Tracheostomy versus prolonged intubation in moderate to severe traumatic brain injury: a multicentre retrospective cohort study.

PURPOSE: Tracheostomy is a surgical procedure that is commonly performed in patients admitted to the intensive care unit (ICU). It is frequently required in patients with moderate to severe traumatic brain injury (TBI), a subset of patients with prolonged altered state of consciousness that may require a long period of mechanical respiratory assistance. While many clinicians favour the use of early tracheostomy in TBI patients, the evidence in favour of this practice remains scarce. The aims of our study were to evaluate the potential clinical benefits of tracheostomy versus prolonged endotracheal intubation, as well as whether the timing of the procedure may influence outcome in patients with moderate to severe TBI. METHODS: We conducted a retrospective multicentre cohort study based on data from the provincial integrated trauma system of Quebec (Québec Trauma Registry). The study population was selected from adult trauma patients hospitalized between 2013 and 2019. We included patients 16 yr and older with moderate to severe TBI (Glasgow Coma Scale score < 13) who required mechanical ventilation for 96 hr or longer. Our primary outcome was 30-day mortality. Secondary outcomes included hospital and ICU mortality, six-month mortality, duration of mechanical ventilation, ventilator-associated pneumonia, ICU and hospital length of stay as well as orientation of patients upon discharge from the hospital. We used propensity score covariate adjustment. To overcome the effect of immortal time bias, an extended Cox shared frailty model was used to compare mortality between groups. RESULTS: From 2013 to 2019, 26,923 patients with TBI were registered in the Québec Trauma Registry. A total of 983 patients who required prolonged endotracheal intubation for 96 hr or more were included in the study, 374 of whom underwent a tracheostomy and 609 of whom remained intubated. We observed a reduction in 30-day mortality (adjusted hazard ratio, 0.33; 95% confidence interval, 0.21 to 0.53) associated with tracheostomy compared with prolonged endotracheal intubation. This effect was also seen in the ICU as well as at six months. Tracheostomy, when compared with prolonged endotracheal intubation, was associated with an increase in the duration of mechanical respiratory assistance without any increase in the length of stay. No effect on mortality was observed when comparing early vs late tracheostomy procedures. An early procedure was associated with a reduction in the duration of mechanical respiratory support as well as hospital and ICU length of stay. CONCLUSION: In this multicentre cohort study, tracheostomy was associated with decreased mortality when compared with prolonged endotracheal intubation in patients with moderate to severe TBI. This effect does not appear to be modified by the timing of the procedure. Nevertheless, the generalization and application of these results remains limited by potential residual time-dependent indication bias.

RéSUMé: INTRODUCTION: La trachéotomie est une intervention chirurgicale communément pratiquée chez les personnes admises à l'unité de soins intensifs (USI). Elle est fréquemment requise chez les patient·es victimes d'un traumatisme craniocérébral (TCC) modéré à grave, un sous-groupe présentant une altération prolongée de l'état de conscience qui peut nécessiter une longue période d'assistance respiratoire mécanique. Bien que bon nombre de cliniciens et cliniciennes soient favorables à l'utilisation d'une trachéotomie précoce chez cette patientèle, les données probantes en faveur de cette pratique restent insuffisantes. Les objectifs de notre étude étaient d'évaluer l'effet de la trachéotomie par rapport à l'intubation endotrachéale prolongée, ainsi que si le moment où la procédure est effectuée pouvait influencer cet effet, chez les personnes ayant subi un TCC modéré à grave. MéTHODES: Nous avons effectué une étude de cohorte rétrospective multicentrique basée sur le système provincial intégré de traumatologie du Québec (Registre des traumatismes du Québec). La population de l'étude a été sélectionnée parmi les patient·es adultes victimes de traumatismes hospitalisé·es entre 2013 et 2019. Nous avons inclus les patient·es âgé·es de 16 ans et plus présentant un TCC modéré à grave (score sur l'échelle de coma de Glasgow [GCS] < 13) ayant nécessité une assistance respiratoire mécanique pendant 96 h ou plus. Notre critère d'évaluation principal était la mortalité à 30 jours. Les critères d'évaluation secondaires comprenaient la mortalité hospitalière et à l'USI, la mortalité à 6 mois, la durée d'assistance respiratoire mécanique, les pneumonies acquises en lien avec l'assistance respiratoire mécanique, les durées de séjour à l'USI et à l'hôpital ainsi que l'orientation des patient·es à leur sortie de l'hôpital. Nous avons utilisé un score de propension pour l'ajustement des covariables. Pour corriger l'effet du biais du temps immortel, un modèle de régression de la fragilité partagée de Cox étendu a été utilisé pour estimer la mortalité entre les groupes. RéSULTATS: De 2013 à 2019, 26 923 personnes victimes de TCC ont été inscrites dans le Registre des traumatismes du Québec. Un total de 983 patient·es ayant nécessité une intubation endotrachéale prolongée de 96 h ou plus ont été inclus·es dans l'étude, dont 374 ont subi une trachéotomie et 609 sont resté·es intubé·es. Nous avons observé une réduction de la mortalité à 30 jours (aHR : 0,33 [0,21 − 0,53]) associée à la trachéotomie en comparaison à l'intubation endotrachéale prolongée. Cet effet a également été observé à l'USI ainsi qu'à 6 mois. La trachéotomie, comparée à l'intubation endotrachéale prolongée, était associée à une augmentation de la durée d'assistance respiratoire mécanique sans augmentation de la durée de séjour. Aucun effet sur la mortalité n'a été observé en comparant les procédures de trachéotomie précoces et tardive. Une procédure précoce a été associée à une réduction de la durée d'assistance respiratoire mécanique ainsi que la durée de séjour à l'USI et à l'hôpital. CONCLUSION: Dans cette étude de cohorte multicentrique, nous avons observé que la trachéotomie est associée à une diminution de la mortalité en comparaison à l'intubation endotrachéale prolongée chez la patientèle ayant subi un TCC modéré ou grave. Cet effet ne semble pas modifié par le moment de la procédure durant l'hospitalisation. La généralisation et l'application de ces résultats restent toutefois limitées par un biais d'indication résiduel potentiel.

Impact of Early Tracheostomy Versus Late or No Tracheostomy in Nonneurologically Injured Adult Patients: A Systematic Review and Meta-Analysis.

OBJECTIVE: The optimal timing of tracheostomy in nonneurologically injured mechanically ventilated critically ill adult patients is uncertain. We conducted a systematic review of randomized controlled trials to evaluate the effect of early versus late tracheostomy or prolonged intubation in this population. DATA SOURCES: We searched MEDLINE, Embase, CENTRAL, CINAHL, and Web of science databases for randomized controlled trials comparing early tracheostomy (<10 d of intubation) with late tracheostomy or prolonged intubation in adults. DATA SELECTION: We selected trials comparing early tracheostomy (defined as being performed less than 10 d after intubation) with late tracheostomy (performed on or after the 10th day of intubation) or prolonged intubation and no tracheostomy in nonneurologically injured patients. The primary outcome was overall mortality. Secondary outcomes included ventilator-associated pneumonia, duration of mechanical ventilation, ICU, and hospital length of stay. DATA EXTRACTION: Two reviewers screened citations, extracted data, assessed the risk of bias, and classification of Grading of Recommendations, Assessment, Development, and Evaluation independently. DATA SYNTHESIS: Our search strategy yielded 8,275 citations, from which nine trials (n = 2,457) were included. We did not observe an effect on the overall mortality of early tracheostomy compared with late tracheostomy or prolonged intubation (risk ratio, 0.91, 95% CI, 0.82-1.01; I2 = 18%). Our results were consistent in all subgroup analyses. No differences were observed in ICU and hospital length of stay, duration of mechanical ventilation, incidence of ventilator-acquired pneumonia, and complications. Our trial sequential analysis showed that our primary analysis on mortality was likely underpowered. CONCLUSION: In our systematic review, we observed that early tracheostomy, as compared with late tracheostomy or prolonged intubation, was not associated with a reduction in overall mortality. However, we cannot exclude a clinically relevant reduction in mortality considering the level of certainty of the evidence. A well-designed trial is needed to answer this important clinical question.

Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol.

INTRODUCTION: Traumatic brain injury (TBI) is the leading cause of mortality and long-term disability in young adults. Despite the high prevalence of anaemia and red blood cell transfusion in patients with TBI, the optimal haemoglobin (Hb) transfusion threshold is unknown. We undertook a randomised trial to evaluate whether a liberal transfusion strategy improves clinical outcomes compared with a restrictive strategy. METHODS AND ANALYSIS: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatiON is an international pragmatic randomised open label blinded-endpoint clinical trial. We will include 742 adult patients admitted to an intensive care unit (ICU) with an acute moderate or severe blunt TBI (Glasgow Coma Scale ≤12) and a Hb level ≤100 g/L. Patients are randomly allocated using a 1:1 ratio, stratified by site, to a liberal (triggered by Hb ≤100 g/L) or a restrictive (triggered by Hb ≤70 g/L) transfusion strategy applied from the time of randomisation to the decision to withdraw life-sustaining therapies, ICU discharge or death. Primary and secondary outcomes are assessed centrally by trained research personnel blinded to the intervention. The primary outcome is the Glasgow Outcome Scale extended at 6 months. Secondary outcomes include overall functional independence measure, overall quality of life (EuroQoL 5-Dimension 5-Level; EQ-5D-5L), TBI-specific quality of life (Quality of Life after Brain Injury; QOLIBRI), depression (Patient Health Questionnaire; PHQ-9) and mortality. ETHICS AND DISSEMINATION: This trial is approved by the CHU de Québec-Université Laval research ethics board (MP-20-2018-3706) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals. TRIAL REGISTRATION NUMBER: NCT03260478.

Red blood cell transfusion in animal models of acute brain injuries: a systematic review protocol.

BACKGROUND: Anemia is common in neurocritically ill patients. Considering the limited clinical evidence in this population, preclinical data may provide some understanding of the potential impact of anemia and of red blood cell transfusion in these patients. We aim to estimate the association between different transfusion strategies and neurobehavioral outcome in animal models. METHODS: We will conduct a systematic review of comparative studies of red blood cell transfusion strategies using animal models of traumatic brain injury, ischemic stroke or cerebral hemorrhage. We will search MEDLINE, EMBASE, and Web of Science databases for eligible studies from inception onwards. Two independent reviewers will perform study selection and data extraction. We will report our results in a descriptive synthesis focusing on characteristics of included studies, reported outcomes, risk of bias, and construct validity. Our primary outcome is the neurological function (neurobehavioral performance) and our secondary outcomes include mortality, infarct size, intracranial pressure, cerebral perfusion pressure, cerebral blood flow, and brain tissue oxygen tension. If appropriate, we will also perform a quantitative synthesis and pool results using random-effect models. Heterogeneity will be expressed with I2 statistics. Subgroup analyses are planned according to animal model characteristics, co-interventions, and risks of bias. DISCUSSION: Our study is aligned with the efforts to better understand the level of evidence on the impact of red blood cell transfusion strategies from preclinical studies in animal models of acute brain injury and the potential translation of information from the preclinical to the clinical research field. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018086662 .

Effect of PPARγ agonist on aerobic exercise capacity in relation to body fat distribution in men with type 2 diabetes mellitus and coronary artery disease: a 1-yr randomized study.

Targeting metabolic determinants of exercise performance with pharmacological agents that would mimic/potentiate the effects of exercise represents an attractive clinical alternative to counterbalance the poor exercise capacity in patients with type 2 diabetes mellitus (T2DM). We examined the effect of 1-yr treatment with the insulin sensitizer peroxisome proliferator-activated receptor (PPAR)γ agonist rosiglitazone on aerobic exercise capacity and body fat composition/distribution in men with T2DM and stable coronary artery disease (CAD). One-hundred four men (age: 64 ± 7 yr; body mass index: 30.0 ± 4.4 kg/m2) with T2DM and CAD were randomized to receive rosiglitazone or placebo for 1 yr. Aerobic exercise capacity (exercise duration) was assessed with a maximal treadmill test, and body composition/distribution were assessed by dual-energy X-ray absorptiometry/computed tomography scans. At 1 yr, patients with T2DM under PPARγ agonist treatment showed a reduction in aerobic exercise capacity compared with the control group (exercise duration change, -31 ± 8 versus 7 ± 11 s, P = 0.009). Significant increases in body fat mass (3.1 ± 0.4 kg, 12%), abdominal and mid-thigh subcutaneous adipose tissue (AT) levels, and mid-thigh skeletal muscle fat were found (all P < 0.01), whereas no effect on visceral AT levels was observed (P > 0.05) under treatment. Subcutaneous fat mass gained under PPARγ agonist was the strongest predictor of the worsening in aerobic exercise capacity (P > 0.0001); no association was found with skeletal muscle fat infiltration nor visceral AT. Treatment with the insulin sensitizer PPARγ agonist rosiglitazone in patients with T2DM and CAD is associated with a worsening in aerobic exercise capacity, which seems to be mainly attributable to weight gain and subcutaneous fat mass expansion.

Transpedal vs. femoral access for peripheral arterial interventions-A single center experience.

OBJECTIVE: To compare the transpedal approach to established femoral approach for endovascular treatment of infrainguinal peripheral arterial disease. BACKGROUND: Endovascular treatment of infrainguinal peripheral arterial disease is on the rise. Femoral approach is widely used but has significant complications. Recently the primary transpedal approach has been described for endovascular interventions. We hypothesized that transpedal approach could reduce access site related complications. We compared the two approaches in a retrospective cross-sectional study at a single center. METHODS: We analyzed demographics, procedural parameters, and complications in patients who underwent a primary transpedal approach for infrainguinal intervention and compared to patients with a traditional femoral approach in our outpatient based endovascular lab. RESULTS: The success rate for access was lower in transpedal group compared to femoral (94% vs. 100%, p = .0002). The contrast dose (44 ± 11 mL vs. 68 ± 13 mL, p < .0001), radiation dose (25 mGy [16-43] vs. 48 mGy [36-67], p < .0001) and fluoroscopy time (5.48 min [3.48-11.71] vs. 9.35 min [6.63-14.11], p < .0001) were significantly lower in transpedal group. CONCLUSION: The transpedal approach for infrainguinal revascularization appears to be a reasonable primary approach with high success and low complication rate with significant reduction in radiation and contrast dose. These findings should be further studied in a randomized controlled trial.

Transradial left gastric artery embolization to treat severe obesity: A pilot study.

BACKGROUND: Bariatric surgery is currently the only effective treatment with long-lasting results to treat severe obesity. OBJECTIVES: We performed a pilot study to evaluate the feasibility, safety and efficacy of percutaneous distal embolization of the left gastric artery (LGA) using a transradial approach. METHODS AND RESULTS: We recruited seven severely obese male patients (mean age 48 ± 7 years) referred for diagnostic coronary angiography. Mean baseline weight was 160 ± 27 kg and body mass index was of 52 ± 8 kg/m2 . We successfully injected 300-500 µm polyvinyl alcohol particles using 5Fr catheters and all distal LGA were occluded at the end of procedures. Mean procedure duration was 24 ± 13 min and mean fluoroscopy time was 10 ± 5 min. Six patients reported mild transient epigastric discomfort, which resolved with proton pump inhibitors. At 2 months, the average weight loss was of 7 ± 6 kg (median loss: -10 kg [-2, -11]), 6 ± 12 kg (median loss: -9 kg [-16, +4]) at 6 months and 13 ± 17 kg (median loss: -11 kg [0, -25]) up to 12 months after index procedures. CONCLUSION: Percutaneous transradial LGA embolization appears to be a promising technique to reduce the obesity burden. Randomized trials are required to further delineate the risk/benefit ratio, potential clinical indications and long term results.

One-year mortality of patients with ST-Elevation myocardial infarction: Prognostic impact of creatinine-based equations to estimate glomerular filtration rate.

BACKGROUND: Renal dysfunction is associated with worse outcomes after primary percutaneous coronary intervention (PCI). However, whether glomerular filtration rate (GFR) estimated with various equations can equally predict outcomes after ST-Elevation Myocardial Infarction (STEMI) is still debated. METHODS: We compared the clinical impact of 3 different creatinine-based equations (Cockcroft and Gault (CG), CKD-epidemiology (CKD-EPI) and Full Age Spectrum (FAS)) to predict 1-year mortality in STEMI patients. RESULTS: Among 1755 consecutive STEMI patients who had undergone primary PCI included between 2006 and 2011, median estimated GFR was 79 (61;96) with the CG, 81 (65;95) with CKD-EPI and 75 (60;91) mL/min/1.73 m2 with FAS equation. Reduced GFR values were independently associated with 1-year mortality risk with the 3 equations. Receiver operating curves (ROC) of CG and FAS equations were significantly superior to the CKD-EPI equation, p = 0.03 and p = 0.01, respectively. Better prediction with FAS and CG equations was confirmed by net reclassification index. CONCLUSIONS: Our results suggest that in STEMI patients who have undergone primary PCI, 1-year mortality is better predicted by CG or FAS equations compared to CKD-EPI.

A Randomized Double-Blind Placebo-Controlled Study Comparing Intracoronary Versus Intravenous Abciximab in Patients With ST-Elevation Myocardial Infarction Undergoing Transradial Rescue Percutaneous Coronary Intervention After Failed Thrombolysis.

The risk and benefit ratio of glycoprotein IIb/IIIa inhibitors with dual oral antiplatelet therapy after failed thrombolysis and rescue percutaneous coronary intervention (PCI) is unclear. Using a randomized placebo-controlled, double-blind design, we compared intravenous (IV) and intracoronary (IC) abciximab delivery in 74 patients referred for rescue transradial PCI. The primary angiographic end points were the final thrombolysis in myocardial infarction flow and myocardial blush grades. Secondary end points included acute and 6-month outcomes using angiographic parameters, platelet aggregation parameters, cardiac biomarkers, cardiac magnetic resonance measurements (CMR) and clinical end points. After rescue PCI, normal thrombolysis in myocardial infarction 3 flows were obtained in 70% in the IC group, 48% in the IV group, and 71% in the placebo group, respectively (p = 0.056). Final myocardial blush grades 2 and 3 were obtained in 43% and 39% in the IC group, 48% and 26% in the IV group, and 46% and 42% in the placebo group (p = 0.67), respectively. Acutely, peak release of cardiac biomarkers, necrosis size, myocardial perfusion and no-reflow as assessed by CMR, and clinical end points were similar between the groups and did not suggest a benefit for IC or IV abciximab compared with placebo. There was no increase in bleeding or access site-related complications with abciximab compared with placebo. Clinical, angiographic, and CMR outcomes at 6 months remained comparable between the groups. In patients with ST-elevation myocardial infarction presenting with failed thrombolysis undergoing transradial rescue PCI, IC or IV abciximab had no significant clinical impact.

Rosiglitazone lowers resting and blood pressure response to exercise in men with type 2 diabetes: A 1-year randomized study.

AIMS: We aimed to determine the effect of 1-year treatment with the insulin sensitizer peroxisome proliferator-activated receptor (PPAR)-γ agonist rosiglitazone on exercise capacity and blood pressure (BP) response to exercise in men with coronary artery disease (CAD) and type 2 diabetes (T2D). MATERIALS AND METHODS: A total of 116 men (age, 64 ± 7 years; body mass index, 30.0 ± 4.4 kg/m2 ) with CAD and T2D were randomized to receive rosiglitazone or placebo for 1 year. Exercise capacity (VO2peak ) and BP response to exercise were assessed with a maximal treadmill test, prior to the intervention and at 1-year follow-up. Exercise-induced hypertension (EIH) was defined as maximal systolic BP ≥ 220 mm Hg and/or diastolic BP ≥ 100 mm Hg. RESULTS: PPAR-γ agonist-treated patients showed improvements in fasting glucose, HbA1c and insulin sensitivity (Homeostasis model assessment of insulin resistance [HOMA-IR]) (all P < .05). Resting BPs, maximal exercise diastolic BP and resting rate-pressure product (RPP) were all reduced in the PPAR-γ agonist group (P < .05). Maximal exercise duration was unchanged. T2D patients who displayed the greatest improvement in insulin sensitivity (HOMA-IR) under PPAR-γ agonist treatment experienced a greater reduction in exercise BP and RPP (P < .05). The proportion of men with EIH decreased in the PPAR-γ agonist group during follow-up (39.00% ± 0.06% vs 21.00% ± 0.05%). In the subgroup with EIH that was treated with a PPAR-γ agonist, resting and exercise diastolic BP, as well as resting RPP, were all reduced at 1-year follow-up (P < .05). CONCLUSIONS: The insulin sensitizer rosiglitazone has a beneficial effect on resting and BP response to exercise in men with CAD and T2D, especially in those with an exaggerated BP response to exercise.

Transradial experience with bioresorbable vascular scaffolds: A case-matched study with metallic drug-eluting stents.

BACKGROUND: Whether polymeric bioresorbable vascular scaffolds (BVS) implantation with transradial approach is feasible and safe is unknown. We compared the feasibility and safety of the transradial approach for BVS delivery with metallic drug-eluting stents (DES). METHODS: We identified 118 consecutive patients who underwent BVS implantation and we compared 30-days and 1-year results with 118 matched patients with DES. Patients were matched for age, sex, risk factors and clinical indication. RESULTS: Rates of transradial approach were 98% in the BVS group vs 95% in the DES group (P = 0.16) with 5Fr used in 38% and 32% (P = 0.34), respectively. The number of stents was similar in both groups, 2.6 ±â€¯1.5 vs 2.4 ±â€¯1.3 (P = 0.23). Although maximal pressure for stent deployment was identical in both groups (16 ±â€¯3 atm), more lesions were pre-dilated (83% vs 52%, P < 0.001) and post-dilated (71% vs 33%, P < 0.001) in the BVS group. Contrast volume (217 ±â€¯97 vs 175 ±â€¯108 ml, P < 0.001), fluoroscopy time (16 [10-23] vs 13 [8-21] min, P = 0.04) and procedure duration (65 ±â€¯31 vs 56 ±â€¯47 min, P = 0.045) were significantly higher in the BVS group. Major adverse cardiac events, including death, myocardial infarction and target vessel revascularization remained similar in both groups, 1.7% vs 0.8% (P = 0.56) at 30 days and 10% vs 8.5% (P = 0.66) at 1 year. At 1 year, stent thrombosis occurred in 2 (1.7%) patients in the BVS group and 1 (0.8%) patient in the DES group (P = 0.56). CONCLUSION: The use of transradial approach for BVS compared to DES implantation was feasible and safe in all-comers, although BVS implantation included more technical challenges. Outcomes up to 1-year remained comparable in both groups.

Feasibility and Safety of Early Repeat Transradial Access Within 30 Days of Previous Coronary Angiography and Intervention.

Transradial approach (TRA) is the default access site for diagnostic angiography and intervention in many centers. Repeat ipsilateral radial artery access late after index procedure has been associated with failures. It is unknown whether early (≤30 days) and very early (<24 hours) repeat radial access is technically feasible and safe. Study population consisted of consecutive patients undergoing repeat (≥2) procedures within 30 days in a high-volume TRA center. Transradial access failure and resulting femoral approach was categorized as primary (no repeat attempt) or secondary (crossover). Timing of repeat access and reasons for failure were recorded. From November 2012 to December 2014, repeat catheterization by TRA was performed twice in 573 of 626 patients (92%) (median delay 4 [2 to 9] days), 3 times in 29 of 38 (76%) patients (median delay 15 [5 to 26] days), and 4 times in 1 patient within 21 days. When repeat catheterization occurred during the first 24 hours following the index procedure, 53% and 75% of patients had second and third procedures using the same ipsilateral radial artery, respectively. Primary radial failure occurred in 5.8% for second attempt and 13% for a third attempt, whereas crossovers were noted in 2.7% and 2.6%, respectively. Main reasons for failed re-access of ipsilateral radial artery were related either to operator's reluctance to repeat attempt (primary failure) or to issues with puncture site (crossover). In a high-volume TRA center, patients who required repeat catheterization within 24 hours and within the first 30 days had the same radial artery re-accessed in the majority of cases.

Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTEry Occlusion Meta-AnalysIS) Systematic Review and Meta-Analysis.

BACKGROUND: Incidence of radial artery occclusions (RAO) and ulnar artery occclusions (UAO) in coronary procedures, factors predisposing to forearm arteries occlusion, and the benefit of anticoaggulation vary significantly in existing literature. We sought to determine the incidence of RAO/UAO and the impact of anticoagulation intensity. METHODS AND RESULTS: Meta-analysis of 112 studies assessing RAO and/or UAO (N=46 631) were included. Overall, there was no difference between crude RAO and UAO rates (5.2%; 95% confidence interval [CI], 4.4-6.0 versus 4.0%; 95% CI, 2.8-5.8; P=0.171). The early occlusion rate (in-hospital or within 7 days after procedure) was higher than the late occlusion rate. The detection rate of occlusion was higher with vascular ultrasonography compared with clinical evaluation only. Low-dose heparin was associated with a significantly higher RAO rate compared with high-dose heparin (7.2%; 95% CI, 5.5-9.4 versus 4.3%; 95% CI, 3.5-5.3; Q=8.81; P=0.003). Early occlusions in low-dose heparin cohorts mounted at 8.0% (95% CI, 6.1-10.6). The RAO rate was higher after diagnostic angiographies compared with coronary interventions, presumably attributed to the higher intensity of anticoagulation in the latter group. Hemostatic techniques (patent versus nonpatent hemostasis), geography (US versus non-US cohorts) and sheath size did not impact on vessel patency. CONCLUSIONS: RAO and UAO occur with similar frequency and in the order of 7% to 8% when evaluated early by vascular ultrasonography following coronary procedures. More-intensive anticoagulation is protective. Late recanalization occurs in a substantial minority of patients.

Clinical value of post-percutaneous coronary intervention fractional flow reserve value: A systematic review and meta-analysis.

BACKGROUND: Fractional flow reserve (FFR) prior to percutaneous coronary intervention (PCI) is useful to guide treatment. Whether post-PCI FFR assessment might have clinical impact is controversial. The aim of this study is to evaluate the range of post-PCI FFR values and analyze the relationship between post-PCI FFR and clinical outcomes. METHODS: We systematically searched the PubMed, EMBASE, and Cochrane Library databases with cross-referencing of articles reporting post-PCI FFR and correlating post-PCI FFR values and clinical outcomes. The outcomes of interest were the immediate post-PCI FFR values and the correlations between post-PCI FFR and the incidence of repeat intervention and major adverse cardiac events (MACE). RESULTS: From 1995 to 2015, a total of 105 studies (n = 7470) were included, with 46 studies reporting post-PCI FFR and 59 studies evaluating relationship between post-PCI and clinical outcomes up to 30 months after PCI. Overall, post-PCI FFR values demonstrated a normal distribution with a mean value of 0.90 ± 0.04. There was a positive correlation between the percentage of stent use and post-PCI FFR (P < .0001). Meta-regression analysis indicated that higher post-PCI FFR values were associated with reduced rates of repeat intervention (P < .0001) and MACE (P = .0013). A post-PCI FFR ≥0.90 was associated with significantly lower risk of repeat PCI (odds ratio 0.43, 95% CI 0.34-0.56, P < .0001) and MACE (odds ratio 0.71, 95% CI 0.59-0.85, P = .0003). CONCLUSIONS: FFR measurement after PCI was associated with prognostic significance. Further investigation is required to assess the role of post-PCI FFR and validate cutoff values in contemporary clinical practice.

Comparison of radiation exposure during transradial diagnostic coronary angiography with single- or multi-catheters approach.

OBJECTIVE: To compare radiation exposure during transradial diagnostic coronary angiography (DCA) using standard single- or multi-catheters with different shapes. BACKGROUND: Transradial DCA can be performed using single- or multi-catheters to canulate left and right coronary ostia. To date, it remains unknown whether there are differences in radiation exposure between the two strategies. METHODS: From November 2012 to June 2014, 3,410 consecutive patients who underwent transradial DCA were recruited. Groups were based on the initial diagnostic catheter used and were dichotomized between single- and multi-catheters approach. All crossovers were excluded. The multi-catheters approach (Multi) group consisted of Judkins left and right catheters, whereas the single-catheter (Single) group included Amplatz, Barbeau, or Multipurpose catheters. Fluoroscopy time (FT) as a surrogate end-point for total radiation exposure and kerma-area product (KAP; patient radiation exposure) were collected as radiation exposure parameters. RESULTS: A single-catheter strategy was used in 439 patients, while 2,971 patients had a multi-catheters approach. There was no significant difference in FT between groups (2.86 ± 1.48 min for Multi vs. 2.87 ± 1.72 min for Single, P = 0.13). The multi-catheters approach was associated with a significant 15% reduction in KAP (3,599 ± 2,214 cGy · cm2 vs. 3,073 ± 1,785 cGy · cm2 , P < 0.0001) compared to the single-catheter approach. When pooling all patients, mean FT was 2.86 ± 1.51 min. Mean KAP was 3,141 ± 1,854 cGy · cm2 . Reference levels in our institution in both groups were below international diagnostic reference levels. Overall both FT and KAP decreased by 15% and 19%, respectively, over the 2-year study period. CONCLUSIONS: Compared to a single-catheter approach, a multi-catheters approach with standard Judkins catheters for DCA significantly reduced patient radiation exposure. Whether single catheter designed for DCA by radial approach can further reduce radiation exposure compared to Judkins catheters remains to be compared in randomized studies. © 2016 Wiley Periodicals, Inc.

Rosiglitazone influences adipose tissue distribution without deleterious impact on heart rate variability in coronary heart disease patients with type 2 diabetes.

INTRODUCTION: Obesity is associated with decreased heart rate variability (HRV). Rosiglitazone, a PPARγ agonist, is generally associated with increases in body mass. PURPOSE: To assess whether the gain in body mass and adiposity expected from rosiglitazone treatment has an influence on HRV in patients with type 2 diabetes and coronary artery disease. METHODS: One hundred and twenty-five patients with type 2 diabetes and coronary artery disease aged between 40 and 75 years were studied. Anthropometric measurements: (1) body mass index (BMI), (2) waist circumference (WC), (3) abdominal computed tomography (CT) scan, and HRV (using a 24 h Holter) were measured at baseline and after 12 months of treatment. Patients were randomized to rosiglitazone or placebo regimen. RESULTS: In the rosiglitazone vs. placebo group, there were significant increases in body mass [3.5 (2.6;4.4); mean (95 % CI) vs. 0.2 (-0.4;0.8)] kg), BMI [1.3 (1.0;1.6) vs. 0.1 (-0.1;0.3) kg/m2], WC [2.1 (0.9;3.3) vs. 0.4 (-0.4;1.2) cm, all p ≤ 0.001] and subcutaneous adipose tissue [253 (187;319) vs. 6 (-24;36) cm3, p ≤ 0.001] without statistically significant changes in visceral adipose tissue [-22 (-91;47) vs. 57 (43;71) cm3, p = 0.546], respectively. There was no change in HRV in either group after 12 months. There were no correlations between changes in HRV variables and fat distribution. CONCLUSION: Our results suggest that changes in adiposity indices observed after 12 months of rosiglitazone therapy have no deleterious influence on HRV in patients with type 2 diabetes and coronary artery disease.

Prediction and impact of failure of transradial approach for primary percutaneous coronary intervention.

OBJECTIVES: To determine predictors of failure of transradial approach (TRA) in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), and develop a novel score specific for this population. METHODS: Consecutive patients with STEMI undergoing primary PCI in a tertiary care high-volume radial centre were included. TRA-PCI failure was categorised as primary (primary transfemoral approach (TFA)) or crossover (from TRA to TFA). Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. Clinical outcomes up to 1 year were assessed. RESULTS: From January 2006 to January 2011, 2020 patients were studied. Primary TRA-PCI failure occurred in 111 (5%) patients and crossover to TFA in 44 (2.2%) patients. Independent predictors of TRA-PCI failure were: weight ≤65 kg (OR: 3.0; 95% CI 1.9 to 4.8, p<0.0001), physician with ≤5% TFA conversion (OR: 0.45; 95% CI 0.2 to 0.9, p=0.033), and physician with ≥10% conversion to TFA (OR: 2.2; 95% CI 1.2 to 3.7, p=0.005), intra-aortic balloon pump (OR: 2.0; 95% CI 0.9 to 4.3, p=0.066), cardiogenic shock (OR: 2.8; 95% CI 1.4 to 5.6, p=0.0035), endotracheal intubation (OR: 107; 95% CI 42 to 339, p<0.0001), creatinine >133 µmol/L (OR: 3.6; 95% CI 1.9 to 6.8, p<0.0001), age ≥75 (OR: 1.7; 95% CI 1.0 to 2.9, p=0.031), prior PCI (OR: 2.6; 95% CI 1.5 to 4.5, p=0.0009), hypertension (OR: 1.8; 95% CI 1.2 to 2.9, p=0.009). An integer risk score ranging from -1 to 12 was developed, and predicted TRA-PCI failure from 0% to 100% (c-statistic of 0.868; 95% CI 0.866 to 0.869). Mortality at 1 year remained significantly higher after TRA-PCI failure (adjusted OR 2.2; 95% CI 1.2 to 3.9, p=0.011). CONCLUSIONS: In a high-volume radial centre, the incidence of TRA-PCI failure is low and can be accurately predicted using a 9-variables risk score. Since outcomes after TRA-PCI failure remained inferior, further effort to maximise the use of radial approach for primary PCI should be investigated.

Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention.

Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.

Efficacy and safety of preoperative intra-aortic balloon pump use in patients undergoing cardiac surgery: a systematic review and meta-analysis.

BACKGROUND: Intra-aortic balloon pump (IABP) can be used prior to coronary artery bypass graft surgery (CABG) in high-risk patients. Whether this technique remains safe and effective in contemporary practice is controversial. OBJECTIVE: We have completed a systematic review and meta-analysis of randomized trials and observational studies to evaluate the safety and benefits of IABP prior to CABG surgery. METHODS: We searched PubMed, EMBASE, Cochrane Library databases, with cross-referencing of relevant articles for studies assessing the impact of IABP prior to and after isolated CABG. Two investigators independently sorted the potentially relevant studies, and three extracted data. The assessed outcomes included in-hospital and 30-day mortality, IABP-related complications and length of intensive care unit and hospital stay. RESULTS: From 1977 to 2015 we included 11 randomized controlled trials (n=1293) (RCTs) and 22 observational studies, including a total of 46,067 patients. Analyses from RCTs suggested that IABP prior to CABG was associated with a significant reduction in hospital mortality (odds ratio (OR) 0.20; 95% confidence interval (CI): 0.09-0.44; P<0.0001) and 30-day mortality compared to no preoperative IABP (OR 0.43, 95% CI: 0.25-0.76; P=0.003). IABP prior to CABG was also associated with shorter intensive care unit (weighted mean difference (WMD) -1.47day; 95% CI: -1.82 to -1.12day; P<0.00001) and hospital length of stay (WMD -3.25days; 95% CI: -5.18 to -1.33days; P=0.0009). However, there were significant bias and limitations among included studies. Furthermore, results for similar outcomes from observational studies remained inconclusive. CONCLUSIONS: In contemporary practice, evidence showing clinical benefit for preoperative IABP in high-risk patients remains limited and requires further validation in an appropriately sized multicenter randomized trial.

Obesity and coronary artery disease: evaluation and treatment.

With the increasing prevalence of obesity, clinicians are now facing a growing population of patients with specific features of clinical presentation, diagnostic challenges, and interventional, medical, and surgical management. After briefly discussing the effect of obesity on atherosclerotic burden in this review, we will focus on strategies clinicians might use to ensure better outcomes when performing revascularization in obese and severely obese patients. These patients tend to present comorbidities at a younger age, and their anthropometric features might limit the use of traditional cardiovascular risk stratification approaches for ischemic disease. Alternative techniques have emerged, especially in nuclear medicine. Positron emission tomography-computed tomography might be the diagnostic imaging technique of choice. When revascularization is considered, features associated with obesity must be considered to guide therapeutic strategies. In percutaneous coronary intervention, a radial approach should be favoured, and adequate antiplatelet therapy with new and more potent agents should be initiated. Weight-based anticoagulation should be contemplated if needed, with the use of drug-eluting stents. An "off-pump" approach for coronary artery bypass grafting might be preferable to the use of cardiopulmonary bypass. For patients who undergo bilateral internal thoracic artery grafting, harvesting using skeletonization might prevent deep sternal wound infections. In contrast to percutaneous coronary intervention, lower surgical bleeding has been observed when lean body mass is used for perioperative heparin dose determination.