Clinical and economic burden among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) receiving first-line (1L) chemoimmunotherapy (CIT) by risk status: A chart-linked claims analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19505-e19505
Author(s):  
Lori A. Leslie ◽  
Nilesh Gangan ◽  
Hiangkiat Tan ◽  
Qing Huang
Keyword(s):  
High Risk ◽  
Median Time ◽  
Economic Burden ◽  
Rate Ratio ◽  
Linear Models ◽  
Lymphocytic Leukemia ◽  
Economic Outcomes ◽  
Research Database ◽  
Risk Status ◽  
Nccn Guidelines

e19505 Background: In patients with CLL/SLL, high risk genetic abnormalities are associated with inferior responses to CIT, and the economic burden of this remains uncertain. This study aimed to compare real world clinical and economic outcomes in high risk and perceived non-high risk patients initiating 1L CIT. Methods: This retrospective cohort study identified patients with CLL/SLL from the HealthCore Integrated Research Database representing a national managed care population with over 58 million members. Medical records were obtained for eligible patients who initiated 1L CIT between 1/1/2007 and 7/31/2019 and underwent prognostic testing to classify them as high risk (HR: del17p, TP53 mutation, del11q or unmutated IGHV) or as non-high risk by FISH only (NHR: non-del17p and non-del11q). The first CIT claim date was the index date. Patients were required to have ≥12 months of pre-index and ≥30 days of post-index eligibility. Study outcomes included testing rate, time to next treatment (NT) or death, time to treatment failure (TF; defined as time to change of therapy, non-chemotherapy intervention, hospice care or death), and total plan paid costs (medical + pharmacy) per patient per month (PPPM) in the 1L period. Cox proportional hazard models and generalized linear models were used to calculate adjusted hazard ratio or rate ratio. Results: Among the 1,808 patients with CLL/SLL, 612 were FISH or IGHV tested and the rate of testing increased from 2007 to 2019 (30% to 44%), especially after adding ibrutinib for 1L CLL with del17p in NCCN guidelines v4.2014. Risk status was available for 253 patients (HR: 119; NHR: 134), with 80% of patients initiating 1L BR/FCR-based therapy in both cohorts. Median follow up was 26.4 vs. 25.8 months (HR vs NHR). HR patients had 65% higher risk of NT/death (median time: 2.4 vs 3.7 years), and 65% higher risk of TF (median time: 3.0 vs 4.9 years) compared to NHR patients (Table). The total costs PPPM were also significantly higher for HR patients in the 1L period ($12,194 vs $9,055, p=0.027; Rate Ratio=1.33, p<0.001). Conclusions: Initiating 1L CIT among HR patients with CLL/SLL was associated with increased risks of NT/death, TF, and higher costs compared to NHR patients identified by FISH only. Assessment of cytogenetic/molecular risk status for appropriate treatment is vital to optimize clinical and economic outcomes, especially in the novel agent era. Recent testing practices to assess genetic risk in CLL remains suboptimal.[Table: see text]

Quantitative PCR Predicts Early Relapse in Patients with Chronic Lymphocytic Leukemia (CLL) Submitted to Autologous Stem Cell Transplantation. The Case for Early Clinical Intervention.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2255-2255
Author(s):  
Carol Moreno ◽  
Neus Villamor ◽  
Dolors Colomer ◽  
Jordi Esteve ◽  
Francesc Bosch ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Median Time ◽  
Residual Disease ◽  
Clinical Intervention ◽  
Complete Response ◽  
Median Number ◽  
Lymphocytic Leukemia ◽  
Clinical Relapse ◽  
Risk Of Relapse

Abstract Autologous stem cell transplants (auto-SCT) are increasingly performed in patients with CLL. Although this procedure results in a high complete response (CR) rate, most patients eventually relapse. The median time to relapse is around 5 years. Increasing levels of minimal residual disease (MRD), detected by PCR or flow cytometry (FC) are associated with clinical relapse. The early detection of patients likely to relapse shortly after SCT may be useful in the management of these patients. With this background, we analyzed the levels of MRD and its correlation with the risk of relapse and clinical outcome in 19 patients with CLL submitted to auto-SCT. MRD was assessed by FC and quantitative real time PCR of the IgH region using allele-specific oligonucleotides (ASO-PCR) in peripheral blood and/or bone marrow DNA samples obtained before SCT and at different time points thereafter. After SCT, 17 patients achieved CR and 2 partial response. A continuous pattern of relapses was observed and, after a median follow-up of 48 months (range, 11–101), 11/19 patients have progressed. The median number of CLL cells detected prior to SCT was 2.4x10−2 decreasing to 5.31x10−4 at 3–6 months after auto-SCT. No further decrease was observed beyond that point. At 3–6 months after auto-SCT, only 3/17 patients in CR had undetectable levels of disease. Patients with a MRD level >10−3 at this time point (3–6 months after transplant) had a significantly higher risk of progression than those who had less than 10−3 CLL cells. All but one patients with MRD>10−3 have relapsed (7/8) whereas only 4/9 with MRD<10−3 did so. As shown in the figure, median time to progression was significantly shorter in those patients with a higher MRD level (16 vs. 55 months; p=0.003) Figure Figure In conclusion, quantification of MRD within the first 6 months after auto-SCT allows the identification of CLL patients with a high risk of early clinical relapse. These data provide background to investigate whether early treatment, before clinically overt relapse occurs, might be useful in patients with high risk of relapse after SCT.

Alemtuzumab and Rituximab for Initial Treatment of High Risk, Early Stage Chronic Lymphocytic Leukemia (CLL).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2050-2050 ◽  
Author(s):  
Clive S. Zent ◽  
Timothy G. Call ◽  
Tait D. Shanafelt ◽  
Diane F. Jelinek ◽  
Renee C. Tschumper ◽  
...  
Keyword(s):  
High Risk ◽  
Disease Progression ◽  
Median Time ◽  
Antimicrobial Prophylaxis ◽  
Early Stage ◽  
Lymphocytic Leukemia ◽  
Color Flow ◽  
Early Stage Disease ◽  
Male Predominance

Abstract Background: CLL is still an incurable lymphoid malignancy. The current standard of care is to treat only patients with obvious clinical progression as defined by the National Cancer Institute Working Group in 1996 (NCI–WG 1996). High risk CLL can be identified at diagnosis by a variety of tests including fluorescence in situ hybridization (FISH), immunoglobulin heavy-chain variable region (IgVH) analysis, and expression of ZAP-70 or CD38. With this information we can identify patients with high risk, early stage disease who are candidates for novel low toxicity therapies that could alter the natural course of their disease. Our hypothesis was that combination monoclonal antibody (MoAb) therapy using alemtuzumab and rituximab would significantly reduce the high risk clone in early stage CLL. Methods: This phase II trial was conducted with IRB approval and accrued the planned 30 patients between January 2005 and July 2007 at Mayo Clinic Rochester. The study enrolled consenting patients with Rai stage 0–II CLL without NCI–WG 1996 criteria for treatment who had high risk CLL as defined as one or more of the following 17p13–, 11q22–, unmutated (UM) IgVH (&lt; 2%) and expression of ZAP–70 (≥ 30%) and/or CD38 (≥20%). Treatment was one 30 day cycle (alemtuzumab 3 mg, 10 mg, 30 mg days 1–3 then 30 mg 3 × week × 4 weeks with all doses subcutaneously and rituximab at 375 mg/m2/week IV × 4 doses from day 8). Patients received 7 days of allopurinol and antimicrobial prophylaxis against PCP and herpes virus infections for 7 months. CMV testing by PCR was done weekly during treatment, then monthly × 6. Results: All 30 patients have completed therapy and 27 have been evaluated for response. The median age of these 27 patients was 62 yr (range 29–77) with 8 patients &gt; 70 years. There was a male predominance (67%) with median time from diagnosis to treatment of 0.7 yr (range 0.1 – 6.1). Stage (Rai) at the start of therapy was 0 in 7 (26%), I in 19 (70%), and II in 1. High risk markers were 17p13– in 9 (33%), 11q22– in 7 (26%), UM IgV and expression of either ZAP–70 or CD38 in 11 (41%). All 27 patients completed therapy without interruption. Non hematological grade 3–4 toxicity occurred in 3 patients (2 drug reactions caused by SMX/TMP, 1 CMV reactivation responsive to IV therapy). Response evaluation at 2 months after completion of therapy using NCI–WG 1996 criteria showed an ORR of 93% with 12 (44%) CR, 8 (30%) nPR, and 5 (19%) PR. Two (7%) patients had disease progression. Median duration of follow up was 14.1 months (range 1.9 – 27.2). Median time to disease progression in the 25 responding patients was 14.4 months (95% CI 5.9 – 22.4). Seven (26%) patients have received subsequent treatment for CLL (median 5.2 months, range 2.4 – 20.1). A minimal residual disease assay using 3-color flow cytometry on peripheral blood was negative in 6 of the 7 patients with CR who had no evidence of residual CLL on immunohistochemical examination of the bone marrow. These 6 patients all remain in sustained CR (median follow up 15 months, range 2 – 27.2). Conclusion: Alemtuzumab and rituximab is an effective and tolerable therapy in patients with high risk early stage CLL. A randomized controlled trial is now required to test if this intervention is better than the standard observation approach. In addition, this combination MoAb regimen could be used as a platform to develop even more effective combination treatments for patients with CLL.

Immunotransplantation for Hematologic Malignancies Using Allogeneic Peripheral Blood Stem Cell Transplantation.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5060-5060
Author(s):  
Sujal Shah ◽  
Edgardo S. Santos ◽  
John Rink ◽  
Todd Roberts ◽  
Hana Safah
Keyword(s):  
High Risk ◽  
Cell Transplantation ◽  
Median Time ◽  
Hematological Malignancies ◽  
Chronic Gvhd ◽  
Conditioning Regimen ◽  
Lymphocytic Leukemia ◽  
High Rate ◽  
Low Grade ◽  
Graft Versus Tumor Effect

Abstract Background: Allogeneic (allo-) transplantation offers a therapeutic option for patients diagnosed with hematological malignancies such as multiple myeloma (MM), chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin’s lymphoma (NHL), and high-risk myelodysplastic syndrome (MDS). Although this approach has shown graft-versus-leukemia effect and potentially being curative, high rate toxicity and treatment-related mortality (TRM) have limited its use other than in the context of clinical trials. The goal of this study was to decrease toxicity of allo- hematopoeitic cell transplantation (HCT) as treatment for patients who had chemosensitive hematological malignancies while allowing the benefit of “graft-versus-tumor” effect by using a non-myeloablative HCT (NM-HCT) approach. Methods: Patients included were newly diagnosed or previously treated MM patients of any stage, NHL patients who failed of ≥ 2 chemotherapies regimens (CHOP and at least one salvage treatment), CLL refractory to standard chemotherapy, and MDS with high-risk cytogenetics. Conditioning regimen consisted of fludarabine at 30 mg/m2/day on days −5, −4, −3 and melphalan at 80 mg/m2 x 2 on days −2 and −1. Graft-versus-host disease (GVHD) prophylaxis included cyclosporine 3 mg/kg intravenous on day −2 and methotrexate at 10 mg/m2 intravenously on days 3, 6, and 11. Results: A total of 17 patients were assessable: 11 MM patients (7 IgG, 1 IgA, 2 light chain restriction, 1 non-secretory MM), 3 NHL patients (1 FL, 1 MCL, 1 LGL-NK cell), 2 CLL, and 1 MDS (with trisomy 8, 5q−) with a median age of 50.4 years old (range, 34 to 60 years). Three patients received more than two regimens prior to NM-HCT. The initial responses to therapy prior to NM-HCT were: 5 CR, 2 nCR, and 10 PR. All patients received identical 6/6 HLA sibling donor stem cells. All patients but one attained CR (94%) after NM-HCT. The median time for ANC engraftment was 15.4 days (range, 10–36 days). Eight patients developed acute GVHD grade I–III (5 skin, 3 gastrointestinal); all of them responded well to methylprednisolone treatment. Nine patients developed chronic GVHD (grade I–II). The 100-day mortality rate was 5.9% (1 patient died at day + 96 without evidence of MM). Post-transplant, all patients have reported a Karnofsky’s scale performance status between 80%–100%. Three patients (all MM) relapsed after 4, 6, and 32 months post-transplantation. Only one patient received auto-HCT, but continues to have progressive disease, and is on thalidomide/dexamethasone. Only 3 patients had relapsed at 5−, 6−, and 25 months (all MM patients). After a median follow-up of 42.5 months (range, 1–78 months), median survival has not been reached. Conclusions: NM-HCT is a feasible treatment option with manageable toxicity profile. TRM was less than those reported for myeloablative HCT, and results suggest a graft-versus-tumor effect on these types of hematological malignancies using a NM-HCT approach based on CR rate observed as well as median time to progression. These encouraging results warrant further investigation.

scholarly journals Clinical and Economic Burden of Tumor Lysis Syndrome Among Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4030-4030
Author(s):  
Kerry Rogers ◽  
Bruno Emond ◽  
Aurélie Côté-Sergent ◽  
Frédéric Kinkead ◽  
Marie-Hélène Lafeuille ◽  
...  
Keyword(s):  
High Risk ◽  
Active Treatment ◽  
Economic Burden ◽  
Research Funding ◽  
Index Date ◽  
Tumor Lysis Syndrome ◽  
Lymphocytic Leukemia ◽  
Small Lymphocytic Lymphoma ◽  
Tumor Lysis ◽  
First 90 Days

Abstract Introduction: Tumor lysis syndrome (TLS) can be a life-threatening complication in patients with hematologic malignancies. In chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), treatment guidelines identify a high risk of TLS for regimens containing anti-CD20-based chemoimmunotherapy (CIT), lenalidomide, obinutuzumab, or venetoclax. Patients who develop TLS require intensive care, adding to the overall clinical and economic burden of CLL/SLL. This study aimed to evaluate the clinical and economic burden of treatment-emergent TLS among patients with CLL/SLL treated with regimens with high risk of TLS. Methods: The IBM MarketScan Research Databases (01/01/2006-04/30/2020) were used to identify adults with CLL/SLL who initiated a CIT-, lenalidomide-, obinutuzumab-, or venetoclax-based regimen on or after 01/01/2007 or upon treatment approval date if post-2007 (index date) and had ≥12 months and ≥30 days of continuous eligibility pre- and post-index date, respectively. Treatment-emergent TLS was defined as developing TLS in the first 90 days of active treatment (based on claims with a TLS diagnosis or laboratory test results). The post-index period was divided into 30-day intervals until the end of the index regimen (earliest of start of next regimen or end of eligibility). Intervals pre-TLS were non-TLS intervals and all intervals starting from the TLS diagnosis were TLS intervals. If TLS occurred after the first 90 days of active treatment (non-treatment-emergent TLS), all intervals were non-TLS intervals and the post-index period was censored at TLS diagnosis. Per-patient-per-month (PPPM) healthcare resource utilization (HRU) and payer paid costs during TLS and non-TLS intervals were compared using rate ratios (RRs) and mean monthly cost differences (MMCDs), respectively, obtained from generalized linear models adjusted for baseline and time-varying confounders. The proportion of patients switching to a next therapy in the first 90 days post-index was compared between patients developing versus not developing TLS using Kaplan-Meier rates with log-rank P-value. Results: Among 6,343 patients with CLL/SLL, 71 (1.1%, mean age: 66.4 years, 26.8% females; 22 treated with venetoclax; mean [median] duration of the entire index regimen: 16.0 [10.0] months) developed TLS during the first 90 days of active treatment and 6,272 (98.9%, mean age: 65.9 years, 34.1% female; 170 treated with venetoclax; mean [median] duration of the entire index regimen: 22.0 [14.5] months) did not. Among all 6,343 patients, there were 1,129 TLS intervals and 138,429 non-TLS intervals observed post-index. All patients incurred considerable cumulative costs over the entire index regimen duration (TLS cohort: $201,200; non-TLS cohort: $158,590). Developing TLS was associated with 1.7 times more inpatient (IP) admissions (P&lt;0.001; Fig. 1a), 2.0 times more days of IP stay (P=0.012), 22% fewer days of antineoplastic drug administration (P=0.020; Fig. 1a), and $3,062 PPPM higher healthcare costs (P=0.016), driven by significantly higher IP costs PPPM (MMCD=$1,688; P=0.044; Fig. 1b) vs. not developing TLS. Higher costs during TLS intervals were observed for patients initiated on a venetoclax-based regimen (TLS intervals: $24,170 PPPM; non-TLS intervals: $20,091 PPPM) and patients initiated on a non-venetoclax-based regimen (TLS intervals: $8,746 PPPM; non-TLS intervals: $6,915 PPPM). In the first 90 days post-index, HRU and costs were higher than when averaged over the entire duration of the index regimen, regardless of developing TLS or not (Table 1). Among patients not developing TLS, those treated with a venetoclax-based regimen had numerically higher cumulative TLS prevention costs during the first 90 days post-index ($4,398) than those treated with a non-venetoclax-based regimen ($2,879). Patients developing TLS switched more quickly to a next line of therapy in the first 90 days of treatment compared to those not developing TLS (12.6% vs. 5.1%, P=0.006; Table 2). Conclusions: In this study of CLL/SLL patients treated with CIT-, lenalidomide-, obinutuzumab-, or venetoclax-based regimens, TLS led to a significant HRU and cost burden (mostly driven by IP admissions) and a higher rate of treatment switching. Consideration of available treatment options based on patient goals and treatment expectations is warranted before selecting a treatment with a high risk of developing TLS. Figure 1 Figure 1. Disclosures Rogers: AstraZeneca: Consultancy; Genentech: Consultancy, Research Funding; Innate Pharma: Consultancy; Pharmacyclics LLC: Consultancy; Janssen Pharmaceuticals, Inc: Research Funding; Acerta Pharma: Consultancy; AbbVie Inc.: Consultancy, Research Funding; ovartis Pharmaceuticals Corporation: Research Funding. Emond: GlaxoSmithKline: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; Pharmacyclics LLC, an AbbVie Company: Consultancy. Côté-Sergent: GlaxoSmithKline: Consultancy; Janssen: Consultancy. Kinkead: Janssen: Consultancy; Otsuka: Consultancy. Lafeuille: Pharmacyclics: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; Pfizer: Consultancy; GlaxoSmithKline: Consultancy. Lefebvre: Pfizer: Consultancy; Pharmacyclics: Consultancy; Otsuka: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy; Novartis: Consultancy; Regeneron: Consultancy. Huang: Johnson & Johnson: Current equity holder in publicly-traded company; Janssen Scientific Affairs, LLC: Current Employment.

Quality management in the prophylaxis of venous thrombembolism - Results of a survey including 464 medical and surgical patients

VASA ◽  
2011 ◽  
Vol 40 (2) ◽  
pp. 123-130
Author(s):  
Klein-Weigel ◽  
Richter ◽  
Arendt ◽  
Gerdsen ◽  
Härtwig ◽  
...  
Keyword(s):  
Renal Function ◽  
High Risk ◽  
Quality Management ◽  
High Risk Group ◽  
Surgical Patients ◽  
Medical Patients ◽  
Risk Status ◽  
Vte Prophylaxis ◽  
Safety Concerns

Background: We surveyed the quality of risk stratification politics and monitored the rate of entries to our company-wide protocol for venous thrombembolism (VTE) prophylaxis in order to identify safety concerns. Patients and methods: Audit in 464 medical and surgical patients to evaluate quality of VTE prophylaxis. Results: Patients were classified as low 146 (31 %), medium 101 (22 %), and high risk cases 217 (47 %). Of these 262 (56.5 %) were treated according to their risk status and in accordance with our protocol, while 9 more patients were treated according to their risk status but off-protocol. Overtreatment was identified in 73 (15.7 %), undertreatment in 120 (25,9 %) of all patients. The rate of incorrect prophylaxis was significantly different between the risk categories, with more patients of the high-risk group receiving inadequate medical prophylaxis (data not shown; p = 0.038). Renal function was analyzed in 392 (84.5 %) patients. In those patients with known renal function 26 (6.6 %) received improper medical prophylaxis. If cases were added in whom prophylaxis was started without previous creatinine control, renal function was not correctly taken into account in 49 (10.6 %) of all patients. Moreover, deterioration of renal function was not excluded within one week in 78 patients (16.8 %) and blood count was not re-checked in 45 (9.7 %) of all patients after one week. There were more overtreatments in surgical (n = 53/278) and more undertreatments in medical patients (n = 54/186) (p = 0.04). Surgeons neglected renal function and blood controls significantly more often than medical doctors (p-values for both < 0.05). Conclusions: We found a low adherence with our protocol and substantial over- and undertreatment in VTE prophylaxis. Besides, we identified disregarding of renal function and safety laboratory examinations as additional safety concerns. To identify safety problems associated with medical VTE prophylaxis and “hot spots” quality management-audits proved to be valuable instruments.

Economic burden of readmission due to postoperative cerebrospinal fluid leak in Chinese patients

2020 ◽  
Vol 9 (16) ◽  
pp. 1105-1115
Author(s):  
Shuqing Wu ◽  
Xin Cui ◽  
Shaoyu Zhang ◽  
Wenqi Tian ◽  
Jiazhen Liu ◽  
...  
Keyword(s):  
Cerebrospinal Fluid ◽  
Generalized Linear Models ◽  
Economic Burden ◽  
Linear Models ◽  
Chinese Patients ◽  
Cerebrospinal Fluid Leakage ◽  
Index Hospitalization ◽  
Real World Data ◽  
Factors Associated ◽  
Hospitalization Cost

Aim: This real-world data study investigated the economic burden and associated factors of readmissions for cerebrospinal fluid leakage (CSFL) post-cranial, transsphenoidal, or spinal index surgeries. Methods: Costs of CSFL readmissions and index hospitalizations during 2014–2018 were collected. Readmission cost was measured as absolute cost and as percentage of index hospitalization cost. Factors associated with readmission cost were explored using generalized linear models. Results: Readmission cost averaged US$2407–6106, 35–94% of index hospitalization cost. Pharmacy costs were the leading contributor. Generalized linear models showed transsphenoidal index surgery and surgical treatment for CSFL were associated with higher readmission costs. Conclusion: CSFL readmissions are a significant economic burden in China. Factors associated with higher readmission cost should be monitored.

scholarly journals 1381. Rotavirus Gastroenteritis among older adults: discussion based on a systematic literature review

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S700-S701
Author(s):  
Cristina Carias ◽  
Susanne Hartwig ◽  
M Nabi Kanibir ◽  
Ya-Ting Chen
Keyword(s):  
Older Adults ◽  
High Risk ◽  
Acute Gastroenteritis ◽  
Rate Ratio ◽  
Rotavirus Gastroenteritis ◽  
Incident Rate Ratio ◽  
The Us ◽  
Incident Rate ◽  
The Uk ◽  
Retrospective Database

Abstract Background While the burden of Rotavirus Gastroenteritis (RGE) is well recognized in young children, it is less so in older adults. However, older adults are also at high-risk of Acute Gastroenteritis (AGE) severe outcomes. In this review, we thus aimed to comprehensively assess RGE burden and vaccination impact in older individuals. Methods We performed a systematic literature review with PubMed and Scopus, from 2000 to 2019, using MESH and free-range terms. We included only studies that reported the incidence, and/or RV vaccination impact, in adults aged 60 and above and using regional specific data-sources. Results We analyzed 11 manuscripts for individuals aged 60 and above (Figure 1). Studies spanned Australia, Sweden, Netherlands, Canada (2), Germany (2), UK (2), and the US (2). Yearly inpatient RV incidence varied between 1.6 per 100,000 in Australia for those 65+ (retrospective database analyses, pre-vaccine); and 26 per 100,000 for those 85+ in Canada (modeling estimates for 2006-10, pre-vaccine). The incidence rate ratio for inpatient RGE between the post and pre-vaccine periods for those 65+ was 0.57 [95% CI: 0.10 – 3.15] in Canada, but 2.24 [95%CI: 1.78-2.83] in Australia, which may be due to increased testing for RV in the elderly post-vaccine. Reductions in the post-vaccination burden of RV and AGE among 60+ were reported in the UK (2 studies), and the US (2 studies) via retrospective database analyses In the UK, post-vaccine reductions in AGE health care-utilization were reported in the Emergency Department (21%), and outpatient centers (walk-in centers: 47%; general practice consultations: 36%). Retrospective database analyses documenting the incident rate ratio (IRR) of Rotavirus Gastroenteritis (RGE) and Acute Gastroenteritis (AGE) in older adults between the pre and post-vaccine period. Retrospective database analyses documenting the incident rate ratio (IRR) of Rotavirus Gastroenteritis (RGE) and Acute Gastroenteritis (AGE) in older adults between the pre and post-vaccine period. Conclusion While the burden of RGE mainly falls on young children, it also affects older adults. Retrospective database analyses reveal that, likely due to indirect vaccination benefits, increases in RV vaccination coverage have had an impact on lowering RGE, and AGE cases and healthcare utilization in older adults, a group at high-risk of severe outcomes for AGE. Disclosures Cristina Carias, PhD, Merck (Employee, Shareholder) Susanne Hartwig, n/a, MSD Vaccins (Employee) M.Nabi Kanibir, MD, Merck/MSD (Employee, Shareholder) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder)

scholarly journals Feasibility of a modified search, coagulation, and clipping method with and without the use of polyglycolic acid sheets and fibrin glue for preventing delayed bleeding after gastric endoscopic submucosal dissection

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Satoshi Abiko ◽  
Soichiro Oda ◽  
Akimitsu Meno ◽  
Akane Shido ◽  
Sonoe Yoshida ◽  
...  
Keyword(s):  
High Risk ◽  
Endoscopic Submucosal Dissection ◽  
Median Time ◽  
Fibrin Glue ◽  
Polyglycolic Acid ◽  
Low Risk ◽  
R0 Resection ◽  
Antithrombotic Agents ◽  
Delayed Bleeding ◽  
Submucosal Dissection

Abstract Background Methods have been developed for preventing delayed bleeding (DB) after gastric endoscopic submucosal dissection (GESD). However, none of the methods can completely prevent DB. We hypothesized that DB could be prevented by a modified search, coagulation, and clipping (MSCC) method for patients at low risk for DB and by combining the use of polyglycolic acid sheets and fibrin glue with the MSCC method (PMSCC method) for patients at high risk for DB (antibleeding [ABI] strategy). This study assessed the technical feasibility of this novel strategy. Method We investigated 123 lesions in 121 consecutive patients who underwent GESD in Kushiro Rosai Hospital between April 2018 and January 2020. The decision for continuation or cessation of antithrombotic agents was based on the Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment. Results Oral antithrombotic agents were administered to 28 patients (22.8%). The en bloc R0 resection rate was 98.4%. The MSCC method and the PMSCC method for preventing DB were performed in 114 and 9 lesions, respectively. The median time of the MSCC method was 16 min, and the median speed (the resection area divided by the time of method used) was 3.6 cm2/10 min. The median time of the PMSCC method was 59 min, and the median speed was 1.3 cm2/10 min. The only delayed procedural adverse event was DB in 1 (0.8%) of the 123 lesions. Conclusions The ABI strategy is feasible for preventing DB both in patients at low risk and in those at high risk for DB after GESD, whereas the PMSCC method may be necessary for reduction of time.

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