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3.
N Engl J Med ; 390(2): 107-117, 2024 Jan 11.
Article in English | MEDLINE | ID: mdl-37952132

ABSTRACT

BACKGROUND: Subclinical atrial fibrillation is short-lasting and asymptomatic and can usually be detected only by long-term continuous monitoring with pacemakers or defibrillators. Subclinical atrial fibrillation is associated with an increased risk of stroke by a factor of 2.5; however, treatment with oral anticoagulation is of uncertain benefit. METHODS: We conducted a trial involving patients with subclinical atrial fibrillation lasting 6 minutes to 24 hours. Patients were randomly assigned in a double-blind, double-dummy design to receive apixaban at a dose of 5 mg twice daily (2.5 mg twice daily when indicated) or aspirin at a dose of 81 mg daily. The trial medication was discontinued and anticoagulation started if subclinical atrial fibrillation lasting more than 24 hours or clinical atrial fibrillation developed. The primary efficacy outcome, stroke or systemic embolism, was assessed in the intention-to-treat population (all the patients who had undergone randomization); the primary safety outcome, major bleeding, was assessed in the on-treatment population (all the patients who had undergone randomization and received at least one dose of the assigned trial drug, with follow-up censored 5 days after permanent discontinuation of trial medication for any reason). RESULTS: We included 4012 patients with a mean (±SD) age of 76.8±7.6 years and a mean CHA2DS2-VASc score of 3.9±1.1 (scores range from 0 to 9, with higher scores indicating a higher risk of stroke); 36.1% of the patients were women. After a mean follow-up of 3.5±1.8 years, stroke or systemic embolism occurred in 55 patients in the apixaban group (0.78% per patient-year) and in 86 patients in the aspirin group (1.24% per patient-year) (hazard ratio, 0.63; 95% confidence interval [CI], 0.45 to 0.88; P = 0.007). In the on-treatment population, the rate of major bleeding was 1.71% per patient-year in the apixaban group and 0.94% per patient-year in the aspirin group (hazard ratio, 1.80; 95% CI, 1.26 to 2.57; P = 0.001). Fatal bleeding occurred in 5 patients in the apixaban group and 8 patients in the aspirin group. CONCLUSIONS: Among patients with subclinical atrial fibrillation, apixaban resulted in a lower risk of stroke or systemic embolism than aspirin but a higher risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; ARTESIA ClinicalTrials.gov number, NCT01938248.).


Subject(s)
Anticoagulants , Aspirin , Atrial Fibrillation , Embolism , Stroke , Aged , Aged, 80 and over , Female , Humans , Male , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Aspirin/adverse effects , Aspirin/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Canada , Embolism/etiology , Embolism/prevention & control , Hemorrhage/chemically induced , Pyridones/adverse effects , Stroke/etiology , Stroke/prevention & control , Treatment Outcome , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/therapeutic use , Double-Blind Method
4.
Neurocirugía (Soc. Luso-Esp. Neurocir.) ; 34(6): 321-325, nov.- dec. 2023. ilus
Article in English | IBECS | ID: ibc-227210

ABSTRACT

Cerebrospinal fluid (CSF) shunt placement is a commonly performed procedure for patients with hydrocephalus of various etiologies. We present the case of a 68-year-old male patient treated with a ventriculoperitoneal shunt for obstructive hydrocephalus management. Eight years later, a computed tomography (CT) scan detected migration of distal catheter into the pulmonary artery. We conducted a systematic review in Medline database using PubMed search engine to identify previous cases and their management. Our literature review identified eighteen single case reports describing this complication and different strategies to attempt catheter retrieval. To the best authors’ knowledge, this is the first case where conservative management was chosen (AU)


Las derivaciones del líquido cefalorraquídeo son un procedimiento quirúrgico frecuente en el manejo de pacientes con hidrocefalia de diversas etiologías. Presentamos el caso de un paciente varón de 68 años portador de una derivación ventrículo-peritoneal por hidrocefalia obstructiva. Ocho años más tarde se detectó la migración del catéter distal de la derivación hacia la arteria pulmonar en una tomografía computarizada (TC) de tórax. Se ha realizado una revisión sistemática de la literatura en la base de datos MEDLINE utilizando el buscador PubMed para identificar casos descritos de esta complicación y su manejo. Se encontraron 18 casos clínicos que describían esta complicación y diferentes estrategias para intentar recuperar el catéter migrado. Con base en nuestra revisión, el caso descrito es, hasta la fecha, el único en el que se decidió no intentar recuperar el catéter migrado (AU)


Subject(s)
Humans , Male , Adolescent , Ventriculoperitoneal Shunt/adverse effects , Ventriculostomy/methods , Hydrocephalus/surgery , Treatment Outcome
7.
Neurocirugia (Astur : Engl Ed) ; 34(6): 321-325, 2023.
Article in English | MEDLINE | ID: mdl-36775740

ABSTRACT

Cerebrospinal fluid (CSF) shunt placement is a commonly performed procedure for patients with hydrocephalus of various etiologies. We present the case of a 68-year-old male patient treated with a ventriculoperitoneal shunt for obstructive hydrocephalus management. Eight years later, a computed tomography (CT) scan detected migration of distal catheter into the pulmonary artery. We conducted a systematic review in Medline database using PubMed search engine to identify previous cases and their management. Our literature review identified eighteen single case reports describing this complication and different strategies to attempt catheter retrieval. To the best authors' knowledge, this is the first case where conservative management was chosen.


Subject(s)
Hydrocephalus , Ventriculoperitoneal Shunt , Male , Humans , Aged , Ventriculoperitoneal Shunt/adverse effects , Pulmonary Artery/diagnostic imaging , Cerebrospinal Fluid Shunts/adverse effects , Hydrocephalus/diagnostic imaging , Hydrocephalus/etiology , Hydrocephalus/surgery , Tomography, X-Ray Computed/adverse effects
9.
BMJ Open ; 12(8): e061208, 2022 08 17.
Article in English | MEDLINE | ID: mdl-35977759

ABSTRACT

OBJECTIVES: The large number of infected patients requiring mechanical ventilation has led to the postponement of scheduled neurosurgical procedures during the first wave of the COVID-19 pandemic. The aims of this study were to investigate the factors that influence the decision to postpone scheduled neurosurgical procedures and to evaluate the effect of the restriction in scheduled surgery adopted to deal with the first outbreak of the COVID-19 pandemic in Spain on the outcome of patients awaiting surgery. DESIGN: This was an observational retrospective study. SETTINGS: A tertiary-level multicentre study of neurosurgery activity between 1 March and 30 June 2020. PARTICIPANTS: A total of 680 patients awaiting any scheduled neurosurgical procedure were enrolled. 470 patients (69.1%) were awaiting surgery because of spine degenerative disease, 86 patients (12.6%) due to functional disorders, 58 patients (8.5%) due to brain or spine tumours, 25 patients (3.7%) due to cerebrospinal fluid (CSF) disorders and 17 patients (2.5%) due to cerebrovascular disease. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was mortality due to any reason and any deterioration of the specific neurosurgical condition. Second, we analysed the rate of confirmed SARS-CoV-2 infection. RESULTS: More than one-quarter of patients experienced clinical or radiological deterioration. The rate of worsening was higher among patients with functional (39.5%) or CSF disorders (40%). Two patients died (0.4%) during the waiting period, both because of a concurrent disease. We performed a multivariate logistic regression analysis to determine independent covariates associated with maintaining the surgical indication. We found that community SARS-CoV-2 incidence (OR=1.011, p<0.001), degenerative spine (OR=0.296, p=0.027) and expedited indications (OR=6.095, p<0.001) were independent factors for being operated on during the pandemic. CONCLUSIONS: Patients awaiting neurosurgery experienced significant collateral damage even when they were considered for scheduled procedures.


Subject(s)
COVID-19 , COVID-19/epidemiology , Humans , Neurosurgical Procedures , Pandemics , Retrospective Studies , SARS-CoV-2 , Spain/epidemiology
11.
BMJ Open ; 11(12): e053983, 2021 12 10.
Article in English | MEDLINE | ID: mdl-34893486

ABSTRACT

OBJECTIVE: To assess the effect of the first wave of the SARS-CoV-2 pandemic on the outcome of neurosurgical patients in Spain. SETTINGS: The initial flood of COVID-19 patients overwhelmed an unprepared healthcare system. Different measures were taken to deal with this overburden. The effect of these measures on neurosurgical patients, as well as the effect of COVID-19 itself, has not been thoroughly studied. PARTICIPANTS: This was a multicentre, nationwide, observational retrospective study of patients who underwent any neurosurgical operation from March to July 2020. INTERVENTIONS: An exploratory factorial analysis was performed to select the most relevant variables of the sample. PRIMARY AND SECONDARY OUTCOME MEASURES: Univariate and multivariate analyses were performed to identify independent predictors of mortality and postoperative SARS-CoV-2 infection. RESULTS: Sixteen hospitals registered 1677 operated patients. The overall mortality was 6.4%, and 2.9% (44 patients) suffered a perioperative SARS-CoV-2 infection. Of those infections, 24 were diagnosed postoperatively. Age (OR 1.05), perioperative SARS-CoV-2 infection (OR 4.7), community COVID-19 incidence (cases/105 people/week) (OR 1.006), postoperative neurological worsening (OR 5.9), postoperative need for airway support (OR 5.38), ASA grade ≥3 (OR 2.5) and preoperative GCS 3-8 (OR 2.82) were independently associated with mortality. For SARS-CoV-2 postoperative infection, screening swab test <72 hours preoperatively (OR 0.76), community COVID-19 incidence (cases/105 people/week) (OR 1.011), preoperative cognitive impairment (OR 2.784), postoperative sepsis (OR 3.807) and an absence of postoperative complications (OR 0.188) were independently associated. CONCLUSIONS: Perioperative SARS-CoV-2 infection in neurosurgical patients was associated with an increase in mortality by almost fivefold. Community COVID-19 incidence (cases/105 people/week) was a statistically independent predictor of mortality. TRIAL REGISTRATION NUMBER: CEIM 20/217.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , Pandemics , Retrospective Studies , Spain/epidemiology
13.
World Neurosurg ; 139: e592-e600, 2020 07.
Article in English | MEDLINE | ID: mdl-32330620

ABSTRACT

BACKGROUND: The prognosis for patients with glioblastoma depends particularly on the degree of tumor resection. Patients with tumor remnants in postsurgical magnetic resonance imaging (<72 hours) may benefit from early reoperation. We present our results concerning the impact on overall survival (OS) and progression-free survival (PFS) of reoperation in patients who have already undergone surgery for glioblastoma. METHODS: This study included all patients who had undergone surgery for glioblastoma with control magnetic resonance imaging, who received adjuvant therapy as per the Stupp protocol, with a minimum follow-up of 24 months. We recorded the number of complete resections, partial resections, and early reoperations. We determined the impact on OS and PFS of the early reoperations and the functional status. We considered complete resection when the volume of the residual tumor was 0 cm3. RESULTS: A total of 112 patients were diagnosed with glioblastoma between March 2014 and March 2017. The study included 58 patients who fulfilled all the inclusion criteria. Complete resection was achieved in 24 patients (41.4%) and partial resection in 34 (58.6%). Of these 34 patients, 11 (32.35%) underwent early reoperation. The final result was complete resection in 58.62% of the patients. In the patients who underwent reoperation, OS and PFS were 30.3 months and 16.6 months compared with 12.7 months and 6.75 months in those without reoperation (P = 0.013 and P = 0.012). The functional prognosis was similar between the 2 groups. CONCLUSIONS: Early reoperation in patients with residual tumor improved OS and PFS without increasing the number of complications compared with the patients who did not undergo reoperation.


Subject(s)
Brain Neoplasms/surgery , Glioblastoma/surgery , Reoperation/statistics & numerical data , Adult , Aged , Brain Neoplasms/diagnostic imaging , Female , Follow-Up Studies , Glioblastoma/diagnostic imaging , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Neoplasm, Residual/surgery , Prognosis , Progression-Free Survival , Retrospective Studies , Second-Look Surgery , Survival Analysis , Treatment Outcome
14.
World Neurosurg ; 137: 164-172, 2020 05.
Article in English | MEDLINE | ID: mdl-31884125

ABSTRACT

BACKGROUND: The surgical approaches to lesions located in the tectal area have remained controversial. The essential functions in the surrounding areas and the difficulties in obtaining a good surgical view during tumor removal have made these procedures risky and challenging. Endoscopic transforaminal approaches have been previously described for biopsy and intraventricular tumor removal. However, the endoscopic transforaminal-transchoroidal gross resection technique for such cases has barely been described. METHODS: The endoscopic entry points and trajectories were planned using preoperative magnetic resonance imaging. Once the endoscope was inside the ventricular system, the angles of work and tumor exposure of the upper posterior part of the third ventricle were carefully evaluated. If the angle of work was insufficient for tumor removal, the choroidal fissure was opened using endoscopic bipolar electrode and dissectors. Tumor removal was performed using an endoscopic ultrasonic aspirator. We have presented a 3-case series of patients affected by tectal tumors that were treated using a fully endoscopic transforaminal-transchoroidal approach. RESULTS: Total gross resection of the tumors was achieved in 2 patients. Subtotal resection was achieved in the third patient. No major complications had developed in relationship to the procedure. No new cognitive impairment was reported secondary to this technique. CONCLUSIONS: In our experience, a fully endoscopic transforaminal-transchoroidal approach was a suitable treatment for this complex pathological entity. Opening of the choroidal fissure added an extra angle of work and improved the exposure of the upper posterior part of the third ventricle.


Subject(s)
Astrocytoma/surgery , Brain Neoplasms/surgery , Neuroendoscopy/methods , Pinealoma/surgery , Tectum Mesencephali/surgery , Adult , Astrocytoma/diagnostic imaging , Brain Neoplasms/diagnostic imaging , Cerebral Ventricles , Child, Preschool , Female , Glioma/diagnostic imaging , Glioma/surgery , Humans , Hydrocephalus/diagnostic imaging , Hydrocephalus/etiology , Magnetic Resonance Imaging , Male , Pinealoma/diagnostic imaging , Surgery, Computer-Assisted , Tectum Mesencephali/diagnostic imaging , Tomography, X-Ray Computed , Ultrasonography
15.
Rev. esp. cardiol. (Ed. impr.) ; 72(12): 1020-1030, dic. 2019. tab
Article in Spanish | IBECS | ID: ibc-190766

ABSTRACT

Introducción y objetivos: Se describen los resultados en España de la segunda encuesta de la Sociedad Europea de Cardiología sobre terapia de resincronización cardiaca (CRT-Survey II) y se comparan con los de los demás países participantes. Métodos: Pacientes a los que se implantó un dispositivo de terapia de resincronización cardiaca entre octubre de 2015 y diciembre de 2016 en 36 centros participantes. Se recogieron datos sobre las características basales de los pacientes y del implante, y un seguimiento a corto plazo hasta el alta hospitalaria. Resultados: La tasa de éxito del implante fue del 95,9%. La mediana [intervalo intercuartílico] de implantes anuales/centro en España fue significativamente menor que en los demás países participantes: 30 [21-50] frente a 55 [33-100] implantes/año (p=0,00003). En los centros españoles hubo una menor proporción de pacientes de edad ≥ 75 años (el 27,9 frente al 32,4%; p=0,0071), una mayor proporción de pacientes en clase funcional II de la New York Heart Association (el 46,9 frente al 36,9%; p <0,00001) y un mayor porcentaje de pacientes con criterios electrocardiográficos de bloqueo de rama izquierda (el 82,9 frente al 74,6%; p <0,00001). La media de la estancia hospitalaria fue menor en los centros españoles (5,8+/-8,5 frente a 6,4+/-11,6; p <0,00001) y una mayor proporción de pacientes recibieron un cable de ventrículo izquierdo cuadripolar (el 74 frente al 56%; p <0,00001) y fueron seguidos a distancia (el 55,8 frente al 27,7%; p <0,00001). Conclusiones: La encuesta CRT-Survey II muestra que en España hay una menor proporción de pacientes de 75 o más años que reciben un dispositivo de terapia de resincronización cardiaca, una mayor proporción de pacientes en clase funcional II de la New York Heart Association, con bloqueo completo de la rama izquierda del haz de His y con seguimiento a distancia, con estancias hospitalarias significativamente menores


Introduction and objectives: We describe the results for Spain of the Second European Cardiac Resynchronization Therapy Survey (CRT-Survey II) and compare them with those of the other participating countries. Methods: We included patients undergoing CRT device implantation between October 2015 and December 2016 in 36 participating Spanish centers. We registered the patients' baseline characteristics, implant procedure data, and short-term follow-up information until hospital discharge. Results: Implant success was achieved in 95.9%. The median [interquartile range] annual implantation rate by center was significantly lower in Spain than in the other participating countries: 30 implants/y [21-50] vs 55 implants/y [33-100]; P=.00003. In Spanish centers, there was a lower proportion of patients ≥ 75 years (27.9% vs 32.4%; P=.0071), a higher proportion in NYHA class II (46.9% vs 36.9%, P <.00001), and a higher percentage with electrocardiographic criteria of left bundle branch block (82.9% vs 74.6%; P <.00001). The mean length of hospital stay was significantly lower in Spanish centers (5.8+/-8.5 days vs 6.4+/-11.6; P <.00001). Spanish patients were more likely to receive a quadripolar LV lead (74% vs 56%, P <.00001) and to be followed up by remote monitoring (55.8% vs 27.7%; P <.00001). Conclusions: The CRT-Survey II shows that, compared with other participating countries, fewer patients in Spain aged ≥ 75 years received a CRT device, while more patients were in New York Heart Association functional class II and had left bundle branch block. In addition, the length of hospital stay was shorter, and there was greater use of quadripolar LV leads and remote CRT monitoring


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Cardiac Resynchronization Therapy/methods , Heart Failure/therapy , Arrhythmias, Cardiac/therapy , Health Care Surveys/statistics & numerical data , Arrhythmias, Cardiac/epidemiology , Heart Failure/epidemiology , Electrocardiography/methods , Spain/epidemiology , Europe/epidemiology , Retrospective Studies
16.
Rev Esp Cardiol (Engl Ed) ; 72(12): 1020-1030, 2019 Dec.
Article in English, Spanish | MEDLINE | ID: mdl-30935899

ABSTRACT

INTRODUCTION AND OBJECTIVES: We describe the results for Spain of the Second European Cardiac Resynchronization Therapy Survey (CRT-Survey II) and compare them with those of the other participating countries. METHODS: We included patients undergoing CRT device implantation between October 2015 and December 2016 in 36 participating Spanish centers. We registered the patients' baseline characteristics, implant procedure data, and short-term follow-up information until hospital discharge. RESULTS: Implant success was achieved in 95.9%. The median [interquartile range] annual implantation rate by center was significantly lower in Spain than in the other participating countries: 30 implants/y [21-50] vs 55 implants/y [33-100]; P=.00003. In Spanish centers, there was a lower proportion of patients ≥ 75 years (27.9% vs 32.4%; P=.0071), a higher proportion in New York Heart Association functional class II (46.9% vs 36.9%; P <.00001), and a higher percentage with electrocardiographic criteria of left bundle branch block (82.9% vs 74.6%; P <.00001). The mean length of hospital stay was significantly lower in Spanish centers (5.8±8.5 days vs 6.4±11.6; P <.00001). Spanish patients were more likely to receive a quadripolar LV lead (74% vs 56%; P <.00001) and to be followed up by remote monitoring (55.8% vs 27.7%; P <.00001). CONCLUSIONS: The CRT-Survey II shows that, compared with other participating countries, fewer patients in Spain aged ≥ 75 years received a CRT device, while more patients were in New York Heart Association functional class II and had left bundle branch block. In addition, the length of hospital stay was shorter, and there was greater use of quadripolar LV leads and remote CRT monitoring.


Subject(s)
Arrhythmias, Cardiac/therapy , Cardiac Resynchronization Therapy/statistics & numerical data , Surveys and Questionnaires , Aged , Arrhythmias, Cardiac/epidemiology , Electrocardiography , Europe/epidemiology , Female , Humans , Male , Middle Aged , Morbidity/trends , Retrospective Studies , Spain/epidemiology
17.
Eur Heart J ; 40(23): 1837-1846, 2019 06 14.
Article in English | MEDLINE | ID: mdl-30793735

ABSTRACT

AIMS: This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. METHODS AND RESULTS: The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001). CONCLUSION: The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.


Subject(s)
Defibrillators, Implantable/adverse effects , Home Care Services , Monitoring, Physiologic/methods , Pacemaker, Artificial/adverse effects , Telemedicine/methods , Adult , Aged , Aged, 80 and over , Cardiovascular Diseases/mortality , Female , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Prospective Studies , Workload/statistics & numerical data , Young Adult
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