Evolving from Past to Future: Facilitating SMART research

In clinical research, there has been an increasing need to titrate ethical, legal and insurance requirements to the type of study, so that higher-risk research receives necessary and appropriate detailed attention, while low-risk studies can proceed more rapidly. Spontaneous Medically Advantageous Research Trials (SMART) are non-profit studies that carry minimal or no risk to patients. This type of investigation, however, is currently hampered by the fact that, in many hospitals and jurisdictions it has to undergo the same bureaucratic procedures and safety assessments as high-risk, for-profit studies. We strongly believe that such practice of scientific research assessment should be radically modified. We advocate a new, specific research category for SMART investigations that grants them a preferential route from conception to ethics assessment to execution. In addition, we argue that such low risk studies assessing common, often not evidence-based applied treatments or investigations should in fact be a mandatory component of modern medicine. All clinicians, scientists, patients, patient associations, politicians, scientific associations and common citizens should be involved in this process, as they all play a crucial role in its evolution and success. We contend that modern medical research and entire health systems should transition to a novel model of healthcare system where SMART execution is embedded into daily practice, in order to minimize anecdotal practice and maximize evidence-based practice

Methicillin-Resistant Staphylococcus Species in a cardiac surgical intensive care unit

Objective. Multi-drug resistant bacterial infections, in particular when Methicillin-Resistant Staphylococcus Aureus (MRSA) is involved, have become a relevant problem in both general and specialized intensive care units. The aim of this study was to identify the epidemiology of MRSA infections in a Cardiac Surgical Intensive Care Unit, to assess their impact on mortality and to identify predictors of MRSA infection and mortality in this population. Design and settings. A 7-year observational study in a cardiac surgery teaching center. Participants. Eight thousand, one hundred and sixty-two microbiological samples were obtained from 7,313 patients who underwent cardiac surgery in the study period. Interventions. None. Variables of interest and main results. Twenty-eight patients (0.38%) had MRSA infection. The most frequent site of MRSA isolation was from bronchoalveolar samples. Hospital mortality was 50% in patients with MRSA infection and 2% in patients without MRSA infection (p<0.001). Few preoperative independent predictors of MRSA infection and hospital mortality were found at multivariate analysis. Outcomes were found to be most influenced by perioperative variables. MRSA infection was the strongest predictor of mortality, with an odds ratio of 20.5 (95% CI 4.143-101.626). Conclusions. Methicillin-resistant Staphylococcus aureus infections following cardiac surgery still have a strong impact on the patients’ outcome. More efforts should be directed toward the development of new risk analysis models that might implement health care practices and might become precious instruments for infection prevention and control

Unreported deaths in pediatric surgery and anesthesia: a national, twenty year report

Introduction. Pediatric perioperative mortality is extremely low but it is underreported in peer-reviewed journals, making it difficult to understand the magnitude of the problem. The aim of this study was to identify pediatric deaths reported by the mass media over a 20- year period in pediatric and non-pediatric hospitals. Materials and methods. The international search engines Google, Yahoo, Bing, and the online archives of major newspapers were searched independently by 3 trained investigators (1st January 1995 to 1st January 2015) looking for children (<18 years old) who died in the perioperative period in Italy, excluding obstetrical or neonatal deaths. Results. A total of 51 fatal events were identified with 41 cases (80%) being elective procedures. Most fatal events (31 cases, 61%) occurred in non-specialized hospitals, 12 cases (23%) occurred in high-volume non-pediatric hospitals, and 8 cases (16%) in pediatric hospitals. The most frequently represented operations were head/neck 21 cases (41%), abdominal 11 cases (21%), and orthopedic surgery 9 cases (18%). The reported causes of death were equally distributed between surgical (25 cases, 49%) and anesthesiological complications. The most common causes of death were hemorrhage (n=11), difficult airway management (n=10), infections (n=6), and allergic reactions (n=4). In 25% of cases (13 cases), the complication resulted in intraoperative death. Conclusion. Our findings suggest that most pediatric deaths reported by mass media occurred in non-pediatric centers during elective surgical procedures (e.g. adenotonsillectomy and appendicectomy), suggesting that referral to large-volume or pediatric hospitals should be preferred. Moreover, one of the most commonly reported complications was difficult airway management, confirming that this aspect should have a central role in physician training and practice

Efficacy and Safety of an Acute Pain Service among 10,760 Postoperative Patients

Introduction. Post-operative pain control improves surgical outcome and many hospitals created multidisciplinary teams, called “Acute Pain Services” (APS). We collected APS data on 10,760 adult patients over a five year period, including complications, side effects and patient satisfaction. Methods. Data on patients managed by APS in a high surgical-volume university hospital over a 5-year period were collected and analyzed. Data included demographic characteristics, primary analgesic modality, adjuvant analgesic treatment, type of surgical procedure, Visual Analogue Scale, and analgesia-related side-effects and complications. Results. Patient controlled analgesia with morphine was used in 4,992 surgical patients while epidural analgesia was used in 3,687 surgical patients and 1,670 pregnant women for delivery analgesia. A total of 411 patients received other forms of analgesia. No epidural haematoma was observed. A single case of respiratory depression occurred in an elderly patient using the patient controlled analgesia system. Acetaminophen was the most frequently adjuvant drug prescribed. Postoperative nausea and vomiting was the most frequent analgesia-related side effect. Visual Analogue Scale at rest and on movement was low on day one (0.84±1.15 and 2.05±1.67) and decreased thereafter with epidural analgesia associated with better pain control following hip and liver surgery, and with less postoperative nausea and vomiting (5.0%) when compared to morphine patient controlled analgesia (7.2%). Conclusions. An APS, with daily postoperative visits, permits adequate post-operative pain control without serious adverse events. Epidural analgesia was associated with less postoperative nausea and vomiting and had at least similar pain control than morphine patient controlled analgesia

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The dentist who sat on her chair and lost a leg. N2O?

A 35-year-old female dentist laid on her chair to test an N2O machine, and after only a few minutes of inhaling the N2O, she developed acute pyramidal syndrome. The patient started walking again eight months later, but still suffers from lower limb motor deficit, in spite of intensive rehabilitation. Genetic tests later showed that the patient had Type 3 homocystinuria. This is the first case report of acute neurological toxicity after brief administration of N2O. We suggest starting vitamin B12 and folic acid supplements promptly in patients who experience neurological symptoms after receiving N2O

Efficacy and Safety of an Acute Pain Service among 10,760 Postoperative Patients

Introduction. Post-operative pain control improves surgical outcome and many hospitals created multidisciplinary teams, called “Acute Pain Services” (APS). We collected APS data on 10,760 adult patients over a five year period, including complications, side effects and patient satisfaction. Methods. Data on patients managed by APS in a high surgical-volume university hospital over a 5-year period were collected and analyzed. Data included demographic characteristics, primary analgesic modality, adjuvant analgesic treatment, type of surgical procedure, Visual Analogue Scale, and analgesia-related side-effects and complications. Results. Patient controlled analgesia with morphine was used in 4,992 surgical patients while epidural analgesia was used in 3,687 surgical patients and 1,670 pregnant women for delivery analgesia. A total of 411 patients received other forms of analgesia. No epidural haematoma was observed. A single case of respiratory depression occurred in an elderly patient using the patient controlled analgesia system. Acetaminophen was the most frequently adjuvant drug prescribed. Postoperative nausea and vomiting was the most frequent analgesia-related side effect. Visual Analogue Scale at rest and on movement was low on day one (0.84±1.15 and 2.05±1.67) and decreased thereafter with epidural analgesia associated with better pain control following hip and liver surgery, and with less postoperative nausea and vomiting (5.0%) when compared to morphine patient controlled analgesia (7.2%). Conclusions. An APS, with daily postoperative visits, permits adequate post-operative pain control without serious adverse events. Epidural analgesia was associated with less postoperative nausea and vomiting and had at least similar pain control than morphine patient controlled analgesia

Unreported deaths in pediatric surgery and anesthesia: a national, twenty year report

Introduction. Pediatric perioperative mortality is extremely low but it is underreported in peer-reviewed journals, making it difficult to understand the magnitude of the problem. The aim of this study was to identify pediatric deaths reported by the mass media over a 20- year period in pediatric and non-pediatric hospitals. Materials and methods. The international search engines Google, Yahoo, Bing, and the online archives of major newspapers were searched independently by 3 trained investigators (1st January 1995 to 1st January 2015) looking for children (<18 years old) who died in the perioperative period in Italy, excluding obstetrical or neonatal deaths. Results. A total of 51 fatal events were identified with 41 cases (80%) being elective procedures. Most fatal events (31 cases, 61%) occurred in non-specialized hospitals, 12 cases (23%) occurred in high-volume non-pediatric hospitals, and 8 cases (16%) in pediatric hospitals. The most frequently represented operations were head/neck 21 cases (41%), abdominal 11 cases (21%), and orthopedic surgery 9 cases (18%). The reported causes of death were equally distributed between surgical (25 cases, 49%) and anesthesiological complications. The most common causes of death were hemorrhage (n=11), difficult airway management (n=10), infections (n=6), and allergic reactions (n=4). In 25% of cases (13 cases), the complication resulted in intraoperative death. Conclusion. Our findings suggest that most pediatric deaths reported by mass media occurred in non-pediatric centers during elective surgical procedures (e.g. adenotonsillectomy and appendicectomy), suggesting that referral to large-volume or pediatric hospitals should be preferred. Moreover, one of the most commonly reported complications was difficult airway management, confirming that this aspect should have a central role in physician training and practice

The importance of liver function assessment before cardiac surgery: A narrative review

The demand for cardiac surgery procedures is increasing globally. Thanks to an improvement in survival driven by medical advances, patients with liver disease undergo cardiac surgery more often. Liver disease is associated with the development of heart failure, especially in patients with advanced cirrhosis. Cardiovascular risk factors can also contribute to the development of both cardiomyopathy and liver disease and heart failure itself can worsen liver function. Despite the risk that liver disease and cirrhosis represent for the perioperative management of patients who undergo cardiac surgery, liver function is often not included in common risk scores for preoperative evaluation. These patients have worse short and long-term survival when compared with other cardiac surgery populations. Preoperative evaluation of liver function, postoperative management and close postoperative follow-up are crucial for avoiding complications and improving results. In the present narrative review, we discuss the pathophysiological components related with postoperative complications and mortality in patients with liver disease who undergo cardiac surgery and provide recommendations for the perioperative management

Urinary neutrophil gelatinase-associated lipocalin as an early predictor of prolonged intensive care unit stay after cardiac surgery.

Neutrophil gelatinase-associated lipocalin (NGAL) is a protein of lipocalin family highly expressed in various pathologic states and is an early biomarker of acute kidney injury in cardiac surgery. We performed an observational study to evaluate the role of NGAL in predicting postoperative intensive care stay in high-risk patients undergoing cardiac surgery. We enrolled 27 consecutive patients who underwent high-risk cardiac surgery with cardiopulmonary bypass. Urinary NGAL (uNGAL) was measured before surgery, at intensive care unit (ICU) arrival and 24 h later. Univariate and multivariate predictors of ICU stay were performed. uNGAL was 18.0 (8.7–28.1) ng/mL at baseline, 10.7 (4.35–36.0) ng/mL at ICU arrival and 29.6 (9.65–29.5) 24 h later. The predictors of prolonged ICU stay at the multivariate analysis were body mass index (BMI), uNGAL 24 h after surgery, and aortic cross-clamp time. The predictors of high uNGAL levels 24 h after at a multivariate analysis were preoperative uNGAL and logistic European System for Cardiac Operative Risk Evaluation. At a multivariate analysis the only independent predictors of prolonged ICU stay were BMI, uNGAL 24 h after surgery and aortic cross-clamp time