A low proportion of patients with ST-elevation myocardial infarction (STEMI) in low- to middle-income countries receive reperfusion therapy. Although primary percutaneous coronary intervention (PCI) ...is the method of choice, a pharmacoinvasive strategy (PIs) is reasonable when primary PCI cannot be delivered on a timely basis. The aim of our study was to assess the efficacy and safety of a PIs compared with primary PCI in a real-world setting.
This was a prospective registry that included patients with STEMI who received reperfusion during the first 12 hours from symptom onset. The primary composite end point was the occurrence of cardiovascular death, cardiogenic shock, recurrent myocardial infarction, or congestive heart failure at 30 days according to the reperfusion strategy used. The key safety end point was major bleeding (Bleeding Academic Research Consortium BARC score 3-5) at 30 days.
We included 579 patients with STEMI, 49.7% underwent primary PCI and 50.2% received PIs. Those who received a PIs approach were more likely to present with Killip class > 1 and to have a history of diabetes but were less likely to have a previous cardiovascular disease diagnosis. No statistically significant difference was shown in the primary composite end point according to reperfusion strategy (hazard ratio for PIs, 0.76; 95% confidence interval, 0.48-1.21; P = 0.24). Major bleeding was not different among groups (hazard ratio for PIs, 0.92; 95% confidence interval, 0.45-1.86; P = 0.81). Two patients in the PIs group (0.6%) and no patients in the PCI group had intracranial bleeding (P = 0.15).
In this prospective real-world registry, major cardiovascular outcomes and bleeding were not different among patients who underwent a PIs or primary PCI. The study suggests that a PIs is an effective and safe option for patients with STEMI when access to primary PCI is limited.
Une faible proportion des patients qui subissent un infarctus du myocarde avec élévation du segment ST (STEMI) dans les pays à revenus faibles/intermédiaires reçoivent un traitement de reperfusion. Même si l’intervention coronarienne percutanée (ICP) primaire constitue la méthode de prédilection, une stratégie pharmaco-invasive représente une option raisonnable lorsque l’ICP primaire ne peut être réalisée dans un délai acceptable. Cette étude visait à évaluer l’efficacité et l’innocuité d’une stratégie pharmaco-invasive comparativement à une ICP primaire dans la pratique courante.
Cette étude consistait en une étude de registre prospective et regroupait des patients présentant un STEMI et ayant subi une reperfusion pendant les 12 heures suivant l’apparition des symptômes. Le principal critère d’évaluation regroupé correspondait à l’occurrence du décès cardiovasculaire, du choc cardiogénique, d’une récidive de l’infarctus du myocarde ou d’une insuffisance cardiaque congestive dans les 30 jours suivants, selon la stratégie de reperfusion utilisée. Le principal critère d’évaluation de l’innocuité était les hémorragies majeures (score de 3 à 5 selon le Bleeding Academic Research Consortium BARC) à 30 jours.
L’étude regroupait 579 patients présentant un STEMI, dont 49,7 % avaient subi une ICP primaire et 50,2 % avaient reçu une stratégie pharmaco-invasive. Les patients ayant reçu une stratégie pharmaco-invasive étaient plus susceptibles de présenter une classe de Killip > 1 et des antécédents de diabète, mais étaient moins susceptibles d’avoir déjà reçu un diagnostic de maladie cardiovasculaire. Aucune différence significative sur le plan statistique n’a été observée pour ce qui est du principal critère d’évaluation regroupé selon la stratégie de reperfusion (rapport des risques instantanés RRI de la stratégie pharmaco-invasive : 0,76; intervalle de confiance IC à 95 % : 0,48-1,21; p = 0,24). Aucune différence n’a été observée entre les groupes quant aux hémorragies majeures (RRI de la stratégie pharmaco-invasive : 0,92; IC à 95 % : 0,45-1,86; p = 0,81). Deux patients du groupe ayant reçu une stratégie pharmaco-invasive (0,6 %) ont présenté une hémorragie intracrânienne, comparativement à aucun patient du groupe ayant subi une ICP (p = 0,15).
Selon cette étude de registre prospective en pratique courante, les résultats concernant les hémorragies et les événements cardiovasculaires majeurs n’ont pas été différents entre les patients ayant subi une ICP primaire et ceux ayant reçu une stratégie pharmaco-invasive. L’étude suggère que la stratégie pharmaco-invasive constitue une option sûre et efficace pour les patients qui présentent un STEMI, lorsque l’accès à une ICP primaire est limité.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Elderly patients can be particularly susceptible to the adverse effects of excessive blood pressure (BP) lowering by antihypertensive treatment. The identification of hypotension is thus especially ...important. Ambulatory BP monitoring (ABPM) is a more accurate technique than office for classifying BP status. This study examined the prevalence of hypotension and associated demographic and clinical factors among very old treated hypertensive patients undergoing ABPM.
Cross-sectional study in which 5066 patients aged 80 years and older with treated hypertension drawn from the Spanish ABPM Registry were included.
Office BP and 24-hour ambulatory BP were determined using validated devices under standardized conditions. Based on previous studies, hypotension was defined as systolic/diastolic BP <110 and/or 70 mmHg with office measurement, <105 and/or 65 mmHg with daytime ABPM, <90 and/or 50 mmHg with nighttime ABPM, and <100 and/or 60 mmHg with 24-hour ABPM.
Participants' mean age was 83.2 ± 3.1 years (64.4% women). Overall, 22.8% of patients had office hypotension, 33.7% daytime hypotension, 9.2% nighttime hypotension, and 20.5% 24-hour ABPM hypotension. Low diastolic BP values were responsible for 90% of cases of hypotension. In addition, 59.1% of the cases of hypotension detected by daytime ABPM did not correspond to hypotension according to office BP. The variables independently associated with office and ABPM hypotension were diabetes, coronary heart disease, and a higher number of antihypertensive medications.
One in 3 very elderly treated hypertensive patients attended in usual clinical practice were potentially at risk of having hypotension according to daytime ABPM. More than half of them had masked hypotension; that is, they were not identified if relying on office BP alone. Thus, ABPM could be especially helpful for identifying ambulatory hypotension and avoiding overtreatment, in particular, in patients with diabetes, heart disease, or on antihypertensive polytherapy.
Summary
Background
Many Spanish hospitals converted scheduled in-person visits to telephone visits during the COVID-19 lockdown. There is scarce information about the performance of those visits.
Aim
...To compare telephone visits during the COVID-19 lockdown period with previous in-person visits.
Design
Retrospective descriptive study.
Methods
Telephone visits from 15 March to 31 May 2020 were compared with in-person visits during the same period in 2019.
Main measures
The proportions of both groups were compared in term of failure to contact patient, requested diagnostic tests/referrals, discharges, admissions and emergency visits within 30–60 days. A sample of patients, and all participating physicians completed surveys. Z-score test was used (statistical significance P<0.05).
Results
A total of 5602 telephone visits were conducted. In comparison to in-person visits, telephone visits showed higher rates of visit compliance (95.9% vs. 85.2%, P<0.001) and discharges (22.12% vs. 11.82%; P<0.001), and lower number of ancillary tests and referrals. During the 30- and 60-day periods following the telephone visit, a reduction of 52% and 47% in the combined number of emergency department visits and hospital admissions was observed compared to in-person visits (P<0.01). Of the 120 patients surveyed, 95% were satisfied/very satisfied with the telephone visits. Of the 26 physicians, 84.6% considered telephone visits were useful to prioritize patients.
Conclusions
During health emergencies, previously scheduled outpatient in-person visits can be converted to telephone visits, reducing absenteeism, increasing the rate of discharges and reducing ancillary tests and referrals without increasing the rate of hospital admissions or emergency department visits.
Abstract Background It is unclear whether a positive skin patch test for metal allergy in patients with skin hypersensitivity to metals is associated with an increased risk of total knee arthroplasty ...(TKA) failure. Our aim was to determine whether patients with a history of metal allergy who had a positive skin patch test (SPT+) had worse outcomes after primary TKA compared with those with a negative skin patch test and compared with controls. Methods Over 12 years, 127 patients underwent 161 TKA after skin patch testing (SPT; 56 were positive). Cases were matched by age, gender, body mass index, American Society of Anesthesiologists score, implant type, and implant manufacturer to 161 control knee arthroplasties without any prior history of metal allergy and no SPT. Median follow-up was 5.3 years. Differences in outcome measures were assessed between groups. Results Patients with a SPT+ to metal did not have a higher complication, reoperation, or revision rates compared with patients with a SPT− and matched controls. Survivorship free of revision at 5 years was 98.1% for SPT+; 100% for SPT−; 97.6% for SPT+ controls, 99.0% for SPT− controls. There was no statistically significant difference in postoperative pain between SPT+ and SPT− patients and matched controls. Conclusion This study was designed to evaluate the effect of metal hypersensitivity on TKA outcomes and the role of SPT in patients before TKA. In this study, a SPT+ for metals was of little practical value in predicting the midterm outcome after TKA and cannot be strongly recommended as a method to guide the selection of implant type.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Background Previous studies have examined control rates of office blood pressure (BP) in chronic kidney disease (CKD). However, recent evidence suggests major discrepancies between office and 24-hour ...BP values in hypertensive populations. This study examined concordance/discordance between office- and ambulatory-based BP control in a large cohort of patients with CKD. Study Design Cross-sectional. Setting & Participants 5,693 hypertensive individuals with CKD stages 1-5 from the Spanish ABPM (ambulatory BP monitoring) Registry. Predictors Thresholds of 140/90 and 130/80 mm Hg for office BP and 24-hour ambulatory BP, respectively. Age, sex, body mass index, waist circumference, hypertension duration, kidney measures, diabetes, dyslipidemia, target-organ damage, and cardiovascular comorbid conditions. Outcomes Misclassification of BP control as “white-coat” hypertension (office BP ≥140/90 mm Hg, 24-hour BP <130/80 mm Hg) or masked hypertension (office BP <140/90 mm Hg, 24-hour BP ≥130/80 mm Hg). Measurements Standardized office-based BP and 24-hour ABPM. Results Mean age was 61.0 ± 13.9 (SD) years and 52.6% were men. The proportion with white-coat hypertension was 28.8% (36.8% of patients with office BP ≥140/90 mm Hg) and that of masked hypertension was 7.0% (but 32.1% of patients with office BP <140/90 mm Hg). Female sex, aging, obesity, and target-organ damage were associated with white-coat hypertension; aging and obesity were associated with masked hypertension. Only 21.7% and 8.1% of the CKD population had office BP <140/90 and <130/80 mm Hg, respectively. In contrast, 43.5% of individuals had average 24-hour BP <130/80 mm Hg. Limitations Cross-sectional design, longitudinal associations cannot be established. Conclusions Misclassification of BP control at the office was observed in 1 of 3 hypertensive patients with CKD. Ambulatory-based control rates were far better than office-based rates. Nevertheless, the burden of uncontrolled ambulatory BP and misclassification of BP control at the office constitutes a call for wider use of ABPM to evaluate the success of hypertension treatment in patients with CKD.
Abstract Background The purpose of this study was to calculate the cumulative risk of periprosthetic joint infection (PJI) after aseptic index knee revisions and to identify the surgical, ...perioperative, and medical comorbidity risk factors associated with deep infection. Methods We retrospectively reviewed 1802 aseptic index revision total knee arthroplasties performed at our institution from 1970 to 2000. From this cohort, there were 60 reoperations performed for deep infection. Results The cumulative risk of infection at 1, 5, 10, and 20 years after index revision was 1%, 2.4%, 3.3%, and 5.6%, respectively. Conclusions Male gender, use of constrained implants, increased operative times, increased Charlson Comorbidity Index, and a history of liver disease were all significantly associated with PJI. The development of cardiovascular disease, endocrine disorders, and renal disease were also associated with PJI.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
To analyze prognostic factors associated with survival in patients after intraoperative electrons containing resective surgical rescue of locally recurrent rectal cancer (LRRC).
From January 1995 to ...December 2011, 60 patients with LRRC underwent extended surgery (n=38: multiorgan 43%, bone 28%, soft tissue 38%) or nonextended (n=22) surgical resection, including a component of intraoperative electron-beam radiation therapy (IOERT) to the pelvic recurrence tumor bed. Twenty-eight (47%) of these patients also received external beam radiation therapy (EBRT) (range, 30.6-50.4 Gy). Survival outcomes were estimated by the Kaplan-Meier method, and risk factors were identified by univariate and multivariate analyses.
The median follow-up time was 36 months (range, 2-189 months), and the 1-year, 3-year, and 5-year rates for locoregional control (LRC) and overall survival (OS) were 86%, 52%, and 44%; and 78%, 53%, 43%, respectively. On multivariate analysis, R1 resection, EBRT at the time of pelvic rerecurrence, no tumor fragmentation, and non-lymph node metastasis retained significance with regard to LRR. R1 resection and no tumor fragmentation showed a significant association with OS after adjustment for other covariates.
EBRT treatment integrated for rescue, resection radicality, and not involved fragmented resection specimens are associated with improved LRC in patients with locally recurrent rectal cancer. Additionally, tumor fragmentation could be compensated by EBRT. Present results suggest that a significant group of patients with LRRC may benefit from EBRT treatment integrated with extended surgery and IOERT.
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GEOZS, IJS, NUK, OILJ, UL, UM, UPUK
Observational data have been conflicted regarding the potential role of HIV antiretroviral therapy (ART) as a causative factor for, or protective factor against, COPD. We therefore aimed to ...investigate the effect of immediate versus deferred ART on decline in lung function in HIV-positive individuals.
We did a nested substudy within the randomised, controlled Strategic Timing of Antiretroviral Treatment (START) trial at 80 sites in multiple settings in 20 high-income and low-to-middle-income countries. Participants were HIV-1 infected individuals aged at least 25 years, naive to ART, with CD4 T-cell counts of more than 500 per μL, not receiving treatment for asthma, and without recent respiratory infections (baseline COPD was not an exclusion criterion). Participants were randomly assigned to receive ART (an approved drug combination derived from US Department of Health and Human Services guidelines) either immediately, or deferred until CD4 T-cell counts decreased to 350 per μL or AIDS developed. The randomisation was determined by participation in the parent START study, and was not specific to the substudy. Because of the nature of our study, site investigators and participants were not masked to the treatment group assignment; however, the assessors who reviewed the outcomes were masked to the treatment group. The primary outcome was the annual rate of decline in lung function, expressed as the FEV
slope in mL/year; spirometry was done annually during follow-up for up to 5 years. We analysed data on an intention-to-treat basis, and planned separate analyses in smokers and non-smokers because of the known effects of smoking on FEV
decline. The substudy was registered at ClinicalTrials.gov number NCT01797367.
Between March 11, 2010, and Aug 23, 2013, we enrolled 1026 participants to our substudy, who were then randomly assigned to either immediate (n=518) or deferred (n=508) ART. Median baseline characteristics included age 36 years (IQR 30-44), CD4 T-cell count 648 per μL (583-767), and HIV plasma viral load 4·2 log
copies per mL (3·5-4·7). 29% were female and 28% were current smokers. Median follow-up time was 2·0 years (IQR 1·9-3·0). We noted no differences in FEV
slopes between the immediate and deferred ART groups either in smokers (difference of -3·3 mL/year, 95% CI -38·8 to 32·2; p=0·86) or in non-smokers (difference of -5·6 mL/year, -29·4 to 18·3; p=0·65) or in pooled analyses adjusted for smoking status at each study visit (difference of -5·2 mL/year, -25·1 to 14·6; p=0·61).
The timing of ART initiation has no major short-term effect on rate of lung function decline in HIV-positive individuals who are naive to ART, with CD4 T-cell counts of more than 500 per μL. In light of updated WHO recommendations that all HIV-positive individuals should be treated with ART, regardless of their CD4 T-cell count, our results suggest an absence of significant pulmonary harm with such an approach.
US National Heart Lung and Blood Institute, US National Institute of Allergy and Infectious Diseases, Division of AIDS, Agence Nationale de Recherches sur le SIDA et les Hipatites Virales (France), Australian National Health and Medical Research Council, Danish National Research Foundation, European AIDS Treatment Network, German Ministry of Education and Research, UK Medical Research Council and National Institute for Health Research, and US Veterans Health Administration Office of Research and Development.
Summary Background Graft-versus-host disease (GVHD) is a major cause of morbidity and mortality after allogeneic haematopoietic cell transplantation from unrelated donors. Anti-T-cell globulins ...(ATGs) might lower the incidence of GVHD. We did a prospective, randomised, multicentre, open-label, phase 3 trial to compare standard GVHD prophylaxis with ciclosporin and methotrexate with or without anti-Jurkat ATG-Fresenius (ATG-F). Methods Between May 26, 2003, and Feb 8, 2007, 202 patients with haematological malignancies were centrally randomly assigned using computer-generated centre-stratified block randomisation between treatment groups receiving ciclosporin and methotrexate with or without additional ATG-F. One patient in the ATG-F group did not undergo transplantation, thus 201 patients who underwent transplantation with peripheral blood (n=164; 82%) or bone marrow (n=37; 18%) grafts from unrelated donors after myeloablative conditioning were included in the full analysis set, and were analysed according to their randomly assigned treatment (ATG-F n=103, control n=98). The primary endpoint was severe acute GVHD (aGVHD) grade III–IV or death within 100 days of transplantation. The trial is registered with the numbers DRKS00000002 and NCT00655343. Findings The number of patients in the ATG-F group who had severe aGVHD grade III–IV or who died within 100 days of transplantation was 12 and 10 (21·4%, 95% CI 13·4–29·3), respectively, compared with 24 and nine (33·7%, 24·3–43·0) patients, respectively, in the control group (adjusted odds ratio 0·59, 95% CI 0·30–1·17; p=0·13). The cumulative incidence of aGVHD grade III–IV was 11·7% (95% CI 6·8–19·8) in the ATG-F group versus 24·5% (17·3–34·7) in the control group (adjusted hazard ratio HR 0·50, 95% CI 0·25–1·01; p=0·054), and cumulative incidence of aGVHD grade II–IV was 33·0% (n=34; 95% CI 25·1–43·5) in the ATG-F group versus 51·0% (n=50; 95% CI 42·0–61·9) in the control group (adjusted HR 0·56, 0·36–0·87; p=0·011). The 2-year cumulative incidence of extensive chronic GVHD was 12·2% (n=11; 95% CI 7·0–21·3) versus 42·6% (n=34; 95% CI 33·0–55·0; adjusted HR 0·22, 0·11–0·43; p<0·0001). There were no differences between treatment groups with regard to relapse, non-relapse mortality, overall survival, and mortality from infectious causes. Interpretation The addition of ATG-F to GVHD prophylaxis with ciclosporin and methotrexate resulted in decreased incidence of acute and chronic GVHD without an increase in relapse or non-relapse mortality, and without compromising overall survival. The use of ATG-F is safe for patients who are going to receive a haematopoietic cell transplantation from matched unrelated donors. Funding Fresenius Biotech GmbH.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Introduction/Purpose:
Avascular necrosis (AVN) is a complication of talar neck fractures associated with chronic pain and poor functional outcomes. Hawkins sign, the radiographic presence of ...subchondral lucency seen in the talar dome 6 to 8 weeks after trauma, is considered to be a strong predictor of preserved talus vascularity. The study sought to assess the accuracy of the Hawkins sign in a large, contemporary cohort and assess factors associated with inaccuracy.
Methods:
A retrospective review of all talar neck fractures from a single level I trauma center from 2008 to 2016 was performed. The presence of Hawkins sign and AVN were determined based on ankle radiographs 8 weeks after injury and at final follow-up, respectively. Patients with less than 6 months follow-up were excluded. Hawkins sign accuracy was assessed using proportions with 95% confidence intervals (C.I.) and associations were examined with Fisher’s exact testing.
Results:
In total, 137 talar neck fractures were identified with 105 having adequate follow-up. Hawkins sign was observed in 21 tali, 3 (14%) of which later developed AVN (95% C.I., 3 – 36%). In the remaining 84 tali without Hawkins sign, 32 (38%) developed AVN (95% C.I., 28 – 49%). Of the 3 tali that developed AVN following observation of Hawkins sign, all patients were smokers.
There were no cases of AVN in non-smokers with Hawkins sign (P=0.21), and smoking was not associated with AVN in patients without Hawkins sign (41% vs 36%, P=0.82).
Conclusion:
Hawkins sign may not be a reliable predictor of preserved talus vascularity in all patients. We identified three patients with positive Hawkins signs who developed AVN, all of whom were smokers. Factors impairing microvascular blood supply to the talus may lead to AVN even in the presence of preserved macrovascular blood flow and an observed Hawkins sign. Close monitoring of select patients with Hawkins sign should be considered and further research is needed to understand the factors limiting Hawkins sign accuracy.
Prognostic accuracy of the Hawkins sign in predicting talar AVN
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