Cross-sectional evaluation of pharmaceutical care competences in nurse education: how well do curricula prepare students of different educational levels?

BACKGROUND: Nurses play an important role in interprofessional pharmaceutical care. Curricula related to pharmaceutical care, however, vary a lot. Mapping the presence of pharmaceutical care related domains and competences in nurse educational programs can lead to a better understanding of the extent to which curricula fit expectations of the labour market. The aim of this study was to describe 1) the presence of pharmaceutical care oriented content in nursing curricula at different educational levels and 2) nursing students' perceived readiness to provide nurse pharmaceutical care in practice. METHODS: A quantitative cross-sectional survey design was used. Nursing schools in 14 European countries offering educational programs for levels 4-7 students were approached between January and April 2021. Through an online survey final year students had to indicate to what extent pharmaceutical care topics were present in their curriculum. RESULTS: A total of 1807 students participated, of whom 8% had level 4-5, 80% level 6, 12% level 7. Up to 84% of the students indicated that pharmaceutical care content was insufficiently addressed in their curriculum. On average 14% [range 0-30] felt sufficiently prepared to achieve the required pharmaceutical care competences in practice. In level 5 curricula more pharmaceutical care domains were absent compared with other levels. CONCLUSIONS: Although several pharmaceutical care related courses are present in current curricula of level 4-7 nurses, its embedding should be extended. Too many students perceive an insufficient preparation to achieve pharmaceutical care competences required in practice. Existing gaps in pharmaceutical care should be addressed to offer more thoroughly prepared nurses to the labour market.

Efficacy of the BNT162b2 mRNA COVID-19 Vaccine in Patients with Chronic Lymphocytic Leukemia: A Serologic and Cellular Study.

BACKGROUND: Antibody response following SARS-CoV-2 vaccination is somewhat defective in chronic lymphocytic leukemia (CLL). Moreover, the correlation between serologic response and status of cellular immunity has been poorly studied. OBJECTIVE: This study was undertaken to assess humoral immune and cellular responses to the BNT162b2 messenger RNA (mRNA) COVID-19 vaccination in CLL. METHODS: The presence of the spike antibodies was assessed at a median time of 14 days from the second vaccine dose of SARS-CoV-2 in 70 CLL patients followed up at a single institution. RESULTS: The antibody response rate (RR) in CLL patients was 58.5%, compared to 100% of 57 healthy controls of the same sex and age (p < 0.0001). Treatment-naïve patients and those in sustained clinical remission after therapy had the highest RR (87.0% and 87.7%, respectively). In contrast, patients on therapy with a pathway inhibitor as monotherapy and those treated with an association of anti-CD20 antibody were unlikely to respond to the SARS-CoV-2 vaccine (52% and 10%, respectively). In multivariate analysis, early Rai stage (OR, 0.19 [0.05-0.79]; p = 0.02) and no previous therapy (OR, 0.06 [0.02-0.27]; p < 0.0001) were found to be independent predictors of vaccination response. An increase in absolute NK cells (i.e., CD16/CD56 positive cells) in patients with a serological response was found following the second dose of vaccine (p = 0.02). CONCLUSIONS: These results confirm that serological response to the BNT162b2 vaccine in patients with CLL is impaired. A third boosting vaccine dosage should be considered for these patients.

The Italian Multicentre Registry of Fenestrated Anaconda™ Endografts for Complex Abdominal Aortic Aneurysms Repair.

OBJECTIVE: The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR). METHODS: Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up. RESULTS: One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively. CONCLUSION: The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies.

Conservative Management of Uncomplicated Acute Type B Intramural Hematoma of the Aorta Not Always Is the Right Solution.

The natural course of intramural hematoma (IMH) of the aorta remains unpredictable and despite an increasing amount of literature reports its treatment is still debatable. IMH typically is diagnosed by computed tomography that has permitted to identify specific images whose onset, in uncomplicated cases, appears to be associated to a dismal prognosis. We report on a case series of acute uncomplicated type B IMH in which early detection of such findings, given the expected poor prognosis associated to the aorta-related mortality, suggests the need to shift toward an aggressive endovascular aortic repair in this subset of patients.

From surveillance to development of nutritional guidelines.

In Italy, like in most parts of the world, 30% of children and almost 50% of adults are overweight. This condition is one of the causes of non-communicable diseases responsible for over two thirds of DALYs, deaths and costs for healthcare. Current surveys confirm that overweight and obesity are associated with food habits which have changed, in Italy, in the last fifty years. Fewer and fewer people have been following a Mediterranean diet, which is considered an effective diet for the prevention of many diseases. The consumption of fruit, vegetables, legumes, whole cereals, and EVO oil has decreased, while the consumption of food with high energetic density and rich in sugar, salt, and added fat has increased, especially when eating out. Schools and workplaces are the best places to promote healthy food habits and an active lifestyle. The aim is to involve families (including low-income families), educators, and catering services. This type of intervention is not new to the National Health System and has already led to improvements: however, it is still possible to improve the use of resources and coordination between social, educational, and health services bringing the community to become its own health promoter. Health operators have to be more aware of overweight as a health threat. The National Health Plan represents a commitment for Italy, the country hosting EXPO 2015, to fulfill the targets of the «Action Plan European Strategy for the Prevention and Control of Non-communicable Diseases 2012-2016¼ entrusting the Departments of Prevention with the interventions and development of a network of stakeholders.

[Relaunching primary healthcaree]. / Rilanciare l'assistenza primaria.

The health environment today is characterized by diffuse inequalities, the emergence of chronic diseases, and the introduction of new technologies, all of which, together with other factors are leading to a healthcare system that is becoming increasingly less sustainable from a financial point of view. Primary healthcare, public health and hospitals should work together to define a comprehensive healthcare delivery model characterized by continuity of care, information and management. The proposed model of disease management, in particular of chronic diseases, must reorganize health services around the needs of citizens and the community and involve patients and their families in the disease management process, by promoting self-help groups and patient organizations that cooperate with health services. In order to put this change into effect, evidence-based medicine and evidence-based practice need to be adopted. From an organizational point of view, it will be important to change wage rules, so as to implement a new payment system based upon performance. In this new contest, physicians specialized in hygiene and public health can play an important role that includes leadership, governance and coordination. By integrating the concepts of accountability, community intervention and training, we can acquire the tools to change the current hospital-based system to a new model of primary healthcare that works together with the community to move the focus from healthcare provider to patient.

Fasting in critical illness: the role of ketonuria - a retrospective observational study.

BACKGROUND: Metabolic acidosis is a frequent finding in patients admitted to the intensive care unit (ICU). It can be caused by prolonged fasting due to surgical procedures or by medical conditions that lead to starvation ketoacidosis (SKA). Early recognition and treatment of SKA could prevent several life-threatening complications, improving survival and reducing the ICU length of stay. METHODS: We retrospectively screened all medical records of patients admitted to the ICU (Maggiore Hospital, Bologna, North Italy) from May 2022 to April 2023. We included patients aged 18 years or older who presented ketonuria detected in the urine sample. RESULTS: We analyzed 190 patients with ketonuria at ICU admission. Postsurgical patients showed lower levels of albumin and a higher rate of shock compared to medical patients. Ketonuric patients with shock had a lower body mass index (BMI) compared to patients without shock (24 versus 26 kg/m2, respectively). There were no differences within groups regarding mortality and ICU readmission rate. Medical patients had a significantly higher ICU length of stay. CONCLUSIONS: This retrospective observational descriptive study showed that patients with ketonuria, hypoalbuminemia, and low BMI at ICU admission have high risk of hemodynamic instability and shock. Surgical patients compared to medical patients are exposed to a catabolic trigger that could worsen a state of malnutrition and induce anabolic resistance; elective and urgent surgical patients did not differ in terms of risk of shock and mortality, probably due to the activation of this catabolic pathway. Early recognition and treatment of starvation ketoacidosis and perioperative nutritional optimization could reduce incidence of hemodynamic and metabolic complications.

Does COVID-19 vaccination protect against pulmonary embolism?

The prevalence of venous thromboembolism (VTE) in COVID-19 patients is highly variable, depending on methodological and clinical factors, among which vaccination (1). The hypothesis of a possible protective role of vaccination in preventing pulmonary embolism (PE) in hospitalized COVID-19 patients has not been explored. The aim of the study was to evaluate PE prevalence in vaccinated versus unvaccinated hospitalized COVID-19 patients. We conducted a retrospective case-control study from 2021/11/01 to 2022/01/15; we reviewed all the chest computed topographies (chest-CT) performed because of a clinical suspicion for PE at our Institution. Sixty-two patients were included in the study: 27/62 (43.5%) were vaccinated and 35/62 (56.4%) were not. Vaccinated patients were older and with more comorbidities than unvaccinated people. Overall, PE was diagnosed in 19/62 patients (30.1% prevalence). CT Severity Score (CT-SS) differs between the two groups; not vaccinated patients had a more severe CT imaging than the vaccinated (< 0.00005). PE prevalence in ICU was 43.2% (16/37 patients), while in the Internal Medicine ward, it was 12% (3/25 cases). PE was significantly higher among unvaccinated people: 16/35 (45.7%) vs 3/27 (11.1%), OR p = 0.04. We observed a strong association between vaccination and protection from PE in hospitalized COVID-19 patients: morbidity was significantly lower in vaccinated versus not vaccinated patients. The issue of the protective role of vaccination in COVID-19-associated VTE should be addressed in adequately designed and powered future prospective studies.

Optimizing the enzymatic release of MMAE from isoDGR-based small molecule drug conjugate by incorporation of a GPLG-PABC enzymatically cleavable linker.

Antibody-Drug Conjugates (ADCs) and Small Molecule-Drug Conjugates (SMDCs) represent successful examples of targeted drug-delivery technologies for overcoming unwanted side effects of conventional chemotherapy in cancer treatment. In both strategies, a cytotoxic payload is connected to the tumor homing moiety through a linker that releases the drug inside or in proximity of the tumor cell, and that represents a key component for the final therapeutic effect of the conjugate. Here, we show that the replacement of the Val-Ala-p-aminobenzyloxycarbamate linker with the Gly-Pro-Leu-Gly-p-aminobenzyloxycarbamate (GPLG-PABC) sequence as enzymatically cleavable linker in the SMDC bearing the cyclo[DKP-isoDGR] αVß3 integrin ligand as tumor homing moiety and the monomethyl auristatin E (MMAE) as cytotoxic payload led to a 4-fold more potent anti-tumoral effect of the final conjugate on different cancer cell lines. In addition, the synthesized conjugate resulted to be significantly more potent than the free MMAE when tested following the "kiss-and-run" protocol, and the relative potency were clearly consistent with the expression of the αVß3 integrin receptor in the considered cancer cell lines. In vitro enzymatic cleavage tests showed that the GPLG-PABC linker is cleaved by lysosomal enzymes, and that the released drug is observable already after 15 min of incubation. Although additional data are needed to fully characterize the releasing capacity of GPLG-PABC linker, our findings are of therapeutic significance since we are introducing an alternative to other well-established enzymatically sensitive peptide sequences that might be used in the future for generating more efficient and less toxic drug delivery systems.

Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study.

BACKGROUND: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. OBJECTIVE: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. METHODS: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. RESULTS: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. CONCLUSIONS: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label. TRIAL REGISTRATION: ClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/36995.

Validation of PARADISE 24 and Development of PARADISE-EDEN 36 in Patients with Dementia.

Dementia was one of the conditions focused on in an EU (European Union) project called "PARADISE" (Psychosocial fActors Relevant to brAin DISorders in Europe) that later produced a measure called PARADISE 24, developed within the biopsychosocial model proposed in the International Classification of Functioning Disability and Health (ICF). The aims of this study are to validate PARADISE 24 on a wider sample of patients with mild to moderate dementia to expand PARADISE 24 by defining a more specific scale for dementia, by adding 18 questions specifically selected for dementia, which eventually should be reduced to 12. We enrolled 123 persons with dementia, recruited between July 2017 and July 2019 in home care and long-term care facilities, in Italy, and 80 participants were recruited in Warsaw between January and July 2012 as part of a previous cross-sectional study. The interviews with the patient and/or family were conducted by health professionals alone or as a team by using the Paradise data collection protocol. The psychometric analysis with the Rasch analysis has shown that PARADISE 24 and the selection of 18 additional condition-specific items can be expected to have good measurement properties to assess the functional state in persons with dementia.

Nurse students' competences in interprofessional pharmaceutical care in Europe: Cross-sectional evaluation.

BACKGROUND: Safe pharmaceutical care requires competent nurses with specific knowledge, skills and attitudes. It is unclear whether nursing students are adequately prepared to perform pharmaceutical care in practice. Mapping their pharmaceutical care competences can lead to a better understanding of the extent to which curricula fit expectations of the labour market. OBJECTIVES: To assess pharmaceutical care competences of final-year nursing students of different educational levels. DESIGN: A cross-sectional survey design. SETTINGS: In 14 European countries, nursing schools who offer curricula for level 4 to 7 students were approached. PARTICIPANTS: Through convenience sampling 1741 final-year student nurses of level 4 to 7 were included. Sampling strategies were country-specific. METHODS: A web-platform was developed with an assessment of the level in which students mastered pharmaceutical care competences. Knowledge questions, case studies (basic/advanced level), self-reported practical skills and attitudes were evaluated. RESULTS: Mean scores for knowledge questions differed significantly (p < 0.001) between level 5 (56/100), level 6 (68/100) and level 7 students (72/100). For basic cases level 5 students reached lower scores (64/100) compared with level 6 (71/100) and level 7 (72/100) students (p = 0.002 and p = 0.005). For more advanced cases no difference between levels was observed (overall mean 61/100). Most students (63-90 %) considered themselves skilled to perform pharmaceutical care and had positive attitudes towards their participation in pharmaceutical care (65-97 %). CONCLUSIONS: Relatively low knowledge scores were calculated for final-year student nurses. In some domains, lower levels of students might be insufficiently prepared to take up responsibilities in pharmaceutical care. Our assessment can be used as a tool for educators to evaluate how prepared nursing students are for pharmaceutical care. Its further implementation for students of different educational levels will allow benchmarking between the levels, both within and between countries.

Endovascular Repair of Primary Thoracic Aortic Mural Thrombus Following Upper Limb Embolization.

We report the case of a 41-year-old female who presented with left upper limb embolization due to primary thoracic aortic mural thrombus; this latter represented an uncommon condition with difficult diagnosis and a high rate of life-threatening complications. Upper extremities embolization is extremely rare because it usually occurs in the lower limbs. Management strategy is still controversial, and no clear guidelines indicate superiority of either conservative or invasive treatment approach to date. Our report illustrates how endovascular exclusion of thoracic aortic mural thrombus has the advantage to be a low-risk procedure that represents a definitive therapy.

Endovascular aortic repair in patients with challenging anatomies: the EXTREME study.

AIMS: The aim of this study was to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent graft in patients judged to be outside the instructions for use (IFU) for conventional endografts, while amenable to treatment within the IFU for Ovation. METHODS AND RESULTS: One hundred and twenty-two patients (78.65±7.67 years; 111 male) were enrolled. Patients were evaluated as being outside the IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (abdominal aortic aneurysm [AAA]) diameter was 52.96±10.1 mm; mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at one month was 96.8%, assisted clinical success 98.4%. There were no type I endoleaks, while 12 (9.8%) type II endoleaks were still evident, in the absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion. CONCLUSIONS: Our experience suggests that, in a selected population of patients with challenging anatomy outside the IFU for conventional endografts, endovascular aneurysm repair (EVAR) using the Ovation stent graft can be performed safely with satisfactory immediate outcomes.

Developing a competence framework for nurses in pharmaceutical care: A Delphi study.

BACKGROUND: Nurses play an important role in pharmaceutical care. They are involved in: detecting clinical change; communicating/discussing pharmacotherapy with patients, their advocates, and other healthcare professionals; proposing and implementing medication-related interventions; and ensuring follow-up of patients and medication regimens. To date, a framework of nurses' competences on knowledge, skills, and attitudes as to interprofessional pharmaceutical care tasks is missing. OBJECTIVES: To reach agreement with experts about nurses' competences for tasks in interprofessional pharmaceutical care. METHODS: A two-phase study starting with a scoping review followed by five Delphi rounds was performed. Competences extracted from the literature were assessed by an expert panel on relevance by using the RAND/UCLA method. The experts (n = 22) involved were healthcare professionals, nurse researchers, and educators from 14 European countries with a specific interest in nurses' roles in interprofessional pharmaceutical care. Descriptive statistics supported the data analysis. RESULTS: The expert panel reached consensus on the relevance of 60 competences for 22 nursing tasks. Forty-one competences were related to 15 generic nursing tasks and 33 competences were related to seven specific nursing tasks. CONCLUSIONS: This study resulted in a competence framework for competency-based nurse education. Future research should focus on imbedding these competences in nurse education. A structured instrument should be developed to assess students' readiness to achieve competence in interprofessional pharmaceutical care in clinical practice.

The NUPHAC-EU Framework for Nurses' Role in Interprofessional Pharmaceutical Care: Cross-Sectional Evaluation in Europe.

Clear role descriptions promote the quality of interprofessional collaboration. Currently, it is unclear to what extent healthcare professionals consider pharmaceutical care (PC) activities to be nurses' responsibility in order to obtain best care quality. This study aimed to create and evaluate a framework describing potential nursing tasks in PC and to investigate nurses' level of responsibility. A framework of PC tasks and contextual factors was developed based on literature review and previous DeMoPhaC project results. Tasks and context were cross-sectionally evaluated using an online survey in 14 European countries. A total of 923 nurses, 240 physicians and 199 pharmacists responded. The majority would consider nurses responsible for tasks within: medication self-management (86-97%), patient education (85-96%), medication safety (83-95%), monitoring adherence (82-97%), care coordination (82-95%), and drug monitoring (78-96%). The most prevalent level of responsibility was 'with shared responsibility'. Prescription management tasks were considered to be nurses' responsibility by 48-81% of the professionals. All contextual factors were indicated as being relevant for nurses' role in PC by at least 74% of the participants. No task nor contextual factor was removed from the framework after evaluation. This framework can be used to enable healthcare professionals to openly discuss allocation of specific (shared) responsibilities and tasks.

Perspectives of nurses' role in interprofessional pharmaceutical care across 14 European countries: A qualitative study in pharmacists, physicians and nurses.

OBJECTIVES: To understand healthcare professionals' experiences and perceptions of nurses' potential or ideal roles in pharmaceutical care (PC). DESIGN: Qualitative study conducted through semi-structured in-depth interviews. SETTING: Between December 2018 and October 2019, interviews were conducted with healthcare professionals of 14 European countries in four healthcare settings: hospitals, community care, mental health and long-term residential care. PARTICIPANTS: In each country, pharmacists, physicians and nurses in each of the four settings were interviewed. Participants were selected on the basis that they were key informants with broad knowledge and experience of PC. DATA COLLECTION AND ANALYSIS: All interviews were conducted face to face. Each country conducted an initial thematic analysis. Consensus was reached through a face-to-face discussion of all 14 national leads. RESULTS: 340 interviews were completed. Several tasks were described within four potential nursing responsibilities, that came up as the analysis themes, being: 1) monitoring therapeutic/adverse effects of medicines, 2) monitoring medicines adherence, 3) decision making on medicines, including prescribing 4) providing patient education/information. Nurses' autonomy varied across Europe, from none to limited to a few tasks and emergencies to a broad range of tasks and responsibilities. Intended level of autonomy depended on medicine types and level of education. Some changes are needed before nursing roles can be optimised and implemented in practice. Lack of time, shortage of nurses, absence of legal frameworks and limited education and knowledge are main threats to European nurses actualising their ideal role in PC. CONCLUSIONS: European nurses have an active role in PC. Respondents reported positive impacts on care quality and patient outcomes when nurses assumed PC responsibilities. Healthcare professionals expect nurses to report observations and assessments. This key patient information should be shared and addressed by the interprofessional team. The study evidences the need of a unique and consensus-based PC framework across Europe.

Transcatheter retrieval of Amplatzer Septal Occluder device embolized into the abdominal aorta.

The use of Amplatzer Septal Occluder device has become an alternative to surgical procedure in selected group of patients affected by atrial septal defect. Percutaneous closure of atrial septal defect has emerged as a low morbidity procedure but, at the same time, showed various complications associated to the device itself. Although embolization to the abdominal aorta is only sporadic reported, it could represent a potential vascular disaster and usually is treated by surgery. Herein, we report on the fourth, in English literature, successfully total transcatheter retrieval of an Amplatzer Septal Occluder device complicated by acute embolization into the abdominal aorta and propose a practical endovascular manoeuvre to address disc removal.

Intravenous paracetamol as adjunctive treatment for postoperative pain after cardiac surgery: a double blind randomized controlled trial.

BACKGROUND: Nonsteroidal anti-inflammatory drugs and opioids are routinely used after cardiac surgery in order to mitigate postoperative pain; however, these drugs are burdened by side effects. Tramadol and paracetamol are believed to be lacking in such side effects. The aim of this study was to examine the efficacy of intravenous paracetamol as an adjunctive analgesic to a tramadol-based background analgesia after cardiac surgery. METHODS: A total of 113 patients participated in this single center, placebo-controlled, double-blind, randomized trial. Fifty-six patients were randomized to receive paracetamol and 57 to placebo. Intravenous study drug (1 g) was administered 15 min before the end of surgery and every 6h for 72 h. Standard analgesia (tramadol) and anti-emetic prophylactic regimen (ondansetron) were available to both patient groups. Postoperative pain was evaluated by visual analog scale, and it was measured at rest and during a deep breath. A rescue dose of 2-5 mg of intravenous morphine was administered whenever the VAS score was greater than 3. RESULTS: Baseline characteristics were equivalent between the two groups. At 12, 18, 24 h after the end of operation, patients who received paracetamol had significantly less pain at rest (p=0.0041, 0.0039, 0.0044, respectively); after this time the two groups did not differ. During a deep breath the difference was significant only at 12 h (p=0.0040). Paracetamol group required less cumulative morphine than placebo group (48 mg vs 97 mg) even if the difference did not reach statistical significance (p=0.274). CONCLUSIONS: In patients undergoing cardiac surgery, intravenous paracetamol in combination with tramadol provides effective pain control.