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The spread of the aggressive disease caused by the novel respiratory syndrome coronavirus-2 (SARS-CoV-2) has had an impact not only on the health and psyche of people, but also on the state of health systems in different countries, by complicating the treatment and diagnostic process. These changes have affected patients with cancers to a greater extent. The diagnosis, treatment, and follow-up of patients are of particular scientific and practical interest when working in conditions of special anti-epidemic control. Objective. To assess the possibility of reducing the frequency of hospitalization of patients with non-muscle-invasive bladder carcinoma (NMIBC) during the Covid-19 period. Subjects and methods. Sixty-four patients with urinary tract malignancy, including 19 (29.7%) patients with low-and high-risk re-current NMIBC, were followed up in two clinics (Saint Petersburg, Russia) in March to October 2020. All the patients were oper-ated on;the patients at high risk for recurrence received a cycle of adjuvant BCG therapy. Methods for cytological examination of urine sediment and the biomarkers UBC and Cyfra 21-1 were used for special laboratory diagnosis;the server stations of both clinics were applied for telehealth consultations (TCs). Results. TCs were used to reduce hospitalization rates: after TCs, all the patients reported a reduction in transport costs and recovery time after hospitalization. TCs could protect the followed-up patients against COVID-19 infection, by observing the rules of clinical examination, and achieve maximum individualization of treatment. The authors refused to perform diagnostic operations for low-risk NMIBC and to use laboratory tests using urinary biomarkers. At the place of their residence, outpatients underwent urinalysis for several indicators, transmitting the result to the clinic's servers or through a monitoring system. Inpatient treatment was used only in cases of gross hematuria or after recording abnormal laboratory test results. Control cystoscopy detected no re-current tumor. Conclusion. During the spread of COVID-19, the periods of endoscopic examinations and control diagnostic operations can be post-poned, by replacing face-to-face consultations with TC monitoring. Outpatient laboratory and radiation examinations are indicat-ed in patients with new-onset gross hematuria or after combination treatment. Repeated operations, including diagnostic ones, should be performed in the case of multiple NMIBCs or after incomplete excision of the primary tumor.Copyright © 2021.
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Background: The use of cryopreservation for stem cell grafts for both autologous stem cell and allogeneic cord blood transplant has been utilized for years. For other allogeneic stem cell transplant sources, the use of fresh collected grafts has been preferred due to concerns that cryopreservation may result in impaired graft function. With the onset of the COVID-19 pandemic a shift was made at our institution to exclusive use of cryopreservation Methods: In this retrospective single-center analysis a total of 133 patients undergoing allogeneic stem cell transplant at the University of Minnesota between 1/2018-6/2021 for a variety of malignancies were included, with 62 patients receiving fresh stem cell product and 71 patients receiving frozen stem cell product. Univariate statistical analysis was performed. Result(s): There was no significant difference between the two groups with regards to product type, sex, age, diagnosis (acute leukemia vs other), disease risk index, conditioning regimen, Karnofsky score, co-morbidity index, or cell dose (Table 1). Donor type was notably different between the two groups (p<0.01): matched sibling grafts were more commonly used for fresh products than frozen (85% vs. 35%), while matched unrelated donors were used more frequently for frozen than for fresh products (54% vs. 6%). Use of frozen product was associated with delayed neutrophil and platelet engraftment compared to fresh (median days to engraftment 15 vs 12 for neutrophils, 23 vs 17 for platelets, p<0.01 for both). Two-year relapse rates were significantly lower for frozen products (4%) than fresh (24%) (Table 2). This may be partially attributable to differences in follow up between the groups, as fresh products had a total of 910 days of follow up vs 432 for frozen products (P<0.0001). The difference in follow up remained statistically significant if the data was censored at 730 days (P<0.0001). Of note, the use of frozen products was associated with a lower rate of chronic graft-versus-host disease at one year post-transplant (p<0.01). There was no significant difference in the rates of acute GVHD between the groups. There were significant differences in GVHD prophylaxis regimens between the fresh and frozen groups (p<0.01). (Figure Presented)Two-year overall survival did not differ between groups (p=0.96). Conclusion(s): Use of cryopreserved stem cell products is associated with similar efficacy and outcomes as those seen with the use of fresh stem cell products. Although the data presented here suggest novel finding of decreased risk of relapse and chronic GVHD with the use of frozen stem cell products, additional follow up may abrogate these differences. Regardless, the logistical benefits of cryopreservation make this an attractive option for continued use in allogeneic transplants and our data presented here suggests that cryopreserved products remain an appropriate option for allogeneic stem cell transplant.Copyright © 2023 American Society for Transplantation and Cellular Therapy
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INTRODUCTION AND OBJECTIVE: Nutrition therapy for stone prevention is indicated if risks are diet-related. Dietary recommendations (DRs) include higher fluid intake, lower salt intake, lower dietary acid load, and normal calcium (neither excessive nor insufficient). Adherence is challenging to assess and optimally includes multiple measures including patient-reported outcomes. We assessed adherence to individualized targeted DRs issued in our multidisciplinary stone prevention clinic. METHOD(S): From 1/2020-1/2021 we invited patients to complete a questionnaire 1 month after their appointment. They were to estimate the number of days within the last week they followed specific DRs prescribed them and number of days they followed all DRs. Questionnaires were sent by mail with postage-paid return envelopes. This was a quality improvement project;patients were offered to respond anonymously. RESULT(S): Respondents (n=132) represented 29% of patients who were sent questionnaires and were 50% female (61+/-13 y). Of those providing clinical details, 77% were recurrent stone formers;46% were on stone medication(s). There were no adherence differences for men vs. women, recurrent vs. one-time stone formers, nor for those on stone-related medications vs. not. Overall, adherence to eating more F/ V was lower (4.7 vs. 5.5 d/week for all other DRs, p<0.004). We separated responses by receipt: summer/fall (April to mid-November) and winter/spring (mid-November to April), and by pre- vs. post- COVID (before/after March 2020). F/V intake was significantly lower during winter/spring than summer/fall (4.4 vs. 5.5 d/week, p=0.009). Related to the COVID pandemic, patients reported lower adherence to all DRs after the pandemic start (5.0 vs. 5.9 d/week, P=0.009 for difference from before). CONCLUSION(S): Overall, adherence to eating more F/V was significantly lower than for other DRs and was lower yet during winter/ spring. The COVID pandemic did not affect F/V intake specifically but did reduce adherence to all DRs. F/V are important in stone prevention because they provide HCO3 precursors that increase urine citrate and pH. F/V also provide other stone inhibitors, including phytate (which in urine inhibits calcium stone formation) and prebiotics, some of which enhance oxalate-degrading gut bacteria. Moreover, F/V intake can account for up to 30% of urine output and thus may help meet fluid recommendations. Barriers to F/V intake, which may include seasonal variations in cost and availability, should be addressed .
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Allogeneic hematopoietic stem cell transplantation (allo- HSCT) has traditionally involves administering fresh peripheral blood or bone marrow stem cells. At onset of the COVID-19 pandemic in March 2020, the National Marrow Donor Program (NDMP) mandated cryopreservation of all unrelated peripheral blood stem cell (PBSC) products to prevent interruptions in transplant plans by donor COVID-19 infection after recipient's start of conditioning chemotherapy. Since the lifting of this mandate, many centers have continued to cryopreserve grafts prior to initiation of conditioning, but the longer-term clinical outcomes of this practice including chronic graft versus host disease (cGVHD) rates of patients receiving cryopreserved stem cells have not been previously well described. Prior work has raised concern for a deleterious effect of cryopreservation on overall survival and non-relapse mortality (PMID: 33865804). However, heterogeneity in the patient population and reason for cryopreservation suggest that further study is needed to assess these outcomes. Here we report our single-institution experience of clinical outcomes using cryopreserved versus fresh URD PBSCs for allo-HSCT. We examined long-term outcomes in 387 patients who received unrelated donor (URD) PBSCs (136 cryopreserved, 251 fresh) between January 1, 2019 and July 31, 2021. The cohorts had similar baseline characteristics including donor/recipient age/sex, disease, conditioning regimen/intensity, and GVHD prophylaxis regimens. Two-year OS, PFS, relapse, NRM, and acute GVHD rates were not different between recipients of fresh versus cryopreserved PBSCs. Strikingly, 2-year incidence of cGVHD (28% vs 52%, p=0.00001) and moderate/severe cGVHD (9% vs 24%, p=0.00016) was substantially lower in recipients of cryopreserved PBSCs compared to fresh, respectively (Figure 1). This difference was only noted in patients receiving a GVHD prophylaxis regimen without post-transplantation cyclophosphamide (PTCY) (no PTCY 2-year cGVHD incidence cryopreserved vs fresh: 29% vs 57%, p=0.000016), moderate/severe cGVHD 16% vs 34%, p=0.0006) (Figure 2). For patients receiving a PTCY-containing GVHD prophylaxis regimen, there was no difference in cGVHD incidence (cGVHD cryopreserved vs fresh: 24% vs 27%, p=0.56, moderate/severe cGVHD 7% vs 9.3%, p=0.3, Figure 3). (Figure Presented) (Figure Presented) (Figure Presented) While survival and relapse rates are not different, cryopreservation is associated with a marked reduction in cGVHD rates in the setting of non-PTCy based GVHD prophylaxis. Larger multicenter or registry analyses are needed to confirm these observations and may prompt a re-assessment of the role of cryopreservation of stem cell products in clinical practice. If confirmed, it will be critical to understand the immunologic consequences of cryopreservation and how they might influence the clinical impact on chronic GVHDCopyright © 2023 American Society for Transplantation and Cellular Therapy
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The World Health Organization (WHO) declared COVID-19 a pandemic in March 2020. Since then, logistical challenges arose regarding the procurement of allogeneic (allo) hematopoietic stem cell (HSC) donor grafts. Little data was available on transplant outcomes using cryo haploidentical (haplo) HSC grafts with post-transplant cyclophosphamide (PTCy) for GVHD prophylaxis. We retrospectively analyzed patients who received a first PTCy-based haplo hematopoietic stem cell transplant (Haplo HCT) at a single outpatient transplant center between January 2015 and December 2021. We identified 294 patients, 179 received a fresh graft and 115 received a cryo graft (Table 1). Both cohorts were similar in terms of median age, diagnoses, HCT-CI score and DRI. Out of 179 fresh haplo grafts, 160 (89.4%) were from peripheral blood stem cells (PBSC) and 19 (10.6%) were bone marrow grafts (BM). There were no cryo BM grafts used. Conditioning intensity were similar amongst both cohorts, with 43% myeloablative, 41.9% non-myeloablative and 15.1% RIC regimens used for fresh Haplo HCT and 39.1% myeloablative, 42.6% non-myeloablative and 18.3% RIC cryo Haplo HCT. Median time to engraftment was 16 days for fresh Haplo HCT and 17 days for cryo HCT (p=0.18). Median time to platelet engraftment was 27 days for fresh Haplo HCT and 27.5 days for cryo HCT (p=0.96). Since March 2020, only 8 transplants performed at our institution were from fresh haplo HSC grafts. Cryo grafts performed after March 2020 accounted for 73 (63.5%) of 115 total cryo Haplo HCT performed in the period reviewed. Using a Cox model to evaluate the effect of graft type and adjusting for significant variables, we found no difference in overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and relapse rates between fresh and cryo Haplo HCT performed (Figure 1). While we found no difference in grades III-IV aGVHD (Table Presented) (Figure Presented) between fresh vs cryo Haplo HCT, we found a statistically significant higher incidence of grades II-IV aGVHD (p=0.033). There was no difference in all-grade cGVHD (p=0.53) or moderate- severe cGVHD (p=0.86) (Figure 2).(Figure Presented) The National Marrow Donor Program (NMDP) released a statement requiring cryopreservation of unrelated donor grafts at the start of the COVID-19 pandemic. The cryopreservation of all types of allo HSC grafts has been adopted by many transplant programs including ours. Our results mimic a CIBMTR analysis published at the start of the pandemic, where survival outcomes using fresh vs cryo haplo HSC grafts with PTCy as GVHD prophylaxis were similar. Contrary to other reports, we did not see differences in graft failure or rates of cGVHD between fresh and cryo Haplo HCT. The use of cryopreserved HSC grafts for Haplo HCT with PTCy results in favorable outcomes in an outpatient transplant setting. Further studies are needed to determine the cost-effectiveness of this practice in the post-pandemic era.Copyright © 2023 American Society for Transplantation and Cellular Therapy
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Background: Neoplastic pericardial effusion (NPE) is a serious complication that occurs in the setting of advanced oncological disease and is associated with a high recurrence rate. Currently, pericardiocentesis (PCT) remains the first therapeutic option and the use of percutaneous balloon pericardiotomy (PBP) is limited to the treatment of recurrences. However, it is not known whether some aspects of the procedure during PBP lead to different outcomes in terms of survival and recurrence, and no such patients have been included in studies during COVID-19 pandemic. Purpose(s): The aim is to analyses the success, complications and recurrence rate (defined as recurrence of NPE requiring PCT, PBP or surgical pericardial window (SPW) of both procedures (BP) in order to establish the optimal entry treatment for these patients. Method(s): This research analyzed the clinical characteristics and prognostic factors of patients with severe pericardial effusion of neoplastic etiology who underwent PBP during the COVID-19 pandemic. A prospective study was conducted involving 23 patients admitted between January 2020 and January 2022 for severe NPE who underwent PCT or PBP as initial treatment of NPE. Result(s): We included 23 patients, 62.9% were male with a mean age of 51.2+/-14.9 years NPE was the first manifestation of the oncological process in 12 patients (52.1%) with lung cancer being the most frequently associated primary cancer (58.7%) followed by breast cancer in 12.7% of cases. A total of 26 procedures were performed, 10 PCT, 15 PBP, 1 SPW, with tumors cells identified in the pericardial fluid in 13.0% of cases. PCT was used as an entry point in 10 patients (43.5%), 6 patients were COVID-19 positive and PCT was performed as the first treatment. While PBP was chosen as the first therapeutic option in 13 patients (56.5%) (2 Re-PBP). The initial efficacy of the procedure was 93.1% and 92.2% respectively (p=0.88), with 1 complication occurring in the PBP group but not requiring scheduled SPW. In the former group, the percentage of recurrences was higher (34.7%;8 recurrences in 10 patients) compared to patients treated with upfront PBP (8.6%;2 recurrences in 13 patients), p=0.09. In addition, only one patient had to resort to surgery. When analyses according to the BP. used, the recurrence rate was 4.0 times higher for PCT (34.7 vs. 8.6% recurrences), although without reaching statistical significance (p=0.16). Conclusion(s): The PBP is a simple, safe and effective technique for the treatment of NPE during the COVID-19 pandemic, in our series it was associated with a lower recurrence rate. Therefore, it could replace PCT in these patients during the COVID-19 pandemic as optimal first line treatment, providing better quality of life and reducing the need for re-interventions. (Figure Presented).
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INTRODUCTION: Patient often experience delays in operative care due to access issues, comorbidities, and other personal reasons. However, during the recent COVID pandemic, hospital resources were severely limited and all patients were forced to endure unprecedented delays, including colon and rectal cancer patients. The oncologic implications of these delays are unknown. METHOD(S): Adult patients who underwent surgery for colon and rectal cancer between January and September of 2020 were retrospectively reviewed. Patients with stage 4 disease were excluded. Patients were categorized as regular or extended interval if time to operation was less than or greater than 40 days for colon cancer and 80 days for rectal cancer. RESULT(S): A total of 186 patients were included, 123 colon cancer and 63 rectal cancer. In the colon cancer group, there were 65 regular interval and 58 prolonged interval patients. There were no significant differences in post-operative, 30-day, or 90-day post-operative outcomes between the two interval groups. During the follow up period (regular vs prolonged: 468.7 +/- 238.3 vs 414.2 +/- 235.5, p = 0.005) there was a higher rate of recurrence in the prolonged group (4.6% vs 17.2%, p = 0.023). Cox regression controlling for disease stage, procedure performed, and resection score demonstrated a significant difference in recurrence-free survival (HR = 7.544, p = 0.007). In the rectal cancer group, there were 48 regular interval and 15 prolonged interval patients. There were no significant differences in postoperative, 30-day, or 90-day outcomes between the two interval groups. During the follow up period (regular vs prolonged: 574.0 +/- 237.3 vs 569.3 +/- 252.2, p = 0.687) there was no difference in recurrence (16.7% vs 26.7%, p = 0.389), but recurrence-free survival was significantly longer in the regular interval group (543.9 +/- 241.6 vs 493.1 +/- 237.4, p = 0.009). However, Cox regression controlling for disease stage, neoadjuvant chemotherapy, procedure performed, resection score demonstrated no difference in recurrence-free survival (HR = 1.403, p = 0.662). CONCLUSION(S): A prolonged time to surgery, greater than 40 days, was associated with decreased recurrence-free survival for color cancer patients. In rectal cancer, no significant reduction in recurrence-free survival was observed despite a longer time to surgery interval in the prolonged group. In events when resources are limited, colon cancer patients may benefit from prioritized treatment and rectal cancer patients may be able to tolerate longer delays without significant impacts on recurrence-free survival.
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Nurses specializing in the care of patients with multiple sclerosis (MS) are uniquely positioned to provide personalized care. Patients prescribed cladribine tablets (taken for <=10 days per year for 2 years), indicated for adults with highly active relapsing MS in the EU and Australia, can benefit from an active partnership with their healthcare professionals, including MS nurses, who can promote an understanding of and the adherence to treatment. In clinical studies, patients treated with cladribine tablets had lower annual relapse rates, greater odds of being relapse free, a longer time to sustained progression of disability and a significant reduction in radiological disease activity compared with patients receiving placebo. Patients should be advised that, although everyone will have a different experience, the safety of cladribine tablets is supported by 16 years of clinical trial and post-approval data. Furthermore, there is no indication of a more serious disease course or more severe outcomes for patients with MS treated with cladribine tablets who acquire coronavirus disease 2019 compared with the general population or other patients with MS. This article presents practical considerations that may help achieve a greater understanding of the potential benefits and drawbacks of MS treatment, build the patient-nurse relationship, encourage shared decision-making and ultimately may improve careCopyright © Touch Medical Media 2022
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Introduction The use of fingolimod as a long-term therapy in people with Multiple Sclerosis (PwMS) is associated with a small increase in the risk of herpes virus reactivation and respiratory tract infections. At the moment, the outbreak of the novel coronavirus SARS-CoV-2 brings new challenges to physicians when deciding to continue or stop the treatment with fingolimod. Objective We report one MS patient tested positive for SARS-CoV-2 that has not discontinued fingolimod treatment and developed only mild symptoms from COVID-19. Method(s): Descriptive observational study. Discussion and conclusion The effects of COVID-19 infection on MS patients treated with fingolimod are still uncertain. This case report outlines promising results by demonstrating a patient who didn't stop the fingolimod treatment during COVID-19 infection and developed only mild symptoms. Nevertheless, more studies are necessary to evaluate the risks and benefits of fingolimod in MS patients infected with COVID-19.Copyright © 2022 The Authors
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Background: Mammographic screening programmes reduce breast cancer mortality, but detect many small tumours with favourable biological features which may not progress during a woman's lifetime. Screen-detected cancers are treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies have evaluated the omission of radiotherapy in this context. However, there is little evidence to support surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Method(s): SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screendetected good prognosis cancers. The main eligibility criteria are age >=47 years, unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery;with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are: 1. Noninferiority comparison of the requirement for a second procedure following excision 2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is the integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audiorecordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Result(s): SMALL opened in December 2019, but recruitment halted in 2020 for 5 months due to COVID-19. At 7st July 2022, 142 patients had been randomised from 26 centres, with a randomisation rate of approximately 45%, and a per site recruitment rate of 0.4-0.5 patients/month, approaching the feasibility recruitment target of 144 patients. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback has commenced, with wider feedback delivered across sites via recruitment training workshops. Conclusion(s): Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes.
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Background: There has been a rampant increase in substance abuse in Kashmir valley for the last few years. Department of Psychiatry SKIMS Medical College Srinagar has extended its services to cater to the needs of the substance users in the valley even during the COVID -19 pandemic. In 2021, de-addiction services were also started among prison inmates of central jail Srinagar. This was the first of its kind of services provided in the valley. The management of substance users with Hepatitis infections had also been challenging. Purpose(s): To describe the management of substance users under special circumstances(COVID-19), special settings(Central Jail Srinagar), high-risk groups(substance users with blood-borne infections). Method(s): Semi-structured proformas were used to collect data from special groups of participants a) those who were seeking treatment during COVID-19 times from the De-addiction center, SKIMS Medical College b) Prison in-mates on treatment for substance-use disorders c) substance users who are hepatitis B and/or positive. This included Socio-demographic details, clinical profile, the pattern of substance use, coping strategies, and treatment seeking. Preliminary Findings: More than 25 percent of the prison in-mates are substance dependent and relapse rate is very high. Psychiatric comorbidity like mood disorders and or personality disorders are present among most of the prison-inmates. During COVID-19 times, 90% patients reported average to very high level of importance and value given to their own health and health of family and friends and focussed on treatment of their illness(85%). Substance users with blood-borne infections were associated with highrisk behavior in the form of needle-sharing. Conclusion(s): The findings provide a voice that there is a need for backup plans that cater to the needs of substance users during in-evitable circumstances like the COVID-19 pandemic. Policymakers should focus on prison mental health for the functioning of a better society. Substance users with blood-borne infections should be rigorously treated to prevent them from taking the shape of an epidemic.
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Introduction: Atrial fibrillation (AF) is one of the most common forms of arrhythmia in the clinic. There are about 10 million AF patients in China, of which 1/3 are paroxysmal AF, and the remaining 2/3 are persistent or permanent AF. Long-term AF impairs cardiac function and leads to heart failure and thromboembolism. Moreover, AF increases the risk of mortality and ischemic stroke. Drug therapy and radiofrequency catheter ablation (RFCA) are still the mainstream treatment for AF patients. However, drug therapy has its drawbacks because of the high recurrence rate and side effects. Therefore, the current antiarrhythmic drugs could not meet all the clinical needs of patients with AF. RFCA is superior to antiarrhythmic drugs in maintaining sinus rhythm, improving symptoms and exercise tolerance, and improving quality of life. The role of RFCA in the treatment of persistent AF has gradually been recognized and affirmed. Although RFCA has been progressively used in the treatment of AF, there is still a high recurrence rate of AF after RFCA, especially in patients with persistent AF. Hence, it is meant to solve the high recurrence rate of AF after RFCA. Shensong Yangxin (SSYX) capsule has been proven to treat arrhythmia both in animal studies and clinical research. SSYX capsule could regulate multi-ion channels, improve cardiomyocyte metabolism and regulate autonomic nervous function. In addition, randomized, double-blind, multicenter clinical research indicated that the SSYX capsule exhibited good clinical efficacy in treating ventricular premature beats and paroxysmal AF. However, the effect of SSYX on recurrence after RFCA for patients with persistent AF remains unclear. High-level randomized controlled trials (RCTs) could offer clinicians high-quality evidence regarding the usage of SSYX capsule, especially in persistent AF patients who received RFCA. Hence, the RCTs aim to evaluate the effect of SSYX capsules on the prognosis in patients with persistent AF after RFCA through multicenter, double-blind RCTs. Method(s): This trial will be conducted with a total of 920 participants diagnosed with persistent AF who received RFCA. The participants will be randomized (1:1) into groups receiving either SSYX or Placebo for 1 year. The primary endpoint includes the recurrence of AF within 1 year after RFCA. The secondary outcome measures include changes of AF load at 3 months, 6 months, 9 months, and 1 year after treatment, the time of first atrial flutter/AF, the incidence of cardioversion 1 year after treatment, changes of transthoracic echocardiographic parameters 1 year after treatment, the incidence of stroke and thromboembolism at 6 months and 1 year after treatment, the score of SF-36 within 1 year after treatment. Application: The trial is ongoing. The trial started in September 2019 and recruiting patients. Data collection will be completed after all participants have completed the treatment course and follow-up assessments (expected in 2022, pending COVID-19). Next Steps/Future: The SS-ADJUST study is a randomized control study of TCM in persistent AF after RFCA. It will determine the place of SSYX capsule as a new treatment approach and provide additional and innovative information regarding TCM and the specific use of SSYX in persistent AF after RFCA.
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The aim of this study was to investigate how breast cancer follow-up in the Netherlands changed during the COVID-19 pandemic, compared to 2018-2019, and to what extent follow-up during the pandemic corresponded to the patient risk of recurrence. During the early phase of the pandemic the Dutch Society for Surgical Oncology (NVCO) issued a report with recommendations on how follow-up could be postponed, as a guidance for the pandemic, based on a low, intermediate or high risk of recurrence. In this study we investigated to what extent this advice was followed. A dataset of 33160 women diagnosed with primary invasive breast cancer between January of 2017 and July of 2021 was selected from the Netherlands Cancer Registry (NCR) and Dutch Hospital Data (DHD). The pandemic, 2020 and weeks 1-32 of 2021, was divided into six periods (A to F), based on the number of hospitalized COVID patients in the Netherlands. The five-year risk of locoregional recurrence (LRR) was determined for each patient with the INFLUENCE nomogram. The LRR risk was compared to the risk groups from the NVCO report with a Kruskal-Wallis test. The percentage of patients who received a mammogram during period A to F was compared to the same periods of 2018-2019 with a chisquared test. Correlation between the LRR risk, and if patients had a mammogram, was investigated with logistic regression. This analysis was repeated separately for the risk groups. Correlation between the LRR risk, and time intervals between surgery and the first and second mammogram was analyzed using cox proportional hazard models, this was also repeated for the risk groups. There was a significant difference in LRR risk between the NVCO risk groups. In the low-risk group (n=7673), 86 patients (1.1%) had a risk >5%. In the intermediate risk group (n=19197), 18364 patients (95.7%) had a risk of < 5%, and 65 patients (0.34%) had a risk of >10%. In the high-risk group (n=2674), 2365 patients (88.4%) had a risk < 10%. The percentage of patients who received a mammogram was significantly lower in periods B to F of the pandemic. Logistic regression showed a negative correlation between the risk of LRR and if patients had a mammogram in 2020 (OR 0.93) and 2021 (OR 0.93). There was also a negative correlation between the risk groups and mammography in 2020 (OR 0.92 for intermediate and 0.80 for high), and for the risk groups and mammography in 2021 (OR 0.98 for intermediate and 0.95 for high). There was no significant impact of LRR risk, or risk group, on time intervals between mammograms. During the pandemic, patients with a higher LRR risk, or a higher risk according to NVCO advice, had lower odds of having a mammogram. If the advice would have been followed, in 0.5% of the patients scheduled for follow-up, the recommendation was to postpone in contrast to a high estimation of the individual risk. For 62.7%, a follow-up was recommended, despite a low estimated individuals risk. Because the number of high-risk patients is relatively low, individual risk prediction could be supportive, in case of future restrictions. This way the high-risk patients can be identified and prioritized for follow-up, and can also be encouraged to come to the hospital.
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During first outburst of COVID-19, several strategies had been applied for surgical oncology patients to minimize COVID-19 transmission. COVID-19 infection seemed to compromise survival and major complication rates of surgical oncology patients. However, survival, tumor progression and recurrence rates of surgical oncology patients were associated to the consequences of COVID-19 pandemic on their management. In addition, the severity of COVID-19 infections has been downgraded. Therefore, management of surgical oncology patients should be reconsidered. © 2022 Wiley Periodicals LLC.
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Introduction: Since the beginning of the Sars-Cov-2 pandemic, several evidences have been gathered on the use of Disease Modifying Drugs (DMTs) in patients with Multiple Sclerosis (MS) .The introduction of the Sars-Cov-2 vaccine marked a turning point for MS patients, considered fragile patients. Aim(s):The objective of this study is to describe changes about the use of first-line DMTs in patients with a new diagnosis of MS, comparing the semester before and after the start of vaccination campaign for Sars-Cov-2. Method(s): The study included patients newly diagnosed with MS according to McDonald's 2017 criteria. The proportion of patients initiated into the use of Interferon Beta (IFN), Dimethylfumarate (DMF) and Teriflunamide (TERI) was defined as a proportion for the previous semester (October 2020- March 2021) and subsequent (April 2021-September 2021) to the avaibility of Sars- Cov-2 vaccine. The determinants of the choice of first-line DMTs were evaluated through regression analysis. Result(s): The study included 134 patients, including 40 (29.9%) male, average age of 38.3 +/- 12.3 years, disease duration of 3.0 +/- 4.6 years, average EDSS of 1.7 +/- 1.1. Among these, 75 (56%) patients started a first-line DMTs in the semester before the start of vaccination campaign [IFN 13 (9.7%), TERI 6 (4.5%), GA 28 (20.9%), DMF 28 (20.9%)], while 59 (44%) in the following semester [IFN 4 (3%), TERI 11(8.2%), GA 12 (8.9%) and DMF 32 (23.9%)]. A reduction of 40% and 53% respectively in the use of GA and IFN was observed in the semester following the start of the vaccination campaign. In contrast, an increase of 29 % in the use of TERI and 6% in the use of DMF respectively was reported in the same semester. The regression analysis shows the use of injection therapies (IFN, GA) being associated with female gender (p= 0.032) and with the previous semester to the availability of Sars- Cov-2 vaccine (p=0.006). In contrast, the use of TERI is associated with male gender (p=0.031) and with the following semester the introduction of the vaccine (p=0.05). About the use of DMF, a relationship with the post-introduction semester of the vaccine has been observed (p=0.037) the relapse rate in the previous 2 years is the strongest determinant in the choice of this treatment (p=0.001). Conclusion(s): Our data show how the start of the vaccination campaign for Sars-Cov-2 influenced the use of first-line immunotheraphies in patients with new diagnosis of MS.
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SESSION TITLE: COVID-19 Case Report Posters 1 SESSION TYPE: Case Report Posters PRESENTED ON: 10/17/2022 12:15 pm - 01:15 pm INTRODUCTION: We describe the clinical course of a COVID-19 patient with Streptococcus Dysgalactiae (SD) infective endocarditis, managed with six weeks of antibiotics and valve replacement surgery. CASE PRESENTATION: A 50-year-old previously healthy man presented with two weeks of fever, congestion, and diarrhea, and one day of acute change in mentation. On arrival, the patient's heart rate was 130/min, respiratory rate 25/min, and temperature 103.5 F. On physical examination, he appeared lethargic. Initial labs showed a white blood count of 16 k/mm with bands and platelets of 64 k/cmm. The patient was treated empirically for severe sepsis with intravenous vancomycin and cefepime. Blood cultures grew SD. Antibiotics were narrowed to intravenous ceftriaxone. A CAT scan of the chest, abdomen, and pelvis identified multiple splenic infarcts. A transesophageal echocardiogram was performed to evaluate the potential source of the splenic emboli, and this showed mild to moderate mitral regurgitation and a large globular mobile vegetation on the anterior mitral valve. Intravenous gentamicin was added to the treatment regimen. Subsequent cultures remained negative, and he underwent bioprosthetic mitral valve replacement on hospital day 11. He received a total of 6 weeks of outpatient intravenous antibiotic therapy. DISCUSSION: SD is a normal commensal of the skin, upper airway, and gastrointestinal tract. It can cause localized and invasive infections. Major risk factors for invasive infections include malignancy, diabetes mellites, and other cardiovascular diseases. Besides a recent COVID-19 infection, our patient was healthy. The COVID-19 infection causes a hypercoagulable state, and when combined with COVID-19 related diarrhea, can lead to the translocation of the gut bacteria, and subsequent infective endocarditis (IE) [1]. SD is a rare cause of IE, but the incidence of IE in bacteremic patients is about 10% [2]. Clinicians should have a low threshold to suspect IE in cases of SD bacteremia. American Heart Association Guidelines on IE [3] state that systemic embolization occurs in 22% to 50% of cases of IE, and the highest incidence of embolism occurs when the vegetation is mobile, on the anterior mitral valve and > 10 mm, like in our case. In such patients, early cardiac surgery should be considered. SD bacteremia recurrence occurs in about 10% of patients within the first year, and patients should be informed about this risk. CONCLUSIONS: Clinicians should suspect IE in the setting of SD bacteremia. COVID-19 infection increases the chances of the development of infective endocarditis. Prolonged intravenous antibiotic therapy and prompt replacement of the involved valve is necessary. SD IE is associated with a high rate of recurrence, and clinicians should be cognizant of this risk. Reference #1: "COVID-19 INFECTION PREDISPOSING ENDOCARDITIS ….” https://www.scienceopen.com/document?vid=02f2bbbe-479d-4d11-ad60-2ceba336a4e1. Accessed 4 Apr. 2022. Reference #2: "Bacteremia caused by group G Streptococci, taiwan - PubMed.” https://pubmed.ncbi.nlm.nih.gov/18439377/. Accessed 4 Apr. 2022. Reference #3: "Clinical relevance of vegetation localization by … - Semantic Scholar.” https://www.semanticscholar.org/paper/Clinical-relevance-of-vegetation-localization-by-in-Rohmann-Erbel/0106e26e3f2102eb6dd2fd7e086210c0a44ebf45. Accessed 4 Apr. 2022. DISCLOSURES: No relevant relationships by Husam Bader No relevant relationships by Poorva Bhide No relevant relationships by Gaurav Mohan No relevant relationships by Muhammad Tayyeb No relevant relationships by Charmee Vyas No relevant relationships by Siva Naga Yarrarapu
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Introduction: Congenital talipes equinovarus (CTEV) is the most common congenital foot disorder, commonly known as congenital clubfoot. Ponseti method of manipulation and serial plaster casting is the gold standard treatment for idiopathic congenital clubfoot. The purpose of this study is to analyse the efficacy of correction of Congenital Talipes Equinovarus deformity (CTEV) using ponseti method. Materials and Methods: This analysis was carried out at the Jhalawar Medical College Hospital's Orthopaedics Department, including 30 children with idiopathic CTEV of age less than 2 years, among which 13 unilateral and 17 bilateral CTEV, total 47 feet, willing for treatment. Patients were followed up weekly for corrective casting till tenotomy and corrective cast was applied for three weeks after final correction or percutaneous tendo-achilles tenotomy. Results: Assessment of results using Pirani severity scoring6,7 at the end of treatment and on regular follow-ups. The most common age group was 0-1 months with 24(80%) cases.Among 30 cases,there were 22 males(73.30%) & 8 females(26.70%). 17 cases were bilateral(56.67%) and 13 cases(43.33%) were unilateral. Post casting treatment, percutaneous tenotomy was done in 14 cases (46.67%) in which 12 cases(54%) were male and 2 cases(16%) were female. No patient has undergone extensive surgery like postero-medial soft tissue release or bony procedures to correct the deformity. Only two recurrence were recorded which was due to non compliance due to occurrence of pandemic COVID-19 Lockdown. They were treated with manipulation and pop cast followed D-B splint. Conclusion: Ponseti method is an excellent conservative method of treatment of Congenital Talipes Equino varus. Treatment must start at the earliest possible for better outcome. Long term follow up till 4 years age would be better to assess the relapse rate.
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Background: A severe antibody-mediated inflammatory demyelinating disease of the central nervous system is neuromyelitis optica spectrum disorder (NMOSD). Azathioprine (AZA) and Rituximab (RTX) were used to treat NMO-SD patients though not FDA approved yet. Aim of the study: To compare the effectiveness and safety of rituximab treatment versus azathioprine in treating individuals with NMOSDs. Methods: Seventy four Egyptian individuals with NMOSDs in this retrospective observational study and collecting their medical records from multiple sclerosis (MS) clinics, Neurology Departments, El-Maadi Military Hospital, and Cairo University hospitals. Fourty four patients received either treatment over two year duration, Group 1 (rituximab group) consisted of 19 patients, while group 2 (azathioprine group) consisted of 25 patients. Their full medical history, general and neurological examination, MRI brain and spinal cord results, and laboratory investigation were collected including immune assays and AQP-4 antibody. Results: There was no statistically significant difference between the groups in terms of brain MRI data at the baseline and outcomes. Between the two groups, there were statistically significant differences in last observer spinal MRI (p=0.025), annual relapse rate before treatment with RTX group (P=0.021), EDSS pretreatment (p=0.005), annual relapse rate post-treatment. When it came to the number of relapses after treatment, there was a high statistically significant difference between the two groups (p=0.016), with group 1 (RTX group) having zero relapses. There was a statistically significant decrease comparing EDDS scores pre-and post-treatment regarding the RTX group (p=0.003). Adverse events were Infusion rate reaction (5.3%) and pneumonic COVID (9.5%) of patients. Conclusion: RTX is more helpful and less harmful for NMO-SD patients than AZA.
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Background: Maintenance in FL patients (pts) improves progression free survival (PFS). SARS-Cov2 pandemic posed unique challenges for immunocompromised pts. Aims: The aim is to evaluate the outcome of FL pts in maintenance with antiCD20-MoAb during SARS-Cov2 pandemic and how suspension of therapy affected lymphoma outcome and the risk of SARS-Cov2 infection and its morbidity and mortality. Methods: This is an observational, multicenter, retrospective and prospective study. Results: A total of 420 from 18 Italian Hematological Centers were included in the analysis. Median age was 62 years old (range 27-91 years), 216 pts (51%) were male. Main clinical characteristics of the population were: histological grade 1-2 vs 3A in 288 (69%) vs 109 (26%), while not valuable in 23 (5%) pts;limited I-II vs advanced III-IV stage in 57 (14%) vs 361 (86%) pts, not reported in 2 cases. FLIPI score was low vs intermediate vs high in 71 (17%) vs 151 (36%) vs 192 (46%) patients, respectively, not valuable in 6 cases. All 420 patients included were in maintenance treatment with antiCD20 MoAb at the time of the onset of SARS-Cov2 pandemic (March 2020): 333 (79%) pts were receiving maintenance after a first line, while 87 (21%) after a second line. 342 (81%) pts were receiving Rituximab, while 75 (18%) Obinutuzumab, 3 patients did not start the planned maintenance because of pandemic spread. Status of disease after induction was complete remission (CR) in 374 (89%), partial response (PR) in 41 (10%), progressive disease (PD) in 1, not evaluated in 4 pts, respectively. At the end of maintenance was CR in 265 (63%), PR in 19 (4%), stable disease (SD) in one and PD in 14 (3%) patients, respectively, maintenance is stiil ongoing in 121 (29%) pts. Because of SARS-Cov2 pandemic from March 2020 consequences on maintenance treatment were: temporary suspension in 122 (29%), definitively interruption in123 (29%), no modification in 175 (42%) of pts, respectively. Median number of maintenance treatment administered at the time of SARS-Cov2 pandemic onset was 2 (range 1-12), median number of courses administered at the time of analysis was 8 (range 0-12), in patients who modified treatment because of pandemic median number of performed courses was 7 (range 0-11) and median number of lost cycles were 2 (range 1-12). Pts were divided into two groups according to type of approach to maintenance during pandemic: pts who interrupted maintenance (temporary or definitively): groups A (245 (58%) pts) vs pts who did not modified maintenance: group B (175 (42%) pts). No differences in clinical characteristics, type of therapy and response were observed between the two groups. 29(7%) relapses were observed: 16 (7%) vs 13 (7%) in group A vs B, respectively. 70 (17%) pts experienced SARS-Cov2 positivity: 47 (19%) vs 23 (13%) in group A vs B, respectively. 53 (76%) pts had symptomatic COVID syndrome and 43 (61%) were hospitalized, with no differences between the two groups. Anti-SARS-Cov2 vaccine was administered in 349 patients, serology assessment was done in 46% of cases, showing 21 (13%) reactive vs 138 (87%) not reactive pts, with no differences between the two groups. 21 (30%) pts died because of COVID: 9 (19%) vs 12 (52%) in groups A vs B, respectively. Summary/Conclusion: Suspension of maintenance treatment during SARS-Cov2 pandemic did not show a protection in terms of SARS-Cov2 positivity and morbidity. A trend in lower mortality is suggested. No differences in terms of relapse rate were observed, but longer follow up is needed.
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Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicenter randomized trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumors (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomized 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Coprimary end-points are: (1) Non-inferiority comparison of the requirement for a second procedure. (2) Single-arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. The DMC will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimize recruitment and informed consent. Recruitment challenges are identified by analyzing recruiter/ patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted for 5 months due to COVID-19. At 11th February 2022, 91 patients had been recruited from 22 centers, with an approached/consented ration of 50%. Drawing from preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomization). Individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion: Despite pandemic-related challenges, SMALL has excellent recruitment to date and is expected to have a global impact on treatment of screen-detected breast cancer.