Age, period and cohort effects on gastric cancer mortality in Spain, 1980-2021.

BACKGROUND: this study aimed to evaluate the effects of age, time period and cohort (A-P-C) on gastric cancer (GC) mortality in Spain from 1980 to 2021. METHODS: an ecological trend study was performed (with aggregated data obtained from the Spanish National Statistics Institute (INE). Joinpoint regression software was used to estimate rates by sex and age group (< 35, 35-64, > 64 years) and mortality trends. The National Cancer Institute A-P-C tools were used to assess the effects of age, time of death and birth cohort. RESULTS: GC mortality rates in Spain decreased significantly in both sexes. In the under-35 age group, rates were stable after an initial significant decline. In the 35-64 age group, the decline was more pronounced in males than in females. In the 65+ age group, rates fell significantly for both sexes, but more so for females than for males. The net drift and local drift also showed significant decreases across all age groups from 24 years onwards. GC mortality rates increased with age and decreased with calendar time and successive birth cohorts, regardless of sex. The ratio of age-specific rates between males and females increased with age, and birth cohort relative risk estimates followed a steady downward trend until the mid-1970s, after which the decline stabilized. The relative risk decreased for both sexes, with a more pronounced decrease in males. CONCLUSION: GC mortality rates in Spain have been decreasing over time and across successive birth cohorts, with a stabilizing trend observed for those under 35 years of age.

Clustering of systemic lupus erythematosus mortality in southwestern Spain.

OBJECTIVE: To analyse time trends in systemic lupus erythematosus (SLE) mortality and explore possible provincial clustering of SLE mortality in Spain (2001-2020). METHODS: We conducted an ecological study using deaths registered in SLE at the Spanish National Institute of Statistics between 2001 and 2020. Jointpoint regression models have been used to evaluate temporal trends. To analyse the spatial pattern of SLE mortality in men and women in Spain, crude rates, age-standardised mortality rates (ASMRs), smooth relative risk (RR) and posterior probabilities (PP) for RR greater than one for the period 2001-2020 were calculated. The Global Moran I index was used to assess the existence of global spatial autocorrelation. Local indicators of spatial association (LISA) and Kulldorff's spatial scan statistic were used to identify clusters. RESULTS: Over the 20 years analyzed in this study, the SLE average ASMR for the period was 2.7 for women and 0.7 for men, with a sex ratio (female/male) of 3.8. In men, no province showed a RR>1. Conversely, in women, eight provinces showed values of RR> 1 with a PP greater than 0.8 (Seville, Cadiz, Huelva and Murcia in the south, Barcelona, Zaragoza, Huesca and Leon in the north). In men, neither of the two methods detected a clustering of provinces. However, in women, both methods identified a cluster of provinces located in the southwest of the country (Huelva, Cádiz, Seville and Malaga) as a cluster with significant excess mortality. In the second cluster (centred on the province of Huelva) obtained with the Kulldorff method, two more provinces were added (Badajoz and Cordoba, also located in the southwest). CONCLUSIONS: We detected a cluster of provinces with an excess risk of female SLE mortality in the southwest of Spain.

Epidemiology of Lung Cancer Mortality in Spain: Updated Information (1982-2021) and Predictions up to 2046.

BACKGROUND: Patterns of lung cancer (LC) mortality are important for planning health services and resource management. OBJECTIVES: We aimed to provide updated information (1982-2021) and project (LC) mortality rates in Spain (2022-2046). METHOD: We analysed data from the Spanish National Statistics Institute about mortality in LC (1982-2021), and we made predictions for the period 2022-2046. RESULTS: In 2021, a total of 22,413 people died of LC, and for the period 2042-2046, the projected annual average was 25,549 deaths. In males, age-standardised mortality rates (ASMR) (overall) after an initial period of increase (1982-1996, 2.2%) declined until 2021 (-1.4% per year), and this decline is expected to continue in the future (-1.9% per year during the period 2022-2046), although the projected decline is slightly higher (-2.0% during the period 2022-2046). In men, ASMR (all ages) after an initial period of increase (1982-1996, 2.2%) declined until 2021 (-1.4% per year), and this decline is expected to continue in the future during the period 2022-2046. In women, both the overall and truncated rates (35-64) increase during the period 1982-2021 (4.1% and 6.0% per year, respectively), and projected rates showed that both will decrease during the period 2022-2046, although more markedly in the truncated rates (-1.9% per year) than in the overall rates (-0.5% per year). CONCLUSIONS: Our projections show the magnitude of a steady upward trend in LC mortality among women in Spain that appears to be beginning to reverse from the current decade (similar to that observed for incidence).

Regional differences in colorectal cancer mortality trends, Spain (1980-2018).

INTRODUCTION: the aim of this study was to describe the trends of colorectal cancer (CRC) mortality by autonomous communities (ACs) and gender in Spain (1980-2018). METHODS: the age-standardized mortality rates (ASMRs) for CRC (per 100,000) were calculated by direct standardization, using the world standard population. Mortality trends were described by ACs using a joinpoint regression model in both sexes. The annual percent changes and average annual percentage of change were computed for trends using the joinpoint regression analysis. RESULTS: during the most recent five-year period (2014-2018), the rates decreased among both males and females and were more pronounced in males (-2.3 %) than in females (-1.1 %), although with differences by ACs. ASMRs decrease in both sexes in the Basque Country, Canary Islands, Catalonia, Castile and Leon, Andalusia, Balearic Islands, Madrid, Murcia and Valencia. Whereas in other ACs, it only increases in males (Navarre, Castile-La Mancha, Extremadura and La Rioja) or females (Aragon, Asturias and Galicia). CONCLUSION: this updated analysis of temporal patterns of CRC mortality in Spain from 1980-2018, divided by ACs and sex, shows gender differences in CRC mortality trends. Despite the favorable trends in both sexes, the gender gap is widening.

Intravenous Thrombolysis Guided by Perfusion CT with Alteplase in >4.5 Hours from Stroke Onset.

INTRODUCTION: The benefit of intravenous thrombolysis (IVT) in wake-up stroke (WUS), stroke of unknown time of onset (SUKO), or when time exceeds 4.5 h from last-seen-normal (LSN) guided by CT perfusion (CTP) or MRI has been recently suggested. However, there is limited information of IVT in those patients in real-world studies. OBJECTIVE: Our aim was to evaluate safety and efficacy of IVT selected by CTP in patients with WUS, SUKO, or stroke of time onset beyond 4.5 h. MATERIAL AND METHODS: We studied a prospective cohort of patients who underwent IVT from January 2010 to December 2017. Two groups were defined: standard of care group (SC) included patients with time onset <4.5 h and CTP group included patients with WUS, SUKO, or onset beyond >4.5 h from LSN with penumbra area in CTP. We evaluated baseline characteristics, functional outcomes according to modified Rankin Scale (mRS) at discharge and at 90 days, and intracranial hemorrhages rates. RESULTS: 657 patients were studied: 604 (92%) were treated in the SC group and 53 (8%) in the CTP group. The mean NIHSS score was 9.8 in the CTP group versus 13 in the SC group (p = 0.001). Seventeen patients in the CTP group (32.1%) received bridging therapy with mechanical thrombectomy (MT). Last time seen well-to-needle time was 538 versus 155 min (p < 0.001). The incidence of symptomatic intracranial hemorrhage was equal in both groups (3.8 vs. 3.8%, p = 1). Good functional outcome (mRS < 2) was achieved in both groups (72 vs. 60.4%, p = 0.107). CONCLUSIONS: IVT in patients with WUS, SUKO, or stroke beyond >4.5 h from LSN, with salvageable brain tissue on CTP, seems to be safe and has similar functional outcomes at 90 days to the standard therapeutic window, even when combined with MT.

Safety of Early Carotid Artery Stenting for Symptomatic Stenosis in Daily Practice.

OBJECTIVE/BACKGROUND: In 2006, the American Heart Association recommended that for preference carotid endarterectomy (CEA) or, alternatively, carotid angioplasty and stenting (CAS) for symptomatic carotid artery stenosis should ideally occur within 14 days of an ischaemic event. The aim was to determine the safety of CAS according to those recommendations in daily practice. METHODS: A retrospective analysis was performed of all consecutive patients (2000-16), with ipsilateral carotid symptoms who underwent CAS for extracranial carotid stenosis ≥70%, who were previously included in a prospective database. Thirty day morbidity was assessed (any stroke without transient ischaemic attack [TIA]/amaurosis fugax), along with mortality of the procedure in the early (≤14 days after stroke onset) and delayed phases (15-180 days after stroke onset). Patients who received CAS and/or mechanical thrombectomy for acute ischaemic stroke treatment were not included. RESULTS: In total, 1227 patients with symptomatic carotid stenosis who underwent CAS were identified. Early and delayed CAS was performed in 291 and 936 patients, respectively. Morbidity (any stroke) and mortality was 2.2% (n = 27) in the whole cohort (n = 8 [2.7%] in early vs. n = 19 [2%] in delayed CAS; p = .47). There were no differences in morbidity between early and delayed CAS regarding TIA (n = 15 vs. 36 [5.2% vs. 3.9%]; p = .33), minor stroke (n = 4 vs. 5 [1.4% vs. 0.5%]; p = .14), or major stroke (n = 2 vs. 6 [0.7% vs. 0.6%]; p = .59). Two patients (0.7%) died after early CAS and eight (0.9%) after delayed CAS (p = .56). CONCLUSION: CAS may be safely performed in the early phase after an ischaemic stroke with low clinical complication rates. Further studies are needed to validate CAS safety conducted even earlier in the acute phase of ischaemic stroke.

Effects of Red Blood Cell Transfusion on Long-Term Disability of Patients with Traumatic Brain Injury.

BACKGROUND: This 3-year prospective study examined the association between red blood cell transfusion (RBCT) and 1-year neurocognitive and disability levels in 309 patients with traumatic brain injury (TBI) admitted to the neurological intensive care unit (NICU). METHODS: Using a telephone interview-based survey, functional outcomes were assessed by the Glasgow Outcome Scale (GOS), Rancho Los Amigos Levels of Cognitive Functioning Scale (RLCFS), and Disability Rating Scale (DRS) and dichotomized as favorable and unfavorable (dependent variable). The adjusted influence of RBCT on unfavorable results was assessed by conventional logistic regression, controlling for illness severity and propensity score (introduced as a continuous variable and by propensity score-matched patients). RESULTS: Overall, 164 (53 %) patients received ≥1 unit of RBCT during their NICU stay. One year postinjury, transfused patients exhibited significantly higher unfavorable GOS (46.0 vs. 22.0 %), RLCFS (37.4 vs. 15.4 %), and DRS (39.6 vs. 18.7 %) scores than nontransfused patients. Although transfused patients were more severely ill upon admission, their adjusted odds ratios (95 % confidence intervals) for unfavorable GOS, RLCFS, and DRS scores were 2.5 (1.2-5.1), 3.0 (1.4-6.3), and 2.3 (1.1-4.8), respectively. These odds ratios remained largely unmodified when the calculated propensity score was incorporated as an independent continuous variable into the multivariate analysis. Furthermore, in 76 pairs of propensity score-matched patients, the rate of an unfavorable RLCFS score at the 1-year (but not 6-month) follow-up was significantly higher in transfused than nontransfused patients [3.0 (1.1-8.2)]. CONCLUSION: Our results strongly suggest an independent association between RBCT and unfavorable long-term functional outcomes of patients with TBI.

Antiplatelet effects of clopidogrel dose adjustment (75 mg/d vs 150 mg/d) after carotid stenting.

OBJECTIVE: Clopidogrel plays a central role in the treatment of patients undergoing carotid artery stenting (CAS). The objective was to evaluate the effect of clopidogrel (75 mg/d) on platelet reactivity in responders and nonresponders and the antiplatelet effect of different doses of clopidogrel in patients with high on-treatment reactivity (OTR) after CAS. METHODS: Patients with high OTR (defined by VerifyNow (Accumetrics, San Diego, Calif) assay as ≥230 P2Y12 reaction units [PRU]) were randomly assigned in a 1:1 ratio to group 1 (standard-dose clopidogrel therapy: 75 mg/d for 30 days) or group 2 (high-dose clopidogrel: 150 mg/d for 30 days). RESULTS: The study enrolled 214 patients. Of these, 115 (53.7%) were clopidogrel responders (group 0), and 99 (46.3%) had high OTR (clopidogrel nonresponders); of which, 50 were randomly assigned to group 1 and 49 to group 2. At baseline, the PRU value did not differ between group 1 (288.50 ± 46) and group 2 (295.45 ± 47.2; P = .308). Patients displayed reduced mean platelet reactivity levels at 30 days in group 1 (238.96 ± 72.25; P < .001) and group 2 (201.85 ± 77.8; P < .001). Although high-dose clopidogrel resulted in more intense platelet function inhibition, the differences between median 30-day PRU values (P = .483) and the percentage change of PRU (P = .442) for groups 1 and 2 were not significant. The incidences of transient ischemic attack, stroke, or death at up to 30 days after CAS in the high-OTR patients were similar between groups 1 and 2 (P = .481). CONCLUSIONS: Patients with high OTR undergoing CAS treated with standard-dose and double-dose clopidogrel had significantly reduced platelet reactivity after 30 days. The double dose did not result in statistically significantly greater reductions in reactivity compared with the standard dose.

Administration of fibrinogen concentrate for refractory bleeding in massively transfused, non-trauma patients with coagulopathy: a retrospective study with comparator group.

BACKGROUND: This retrospective, single centre study was conducted to investigate the efficacy of fibrinogen concentrate (FBNc) in decreasing blood requirements and reaching optimal fibrinogen level, in non-trauma, massively transfused, bleeding patients with coagulopathy. METHODS: Over a 3-years period, all patients for whom a massive transfusion protocol was activated and had received ≥ 4 units of allogeneic blood components within a ≤ 4 h period, were included. Patients were classified according to whether they received FBNc or achieved an optimal fibrinogen level of ≥ 2 g/L within 24 h after FBNc administration. RESULTS: Seventy-one patients received 2 [2,4] g of FBNc (FBNc group) and 72 did not (comparator group). FBNc was administered after transfusing 5 [5,9] blood component units, 3 [2,6] hours after massive transfusion protocol activation. Linear regression analysis showed that SOFA (AOR 0.75 [95% CI:0.08-1.43]) and admission fibrinogen level (AOR -2.7 [95% CI:-4.68 - -0.78]), but not FBNc administration, were independently associated with total transfused units. There was a significant inverse relation between both admission and target fibrinogen levels, and total transfused components. Logistic regression showed a direct relationship between admission fibrinogen level and achieving a target level ≥ 2 g/L (AOR 3.29 [95% CI;1.95-5.56]). No thromboembolic events associated with FBNc were observed. CONCLUSIONS: In massively transfused, non-trauma patients with coagulopathy and refractory bleeding, late administration of low FBNc dosage was not associated with decreased blood transfusion or increased post-infusion fibrinogen level. Given that both fibrinogen upon admission and target fibrinogen levels were associated with decreased blood transfusion, earlier administration and higher doses of FBNc could be needed.

Myelodysplastic syndromes mortality in Spain: a comprehensive age-period-cohort and joinpoint analysis.

OBJECTIVE: The present study aims to assess the mortality trends in myelodysplastic syndromes (MDS) in Spain from 1980 to 2021. METHODS: Deaths and mid-year population data were collected from the National Institute of Statistics. We estimated age-standardised mortality rates (ASMRs) per 100,000 person-years for all ages and ages 35-64. Joinpoint regression identified significant changes in mortality trends. The independent effects of age, period and birth cohort on MDS mortality were also examined. RESULTS: MDS-related deaths gradually increased from 36 in 1980 to 1118 in 2021, with an overall increase of 6.6% in age-standardised mortality rates (ASMRs) for both men and women. Joinpoint analysis identified four periods for both men and women: 1980-1987 (stable rates), 1987-1990 (sharp increase), 1990-1999 (slower increase) and 1999-2021 (stable rates). ASMRs (35-64 years) increased by 2.5% over the study period, with a turning point identified in 1996 when rates decreased. Mortality from MDS increases with age and is higher in men. The cohort's relative risk increased until the mid-1950s and then stabilised, whilst the period relative risk increased between 1982 and 1996 and then stabilised. CONCLUSION: The results of this study indicate a progressive increase in MDS-related deaths in Spain between 1980 and 2021. Notably, this increase was more pronounced in men than in women. Analysis of birth cohort trends revealed shifts in MDS risk, characterised by an increase until the mid-twentieth century, followed by a stabilisation. Using joinpoint analysis, four distinct periods were identified, shedding light on the changing patterns of mortality over time. These findings help to shape future research directions and inform public health strategies. They also provide optimism for advances in MDS treatment and potential reductions in mortality.

Unveiling sex-based geographical disparities in myelodysplastic syndrome mortality trends in Spain (1999-2022).

AIM: To comprehensively analyze trends in myelodysplastic neoplasm (MDS) mortality across Spain (1999-2022), examining sex and regional differences. METHODS: We analyzed nationwide death records and population data, calculating age-standardized mortality rates (ASMRs) and standardized mortality ratios (SMRs) stratified by sex and Autonomous Community (AC). Joinpoint regression identified significant shifts in trends. RESULTS: Across Spain, MDS mortality risk varied among men, with rates ranging from 1.08 to 4.38 per 100,000 across regions, while women's rates ranged from 1.23 to 2.02. Five regions had higher risks than the national average, while six had lower risks. Joinpoint analysis revealed three periods nationally: a decline until 2008, and an increase until 2017, followed by a significant decrease. Despite the overall stable national trend (-0.5% annual change), significant regional variations emerged. Andalusia stood out with a worrying increase in MDS mortality, while Aragon and Murcia demonstrated promising declines. Extremadura displayed a unique trajectory with an initial rise followed by stabilization, while Galicia exhibited a contrasting trend with an initial decline and subsequent increase. Notably, men consistently faced a higher risk of MDS mortality compared to women, with significant disparities across regions. Extremadura, in particular, showed a marked difference in risk between genders. CONCLUSION: MDS mortality trends in Spain are complex, and influenced by gender, region, and time. Further research is needed to understand regional disparities, recent national decline, and higher risk in specific demographics. Tailored interventions based on local factors and targeted research are crucial to address these complexities and improve patient outcomes.

Spain's Rising Melanoma Threat: A Comprehensive 30-Year Analysis (1990-2019).

AIM: This study aims to elucidate the factors driving melanoma incidence trends in Spain by analyzing the GBD-2019 dataset (1990-2019) and investigating the age-specific, birth cohort, and period effects on incidence rates. MATERIALS AND METHODS: This study analyzed melanoma incidence trends in Spain from 1990 to 2019 using an ecological design. Data were sourced from the Global Burden of Disease Study 2019 and Spain's National Statistics Institute. Age-standardized incidence rates (ASIRs) were calculated using joinpoint regression analysis, and age-period-cohort (A-P-C) modeling was employed to assess the effects of age, time period, and birth cohort on incidence rates. RESULTS: Between 1990 and 2019, an estimated 147,823 melanoma cases were diagnosed in Spain. The ASIRs showed a steady increase for both sexes, with slightly higher rates observed in men. Both men (average annual percentage change (AAPC): 2.8%) and women (AAPC: 2.4%) showed a steady increase in the ASIR over the period. Joinpoint analysis revealed distinct periods of incidence rate changes, with significant upward trends in earlier years followed by stabilization in recent years. Incidence rates increased steadily with age, with the highest rates in the 80-84 age group. Women tended to have slightly higher rates in younger age groups, while men had higher rates in older age groups. Both men and women experienced a steady increase in relative risk of melanoma throughout the 30-year study period, with significant upward trends across birth cohorts. CONCLUSIONS: Despite limitations, this study provides valuable insights into factors influencing melanoma incidence in Spain. By understanding age, period, and cohort effects, effective prevention strategies can be developed to reduce melanoma incidence.

Trends in lung cancer incidence in Spain (1990-2019): insights from Global Burden of Diseases data.

BACKGROUND: This study examines lung cancer incidence in Spain (1990-2019) through age-period-cohort (A-P-C) analysis and Global Burden of Diseases (GBD) data, unravelling the complex interplay of age, period, and birth cohort in shaping these trends. METHODS: Utilizing GBD and Spanish population data, the study calculates age-standardized incidence rates (ASIRs) and employs Joinpoint analysis to identify significant trends. A-P-C analysis dissects the individual effects of age, calendar period, and birth cohort on incidence patterns. RESULTS: Between 1990 and 2019, almost 738,000 cases of lung cancer were diagnosed in Spain, with an average annual increase of 1.7%. The ASIR of lung cancer in Spain from 1990 to 2019 showed a sustained upward trend in women (Average Annual Per cent Change: 2.5%, P < 0.05), reaching 23.3 cases per 100,000 in 2019, whilst men experienced a significant decrease in incidence rates (AAPC: -0.6%, P < 0.05), falling to 108.9 in 2019. The male-to-female incidence ratio decreased from 12.2 in 1992 to 4.9 in 2019. Joinpoint analysis identified distinct periods for both sexes, with men showing stability, decline and then a significant decrease, whereas women showed an initial increase followed by a decrease. The longitudinal age curves showed a consistently higher incidence risk in men, peaking in the 80-84 age group. Male cohorts since the 1920s showed a decreasing relative risk, whereas women showed fluctuations in risk over time. CONCLUSION: Lung cancer rates are falling in Spain, especially amongst men, due to lower smoking rates. The gender gap is closing, but prevention targeted at women is needed. Tighter tobacco control and research into other risk factors are essential. Understanding the long-term effects of smoking and early exposure is key to better prevention and treatment in Spain.

Chronic obstructive pulmonary disease mortality trends in Spain, 1980-2020.

OBJECTIVES: In Spain, there has been a recent increase in the mortality rate for chronic obstructive pulmonary disease (COPD) in younger women. This study aimed to analyze trends in the COPD mortality rate in Spain from 1980 to 2020, evaluating any differences between genders and age groups. METHODS: Death certificates and mid-year population data were obtained from the Spanish National Institute of Statistics. For both genders, age group-specific and standardized (overall and truncated) rates were calculated by the direct method using the world standard population. The data were analyzed using the joinpoint regression method. RESULTS: In both men and women, the number of COPD deaths increased from 1980 to 1999 (average annual increase of 7% in men and 4% in women), while from 1999 onwards, deaths decreased by -1.0% per year in both genders. In women, there was a significant final period of increase in the 55-59 to 70-74 age groups and a slowing of the decline in the over 75 age group. Additionally, an increase in mortality for the truncated rates was observed for women between 2006 and 2020. In men under 70 years of age, there was an initial period in which death rates remained stable or significantly increased, followed by a period in which they decreased significantly. CONCLUSIONS: Our study shows age and gender differences in COPD mortality trends in Spain. Although the data show a downward trend, we have identified a worrying increase in the truncated rates in women for the last few years.

Age-period-cohort effect on lung cancer mortality in Spain, 1982-2021.

BACKGROUND: The aim of the study is to provide up-to-date information and evaluate the age-period-cohort effects of age-period cohorts on lung cancer (LC) mortality in Spain for the period 1982 to 2021. METHODS: We analysed deaths by LC and population for the period 1982-2021, available from the Spanish National Institute of Statistics. The LC corresponds to code 162 and codes C33 and C34 of the 9th and 10th editions of the International Classification of Diseases, respectively. Age-period-cohort (A-P-C) modelling was applied to compute the net drift, local drift, longitudinal age curve, and rate ratios (RR) of each period and cohort. A-P-C analysis was performed using the A-P-C Web Tool provided by the National Cancer Institute of the United States. RESULTS: Estimated relative risk in the male birth cohorts has followed a steady downward trend in all cohorts born since 1922, showing an initial period (1922-1947) of slight decline, followed by a more marked decrease in the cohorts born during the period 1947-1977. In the younger cohorts (1977-1997), the decline appears to have stabilised. In women, a strong cohort effect is observed. In those born after the Spanish Civil War (1936 to 1939), the risk increased until it peaked in the 1960s, after which it started to decrease with the same intensity. Period RR in men decreased from 1987 to 1991 (1.1) to 2017-2021 (0.6), while period RR in women increased during this time (from 0.8 to 1.6). CONCLUSIONS: The cohort effect observed in women born after the Civil War suggests that the onset of the LC epidemic may have been due to a higher prevalence of women smokers in these cohorts. However, the trend observed in the younger cohorts suggests a possible slowing-down in the increase in mortality risk in the following years.

Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial.

BACKGROUND AND PURPOSE: Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke. METHODS: A single-blind (outcomes assessor) controlled Phase I/II trial was conducted in patients with middle cerebral artery stroke. Autologous BM-MNCs were injected intra-arterially between 5 and 9 days after stroke. Follow-up was done for up to 6 months and blood samples were collected for biological markers. The primary outcome was safety and feasibility of the procedure. The secondary outcome was improvement in neurological function. RESULTS: Ten cases (BM-MNC-treated) and 10 control subjects (BM-MNC-nontreated) were consecutively included. Mean National Institutes of Health Stroke Scale before the procedure was 15.6. Mean BM-MNCs injected were 1.59×10(8). There was no death, stroke recurrence, or tumor formation during follow-up, although 2 cases had an isolate partial seizure at 3 months. After transplantation, higher plasma levels of beta nerve growth factor (ß-nerve growth factor) were found compared with control subjects (P=0.02). There were no significant differences in neurological function at 180 days. A trend to positive correlation between number of CD34+ cells injected and Barthel Index was found (r=0.56, P=0.09). CONCLUSIONS: Intra-arterial BM-MNC transplantation in subacute ischemic stroke is feasible and seems to be safe. Larger randomized trials are needed to confirm the safety and elucidate the efficacy of BM-MNC transplantation. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifier: NCT00761982.

Carotid plaque characterization by virtual histology intravascular ultrasound related to the timing of carotid intervention.

PURPOSE: To determine the incidence of vulnerable plaques characterized by virtual histology intravascular ultrasound (VH IVUS) in patients with severe internal carotid artery (ICA) stenosis and its relationship to the timing of protected carotid artery stenting (CAS). METHODS: The study included 141 patients (119 men; mean age 66.9 ± 9 years) with severe ICA stenosis undergoing CAS with cerebral protection. Patients were classified in 3 groups: 39 symptomatic early CAS (<14 days from clinical symptoms); 58 symptomatic delayed CAS (range 15-180 days), and 44 asymptomatic CAS. Culprit plaque component was evaluated by VH IVUS. A vulnerable plaque was defined by a thin-cap fibroatheroma and/or calcified thin-cap fibroatheroma. RESULTS: The composite disabling stroke/mortality was 2.1%. The incidence of vulnerable plaques was significantly higher in the symptomatic early CAS group (25/39, 64.1%) than in the symptomatic delayed CAS group (26/58, 44.8%; p=0.048) or the asymptomatic CAS group (14/44, 31.8%; p=0.003). Symptomatic patients showed a significantly higher incidence of vulnerable plaques (52.6%) than asymptomatic patients (31.8%, p=0.022). There were no significant differences between the symptomatic delayed and asymptomatic groups (p=0.129). By clinical subgroup, a vulnerable plaque was observed in 29 (52.7%) of the patients with 55 transient ischemic attacks, 22 (52.4%) of the 42 minor stroke patients, and 14 (31.8%) of the 44 asymptomatic patients (p=0.152). CONCLUSION: The incidence of vulnerable plaques was significantly higher in symptomatic patients, increasing as the intravascular study was performed closer to the index ischemic episode.

Facial disability index (FDI): adaptation to Spanish, reliability and validity.

OBJECTIVES: To adapt to Spanish the facial disability index (FDI) described by VanSwearingen and Brach in 1995 and to assess its reliability and validity in patients with facial nerve paresis after parotidectomy. STUDY DESIGN: The present study was conducted in two different stages: a) cross-cultural adaptation of the questionnaire and b) cross-sectional study of a control group of 79 Spanish-speaking patients who suffered facial paresis after superficial parotidectomy with facial nerve preservation. The cross-cultural adaptation process comprised the following stages: (I) initial translation, (II) synthesis of the translated document, (III) retro-translation, (IV) review by a board of experts, (V) pilot study of the pre-final draft and (VI) analysis of the pilot study and final draft. RESULTS: The reliability and internal consistency of every one of the rating scales included in the FDI (Cronbach's alpha coefficient) was 0.83 for the complete scale and 0.77 and 0.82 for the physical and the social well-being subscales. The analysis of the factorial validity of the main components of the adapted FDI yielded similar results to the original questionnaire. Bivariate correlations between FDI and House-Brackmann scale were positive. The variance percentage was calculated for all FDI components. CONCLUSIONS: The FDI questionnaire is a specific instrument for assessing facial neuromuscular dysfunction which becomes a useful tool in order to determine quality of life in patients with facial nerve paralysis. Spanish adapted FDI is equivalent to the original questionnaire and shows similar reliability and validity. The proven reproducibility, reliability and validity of this questionnaire make it a useful additional tool for evaluating the impact of facial nerve paralysis in Spanish-speaking patients.

Magnetic resonance imaging in patients with cardiac implantable electronic devices: A prospective study.

BACKGROUND: The number of patients with cardiac implantable electronic devices in whom magnetic resonance imaging (MRI) is indicated is constantly increasing. The potential risk of electromagnetic interference has limited its use and it is still contraindicated by the Food and Drug Administration in some cases. The aim of this study is to evaluate the safety and efficacy of MRI in these patients. METHODS: A prospective registry comprising patients with a pacemaker (PM) or implantable cardioverter-defibrillator (ICD), MRI-conditional or not, who were candidates for MRI (at 1.5 T) with no suitable alternative diagnostic technique. All devices were programmed before the procedure and patients were monitored throughout the test. Clinical, electrical, and technical parameters were evaluated before and after MRI. RESULTS: 147 MRI examinations (132 PM and 15 ICD) were performed. There were no clinical events or significant differences in the electrical parameters of the leads after MRI. A variation in the impedance of the ventricular leads was detected, although the difference was not clinically relevant. In one patient with a PM, a failure in release of the safety impulse was detected in the auto-threshold test, although the threshold was correctly determined. In 11 of the 17 thoracic MRIs, image artifacts were detected, preventing the diagnosis in two of them. CONCLUSIONS: In patients with cardiac implantable electronic devices, MRIs performed under a specific protocol has been shown to be safe in the short term even in the thoracic region, as well as interpretable in most cases.

Gender influences cerebral oxygenation after red blood cell transfusion in patients with severe traumatic brain injury.

BACKGROUND: Important differences with respect to gender exist in the prognosis and mortality of traumatic brain injury (TBI) patients. The objective of this study was to assess the role of gender as an independent factor in cerebral oxygenation variations following red blood cell transfusion (RBCT). METHODS: This retrospective analysis of a prospective study was conducted on patients with severe TBI. Hemoglobin levels were measured at baseline and 6 h after transfusion. Brain tissue oxygen pressure (PbrO(2)), cerebral perfusion pressure (CPP), intracranial pressure (ICP), and mean arterial pressure (MAP) were measured at baseline, at the end of RBCT and at 1, 2, 3, 4, 5, and 6 h after transfusion. After the patients were stratified into two groups according to gender, the effect of RBCT on PbrO(2) (cerebral oxygenation) was analyzed using a multivariate analysis of variance with repeated measures (MANOVA). The MANOVA was repeated after adjusting for all covariables with baseline differences between groups. RESULTS: At baseline, we found differences in age (P = 0.01), weight (P = 0.03), MAP (P = 0.01), ISS (P = 0.05), and CCP (P = 0.01) between the groups. After adjusting for these co-variables, we observed that gender and age were related to the increase in PbrO(2) (P = 0.05 and P = 0.04, respectively). CONCLUSIONS: Our results suggest that the effect of RBCT on cerebral oxygenation, as measured by PbrO(2), is greater in women than in men.