes. Overall survival, local-regional control, and disease-free survival were estimated by the Kaplan-Meier method. Treatment-related toxicities were recorded according to the Common Terminology Criteria for Adverse Events (version 4.03) scale.

Results: The cohort consisted of 573 patients treated from February 2006 to June 2018. Median patient age was 61 years. Oropharynx (33.3%; n = 191), paranasal sinus (11%; n = 63), and periorbital tissues (11%; n = 62) were the most common primary sites. Patients with T3/T4 or recurrent disease comprised 46% (n = 262) of the cohort. The intent of PT was definitive in 53% (n = 303), postoperative in 37% (n = 211), and reirradiation in 10% (n = 59). Median dose was 66 Gy (radiobiological equivalent). Regarding systemic therapy, 43% had received concurrent (n = 244), 3% induction (n = 19), and 15% (n = 86) had both. At a median follow-up of 2.4 years, 88 patients (15%) had died and 127 (22%) developed disease recurrence. The overall survival, local-regional control, and disease-free survival at 2 and 5 years were, respectively, 87% and 75%, 87% and 78%, and 74% and 63%. Maximum toxicity (acute or late) was grade 3 in 293 patients (51%), grade 2 in 234 patients (41%), and grade 1 in 31 patients (5%). There were 381 acute grade 3 and 190 late grade 3 unique toxicities across 212 (37%) and 150 (26%) patients, respectively. There were 3 late-grade 4 events across 2 patients (0.3%), 2 (0.3%) acute-grade 5, and no (0%) late-grade 5 events.

Conclusions: The overall results from this prospective study of our initial decade of experience with PT for HNC show favorable disease control and toxicity outcomes in a multidisease-site cohort and provide a reference benchmark for future comparison and study.
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http://dx.doi.org/10.14338/IJPT-20-00065.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8270083PMC
June 2021

Stereotactic body ablative radiotherapy for reirradiation of small volume head and neck cancers is associated with prolonged survival: Large, single-institution, modern cohort study.

Head Neck 2021 11 16;43(11):3331-3344. Epub 2021 Jul 16.

Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.

Background: Recurrent head and neck cancer has poor prognosis. Stereotactic body radiotherapy (SBRT) may improve outcomes by delivering ablative radiation doses.

Methods: We reviewed patients who received definitive-intent SBRT reirradiation at our institution from 2013 to 2020. Patterns of failure, overall survival (OS), and toxicities were analyzed.

Results: One hundred and thirty-seven patients were evaluated. The median OS was 44.3 months. The median SBRT dose was 45 Gy and median target volume 16.9 cc. The 1-year local, regional, and distant control was 78%, 66%, and 83%, respectively. Systemic therapy improved regional (p = 0.004) and distant control (p = 0.04) in nonmetastatic patients. Grade 3+ toxicities were more common at mucosal sites (p = 0.001) and with concurrent systemic therapy (p = 0.02).

Conclusions: In a large cohort of SBRT reirradiation for recurrent, small volume head and neck cancers, a median OS of 44.3 months was observed. Systemic therapy improved regional and distant control. Toxicities were modulated by anatomic site and systemic therapy.
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http://dx.doi.org/10.1002/hed.26820DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8511054PMC
November 2021

High-dose irradiation in combination with non-ablative low-dose radiation to treat metastatic disease after progression on immunotherapy: Results of a phase II trial.

Radiother Oncol 2021 09 5;162:60-67. Epub 2021 Jul 5.

Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, USA.

Aim: To report early findings from a phase II trial of high-dose radiotherapy (HD-RT) with or without low-dose RT (LD-RT) for metastatic cancer.

Methods: Eligible patients had metastatic disease that progressed on immunotherapy within 6 months. Patients were given either HD-RT (20-70 Gy total; 3-12.5 Gy/f), or HD-RT + LD-RT (0.5-2 Gy/f up to 1-10 Gy total) to separate lesions, with continued immunotherapy. Radiographic response was assessed per RECIST 1.1 and Immune-Related Response Criteria (irRC). Primary endpoints: (1) 4-month disease control (DCR, complete/partial response [CR/PR] or stable disease [SD]) or an overall response (ORR, CR/PR) at any point in ≥10% of patients, per RECIST 1.1; (2) dose-limiting toxicity within 3 months not exceeding 30%. Secondary endpoint was lesion-specific response.

Results: Seventy-four patients (NSCLC, n = 38; melanoma n = 21) were analyzed (39 HD-RT and 35 HD-RT + LD-RT). The median follow-up time was 13.6 months. The primary endpoint was met for 72 evaluable patients, with a 4-month DCR of 42% (47% [16/34] vs. 37% [14/38] in HD-RT + LD-RT vs. HD-RT, P = 0.38), and 19% ORR at any time (26% [9/34] vs. 13% [5/38] in HD-RT + LD-RT vs. HD-RT, P = 0.27). Three patients had toxicity ≥grade 3. LD-RT lesion response (53%) was improved compared to nonirradiated lesions in HD-RT + LD-RT (23%, P = 0.002) and HD-RT (11%, P < 0.001). T- and NK cell infiltration was enhanced in lesions treated with LD-RT.

Conclusions: HD-RT plus LD-RT safely improved lesion-specific response in patients with immune resistant solid tumors by promoting infiltration of effector immune cells into the tumor microenvironment.
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http://dx.doi.org/10.1016/j.radonc.2021.06.037DOI Listing
September 2021

Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy.

Curr Treat Options Oncol 2021 06 4;22(6):54. Epub 2021 Jun 4.

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA.

Opinion Statement: The rise in the incidence of human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPC), the relatively young age at which it is diagnosed, and its favorable prognosis necessitate the use of treatment techniques that reduce the likelihood of side effects during and after curative treatment. Intensity-modulated proton therapy (IMPT) is a form of radiotherapy that de-intensifies treatment through dose de-escalation to normal tissues without compromising dose to the primary tumor and involved, regional lymph nodes. Preclinical studies have demonstrated that HPV-positive squamous cell carcinoma is more sensitive to proton radiation than is HPV-negative squamous cell carcinoma. Retrospective studies comparing intensity-modulated photon (X-ray) radiotherapy to IMPT for OPC suggest comparable rates of disease control and lower rates of pain, xerostomia, dysphagia, dysgeusia, gastrostomy tube dependence, and osteoradionecrosis with IMPT-all of which meaningfully affect the quality of life of patients treated for HPV-associated OPC. Two phase III trials currently underway-the "Randomized Trial of IMPT versus IMRT for the Treatment of Oropharyngeal Cancer of the Head and Neck" and the "TOxicity Reduction using Proton bEam therapy for Oropharyngeal cancer (TORPEdO)" trial-are expected to provide prospective, level I evidence regarding the effectiveness of IMPT for such patients.
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http://dx.doi.org/10.1007/s11864-021-00847-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178129PMC
June 2021
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