Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up.

BACKGROUND: Patient self-management (PSM) of vitamin K antagonists (VKA) seems a very promising model of care for oral anticoagulation in terms of efficacy and safety. In comparison with other management models of VKA therapy, the number of scientific publications supporting the advantages of PSM is more limited. Currently, most of the scarce information comes from randomized clinical trials. Moreover, a small number of studies have assessed PSM of VKA therapy in real life conditions. METHODS: We analyzed clinical outcomes of 927 patients in a single center (6018.6 patient-years of follow-up). Recruitment took place between 2002 and 2017. All patients followed a structured training program, conducted by specialized nurses. RESULTS: Fifty percent of individuals had a mechanical heart valve (MHV), 23% suffered from recurrent venous thromboembolism (VTE) or high-risk thrombophilia, and 13% received VKA therapy because of atrial fibrillation (AF). Median follow-up was 6.5 years (range 0.1-15.97 years), median age was 58.1 years (IQR 48-65.9) and 46.5% were women. The incidence of major complications (either hemorrhagic or thromboembolic) was 1.87% patient-years (pt-ys) with a 95% CI of 1.54-2.27. The incidence of major thromboembolic events was 0.86% pt-ys (95% CI 0.64-1.13) and that of major hemorrhagic events was 1.01% pt-ys (95% CI 0.77-1.31). The incidence of intracranial bleeding was 0.22% pt-ys (95% CI 0.12-0.38). In terms of clinical indication for VKA therapy, the incidence of total major complications was 2.4% pt-ys, 2.0% pt-ys, 0.9% pt-ys and 1.34% pt-ys for MHV, AF, VTE and other (including valvulopathies and myocardiopathies), respectively. Clinical outcomes were worse in patients with multiple comorbidities, previous major complications during conventional VKA therapy, and in older individuals. The percentage of time in therapeutic range (TTR) was available in 861 (93%) patients. Overall, the mean (SD) of TTR was 63.6 ± 13.4%, being higher in men (66.2 ± 13.1%) than women (60.6 ± 13.2%), p < 0.05. CONCLUSIONS: In terms of clinically relevant outcomes (incidence of major complications and mortality), PSM in real life setting seems to be a very good alternative in properly trained patients.

[Oral ketamine-midazolam premedication of uncooperative patients in major outpatient surgery]. / Premedicación con ketamina-midazolam oral en pacientes no colaboradores en cirugía mayor ambulatoria.

BACKGROUND: Currently, ketamine is not often used as an anesthetic. Its clinical characteristics and mechanism of action largely depend on antagonism of the N-methyl-D-aspartate receptor. OBJECTIVE: To evaluate the utility of oral ketamine as a preanesthetic agent to lower surgical stress for patients with mental disability. MATERIAL AND METHODS: Observational, retrospective study of 112 mentally disabled patients undergoing major dental surgery on an outpatient basis. The study group received oral midazolam, ibuprofen, and 6 mg/kg of ketamine; the control group received only midazolam and ibuprofen. We recorded data concerning demographics, anesthesia, surgery, physiologic variables, Glasgow score, time of onset of anxiolysis, duration of stay in the recovery ward, and adverse events. RESULTS: Conservative odontologic treatment was provided in 66.3% of the cases. Seventy-one patients (64.4%) were in the control group and 41 patients (36.6%) in the study group. Hemodynamic, respiratory, and neurologic changes were minimal and there were no significant between-group differences. Level of sedation differed significantly between groups (P = .001) at 15 and 30 minutes; differences were also observed within the study group. Mean (SD) duration of surgery was 72.6 (29.7) minutes. Mean duration of stay in the postoperative recovery ward was 140.9 (52.1) minutes (135.8 [54.89] minutes in the study group and 144.2 [50.5] minutes in the control group). The incidence of adverse events did not differ significantly between groups. CONCLUSIONS: Oral ketamine is an effective premedication for major ambulatory surgery and does not increase the incidence of side effects.

Premedicación con ketamina-midazolam oral en pacientes no colaboradores en cirugía mayor ambulatoria / Oral ketamine-midazolam premedication of uncooperative patients in major outpatient surgery

INTRODUCCIÓN: La ketamina es un fármaco con una baja utilización actualmente como anestésico. Sus características clínicas y mecanismo de acción dependen en gran parte de su efecto antagonista en el receptor del Nmetil- D-aspartato. OBJETIVO: Valorar la idoneidad de la ketamina vía oral como agente preanestésico para la atenuación del estrés quirúrgico en pacientes discapacitados psíquicos. MATERIAL Y MÉTODOS: Estudio retrospectivo y observacional de 112 pacientes discapacitados psíquicos intervenidos de cirugía odontológica en régimen de cirugía mayor ambulatoria. Se incluyeron dos grupos, la premedicación con midazolam e ibuprofeno vía oral (grupo control), y la adicción a los anteriores de ketamina oral a dosis de 6 mg/kg (grupo de estudio). Se recogieron datos demográficos, anestésicos, quirúrgicos, variables fisiológicas, escala de Glasgow, tiempo de inicio de ansiolisis, así como el tiempo de estancia en la sala de recuperación e incidentes. RESULTADOS: En el 66,3% de los pacientes se realizó tratamiento odontológico conservador. Setenta y un pacientes (64,4%) correspondieron al grupo control y 41 pacientes (36,6%) al grupo de estudio. Los cambios hemodinámicos, respiratorios y neurológicos fueron mínimos, sin diferencias estadísticamente significativas entre los grupos. Entre ambos grupos e intragrupo en el grado de sedación a los 15 y 30 minutos en el grupo de estudio (p=0,0001) hubo diferencias estadísticamente significativas. El tiempo medio de la cirugía fue de 72,6±29,7 minutos. La permanencia de los pacientes en las salas de Reanimación postquirúrgica y de readaptación al medio fue de 140,9±52,1 minutos (135,8±54,89 minutos en el grupo de estudio y de 144,2±50,5 minutos en el grupo control). No existieron diferencias estadísticamente significativas en la aparición de efectos adversos. CONCLUSIONES: La ketamina vía oral es eficaz en la premedicación en cirugía mayor ambulatoria sin conllevar un aumento de efectos adversos(AU)

BACKGROUND: Currently, ketamine is not often used as an anesthetic. Its clinical characteristics and mechanism of action largely depend on antagonism of the N-methyl-D-aspartate receptor. Objective: To evaluate the utility of oral ketamine as a preanesthetic agent to lower surgical stress for patients with mental disability. MATERIAL AND METHODS: Observational, retrospective study of 112 mentally disabled patients undergoing major dental surgery on an outpatient basis. The study group received oral midazolam, ibuprofen, and 6 mg/kg of ketamine; the control group received only midazolam and ibuprofen. We recorded data concerning demographics, anesthesia, surgery, physiologic variables, Glasgow score, time of onset of anxiolysis, duration of stay in the recovery ward, and adverse events. RESULTS: Conservative odontologic treatment was provided in 66.3% of the cases. Seventy-one patients (64.4%) were in the control group and 41 patients (36.6%) in the study group. Hemodynamic, respiratory, and neurologic changes were minimal and there were no significant between-group differences. Level of sedation differed significantly between groups (P=.001) at 15 and 30 minutes; differences were also observed within the study group. Mean (SD) duration of surgery was 72.6 (29.7) minutes. Mean duration of stay in the postoperative recovery ward was 140.9 (52.1) minutes (135.8 [54.89] minutes in the study group and 144.2 [50.5] minutes in the control group). The incidence of adverse events did not differ significantly between groups. CONCLUSIONS: Oral ketamine is an effective premedication for major ambulatory surgery and does not increase the incidence of side effects(AU)