Procedural Aspects of Epidural Catheter Placement: A Prospective Observational Study of 173 Epidural Catheter Insertions.

OBJECTIVE: The risks and benefits of epidural analgesia have been studied extensively, but information regarding many other aspects of epidural catheter insertion is limited. The authors aimed to add information regarding procedural pain, procedure duration, failure rates, and the effect of experience to the ongoing discussion on this procedure. DESIGN: A prospective observational study. SETTING: A Danish tertiary hospital. PARTICIPANTS: Patients scheduled to undergo video-assisted thoracic surgery. INTERVENTIONS: Epidural catheter insertion in 173 patients undergoing video-assisted thoracic surgery for lung cancer. MEASUREMENTS AND MAIN RESULTS: The authors recorded the time required for the epidural insertion procedure, the attempts used, insertion level, access use, patient position, placement technique used, and the designation of the physician placing the catheter. Furthermore, the authors asked the patients to evaluate the expected procedural pain, and after the procedure the authors asked them to evaluate the actual level of pain experienced. Six and 24 months after discharge, the authors examined persistent sequelae by using questionnaire assessments. The median procedure duration was 13 minutes, with 75% of the catheters placed within 22 minutes. Actual procedure-related pain (mean score [M] = 3.5, SD = 2.0) was significantly (p < 0.0001) less than that expected before the procedure (M = 4.9, SD = 2.0). The patients' expected pain, attempts required for successful catheter placement, and approach used to access the epidural space significantly affected the actual procedure-related pain (p = 0.001, p ≤ 0.003, and p = 0.023, respectively). Persistent pain and sensory disturbances were observed in 11% and 4% of the patients, respectively, after 6 months and in 6% and 4% of the patients, respectively, after 2 years. CONCLUSIONS: In this study, the authors examined several lesser-known aspects of epidural procedures. The use of epidural analgesia as part of the pain management plan after surgery requires a more complex evaluation instead of merely discussing the possibility of procedural infections, hematomas, or neurologic injuries. The procedure time, patients' expected and experienced pain related to the procedure, and the potential long-term side effects should be a part of the decision-making process.

Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial.

BACKGROUND: Video-assisted thoracoscopic surgery (VATS) is used increasingly as an alternative to thoracotomy for lobectomy in the treatment of early-stage non-small-cell lung cancer, but remains controversial and worldwide adoption rates are low. Non-randomised studies have suggested that VATS reduces postoperative morbidity, but there is little high-quality evidence to show its superiority over open surgery. We aimed to investigate postoperative pain and quality of life in a randomised trial of patients with early-stage non-small-cell lung cancer undergoing VATS versus open surgery. METHODS: We did a randomised controlled patient and observer blinded trial at a public university-based cardiothoracic surgery department in Denmark. We enrolled patients who were scheduled for lobectomy for stage I non-small-cell lung cancer. By use of a web-based randomisation system, we assigned patients (1:1) to lobectomy via four-port VATS or anterolateral thoracotomy. After surgery, we applied identical surgical dressings to ensure masking of patients and staff. Postoperative pain was measured with a numeric rating scale (NRS) six times per day during hospital stay and once at 2, 4, 8, 12, 26, and 52 weeks, and self-reported quality of life was assessed with the EuroQol 5 Dimensions (EQ5D) and the European Organisation for Research and Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30) during hospital stay and 2, 4, 8, 12, 26, and 52 weeks after discharge. The primary outcomes were the proportion of patients with clinically relevant moderate-to-severe pain (NRS ≥3) and mean quality of life scores. These outcomes were assessed longitudinally by logistic regression across all timepoints. Data for the primary analysis were analysed by modified intention to treat (ie, all randomised patients with pathologically confirmed non-small-cell lung cancer). This trial is registered with ClinicalTrials.gov, number NCT01278888. FINDINGS: Between Oct 1, 2008, and Aug 20, 2014, we screened 772 patients, of whom 361 were eligible for inclusion and 206 were enrolled. We randomly assigned 103 patients to VATS and 103 to anterolateral thoracotomy. 102 patients in the VATS group and 99 in the thoracotomy group were included in the final analysis. The proportion of patients with clinically relevant pain (NRS ≥3) was significantly lower during the first 24 h after VATS than after anterolateral thoracotomy (VATS 38%, 95% CI 0·28-0·48 vs thoracotomy 63%, 95% CI 0·52-0·72, p=0·0012). During 52 weeks of follow-up, episodes of moderate-to-severe pain were significantly less frequent after VATS than after anterolateral thoracotomy (p<0·0001) and self-reported quality of life according to EQ5D was significantly better after VATS (p=0·014). By contrast, for the whole study period, quality of life according to QLQ-C30 was not significantly different between groups (p=0·13). Postoperative surgical complications (grade 3-4 adverse events) were similar between the two groups, consisting of prolonged air leakage over 4 days (14 patients in the VATS group vs nine patients in the thoracotomy group), re-operation for bleeding (two vs none), twisted middle lobe (one vs three) or prolonged air leakage over 7 days (five vs six), arrhythmia (one vs one), or neurological events (one vs two). Nine (4%) patients died during the follow-up period (three in the VATS group and six in the thoracotomy group). INTERPRETATION: VATS is associated with less postoperative pain and better quality of life than is anterolateral thoracotomy for the first year after surgery, suggesting that VATS should be the preferred surgical approach for lobectomy in stage I non-small-cell lung cancer. FUNDING: Simon Fougner Hartmanns Familiefond, Guldsmed AL & D Rasmussens Mindefond, Karen S Jensens legat, The University of Southern Denmark, The Research Council at Odense University Hospital, and Department of Cardiothoracic Surgery, Odense University Hospital.

Recurrent Primary Spontaneous Pneumothorax is Common Following Chest Tube and Conservative Treatment.

INTRODUCTION: Previous studies on primary spontaneous pneumothorax reported variable recurrence rates, but they were based on heterogeneous patient populations including secondary pneumothorax. We investigated young patients with primary spontaneous pneumothorax exclusively and used a national registry to track readmissions and calculate independent predictors of recurrence. METHODS: A prospective cohort study of consecutive young patients who were admitted over a 5-year period with their first episode of primary spontaneous pneumothorax and treated conservatively with a chest tube. Baseline characteristics were obtained from questionnaires presented on admittance. All patients were discharged with fully expanded lungs on chest radiography. Patient charts were identified in the national electronic patient registry for detailed information on readmissions due to recurrent spontaneous pneumothorax. RESULTS: We included 234 patients. Male/female = ratio 5/1. After a median observation period of 3.6 years (range 1-6 years), recurrent pneumothorax was observed in 54 %. Ipsilateral recurrence was the most common (79 %) but 30 % also experienced contralateral pneumothorax during the study period. Females had a significantly higher age at debut (p < 0.01) and experienced significantly more recurrences over time (p < 0.01). Low body weight (<60 kg) was an independent predictor of recurrence and patients with repeated recurrences were significantly younger at debut (p = 0.01). CONCLUSIONS: Primary spontaneous pneumothorax in younger patients with their first episode had a much higher recurrence rate than previously reported. Every doctor who treats patients with primary spontaneous pneumothorax should be aware and patients informed.

Sympathicotomy for isolated facial blushing: long-term follow-up of a randomized trial.

OBJECTIVES: Thoracoscopic sympathicotomy may be an effective treatment for disabling facial blushing in selected patients. Short- and mid-term results are good but very long-term results are scarce in the medical literature and there is no knowledge which extent of sympathicotomy is better long-term for isolated facial blushing. METHODS: We previously randomized 100 patients between a rib-oriented R2 or R2-R3 sympathicotomy for isolated facial blushing, and reported local effects, side effects and quality of life after 12 months. In the present study, we sent identical questionnaires to all patients after a median of 16 years (interquartile range 15-17 years). RESULTS: The response rate was 66%. Overall, 82% reported excellent or satisfactory results on facial blushing, with significant better local effect after R2 sympathicotomy compared with R2-R3 sympathicotomy. Patients who underwent R2 sympathicotomy were also significantly more satisfied with the operation. We found no significant difference between R2 and R2-R3 sympathicotomy in quality of life or rates of compensatory sweating (77%) and recurrence of blushing (41%) which was milder than preoperatively in most patients. CONCLUSIONS: R2 sympathicotomy should be the preferred approach for isolated facial blushing because of better local effect and higher satisfaction rates. Although this was a very long-term follow-up of the only randomized trial of its kind the response rate was limited leaving a risk of undetected bias.

Cost-utility analysis of minimally invasive surgery for lung cancer: a randomized controlled trial.

OBJECTIVES: Minimally invasive video-assisted thoracic surgery (VATS) was first introduced in the early 1990s. For decades, numerous non-randomized studies demonstrated advantages of VATS over thoracotomy with lower morbidity and shorter hospital stay, but only recently did a randomized trial document that VATS results in lower pain scores and better quality of life. Opposing arguments for VATS have always been increased costs and concerns about oncological adequacy. In this paper, we aim to investigate the cost-effectiveness of VATS. METHODS: The study was designed as a cost-utility analysis of the first 12 months following surgery and was performed together with a clinical randomized controlled trial of VATS versus thoracotomy for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014). All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors. RESULTS: One hundred and three VATS patients and 103 thoracotomy patients were randomized. Mean costs per patient operated by VATS were 103 108 Danish Kroner (Dkr) (€13 818) and 134 945 Dkr (€18 085) by thoracotomy, making the costs for VATS 31 837 Dkr (€4267) lower than thoracotomy (P < 0.001). The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021 (P = 0.048, 95% confidence interval -0.04 to -0.00015) in favour of VATS. The median duration of the surgical procedure was shorter after thoracotomy (79 vs 100 min; P < 0.001). The mean length of hospitalization was shorter following VATS (4.8 vs 6.7 days; P = 0.027). The use of other resources was not significantly different between groups. The costs of resources were lower in the VATS group. This difference was primarily due to reduced costs of readmissions (VATS 29 247 Dkr vs thoracotomy 51 734 Dkr; P < 0.001) and costs of outpatient visits (VATS 51 412 Dkr vs thoracotomy 61 575 Dkr; P = 0.012). CONCLUSIONS: VATS is a cost-effective alternative to thoracotomy following lobectomy for stage 1 lung cancer. Economical outcomes as measured by quality-adjusted life years were significantly better and overall costs were lower for VATS. CLINICAL TRIAL REGISTRATION NUMBER: NCT01278888.

Incidence of primary spontaneous pneumothorax: a validated, register-based nationwide study.

OBJECTIVES: The incidence of primary spontaneous pneumothorax is partly unknown. Commonly quoted estimates were published decades ago and recent large-scale epidemiological publications lack validation. We validated the pneumothorax diagnosis in a national registry and estimated the incidence of primary spontaneous pneumothorax in young patients. METHODS: Complete data on patients with an assigned pneumothorax diagnosis was retrieved from the National Danish Patient Registry. Initially, we validated the diagnosis in a selected population: all patient charts with an assigned pneumothorax diagnosis from one cardiothoracic department over a 25-year period (1984-2008) were reviewed. Subsequently, the national incidence of primary spontaneous pneumothorax in young, healthy individuals was estimated by restricting our population to patients ≤40 years of age admitted during a 5-year period (2009-2014). We performed a systematic read-though of patient charts in 50% of the complete national cohort to ensure that we only included patients with their first episode of primary spontaneous pneumothorax. RESULTS: Validation revealed a poor inter-rater agreement (κ=0.08). Therefore, we abstained from further analysis on directly retrieved data from the national database. Subsequently, a systematic re-evaluation of 7022 patients revealed an incidence rate of 12.3 cases per 100 000 (95% CI 11.5-13.1) in males and 2.2 cases per 100 000 (95% CI 1.9-2.6) in females (male/female ratio 5.9). Compared with the general Danish population, pneumothorax patients had a lower body mass index (p<0.001) and smoked more than the Danish population in general (p<0.001). CONCLUSIONS: The incidence of primary spontaneous pneumothorax in a validated national study was lower than previously reported.

Surgical treatment versus conventional chest tube drainage in primary spontaneous pneumothorax: a randomized controlled trial.

OBJECTIVES: Primary spontaneous pneumothorax frequently recurs after chest tube management. Evidence is lacking whether patients may benefit from surgery following their first episode. METHODS: We performed a multicentre, randomized trial and enrolled young, otherwise healthy patients admitted with their first episode of primary spontaneous pneumothorax and treated using conventional chest tube drainage. Patients underwent high-resolution computed tomography on fully expanded lungs, and using web-based randomization, we assigned patients to continued conservative chest tube treatment or chest tube treatment followed by video-assisted thoracoscopic surgery (VATS) with the resection of bullae/blebs and mechanical pleurodesis. Patients were stratified into 2 groups based on the presence of bullae ≥1 cm on high-resolution computed tomography. The primary end point was readmission with ipsilateral recurrence. Secondary end points were complications and length of hospitalization. RESULTS: Between 1 August 2009 and 4 November 2016, we screened 457 patients, of whom 373 were eligible for inclusion and 181 were enrolled: male/female ratio = 5.0. We identified 88 patients with blebs <1 cm: 50 were randomly assigned to chest tube treatment and 38 to VATS. Ninety-three patients had bullae ≥1 cm: 43 were randomly assigned to chest tube treatment and 50 to VATS. Forty-three (23.8%) patients experienced recurrence during the follow-up period. Overall, recurrence was significantly lower following VATS when compared with conventional chest tube treatment (P = 0.0012). When stratified by bullae size, VATS proved significantly better for bullae ≥1 cm (P = 0.014). We observed a size-response relationship with increased risk of recurrence for larger bullae (P = 0.013). CONCLUSIONS: Surgery was an effective treatment to prevent recurrence in patients with their first presentation of primary spontaneous pneumothorax and should be the standard of care when high-resolution computed tomography demonstrates bullae ≥2 cm. Clinical trial registration: ClinicalTrial.gov: NCT 02866305.

Variation and importance of aspirin resistance in patients with known cardiovascular disease.

AIM: To investigate whether aspirin resistance is a persistent condition, and to evaluate if aspirin resistance affects one-year clinical outcome. METHODS AND RESULTS: Previously we studied 298 patients admitted to hospital with symptoms suggestive of an acute myocardial infarction (MI) despite treatment with aspirin, and 70 patients (23.5%) were aspirin resistant. In the present study, platelet function was reassessed by use of a Platelet Function Analyzer-100 one year later. A total of 187 patients were re-examined, and 17 (9.1%) demonstrated aspirin resistance. Of these 17 patients, 12 also exhibited aspirin resistance at baseline resulting in a 6% (12/187) prevalence of persistent aspirin resistance. A total of 34 patients had changed from aspirin resistant at baseline to aspirin sensitive at follow-up. We found a significant decrease in the prevalence of aspirin resistance from baseline (43%) to follow-up (11%) in patients with MI at baseline (p=0.0018). Furthermore, a significant decrease was found for patients without MI at baseline (20% to 9%, p=0.0009). During follow-up, 17% (12/70) of the patients with aspirin resistance at baseline suffered death, MI or stroke compared to 16% (37/227) of aspirin sensitive patients (p=0.868). CONCLUSION: The prevalence of aspirin resistance varies with the clinical status of the patients, and indeed an acute MI is associated with temporary aspirin resistance. We also found that 6% of patients demonstrate persistent aspirin resistance. The presence of aspirin resistance did not affect one-year clinical outcome.

Prevalence of aspirin resistance in patients with an evolving acute myocardial infarction.

OBJECTIVE: To study the prevalence and importance of aspirin resistance in patients with an evolving acute myocardial infarction (AMI) by use of the Platelet Function Analyzer-100. INTRODUCTION: Previous studies have demonstrated the existence of aspirin resistance, but the clinical relevance of the phenomenon remains to be clarified. If aspirin resistant patients comprise a high-risk subgroup, it might be expected that the prevalence of aspirin resistance in patients with AMI would be higher than in patients without AMI. We hypothesized that the prevalence of aspirin resistance in patients with AMI was twice the prevalence in patients without AMI. METHODS: We included 298 consecutive patients with known cardiovascular disease who were admitted to hospital with symptoms suggestive of an AMI. All had been taking aspirin 150 mg/day for at least 7 days prior to hospital admission. Platelet function was measured immediately at admission, and aspirin resistance was defined as a collagen/epinephrine Closure Time (CT(CEPI))<165 s. RESULTS: We found that 70 (23.5%) patients were aspirin resistant, and 70 (23.5%) patients ended up with the diagnosis of an AMI. The prevalence of aspirin resistance was significantly higher in patients with AMI as compared to patients without (36% versus 20%, OR 2.26, CI 95% 1.19-4.22, p=0.0058). The CT(CEPI) measured at admission was an independent factor associated with an AMI. CONCLUSIONS: Aspirin resistance is present in almost one fourth of patients admitted to hospital with symptoms suggestive of an AMI, and aspirin resistance is significantly associated with the diagnosis of a definite AMI.

Using the Platelet Function Analyzer-100 for monitoring aspirin therapy.

INTRODUCTION: The aim of the study was to evaluate the test characteristics of the Platelet Function Analyzer-100 (PFA-100) in patients treated with aspirin. METHODS AND RESULTS: The study consisted of two sub-studies. In study 1, 10 patients with ischemic heart disease (IHD) and 10 controls had platelet function assessed by optical platelet aggregation and the PFA-100 method in two 5-week periods. Patients with IHD were treated with aspirin 150 mg/day (first 5-week period), and 300 mg/day (second 5-week period), whereas the controls only received aspirin (150 mg/day) during the second 5-week period. From the results of study 1, we found that a cut-off value for the PFA-100 collagen/epinephrine cartridge <165 s identified patients not taking aspirin (sensitivity 0.91, specificity 1.00). A good agreement between the PFA-100 method and optical platelet aggregation was found. Within-subject variation for the PFA-100 collagen/epinephrine cartridge was +/-28%, as compared to +/-17% for the optical platelet aggregation. Study 2 included 298 aspirin treated patients who were admitted with symptoms suggestive of an acute myocardial infarction. Platelet function was assessed in duplicate by the PFA-100 collagen/epinephrine cartridge, and a 95% Limit of Agreement interval at [-65%, 65%] indicated a limited precision. CONCLUSION: We defined a cut-off value below which patients not taking aspirin can be identified. However, due to imprecision of the PFA-100 method repeated duplicate assessment of the collagen/epinephrine Closure Time is recommended.

Minimal Invasive Repair of Pectus Excavatum and Carinatum.

Minimal invasive surgery has become the gold standard for surgical repair of pectus excavatum. The procedure can be performed as fast-track surgery and cosmetic results are excellent. In addition, cardiac performance improves after correction. With increased awareness on the Internet, the number of patients who seek help continues to rise, primarily for cosmetic reasons. Pectus carinatum is much less frequent than pectus excavatum. Over the past decade surgery has largely been replaced by compression techniques that use a brace, and cosmetic results are good. Rare combinations of pectus excavatum and carinatum may be treated by newer surgical methods.

Cannabis increased the risk of primary spontaneous pneumothorax in tobacco smokers: a case-control study.

OBJECTIVES: Previous smaller case series suggested that cannabis smoking may cause spontaneous pneumothorax, but this finding remains controversial. We investigated the possible association between smoking tobacco and cannabis and the risk of having a primary spontaneous pneumothorax in a large, homogeneous cohort of young, healthy individuals. METHODS: In a case-control study, we prospectively investigated young (≤40 years) patients admitted in Western Denmark from 2009 to 2016 with their first episode of primary spontaneous pneumothorax. Baseline characteristics and smoking habits including both tobacco and cannabis were obtained from questionnaires presented on admittance. We compared our findings with those of a population-based control group matched by age, sex and geographical area. Calculated odds ratios were compared using the Fisher's exact test for small frequencies and the χ2 test or the Mann-Whitney test for larger frequencies. RESULTS: A total of 416 patients participated (male/female ratio = 3.9). We observed a significantly increased risk of primary spontaneous pneumothorax in daily smokers compared with female never smokers (odds ratio = 8.10, 95% confidence interval: 4.61-14.14, P < 0.001) and male never smokers (odds ratio = 4.85, 95% confidence interval: 3.23-7.19, P < 0.001). The combination of smoking both cannabis and tobacco in men increased the risk of spontaneous pneumothorax significantly (odds ratio = 8.74, 95% confidence interval: 4.30-19.51, P < 0.001). In contrast, the cannabis habits of female patients did not differ from those of the Danish population in general. CONCLUSIONS: Combined smoking of tobacco and cannabis significantly aggravates the risk of having a primary spontaneous pneumothorax in young men compared to both never smokers and daily smokers.

[Epiphrenic oesophageal diverticulum with an oesophagobronchial fistula resulting in a lung abscess].

Epiphrenic oesophageal diverticula are rare and often asymptomatic. In this case report a 58-year-old woman was diagnosed with an epiphrenic oesophageal diverticulum, which developed an oesophagobronchial fistula leading to a pulmonary abscess in the right lower lobe, septicaemia and acute respiratory failure. The patient underwent right lower lobectomy and the diverticulum was stapled off the oesophagus. The post-operative course was uneventful. This complication is only rarely described previously.

Endobronchial ultrasound-guided transbronchial needle aspiration is a sensitive method to evaluate patients who should not undergo pulmonary metastasectomy†.

OBJECTIVES: Pulmonary metastasectomy is considered an effective treatment in selected patients with extrapulmonary cancer and oligometastatic disease. We know that the presence of mediastinal lymph node metastases reduces survival significantly, but the mediastinum is rarely evaluated before metastasectomy in these patients. We prospectively evaluated how endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) could identify metastases to the mediastinal lymph nodes in patients referred for pulmonary metastasectomy. METHODS: All patients with extrapulmonary cancer and oligometastatic disease confined to the lungs on positron emission tomography-computed tomography, and who were considered eligible for pulmonary metastasectomy, routinely underwent EBUS-TBNA of the mediastinal lymph nodes. If EBUS-TBNA did not reveal malignant spread, the patient subsequently underwent pulmonary metastasectomy with systematic sampling of mediastinal lymph nodes for histological evaluation. RESULTS: One hundred and three eligible patients were referred for EBUS-TBNA during a 4-year period. The primary cancers were located in the colon/rectum (n = 64), kidney (n = 16) and other sites (n = 23). EBUS-TBNA sampled 248 lymph nodes and adequate cytology was obtained in 93 patients (90%). EBUS-TBNA found lymph node metastases in 17 patients (16.5%) and during subsequent pulmonary metastasectomy in the remaining 86 patients 1 (1.0%) had a lymph node metastasis. The sensitivity, specificity, NPV and PPV of EBUS-TBNA for diagnosis of mediastinal lymph node metastasis were 94.4, 100, 98.8 and 100%, respectively. CONCLUSIONS: EBUS-TBNA is a sensitive minimally invasive modality for evaluation of mediastinal lymph node metastases in patients with oligometastatic pulmonary disease. It allows surgeons to select patients who will not benefit from pulmonary metastasectomy.

Isolated pleural metastases from renal cell carcinoma.

A 71-year-old female was referred with three right-sided intrathoracic tumours. In 2003, she underwent radical left nephrectomy for renal cell cancer (RCC) clinical stage 1. She was since followed at her local hospital with annual computed tomography (CT)-scans during the first five years and did not present any symptoms until October 2009 when she was admitted with shortness of breath, cough and tiredness. The patient was scheduled for a diagnostic thoracoscopy when it was discovered that her lesions were not located in the lung parenchyma but were protruding nodules from the parietal pleura. Histology demonstrated metastases from RCC which apparently can reach the parietal pleura without lung metastases.