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Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.
No full text20.500.12530/87852Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs
Criteria for the selection of paediatric patients susceptible to reconciliation error.
No full text20.500.12530/87892Many medication errors occur during care transitions, which are critical points for patient safety. There is strong evidence in favour of medication reconciliation as a strategy to avoid errors in adults, though few studies have been made in the paediatric setting. Likewise, no recommendations have been established for the selection and/or prioritisation of paediatric patients amenable to reconciliation. A retrospective study was conducted involving patients subjected to reconciliation by a pharmacist on admission to hospital and who experienced at least one reconciliation error between January and November 2018. Univariable and multivariable analyses were performed to identify possible factors associated with reconciliation error, using a logistic regression model to determine the odds ratio (OR) with the corresponding 95% confidence interval (95% CI). The group of patients with at least one reconciliation error included 334 patients, compared with the group of patients without reconciliation errors, which included 1426 patients. It was determined that schoolchildren and adolescent patients had a risk of presenting a reconciliation error on hospital admission that was more than double for younger patients (OR 2.32, 95% CI 1.26 to 4.25, and OR 2.68, 95% CI 1.44 to 4.99, respectively). This risk was multiplied by five if we compared polymedicated patients versus non-polymedicated patients (OR 4.48, 95% CI 3.35 to 5.99). Patients with a neurological or onco-haematological underlying disease had a 12 and 10 times higher risk of presenting a reconciliation error compared with patients with other types of underlying diseases (OR 11.97, 95% CI 7.57 to 18.92, and OR 9.96, 95% CI 6.09 to 16.28, respectively). Finally, patients with narrow therapeutic index medicines in their usual treatment had an almost three times greater risk of presenting a reconciliation error when admitted to the hospital, although this last factor was not determined as an independent risk factor as for the others (OR 2.98, 95% CI 2.22 to 3.99). The paediatric population is characterised by a number of risk factors for reconciliation error. Knowledge of these factors can allow the prioritisation of medication reconciliation in a concrete group of patients. In order to generalise the results obtained in this study, they must be confirmed in other paediatric care settings involving larger samples and different types of patients
Giant Cellulitis-like Sweet Syndrome: Contribution of a New Case and Medical Literature Review
No full text20.500.12530/8789
Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial.
No full text20.500.12530/87855Canakinumab, an interleukin-1 beta inhibitor, previously showed reduced lung cancer incidence and mortality (CANTOS). Here, we compare the efficacy/safety of canakinumab versus placebo in patients with advanced non-small cell lung cancer (NSCLC) who had progressed after platinum-based doublet chemotherapy (PDC) and immunotherapy. CANOPY-2, a randomized, double-blind, phase 3 trial, enrolled adult patients with stage IIIB/IV NSCLC, without EGFR or ALK alterations, who had received one prior PDC regimen and one prior programmed death-1/programmed death-ligand 1 inhibitor and experienced subsequent disease progression. Patients were randomized to canakinumab plus docetaxel or placebo plus docetaxel. A total of 237 patients were randomly allocated: 120 (51 %) to canakinumab and 117 (49 %) to placebo, stratified by histology and prior lines of therapy. Three patients in the placebo arm did not receive study treatment. The trial did not meet its primary endpoint of overall survival: median 10.6 months (95 % confidence interval [CI], 8.2-12.4) for the canakinumab arm and 11.3 months (95 % CI, 8.5-13.8) for the placebo arm (hazard ratio, 1.06 [95 % CI, 0.76-1.48]; one-sided P-value = 0.633). AEs (any grade) were reported in 95 % of patients in the canakinumab group and in 98 % of patients in the placebo group. Grade 3-4 AEs were experienced by 62 % and 64 % of patients in the canakinumab and placebo groups, respectively, and grade 5 AEs were experienced by 8 % and 5 %. Prespecified, post-hoc subgroup analyses showed that patients with undetected circulating tumor DNA (ctDNA) and/or lower levels ( Adding canakinumab to docetaxel did not provide additional benefit for patients with advanced NSCLC who had progressed after PDC and immunotherapy. NCT03626545
Hernia Correction After Liver Transplantation Using Nonvascularized Fascia.
No full text20.500.12530/87912Liver transplantation is an increasingly frequent surgical procedure, with elevated rates of postoperative incisional hernias ranging from 5% to 46%. There are numerous known risk factors for incisional hernia, including the type of incision, patient sex, and presence of comorbidities such as diabetes, ascites, older age, and the use of steroids. Most studies on the treatment of incisional hernias in patients who have undergone liver transplantation have shown consistently high rates of complications. Consequently, we propose the use of nonvascular fascia for the symptomatic treatment of incisional hernias in patients with concomitant liver transplantation. We performed our new technique on 8 patients, who had previously undergone liver transplantation, between January 2019 and January 2023. The patients were examined using imaging techniques during the follow-up period. Of the 8 patients, 7 were liver transplant recipients and 1 was a combined liver-kidney transplant patient. The median donor age was 57 y (5-66 y), whereas the mean recipient age was 58 y (31-66 y). The median patient height and weight were 163 cm (117-185 cm) and 76 kg (17-104 kg), respectively. Immunosuppression did not change in fascia recipients. The median time between transplantation and hernia repair surgery was 41 mo (5-116 mo). The sizes of the aponeurotic defects varied from 6 × 6 to 25 × 20 cm. Two patients experienced complications: one experienced bulging that required reintervention and the other experienced surgical site seroma. There was no mortality related to the use of the technique, and none were reported during follow-up. With its promising results, nonvascularized fascial transplantation can be a successful treatment for incisional hernias in patients who had previously received a liver transplant
Approach to Mycosis Fungoides in children: Consensus-based recommendations.
No full textPediatric Mycosis fungoides (MF) management extrapolates from adult guidelines, despite differing clinical aspects. Recommendations are essential to address unique challenges in this distinct patient group. This project aims to derive consensus recommendations for pediatric MF management. Experts from pediatric dermatology, general dermatology, dermatopathology, and pediatric hematology-oncology (N = 83) were invited to contribute to consensus recommendations. The process involved 3 electronic Delphi rounds, concluding with a final consensus meeting using a modified Nominal Group Technique for unresolved items. Consensus included more clinical severity measures than tumor-node-metastasis-blood staging: pruritus, functional or esthetic impairment (eg, palms, soles, genitalia), quality of life impact, and psychological aspects (eg, embarrassment, anxiety, depression), plus parental anxiety. Ten recommendations were made for managing early and advanced pediatric MF. Disagreement emerged in choosing therapies beyond stage I of the disease. This multinational initiative aimed to standardize optimal pediatric MF management and successfully generated consensus recommendations. Additional work is needed for structured, prospective protocols in advanced-stage pediatric MF. Lack of pediatric hematologists-oncologists and patients' representatives. Documentation of extended clinical severity and outcome measures is recommended. Addressing the need for structured protocols in advanced-stage pediatric MF and implementing systematic, prospective data collection is crucial
Influence of surgical timing on the visual prognosis of patients suffering from a pituitary apoplexy with visual impairment.
No full text20.500.12530/87854Pituitary apoplexy is a clinical syndrome that can cause vision loss and oculomotor (OM) deficits. Neurosurgical decompression is still considered the treatment of choice for those with visual impairment. We aim to explore the influence of timing of neurosurgical decompression on visual outcome. Multicentre retrospective study of patients presenting with pituitary adenoma and pituitary apoplexy who were operated in three Spanish tertiary hospitals between 2008 and 2022. We identified 49 patients with pituitary apoplexy with visual symptoms and were operated. Among the visual symptoms, 35 patients (73%) had visual acuity (VA) impairment and 33 (67%) had an OM nerve paresis. Twenty-three of the 35 patients improved their VA, and 24 of the 33 improved their OM nerve paresis after surgery. The median time between apoplexy to surgery was 10 days (range 0-164). Regarding visual acuity, 50% (3 out of 6) of those operated within 3 days of apoplexy showed improvement, compared to 69% (20 out of 29) of those operated beyond (p = 0.37).Regarding OM paresis, 62.5% (5 out of 8) of those operated within 3 days of apoplexy improved, compared to 76% (19 out of 25) of those operated beyond (p = 0.56).Mean apoplexy to surgery time was 18 ± 19 days in those whose VA improved (vs. 32 ± 51; p = 0.46); and mean apoplexy to surgery time for those whose OM symptoms improved was 21+/- 35 days (vs. 24 +/- 37; p = 0.86). Our results suggest that timing of neurosurgical decompression does not affect the visual outcome of patients with pituitary apoplexy
Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.
No full text20.500.12530/87857Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI). To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease. This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document. Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy. The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5. Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points. HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI. ClinicalTrials.gov Identifier: NCT03772743
Depurative capacity toward medium molecules of the dialyzer Toray NV-U® Hydrolink™: A new hydrophilic membrane to perform online hemodiafiltration.
No full text20.500.12530/87858New dialysis membranes with new properties are being developed to improve efficacy and tolerance. The hemocompatibility of a polymeric biomaterial is influenced by the layer of water at the blood membrane interface. The new dialyzer TORAY NV-U® has a membrane Hydrolink™, designed to suppress platelet adhesion and to improve the hemocompatibility. Until now, there is no experience in online hemodiafiltration (OL-HDF).The objective of the present study is to evaluate the efficacy of this new membrane in OL-HDF therapy compared to another membrane commonly used. Other objectives are to evaluate the inflammatory response, hemodynamic tolerance, and the anticoagulation regimes. This is a prospective pilot study performed in five anuric patients receiving OL-HDF. For 1 month patients were kept with their usual dialyzer FX1000® (FMC). Subsequently, the dialyzer was changed to TORAY NV-U® (Hydrolink®) for 1 month. In the last dialysis session of each dialyzer, blood tests were performed to evaluate inflammation and depurative capacity. We did not find differences in medium size removal molecules and convective volume: FX1000®: 31 ± 9 l per session and Hydrolink™ 30 ± 8 l; p = 0.7); β2microglobulin reduction ratio (RR) FX1000® FMC 83 ± 3%; Hydrolink™ 79 ± 4; p = 0.14; Myoglobin RR FX1000® FMC 72 ± 7%; Hydrolink™ 76 ± 4; p = 0.28. We did not find differences in inflammation parameters: serum IL6 with FX1000® 6.0 ± 4.2 pg/mL; Hydrolink™ 7.6 ± 5.0 pg/mL; p = 0.3.During all sessions with the two dialyzers there was adequate plasmatic filling, reaching 85 % filling. All patients had "good" dialyzer status in all dialysis sessions with TORAY NV-U®, while the dialyzer status with FX1000® was "good" in 20% of the sessions, "medium" in 30%, and "dirty" in the remaining 50% dialysis sessions. The new dialyzer Hydrolink™, TORAY NV-U® is not inferior to perform OL-HDF compared to dialyzers usually used for this therapy, and could allow decrease heparin doses. Further studies with a bigger sample size and longer follow-up will answer if Hydrolink improves inflammation and assess a better hemodynamic tolerance
Characterization of Chronic Graft-versus-host Disease After Haploidentical Stem Cell Transplantation With Posttransplant Cyclophosphamide: A Study on Behalf of GETH-TC.
No full text20.500.12530/87858Chronic graft-versus-host disease (cGVHD) is a cause of late morbidity and nonrelapse mortality (NRM) after allogenic hematopoietic stem cell transplantation (allo-HSCT). Although studies evaluating haploidentical allo-HSCT (haplo-HSCT) using posttransplant cyclophosphamide (PTCy) demonstrate lower cGVHD rates, comprehensive data describing the clinical profile, risk factors, or outcomes of cGVHD within this platform are scarce. We conducted a retrospective multicenter analysis of 389 consecutive patients who underwent haplo-HSCT PTCy in 7 transplant centers of the Spanish Group Grupo Español de Trasplante Hematopoyético y Terapia Celular (GETH-TC) between 2008 and 2020 describing incidence, clinical profile, risk factors, and cGVHD outcomes. Ninety-five patients of 389 developed cGVHD. Our data revealed that the incidence and severity of cGVHD are lower than those reported for HLA-identical transplantation with conventional prophylaxis and that the strongest predictor for cGVHD was previous acute GVHD ( P = 0.031). Also, recipient age ≥60 y ( P = 0.044) was protective against cGVHD. Moreover, patients with moderate cGVHD had longer event-free survival at 3 y than other patients ( P = 0.016) and a lower relapse rate at 3 y ( P = 0.036). Our results support the fact that the incidence and severity of cGVHD are lower than those reported for HLA-identical transplantation with conventional prophylaxis. In this series, patients who develop moderate cGVHD after haplo-HSCT PTCy had a higher overall survival and event-free survival, and lower relapse, suggesting higher graft-versus-leukemia effect. Although this is the largest series focused on characterizing cGVHD in haplo-HSCT PTCy, further prospective studies are needed to confirm the findings