Fibrinolysis for patients with intermediate-risk pulmonary embolism.

BACKGROUND: The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial. METHODS: In a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization. RESULTS: Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42). CONCLUSIONS: In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; ClinicalTrials.gov number, NCT00639743.).

Outcome of patients with right heart thrombi: the Right Heart Thrombi European Registry.

Our aim was the assessment of the prognostic significance of right heart thrombi (RiHT) and their characteristics in pulmonary embolism in relation to established prognostic factors.138 patients (69 females) aged (mean±sd) 62±19 years with RiHT were included into a multicenter registry. A control group of 276 patients without RiHT was created by propensity scoring from a cohort of 963 contemporary patients. The primary end-point was 30-day pulmonary embolism-related mortality; the secondary end-point included 30-day all-cause mortality. In RiHT patients, pulmonary embolism mortality was higher in 31 patients with systolic blood pressure <90 mmHg than in 107 normotensives (42% versus 12%, p=0.0002) and was higher in the 83 normotensives with right ventricular dysfunction (RVD) than in the 24 normotensives without RVD (16% versus 0%, p=0.038). In multivariable analysis the simplified Pulmonary Embolism Severity Index predicted mortality (hazard ratio 2.43, 95% CI 1.58-3.73; p<0.0001), while RiHT characteristics did not. Patients with RiHT had higher pulmonary embolism mortality than controls (19% versus 8%, p=0.003), especially normotensive patients with RVD (16% versus 7%, p=0.02).30-day mortality in patients with RiHT is related to haemodynamic consequences of pulmonary embolism and not to RiHT characteristics. However, patients with RiHT and pulmonary embolism resulting in RVD seem to have worse prognosis than propensity score-matched controls.

Immediate placement of extra-short implants in refined scapula tip microvascular free flaps: In house virtual planning and surgical technique - Proof of concept.

Scapula tip flaps have been introduced in the literature as an ideal surgical treatment option for large defects in the horizontal plane of the maxilla. This article aims to present a unique step by step protocol for a near total maxillectomy with a pterygoid bone resection and consecutive microvascular reconstruction with a harvested scapula tip flap. The protocol includes immediate placement of extra-short implants in donor bone with the aid of Virtual Surgical Planning (VSP), and an in-house 3D printing of medical 3D models and surgical guides. So far, there has been no presented surgical technique combining immediate implant placement in the scapula region with simultaneous microvascular repair. This technique allows: tumour resection; flap harvesting; extra-short implant placements and reconstruction to be performed in one simultaneous procedure. The technique is presented with illustrations, VSP (presented on videos), radiographs, and surgical findings. We discovered that this refinement of the scapula tip surgery has enabled reconstructive procedures to be performed at the same time as implant placements, providing expedited functional and aesthetic outcomes in selected cases. Moreover, modification of the surgical technique could enhance the competence of the oropharyngeal edge. In conclusion, this new surgical protocol utilizing VSP, 3D models and simultaneous extra-short implant placement provides indispensable advantages for such a complicated surgical procedures, while significantly shortening the duration of surgery.

Early dumping syndrome and reflux esophagitis prevention with pouch reconstruction.

BACKGROUND: Total gastrectomy causes numerous disorders, such as reflux esophagitis, dumping syndrome, malabsorption, and malnutrition. To minimize the consequences, different variants of reconstruction are performed. The aim of our study is the comparison of two reconstructive methods: the standard Roux-en-Y and a new modality of pouch interposition, preduodenal-pouch interposition. This study aims to investigate the advantage of bile reflux prevention and to reduce symptoms of dumping syndrome after 3- and 6-mo follow-up. MATERIALS AND METHODS: A total of 60 patients were divided in two groups: (A) 30 patients with Roux-en-Y reconstruction, and (B) 30 patients with the preduodenal-pouch (PDP) type of reconstruction. Endoscopic examination and endoluminal jejunal limb pressure measurements were performed. Scintigraphic measurements of half-emptying time were performed to evaluate meal elimination in the context of reflux esophagitis and early dumping syndrome. The Japan Society of Gastrointestinal Surgery has provided guidelines with which to classify the symptoms of early dumping syndrome. Patients were followed up for periods of 3 and 6 mo after the surgery. RESULTS: Our study groups did not differ with regard to the level of reflux esophagitis (P = 0.688). Average values of pressure at 10 and 15 cm below the esophago-jejunal junction were significantly lower in the PDP group (P < 0.001). Elimination of the test meal between two groups was not significant (P = 0.222). Evaluation of early dumping syndrome symptoms revealed a significant reduction among PDP patients after 3 and 6 mo. CONCLUSION: Our study showed significant superiority of the new pouch reconstruction over the standard Roux-en-Y approach in the treatment of early dumping syndrome.

The efficacy of three transection techniques of the liver resection: a randomized clinical trial.

BACKGROUND/AIMS: Liver resection is a demanding procedure due to the risk of massive blood loss. Different instruments for liver transection are available today. The aim of this randomized clinical trial was to analyze the efficacy of three different parenchyma transection techniques of liver resection. METHODOLOGY: A total of 60 non-cirrhotic patients undergoing hepatectomy were randomly selected for clamp crushing technique (CRUSH), ultrasonic dissection (CUSA) or bipolar device (LigaSure), n=20 in each group. All patients had liver resection under low central venous pressure anaesthesia (CVP), with ischemic preconditioning and intermittent inflow occlusion. Primary endpoints were surgery duration, transection duration, cumulative pedicle clamping time, intraoperative blood loss and blood transfusion. Secondary endpoints included the postoperative liver injury, postoperative morbidity and mortality. RESULTS: Overall surgery duration was 295 vs. 270 vs. 240min for LigaSure, CUSA and Clamp Crushing Technique, respectively. The transection duration was 85 vs. 52.5 vs. 40 minutes, respectively. These three different resection techniques of non-cirrhotic liver produced similar outcome in terms of intraoperative blood loss, blood transfusion, postoperative complications and mortality. CONCLUSIONS: The Clump Crushing Technique, CUSA and Liga Sure are equally safe for resection of non-cirrhotic liver. Liver resections can be performed safely if the entire concept is well designed and the choice of dissection device does not affect the outcome of hepatectomy.

Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial.

Intermediate-high-risk pulmonary embolism (PE) is characterized by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent hemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of hemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International THrOmbolysis (PEITHO)-3 study (ClinicalTrials.gov Identifier: NCT04430569) is a randomized, placebo-controlled, double-blind, multicenter, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate-high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure ≤110 mm Hg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, hemodynamic decompensation, or PE recurrence within 30 days of randomization. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, hemodynamic decompensation, or stroke within 30 days; dyspnea, functional limitation, or RV dysfunction at 6 months and 2 years; and utilization of health care resources within 30 days and 2 years. The study is planned to enroll 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.

SIRS score on admission and initial concentration of IL-6 as severe acute pancreatitis outcome predictors.

BACKGROUND/AIMS: Early recognition of severe form of acute pancreatitis is important because these patients need more agressive diagnostic and therapeutical approach an can develope systemic complications such as: sepsis, coagulopathy, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Dysfunction Syndrome (MODS), Multiple Organ Failure (MOF). To determine role of the combination of Systemic Inflammatory Response Syndrome (SIRS) score and serum Interleukin-6 (IL-6) level on admission as predictor of illness severity and outcome of Severe Acute Pancreatitis (SAP). METHODOLOGY: We evaluated 234 patients with first onset of SAP appears in last twenty four hours. A total of 77 (33%) patients died. SIRS score and serum IL-6 concentration were measured in first hour after admission. RESULTS: In 105 patients with SIRS score 3 and higher, initial measured IL-6 levels were significantly higher than in the group of remaining 129 patients (72 +/- 67 pg/mL, vs 18 +/- 15 pg/mL). All nonsurvivals were in the first group, with SIRS score 3 and 4 and initial IL-6 concentration 113 +/- 27 pg/mL. The values of C-reactive Protein (CRP) measured after 48h, Acute Physiology and Chronic Health Evaluation (APACHE II) score on admission and Ranson score showed the similar correlation, but serum amylase level did not correlate significantly with Ranson score, IL-6 concentration and APACHE II score. CONCLUSION: The combination of SIRS score on admission and IL-6 serum concentration can be early, predictor of illness severity and outcome in SAP.

Renal dysfunction as intrahospital prognostic indicator in acute pulmonary embolism.

BACKGROUND: Acute pulmonary embolism (PE), due to hemodynamic disturbances, may lead to multi-organ damage, including acute renal dysfunction. The aim of our study was to investigate the predictive role of renal dysfunction at admission regarding the short-term mortality and bleeding risk in hospitalized PE patients. METHODS: The retrospective cohort study included 1330 consecutive patients with PE. The glomerular filtration rate (GFR) was calculated using the serum creatinine value and Cocroft-Gault formula, at hospital admission. Primary outcomes were all-cause mortality and PE-related mortality in the 30 days following admission, as well as major bleeding events. RESULTS: Based on the estimated GFR, patients were divided into three groups: the first with GFR < 30 mL/min, the second with GFR 30-60 mL/min, and the third group with GFR > 60 mL/min. A multivariable analysis showed that GFR at admission was strongly associated with all-cause death, as well as with death due to PE. Patients in the first and second group had a significantly higher risk of 30-day all-cause mortality (HR 7.109, 95% CI 4.243-11.911, p < 0.001; HR 2.554, 95% CI 1.598-4.081, p < 0.001). Fatal bleeding was recorded in 1.6%, 0.5% and 0.8% of patients in the first, second and in the third group (p < 0.05). There were no significant differences regarding major bleeding rates among the groups. CONCLUSION: Renal dysfunction at admission in patients with acute pulmonary embolism is strongly associated with overall PE mortality.

In-hospital and long-term prognosis after myocardial infarction in patients with prior coronary artery bypass surgery; 19-year experience.

To present a 19-year experience of the prognosis of patients with acute myocardial infarction (AMI) and prior coronary artery bypass surgery (CABS), 748 patients with AMI after prior CABS (postbypass group) and a control group of 1080 patients with AMI, but without prior CABS, were analyzed. All indexes of infarct size were lower in the postbypass group. There was more ventricular fibrillation in the postbypass group. In-hospital mortality was similar (p = 0.3675). In the follow-up period, postbypass patients had more heart failure, recurrent CABS, reinfarction, and unstable angina than did control patients. Cumulative survival was better in the control group than in the postbypass group (p = 0.0403). Multiple logistic regression model showed that previous angina (p = 0.0005), diabetes (p = 0.0058), and age (p = 0.0102) were independent predictor factors for survival. Use of digitalis and diuretics, together with previous angina, also influenced survival (p = 0.0092), as well as male gender, older patients, and diabetes together (p = 0.0420). Patients with AMI after prior CABS had smaller infarct, but more reinfarction, reoperation, heart failure, and angina. Previous angina, diabetes, and age, independently, as well as use of digitalis and diuretics together with angina, and male gender, older patients, and diabetes together, influenced a worse survival rate in these patients.

The timing of infarction pain in patients with acute myocardial infarction after previous revascularization.

Circadian variation of onset of acute myocardial infarction (AMI) has been noted in many studies, but there are no data about subgroups of patients with previous coronary artery bypass grafting (CABG). Because of abnormalities in the circadian rhythm of autonomic tone after surgery, it was very interesting to analyze the circadian patterns in the onset of symptoms of AMI in various subgroups of 1784 patients with previous CABG. As in the other studies, a peak occurred in the morning hours with 26.3% of the patients, but there was a second nearly equal, but higher, peak (26.4%) in the evening hours. The subgroups with specific clinical characteristics exhibited different patterns that determined these peaks in all populations. In patients older than 70 years of age, in both sexes, in smokers, diabetics, in patients with hypertension, in those undergoing beta-blocker therapy, and in patients without previous angina, two nearly equal peaks were observed, with higher evening peaks, except in those patients with hypertension and without angina. Only one peak in the evening hours was observed in a subgroup of patients with previous congestive heart failure (CHF) and non-STEMI. The subgroup of patients with previous angina and previous AMI exhibited no discernible peaks. The distribution of time of onset within the four intervals was not uniform, and the difference was statistically significant only for patients undergoing beta-blocker therapy at time of onset (p = 0.0013), nonsmokers (p = 0.0283), and patients with non-STEMI (p = 0.0412). It is well known that patients with AMI have a dominant morning peak of circadian variation of onset. However, analyzing a different subgroup of patients with AMI after previous CABG, it was found that some subgroups had two peaks of onset, but a higher evening peak (patients older than 70 years of age, smokers, diabetics, and a group of patients who were taking beta-blocker therapy). This subgroup of patients, together with the subgroups of patients with a dominant evening peak (patients with CHF and those with non-STEMI) and with patients with no peak (patients with previous angina and previous AMI), probably appear to modify characteristic circadian variation of infarction onset, expressing a higher evening peak, respectively to the previous CABG, with adverse consequences for central nervous system functioning.

Three-Year Impact of Immediate Invasive Strategy in Patients With Non-ST-Segment Elevation Myocardial Infarction (from the RIDDLE-NSTEMI Study).

Previous studies compared clinical outcomes of early versus delayed invasive strategy in patients with non-ST-elevation acute coronary syndrome up to 1-year follow-up, but long-term data remain scarce. Our aim was to evaluate the long-term effects of immediate invasive intervention in patients with Non-ST-Segment Elevation Myocardial Infarction (NSTEMI). The Randomized Study of Immediate Versus Delayed Invasive Intervention in Patients With Non-ST-Segment Elevation Myocardial Infarction (RIDDLE-NSTEMI) was a randomized, investigator-initiated, parallel-group trial that assigned 323 patients with NSTEMI (1:1) to either immediate (median time to intervention 1.4 hours) or delayed invasive strategy (61.0 hours). The primary end point was the composite of death or new myocardial infarction (MI). At 3 years, immediate invasive intervention was associated with a lower rate of death or new MI, compared with a delayed invasive strategy (12.3% vs 22.5%, hazard ratio 0.50, 95% confidence interval 0.29 to 0.87, p = 0.014). The observed benefit of immediate intervention was mainly driven by an increased early reinfarction risk in delayed strategy, with similar new MI rates beyond 30 days (4.4% in the immediate and 5.6% in the delayed group, p = 0.61). Three-year mortality was 9.3% in the immediate invasive strategy, and 10.0% in the delayed strategy (p = 0.83). High baseline Global Registry of Acute Coronary Events score (>140) was associated with a significant increase in long-term mortality, regardless of the timing of invasive intervention. In conclusion, whereas immediate invasive intervention significantly reduced the early risk of new MI, the timing of invasive intervention appears to have no significant impact on clinical outcomes beyond 30 days, which seem to mostly be related to the baseline clinical risk profile.

Influence of Syrgical Trauma on Nitric Oxide and Nitrotyrosine Serum Levels in Patients Undergoing Laparoscopic Or Conventional Cholecystectomy.

BACKGROUND: Oxidative stress represents tissue damage caused by reactive forms of oxygen and nitrogen due to the inability of antioxidant mechanisms to reduce reactive forms into more stable ones. The aim of the study was to evaluate the influence of surgical trauma on nitric oxide (NO) and nitrotyrosine (NT) values in patients undergoing conventional and laparoscopic cholecystectomy. METHODS: A prospective study included sixty patients from the Department of Emergency Surgery, Clinical Centre of Serbia who were operated for gallstone related chronic cholecystitis. All the patients enrolled in the study underwent cholecystectomy; the first group was operated conventionally (30 patients - control group), while the second group was operated laparoscopically (30 patients - treatment group). RESULTS: There were no statistically significant differences in the values of NO and its postoperative changes in both groups, the conventionally operated group (p=0.943) and the laparoscopically operated group (p=0.393). We found an increase in NT values 24 hours postoperatively (p=0.000) in the conventionally operated patients, while in the group operated laparoscopically we didn't find statistically significant changes in the values of NT (conventionally operated group (p=0.943) and laparoscopically operated group (p=0.393)). CONCLUSIONS: In our study, we found a significant increase in NT values 24 hours postoperatively in conventionally operated patients i.e. the control group, vs. the treatment group. Further randomized studies are needed for a better understanding of the impact of surgical trauma on oxidative stress response.

Elevated Serum Protein S100B and Neuron Specific Enolase Values as Predictors of Early Neurological Outcome After Traumatic Brain Injury.

BACKGROUND: The objective of our study was to determine the serum concentrations of protein S100B and neuron specific enolase (NSE) as well as their ability and accuracy in the prediction of early neurological outcome after a traumatic brain injury. METHODS: A total of 130 polytraumatized patients with the associated traumatic brain injuries were included in this prospective cohort study. Serum protein S100B and NSE levels were measured at 6, 24, 48 and 72 hours after the injury. Early neurological outcome was scored by Glasgow Outcome Scale (GOS) on day 14 after the brain injury. RESULTS: The protein S100B concentrations were maximal at 6 hours after the injury, which was followed by an abrupt fall, and subsequently slower release in the following two days with continual and significantly increased values (p<0.0001) in patients with poor outcome. Secondary increase in protein S100B at 72 hours was recorded in patients with lethal outcome (GOS 1). Dynamics of NSE changes was characterized by a secondary increase in concentrations at 72 hours after the injury in patients with poor outcome. CONCLUSION: Both markers have good predictive ability for poor neurological outcome, although NSE provides better discriminative potential at 72 hours after the brain injury, while protein S100B has better discriminative potential for mortality prediction.

Dabigatran after Short Heparin Anticoagulation for Acute Intermediate-Risk Pulmonary Embolism: Rationale and Design of the Single-Arm PEITHO-2 Study.

Patients with intermediate-risk pulmonary embolism (PE) may, depending on the method and cut-off values used for definition, account for up to 60% of all patients with PE and have an 8% or higher risk of short-term adverse outcome. Although four non-vitamin K-dependent direct oral anticoagulants (NOACs) have been approved for the treatment of venous thromboembolism, their safety and efficacy as well as the optimal anticoagulation regimen using these drugs have not been systematically investigated in intermediate-risk PE. Moreover, it remains unknown how many patients with intermediate-high-risk and intermediate-low-risk PE were included in most of the phase III NOAC trials. The ongoing Pulmonary Embolism International Thrombolysis 2 (PEITHO-2) study is a prospective, multicentre, multinational, single-arm trial investigating whether treatment of acute intermediate-risk PE with parenteral heparin anticoagulation over the first 72 hours, followed by the direct oral thrombin inhibitor dabigatran over 6 months, is effective and safe. The primary efficacy outcome is recurrent symptomatic venous thromboembolism or death related to PE within the first 6 months. The primary safety outcome is major bleeding as defined by the International Society on Thrombosis and Haemostasis. Secondary outcomes include all-cause mortality, the overall duration of hospital stay (index event and repeated hospitalizations) and the temporal pattern of recovery of right ventricular function over the 6-month follow-up period. By applying and evaluating a contemporary risk-tailored treatment strategy for acute PE, PEITHO-2 will implement the recommendations of current guidelines and contribute to their further evolution.

Immunoscintigraphy of colorectal carcinomas with radiolabeled monoclonal antibody fragments.

BACKGROUND/AIMS: The aim was evaluation of the accuracy and clinical impact of the immunoscintigraphy for the detection of metastases and recurrences of colorectal carcinomas using two different radiolabeled antibody fragments. METHODOLOGY: The study was performed in 5 patients with IMACIS 1 containing the cocktail of 111MBq 131I MoAb 19-9 F(ab')2 and MoAb anti-CEA F(ab')2 and 8 patients with INDIMACIS 19-9 containing 150MBq of 111In-labeled MoAb 19-9 F(ab')2. RESULTS: With IMACIS 1, in all the patients, both tumor marker values were elevated. The number of TN was 3/5 and TP 2/5. From 2 TP, one had recurrence of the diseases with peritoneal carcinosis and one with liver metastases. In one patient, the results influenced the therapeutical management. With INDIMACIS 19-9, there were 2/8 TN, with borderline value of CEA and CA 19-9. TP were 6/8 (all with elevated tumor marker values, five of them many times; 3 with recurrences, 1 with recurrence and liver metastases and two with only liver metastases. In three patients, immunoscintigraphy influenced patient management. CONCLUSIONS: With both radiopharmaceuticals, immunoscintigraphy significantly influenced the patient management or it was complementary. It would be performed in the detection of recurrence, assessment of viability and follow-up of the therapy.

Simultaneous dynamic study of gastric emptying and changes of serum levels of gut hormones in patients after peptic ulcer surgery.

BACKGROUND: The aim was to examine the influence of different modalities of peptic ulcer surgery on the gastric emptying (GE) pattern and related serum level changes of selected gut hormones. MATERIAL AND METHODS: Fifty eight subjects were examined. In 48 of them peptic ulcer surgery was performed at least six months before the examination: Billroth I (B1) in 11, Billroth II (B2) in 16, B1 with the selective vagotomy--Harkins 1 (H1) in 9 and B2 with the selective vagotomy--Harkins 2 (H2) in 12. Ten healthy volunteers (C) were also examined. RESULTS: The results of gastric emptying showed that the lag phase duration was inversely related to the GE rates, and the GE pattern was linear in both controls (C) and in operated patients, except in B2 group, in which the GE pattern was exponential. In comparison with C group, GE was slower in B1, H1 and H2 groups, and faster in B2 group. The plasma gastrin values in C group, showing two peaks, were higher in relation to other groups. In relation to C group, higher values of motilin were obtained in patients after the selective vagotomy. The plasma somatostatin values recorded in B1 and H1 groups, showing the marked peaks, were higher in relation to C group. In relation to C group the highest plasma neurotensin values were obtained in B2 group. CONCLUSIONS: In order to understand entirely the influence of peptic ulcer surgery on the GI function, further research of the role of specific hormones and neuropeptides is needed, which would enable more precise selection of the therapy in order to prevent postvagotomy and postgastrectomy syndromes.

Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients: The RIDDLE-NSTEMI Study.

OBJECTIVES: This study aimed to assess the clinical impact of immediate versus delayed invasive intervention in patients with non-ST-segment myocardial infarction (NSTEMI). BACKGROUND: Previous studies found conflicting results on the effects of earlier invasive intervention in a heterogeneous population of acute coronary syndromes without ST-segment elevation. METHODS: We randomized 323 NSTEMI patients to an immediate-intervention group (<2 h after randomization, n = 162) and a delayed-intervention group (2 to 72 h, n = 161).The primary endpoint was the occurrence of death or new myocardial infarction (MI) at 30-day follow-up. RESULTS: Median time from randomization to angiography was 1.4 h and 61.0 h in the immediate-intervention group and the delayed-intervention group, respectively (p < 0.001). At 30 days, the primary endpoint was achieved less frequently in patients undergoing immediate intervention (4.3% vs. 13%, hazard ratio: 0.32, 95% confidence interval: 0.13 to 0.74; p = 0.008). At 1 year, this difference persisted (6.8% in the immediate-intervention group vs. 18.8% in delayed-intervention group; hazard ratio: 0.34, 95% confidence interval: 0.17 to 0.67; p = 0.002). The observed results were mainly attributable to the occurrence of new MI in the pre-catheterization period (0 deaths + 0 MIs in the immediate-intervention group vs. 1 death + 10 MIs in the delayed-intervention group). The rate of deaths, new MI, or recurrent ischemia was lower in the immediate-intervention group at both 30 days (6.8% vs. 26.7%; p < 0.001) and 1 year (15.4% vs. 33.1%; p < 0.001). CONCLUSIONS: Immediate invasive strategy in NSTEMI patients is associated with lower rates of death or new MI compared with the delayed invasive strategy at early and midterm follow-up, mainly due to a decrease in the risk of new MI in the pre-catheterization period. (Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients [RIDDLE-NSTEMI]; NCT02419833).

Sex and age differences and outcomes in acute coronary syndromes.

BACKGROUND: There is conflicting information about sex differences in presentation, treatment, and outcome after acute coronary syndromes (ACS) in the era of reperfusion therapy and percutaneous coronary intervention. The aim of this study was to examine presentation, acute therapy, and outcomes of men and women with ACS with special emphasis on their relationship with younger age (≤65years). METHODS: From January 2010 to June 2015, we enrolled 5140 patients from 3 primary PCI capable hospitals. Patients were registered according to the International Survey of Acute Coronary Syndrome in Transitional Countries (ISACS-TC) registry protocol (ClinicalTrials.gov: NCT01218776). The primary outcome was the incidence of in-hospital mortality. RESULTS: The study population was constituted by 2876 patients younger than 65years and 2294 patients older. Women were older than men in both the young (56.2±6.6 vs. 54.1±7.4) and old (74.9±6.4 vs. 73.6±6.0) age groups. There were 3421 (66.2%) patients with ST elevation ACS (STE-ACS) and 1719 (33.8%) patients without ST elevation ACS (NSTE-ACS). In STE-ACS, the percentage of patients who failed to receive reperfusion was higher in women than in men either in the young (21.7% vs. 15.8%) than in the elderly (35.2% vs. 29.6%). There was a significant higher mortality in women in the younger age group (age-adjusted OR 1.52, 95% CI: 1.01-2.29), but there was no sex difference in the older group (age-adjusted OR 1.10, 95% CI: 0.87-1.41). Significantly sex differences in mortality were not seen in NSTE-ACS patients. CONCLUSIONS: In-hospital mortality from ACS is not different between older men and women. A higher short-term mortality can be seen only in women with STEMI and age of 65 or less.

Effects of glucose-insulin-potassium infusion on ST-elevation myocardial infarction in patients treated with thrombolytic therapy.

The role of glucose-insulin-potassium (GIK) infusion in the management of acute myocardial infarction is not well established. This prospective, randomized study comprised 120 patients who had ST-elevation myocardial infarction that was treated within 12 hours from symptom onset with a high dose of GIK (25% glucose, 50 IU of soluble insulin per liter, and 80 mmol of potassium chloride per liter at 1 ml/kg/hour over 24 hours) as adjunct to thrombolytic therapy (1.5 MU of streptokinase/30 to 60 minutes; GIK group) or thrombolytic therapy alone (control group). The primary end point of the study was the rate of major adverse cardiac events (MACEs) at 1 month, defined as a composite of cardiac death, reinfarction, serious arrhythmias (ventricular fibrillation and/or tachycardia), and severe heart failure. The secondary end points were the rate of MACEs at 1 year and improvement in left ventricular systolic function. The incidence of MACEs at 1 month was significantly lower in the GIK group (10% vs 32.5%, relative risk 0.24, 95% confidence interval 0.09 to 0.63, p = 0.0043). Patients in the GIK group had significant decreases in ventricular tachycardia and/or fibrillation (1.3% vs 15.0%, p = 0.003) and severe heart failure (3% vs 12.5%, p = 0.031). The rate of MACEs at 1 year was also significantly lower in the GIK group (13% vs 40.0%, relative risk 0.22, 95% confidence interval 0.09 to 0.55, p = 0.0012). After 1 year, there was a significant improvement in left ventricular ejection fraction in the GIK group (from 48 +/- 8% to 51 +/- 10%, p <0.01), which was not observed in the control group. In conclusion, high-dose GIK, used as an adjunct to thrombolytic therapy, was safe and improved clinical outcome at 1 month. The beneficial effect of GIK infusion was maintained up to 1 year.

Surgical management of AAST grades III-V hepatic trauma by Damage control surgery with perihepatic packing and Definitive hepatic repair-single centre experience.

BACKGROUND: Severe liver injury in trauma patients still accounts for significant morbidity and mortality. Operative techniques in liver trauma are some of the most challenging. They include the broad and complex area, from damage control to liver resection. MATERIAL AND METHOD: This is a retrospective study of 121 trauma patients with hepatic trauma American Association for Surgery of Trauma (AAST) grade III-V who have undergone surgery. Indications for surgery include refractory hypotension not responding to resuscitation due to uncontrolled hemorrhage from liver trauma; massive hemoperitonem on Focused assessment by ultrasound for trauma (FAST) and/or Diagnostic peritoneal lavage (DPL) as well as Multislice Computed Tomography (MSCT) findings of the severe liver injury and major vascular injuries with active bleeding. RESULTS: Non-survivors have significantly higher AAST grade of liver injury and higher Injury Severity Score (ISS) (p = 0.000; p = 0.0001). Non-survivors have significant hypotension on arrival and lower Glasgow Coma Scale (GCS) on admission (p = 0.000; p = 0.0001). Definitive hepatic repair was performed in 62(51.2 %) patient. Damage Control, liver packing and planned re-laparotomy after 48 h were used in 59(48.8 %). There was no statistically significant difference in terms of the surgical approach. There was significant difference in the amount of red blood cells (RBC) transfusion in the first 24 h between survivors and non-survivors (p = 0.001). Overall mortality rate was 33.1 %. Regarding complications non-survivors had significantly prolonged bleeding and higher rate of Acute respiratory distress syndrome (ARDS) (p = 0.0001; p = 0.0001), while survivors had significantly higher rate of pleural effusion (p = 0.0001). CONCLUSION: All efforts in the treatment of severe liver injuries should be directed to the rapid and effective control of bleeding, because uncontrollable hemorrhage is the cause of early death and it requires massive blood transfusion, all of which contributes to the late fatal complication.