RESUMEN
The issue of withrawing and withholding life-sustaining interventions is an important source of controversy among healthcare professionals caring for patients with serious illnesses. Misguided decisions, both in terms of the introduction/maintenance and the withdrawal/withholding of these measures, represent a source of avoidable suffering for patients, their loved ones, and healthcare professionals. This document represents the position statement of the Bioethics Committee of the Brazilian Palliative Care Academy on this issue and establishes seven principles to guide, from a bioethical perspective, the approach to situations related to this topic in the context of palliative care in Brazil. The position statement establishes the equivalence between the withdrawal and withholding of life-sustaining interventions and the inadequacy related to initiating or maintaining such measures in contexts where they are in disagreement with the values and care goals defined together with patients and their families. Additionally, the position statement distinguishes strictly futile treatments from potentially inappropriate treatments and elucidates their critical implications for the appropriateness of the medical decision-making process in this context. Finally, we address the issue of conscientious objection and its limits, determine that the ethical commitment to the relief of suffering should not be influenced by the decision to employ or not employ life-sustaining interventions and warn against the use of language that causes patients/families to believe that only one of the available options related to the use or nonuse of these interventions will enable the relief of suffering.
Asunto(s)
Cuidados Paliativos , Privación de Tratamiento , Humanos , Cuidados Paliativos/ética , Cuidados Paliativos/métodos , Privación de Tratamiento/ética , Brasil , Cuidados para Prolongación de la Vida/ética , Inutilidad Médica/éticaRESUMEN
Out-of-hospital cardiac arrest (OHCA) is associated with very poor outcomes. Extracorporeal cardiopulmonary resuscitation (eCPR) for selected patients is a potential therapeutic option for refractory cardiac arrest. However, randomised controlled studies applying eCPR after refractory OHCA have demonstrated conflicting results regarding survival and good functional neurological outcomes. eCPR is an invasive, labour-intensive, and expensive therapeutic approach with associated side-effects. A rapid monitoring device would be valuable in facilitating selection of appropriate patients for this expensive and complex treatment. To this end, rapid diagnosis of hyperfibrinolysis, or premature clot dissolution, diagnosed by viscoelastic testing might represent a feasible option. Hyperfibrinolysis is an evolutionary response to low or no-flow states. Studies in trauma patients demonstrate a high mortality rate in those with established hyperfibrinolysis upon emergency room admission. Similar findings have now been reported for the first time in OHCA patients. Hyperfibrinolysis upon admission diagnosed by rotational thromboelastometry was strongly associated with mortality and poor neurological outcomes in a small cohort of patients treated with extracorporeal membrane oxygenation.
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Reanimación Cardiopulmonar , Oxigenación por Membrana Extracorpórea , Fibrinólisis , Paro Cardíaco Extrahospitalario , Humanos , Oxigenación por Membrana Extracorpórea/métodos , Paro Cardíaco Extrahospitalario/terapia , Paro Cardíaco Extrahospitalario/mortalidad , Reanimación Cardiopulmonar/métodos , Tromboelastografía/métodos , Toma de Decisiones Clínicas/métodos , Inutilidad MédicaRESUMEN
BACKGROUND: Intraoperative unresectability, postoperative deaths and early recurrences remain devastating futile events in the surgical management of Intrahepatic cholangiocarcinomas (iCCA) and Perihilar cholangiocarcinomas (pCCA). The present study aims to determine the preoperative predictors of futile surgery in cholangiocarcinomas. METHODS: Consecutive hepatectomies for iCCA and pCCA, between September 2010 and June 2022 were included. Futility of surgery was defined as either intraoperative unresectability, postoperative 30-day mortality or recurrence within six months of surgery. Multivariable logistic regression was used to identify predictors of futility. RESULTS: One hundred and fifty patients of iCCA and pCCA underwent surgery during the time period. Thirty-seven (38.1 %) out of 97 patients of iCCA and 25(47.16 %) out of 53 patients of pCCA underwent futile resection. The predictive factors of futile surgery for iCCA were tumour number (≥2) (OR, 9.705; 95%CI, 2.378-39.614; p = 0.002), serum aspartate transaminase (OR, 8.31; 95%CI, 2.796-24.703; p < 0.001) and serum CA-19.9 (>37 U/ml) (OR, 2.95; 95%CI, 1.051-8.283; p = 0.04). The predictive factors of futility for pCCA were lymph node involvement (OR, 7.636; 95%CI, 1.824-31.979; p = 0.005) and serum alkaline phosphatase (>562.5 U/L) (OR, 11.211; 95%CI, 1.752-71.750; p = 0.011). CONCLUSION: Futile surgery was observed in over one third of our patients. Five strong preoperative predictors of futility were identified. Careful analysis of these factors may reduce futile surgical explorations.
Asunto(s)
Neoplasias de los Conductos Biliares , Hepatectomía , Tumor de Klatskin , Inutilidad Médica , Selección de Paciente , Humanos , Masculino , Femenino , Neoplasias de los Conductos Biliares/cirugía , Neoplasias de los Conductos Biliares/patología , Persona de Mediana Edad , Tumor de Klatskin/cirugía , Tumor de Klatskin/patología , Hepatectomía/métodos , Hepatectomía/mortalidad , Anciano , Estudios de Seguimiento , Pronóstico , Tasa de Supervivencia , Estudios Retrospectivos , Colangiocarcinoma/cirugía , Colangiocarcinoma/patología , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/cirugíaRESUMEN
BACKGROUND: Emergent surgical conditions are common in geriatric patients, often necessitating major operative procedures on frail patients. Understanding risk profiles is crucial for decision-making and establishing goals of care. METHODS: We queried NSQIP 2015-2019 for patients ≥65 years undergoing open abdominal surgery for emergency general surgery conditions. Logistic regression was used to identify 30-day mortality predictors. RESULTS: Of 41,029 patients, 5589 (13.6 â%) died within 30 days of admission. The highest predictors of mortality were ASA status 5 (aOR 9.7, 95 â% CI,3.5-26.8, p â< â0.001), septic shock (aOR 4.9, 95 â% CI,4.5-5.4, p â< â0.001), and dialysis (aOR 2.1, 95 â% CI,1.8-2.4, p â< â0.001). Without risk factors, mortality rates were 11.9 â% after colectomy and 10.2 â% after small bowel resection. Patients with all three risk factors had a mortality rate of 79.4 â% and 100 â% following colectomy and small bowel resection, respectively. CONCLUSIONS: In older adults undergoing emergent open abdominal surgery, septic shock, ASA status, and dialysis were strongly associated with futility of surgical intervention. These findings can inform goals of care and informed decision-making.
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Inutilidad Médica , Humanos , Anciano , Femenino , Masculino , Anciano de 80 o más Años , Factores de Riesgo , Urgencias Médicas , Procedimientos Quirúrgicos Operativos/mortalidad , Procedimientos Quirúrgicos Operativos/efectos adversos , Medición de Riesgo , Estudios Retrospectivos , Cirugía de Cuidados IntensivosRESUMEN
OBJECTIVE: To establish a machine learning model based on radiomics and clinical features derived from non-contrast CT to predict futile recanalization (FR) in patients with anterior circulation acute ischemic stroke (AIS) undergoing endovascular treatment. METHODS: A retrospective analysis was conducted on 174 patients who underwent endovascular treatment for acute anterior circulation ischemic stroke between January 2020 and December 2023. FR was defined as successful recanalization but poor prognosis at 90 days (modified Rankin Scale, mRS 4-6). Radiomic features were extracted from non-contrast CT and selected using the least absolute shrinkage and selection operator (LASSO) regression method. Logistic regression (LR) model was used to build models based on radiomic and clinical features. A radiomics-clinical nomogram model was developed, and the predictive performance of the models was evaluated using area under the curve (AUC), accuracy, sensitivity, and specificity. RESULTS: A total of 174 patients were included. 2016 radiomic features were extracted from non-contrast CT, and 9 features were selected to build the radiomics model. Univariate and stepwise multivariate analyses identified admission NIHSS score, hemorrhagic transformation, NLR, and admission blood glucose as independent factors for building the clinical model. The AUC of the radiomics-clinical nomogram model in the training and testing cohorts were 0.860 (95%CI 0.801-0.919) and 0.775 (95%CI 0.605-0.945), respectively. CONCLUSION: The radiomics-clinical nomogram model based on non-contrast CT demonstrated satisfactory performance in predicting futile recanalization in patients with anterior circulation acute ischemic stroke.
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Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Aprendizaje Automático , Tomografía Computarizada por Rayos X , Humanos , Masculino , Femenino , Estudios Retrospectivos , Anciano , Persona de Mediana Edad , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/cirugía , Accidente Cerebrovascular Isquémico/terapia , Tomografía Computarizada por Rayos X/métodos , Procedimientos Endovasculares/métodos , Nomogramas , Inutilidad Médica , Pronóstico , RadiómicaRESUMEN
Moral distress can impact nurses and the care team significantly. A profession dedicated to the principles of caring and compassion is often subjected to patients receiving futile treatment. With the proliferation of extreme life-prolonging measures come the difficulties in the withdrawal of those medical modalities. If a prognosis is poor and care is perceived as curative rather than palliative, providers may often feel conflicted and distressed by their interventions. The American Association of Colleges of Nursing has expressed growing concern about an increase in the use of inappropriate life-support treatments related to futile care. The compelling case of a severely beaten 69-year-old homeless man who had cardiac-arrested and was resuscitated after an unknown amount of down-time, provides the contextual framework for this report. Ethical conflicts can become very challenging, which inevitably increases the suffering of the patient and their caregivers. Research findings suggest that health care organizations can benefit from enacting processes that make ethical considerations an early and routine part of everyday clinical practice. A proactive approach to ethical conflicts may improve patient care outcomes and decrease moral distress.
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Inutilidad Médica , Humanos , Anciano , Masculino , Inutilidad Médica/ética , Cuidados para Prolongación de la Vida/ética , Principios Morales , Privación de Tratamiento/ética , Estrés Psicológico , Personas con Mala Vivienda/psicologíaRESUMEN
OBJECTIVE: Endovascular therapy (EVT) is the most successful treatment for patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) in the anterior circulation. However, futile recanalization (FR) seriously affects the prognosis of these patients. The aim of this study was to investigate predictors of FR after EVT in patients with AIS. METHOD: Patients diagnosed with AIS due to anterior circulation LVO and receiving EVT between June 2020 and October 2022 were prospectively enrolled. FR after EVT was defined as a poor 90-day prognosis (modified Rankin Scale [mRS] score ≥ 3) despite achieving successful reperfusion (modified Thrombolysis in Cerebral Infarction [mTICI] classification of 2b-3). All included patients were categorized into control group (mRS score < 3) and FR group (mRS score ≥ 3). Demographic characteristics, comorbidities (hypertension, diabetes, atrial fibrillation, smoking, etc.), stroke-specific data (NIHSS score, ASPECT score and site of occlusion), procedure data (treatment type [direct thrombectomy vs. bridging thrombectomy], degree of vascular recanalization [mTICI], procedure duration time and onset-recanalization time), laboratory indicators (lymphocytes count, neutrophils count, monocytes count, C-reactive protein, neutrophil-to-lymphocyte ratio [NLR], monocyte-to-high-density lipoprotein ratio [MHR], lymphocyte-to-monocyte ratio [LMR], lymphocyte-to-C-reactive protein ratio [LCR], lymphocyte-to-high-density lipoprotein ratio[LHR], total cholesterol and triglycerides.) were compared between the two groups. Multivariate logistic regression analysis was performed to explore independent predictors of FR after EVT. RESULTS: A total of 196 patients were included in this study, among which 57 patients were included in the control group and 139 patients were included in the FR group. Age, proportion of patients with hypertension and diabetes mellitus, median NIHSS score, CRP level, procedure duration time, neutrophil count and NLR were higher in the FR group than in the control group. Lymphocyte count, LMR, and LCR were lower in the FR group than in the control group. There were no significant differences in platelet count, monocytes count, total cholesterol, triglycerides, HDL, LDL, gender, smoking, atrial fibrillation, percentage of occluded sites, onset-recanalization time, ASPECT score and type of treatment between the two groups. Multivariate logistic regression analysis demonstrated that NLR was independently associated with FR after EVT (OR = 1.37, 95%CI = 1.005-1.86, P = 0.046). CONCLUSION: This study demonstrated that high NLR was associated with a risk of FR in patients with AIS due to anterior circulation LVO. These findings may help clinicians determine which patients with AIS are at higher risk of FR after EVT. Our study can provide a theoretical basis for interventions in the aforementioned population.
Asunto(s)
Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Humanos , Masculino , Femenino , Accidente Cerebrovascular Isquémico/cirugía , Accidente Cerebrovascular Isquémico/terapia , Anciano , Procedimientos Endovasculares/métodos , Persona de Mediana Edad , Anciano de 80 o más Años , Inutilidad Médica , Trombectomía/métodos , Estudios Prospectivos , PronósticoRESUMEN
BACKGROUND: Endovascular treatment (EVT) is the standard of care of ischaemic stroke due to occlusion of large vessels. Although EVT can significantly improve short- and long-term outcomes, functional dependence can persist despite the achievement of a successful recanalization. The evidence about the predictors of post-stroke epilepsy (PSE) in patients with stroke treated by EVT is limited. We aimed to evaluate the relationship between futile recanalization and the risk of PSE. METHODS: We retrospectively identified consecutive adults with first-ever ischaemic stroke of anterior circulation who were treated with EVT. Futile recanalization was defined as poor 3-month functional status (modified Rankin scale score ≥ 3) despite complete or near-complete recanalization. Study outcome was the occurrence of PSE during the follow-up. RESULTS: The study included 327 patients with anterior circulation ischaemic stroke treated with EVT. Futile recanalization occurred in 116 (35.5%) patients and 26 (8.0%) developed PSE during a median follow-up of 35 [interquartile range, 22.7-55.2] months. Futile recanalization was more common among patients who developed PSE compared to those who did not (76.9% versus 31.9%; p < 0.001). Futile recanalization [hazard ratio (HR) = 5.63, 95% confidence interval (CI): 1.88-16.84; p = 0.002], large artery atherosclerosis (HR = 3.48, 95% CI: 1.44-8.40; p = 0.006), cortical involvement (HR = 15.51, 95% CI: 2.06-116.98; p = 0.008), and acute symptomatic status epilepticus (HR = 14.40, 95% CI: 2.80-73.98; p = 0.001) increased the risk of PSE. CONCLUSIONS: Futile recanalization after EVT is associated with increased risk of PSE in patients with ischaemic stroke due to occlusion of large vessel of the anterior circulation.
Asunto(s)
Procedimientos Endovasculares , Epilepsia , Accidente Cerebrovascular Isquémico , Humanos , Masculino , Femenino , Anciano , Estudios Retrospectivos , Persona de Mediana Edad , Accidente Cerebrovascular Isquémico/complicaciones , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Epilepsia/etiología , Epilepsia/diagnóstico por imagen , Procedimientos Endovasculares/métodos , Inutilidad Médica , Estudios de Seguimiento , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/diagnóstico por imagen , Anciano de 80 o más Años , Factores de RiesgoRESUMEN
OBJECTIVES: To investigate if a prospective feedback loop that flags older patients at risk of death can reduce non-beneficial treatment at end of life. DESIGN: Prospective stepped-wedge cluster randomised trial with usual care and intervention phases. SETTING: Three large tertiary public hospitals in south-east Queensland, Australia. PARTICIPANTS: 14 clinical teams were recruited across the three hospitals. Teams were recruited based on a consistent history of admitting patients aged 75+ years, and needed a nominated lead specialist consultant. Under the care of these teams, there were 4,268 patients (median age 84 years) who were potentially near the end of life and flagged at risk of non-beneficial treatment. INTERVENTION: The intervention notified clinicians of patients under their care determined as at-risk of non-beneficial treatment. There were two notification flags: a real-time notification and an email sent to clinicians about the at-risk patients at the end of each screening day. The nudge intervention ran for 16-35 weeks across the three hospitals. MAIN OUTCOME MEASURES: The primary outcome was the proportion of patients with one or more intensive care unit (ICU) admissions. The secondary outcomes examined times from patients being flagged at-risk. RESULTS: There was no improvement in the primary outcome of reduced ICU admissions (mean probability difference [intervention minus usual care] = -0.01, 95% confidence interval -0.08 to 0.01). There were no differences for the times to death, discharge, or medical emergency call. There was a reduction in the probability of re-admission to hospital during the intervention phase (mean probability difference -0.08, 95% confidence interval -0.13 to -0.03). CONCLUSIONS: This nudge intervention was not sufficient to reduce the trial's non-beneficial treatment outcomes in older hospital patients. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry, ACTRN12619000675123 (registered 6 May 2019).
Asunto(s)
Cuidado Terminal , Humanos , Masculino , Anciano de 80 o más Años , Femenino , Anciano , Cuidado Terminal/métodos , Estudios Prospectivos , Queensland , Unidades de Cuidados Intensivos , Inutilidad Médica , Retroalimentación , Admisión del Paciente , Factores de Edad , Medición de RiesgoRESUMEN
PURPOSE: Interhospital transfer of critically injured patients to a major trauma service reduces preventable death in major trauma. Yet some of those transferred die without intervention. These 'futile' interhospital trauma transfers (IHTs), and other potentially avoidable IHTs place enormous stress on families of trauma victims, can delay care, and incur great cost to public health resources. This study sought to characterise these IHTs using current state guidelines for interhospital transfer. METHODS: A retrospective cohort study was conducted using our institution's trauma registry from January 2016-December 2020. All adult patients transferred to our major trauma service were analysed. Futile IHTs were defined as death or transfer to hospice care without surgical, endoscopic, or radiological intervention, and without ICU admission, within 72 h of admission. Potentially avoidable IHTs were defined as all patients discharged alive without intervention or ICU care, and secondary over-triage patients are a subset of these patients who were discharged within 72 h of admission. Patient demographics, injuries, and treatments were categorised from electronic records and analysed. RESULTS: Of 2,837 IHTs, seven (0.2 %) met criteria for futility. The majority were female, median age of 80 (IQR 85-75) and had a median Injury Severity Score (ISS) of 16 (IQR 25.5-11.5). By contrast, 1391 patients (49 %) were classified as potentially avoidable and 513 (18 %) were considered secondary over-triage. The majority were male, median age of 43 (IQR 62-28), and had a median ISS of 9 (IQR 13-4). Of these potentially avoidable IHTs, 984 (70.7 %) were discharged directly home. CONCLUSION: Futile IHTs were infrequent, however over half of all trauma patients transferred from other hospitals were discharged without tertiary-level intervention. Trauma services should consider developing systems such as telehealth to support regional general and orthopaedic surgeons to co-manage lower risk trauma, particularly minor head and minor spinal trauma patients. This could be an integral part of safely reducing potentially avoidable IHTs and their associated costs while maintaining a low rate of preventable mortality in trauma.
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Puntaje de Gravedad del Traumatismo , Inutilidad Médica , Transferencia de Pacientes , Centros Traumatológicos , Humanos , Transferencia de Pacientes/estadística & datos numéricos , Femenino , Masculino , Estudios Retrospectivos , Anciano , Anciano de 80 o más Años , Sistema de Registros , Heridas y Lesiones/terapia , Heridas y Lesiones/epidemiología , Triaje , Mortalidad Hospitalaria , Persona de Mediana Edad , Unidades de Cuidados Intensivos , Adulto , Alta del Paciente/estadística & datos numéricosRESUMEN
As the principle of respect for patient autonomy has gained salience over the past 75 years, surgeons now struggle to resolve conflicts between autonomy and beneficence in certain clinical scenarios. One such conflict occurs when a patient desires a surgical intervention, but the surgeon concludes that the patient is "too sick for surgery" and hence would not benefit from the operation. We provide historical context for the principle of respect for patient autonomy and review recent qualitative data that demonstrate surgeons experience significant moral distress when asked to perform nonbeneficial surgery. Therefore, we sought to empower surgeons with the appropriate ethical justifications to decline to perform surgery when they believe it would be nonbeneficial or harmful to patients. We outline 4 concepts that can help surgeons engage with patients, families, and colleagues in these scenarios. First, we describe the term "futility" and explain the difficulty in precisely defining and using the term in practice. Second, we contrast patients' positive and negative rights, drawing on historical context to argue that patients have robust negative rights but limited positive rights to request nonbeneficial interventions. Third, we use the centuries-old notion of medicine as a profession to show that surgeons have a fiduciary responsibility to act in the best interests of their patients, including and especially when patients request interventions that are not beneficial. Finally, we draw on virtue ethics to give surgeons character-based resources for fulfilling their professional obligations to patients. We contend that surgeons owe their patients the ability to trust that they will always use their knowledge and skills for patients' benefit, even if surgeons must limit patients' autonomy in certain ways to do so.
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Autonomía Personal , Relaciones Médico-Paciente , Cirujanos , Humanos , Cirujanos/ética , Cirujanos/psicología , Relaciones Médico-Paciente/ética , Obligaciones Morales , Inutilidad Médica/ética , Beneficencia , Procedimientos Quirúrgicos Operativos/éticaRESUMEN
BACKGROUND: Clinical trials often involve some form of interim monitoring to determine futility before planned trial completion. While many options for interim monitoring exist (e.g., alpha-spending, conditional power), nonparametric based interim monitoring methods are also needed to account for more complex trial designs and analyses. The upstrap is one recently proposed nonparametric method that may be applied for interim monitoring. METHODS: Upstrapping is motivated by the case resampling bootstrap and involves repeatedly sampling with replacement from the interim data to simulate thousands of fully enrolled trials. The p-value is calculated for each upstrapped trial and the proportion of upstrapped trials for which the p-value criteria are met is compared with a pre-specified decision threshold. To evaluate the potential utility for upstrapping as a form of interim futility monitoring, we conducted a simulation study considering different sample sizes with several different proposed calibration strategies for the upstrap. We first compared trial rejection rates across a selection of threshold combinations to validate the upstrapping method. Then, we applied upstrapping methods to simulated clinical trial data, directly comparing their performance with more traditional alpha-spending and conditional power interim monitoring methods for futility. RESULTS: The method validation demonstrated that upstrapping is much more likely to find evidence of futility in the null scenario than the alternative across a variety of simulations settings. Our three proposed approaches for calibration of the upstrap had different strengths depending on the stopping rules used. Compared to O'Brien-Fleming group sequential methods, upstrapped approaches had type I error rates that differed by at most 1.7% and expected sample size was 2-22% lower in the null scenario, while in the alternative scenario power fluctuated between 15.7% lower and 0.2% higher and expected sample size was 0-15% lower. CONCLUSIONS: In this proof-of-concept simulation study, we evaluated the potential for upstrapping as a resampling-based method for futility monitoring in clinical trials. The trade-offs in expected sample size, power, and type I error rate control indicate that the upstrap can be calibrated to implement futility monitoring with varying degrees of aggressiveness and that performance similarities can be identified relative to considered alpha-spending and conditional power futility monitoring methods.
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Ensayos Clínicos como Asunto , Simulación por Computador , Inutilidad Médica , Proyectos de Investigación , Humanos , Ensayos Clínicos como Asunto/métodos , Tamaño de la Muestra , Interpretación Estadística de Datos , Modelos Estadísticos , Resultado del TratamientoRESUMEN
This Viewpoint describes the failure of yet another state institution to generate meaningful guidance about medical exceptions to abortion bans.
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Aborto Legal , Atención a la Salud , Consejo Directivo , Servicios de Salud Materna , Complicaciones del Embarazo , Femenino , Humanos , Embarazo , Aborto Inducido/ética , Aborto Inducido/legislación & jurisprudencia , Aborto Legal/ética , Aborto Legal/legislación & jurisprudencia , Inutilidad Médica/legislación & jurisprudencia , Inutilidad Médica/ética , Texas/epidemiología , Consejo Directivo/ética , Consejo Directivo/legislación & jurisprudencia , Mortalidad Materna , Servicios de Salud Materna/ética , Servicios de Salud Materna/legislación & jurisprudencia , Servicios de Salud Materna/normas , Complicaciones del Embarazo/mortalidad , Complicaciones del Embarazo/cirugía , Atención a la Salud/ética , Atención a la Salud/legislación & jurisprudencia , Atención a la Salud/normas , Calidad de la Atención de Salud/ética , Calidad de la Atención de Salud/legislación & jurisprudencia , Calidad de la Atención de Salud/normasRESUMEN
BACKGROUND: There is a lack of data regarding patients aged 90 years or older undergoing mechanical thrombectomy and their predictors of futile recanalization. AIMS: We sought to evaluate the predictors of futile recanalization in patients ≥ 90 years with large vessel occlusion undergoing mechanical thrombectomy. METHODS: This multi-center observational retrospective study included patients ≥ 90 years consecutively treated with mechanical thrombectomy in four thrombectomy capable centers between January 1st, 2016 and 30th March 2023. Futile recanalization was defined as large vessel occlusion patients experiencing a 90-day poor outcome (mRS 3-6) despite successful recanalization (mTICI ≥ 2b) after mechanical thrombectomy. RESULTS: Our cohort included 139 patients ≥ 90 years with acute ischemic stroke due to anterior circulation large vessel occlusion treated with mechanical thrombectomy. One hundred seventeen of one hundred thirty-nine patients ≥ 90 years who achieved successful recanalization were included in the analysis (seventy-six female (64.9%)), of whom thirty-one (26.49%) experienced effective recanalization and eighty-six (73.51%) experienced futile recanalization. Patients with futile recanalization had higher NIHSS on admission (p < 0.001); they were less frequently treated with intravenous thrombolysis (p = 0.048), had more often general anesthesia (p = 0.011), and longer door to groin puncture delay (p = 0.002). Univariable regression analysis showed that use of intravenous thrombolysis (0.29, 95% CI 0.02-0.79, p = 0.034) and site of occlusion distal vs proximal (0.34, 95% CI 0.11-0.97, p = 0.044) were associated with reduced probability of futile recanalization while NIHSS on admission (1.29, 95% CI 1.16-1.45, p < 0.001), NIHSS at 24 h (1.15, 95% CI 1.07-1.25, p = 0.002), type of anesthesia used (4.18, 95% CI 1.57-11.08, p = 0.004), and door to groin puncture time (1.02, 95% CI 1.00-1.05, p = 0.005) were associated with increased probability of futile recanalization. Multivariable regression analysis showed that use of intravenous thrombolysis (0.44, 95% CI 0.09-0.88, p = 0.039) was associated with reduced probability of futile recanalization. CONCLUSION: Our study seems to suggest that mechanical thrombectomy with intravenous thrombolysis is associated with reduced probability of futile recanalization in a multi-center cohort of patients aged 90 years or older.
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Accidente Cerebrovascular Isquémico , Inutilidad Médica , Trombectomía , Humanos , Femenino , Masculino , Anciano de 80 o más Años , Estudios Retrospectivos , Accidente Cerebrovascular Isquémico/cirugía , Accidente Cerebrovascular Isquémico/terapia , Resultado del TratamientoRESUMEN
INTRODUCTION: Mechanical thrombectomy (MT) is the standard treatment for acute ischemic stroke (AIS) due to anterior large vessel occlusion (LVO). Despite successful recanalization, some patients remain disabled after 3 months. Mechanisms that can cause futile recanalization (FR) are still largely unknown. We investigated if stress hyperglycemia might be associated with FR. PATIENTS AND METHODS: This is a retrospective analysis of consecutive patients with successful recanalization treated in four participating centers between January 2021 and December 2022. According to the modified Rankin scale (mRS) status at 3 months, patients were divided into two groups: FR, if mRS score >2, and useful recanalization (UR), if mRS score ⩽2. Stress hyperglycemia was estimated by the glucose-to-glycated hemoglobin ratio (GAR) index. RESULTS: A total of 691 subjects were included. At 3 months, 403 patients (58.3%) were included in the FR group, while the remaining 288 patients (41.7%) were included in the UR group. At the multivariate analysis, variables independently associated with FR were the following: age (OR 1.04, 95% CI 1.02-1.06, p < 0.001), GAR index (OR 1.08, 95% CI 1.03-1.14, p = 0.003), NIHSS at admission (OR 1.16, 95% CI 1.11-1.22; p < 0.001), and procedure length (OR 1.01, 95% CI 1.00-1.02; p = 0.009). We observed that the model combining age, GAR index, NIHSS at admission, and procedure length had good predictive accuracy (AUC 0.78, 95% CI 0.74-0.81). CONCLUSIONS: Stress hyperglycemia predicts FR in patients with successful recanalization after MT. Further studies should explore if managing stress hyperglycemia may reduce futile recanalization. Additionally, we recommend paying close attention to AIS patients with a GAR index greater than 24.8 who exhibit a high risk of FR.
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Hiperglucemia , Accidente Cerebrovascular Isquémico , Trombectomía , Humanos , Masculino , Femenino , Anciano , Estudios Retrospectivos , Persona de Mediana Edad , Accidente Cerebrovascular Isquémico/cirugía , Accidente Cerebrovascular Isquémico/terapia , Accidente Cerebrovascular Isquémico/sangre , Trombectomía/métodos , Glucemia/análisis , Glucemia/metabolismo , Anciano de 80 o más Años , Resultado del Tratamiento , Inutilidad Médica , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismoRESUMEN
Conditional power (CP) serves as a widely utilized approach for futility monitoring in group sequential designs. However, adopting the CP methods may lead to inadequate control of the type II error rate at the desired level. In this study, we introduce a flexible beta spending function tailored to regulate the type II error rate while employing CP based on a predetermined standardized effect size for futility monitoring (a so-called CP-beta spending function). This function delineates the expenditure of type II error rate across the entirety of the trial. Unlike other existing beta spending functions, the CP-beta spending function seamlessly incorporates beta spending concept into the CP framework, facilitating precise stagewise control of the type II error rate during futility monitoring. In addition, the stopping boundaries derived from the CP-beta spending function can be calculated via integration akin to other traditional beta spending function methods. Furthermore, the proposed CP-beta spending function accommodates various thresholds on the CP-scale at different stages of the trial, ensuring its adaptability across different information time scenarios. These attributes render the CP-beta spending function competitive among other forms of beta spending functions, making it applicable to any trials in group sequential designs with straightforward implementation. Both simulation study and example from an acute ischemic stroke trial demonstrate that the proposed method accurately captures expected power, even when the initially determined sample size does not consider futility stopping, and exhibits a good performance in maintaining overall type I error rates for evident futility.