Nurses' Attitudes, Practices, and Barriers to Assessing Symptoms of Discomfort in Mechanically Ventilated Patients: A Cross-Sectional Study.

Introduction: Critically ill patients experience various stressful symptoms of discomfort, including dyspnea, pain, and sleep disruption. Notably, ventilated patients have difficulty self-reporting discomfort symptoms. Nurses need to assess discomfort symptoms to alleviate them, but limited research exists on discomfort symptom assessment and management in critically ill patients. Objective: To identify the practices, attitudes, and barriers among nurses related to the assessment of discomfort symptoms in mechanically ventilated patients. Methods: Using a cross-sectional, descriptive study design, a web-based survey was conducted between May and June 2022 with critical care nurses sampled through Japanese academic societies and social networking services. The survey contained questions relative to the above-stated objective. Descriptive statistical analysis was performed without sample size calculation because of the descriptive and exploratory nature of this study. Results: There were 267 respondents to the questionnaire. The discomfort symptoms that nurses perceived as important to assess were pain (median 100 [interquartile range, IQR 90-100]), insomnia (99 [80-100]), and dyspnea (96.5 [75-100]). Most participants (89.8%) routinely assessed pain in mechanically ventilated patients using a scale; however, other discomfort symptoms were assessed by less than 40% (dyspnea [28.4%], fatigue [8.1%], thirst [13.1%], insomnia [37.3%], and anxiety [13.6%]). Two major barriers to assessing discomfort symptoms were lack of assessment culture within the intensive care unit and lack of knowledge of the relevant evaluation scales. Conclusions: Nurses were aware of the importance of using scales to assess the discomfort symptoms experienced by mechanically ventilated patients. However, except for pain, most nurses did not routinely use scales to assess discomfort symptoms. Barriers to routine discomfort symptom assessment included the lack of an assessment culture and the lack of knowledge of the assessment scales. Clinicians should be educated regarding the existence of validated rating scales and develop additional rating scales utilizable for minor discomforts in mechanically ventilated patients.

Thoracoscopic Direct Suture Closure for a Large Bulla With Severe Adhesion Under Local Anesthesia: A Case Report.

Although the usefulness of thoracoscopic surgery under local anesthesia for pneumothorax has been reported, there are some cases of failure. Therefore, it is important to share the various techniques and potential challenges associated with procedures performed under local anesthesia. A 79-year-old male, under monitoring for a left chronic pneumothorax, was newly diagnosed with a right pneumothorax. Chest computed tomography taken after thoracic drainage showed a poorly expanded right lung with severe adhesions and multiple bullae in the right lung, in addition to identifying a left pneumothorax. Although significant air leakage persisted, general anesthesia was deemed unsuitable, necessitating thoracoscopic surgery under local anesthesia. A fistula of approximately 1 × 1 cm was identified on the bulla wall, which was closed with 4-0 Prolene®sutures (Johnson&Johnson, New Jersey, United States), each reinforced with pledgets and covered with a polyglycolic acid sheet and fibrin glue. The patient was discharged on postoperative day six and no recurrence of pneumothorax was noted after discharge. Direct suture closure of the bulla wall under local anesthesia can be an alternative technique for the treatment of pneumothorax caused by large bulla collapse in patients at high risk for general anesthesia.

[Racemose Hemangioma of the Bronchial Artery with Pulmonary Artery Fistula].

A 55-year-old woman was suspected of having hilar lymph node enlargement on a routine examination of the chest computed tomography( CT) scan at our hospital. On further examination, thoracic contrast CT and bronchial arteriography showed prominent dilation and meandering of the right bronchial artery with an aneurysm which formed a fistula to the pulmonary artery A7 at its distal end. Diagnosed as racemose hemangioma of bronchial artery with pulmonary artery fistula, we performed a surgical resection by open thoracotomy on the second day following bronchial artery embolization( BAE). No recurrence was observed in the five years of follow-up period after surgery. Therefore, surgical resection for asymptomatic racemose hemangioma of bronchial artery with bronchial artery-pulmonary artery fistula can be considered an effective method for the long-term prevention of bleeding.

Positive Predictors for Response to Ambrisentan Combination Therapy in Pulmonary Arterial Hypertension.

The AMBITION study (NCT01178073) provided the first long-term clinical evidence for initial combination therapy with ambrisentan and tadalafil in patients with pulmonary arterial hypertension (PAH). Nevertheless, predictors of treatment response were not assessed.To identify predictors for response to initial combination therapy, we examined data from 302 patients with PAH (World Health Organization Functional Class II or III) who received initial combination therapy from the modified intention-to-treat population of the AMBITION study (n = 605). A responder was defined as not having undergone a clinical failure event. Univariate and multivariate analyses were performed. Multivariate logistic regression with interactive backward selection was used to assess the independent association of potential predictors with response.Treatment responders were younger, more often female, and less likely to have comorbidities or a requirement for oxygen therapy, compared with nonresponders. At multivariate analysis, female sex (odds ratio [OR] 2.67; 95% confidence interval [CI] 1.29, 5.52; P = 0.0081), longer 6-minute walk distance (OR 1.01; 95% CI 1.00, 1.01; P = 0.0039), lower baseline log N-terminal-prohormone of brain natriuretic peptide (OR 0.70; 95% CI 0.52, 0.94; P = 0.0190), and aldosterone antagonist use (OR 2.54; 95% CI 1.03, 6.26; P = 0.0436) independently predicted response to initial combination therapy.Besides demographic factors, the absence of comorbidities and less severe disease state, and the use of aldosterone antagonist therapy identified patients with PAH most likely to respond to initial combination therapy with ambrisentan and tadalafil. Further study to evaluate the role of aldosterone antagonist therapy in PAH is warranted.

A case of giant intradiaphragmatic bronchogenic cyst.

We present the case of a giant bronchogenic cyst (BC) that appeared just within the right diaphragm. A 51-year-old man was referred to our hospital with a chief complaint of pain from the lumbar area to the right shoulder. Computed tomography images showed a cystic mass measuring 18.0 × 17.5 × 12.8 cm in the right thoracic cavity. Right posterolateral thoracotomy from the eighth intercostal space was performed, and the cyst wall and diaphragm were resected together. The defect of the diaphragm was repaired using a 2-mm-thick Gore-Tex™ expanded polytetrafluoroethylene patch. It is embryologically rare for a giant BC to develop within the right diaphragm. As BCs may be associated with malignant tumours or infection, complete resection of the cyst wall is required. Literature review revealed no consensus on the best surgical procedure. Therefore, it is important to consider the appropriate surgical procedure for each case.

[Pulmonary Congestion and Stump Bleeding after Wedge Resection].

A 50's-year-old woman was pointed out an abnormal shadow in the right lung field on chest X-ray. Chest computed tomography revealed a nodule in the upper lobe of the right lung. No specific finding was shown by bronchoscopy. A thoracoscopic operation was performed. Wedge resection was performed using automatic suturing devices. Intraoperative pathology revealed the lesion to be necrotizing granuloma, and the operation was finished without resection of the residual upper lobe. After surgery, the upper right lung field shadow and intrathoracic hematoma were observed, and reoperation was performed. The residual upper lobe was highly congested with bleeding from the stump, requiring lobectomy. It was possibly caused by a deep cut of the lung parenchyma with automatic suturing devices at lung wedge resection, resulting in obstruction of the drainage vein.

Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis.

OBJECTIVES: To evaluate initial combination therapy with ambrisentan plus tadalafil (COMB) compared with monotherapy of either agent (MONO), and the utility of baseline characteristics and risk stratification in predicting outcomes, in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation. METHODS: This post hoc analysis of the Ambrisentan and Tadalafil in Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population. Time to clinical failure (TtCF) was assessed by baseline characteristics, treatment assignment and risk group (low, intermediate and high) at baseline and week 16. TtCF was compared between groups using Kaplan-Meier curves and Cox proportional hazards regression modelling. RESULTS: The analysis included 216 patients (COMB, n=117; MONO, n=99). The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline. The risk of clinical failure was lower with COMB versus MONO in the baseline low-risk group (HR not calculated due to no events in COMB), baseline intermediate-risk group (HR 0.519, 95% CI 0.297 to 0.905) and in the week 16 low-risk group (HR 0.069, 95% CI 0.009 to 0.548). CONCLUSIONS: The benefit of COMB over MONO was demonstrated in patients with CTD-PAH, particularly in those with typical PAH haemodynamic characteristics at baseline. COMB is appropriate for patients categorised as low risk and intermediate risk at baseline and low risk at follow-up. TRIAL REGISTRATION NUMBER: NCT01178073.

Safety and Efficacy of Ambrisentan-Phosphodiesterase Type 5 (PDE5) Inhibitor Combination Therapy for Japanese Pulmonary Arterial Hypertension Patients in Real-World Clinical Practice.

Background: This retrospective study was conducted to evaluate the safety and efficacy of ambrisentan combination therapy with phosphodiesterase type 5 (PDE5) inhibitors in Japanese patients with pulmonary arterial hypertension (PAH). Methods and Results: PAH patients who received ambrisentan for the first time in combination with a PDE5 inhibitor between January 2013 and the end of August 2015 were included in this study. Adverse drug reaction (ADR) safety analysis, as well as the efficacy analysis focusing on changes in clinical parameters, were investigated for overall cases and cases stratified by patient background. Forty-eight consecutive patients (n=21, 43.8% with idiopathic PAH; male/female, 18/30; average age, 43.3±17.4 years; World Health Organization functional class III/IV, n=22, 45.8%) who were treated with ambrisentan and a PDE5 inhibitor in Japan underwent the safety analysis. A total of 14 ADR occurred in 10 patients (20.8%). ADR included headache (8.3%), face edema (4.2%), angina pectoris (2.1%), hyperemia (2.1%), dyspnea (2.1%), pulmonary hypertension (i.e., worsening of PAH, 2.1%), nausea (2.1%), hepatic function abnormal (2.1%), edema (2.1%), and sudden death (2.1%). On analysis of hemodynamics parameters, there was a significant improvement in the mean pulmonary arterial pressure (-13.5 mmHg, P=0.0001) and pulmonary vascular resistance (-563.53 dyn·s·cm-5, P=0.0033). Conclusions: Ambrisentan combination therapy is safe and effective in hemodynamics improvement.

Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

BACKGROUND AND OBJECTIVE: Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. METHODS: PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. RESULTS: Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. CONCLUSION: The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with previous clinical trials in Japan and the rest of the world. Thus, these results provided another corroboration of the tolerability of ambrisentan and we continue to monitor proper use information via the post-marketing surveillance to ensure any new safety signals are identified in a timely manner (ClinTrial.gov: NCT01406327).

[Surgical Repair for Blunt Cardiac Rupture].

Blunt cardiac injury is a life-threatening condition. We report 3 successful cases in which we performed surgery for blunt cardiac injury. Three individuals were injured, 2 in traffic accidents and the other being caught between a crane and a steel frame. Echocardiograms and computed tomography scans revealed pooling of bloody pericardial fluid in all 3 patients, who underwent emergency surgery. Two patients needed sutures to control persistent bleeding. Although a heart-lung machine was prepared at the start of surgery in all 3 cases, we did not need to use it for any patient. Thus, prior to performing such surgery, it is necessary to ascertain its need.

Cost-effectiveness of the oral adsorbent AST-120 versus placebo for chronic kidney disease.

AIM: This study was designed to evaluate the cost-effectiveness of AST-120, an oral adsorbent that attenuates the progression of chronic kidney disease. METHODS: We developed a Markov model with six health states, including four levels of serum creatinine, haemodialysis and death, using data from a randomized clinical trial conducted in Japan. Direct costs relevant to chronic kidney disease were calculated from a Japanese reimbursement perspective. Projected quality-adjusted life years (QALY) and costs were compared between the AST-120 and placebo groups. The target population was nondiabetic patients with serum creatinine levels from 5.0 to 8.0 mg/dL (442-707 micromol/L) at baseline. Probabilistic sensitivity analysis was performed to evaluate the stability of the results. RESULTS: At 3 years, mean total costs per patient were estimated at 6.67 million yen (US$56,982) in the AST-120 group and 9.38 million yen (US$80,196) in the placebo group. Mean total costs were 2.72 million yen (US$23,205) lower among patients receiving AST-120. QALY per patient were 0.295 (approximately 3.5 months) greater for patients receiving AST-120 than for those receiving placebo over 3 years. The finding that treatment with AST-120 dominated placebo (i.e. was less costly and resulted in more QALY) was upheld in sensitivity analyses. CONCLUSION: The use of AST-120 in patients with advanced chronic kidney disease may help to slow the rate of growth in expenditures for kidney disease.