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1.
Arch Orthop Trauma Surg ; 144(5): 2337-2346, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38416136

RESUMEN

PURPOSE: Anemia has been shown to be a modifiable pre-operative, patient factor associated with outcome following arthroplasty. The aims of this retrospective study were to (1) ascertain the prevalence of preoperative anemia in patients undergoing primary and revision hip and knee arthroplasty at a tertiary referral center and (2) to test the association with outcome and whether it differs between primary and revision cases. METHODS: All hip and knee primary and revision arthroplasties performed at a Canadian academic, tertiary-care, arthroplasty center between 2012 and 2017 were included in this study. The study group consisted of 5944 patients, of which 5251 were primary Total Hip and Knee Arthroplasties or Hip Resurfacings and 693 were revision arthroplasties (65% hip revisions/35% knee revisions). Anemia was classified as per WHO definition (hemoglobin < 130 g/L for men and < 120 g/L for women). All anemic patients were grouped into mild, moderate or severe anemia. Length-of-stay, perioperative transfusion-rate, 90-day readmission, overall complication rate and reoperation rates were recorded. The effect of preoperative anemia and the effect of severity of the anemia was evaluated through multivariable regression analysis controlling for relevant covariates. RESULTS: Preoperatively, 15% (786/5251) of the primary patients and 47% (322/693) of the revision arthroplasty patients were anemic preoperatively. Anemic revision patients were 3.1 times more likely (95% CI: 1.47-6.33) to obtain blood transfusions during the hospital stay, compared to a 4.9 times higher risk in primary patients. The odds ratio to sustain any postoperative complication if anemic was 1.5 times higher (95% CI: 0.73-3.16) in revision patients and 1.7 in primary cases. In addition, the 90-day readmission rate among both groups was 1.6 times higher in anemic patients. Furthermore, anemic revision patients had a 5.3 days longer length of stay (95% CI: 2.63-7.91), compared to only 1 additional day in anemic primary patients (95% CI: 0.69-1.34). CONCLUSION: In this study cohort, the prevalence of anemia in patients awaiting revision arthroplasty was 3 times higher (46.6%) than in primary arthroplasty patients (18.7%). Preoperative anemia was associated with similarly, inferior outcomes in both groups. To reduce postoperative complications and the "burden" associated with anemia, these findings strongly recommend optimizing the preoperative hemoglobin in all arthroplasty patients. However, revision patients are affected more frequently, and particular attention must therefore be taken to this growing group in the future. LEVEL OF EVIDENCE: Level III.


Asunto(s)
Anemia , Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Complicaciones Posoperatorias , Reoperación , Humanos , Masculino , Anemia/epidemiología , Femenino , Artroplastia de Reemplazo de Rodilla/estadística & datos numéricos , Artroplastia de Reemplazo de Cadera/estadística & datos numéricos , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Anciano , Prevalencia , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Tiempo de Internación/estadística & datos numéricos , Readmisión del Paciente/estadística & datos numéricos , Transfusión Sanguínea/estadística & datos numéricos , Resultado del Tratamiento
2.
Thromb Res ; 231: 32-38, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37801772

RESUMEN

INTRODUCTION: While several risk stratification tools have been developed to predict the risk of recurrence in patients with an unprovoked venous thromboembolism (VTE), only 1 in 4 patients are categorized as low-risk. Rather than a one-time measure, serial D-dimer assessment holds promise to enhance the prediction of VTE recurrence after oral anticoagulant (OAC) cessation. METHODS: Using the REVERSE cohort, we compared VTE recurrence among patients with normal D-dimer levels (<490 ng/mL among males under age 70, <500 ng/mL in others) at OAC cessation and 1-month follow-up, to those with an elevated D-dimer level at either timepoint. We also evaluated VTE recurrence based on absolute increase in D-dimer levels between the two timepoints (e.g., ∆D-dimer) according to quartiles. RESULTS: Among 214 patients with serial D-dimer levels measured at OAC cessation and 1-month follow-up, an elevated D-dimer level at either timepoint was associated with a numerically higher risk of recurrent VTE than patients with normal D-dimer levels at both timepoints (6.9 % vs. 4.2 % per year, hazard ratio 1.6; 95 % CI 0.9-2.7). Among women with <2 HERDOO2 criteria, a normal D-dimer level at both timepoints predicted a very low risk of recurrent VTE during follow-up (0.8 % per year, 95 % CI 0.1-2.8). Irrespective of baseline value, recurrent VTE risk was only 3 % per year (95 % CI 1.4-5.6) among patients in the lowest ∆D-dimer quartile. CONCLUSION: Serial normal D-dimer levels have the potential to identify patients at a low risk of recurrent VTE. In addition, ∆D-dimer, irrespective of its elevation above cutoff threshold, may predict recurrent VTE.


Asunto(s)
Anticoagulantes , Tromboembolia Venosa , Masculino , Humanos , Femenino , Anciano , Anticoagulantes/efectos adversos , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/inducido químicamente , Estudios de Cohortes , Factores de Riesgo , Recurrencia , Productos de Degradación de Fibrina-Fibrinógeno
3.
J Crohns Colitis ; 17(10): 1624-1630, 2023 Nov 08.
Artículo en Inglés | MEDLINE | ID: mdl-37101357

RESUMEN

BACKGROUND: Accurate tools to distinguish Crohn's disease [CD] from cryptoglandular disease in patients with perianal fistulas without detectable luminal inflammation on ileocolonoscopy and abdominal enterography (isolated perianal fistulas [IPF]) are lacking. We assessed the ability of video capsule endoscopy [VCE] to detect luminal inflammation in patients with IPF. METHODS: We studied consecutive adults [>17 years] with IPF who were evaluated by VCE after a negative ileocolonoscopy and abdominal enterography between 2013 and 2022. We defined luminal CD by VCE as diffuse erythema, three or more aphthous ulcers, or a Lewis score greater than 135. We compared rates of intestinal inflammation in this cohort with age- and sex-matched controls without perianal fistulas, who underwent VCE for other indications. We excluded persons with pre-existing inflammatory bowel disease [IBD] and exposure to non-steroidal anti-inflammatory drugs or immunosuppressive treatments. RESULTS: A total of 45 patients with IPF underwent VCE without complications. Twelve patients [26%] met our definition of luminal CD. Luminal CD was more common in patients with IPF than in controls [26% vs 3%; p <0.01]. Among patients with IPF, male sex (OR [odds ratio], 9.2; 95% confidence interval [CI] [1.1-79.4]), smoking (OR, 4.5; 95% CI [0.9-21.2]), abscess (OR, 6.3; 95% CI [1.5-26.8]), rectal enhancement on magnetic resonance imaging [MRI] (OR, 9.0; 95% CI [0.8-99.3]), and positive antimicrobial serology (OR, 7.1; 95% CI, [0.7-70.0]) were more common in those with a positive VCE study. CONCLUSIONS: VCE detected small intestinal inflammation suggestive of luminal CD in approximately one-quarter of patients with IPF. Larger studies are required to validate these findings.


Asunto(s)
Endoscopía Capsular , Enfermedad de Crohn , Fístula , Fístula Rectal , Adulto , Humanos , Masculino , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/diagnóstico , Imagen por Resonancia Magnética , Inflamación/complicaciones , Fístula/complicaciones , Fístula Rectal/diagnóstico por imagen , Fístula Rectal/etiología
4.
Crit Care Med ; 51(3): e73-e80, 2023 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-36728823

RESUMEN

OBJECTIVES: The Age of Blood Evaluation (ABLE) study reported no clinical benefit in fresher compared with standard delivery RBC units (length of storage: 6.9 ± 4.1 vs 22.0 ± 8.4 d, respectively). Perioperative patients are often anemic, at risk of blood loss, and more exposed to RBC transfusions. We address the question whether fresh RBC units are safer than standard delivery RBC units in perioperative ICU patients. DESIGN: Subgroup analysis of surgical nontrauma adults enrolled in the ABLE randomized controlled trial. SETTING: ICUs. PATIENTS: Three hundred twenty surgical patients among the 2,510 ICU adults recruited in the ABLE study who had a request for a first RBC transfusion in the first week in ICU stay and an anticipated length of mechanical ventilation greater than or equal to 48 hours. We included perioperative patients but excluded elective cardiac surgery and trauma. INTERVENTIONS: Surgical participants were allocated to receive either RBC units stored less than or equal to 7 days or standard issue RBC. MEASUREMENTS AND MAIN RESULTS: The primary outcome was 90-day all-cause mortality. One hundred seventy-two perioperative patients were allocated to the fresh and 148 to the standard group. Baseline data were similar. The length of storage was 7.2 ± 6.4 in fresh and 20.6 ± 8.4 days in standard group ( p < 0.0001). The 90-day mortality was 29.7% and 28.4%, respectively (absolute risk difference: 0.01; 95% CI -0.09 to 0.11; p = 0.803). No significant differences were observed for all secondary outcomes, including 6-month mortality, even after adjustment for age, country, and Acute Physiology and Chronic Health Evaluation score. CONCLUSIONS: There was no evidence that fresh red cells improved outcomes as compared to standard issue red cells in critically ill surgical patients, consistent with other patients enrolled in the ABLE trial.


Asunto(s)
Anemia , Enfermedad Crítica , Humanos , Adulto , Conservación de la Sangre , Transfusión de Eritrocitos , Eritrocitos , Anemia/etiología
5.
Am J Sports Med ; 51(2): 323-330, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36453726

RESUMEN

BACKGROUND: Despite recent advances in arthroscopic rotator cuff repair, the retear rate remains high. New methods to optimize healing rates must be sought. Bone channeling may create a quicker and more vigorous healing response by attracting autologous mesenchymal stem cells, cytokines, and growth factors to the repair site. HYPOTHESIS: Arthroscopic rotator cuff repair with bone channeling would result in a higher healing rate compared with arthroscopic rotator cuff repair without adjuvant channeling. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Secondary objectives included comparisons of the Western Ontario Rotator Cuff Index (WORC) score, American Shoulder and Elbow Surgeons (ASES) score, Constant score, Constant strength subscore, and visual analog scale (VAS) for pain score between groups. Patients undergoing arthroscopic rotator cuff repair were recruited at 3 sites and were randomized to receive either bone channeling augmentation or standard repair. Healing was determined via ultrasound at 24 months postoperatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12, and 24 months postoperatively. RESULTS: A total of 168 patients were enrolled between 2013 and 2018. Intention-to-treat analysis revealed no statistical differences in healing rates between the 2 interventions at 24 months postoperatively. Statistically significant improvements occurred in both groups from preoperatively to all time points for the WORC, the ASES score, the Constant score or Constant strength subscore, and the VAS for pain (P < .0001). No differences were observed between the bone channeling and control groups in WORC, ASES, Constant, and VAS pain scores at any time point. CONCLUSION: This trial did not demonstrate the superiority of intraoperative bone channeling in rotator cuff repair over standard rotator cuff repair at 24 months postoperatively. Healing rates, patient-reported function, and quality-of-life outcomes were similar between groups. REGISTRATION: NCT01877772 (ClinicalTrials.gov identifier).


Asunto(s)
Lesiones del Manguito de los Rotadores , Manguito de los Rotadores , Humanos , Manguito de los Rotadores/cirugía , Lesiones del Manguito de los Rotadores/cirugía , Resultado del Tratamiento , Hombro , Artroscopía/métodos , Dolor
6.
Inflamm Bowel Dis ; 29(5): 763-770, 2023 05 02.
Artículo en Inglés | MEDLINE | ID: mdl-35815783

RESUMEN

BACKGROUND: Multidisciplinary care involving exam under anesthesia (EUA) and tumor necrosis factor (TNF) inhibitors is recommended for perianal Crohn's disease. However, the impact of this combined approach is not well established. METHODS: We performed a comparative cohort study between 2009 and 2019. Patients with perianal Crohn's disease treated with EUA before anti-TNF therapy (combined modality therapy) were compared with anti-TNF alone. The primary outcome was fistula closure assessed clinically. Secondary outcomes included subsequent local surgery and fecal diversion. Multivariable analysis adjusted for abscesses, concomitant immunomodulators, and time to anti-TNF initiation was performed. RESULTS: Anti-TNF treatment was initiated 188 times in 155 distinct patients: 66 (35%) after EUA. Abscesses (50% vs 15%; P < .001) and concomitant immunomodulators (64% vs 50%; P = .07) were more common in the combined modality group, while age, smoking status, disease duration, and intestinal disease location were not significantly different. Combined modality therapy was not associated with higher rates of fistula closure at 3 (adjusted odds ratio [aOR], 0.7; 95% confidence interval [CI], 0.3-1.8), 6 (aOR, 0.8; 95% CI, 0.4-2.0) and 12 (aOR, 1.0; 95% CI, 0.4-2.2) months. After a median follow-up of 4.6 (interquartile range, 5.95; 2.23-8.18) years, combined therapy was associated with subsequent local surgical intervention (adjusted hazard ratio, 2.2; 95% CI, 1.3-3.6) but not with fecal diversion (adjusted hazard ratio, 1.3; 95% CI, 0.45-3.9). Results remained consistent when excluding patients with abscesses and prior biologic failure. CONCLUSIONS: EUA before anti-TNF therapy was not associated with improved clinical outcomes compared with anti-TNF therapy alone, suggesting that EUA may not be universally required. Future prospective studies controlling for fistula severity are warranted.


This comparative cohort study found that an exam under anesthesia before initiation of anti-tumor necrosis factor therapy in perianal Crohn's disease was not associated with higher rates of fistula closure, suggesting that an exam under anesthesia may not be universally required in patients with perianal Crohn's disease.


Asunto(s)
Anestesia , Enfermedad de Crohn , Fístula Rectal , Humanos , Estudios de Cohortes , Enfermedad de Crohn/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Estudios Prospectivos , Absceso , Fístula Rectal/tratamiento farmacológico , Factores Inmunológicos/uso terapéutico , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa/uso terapéutico , Estudios Retrospectivos , Infliximab/uso terapéutico
7.
Sci Rep ; 12(1): 1337, 2022 01 25.
Artículo en Inglés | MEDLINE | ID: mdl-35079040

RESUMEN

Delayed entry of blood culture bottles is frequent in consolidated laboratories. A retrospective study evaluated time from insertion to detection and total detection time as a function of preincubation time, and we prospectively looked for false negative results. 69,604 blood culture bottles were reviewed for preincubation time, incubation time and total detection time. Positive cultures for specific bacterial subtypes were reviewed to assess the effect of preincubation time on likelihood of detection. 492 negative blood cultures were prospectively tested by 16S RNA PCR and Staphylococcus-specific PCR for the presence of bacterial DNA. Mean preincubation time for samples collected within the city-limits was 3.94 h versus 9.49-18.89 h for other client sites. Higher preincubation times were partially mitigated by a lower incubation time, with an overall increase in total detection time. A lower odds ratio of recovery of Staphylococcus spp was identified, but not confirmed by terminal subcultures and molecular assays. Prolonged preincubation of blood cultures affects total detection time despite a reduction in incubation time. Successful centralization of microbiological services may depend upon optimization of courier routes for inoculated blood culture bottles. Our data supports consideration for an increase in suggested maximum preincubation times.


Asunto(s)
Técnicas Bacteriológicas/métodos , Medios de Cultivo , ADN Bacteriano/análisis , Staphylococcus/aislamiento & purificación , Humanos , Estudios Retrospectivos
8.
Psychol Health Med ; 27(8): 1813-1820, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-34281438

RESUMEN

Burnout is a growing concern, with significant negative consequences for physicians and patient care. Burnout is negatively associated with physician empathy, while resilience may be a protective factor against the development of burnout but few studies have examined all three constructs in the same cohort. Understanding the associations between these constructs could aid in the development of interventions for physicians experiencing burnout and improve the delivery of compassionate care. We conducted a cross-sectional survey to determine levels of burnout, empathy and resilience in a sample of academic physicians and investigate the relationships between these variables. Validated scales were administered online to measure burnout (Maslach Burnout Inventory - Human Services Survey, MBI-HSS), empathy (Jefferson Scale of Empathy - Physicians/Health Professions Version, JSE) and resilience (Connor-Davidson Resilience Scale, CD-RISC). Descriptive statistics, correlation coefficients, and group comparisons were examined. Eighty-three physicians completed the JSE and CD-RISC, while a subset of 49 physicians also completed the MBI-HSS. Response rates were 31.9% and 18.8%, respectively. High burnout was reported by 49% of the sample. Physicians with high burnout reported lower levels of resilience than those who were not burnt-out. No differences in levels of empathy were observed between these two groups. Older physicians (>45 years) reported higher resilience scores than younger physicians. Resilience and empathy were significantly positively correlated. The reported rate of physician burnout in this sample of academic physicians is concerning, with burnout associated with lower levels of resilience. Further research is required to explore the relationship between physician age and resilience, the impact of resilience-building interventions on burnout and empathy in physicians, and how modifying these variables influences the delivery of compassionate care for patients.


Asunto(s)
Agotamiento Profesional , Médicos , Agotamiento Profesional/epidemiología , Estudios Transversales , Empatía , Humanos , Encuestas y Cuestionarios
9.
Ann Intensive Care ; 11(1): 174, 2021 Dec 13.
Artículo en Inglés | MEDLINE | ID: mdl-34902089

RESUMEN

BACKGROUND: Hemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treatments in the ICU. Intravenous hyperoncotic albumin may prevent hypotension and facilitate ultrafiltration. In this feasibility trial, we sought to determine if a future trial, powered to evaluate clinically relevant outcomes, is feasible. METHODS: This single-center, blinded, placebo-controlled, randomized feasibility trial included patients with acute kidney injury who started SLED in the ICU. Patients were randomized to receive 25% albumin versus 0.9% saline (control) as 100 mL boluses at the start and midway through SLED, for up to 10 sessions. The recruitment rate and other feasibility outcomes were determined. Secondary exploratory outcomes included ultrafiltration volumes and metrics of hemodynamic instability. RESULTS: Sixty patients (271 SLED sessions) were recruited over 10 months. Age and severity of illness were similar between study groups. Most had septic shock and required vasopressor support at baseline. Protocol adherence occurred for 244 sessions (90%); no patients were lost to follow-up; no study-related adverse events were observed; open label albumin use was 9% and 15% in the albumin and saline arms, respectively. Ultrafiltration volumes were not significantly different. Compared to the saline group, the albumin group experienced less hemodynamic instability across all definitions assessed including a smaller absolute decrease in systolic blood pressure (mean difference 10.0 mmHg, 95% confidence interval 5.2-14.8); however, there were significant baseline differences in the groups with respect to vasopressor use prior to SLED sessions (80% vs 61% for albumin and saline groups, respectively). CONCLUSIONS: The efficacy of using hyperoncotic albumin to prevent hemodynamic instability in critically ill patients receiving SLED remains unclear. A larger trial to evaluate its impact in this setting, including evaluating clinically relevant outcomes, is feasible. Trial registration ClinicalTrials.gov (NCT03665311); First Posted: Sept 11th, 2018. https://clinicaltrials.gov/ct2/show/NCT03665311?term=NCT03665311&draw=2&rank=1.

10.
PLoS One ; 16(8): e0255538, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34347804

RESUMEN

This study investigated the association between post-stroke fatigue and inability to return to work/drive in young patients aged <60 years with first stroke who were employed prior to infarct while controlling for stroke severity, age, extent of disability, cognitive function, and depression. The Fatigue Severity Scale (FSS) was used to evaluate post-stroke fatigue in this 1-year prospective cohort study. Follow-ups were completed at 3, 6, and 12 months post rehabilitation discharge. A total of 112 patients were recruited, 7 were excluded, due to loss to follow-up (n = 6) and being palliative (n = 1), resulting in 105 participants (71% male, average age 49 ±10.63 years). Stroke patients receiving both inpatient and outpatient rehabilitation were consecutively recruited. Persistent fatigue remained associated with inability to return to work when controlling for other factors at 3 months (adjusted OR = 18, 95% CI: 2.9, 110.3, p = 0.002), 6 months (adjusted OR = 29.81, 95% CI: 1.7, 532.8, p = 0.021), and 12 months (adjusted OR = 31.6, 95% CI: 1.8, 545.0, p = 0.018). No association was found between persistent fatigue and return to driving. Fatigue at admission was associated with inability to return to work at 3 months but not return to drive. Persistent fatigue was found to be associated with inability to resume work but not driving. It may be beneficial to routinely screen post-stroke fatigue in rehabilitation and educate stroke survivors and employers on the impacts of post-stroke fatigue on return to work.


Asunto(s)
Personas con Discapacidad/psicología , Fatiga/epidemiología , Reinserción al Trabajo/estadística & datos numéricos , Rehabilitación de Accidente Cerebrovascular/métodos , Accidente Cerebrovascular/complicaciones , Sobrevivientes/psicología , Fatiga/etiología , Fatiga/psicología , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Reinserción al Trabajo/psicología
11.
Spine (Phila Pa 1976) ; 46(18): E998-E1005, 2021 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-34435993

RESUMEN

STUDY DESIGN: A pilot, two-group pretest-posttest randomized controlled, single blinded study. OBJECTIVE: Our study aim was to compare the changes in low back pain level, fear avoidance, neurodynamic mobility, and function after early versus later exercise intervention following a unilateral lumbar microdiscectomy. SUMMARY OF BACKGROUND DATA: Exercise is commonly recommended to patients following a lumbar microdiscectomy although controversy remains as to the timing and protocols for exercise intervention. METHODS: Forty patients were randomly allocated to early (Group 1) or later (Group 2) exercise intervention group. The low back pain and fear avoidance were evaluated using Oswestry Low Back Pain Disability Questionnaire, Numeric Pain Rating Scale, and Fear-Avoidance Beliefs Questionnaire. The neurodynamic mobility and function were recorded with Dualer Pro IQ Inclinometer, 50-foot walk test, and Patient-Specific Functional Scale. Two-sided t test for continuous variables and chi-square or Fisher exact test for categorical variables were used to compare the two groups' demographic data. The Wilcoxon signed-rank and rank-sum tests were used to compare the changes and the differences, respectively, in low back pain, fear avoidance, neurodynamic mobility, and function between baseline (before surgery) and postoperative repeated measurements (at 1-2, 4-6, and 8-10 wks after surgery) within each study group, after exercise intervention. RESULTS: Both groups showed a significant decrease in low back pain levels and fear avoidance as well as a significant improvement in neurodynamic mobility and function at 4 and 8 weeks after surgery. However, no significant difference was reported between the two groups. CONCLUSION: Our study results showed that early exercise intervention after lumbar microdiscectomy is safe and may reduce the low back pain, decrease fear avoidance, and improve neurodynamic mobility and function. A randomized controlled trial is needed to evaluate the early exercise intervention's effectiveness after lumbar microdiscectomy, and thus validate our findings.Level of Evidence: 4.


Asunto(s)
Terapia por Ejercicio , Dolor de la Región Lumbar , Evaluación de la Discapacidad , Discectomía , Ejercicio Físico , Humanos , Dolor de la Región Lumbar/cirugía , Proyectos Piloto , Resultado del Tratamiento
12.
BMJ ; 373: n1205, 2021 06 09.
Artículo en Inglés | MEDLINE | ID: mdl-34108229

RESUMEN

OBJECTIVE: To determine the efficacy and safety of dalteparin postoperative bridging treatment versus placebo for patients with atrial fibrillation or mechanical heart valves when warfarin is temporarily interrupted for a planned procedure. DESIGN: Prospective, double blind, randomised controlled trial. SETTING: 10 thrombosis research sites in Canada and India between February 2007 and March 2016. PARTICIPANTS: 1471 patients aged 18 years or older with atrial fibrillation or mechanical heart valves who required temporary interruption of warfarin for a procedure. INTERVENTION: Random assignment to dalteparin (n=821; one patient withdrew consent immediately after randomisation) or placebo (n=650) after the procedure. MAIN OUTCOME MEASURES: Major thromboembolism (stroke, transient ischaemic attack, proximal deep vein thrombosis, pulmonary embolism, myocardial infarction, peripheral embolism, or vascular death) and major bleeding according to the International Society on Thrombosis and Haemostasis criteria within 90 days of the procedure. RESULTS: The rate of major thromboembolism within 90 days was 1.2% (eight events in 650 patients) for placebo and 1.0% (eight events in 820 patients) for dalteparin (P=0.64, risk difference -0.3%, 95% confidence interval -1.3 to 0.8). The rate of major bleeding was 2.0% (13 events in 650 patients) for placebo and 1.3% (11 events in 820 patients) for dalteparin (P=0.32, risk difference -0.7, 95% confidence interval -2.0 to 0.7). The results were consistent for the atrial fibrillation and mechanical heart valves groups. CONCLUSIONS: In patients with atrial fibrillation or mechanical heart valves who had warfarin interrupted for a procedure, no significant benefit was found for postoperative dalteparin bridging to prevent major thromboembolism. TRIAL REGISTRATION: Clinicaltrials.gov NCT00432796.


Asunto(s)
Anticoagulantes/administración & dosificación , Fibrilación Atrial/complicaciones , Dalteparina/administración & dosificación , Prótesis Valvulares Cardíacas/efectos adversos , Procedimientos Quirúrgicos Operativos , Tromboembolia/prevención & control , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Estudios Prospectivos , Tromboembolia/etiología , Warfarina/administración & dosificación
13.
J Thromb Haemost ; 19(6): 1526-1532, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33724705

RESUMEN

INTRODUCTION: The risk of recurrent venous thromboembolism (VTE) after combined oral contraceptive (COC) use is variably reported. We assessed the long-term risk of recurrent VTE in women on COC at the time of a first VTE, in comparison to women without COC use. Our secondary aim assessed the impact of COC use on the recurrent VTE risk in high-risk and low-risk hyperpigmentation, edema, or redness in either leg; D-dimer level ≥250 µg/L; obesity with body mass index ≥30; or older age, ≥65 years (HERDOO2) subgroups. METHODS: The REVERSE cohort study derived the HERDOO2 clinical decision rule to predict recurrent VTE in patients who discontinued anticoagulation after 5-7 months for a first unprovoked VTE. Incidence rates of recurrent VTE among women with and without COC exposure were calculated as the number of recurrent VTE over the number of person-years of follow-up, and Cox proportional hazards model was used to compare risks between groups. RESULTS: The risk of recurrent VTE among COC users was 1.1% (95% confidence interval [CI] 0.3-2.9) per patient-year as compared with 3.2% per patient-year (95% CI 2.4-4.3) among nonusers (hazard ratio 0.37; 95% CI 0.1-1.0). Women who were COC users and high risk by HERDOO2 score had a recurrence rate of 3.5% (95% CI 0.4-12.5) compared with 6.1% (95% CI 4.3-8.5) among women who were non-COC users and at high risk by HERDOO2 score (HR 0.6, 95% CI 0.1-2.5). CONCLUSIONS: Women who were COC users at the time of an otherwise unprovoked VTE event had a lower VTE recurrence rate during long-term follow-up, compared with nonusers. The use of HERDOO2 rule may help identify higher risk women with COC use.


Asunto(s)
Tromboembolia Venosa , Anciano , Anticoagulantes/efectos adversos , Estudios de Cohortes , Anticonceptivos , Femenino , Humanos , Recurrencia Local de Neoplasia , Recurrencia , Factores de Riesgo , Tromboembolia Venosa/inducido químicamente , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiología
14.
J Can Assoc Gastroenterol ; 3(4): 169-176, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32671326

RESUMEN

BACKGROUND AND AIMS: Rates and predictors of complications among hospitalized ulcerative colitis (UC) patients requiring high-dose corticosteroids have not been well-characterized, especially in the era of biologics. METHODS: We retrospectively studied consecutive UC admitted for a colitis flare requiring high-dose corticosteroids between April 2006 and December 2016. We evaluated rates and determinants of serious in-hospital complications (colitis-related complications, systemic complications, peri-operative complications and death) and colectomy. We performed multivariable logistic regression analysis to assess the independent association between day 3 steroid response and the risk of incurring in-hospital complications and colectomy. RESULTS: Of 427 consecutive admissions, serious in-hospital complications occurred in 87 cases (20%), while colitis-related complications occurred in 47 cases (11%). There were significantly fewer colitis-related complications during the 2012 to 2016 period as compared to the 2006 to 2011 period (7% versus 16%, P < 0.01), but significantly more systemic complications (16% versus 5%, P = 0.001). In-hospital colectomy occurred in 50 hospitalizations (12%). Day 3 steroid response was achieved in 167 hospitalizations (39%). Day 3 steroid nonresponse was significantly associated with colitis-related complications among males (adjusted odds ratio [aOR] 8.22, 95% confidence interval [CI] 1.77 to 38.17), but not among females (aOR 1.39, 95% CI 0.54 to 3.60). Older age, C. difficile infection and admission to a non-gastroenterology service were also associated with a higher risk of in-hospital complications. Day 3 steroid nonresponse was significantly associated with in-hospital colectomy (aOR 10.10, 95% CI 3.56 to 28.57). CONCLUSION: In our series of UC hospitalizations for a colitis flare, absence of day 3 steroid response was associated with an increased risk of colitis-related complications among males and of in-hospital colectomy. Clinicians should recognize the importance of early steroid response as a marker to guide the need for treatment optimization.

15.
J Assist Reprod Genet ; 37(8): 1895-1901, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32449098

RESUMEN

PURPOSE: There is controversy whether teratospermia is associated with poorer IVF outcomes and if ICSI may overcome this deficit. The debate likely lies in study heterogeneity, poor adjustment for confounders, and inter-observer variation in sperm morphology assessment. Given the current literature, a shift in practice was implemented at our center in February 2017, whereby teratospermia was no longer a criterion for ICSI. We hypothesized that, despite decreasing ICSI rates, we would see no change in ART outcomes. METHODS: A retrospective study was performed including 1821 couples undergoing IVF/ICSI at a single center from January 2016 to December 2018, divided into cohorts before and after the practice change. The primary outcome of clinical pregnancy and secondary outcomes of fertilization, fertilization failure, good quality blastocyst formation, embryo utilization, positive hCG, and miscarriage rates was compared, adjusting for potential confounders. Subgroup analysis was performed evaluating teratospermia as the only reason for a male factor infertility diagnosis. RESULTS: Despite a decrease in ICSI rate of 30.3%, we found no significant difference in clinical intrauterine pregnancy rate, with an adjusted relative risk of 0.93 (0.81, 1.07, P = 0.3008). There were no significant differences in other secondary outcomes after multivariate adjustment. Subgroup analysis for those with male factor infertility due to teratospermia showed no difference in outcomes. CONCLUSION: This study concurs with the recent data suggesting that employing ICSI solely for teratospermia is unnecessary. This may allow clinics to decrease ICSI rates without sacrificing success rates, leading to lower cost and risk associated with treatment.


Asunto(s)
Fertilización In Vitro , Infertilidad Masculina/genética , Inyecciones de Esperma Intracitoplasmáticas , Teratozoospermia/fisiopatología , Adulto , Tasa de Natalidad , Desarrollo Embrionario/genética , Femenino , Humanos , Infertilidad Masculina/fisiopatología , Infertilidad Masculina/terapia , Nacimiento Vivo , Masculino , Embarazo , Índice de Embarazo , Estudios Retrospectivos , Teratozoospermia/genética
16.
Leuk Lymphoma ; 61(1): 156-164, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31387422

RESUMEN

Patients with hematological malignancies (HM) or undergoing hematopoietic cell transplantation (HCT) require reliable vascular access. Peripherally inserted central catheters (PICC) meet this need, however, studies suggest these patients have higher rates of PICC-associated complications. This retrospective cohort study evaluates the influence of PICC type on the rates and incidences of complications. Four hundred and eighty-five dual lumen PICCs were inserted into 469 complex patients with HM or undergoing HCT: 161 Groshong®, 60 PowerPICC® Solo, 165 BioFlo®, and 99 Arrow®. The rates and incidences of complications differed significantly across the PICC types. The overall rate of complication ranged from 7.40 to 26.4/1000 catheter days (CDs). The rate of deep vein thrombosis (0.31-1.48/1000 CDs) and occlusion differed across the PICC types, while the rate of central line-associated bloodstream infection (0.53-0.74/1000 CDs) did not. Following multivariate adjustment, PICC type was associated with complication rate. This highlights that PICC type should be considered in clinical decisions.


Asunto(s)
Infecciones Relacionadas con Catéteres , Cateterismo Venoso Central , Cateterismo Periférico , Neoplasias Hematológicas , Infecciones Relacionadas con Catéteres/epidemiología , Infecciones Relacionadas con Catéteres/etiología , Cateterismo Venoso Central/efectos adversos , Cateterismo Periférico/efectos adversos , Catéteres , Catéteres de Permanencia/efectos adversos , Neoplasias Hematológicas/complicaciones , Neoplasias Hematológicas/epidemiología , Neoplasias Hematológicas/terapia , Humanos , Incidencia , Estudios Retrospectivos , Factores de Riesgo
18.
Dig Dis Sci ; 65(6): 1784-1789, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-31642006

RESUMEN

BACKGROUND: Complex perianal fistulas occurring in the absence of luminal inflammation (isolated perianal disease, IPD) may represent a specific phenotype of Crohn's disease (CD). AIM: We assessed the effectiveness of tumor necrosis factor (TNF)-antagonists in patients with IPD compared to those with perianal CD (PCD) with luminal inflammation. METHODS: Patients were identified through our institutional radiology database and were classified as PCD or IPD based on the presence or absence of luminal inflammation by ileocolonoscopy and abdominal enterography. Consecutive adults (> 17 years) with recurrent IPD who were treated with TNF antagonists were matched by age and gender to patients with complex PCD (1:2 ratio). Fistula remission was defined as an absence of fistula drainage. Surgery-free survival was assessed by Cox proportional hazard models. RESULTS: Twenty-two patients with IPD treated with a TNF antagonist were compared with 44 matched patients with PCD. A similar proportion of patients with IPD and PCD were treated with concomitant immunomodulators (55% vs. 66%) and underwent examinations under anesthesia prior to therapy (36% vs. 46%). Fistula remission at 3, 6, and 12 months was lower for the IPD cohort: 9.5% versus 34%; 19% versus 39%; and 19% versus 43%. Surgical intervention after initiating anti-TNF therapy was more common for patients with IPD (HR 3.99: 95% CI, 1.62-9.83; p = 0.0026). CONCLUSIONS: Fewer patients with IPD achieved fistula remission, and more required surgical intervention after anti-TNF therapy, suggesting that TNF antagonists may not be as effective in these patients.


Asunto(s)
Adalimumab/uso terapéutico , Enfermedad de Crohn/complicaciones , Infliximab/uso terapéutico , Fístula Rectal/tratamiento farmacológico , Fístula Rectal/etiología , Antiinflamatorios/uso terapéutico , Estudios de Cohortes , Femenino , Fármacos Gastrointestinales/uso terapéutico , Humanos , Masculino , Estudios Retrospectivos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores
19.
BMJ ; 366: l4363, 2019 07 24.
Artículo en Inglés | MEDLINE | ID: mdl-31340984

RESUMEN

OBJECTIVES: To determine the rate of a first recurrent venous thromboembolism (VTE) event after discontinuation of anticoagulant treatment in patients with a first episode of unprovoked VTE, and the cumulative incidence for recurrent VTE up to 10 years. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, and the Cochrane Central Register of Controlled Trials (from inception to 15 March 2019). STUDY SELECTION: Randomised controlled trials and prospective cohort studies reporting symptomatic recurrent VTE after discontinuation of anticoagulant treatment in patients with a first unprovoked VTE event who had completed at least three months of treatment. DATA EXTRACTION AND SYNTHESIS: Two investigators independently screened studies, extracted data, and appraised risk of bias. Data clarifications were sought from authors of eligible studies. Recurrent VTE events and person years of follow-up after discontinuation of anticoagulant treatment were used to calculate rates for individual studies, and data were pooled using random effects meta-analysis. Sex and site of initial VTE were investigated as potential sources of between study heterogeneity. RESULTS: 18 studies involving 7515 patients were included in the analysis. The pooled rate of recurrent VTE per 100 person years after discontinuation of anticoagulant treatment was 10.3 events (95% confidence interval 8.6 to 12.1) in the first year, 6.3 (5.1 to 7.7) in the second year, 3.8 events/year (95% confidence interval 3.2 to 4.5) in years 3-5, and 3.1 events/year (1.7 to 4.9) in years 6-10. The cumulative incidence for recurrent VTE was 16% (95% confidence interval 13% to 19%) at 2 years, 25% (21% to 29%) at 5 years, and 36% (28% to 45%) at 10 years. The pooled rate of recurrent VTE per 100 person years in the first year was 11.9 events (9.6 to 14.4) for men and 8.9 events (6.8 to 11.3) for women, with a cumulative incidence for recurrent VTE of 41% (28% to 56%) and 29% (20% to 38%), respectively, at 10 years. Compared to patients with isolated pulmonary embolism, the rate of recurrent VTE was higher in patients with proximal deep vein thrombosis (rate ratio 1.4, 95% confidence interval 1.1 to 1.7) and in patients with pulmonary embolism plus deep vein thrombosis (1.5, 1.1 to 1.9). In patients with distal deep vein thrombosis, the pooled rate of recurrent VTE per 100 person years was 1.9 events (95% confidence interval 0.5 to 4.3) in the first year after anticoagulation had stopped. The case fatality rate for recurrent VTE was 4% (95% confidence interval 2% to 6%). CONCLUSIONS: In patients with a first episode of unprovoked VTE who completed at least three months of anticoagulant treatment, the risk of recurrent VTE was 10% in the first year after treatment, 16% at two years, 25% at five years, and 36% at 10 years, with 4% of recurrent VTE events resulting in death. These estimates should inform clinical practice guidelines, enhance confidence in counselling patients of their prognosis, and help guide decision making about long term management of unprovoked VTE. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017056309.


Asunto(s)
Anticoagulantes/uso terapéutico , Medición de Riesgo/métodos , Tromboembolia Venosa , Privación de Tratamiento , Humanos , Recurrencia , Tiempo , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/fisiopatología
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