Impact of Aldosterone Antagonists on Sudden Cardiac Death Prevention in Heart Failure and Post-Myocardial Infarction Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND AND OBJECTIVES: Sudden cardiac death (SCD) is a severe burden of modern medicine. Aldosterone antagonist is publicized as effective in reducing mortality in patients with heart failure (HF) or post myocardial infarction (MI). Our study aimed to assess the efficacy of AAs on mortality including SCD, hospitalization admission and several common adverse effects. METHODS: We searched Embase, PubMed, Web of Science, Cochrane library and clinicaltrial.gov for randomized controlled trials (RCTs) assigning AAs in patients with HF or post MI through May 2015. The comparator included standard medication or placebo, or both. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Event rates were compared using a random effects model. Prospective RCTs of AAs with durations of at least 8 weeks were selected if they included at least one of the following outcomes: SCD, all-cause/cardiovascular mortality, all-cause/cardiovascular hospitalization and common side effects (hyperkalemia, renal function degradation and gynecomastia). RESULTS: Data from 19,333 patients enrolled in 25 trials were included. In patients with HF, this treatment significantly reduced the risk of SCD by 19% (RR 0.81; 95% CI, 0.67-0.98; p = 0.03); all-cause mortality by 19% (RR 0.81; 95% CI, 0.74-0.88, p<0.00001) and cardiovascular death by 21% (RR 0.79; 95% CI, 0.70-0.89, p<0.00001). In patients with post-MI, the matching reduced risks were 20% (RR 0.80; 95% CI, 0.66-0.98; p = 0.03), 15% (RR 0.85; 95% CI, 0.76-0.95, p = 0.003) and 17% (RR 0.83; 95% CI, 0.74-0.94, p = 0.003), respectively. Concerning both subgroups, the relative risks respectively decreased by 19% (RR 0.81; 95% CI, 0.71-0.92; p = 0.002) for SCD, 18% (RR 0.82; 95% CI, 0.77-0.88, p < 0.0001) for all-cause mortality and 20% (RR 0.80; 95% CI, 0.74-0.87, p < 0.0001) for cardiovascular mortality in patients treated with AAs. As well, hospitalizations were significantly reduced, while common adverse effects were significantly increased. CONCLUSION: Aldosterone antagonists appear to be effective in reducing SCD and other mortality events, compared with placebo or standard medication in patients with HF and/or after a MI.

Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study.

PURPOSE: This multicenter phase III study evaluated the efficacy and safety of lapatinib, an epidermal growth factor receptor/ErbB2 inhibitor, administered concomitantly with chemoradiotherapy and as maintenance monotherapy in patients with high-risk surgically treated squamous cell carcinoma of the head and neck (SCCHN). PATIENTS AND METHODS: Patients with resected stage II to IVA SCCHN, with a surgical margin ≤ 5 mm and/or extracapsular extension, were randomly assigned to chemoradiotherapy (66 Gy total radiation dose and cisplatin 100 mg/m(2) per day administered on days 1, 22, and 43) plus placebo or lapatinib (1,500 mg per day) before and during chemoradiotherapy, followed by 12 months of maintenance monotherapy. RESULTS: Six hundred eighty-eight patients were enrolled (lapatinib, n = 346; placebo, n = 342). With a median follow-up time of 35.3 months, the study ended early because of the apparent plateauing of disease-free survival (DFS) events. Median DFS assessed by an independent review committee was 53.6 months and not reached for lapatinib and placebo, respectively (hazard ratio, 1.10; 95% CI, 0.85 to 1.43). Investigator-assessed results confirmed the independent review committee assessment. No significant differences in DFS by human papillomavirus status or overall survival were observed between treatment arms. Similar numbers of patients in both treatment arms experienced adverse events (AEs), with more patients in the lapatinib arm than the placebo arm experiencing serious AEs (48% v 40%, respectively). The most commonly observed treatment-related AEs were diarrhea and rash, both predominantly in the lapatinib arm. CONCLUSION: Addition of lapatinib to chemoradiotherapy and its use as long-term maintenance therapy does not offer any efficacy benefits and had additional toxicity compared with placebo in patients with surgically treated high-risk SCCHN.

Optimization of OSEM parameters in myocardial perfusion imaging reconstruction as a function of body mass index: a clinical approach

AbstractObjective:The present study is aimed at contributing to identify the most appropriate OSEM parameters to generate myocardial perfusion imaging reconstructions with the best diagnostic quality, correlating them with patients' body mass index.Materials and Methods:The present study included 28 adult patients submitted to myocardial perfusion imaging in a public hospital. The OSEM method was utilized in the images reconstruction with six different combinations of iterations and subsets numbers. The images were analyzed by nuclear cardiology specialists taking their diagnostic value into consideration and indicating the most appropriate images in terms of diagnostic quality.Results:An overall scoring analysis demonstrated that the combination of four iterations and four subsets has generated the most appropriate images in terms of diagnostic quality for all the classes of body mass index; however, the role played by the combination of six iterations and four subsets is highlighted in relation to the higher body mass index classes.Conclusion:The use of optimized parameters seems to play a relevant role in the generation of images with better diagnostic quality, ensuring the diagnosis and consequential appropriate and effective treatment for the patient.

Simultaneous acute pulmonary embolism and isolated septal myocardial infarction in a young patient

While the overall incidence of myocardial infarction (MI) has been decreasing since 2000 [1], there is an increasing number of younger patients presenting with MI [2]. Few studies have focused on MI in very young patients, aged 35 years or less, as they only account for a minority of all patients with myocardial infarction [3]. According to the age category, MI differs in presentation, treatment and outcome, as illustrated in table 1. Echocardiography is considered mandatory according to scientific guidelines in the management and diagnosis of MI [4,5,6]. However, new imaging techniques such as cardiac magnetic resonance (CMR) and computed tomography (CT) are increasingly performed and enable further refinement of the diagnosis of MI. These techniques allow, in particular, precise location and quantification of MI. In this case, MI was located to the septum, which is an unusual presentation of MI. The incidence of pulmonary embolism (PE) has also increased in young patients over the past years [7]. Since symptoms and signs of PE may be non-specific, establishing its diagnosis remains a challenge [8]. Therefore, PE is one of the most frequently missed diagnosis in clinical medicine. Because of the widespread use of CT and its improved visualization of pulmonary arteries, PE may be discovered incidentally [9]. In the absence of a congenital disorder, multiple and/or simultaneous disease presentation is uncommon in the young. We report the rare case of a 35 year old male with isolated septal MI and simultaneous PE. The diagnosis of this rare clinical entity was only possible by means of newer imaging techniques.

A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trial?.

AIMS: Clinical trials suggest that intracoronary delivery of autologous bone marrow-derived cells (BMCs) 1-7 days post-acute myocardial infarction (AMI) may improve left ventricular (LV) function. Earlier time points have not been evaluated. We sought to determine the effect of intracoronary autologous BMC on LV function when delivered within 24 h of successful reperfusion therapy. METHODS AND RESULTS: A multi-centre phase II randomized, double-blind, and placebo-controlled trial. One hundred patients with anterior AMI and significant regional wall motion abnormality were randomized to receive either intracoronary infusion of BMC or placebo (1:1) within 24 h of successful primary percutaneous intervention (PPCI). The primary endpoint was the change in left ventricular ejection fraction (LVEF) between baseline and 1 year as determined by advanced cardiac imaging. At 1 year, although LVEF increased compared with baseline in both groups, the between-group difference favouring BMC was small (2.2%; 95% confidence interval, CI: -0.5 to 5.0; P = 0.10). However, there was a significantly greater myocardial salvage index in the BMC-treated group compared with placebo (0.1%; 95% CI: 0.0-0.20; P = 0.048). Major adverse events were rare in both treatment groups. CONCLUSION: The early infusion of intracoronary BMC following PPCI for patients with AMI and regional wall motion abnormality leads to a small non-significant improvement in LVEF when compared with placebo; however, it may play an important role in infarct remodelling and myocardial salvage. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT00765453 and EudraCT 2007-002144-16.

Anoxic-ischemic encephalopathy: association of predictors with the vital and functional prognosis of patients

Improve the prediction of the vital and functional prognosis of comatose patients suffering from anoxic-ischemic encephalopathy after successful resuscitation from a cardiac arrest, addmitted to the Intensive Care and Coronary Units of the Dr. Josep Trueta Hospital, based on clinical, neurophysiological and biochemical results.The results of these different tests, revised and combined all together, will improve the prediction of the patients' prognosis, leading to an accurate vital and functional outcome, as they only have been studied separately so far. Anoxia is the third most frequent cause of coma, and the most common cause of post-anoxic coma in adults is the cardiac arrest. The incidence of hypoxic-ischemic brain injury is not well known, but it is certain that cardiac arrest, the most common cause of post-anoxic coma, affects approximately 24000 to 50000 Spanish people every year, most of them occuring out of the hospital. A cardiac arrest is the abrupt cessation of normal circulation of the blood due to failure of the heart to contract effectively during systole. It is different from, but may be caused by, a heart attack or myocardial infarction, where blood flow to the still-beating heart is interrupted. Arrested blood circulation prevents delivery of oxygen to all parts of the body. Cerebral hypoxia, or lack of oxygen supply to the brain, causes victims to lose consciousness and to stop normal breathing, although agonal breathing may still occur. Brain injury is likely if cardiac arrest is untreated for more than five minutes

Efficacy of methotrexate to prevent postoperative recurrence of Crohn's disease

BACKGROUND: endoscopic postoperative recurrence (POR) of Crohn’s disease (CD) is the presence of lesions in previously unaffected intestinal segments and occurs in up to 85% of patients one year after bowel resection. Patients at low risk for POR can either remain untreated until lesions recur or receive immediate prevention after surgery with mesalazine, azathioprine (AZA) and/or metronidazole, although with moderate benefit. Out of the postoperative setting, methotrexate (MTX) has been shown to be efficacious for induction and maintenance of remission and has been established as the second-line immunosuppressant for patients with CD unresponsive or intolerant to AZA.AIMS: to determine the efficacy and safety of MTX to prevent endoscopic and clinical POR at 24 weeks after surgery in low risk patientsMETHODS: the study consists on a multicenter, randomized, double-blind and placebo-controlled clinical trial that will enroll 132 patients at low risk for POR (non-smokers, first intestinal resection, non-penetrating behavior). Patients will be randomized to receive subcutaneous MTX at doses of 25 mg/week or an identical placebo, for 24 weeks. Endoscopic and clinical assessment of POR will be performed after 24 weeks (6 months) of treatment. The main outcome is endoscopic POR, defined as a Rutgeerts score of >i2, and secondary outcomes include clinical POR, defined as >i2 lesions plus a Crohn’s Disease Activity Index (CDAI) >150, and description of adverse events

Prehospital ticagrelor in ST-segment elevation myocardial infarction

Background:The direct-acting platelet P2Y receptor antagonist ticagrelor can reduce the incidence of major adverse cardiovascular events when administered at hospital admission to patients with ST-segment elevation myocardial infarction (STEMI). Whether prehospital administration of ticagrelor can improve coronary reperfusion and the clinical outcome is unknown. Methods: We conducted an international, multicenter, randomized, double-blind study involving 1862 patients with ongoing STEMI of less than 6 hours' duration, comparing prehospital (in the ambulance) versus in-hospital (in the catheterization laboratory) treatment with ticagrelor. The coprimary end points were the proportion of patients who did not have a 70% or greater resolution of ST-segment elevation before percutaneous coronary intervention (PCI) and the proportion of patients who did not have Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography. Secondary end points included the rates of major adverse cardiovascular events and definite stent thrombosis at 30 days. Results: The median time from randomization to angiography was 48 minutes, and the median time difference between the two treatment strategies was 31 minutes. The two coprimary end points did not differ significantly between the prehospital and in-hospital groups. The absence of ST-segment elevation resolution of 70% or greater after PCI (a secondary end point) was reported for 42.5% and 47.5% of the patients, respectively. The rates of major adverse cardiovascular events did not differ significantly between the two study groups. The rates of definite stent thrombosis were lower in the prehospital group than in the in-hospital group (0% vs. 0.8% in the first 24 hours; 0.2% vs. 1.2% at 30 days). Rates of major bleeding events were low and virtually identical in the two groups, regardless of the bleeding definition used

Therapeutic Properties of Superoxide Dismutase 3 and Mesenchymal Stromal Cells in Peripheral Ischemia

The aim of this study was to characterize the cellular mechanisms leading to the beneficial effect of anti-oxidative gene therapy and pro-angiogenic stem cell therapy in acute peripheral ischemia. Post-ischemic events aim to re-establish tissue blood perfusion, to clear cellular debris, and to regenerate lost tissue by differentiation of satellite cells into myoblasts. Although leukocytes have an essential role in clearing cellular debris and promoting angiogenesis, they also contribute to tissue injury through excessive ROS production. First, we investigated the therapeutic properties of extracellular superoxide dismutase (SOD3) gene transfer. SOD3 was shown to reduce oxidative stress, to normalize glucose metabolism, and to enhance cell proliferation in the ischemic muscle. Analysis of the mitogenic Ras-Erk1/2 pathway showed SOD3 mediated induction offering a plausible explanation for enhanced cell proliferation. In addition, SOD3 reduced NF-κB activity by enhancing IκBα expression thus leading to reduced expression of inflammatory cytokines and adhesion molecules with consequent reduction in macrophage infiltration. Secondly, we sought to determine the fate and the effect of locally transplanted mesenchymal stem/stromal cells (MSCs) in acute ischemia. We showed that a vast majority of the transplanted cells are cleared from the injury site within 24 hours after local transplantation. Despite rapid clearance, transplantation was able to temporarily promote angiogenesis and cell proliferation in the muscle. Lack of graft-derived growth factor expression suggests other than secretory function to mediate this observed effect. In conclusion, both SOD3 and MSCs could be utilized to alleviate peripheral ischemia induced tissue injury. We have described a previously unidentified growth regulatory role for SOD3, and suggest a novel mechanism whereby transplanted MSCs enhance the reparative potential of the recipient tissue through physical contacts.

Nurse-led interpersonal counselling for depressive symptoms in patients with myocardial infarction

The broad interest of this intervention study is in two worldwide remarkable diseases, myocardial infarction and depression. The purpose of the 18-month follow-up study was to evaluate the outcomes of interpersonal counselling implemented by a psychiatric nurse, and to examine the recovery experienced by the patients after myocardial infarction. The interpersonal counseling consisted of a short-term (max 6 sessions) depression-focused intervention modified for myocardial infarction patients. The main principle of interpersonal counselling is that depressive symptoms relate to interpersonal relations. The measured outcomes of the intervention consisted of changes in depressive symptoms and distress, health-related quality of life and the use of health care services. The data consisted of 103 patients with acute myocardial infarction and with sufficient knowledge of Finnish language, and they were randomized into intervention group (n=51) and control group (n=52) with standard care. Depressive symptoms were measured using Beck Depression Inventory, and distress using Symptom Checklist-25. The instrument to measure health-related quality of life was EuroQol-5 Dimensions. All instruments were used at three measurements: in hospital, at 6 months and at 18 months after hospital discharge. The Use of Health Care Services questionnaire was used during the 6- and 18-month period after hospital discharge. In addition, satisfaction with the intervention and with information received from the health-care professional was evaluated during the follow-up. To examine recovery, the patients kept diaries during a 6-month period and they were interviewed at 18 months after myocardial infarction. The number of patients with depressive symptoms decreased significantly more in the intervention group compared with the control group during 18 months of follow-up. Distress decreased significantly more among patients under 60 years in the intervention group than in the control group, but the difference was not significant between the groups. No differences in the changes of health-related quality of life were found between the groups during follow-up. However, in the group of patients under 60 years, the improvement of health-related quality of life in the intervention was significantly better in the intervention group compared with the control group during the follow-up. During the follow-up period, there was even a decline in the use of somatic specialized health care services in the intervention group and among intervention patients who had no other long-term disease. Considering recovery experienced by the patients, main categories including many supporting and inhibiting factors and subcategories were identified: clinical and physical, psychological, social, functional and professional category. No differences between the groups were found in satisfaction with information received from the professionals. The brief and easy-to-learn intervention, with which the patients were satisfied, seems to decrease depressive symptoms after myocardial infarction. Interpersonal counselling seems to be beneficial especially with younger patients. These results justify adopting depression screening and interpersonal counselling as part of routine care after myocardial infarction. The first stage evaluation of the use of health care services is interesting, and calls for more studies. From the perspective of individual patients, recovery after myocardial infarction seems to consist of many supporting and inhibiting factors. This is something that is important to take into account in developing nursing practice. The results indicate a need for further studies in outcomes of interpersonal counselling and recovery experienced by the patients after myocardial infarction. In addition, the results encourage widening the research perspective to nursing administration and educational level.

Postoperative topical analgesia of hemorrhoidectomy with policresulen and cinchocaine: a prospective and controlled study

OBJECTIVE: To evaluate the effects of topical policresulen and cinchocaine in the postoperative pain behavior of open hemorrhoidectomy.METHODS: We conducted a prospective, double-blinded, controlled study. The control group received the usual guidelines with oral medications. The topical treatment group received, in addition, the application of the ointment and was comprised of two subgroups (policresulen + cinchocaine, and placebo). Pain intensity was recorded with the visual analogue scale.RESULTS: 43 patients were operated on: control group - n = 13, one excluded; placebo - n = 15; and policresulen + cinchocaine - n = 15. The mean age was 45.98 years and 37.2% were men. The average pain intensity was 4.09 (immediate postoperative), 3.22 (hospital discharge), 5.73 (day 1) , 5.77 (day 2), 5.74 (day 3), 5.65 (day 7), 5.11 (day 10), 2.75 (day 15) and 7.70 (first bowel movement), with no difference between groups in all periods.CONCLUSION: This study showed no reduction in pain after hemorrhoidectomy with the use of topical policresulen and cinchocaine.

The cost of excessive postoperative use of antimicrobials: the context of a public hospital

OBJECTIVE: To evaluate the improper use of antimicrobials during the postoperative period and its economic impact.METHODS: We conducted a prospective cohort study by collecting data from medical records of 237 patients operated on between 01/11/08 and 31/12/08.RESULTS: from the 237 patients with the information collected, 217 (91.56%) received antimicrobials. During the postoperative period, 125 (57.7%) patients received more than two antimicrobials. On average, 1.7 ± 0.6 antimicrobials were prescribed to patients, the most commonly prescribed antibiotic being cephalothin, in 41.5% (154) of cases. The direct cost of antimicrobial therapy accounted for 63.78% of all drug therapy, this large percentage being attributed in part to the extended antimicrobial prophylaxis. In the case of clean operations, where there was a mean duration of 5.2 days of antibiotics, antimicrobials represented 44.3% of the total therapy cost.CONCLUSION: The data illustrate the impact of overuse of antimicrobials, with questionable indications, creating situations that compromise patient safety and increasing costs in the assessed hospital.

Atenolol prevents the formation of expansive hematoma after rhytidoplasty

Objective: To evaluate the perioperative use of atenolol in reducing the incidence of hematoma after rhytidoplasty.Methods: Between January 2007 and February 2013, 80 patients were randomized into two groups: Group A (n = 26) received perioperative atenolol in order to maintain heart rate (PR) around 60 per minute; Group B (n = 54) did not receive atenolol. Both groups underwent the same anesthetic and surgical technique. We monitored blood pressure (BP), HR, hematoma formation and the need for drainage. Patients were followed-up until the 90th postoperative day. The variables were compared between the groups using the ANOVA test. Continuous variables were presented as mean ± standard deviation and the differences were compared with the Student's t test. Values of p d" 0.05 were considered significant.Results: In group A the mean BP (110-70mmHg ± 7.07) and HR (64 / min ± 5) were lower (p d" 0.05) than in group B (135-90mmHg ± 10.6) and (76 / min ± 7.5), respectively. There were four cases of expansive hematoma in group B, all requiring reoperation for drainage, and none in group A (p d" 0,001).Conclusion: The perioperative use of atenolol caused a decrease in blood pressure and heart rate and decreased the incidence of expanding hematoma after rhytidectomy.

Safety and tolerability of controlled-release oxycodone on postoperative pain in patients submitted to the oncologic head and neck surgery

Objective: To evaluate the safety and tolerability of controlled-release oxycodone in the treatment of postoperative pain of head and neck oncologic resections.Methods: We conducted a prospective, observational and open study, with 83 patients with moderate to severe pain after head and neck oncological operations. All patients received general anesthesia with propofol, fentanyl and sevoflurane. Postoperatively, should they have moderate or severe pain, we began controlled-release oxycodone 20 mg 12/12 b.i.d on the first day and 10 mg b.i.d. on the second. We assessed the frequency and intensity of adverse effects, the intensity of postoperative pain by a verbal numeric scale and the use of rescue analgesia from 12 hours after administration of the drug and between 7 and 13 days after the last oxycodone dose.Results: The most common adverse events were nausea, vomiting, dizziness, pruritus, insomnia, constipation and urinary retention, most mild. No serious adverse events occurred. In less than 12 hours after the use of oxycodone, there was a significant decrease in the intensity of postoperative pain, which remained until the end of the study. The rescue medication was requested at a higher frequency when the opioid dose was reduced, or after its suspension.Conclusion: Controlled release oxycodone showed to be safe and well tolerated and caused a significant decrease in post-operative pain.

Epidemiological profile and postoperative complications of women undergoing gynecological surgery in a reference center in the northern brazilian legal amazon

Objective: To evaluate the epidemiological profile and the operative complications of patients undergoing gynecological operations for benign diseases in a tertiary public hospital in the state of Roraima, Brazil. Methods: We conducted a retrospective survey through the analysis of 518 records of patients submitted to gynecological operations between January and June 2012. We included the three major operations during this period (n = 175): hysterectomy, colpoperineoplasty and suburethral sling placement. We excluded 236 cases of tubal ligation and 25 cases where it was not possible to access to medical records. Results: The mean age was 47.6 years; the education level of most patients was completed junior high (36.6%); 77% were from the State capital, 47.4% were in stable relationships and 26.3% were housewives. The majority of patients had given birth three or more times (86.6%), with previous vaginal delivery in 50.2%, and cesarean delivery, 21%. The main diagnostic indications for surgical treatment were uterine myoma (46.3%), urinary incontinence (27.4%) and genital dystopias (17.7%). We found three cases (1.7%) of high-grade intraepithelial lesions on Pap smear. The most common procedure was total hysterectomy (19.8%), 15.5% vaginally. The most common complication was wound infection (2.2%). Conclusion: Women undergoing gynecological operations due to benign disease had a mean age of 47 years, most had levels of basic education, came from the capital, were in stable relationships, predominantly housewives, multiparous and showed low operative complication rates.