Reviews on Recent Clinical Trials - Volume 14, Issue 2, 2019

Background: Cardiovascular disease is the most common cause of morbidity and mortality worldwide, with ischemic heart disease (IHD) accounting for roughly 50% of these events in industrialized nations. In recent years, the relative importance of IHD in less industrialized countries is also rising at an alarming and steadily-increasing rate. Objectives: Many experimental, observational and epidemiological studies have demonstrated the importance of psychosocial risk factors in the development and clinical manifestations of IHD. They act both indirectly, associated with an unhealthy lifestyle; and directly, through the activation of inflammatory cascades and the sympathetic nervous system. They also cluster with biological risk factors to increase the incidence and clinical manifestations of IHD. From these assumptions, there emerges the potential that an integrated approach that incorporates psychological therapy in various forms might reduce IHD patients’ symptoms and maladaptive behaviors, and thereby enhance their prognosis. Methods: To date, three psychotherapeutic approaches have been utilized within cardiac psychology practice: (1) cognitive-behavioral psychotherapy; (2) psychodynamic psychotherapy; and (3) ontopsychological psychotherapy. The current article briefly describes these three approaches and how their use might enhance the care of IHD patients. Results: A range of psychological characteristics influence the development, course and management of cardiac patients’ IHD. Among others, these include patients’ emotions, attitudes, behaviors, relationships, and stressors. State-of- the-art literature suggests that psychological interventions should be considered in much the same way as medical interventions, in terms of their relevance to both patient management and outcomes. Conclusion: For this reason, it is essential that professional psychological and psychotherapeutic support be rendered available to cardiology patients, as a means to enhance both the effectiveness and efficiency of care.

Background: Several risk factors have been empirically linked to an increased risk of cardiovascular disease. Some of them are therapeutically amenable to modification; while others are not. Modifiable risk factors include physical inactivity, tobacco use, diet, “bad fats” in the blood, hypertension, and being overweight; while non-modifiable risk factors include the patient’s family history, the presence versus absence of diabetes mellitus, and demographic characteristics like age, gender, ethnicity, and socio-economic status. Methods: In this article, we review those risk factors that are both clinically important and amenable to change. Conclusion: To prevent cardiovascular disease, it is important to minimize modifiable risk factors, like LDL cholesterol.

Introduction: Ischemic heart diseases are the major leading cause of death worldwide. Revascularization procedures dramatically reduced the overall risk for death related to acute coronary syndromes. Two kinds of myocardial revascularization can grossly be outlined: percutaneous coronary intervention (PCI) and surgical coronary artery bypass graft intervention (CABG). The net clinical benefit coming from these two kinds of procedures is still under debate. Methods: We have traced the state-of-the-art background about myocardial revascularization procedures by comparing the most important trials dealing with the evaluation of percutaneous interventions versus a surgical approach to coronary artery diseases. Results: Both PCI and CABG have become effective treatments for revascularization of patients suffering from advanced CAD. The advance in technology and procedural techniques made PCI an attractive and, to some extent, more reliable procedure in the context of CAD. However, there are still patients that cannot undergo PCI and have to be rather directed towards CABG. Conclusion: CABG still remains the best strategy for the treatment of multiple vessel CAD due to improved results in term of survival and freedom from reintervention. Anyway, a systematic, multidisciplinary approach to revascularization is the fundamental behaviour to be chased in order to effectively help the patients in overcoming its diseases. The creation of the “heart team” seems to be a good option for the correct treatment of patients suffering from stable and unstable CAD.

Background: Coronary artery bypass grafting (CABG) remains the standard of care for patients with coronary artery disease (CAD). Debate exists concerning several factors, which include percutaneous coronary intervention (PCI) vs. CABG, single vs. bilateral mammary artery grafts, radial artery vs. saphenous vein grafts, right internal mammary artery vs. radial artery grafts, endoscopic vs. open vein-graft harvesting, and on-pump vs. off- pump surgery. Moreover, challenging is the management of diabetic patients with CAD undergoing CABG. This review reports current indications, practice patterns, and outcomes of CABG. Methods: Randomized controlled trials comparing CABG to other therapeutical strategies for CAD were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. Results: Large multicenter randomized and observational studies (SYNTAX, BEST, PRECOMBAT, ASCERT) have reported excellent outcomes in CABG patients, with always fewer rates of operative mortality and major morbidity, than PCI. The 10-year follow-up of ARTS II trial showed no difference between single and bilateral mammary artery. BARI 2D, MASS II, CARDia, FREEDOM trials showed that CABG is the best choice for diabetic patients. Conclusion: CABG still represents one of the most widespread major surgeries, with well-known benefits on symptoms and prognosis in patients with CAD. However, further studies and follow-up data are needed to validate these evidences.

Background: Before the advent of CABG, standardized in the late '60s by Favaloro and Effler, patients with myocardial ischemia underwent indirect and heterogeneous off-pump methods of myocardial revascularization. Methods & Results: Indirect revascularization, such as periaortic nerve plexus interruption, Vineberg operation, Sen procedure and, less remotely, TMR Laser and stem cell transplantation, represented some of the ways to achieve myocardial revascularization. Nowadays, direct coronary revascularization is the only established technique and may be performed either on-pump or off-pump. Conclusion: The comparison of off-pump and on-pump myocardial revascularization paved the way to an endless debate between the advantages and disadvantages of each technique. In this article, we review the old and current off-pump approaches of surgical myocardial revascularization.

Background: Lung cancer is the leading cause of cancer mortality, being responsible for more than 1.6 million deaths each year worldwide and non-small-cell lung cancer (NSCLC) accounts for approximately 85% of lung cancers; moreover, 10 to 15% of all NSCLCs harbor EGFR (epidermal growth factor receptor) activating mutations, being suitable for EGFR-Tyrosine Kinase Inhibitors (TKI) molecular targeted therapy. However, EGFR+ NSCLCs gain acquired resistance to these agents, representing one of the key challenges for modern precision oncology. Objective: Therefore, this paper aims to provide an extensive state of the art review, alongside with hints about future perspectives. Conclusion: To date, in the light of the data from the FLAURA study, osimertinib represents the best first-line option in NSCLC patients with EGFR activating mutations; EGFR-TKI plus chemotherapy combination therapies, even though interesting, must still be considered investigational.

Introduction: Historically, spontaneous bacterial peritonitis (SBP) has represented one of the most frequent and relevant infectious complications of advanced liver disease, and this is still valid today. Nevertheless, in recent years the role of fungi as causative pathogens of primary peritonitis in patients with cirrhosis has become not negligible. Another issue is linked with the traditional distinction, instrumental in therapeutic choice, between community-acquired and nosocomial forms, according to the onset. Between these two categories, another one has been introduced: the so-called “healthcare-associated infections”. Objective: To discuss the most controversial aspects in the management of SBP nowadays in the light of best available evidence. Methods: A review of recent literature through MEDLINE was performed. Results: The difference between community-acquired and nosocomial infections is crucial to guide empiric antibiotic therapy, since the site of acquisition impact on the likelihood of multidrug-resistant bacteria as causative agents. Therefore, third-generation cephalosporins cannot be considered the mainstay of treatment in each episode. Furthermore, the distinction between healthcare-associated and nosocomial form seems very subtle, especially in areas wherein antimicrobial resistance is widespread, warranting broad-spectrum antibiotic regimens for both. Finally, spontaneous fungal peritonitis is a not common but actually underestimated entity, linked to high mortality. Especially in patients with septic shock and/or failure of an aggressive antibiotic regimen, the empiric addition of an antifungal agent might be considered. Conclusion: Spontaneous bacterial peritonitis is one of the most important complications in patients with cirrhosis. A proper empiric therapy is crucial to have a positive outcome. In this respect, a careful assessment of risk factors for multidrug-resistant pathogens is crucial. Likewise important, mostly in nosocomial cases, is not to overlook the probability of a fungal ascitic infection, namely a spontaneous fungal peritonitis.

Background: Mitral stenosis is one of the most commonly encountered valvular heart diseases during pregnancy, the majority are rheumatic in origin and poorly tolerated due to cardiocirculatory changes that occur during pregnancy, labor and postpartum. Objective: The distinctive physiological events that arise during pregnancy and labor and the influence of mitral stenosis are tackled in this article. Methods: Through PUBMED and MEDLINE searches, we reviewed the literature of the last decade as well as the recommendations from guidelines of high-impact worldwide. Results: Cardiac decompensation usually takes place late in pregnancy as the hemodynamic burden of pregnancy become more pronounced as well as after delivery due to an abrupt increase of preload secondary to autotransfusion and aorto-caval decompression. The maternal and fetal complications correlate with the New York Heart Association (NYHA) functional classification and the grade of mitral stenosis. Medical therapy should be tried first. If symptoms continue in spite of optimal medical therapy, invasive procedures are recommended. Several studies revealed that vaginal delivery under epidural anesthesia is endurable and of low-risk unless obstetrically contraindicated. Conclusion: Pregnancy and mitral stenosis remain a complex entity and a well-known trigger of maternal mortality during pregnancy and peri-partum period if not managed adequately. A good appreciation and recognition of the physiology of pregnancy and its impact on the pre-existing mitral stenosis and the presence of a specialized multidisciplinary team to handle such cases significantly decrease maternal and fetal mortality and morbidity.

Background: Laparoscopic Incisional and Ventral Hernia Repair (LIVHR) is a safe and worldwide accepted procedure performed using absorbable tacks. The aim of the study was to evaluate recurrence rate in a long term follow-up and whether the results of laparoscopic IVH repair in the elderly (≥65 years old) are different with respect to results obtained in younger patients. Methods: One hundred and twenty-nine consecutive patients (74 women and 55 men, median age 67 years, range = 30-87 years) with ventral (N = 42, 32.5%) or post incisional (N = 87, 67.5%) hernia were enrolled in the study. Patients were divided into two groups according to their age: group A (N = 55, 42.6%) aged <65 years and group B (N = 74, 57.4%) aged ≥65 years. Results: The mean operative time was not significantly different between groups (66.7 ± 37 vs. 74 ± 48.4 min, p = 0.4). To the end of 2016, seven recurrences had occurred (group A = 3, group B = 4, p = 1). Complications occurred in 8 (16%) patients in group A and 21 (28.3%) patients in group B. Conclusion: In conclusion, our results confirm that the use of absorbable tacks does not increase recurrence frequency and laparoscopic incisional and ventral repair is a safety procedure also in elderly patients.

Introduction: Urinary tract infections (UTIs) are among the most common bacterial infections, affecting 150 million people worldwide each year. Importantly, the incidence of UTI increases markedly with age. The increasing resistance to empirically prescribed antimicrobial agents complicates the management of this disease. This makes UTI an important issue in increasingly aging population and updated epidemiological investigation is advisable. To understand the epidemiological variation in UTI resistance patterns among differently aged populations, we conducted a retrospective study among patients presenting to the emergency department (ED) of a large tertiary-care hospital in Italy during January 2013 and June 2017. Methods: 1281 patients who presented with UTI symptoms to the ED, were stratified into four age categories: young adults (18-44 years old;), adults (45-64), the elderly (65-84), and the oldest old (≥ 85). Inclusion criteria were urine collected in ED patients with UTI symptoms and first positive culture from one given patient in a given year. Results: 362 (28.2%) patients had a urine culture with positive result, leading to a total of 459 germs isolated, stratified into four categories: young adults (58 isolates, 12.6%), adults (98, 21.4%), the elderly (174, 37.9%), and the oldest old (129, 28.1%). Escherichia coli represents the 60% of all monomicrobial infections, followed in frequency by Klebsiella pneumoniae (15%), and Enterococcus faecalis (5%). The other 20% of the infections are caused by various germs. The most common association of germs in polymicrobial is E. coli + E. faecalis, accounting for the 28% of all infections. Overall, we found a peak of susceptibility to amoxicillin (AMX) in the oldest old ( 81%), significantly higher compared to young adults (54%), adults (47%) and elderly (35%) (p<0,001). For ciprofloxacin (CIP) there is a greater susceptibility in the young adult (55.5%), but not so marked compared to the other three groups; for fosfomicin (FOS) the susceptibility was greater in the group of adults (60%) compared to young adults, elderly and the oldest old. Also for trimethoprim/ sulfamethoxazole (TMP-SMX) we found greater susceptibility in the adult group (60%), followed by the oldest old (57,6%), young adults (49%) and elderly (47%). Conclusion: Age-related differences in antimicrobial-resistant microorganisms were evident for adults with UTI, and could potentially contribute to the risk of inappropriate empirical therapy in elderly patients. Thus, different empirical antimicrobial regimens should be considered for distinct age groups.