Routine invasive strategy in acute coronary syndrome patients with renal dysfunction. Results of the ARIAM-SEMICYUC registry. / Estrategia invasiva de rutina en el síndrome coronario agudo sin elevación del segmento ST con disfunción renal. Resultados del registro ARIAM-SEMICYUC.

OBJECTIVE: To evaluate the use and effectiveness of a routine invasive strategy (RIS) in patients with acute coronary syndrome without persistent ST-segment elevation with renal dysfunction in the real world scenario. METHODS: A retrospective cohort study based on the ARIAM-SEMICYUC Registry (2011-2014) was carried out. Renal dysfunction was defined as GFR (Cockroft-Gault)<60ml/min (moderate dysfunction) or<30ml/min (severe dysfunction). Patients in which early angiography (<72h) was performed due to cardiogenic shock or recurrent myocardial ischemia were excluded. The primary endpoint was hospital mortality. Confounding factors were controlled using propensity score analysis. RESULTS: A total of 4,279 patients were analyzed, of which 26% had moderate renal dysfunction and 5% severe dysfunction. Patients with renal dysfunction had greater severity and comorbidity, higher hospital mortality (8.6 vs. 1.8%), and lesser use of the RIS (40 vs. 52%). The adjusted OR for mortality in patients without/with renal dysfunction were 0.38 (95% confidence interval [95%CI] 0.17 to 0.81) and 0.52 (95%CI 0.32 to 0.87), respectively (interaction P-value=.4779). The impact (adjusted risk difference) of RIS was higher in the group with renal dysfunction (-5.1%, 95%CI -8.1 to -2.1 vs. -1.6%, 95%CI -2.6 to -0.6; interaction P-value=.0335). No significant interaction was detected for the other endpoints considered (ICU mortality, 30-day mortality, myocardial infarction, acute renal failure or moderate/severe bleeding). CONCLUSIONS: The results suggest that the effectiveness of IRS is similar in patients with normal or abnormal renal function, and alert to the under-utilization of this strategy in such patients.

[Accessibility to health care of diabetic patients with acute coronary syndrome ST-segment elevation]. / Accesibilidad al sistema sanitario de los pacientes diabéticos con síndrome coronario agudo con elevación del segmento ST.

OBJECTIVES: To measure accessibility to health care among diabetic patients and analyze whether differences in delay explain differences in hospital mortality. METHODS: A retrospective cohort study was conducted in diabetic patients with acute coronary syndrome with ST-segment elevation included in the ARIAM-SEMICYUC registry (2010-2013). Crude and adjusted analyses were performed using unconditional logistic regression. RESULTS: A total of 4817 patients were analyzed, of whom 1070 (22.2%) were diabetics. No differences were found in access to health care between diabetic and non-diabetic patients. Diabetic patients presented with longer patient delay (90 min vs. 75 min; p=.004) and prehospital delay (150 min vs. 130 min; p=.002). Once the health system was contacted, diabetic patients had a lower reperfusion rate (50% vs. 57.7%; p<.001), but no longer delay in treatment was observed compared with the non-diabetic individuals. Diabetic patients have greater in-hospital mortality (12.5 vs. 6%; p <.001), though neither patient delay nor prehospital delay were identified as independent predictors of in-hospital mortality. CONCLUSIONS: Diabetic patients had a longer delay in access to health care, though such delay was not independently related to increased mortality.

[Predictors of the use of the early invasive strategy in women with non-ST-elevation acute coronary syndrome]. / Predictores del uso de la estrategia invasiva precoz en mujeres con síndrome coronario agudo sin elevación de ST.

OBJECTIVE: To identify determinants associated to an early invasive strategy in women with acute coronary syndromes without ST elevation (NSTE-ACS). DESIGN: A retrospective cohort study was made. Crude and adjusted analysis of the performance of the early invasive strategy using logistic regression. SETTING: Coronary Units enrolled in 2010 - 2011 in the ARIAM-SEMICYUC registry. PATIENTS: A total of 440 women with NSTE-ACS were studied. Sixteen patients were excluded due to insufficient data, together with 58 patients subjected to elective coronary angiography (> 72 h). VARIABLES ANALYZED: Demographic parameters, coronary risk factors, previous medication, comorbidity. Clinical, laboratory, hemodynamic and electrocardiographic data of the episode. RESULTS: Women treated conservatively were of older age, had oral anticoagulation, diabetes, previous coronary lesions, and heart failure (p<0.005), increased baseline bleeding and ischemic risk (p=0.05) and a higher heart rate upon admission (p<0.05). After adjustment, only age > 80 years (OR 0.48, 95% CI 0.27 to 0.82, p=0.009), known coronary lesions (OR 0.47, 95% CI 0.26-0.84, p=0.011), and heart rate (OR 0.98, 95% CI 0.97-0.99, p=0.003) were independently associated to conservative treatment. Smoking (OR 2.50, 95% CI 1.20 to 5.19, p=0.013) and high-risk electrocardiogram (OR 2.96, 95% CI 1.72 to 4.97, p<0.001) were associated to the early invasive strategy. The exclusion of early deaths (<24 h) did not alter these results. CONCLUSIONS: In women with NSTE ACS, smoking and a high-risk electrocardiogram upon admission were independent factors associated to the early invasive strategy. Previous coronary lesions, age > 80 years and increased heart rate were independent factors associated to conservative treatment.

[New recommendations on the use of human albumin solutions in patients with severe sepsis and septic shock. A critical evaluation of the literature]. / Nuevas recomendaciones sobre la utilización de soluciones de albúmina humana en pacientes con sepsis grave y shock séptico. Una evaluación crítica de la literatura.

The third edition of the Surviving Sepsis Campaign guidelines opens the door to the use of albumin for fluid resuscitation in patients with severe sepsis and septic shock. This recommendation is based on a recent meta-analysis that included studies with evidence of insufficient plasma expansion in the control group and studies performed in children with malaria with clear statistical heterogeneity (P for interaction=.02). After excluding pediatric studies, the confidence interval of the effect estimate was consistent with a mortality excess in the group treated with albumin (OR=.87 [95%CI: .71 to 1.07]). Two new randomized studies reported after publication of the meta-analysis found no benefit in patients treated with albumin. Given the uncertainty about the true effect of albumin (due to the existence of indirectness and imprecision) and its cost considerations, it is suggested not to use albumin in the initial resuscitation of patients with severe sepsis and septic shock (GRADE2C).

[Thrombolysis in acute ischemic stroke in centers lacking a stroke unit: referral to reference center or on-site treatment?]. / Trombolisis en el ictus isquémico agudo en centros sin unidad de ictus: ¿derivación a centro de referencia o tratamiento in situ?

OBJECTIVE: To assess the clinical impact of on-site thrombolysis versus referral to another hospital in patients with ischemic stroke attended in a hospital lacking a stroke unit. DESIGN: Expected value decision analysis and Monte Carlo simulation. PATIENTS AND SETTING: Decision analysis based on a cohort study (SIT-MOST) and a meta-analysis of randomized trials of thrombolysis versus placebo in patients with acute ischemic stroke. INTERVENTIONS: On-site thrombolysis (in hospitals lacking a stroke unit) versus delayed thrombolysis in a reference hospital. MAIN OUTCOMES: Neurological outcome (modified Rankin scale) three months after admission according to the delay in the administration of thrombolysis. RESULTS: At baseline (initial delay of 135 min, travel time 60 minutes), on-site treatment was more effective than referral to another hospital (number of patients with favorable neurological outcome 45.3% versus 41.3%). In patients seen within 45 minutes of the onset of symptoms, for every 10 patients transferred there was an additional case with an unfavorable neurological outcome that could have been avoided with on-site thrombolysis. In the Monte Carlo analysis, biased against on-site treatment by a reduction in effectiveness of 30%, on-site treatment was superior to patient referral in 77.2% of the cases. CONCLUSIONS: The available evidence does not support the recommendations of the national stroke strategy or some regional plans that discourage the administration of thrombolysis in hospitals without stroke units.

[Early invasive strategy in non-ST-segment elevation acute coronary syndrome. The paradox continues]. / Uso de la estrategia invasiva precoz en el síndrome coronario agudo sin elevación de ST. La paradoja continúa.

OBJECTIVE: Observational studies have reported a paradoxical inverse relationship between the use of an early invasive strategy (EIS) and the risk of events in patients with non-ST-segment elevation acute coronary syndrome (NSTE ACS). The study objectives are: 1) to examine the association between baseline risk in patients with NSTE ACS and the use of EIS; and 2) to identify some of the factors independently associated to the use of EIS. DESIGN: Retrospective cohort study. SETTING: Intensive care units participating in the SEMICYUC ARIAM Registry. PATIENTS: Consecutive patients admitted with a diagnosis of NSTE-ACS within 48 hours of evolution between the months of April-July 2010. INTERVENTIONS: None. MAIN OUTCOMES: Coronary angiography with or without angioplasty within 72 hours, risk stratification using the GRACE scale. RESULTS: We analyzed 543 patients with NSTE-ACS, of which 194 were of low risk, 170 intermediate risk and 179 high risk. The EIS was used in 62.4% of the patients at low risk, in 60.2% of those with intermediate risk, and in 49.7% of those at high risk (p for tendency 0.0144). The EIS was used preferentially in patients with low severity and comorbidity. In the logistic regression model, EIS was independently associated to the availability of a catheterization laboratory (OR 2.22 [CI 95% 1.55 to 3.19]), the presence of ST changes on ECG (OR 1.80 [1.23 to 2.64]), or the existence of a low risk of bleeding (OR 0.76 [0.66 to 0.88)]. Conversely, EIS was less prevalent in patients with diabetes (OR 0.60 [0.41 to 0.88]) or tachycardia upon admission (OR 0.54 [0 36 to 0.82]). CONCLUSIONS: In 2010 there remained a lesser relative use of EIS in patients at high risk, due in part to an increased risk of bleeding in these patients.

Can we still consider treatment with colchicine effective in SARS-COV-2 infection? Systematic review, meta-analysis, and trial sequential analysis.

OBJECTIVE: To assess the effectiveness of colchicine, compared with standard of care, for reducing mortality, admission to intensive care, and use of mechanical ventilation. MATERIALS AND METHODS: We performed a systematic review, meta-analysis, and sequential trial analysis. The terms (SARS-CoV-2 OR COVID-19 OR coronavirus) AND (colchicine) were searched in MEDLINE, Scopus, Embase, Cochrane Central Register of Controlled Trials, and preprint repositories (February 2020 to April 2021, extended to June 2021). Risk of bias for randomised controlled trials and observational studies were assessed using the tools RoB 2.0 and ROBINS-I, respectively. We performed subgroup analyses based on study design and sensitivity analyses based on time of colchicine administration. RESULTS: We included six observational studies (1329 patients) and five clinical trials (16,048 patients). All studies but one were conducted in the hospital setting. Colchicine treatment was not associated with a significant decrease in mortality (RR 0.93, 95% CI 0.87 to 1; p=0.06, I2=72%) with a significant subgroup effect (p<0.001) depending on the design of the studies. The drug was effective in observational studies (RR 0.57, 95% CI 0.46 to 0.70, p<0.001, I2=50%) but not in clinical trials (RR 0.99, 95% CI 0.92 to 1.07, p=0.89, I2=21%). The effect of colchicine on intensive care admissions and the need for mechanical ventilation could not be confirmed. Trial sequential boundaries for cumulative meta-analyses of randomised controlled trials suggested no significant effect on mortality (p=0.182) beyond the optimal information size (13,107 patients). CONCLUSIONS: Our results suggest that colchicine treatment has no effect on mortality in hospitalised patients with SARS-CoV-2 infection, and that no further confirmatory clinical trials are needed owing to futility.

Clinical research in critical care. Difficulties and perspectives. / Investigación en el enfermo crítico. Dificultades y perspectivas.

In the field of Intensive Care Medicine, improved survival has resulted from better patient care, the early detection of clinical deterioration, and the prevention of iatrogenic complications, while research on new treatments has been followed by an overwhelming number of disappointments. The origins of these fiascos must be sought in the conjunction of methodological problems - common to other disciplines - and the particularities of critically ill patients. The present article discusses both aspects and suggests some options for progress.

Myocardial infarct extension. Identification of subgroups by the pattern of the serum CKMB level.

To examine the clinical course of patients with acute myocardial infarction complicated by "extension", we studied prospectively 141 patients who had been diagnosed as having acute myocardial infarction. The serum CKMB level of these patients was determined at 8-h intervals during the first 5 days following admission. The patients were classified into 3 groups. Group A (early extension): patients who showed CKMB re-elevation before the CKMB values reached normal levels (28%). Group B (late extension): patients who showed CKMB re-elevation after the normalization of serum CKMB levels (21%). Group C (control group): patients without CKMB re-elevation (51%). Patients in group A showed the most unfavourable clinical course with a greater rate of haemodynamic deterioration compared with patients in the B or C groups, and a higher rate of recurrent ischemic pain. We found no significant differences in these parameters between the B and C groups. We were unable to find any risk factor associated with the development of extension. The pattern of the serum CKMB curve may allow a separation of two different subgroups of patients with acute myocardial infarct extension: patients with early extension, who show a high prevalence of haemodynamic deterioration, and patients with late extension, characterized by small infarcts and a benign clinical course.

The association between vasectomy and prostate cancer: a systematic review of the literature.

OBJECTIVE: To evaluate the possible association between vasectomy and prostate cancer. DESIGN: Systematic review of the literature. PATIENT(S): Fourteen original studies published between January 1985 and December 1996 that addressed the association between vasectomy and prostate cancer. MAIN OUTCOME MEASURE(S): The strength of the association was estimated with the use of a meta-analysis (DerSimonian and Laird method). A sensitivity analysis was conducted to assess the impact of different sources of heterogeneity. RESULT(S): Fourteen original papers were reviewed (5 cohort and 9 case-control studies). Relative risks ranged between 0.44 (95% confidence interval [CI] = 0.1-4.0) and 6.70 (95% CI = 2.1-21.6). The overall relative risk (DerSimonian and Laird estimate) was 1.23 (95% CI = 1.01-1.49). The sensitivity analysis showed that this measure was very sensitive to the study base, the type of design used, and the possibility of bias. Further, the funnel plot demonstrated the probable existence of publication bias. CONCLUSION(S): No causal association was found between vasectomy and prostate cancer. Individuals who have undergone vasectomy are not at high risk for the development of prostate cancer.

PIP: The absence of a plausible biologic model, methodologic problems, and lack of consistency between the results of different studies have created skepticism about any association between vasectomy and prostate cancer. To clarify further the possibility of such a link, a systematic review of the empirical literature published in 1988-96 was conducted. 14 such studies (5 cohort and 9 case-control) were identified, 11 of which found an excess risk of prostate cancer in men who had undergone vasectomy. Relative risks ranged from 0.44 (95% confidence interval (CI), 0.1-4.0) and 6.70 (95% CI, 2.1-21.6). The risk was statistically significant in 6 studies. The weighted relative risk obtained using the age-adjusted results of the individual studies was 1.23 (95% CI, 1.01-1.49). However, both the statistical tests and the qualitative analysis detected heterogeneity between the studies. Possible sources of this heterogeneity include type of design, study base, presence of detection bias, and inadequate selection of controls. Moreover, the sensitivity analysis indicated that the detected effect depends to a great extent on studies that are more vulnerable to bias (i.e., case-control and hospital-based studies) and those that have internal validity problems. Further, the funnel plot demonstrated the possible existence of publication bias. Finally, when the relative risk was recalculated to exclude early stage tumors (located by active detection in vasectomy cases), the previously found association between vasectomy and prostate cancer disappeared. It is concluded that the available empiric evidence is of low quality because of multiple sources of bias that favor the overestimation of the effect of vasectomy on prostate cancer risk. These validity problems, along with the lack of a biologic model to explain the association, strongly suggest the association is not causal.

Socioeconomic status and severity of illness on admission in acute myocardial infarction patients.

The objective of this research is to test the hypothesis of the existence of an association between socioeconomic status and severity of illness of the patients admitted to the hospital with acute myocardial infarction. The design was a retrospective cohort study of consecutive patients admitted to the coronary care unit with the diagnosis of acute myocardial infarction in six public hospitals from the Spanish region of Valenciá. A total of 369 patients admitted to the intensive care units of the participating hospitals were studied. The socioeconomic status was measured using an ad hoc index based upon the occupational level, income and educational level of the patient. The patients below the 20% percentile were considered as disadvantaged, and the patients whose Killip class on admission was 3 or 4 were considered as complicated. The effect of potential confounders was controlled using unconditional logistic regression analysis. The results were validated in an independent but comparable population of 331 patients. The disadvantaged patients showed a higher prevalence of open cardiac failure on admission (Killip classes 3 or 4) than the remainder (crude odds ratio = 3.1, 95% confidence interval between 1.57 and 6.1). The association between socioeconomic status and severity of illness persisted after controlling for important covariates (age, diabetes mellitus, gender and marital status): adjusted odds ratio = 2.4, 95% confidence interval between 1.1 and 5.2. These results were highly consistent with those in the validation group. Our results suggest that socioeconomic status is an independent predictor of the severity of illness on admission to coronary care units in acute myocardial infarction patients. These results are consistent with the existence of a low accessibility of patients in the lower socioeconomic levels.

[Tuberculous liver abscess in an immigrant patient with pulmonary tuberculosis]. / Absceso hepático tuberculoso en paciente inmigrante con tuberculosis pulmonar.

Liver abscess due to Mycobacterium tuberculosis associated with pulmonary tuberculosis is a rare diagnosis, particularly in patients without AIDS. We report the case of a male immigrant with no HIV infection who developed a tuberculous liver abscess and pulmonary tuberculosis simultaneously. Ziehl-Neelsen stain, PCR and Löwenstein-Jensen culture of material sampled from the abscess established the microbiological diagnosis. The patient's course was good, with disappearance of symptoms and the abscess after tuberculostatic treatment and drainage of the abscess with monitoring by computed tomography.

[Evaluation of the use of the pulmonary artery catheter in patients with acute myocardial infarct: The PAEEC study. Project of the Epidemiologic Analysis of Critical Illness]. / Evaluación del uso del catéter de arteria pulmonar en pacientes con infarto agudo de miocardio: el estudio PAEEC. Proyecto de Anánlisis Epidemiológico de Enfermos Críticos.

BACKGROUND: The aim of the study was to evaluate the impact of the use of the pulmonary artery catheter on hospital mortality in patients admitted to hospital for acute myocardial infarction. PATIENTS AND METHODS: This retrospective cohort study, included 1,721 patients whose main diagnosis was acute myocardial infarction and who were registered in the PAEEC study (a multicenter study including 86 intensive care units throughout Spain). RESULTS: A pulmonary artery catheter was implanted in 82 patients (4.8%). The mortality of the group with the catheter was 51.2%, being greater than that of the control group which did not receive the catheter (odds ratio [OR] = 8.56, 95% confidence interval [CI] range 5.25-13.93; p < 0.001). This excessive mortality persisted on adjusting for the APACHE-III, age, sex, diabetes, use of mechanical ventilation, vasoactive drugs and thrombolytic treatment (adjusted OR = 3.11; CI 1.59-5.57; p < 0.001). The TISS values of the patients in whom the catheter was implanted were greater than those expected for their age and APACHE-III level, being interpreted as an indicator of occult severity. On inclusion of the TISS values in the logistic regression model, the differences in mortality between the catheter and the control group decreased, but remained statistically significant (OR = 2.05; CI: 1.04-4.0; p = 0.039). CONCLUSIONS: The use of the pulmonary artery catheter was not found to contribute to reducing the mortality of patients with acute myocardial infarction. In fact, these results questions its use, particularly in less severe patients.

[The therapeutic effort on admission for women with an acute myocardial infarct. The Valencia Group for the Study of Hospital Inequities in Health]. / Esfuerzo terapéutico al ingreso en mujeres con infarto agudo de miocardio. Grupo Valenciano para el Estudio de las Desigualdades Hospitalarias en Salud.

BACKGROUND: Recent studies have suggested that women with ischemic heart disease receive lesser therapeutic care than males. The aim of this study was to verify the hypothesis that sex is an independent predictive factor in therapeutic care upon admission in patients with acute myocardial infarction. METHODS: Secondary analysis was performed by multiple linear regression of 429 males and 124 females admitted to 6 general intensive care units for acute myocardial infarction. Therapeutic effort was measured according to the Therapeutic Intervention Scoring System (TISS) index. Age, initial severity measured by the Simplified Acute Physiological Score (SAPS) and the Killip group were considered as possible variables of confusion upon admission. RESULTS: Upon comparison with males the group of women was characterized by a greater age (p < 0.0001), higher SAPS score (p = 0.0028) and lesser relative therapeutic effort (p = 0.0990), and a higher Killip group upon admission (p < 0.0001). Regression analysis identified the Killip group (p < 0.0001), the SAPS index (p < 0.0001) and age (p = 0.0011) but not sex (p = 0.3875) as independent predictors of therapeutic effort. CONCLUSIONS: The results of the present study do not support the hypothesis that sex is an independent predictor of therapeutic effort. The indexes of lesser relative therapeutic effort in women admitted for acute myocardial infarction were found to be attributed to a higher mean age.

[Prehospital delay in patients with ischemic chest pain in the Province of Alicante. Multicenter Study of Prehospital Delay in Patients with chest Pain]. / Demora prehospitalaria en pacientes con dolor torácico isquémico en la provincia de Alicante. Estudio Multicéntrico sobre Retraso Prehospitalario en Pacientes con Dolor Torácico.

BACKGROUND: The objectives of this study are: 1) to estimate the pre-hospital delay between onset of symptoms and admission in patients with ischemic chest pain in 5 hospitals from the Spanish Region of Valencia, and 2) to determine the socio-demographic variables that are associated with this delay. PATIENTS AND METHODS: We studied prospectively 426 patients admitted to the emergency area of the 5 participating hospitals with chest pain and a probability of infarction > or = 0.08. In each patient we determined the probability of acute myocardial infarction, the length of time between onset of symptoms and hospital arrival (patient's decision time and transportation time), and some socio-demographic variables presumably related to the delay. RESULTS: The median between onset of symptoms and arrival to the hospital was 120 minutes, corresponding the biggest part to decision time (median 73 minutes), whilst the median of transportation time was 20 minutes. Cox's regression analysis identified the following independent predictors of delay: age of the patient (p = 0.012), living with relatives (p = 0.026), onset during the night (p < 0.001) or at home (p = 0.021), low severity of pain (p < 0.001), being autoctonous (p = 0.023) and participation of health care individuals in the referral process (p = 0.011). CONCLUSIONS: The pre-hospital delay detected in our study is comparable to that detected in other settings. The determinants of the delay identified in this study are consistent with previously published findings.