Summary Background Dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor prevents ischaemic events after coronary stenting, but increases bleeding. Guidelines support weighting ...bleeding risk before the selection of treatment duration, but no standardised tool exists for this purpose. Methods A total of 14 963 patients treated with DAPT after coronary stenting—largely consisting of aspirin and clopidogrel and without indication to oral anticoagulation—were pooled at a single-patient level from eight multicentre randomised clinical trials with independent adjudication of events. Using Cox proportional hazards regression, we identified predictors of out-of-hospital Thrombosis in Myocardial Infarction (TIMI) major or minor bleeding stratified by trial, and developed a numerical bleeding risk score. The predictive performance of the novel score was assessed in the derivation cohort and validated in patients treated with percutaneous coronary intervention from the PLATelet inhibition and patient Outcomes (PLATO) trial (n=8595) and BernPCI registry (n=6172). The novel score was assessed within patients randomised to different DAPT durations (n=10 081) to identify the effect on bleeding and ischaemia of a long (12–24 months) or short (3–6 months) treatment in relation to baseline bleeding risk. Findings The PRECISE-DAPT score (age, creatinine clearance, haemoglobin, white-blood-cell count, and previous spontaneous bleeding) showed a c-index for out-of-hospital TIMI major or minor bleeding of 0·73 (95% CI 0·61–0·85) in the derivation cohort, and 0·70 (0·65–0·74) in the PLATO trial validation cohort and 0·66 (0·61–0·71) in the BernPCI registry validation cohort. A longer DAPT duration significantly increased bleeding in patients at high risk (score ≥25), but not in those with lower risk profiles (pinteraction =0·007), and exerted a significant ischaemic benefit only in this latter group. Interpretation The PRECISE-DAPT score is a simple five-item risk score, which provides a standardised tool for the prediction of out-of-hospital bleeding during DAPT. In the context of a comprehensive clinical evaluation process, this tool can support clinical decision making for treatment duration. Funding None.
Complications after device closure of ostium secundum defects are rare but possible. We present a very late erosion of the interatrial septum after a percutaneous closure of an ostium secundum ...defect. Identification of early clinical and imaging clues associated with this condition is fundamental for a timely diagnosis and treatment. (Level of Difficulty: Intermediate.)
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Background Proton pump inhibitors (PPIs) are frequently prescribed in combination with clopidogrel, but conflicting data exist as to whether PPIs diminish the efficacy of clopidogrel. We assessed the ...association between PPI use and clinical outcomes for patients treated with percutaneous coronary intervention (PCI) and dual-antiplatelet therapy (DAPT) with clopidogrel plus aspirin. Methods and results In the PRODIGY trial, 1,970 patients were randomized to 6- or 24-month DAPT at 30 days from index procedure. Among them, 738 patients (37.5%) received PPI (mainly lansoprazole; 90.1%) at the time of randomization. Proton pump inhibitor users were older, were most likely to be woman, had a lower creatinine clearance, presented more frequently with acute coronary syndrome, and had a higher CRUSADE bleeding score. After adjustment, the primary efficacy end point (composite of all-cause death, myocardial infarction, and cerebrovascular accident) was similar between no PPI and PPI users (9.2% vs 11.5%, adjusted hazard ratio HR 1.051, 95% CI 0.788-1.400, P = .736). Bleeding rates did not differ between the 2 groups (Bleeding Academic Research Consortium type 2, 3, or 5: adjusted HR 0.996, 95% CI 0.672-1.474, P = .980). Net clinical adverse events were also similar in no PPI and PPI patients (12.9% vs 14.9%, adjusted HR 0.99, 95% CI 0.772-1.268, P = .93). Results remained consistent at sensitivity analysis when focusing on the 548 patients who remained on PPI for the whole study duration. Conclusions The current findings suggest that the concomitant use of PPIs, when clinically indicated, in patients receiving clopidogrel is not associated with adverse clinical outcome.
Objective Weaning from veno-arterial extracorporeal life support is challenging. The objective of this trial was to investigate the endothelial and hemodynamic effects of levosimendan in cardiogenic ...shock patients supported with veno-arterial extracorporeal life support. Design This was a prospective observational trial. Setting Cardiovascular intensive care unit of a large tertiary care university hospital in Monza, Italy. Participants and Interventions Flow-mediated dilatation of the brachial artery and hemodynamic parameters were assessed in 10 cardiogenic shock patients supported with veno-arterial extracorporeal life support, before and after the infusion of levosimendan. Measurements and Results Flow-mediated dilatation increased both as absolute value and as a percentage after levosimendan, from 0.10±0.12 to 0.61±0.21 mm (p<0.001) and from 3.2±4.2% to 17.8±10.4% (p<0.001), respectively. Cardiac index increased from 1.93±0.83 to 2.64±0.97 L/min/m2 (p = 0.008) while mixed venous oxygen saturation increased from 66.0% to 71.5% (p = 0.006) and arterial lactate levels decreased from 1.25 to 1.05 mmol/L (p = 0.004) without significant variations in arterial oxygen saturation or hemoglobin levels. This made it possible for clinicians to reduce extracorporeal membrane oxygenation blood flow from 1.92±0.65 to 1.12±0.49 L/min/m2 (p<0.001). Conclusion In conclusion, in the authors’ study population of adult cardiogenic shock patients supported with veno-arterial extracorporeal life support, their observations supported the use of levosimendan to improve endothelial function and hemodynamics and facilitate weaning from the extracorporeal support.
Death traditionally comprises a small fraction of such composite outcomes after percutaneous coronary intervention. ...the underlying foundation for combining fatal and nonfatal outcomes as a ...reliable measure of a given treatment effect requires that nonfatal endpoints are independently associated with fatal events and that the strength of this association is somewhat comparable across nonfatal endpoints.
Abstract Background context In spinal surgery, newly developed technology seems to play a key role, especially with the use of computer-assisted image-guided navigation, giving excellent results. ...However, these tools are expensive and may not be affordable for many facilities. Purpose To compare the cost-effectiveness of preoperative versus intraoperative CT (computed tomography) guidance in spinal surgery. Study design A retrospective economic study. Methods A cost-effectiveness study was performed analyzing the overall costs of a population of patients operated on for lumbar degenerative spondylolisthesis using an image-guided system (IGS) based on a CT scan. The population was divided into two groups according to the type of CT data set acquisition adopted: Group I (IGS based on a preoperative spiral CT scan), Group II (IGS based on an intraoperative CT scan—O-Arm system). The costs associated with each procedure were assessed through a process analysis, where clinical procedures were broken down into single phases and the related costs from each phase were evaluated. No benefits in any form have been or will be received from commercial parties directly or indirectly related to the subject of this article. Results Four hundred ninety-nine patients met the criteria for this study. In total, 2,542 screws were inserted with IGS. Baseline data were similar for the two groups, as were hospitalization and complications. The surgical time was 119±43 minutes in Group I and 92±31 minutes in Group II. The full cost of the two procedures was analyzed: the mean cost, using the O-Arm system (Group II), was found to be €255.83 (3.80%) less than the cost of Group I. Moreover, the O-Arm system was also used in other surgical procedures as an intraoperative control, thus reducing the final costs of radiologic examinations (a reduction of around 550 CT scans/year). Conclusions In conclusion, the authors of the study are of the opinion that the surgical procedure of pedicle screw fixation, using a CT-based computer-guidance system with support of the O-Arm system, allows a shortening of procedure time that might improve the clinical result. However, the present study failed to determine a clear cost-effectiveness with respect to other CT-based IGS.
Abstract Background context There is no universal consensus regarding the biomechanical aspects and relevance on the primary stability of misplaced pedicle screws. Purpose The study is aimed to the ...determination of the correlation between axial pullout forces of pedicle screws with the possible screw misplacement, including mild and severe cortical violations. Methods Eighty-eight monoaxial pedicle screws were implanted into 44 porcine lumbar vertebral bodies, paying attention on trying to obtain a wide range of placement accuracy. After screw implantation, all specimens underwent a spiral computed tomography scan, and the screw placements were graded following the scales of Laine et al. and Abul Kasim et al. Axial pullout tests were then performed on a servohydraulic material testing system. Results Decreasing pullout forces were determined for screws implanted with increasing cortical violation. A smaller influence of cortical violations in the medial direction with respect to the lateral direction was observed. Screws implanted with a large cortical violation and misplacement in the craniocaudal direction were found to be significantly less stable than screws having comparable cortical violation but in a centered sagittal position. Conclusions These results provide adjunctive criteria to evaluate more accurately the fate of a spine instrumentation. Particular care should be placed in the screw evaluation regarding the craniocaudal positioning and alignment.
Objective Cardiopulmonary bypass (CPB) exerts several deleterious effects on inflammatory pathways. Most of these can be related to an endothelial insult leading to endothelial dysfunction. To date, ...the degree of endothelial damage only has been evaluated on a cellular and molecular level, but no studies exist looking at the functional effects of CPB on the endothelium. Design Previous studies hypothesized a negative effect of continuous flow as opposed to the physiologic pulsatile flow. The aim of the present retrospective study was to investigate how different perfusion modalities during CPB (ie, continuous v pulsatile flow) or its avoidance differently impact endothelial function. Setting Cardiovascular operating room and intensive care unit of a large tertiary University Hospital in Monza, Italy. Participants Flow-mediated dilatation (FMD) of the brachial artery was assessed in 29 patients undergoing elective myocardial revascularization. Ten patients receiving continuous-flow CPB, 10 receiving pulsatile-flow CPB, and 9 scheduled for beating-heart revascularization were studied. Interventions Patients were studied at baseline (after induction of general anesthesia), after CPB upon intensive care unit (ICU) admission after surgery, and on the first postoperative day before discharge from the ICU (on average, 24 hours after CPB discontinuation). Measurements and Main Results The continuous-flow CPB group demonstrated a significant reduction in FMD after CPB, (12.8%±9.7% v 1.6%±1.5%, p<0.01), which lasted up to the first postoperative day (5.9%±4.1%). On the other hand, FMD did not change in the pulsatile-flow group (12.5%±10.5%, 11.0%±7.2%, and 16.6%±11.7%, respectively). FMD also was unaffected in the beating-heart group, thus suggesting a direct effect of CPB itself on endothelial function. Conclusions In conclusion, in this study population of adult patients undergoing elective coronary revascularization, continuous-flow CPB markedly impaired endothelial function, although this was not the case with pulsatile-flow CPB. This study posed the rationale for further investigations on the potential value of FMD to predict cardiovascular events in these patients.
Objective To assess if being small for gestational age impacts parenteral nutrition–associated cholestasis (PNAC) development. Study design We reviewed all the very low–birth weight infants exposed ...to parenteral nutrition for >14 days from 1996 to 2006, comparing auxological and clinical data, as well as nutritional history, during the first 4 weeks of life of infants with cholestasis and control subjects. Results Of 445 very low–birth weight infants, 55 had development of PNAC. Infants with cholestasis had lower birth weight and gestational age but similar birth weight z-score compared with infants without cholestasis, and they received a lower amount of enteral feeds (25.8 ± 20.7 vs 67.9 ± 33.0mL/kg, P < .001), a greater amount of intravenous glucose (10.6 ± 1.3 vs 7.5 ± 2.5g/kg, P < .0001), lipids (1.8 ± 0.4 vs 1.3 ± 0.5, P < .0001) and proteins (2.7 ± 0.5 vs 1.9 ± 0.7, P < .0001), and needed a higher number of days of fasting (13.2 ± 6.7 vs 6.5 ± 4.8, P < .001). Enteral intake between 0 and 21 days of life (OR 0.66; 95% CI 0.53, 0.81, P < .0001) and oxygen therapy (OR 1.05; 95% CI 1.01, 1.09; P = .030) were identified as the best independent predictors of PNAC. Conclusions Enteral feeding remains the main factor for the prevention of PNAC, whereas small for gestational age infants do not have a higher risk of PNAC.
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