Objective To assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion. Study design This was a multicenter, randomized, double blind, ...parallel-group, placebo-controlled clinical trial of 60 children, ranging in age from 1 month to 14 years, with community-acquired pneumonia (CAP) and pleural effusion. Patients received either intravenous DXM (0.25 mg/kg/dose) or placebo every 6 hours over a period of 48 hours, along with antibiotics. The primary endpoint was the time to recovery in hours, defined objectively. We also evaluated complications and adverse events. Results Among the 60 randomized patients (mean age, 4.7 years; 58% female), 57 (95%) completed the study. Compared with placebo recipients, the patients receiving DXM had a shorter time to recovery, after adjustment by severity group and stratification by center (hazard ratio, 1.95; 95% CI, 1.10-3.45; P = .021). The median time to recovery for patients receiving DXM was 68 hours (2.8 days) shorter than patients receiving placebo (109 hours vs 177 hours; P = .037). In exploratory subgroup analysis, the median time to recovery for patients with simple effusion receiving DXM was 76 hours (3.1 days) shorter than for patients with simple effusion receiving placebo ( P = .017). The median time to recovery for patients with complicated effusion receiving DXM was 14 hours (0.5 days) shorter than for patients with complicated effusion receiving placebo ( P = .66). The difference in the effect of DXM in the 2 severity groups was not statistically significant ( P = .138 for interaction). There were no significant differences in complications or adverse events attributable to the study drugs, except for hyperglycemia. Conclusion In this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion. Trial registration ClinicalTrials.gov : NCT01261546.
...in previous small clinical series analyzing the effect of therapeutic hypothermia (TH) in patients who undergo PPCI, it was observed that there was an increased rate of stent thrombosis (ST) in ...TH- compared with non-TH-treated patients (2). In the present observational study, even under the prelude of greater hemodynamic support and a higher frequency of hemorrhagic complications in the PPCI-TH-treated patients, the incidence of ST was almost identical to that of patients not treated with TH. ...under the need of further prospective trials, we believe that adequate antithrombotic management could be achieved in this population with both the progressive introduction of third-generation P2Y12 inhibitors and consideration that the route (intravenous aspirin and crushed nasogastric P2Y12) (5) and time (before PPCI) of administration may influence the final result.
Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to ...embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI. Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients. Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.
Objectives This study sought to evaluate the impact of SYNTAX score (SXscore), and compare its performance in isolation and combination with the PAMI (The Primary Angioplasty in Myocardial Infarction ...Study) score, for the prediction of 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Background Patients with STEMI were excluded from the original SYNTAX score (SXscore) algorithm. Therefore, the utility of using the SXscore in this patient group remains undefined. Methods SXscore was calculated retrospectively in 807 patients with STEMI enrolled in the randomized STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) clinical trials. Clinical outcomes of all-cause death, reinfarction, and clinically driven target vessel revascularization were subsequently stratified according to SXscore tertiles: SXLOW ≤9 (n = 311), 9 < SXMID ≤16 (n = 234), SXHIGH >16 (n = 262). Results At 1-year follow-up, all clinical outcomes including mortality, mortality/reinfarction, major adverse cardiac events (MACE) (a composite of all-cause death, reinfarction and target vessel revascularization), and definite, definite/probable, and any stent thrombosis were all significantly higher in patients in the highest SXscore tertile. SXscore was identified as an independent predictor of mortality, MACE, and stent thrombosis out to 1-year follow-up. The combination SYNTAX-PAMI score led to a net reclassification improvement of 15.7% and 4.6% for mortality and MACE, respectively. The C-statistics for the SXscore, PAMI score, and the combined SYNTAX-PAMI score were 0.65, 0.81, and 0.73 for 1-year mortality, and 0.68, 0.64, and 0.69 for 1-year MACE, respectively. Conclusions SXscore does have a role in the risk stratification of patients with STEMI having primary percutaneous coronary intervention; however, this ability can be improved through a combination with clinical variables. (Multicentre 2×2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI; NCT00229515 )
Objectives: The aim of this study is to compare the postoperative complications, perioperative course, and survival among patients from the multicentric Spanish Video-assisted Thoracic Surgery Group ...database who received video-assisted thoracic surgery lobectomy or video-assisted thoracic surgery anatomic segmentectomy. Methods: From December 2016 to March 2018, a total of 2250 patients were collected from 33 centers. Overall analysis (video-assisted thoracic surgery lobectomy = 2070; video-assisted thoracic surgery anatomic segmentectomy = 180) and propensity score–matched adjusted analysis (video-assisted thoracic surgery lobectomy = 97; video-assisted thoracic surgery anatomic segmentectomy = 97) were performed to compare postoperative results. Kaplan–Meier and competing risks method were used to compare survival. Results: In the overall analysis, video-assisted thoracic surgery anatomic segmentectomy showed a lower incidence of respiratory complications (relative risk, 0.56; confidence interval, 0.37-0.83; P = .002), lower postoperative prolonged air leak (relative risk, 0.42; 95% confidence interval, 0.23-0.78; P = .003), and shorter median postoperative stay (4.8 vs 6.2 days; P = .004) than video-assisted thoracic surgery lobectomy. After propensity score–matched analysis, prolonged air leak remained significantly lower in video-assisted thoracic surgery anatomic segmentectomy (relative risk, 0.33; 95% confidence interval, 0.12-0.89; P = .02). Kaplan–Meier and competing risk curves showed no differences during the 3-year follow-up (median follow-up in months: 24.4; interquartile range, 20.8-28.3) in terms of overall survival (hazard ratio, 0.73; 95% confidence interval, 0.45-1.7; P = .2), tumor progression–related mortality (subdistribution hazard ratio, 0.41; 95% confidence interval, 0.11-1.57; P = .2), and disease-free survival (subdistribution hazard ratio, 0.73; 95% confidence interval, 0.35-1.51; P = .4) between groups. Conclusions: Video-assisted thoracic surgery segmentectomy showed results similar to lobectomy in terms of postoperative outcomes and midterm survival. In addition, a lower incidence of prolonged air leak was found in patients who underwent video-assisted thoracic surgery anatomic segmentectomy.
Objectives We assessed the relation between female sex and sirolimus-eluting stent (SES) use on long-term outcomes in acute myocardial infarction. Background There are no data on sex-specific ...differences in long-term benefit of SES use compared with bare-metal stent (BMS) use among patients undergoing primary percutaneous coronary interventions. Methods We performed a post hoc analysis of the MULTISTRATEGY trial. Hazard ratios (HRs) of events with 95% CI for sex and stent type were computed using Cox proportional regression with adjustment for confounders. Results A total of 744 patients, 64 years old (55-73 years old), 179 (24.1%) women, were enrolled. After a follow-up of 1,080 days, SES use was associated with a significant reduction of major adverse cardiovascular events, that is, the composite of all-cause death, reinfarction, or clinically driven target vessel revascularization (TVR) (13.9% vs 23.6%, adjusted HR 0.62, 95% CI 0.41-0.94, P = .026) and of TVR (6.1% vs 15.1%, adjusted HR 0.35, 95% CI 0.19-0.63, P < .001) in men. Conversely, SES use was not associated to a better outcome among women (major adverse cardiovascular events 21.9% in SES vs 18.2% in the BMS group, adjusted HR 1.27, 95% CI 0.53-3.02, P = .59; TVR 6.6% vs 9.1%, adjusted HR 0.62, 95% CI 0.17-2.21, P = .46). Conclusions In this analysis, the clinical benefit of SES use, over BMS, at 3-year follow-up was restricted to men and was not observed among women.
Purpose Traditional donor-site closure has been associated with serious esthetic and functional morbidity. The purpose of this study was to assess morbidity in esthetics and function and measure the ...postoperative complications of the radial forearm free flap (RFFF) donor site after using combined local triangular full-thickness skin grafting. Materials and Methods This prospective study of patients who underwent reconstruction of head and neck defects using an RFFF was conducted from July 2008 through December 2014. The donor site was repaired with a combined local triangular full-thickness skin graft. Quality of the scar, color match, tendon exposure, presence of necrosis, dehiscence of the suture, and presence of dysesthesia were recorded and analyzed using SPSS 21.0 software. Results One hundred consecutive patients (71 male and 29 female) underwent RFFF harvesting. RFFF donor-site defects ranged from 15 to 70 cm2 ; partial skin graft loss occurred in 7% of patients. Five patients (5%) had small dehiscences of the forearm skin graft, and 2 cases (2%) presented tendon exposure. In all cases, these sites healed secondarily by conservative management, with no final impairment of function. Esthetic results were considered excellent in 87%, good in 11%, and suboptimal in 2% of the cases. Conclusions The combined local triangular full-thickness skin graft is a reliable method for closing RFFF donor-site defects because it obviates a second surgical site, it provides excellent color match and pliability, and it can be used for covering large defects of the donor site.
Objectives These studies sought to investigate the impact on mortality of coronary flow after passage of the wire through the culprit vessel in patients with ST-segment elevation myocardial ...infarction (STEMI) undergoing mechanical reperfusion. Background Reduced spontaneous coronary flow before percutaneous coronary intervention influences mortality in patients with STEMI. Response to vessel wiring in patients with an occluded coronary artery before intervention might further discriminate outcomes irrespective of pre- and post-intervention coronary flow. Methods Data from the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) trials were pooled: of 919 index procedures, 902 films (98%) were technically adequate for core laboratory TIMI (Thrombolysis In Myocardial Infarction) flow determination. Results TIMI flow grade 0 was present before percutaneous coronary intervention in 59% of infarct vessels, TIMI flow grade 1 to 2 was found in 21%, whereas the remainder of infarct arteries presented with TIMI flow grade 3. In 49% of patients who showed persistent TIMI flow grade 0 after wire insertion (AWI), mortality was higher at 30 days (5.3%) and 1 year (9.4%) compared with patients in whom TIMI flow grade before percutaneous coronary intervention was either >0 (0.8%; p < 0.003 and 3.6%, p < 0.008) or improved from 0 AWI (1.5%, p < 0.04 and 3.6%, p < 0.02). After correcting for multiple imbalances, including baseline and final flow, persistent TIMI flow grade 0 AWI remained associated at 30 days to 2-fold (risk ratio RR: 2.1, 95% confidence interval CI: 1.08 to 5.00; p = 0.038) and at 1 year to almost 3-fold increases of mortality (RR: 2.7, 95% CI: 1.3 to 5.6; p = 0.008). Conclusions STEMI patients displaying persistent no-flow AWI have a lower survival rate despite an apparently successful mechanical intervention. As an early marker for high residual mortality risk, persistent no-flow AWI may qualify STEMI patients for dedicated pharmacomechanical treatment strategies.
Abstract Objectives The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis ...severity, as defined by fractional flow reserve (FFR) ≤0.80, in a prospective, independent, controlled, core laboratory–based environment. Background Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons. Methods A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report. Results The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 95% confidence interval (CI): 0.88 to 0.92, p < 0.001). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≤0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses. Conclusions The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach. (ADenosine Vasodilator Independent Stenosis Evaluation II–ADVISE II; NCT01740895 )
PDF
