Reasons For Outcomes Research Articles

Real-world evidence of efficacy and safety of pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients: Czech registry data.

We assessed the outcomes of pomalidomide and dexamethasone treatment in relapsed/refractory multiple myeloma (RRMM) patients with ≥1 prior line of therapy. We analyzed the data of all RRMM patients treated with pomalidomide and dexamethasone at nine Czech centers between 2013 and 2018. The source of the data was the Registry of Monoclonal Gammopathies of the Czech Republic. Primary endpoints included response rates based on International Myeloma Working Group criteria and survival measures, including progression-free survival (PFS) and overall survival (OS). Secondary endpoints were toxicities and previous treatment patterns, including refractory to lenalidomide, and their impact on final outcomes. The overall response rate was 51.8% and the clinical benefit rate (including patients with minimal response) was 67.1%, with 0.6% of complete responses, 8.5% of very good partial responses, and 42.1% of partial responses (PR). Overall, 16.5% of patients had a minimal response, and 32.3% had stable disease /progression. Median PFS was 8.8 months and the median OS was 14.2 months. In patients who achieved ≥PR, the median PFS and OS were significantly longer compared to non-responders (median PFS (12.1 vs. 4.5 months, p≤0.001 respectively), median OS (22.1 vs. 7.7 months, p≤0.001, respectively). The most frequent adverse events (AEs) were neutropenia (29.9%) and anemia (18.9%), non-hematological AEs included infections (14.6%) and fatigue (7.3%). Our analysis confirmed the effectiveness of pomalidomide and dexamethasone in a real-world setting. This therapy achieved reasonable outcomes comparable to the data from clinical trials even though this was an unbiased cohort of patients.

Health Monitoring System Using IoT

Abstract: Health on of the key aspects of any human’s life and one needs to keep up good health to make progress in life. We see most of the people facing health issues during different times during their life and it is their first job as an individual to keep up their health. As weare already seeing the novel coronavirus has devastated the world for the past few months and continues to do so. We see many cases like people living in distant villages and towns where there are no proper medical facilities to have a health check-up once in a while, they need to travel long distances to get a basic health checkup done. Especially the old people who cannot travel much due to their age. A human's health can be carefully monitored and a reasonable outcome can be predicted to avoid unfortunate deaths or misfortunate occurrences by measuring temperature, sp02, or pulse and Strain upon the muscles. These factors are being collected by various devices, but have never been classified and carefully monitored for anomalies. So this system is the best option to counter the situation as it collects data and stores it in the webserver and also gives alerts. Keywords: Health, Sensors, Internet of things

Do triangular fibrocartilage complex foveal injuries affect the clinical outcome of ulnar shortening osteotomy for ulnar impaction syndrome?

BackgroundUlnar shortening osteotomy (USO), as its name implies, is used to shorten the ulna. It subsequently tightens the triangular fibrocartilage complex (TFCC) and ulnar wrist. TFCC foveal insertion is a primary stabilizer of the distal radioulnar joint. It is unclear whether USO is effective in TFCC foveal injuries. The purpose of this study was to review the clinical outcomes of ulnar shortening osteotomies with and without TFCC foveal injuries. MethodsWe retrospectively reviewed patients with ulnar wrist pain treated with USO and wrist arthroscopy including the distal radioulnar joint (DRUJ). Sixty-five patients were included in this study. An algorithm was used to guide surgical decision-making. After arthroscopic confirmation of ulnar impaction syndrome, we performed USO with a locking compression plate (mean length of shortening, 2.7 mm; range, 1–7.5 mm). The flattened TFCC disc due to ulnar shortening was confirmed arthroscopically. If the DRUJ was unstable after USO, we repaired the TFCC foveal insertion. ResultsThere were 32 post-traumatic and 33 idiopathic cases. We detected TFCC disc injuries in 34 wrists and TFCC foveal injuries in 33 wrists; both types were found in 15 wrists. TFCC foveal injuries were not significantly correlated with patient age, history of trauma, or clinical outcome. Most patients showed good clinical outcomes; 31 of 65 patients had preoperative DRUJ instability, with a significant number having foveal but not disc injuries. ConclusionUSO achieved reasonable outcomes, even in patients with TFCC foveal injuries. In cases demonstrating ulnar impaction, USO should be prioritized over TFCC repair.

Treatment of Advanced Coats' Disease With Combination Therapy of Laser Photocoagulation, Intravitreal Ranibizumab, and Sub-Tenon Methylprednisolone Acetate.

To investigate the efficacy of combination therapy with laser photocoagulation, intravitreal ranibizumab, and sub-Tenon methylprednisolone acetate in patients presenting with advanced Coats' disease. This was a retrospective analysis of 16 patients who underwent laser photocoagulation combined with intravitreal ranibizumab and sub-Tenon methylprednisolone acetate between 2008 and 2017. The primary outcome was anatomic success and the secondary outcomes were globe preservation and final visual acuity. The average age at surgery was 5.12 ± 2.7 years (range: 3 to 10 years). The mean follow-up time was 45.43 ± 29.01 months (range: 12 to 108 months). Of the 16 patients (16 eyes) reviewed, 6 patients had stage 3A and 10 patients had stage 3B Coats' disease. The mean number of applications was 10 (range: 4 to 18). Globe preservation was achieved in all patients. Final visual acuity outcomes were satisfactory: 20/20 to 20/50 in 2 patients, 20/60 to 20/100 in 1 patient, and 20/200 or worse in 13 patients. Intravitreal ranibizumab used in combination with laser photocoagulation and sub-Tenon methylprednisolone acetate could be an effective treatment option for patients with advanced Coats' disease. The combined therapy achieved anatomical success, globe preservation, and reasonable visual acuity outcomes. [J Pediatr Ophthalmol Strabismus. 2022;59(3):187-191.].

Decision aids can decrease decisional conflict in patients with hip or knee osteoarthritis: Randomized controlled trial.

BACKGROUNDThe interest in shared decision making has increased considerably over the last couple of decades. Decision aids (DAs) can help in shared decision making. Especially when there is more than one reasonable option and outcomes between treatments are comparable.AIMTo investigate if the use of DAs decreases decisional conflict in patients when choosing treatment for knee or hip osteoarthritis (OA).METHODSIn this multi-center unblinded randomized controlled trial of patients with knee or hip OA were included from four secondary and tertiary referral centers. One-hundred-thirty-one patients who consulted an orthopedic surgeon for the first time with knee or hip OA were included between December 2014 and January 2016. After the first consultation, patients were randomly assigned by a computer to the control group which was treated according to standard care, or to the intervention group which was treated with standard care and provided with a DA. After the first consultation, patients were asked to complete questionnaires about decisional conflict (DCS), satisfaction, anxiety (PASS-20), gained knowledge, stage of decision making and preferred treatment. Follow-up was carried out after 26 wk and evaluated decisional conflict, satisfaction, anxiety, health outcomes (HOOS/KOOS), quality of life (EQ5D) and chosen treatment. RESULTSAfter the first consultation, patients in the intervention group (mean DCS: 25 out of 100, SD: 13) had significantly (P value: 0.00) less decisional conflict compared to patients in the control group (mean DCS: 39 out of 100, SD 11). The mean satisfaction score for the given information (7.6 out of 10, SD: 1.8 vs 8.6 out of 10, SD: 1.1) (P value: 0.00), mean satisfaction score with the physician (8.3 out of 10, SD: 1.7 vs 8.9 out of 10, SD: 0.9) (P value: 0.01) and the mean knowledge score (3.3 out of 4, SD: 0.9 vs 3.7 out of, SD: 0.6) (P value: 0.01) were all significantly higher in the intervention group. At 26-wk follow-up, only 75 of 131 patients (57%) were available for analysis. This sample is too small for meaningful analysis. CONCLUSIONProviding patients with an additional DA may have a positive effect on decisional conflict after the first consultation. Due to loss to follow-up we are unsure if this effect remains over time.

Revisiting One-Stage Urethroplasties for Distal Urethral Strictures.

Background: Reconstructive approaches for distal urethral strictures range from simple meatotomy to utilizing grafts or flaps depending on the etiology, length and location. We describe a contemporary cohort of distal urethral strictures and report a surgical technique termed distal one-stage urethroplasty developed to address the majority of distal urethral strictures encountered. Methods: Thirty-four patients were included. The mean age was 56.7 years (range 15.7–84.9 years), the mean stricture length was 1.1 cm (0.5–1.5) and the mean follow-up was 42.5 months (28–61.3). Results: The vast majority of distal strictures (27/34 (79.4%)) were treated with our hybrid one-stage approach combining a distal urethral reconstruction with excision of the scar tissue without the need to use grafts or flaps. The average stricture length was 0.68 cm and average operative time was 24.43 min. Post-operative spraying was reported in a minority of patients (4/27 (14.8%)). The length of stricture and surgery were significantly longer in those 7/34 (20.6%) patients in whom grafts or flaps were used (2.88 cm and 154.8 min, respectively, p < 0.001 for both when compared to the hybrid one-stage approach). We noted 6/34 (17.6%) recurrences of distal urethral strictures, all of which were treated successfully with graft and flap repairs. Conclusions: The vast majority of distal urethral strictures are amenable to a distal one-stage urethroplasty, avoiding the use of grafts and/or flaps while achieving reasonable outcomes. This limited approach, at least initially, is associated with shorter operative time and time of catheter placement and avoids morbidity associated with graft or flap harvesting. Spraying of urine is seldomly encountered and comparable to other approaches addressing distal urethral strictures.

Analysis of Hydrological Characteristics of Blue Nile Basin, Nashe Watershed

Hydrological modeling is a technique for understanding hydrologic characteristics and estimation of the water balance of watersheds for integrated water resources development and management. The Soil and Water Assessment Tool (SWAT) model was used for modeling the hydrological behavior of the Nashe watershed in the north-western part of Ethiopia. The spatial data, daily climate, and stream flow were the required input data for the model. The observed monthly stream flow data at the outlet and selected sub-watersheds in the catchment were used to calibrate and validate the model. The model performance was assessed between the simulated and observed streamflow by using sequential uncertainty fitting-2 (SUFI-2), generalized likelihood uncertainty estimation, parameter solution (Parasol) and particle swarm optimization. The sensitivity of 18 parameters was tested, and the most sensitive parameters were identified. The model performance was evaluated using p and r- factor, coefficient of determination, Nash Sutcliffe coefficient efficiency, percent bias during uncertainty analysis, calibration and validation. Therefore, based on the set of proposed evaluation criteria, the SUFI-2 algorithm has been able to provide slightly more reasonable outcomes and Parasol is the worst compared to the other algorithms. An analysis of monthly and seasonal water balance has been also accomplished for the Nashe catchment. The water balance parameters were distinct for the three seasonal periods in the catchment. The seasonal water budget analysis reveals that the watershed receives around 19%, 69%, and 12% of rainfall through the short rain, long rain and dry seasons, respectively. The received precipitation was lost due to evapotranspiration by 29%, 34% and 37% for each season respectively. The surface runoff contributes to the catchment by 5%, 86% and 9% of the water yield.

On Ulam Stability of a Generalized Delayed Differential Equation of Fractional Order

We investigate Ulam stability of a general delayed differential equation of a fractional order. We provide formulas showing how to generate the exact solutions of the equation using functions that satisfy it only approximately. Namely, the approximate solution phi generates the exact solution as a pointwise limit of the sequence varLambda ^nphi with some integral (possibly, nonlinear) operator varLambda . We estimate the speed of convergence and the distance between those approximate and exact solutions. Moreover, we provide some exemplary calculations, involving the Chebyshev and Bielecki norms and some semigauges, that could help to obtain reasonable outcomes for such estimations in some particular cases. The main tool is the Diaz–Margolis fixed point alternative.

Bending characteristics of carbon nanotubes: Micropolar elasticity models and molecular dynamics simulations

The present paper aims at evaluating non-classical continuum parameters for each class of armchair and zigzag single-walled CNTs focusing on the scale effect in their flexural behavior observed in molecular dynamics (MD) simulations. Through a non-linear optimization approach, the bending rigidities obtained from atomistic simulations are compared to those derived from non-classical continua. For MD simulations, a novel method ensuring pure bending is introduced and for continuum modeling, micropolar, constrained micropolar, and modified couple stress theories are employed. The results reveal that adopted non-classical theories, notably micropolar theory, provide reasonable outcomes with an obvious failure of classical Cauchy theory.

Decline in mortality due to respiratory diseases in Japan during the coronavirus disease 2019 pandemic

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Clinical judgment conceptualization scoping review protocol

Clinical judgment within nursing is best understood as the observable outcome of clinical reasoning and critical thinking. However, clinical judgment is poorly conceptualized and lacks a universal definition within nursing. Clinical judgment, clinical reasoning, and critical thinking have been used interchangeably in practice and literature. The objectives of this scoping review are to (1) investigate the extent, range, and nature of the literature pertaining to clinical judgment; (2) provide a synthesis of the current literature as related to clinical judgment within nursing; and (3) inform future research regarding clinical judgment in nursing. Twenty-four English peer-reviewed literature, including primary research studies, systematic reviews, meta-analyses, and guidelines, were included in this study. The identified literature was charted using a summary table of included sources of evidence from the databases. Four main themes were extracted from the review: (1) Varying definitions of clinical judgment; (2) Clinical Judgment, Experience, and Intuition; (3) Clinical Judgment and Evidence-Based Practice; and (4) Clinical Judgment, Clinical Reasoning, and Critical Thinking. The authors conclude that there are evident discrepancies in the definition of clinical judgment. Clinical judgment in nursing is multifaceted and involves both experiential knowledge as well as evidence-based knowledge.

Efficacy and safety of anal encirclement combining the Leeds-Keio artificial ligament with injection sclerotherapy using aluminum potassium sulfate and tannic acid in the management of rectal prolapse: a single-center observational study.

Perineal procedures are an important surgical option for frail and high-risk patients with rectal prolapse. This study aimed to evaluate the efficacy and safety of combined therapy using injection sclerotherapy, with aluminum potassium sulfate and tannic acid (ALTA), and the Thiersch procedure, using the Leeds-Keio ligament (ALTA-Thiersch). This study included 106 consecutive patients (mean age, 81.2 years) who underwent ALTA-Thiersch for rectal prolapse. The procedure was performed under caudal epidural anesthesia. ALTA was injected into the submucosa from the tip of the prolapsed rectum down to the dentate line, circumferentially, at 20 to 40 locations. The ligament tape was placed outside the external sphincter muscle and at an approximate depth of 2 cm into the middle anal canal. Of 106 patients, rectal prolapse was cured shortly after surgery in 105 patients. An additional tape was inserted in 1 patient who had persistent prolapse. Postoperative complications were observed in 27 patients (25.5%). Fecal impaction occurred in 12 patients; however, since it was temporary, no tape removal was required. Of the 12 cases in which the tape was infected or exposed, 11 required tape removal. There were 18 cases of recurrence at a mean follow-up of 22.1 months. Cumulative recurrence rates at 3 and 5 years were 21.3% and 38.6%, respectively. ALTA-Thiersch is a simple and safe procedure for rectal prolapse, having reasonable outcomes. The use of the Leeds-Keio ligament for anal encircling can help compensate for the disadvantages of the Thiersch operation.

Effects of melatonin and human follicular fluid supplementation of in vitro maturation medium on mouse vitrified germinal vesicle oocytes: A laboratory study.

Background Vitrification as the most efficient method of cryopreservation, enables successful storage of oocytes for couples who undergo specific procedures including surgery and chemotherapy. However, the efficacy of in vitro maturation (IVM) methods with vitrified germinal vesicle (GV) oocytes could be improved.Objective As melatonin and follicular fluid (FF) might enhance IVM conditions, we used these supplements to assess the maturation rate of vitrified GV oocytes and their artificial fertilization rate.Materials and MethodsFour hundred mouse GV oocytes were harvested, vitrified, and assigned into control (C-Vit-GV) and treatment groups of melatonin (M-Vit-GV), human follicular fluid (HFF-Vit-GV), and a combination (M + HFF-Vit-GV). A non-vitrified group of GV oocytes (non-Vit-GV) and a group of in vivo matured metaphase II (Vivo-MII) oocytes served as control groups to evaluate the vitrification and IVM conditions, respectively. Maturation of GV oocytes to MII and further development to two-cell-stage embryos were determined in the different groups.ResultsDevelopment to two-cell embryos was comparable between the Vivo-MII and non-Vit-GV groups. IVM and in vitro fertilization (IVF) results in the non-Vit-GV group were also comparable with the C-Vit-GV oocytes. In addition, the IVM and IVF outcomes were similar across the different treatment groups including the M-Vit-GV, HFF-Vit-GV, M + HFF-Vit-GV, and C-Vit-GV oocytes.ConclusionEmploying an appropriate technique of vitrification followed by suitable IVM conditions can lead to reasonable IVF outcomes which may not benefit from extra supplementations. However, whether utilizing other supplementation formulas could improve the outcome requires further investigation.

P.070 Introducing Stroke Endovascular Thrombectomy Into A Smaller Canadian Site, Is It Safe?

Background: Success of Endovascular Thrombectomy (EVT) requires ultra-fast access to specialized neuro imaging, neurological assessment and an angio suite with interventional radiologists. Prior access was via transport to Vancouver and outcomes were poor, with a high rate of disability or death. This appeared primarily due to long delays. Methods: Quality control process, in parallel to the introduction of a new intervention, EVT, to Vancouver Island, to determine if this intervention could be delivered with reasonable safety and good outcomes. Patients receiving EVT from May, 2016 until Sep, 2019 are included, with 90-day outcomes. Data was collected by stroke nurses. Results: The proportion of patients having a good outcome was comparable to that of the major clinical trial involving Canadian academic centres. The proportion sustaining a poor outcome was comparable to the control group in that trial population (who still received tPA treatment where possible). This was despite a median age 4.5 years greater than in that trial. Conclusions: EVT required coordination of multiple services. Victoria General Hospital performance in terms of speed to treatment was slower than in the published trials. This is a factor in determining outcome and is therefore an important quality improvement target moving forward.

SP4.2.6 Colorectal cancer services during COVID-19; an experience of a tertiary centre

Abstract Aims COVID19 has placed unprecedented constraints on healthcare services. Colorectal cancer (CRC) care was one of the many areas predicted to suffer due to these additional pressures. We believe that despite the challenges posed by COVID19, we have continued to deliver a standard of care for elective and emergency CRC resection that compares favorably with the national average. Method We conducted an analysis of the elective and emergency CRC resections carried out at a tertiary center over a 10-month period (Feb-Dec 2020). Data was collated from patient, operative, and theatre records and compared to the national average as defined by the 2020 National Bowel Cancer Audit (NBOCA). Results A total of 227 patients underwent surgery (189 elective and 38 emergencies), with a median age of 69. Of these, 153 were laparoscopic (67%), 57 open (27%), and 17 robotic (7%). The median length of stay was less than the national average; 5 days for elective surgery (NBOCA: 6) and 8 days for emergencies (NBOCA: 10). Within 30 days, overall unplanned readmissions rate was 6.5% (NBOCA: 11.6%) and return to theatre was 3.2% (NBOCA: 8.4%). Elective surgery had a 90-day mortality of 1% (NBOCA: 3%) compared to 7.8% for emergencies (NBOCA: 10.5%). Conclusion Despite the added constraints of the COVID19 pandemic, CRC resection in our unit remains safe with better outcomes than the national standard. We have demonstrated that with adequate precaution and a concerted team effort, delivery of safe care with reasonable outcome is achievable.

Deep Femoral Vein Reconstruction for Abdominal Aortic Graft Infections is Associated with Low Aneurysm Related Mortality and a High Rate of Permanent Discontinuation of Antimicrobial Treatment

Aortic prosthesis infection is a devastating complication of aortic surgery. In situ reconstruction with the neo-aorto-iliac system (NAIS) bypass technique has become increasingly used and is recommended in recent treatment guidelines. The main aim was to evaluate NAIS procedural outcomes when undertaken after previous open or endovascular aortic repair in Sweden. In this retrospective study, The National Quality Registry for Vascular Surgery (Swedvasc) was used to identify Swedish centres that offered the NAIS bypass procedure for aortic prosthesis infection between 2008 and 2018. Variables of special interest were procedural details, short and long term survival, renal and other complications, and the durtion of antimicrobial treatment. Forty patients (36 males, four females [mean age 69 years], 32 open repairs, seven endovascular aortic repairs [EVAR] and one fenestrated EVAR; 21 presented with aorto-enteric fistula) operated on with NAIS bypass were reviewed. The median time from the primary aortic intervention to the NAIS bypass procedure was 32 months (range 0 - 252 months). Mean ± standard deviation operating time was 645 ± 160 minutes, mean blood loss was 6 277 ± 6 525 mL, mean length of intensive care unit stay was 5.3 ± 3.7 days, and mean length of overall hospital stay was 21.2 ± 11.4 days. Thirty-five patients (88%) had a positive microbial culture; the most commonly isolated pathogen was Candida spp. The majority of patients survived for 30 days (n= 35 [88%]), and 33 (83%) and 32 (80%) patients survived for 90 days and one year, respectively. The number of surviving patients free from antimicrobial treatment at 90 days, six months, and one year was 19 (58%), 29 (88%), and 30 (94%). After a mean long term follow up of 69.9 ± 44.7 months, 20 patients were still alive. The NAIS bypass procedure offered reasonable survival and functional outcomes, and was associated with a high cure rate, defined as freedom from any antimicrobial treatment.

Comparison and Combination of Pseudo Two-Dimensional and Machine Learning Models for Prediction of Electrochemical Properties of Thick Sintered Lithium-Ion Battery Electrodes

Investigations of lithium-ion battery materials and processing continues to grow as the performance demands for energy storage applications increases. Modeling tools can facilitate more time and cost efficient investigation of new battery materials and processing. Ideally, these tools will predict with reasonable accuracy relevant battery performance outcomes as a function of the parameters being modified to reduce the experimental system space. However, there are limits to the information and data sizes available to train the models in the case of machine learning (ML) algorithms, and for physics-based models often obtaining every necessary physical property, including the variation in those properties as a function of electrochemical sample space is also a challenge. For this study, a physics-based pseudo two-dimensional (P2D) model was used to predict the cycling behavior of thick sintered lithium-ion battery electrodes. In addition, multiple ML algorithms were applied to data collected on sintered electrodes of varying compositions. This work will describe comparisons between using a ML approach, a P2D model, and a hybrid where the P2D model provides an additional input to the ML algorithm.

Virtual-assisted lung mapping in sublobar resection of small pulmonary nodules, long-term results.

The short-term efficacy of virtual-assisted lung mapping (VAL-MAP), a preoperative bronchoscopic multi-spot lung-marking technique, has been confirmed in 2 prospective multicentre studies. The objectives of this study were to analyse the local recurrence and survival of patients enrolled in these studies, long-term. Of the 663 patients enrolled in the 2 studies, 559 patients' follow-up data were collected. After excluding those who did not undergo VAL-MAP, whose resection was not for curative intent, who underwent concurrent resection without VAL-MAP, or who eventually underwent lobectomy instead of sublobar resection (i.e. wedge resection or segmentectomy), 422 patients were further analysed. Among 264 patients with primary lung cancer, the 5-year local recurrence-free rate was 98.4%, and the 5-year overall survival (OS) rate was 94.5%. Limited to stage IA2 or less (≤2 cm in diameter; n = 238, 90.1%), the 5-year local recurrence-free and OS rates were 98.7% and 94.8%, respectively. Among 102 patients with metastatic lung tumours, the 5-year local recurrence-free rate was 93.8% and the 5-year OS rate was 81.8%. Limited to the most common (colorectal) cancer (n = 53), the 5-year local recurrence-free and OS rates were 94.9% and 82.3%, respectively. VAL-MAP, which is beneficial in localizing small barely palpable pulmonary lesions and determining the appropriate resection lines, was associated with reasonable long-term outcomes. 152, 1542.

Occipital transtentorial approach for pineal region lesions: Addressing the controversies in conventional teaching.

Background: The occipital transtentorial (OT) approach is well-established approach for pineal region tumors and can be of choice for the lesions located around the suboccipital part of tentorium such as the quadrigeminal plate, posterior part of thalamus, tentorial surface of cerebellum, splenial region, posterior falx, and lesions around the tentorial incisura. However, it is not very much extensively used in the above-mentioned locations other than the pineal region.Methods: Thirty-one patients of pineal region lesions were operated by OT approach, the role of conventional preoperative evaluation of the anatomy of the venous sinuses, deep venous system, and tentorial angle was investigated.Results: A variety of lesions were operated using this approach achieving gross and near total resection in majority of the cases (76.6%), with acceptable postoperative mean modified Rankin scales (1.8).Conclusion: The OT is a preferable approach for pineal region lesions for patients of all ages and can be tailored for achieving high resectability rates irrespective of the status of the deep venous system and tentorial angle, with reasonable postoperative surgical outcome.

Haploidentical transplantation is feasible and associated with reasonable outcomes despite major infective complications–A single center experience from India

Haploidentical stem cell transplantation (SCT) using post-transplantation cyclophosphamide for graft-versus-host disease (GVHD) prophylaxis is a reasonable therapeutic option for patients who do not have a matched sibling donor. Between 2010 and June 2020, 257 patients underwent 269 Haploidentical transplantations, including 122 children. Indications included both malignant (56.8%) and non-malignant (43.2%) diseases. Conditioning regimens included both myeloablative (57.6%) and nonmyeloablative regimens (42.4%). Peripheral blood stem cells were the predominant graft source (96.2%). Based on the disease risk index, patients were classified into early-, intermediate-, and late-stage disease. Engraftment was seen in 205 patients (76.2%) whereas 39 (14.4%) died before engraftment and 23 (8.6%) had primary graft failure. The cumulative incidence of grade II-IV acute GVHD was 47.8% with a 23.9% incidence of grade III-IV acute GVHD. Chronic GVHD was seen in 41.9% with a 15.4% incidence of extensive chronic GVHD. More than 90% had at least 1 documented infection with a 44% incidence of bacterial, 71% viral, and 38% fungal infection. The 2-year overall survival is 40.5% ± 3.2% with a higher survival among children (48.2% ± 3.4%) compared to adults (34.2% ± 4.1%). Survival was poor with late-stage disease (23.6% ± 4.3%) compared to early- (62.5% ± 7.5%) and intermediate-stage (50.3% ± 4.3%). Factors adversely affecting survival included older age of patient (P = .007), late disease status (P = .000), nonmyeloablative conditioning regimen (P = .003), bone marrow as graft source (P = .006), presence of acute GVHD (P = .069), primary graft failure (P = .000), and presence of a documented bacterial (P = .000) and fungal infection (P = .000). On multivariate analysis, older age (P = .027), presence of acute GVHD (P = .033), documented bacterial infection (P = .000), documented fungal infection (P = .000) and primary graft failure (P = .012) continued to remain significant. Haploidentical SCT offers a reasonable chance of cure for patients with both malignant and nonmalignant hematological diseases. Strategies to reduce aGVHD and infection related mortality needs to be explored further.© 20XX American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.