Fospropofol Disodium for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy.

BACKGROUND: Fospropofol disodium is a water-soluble prodrug of propofol. A subset analysis was undertaken of elderly patients (≥65 y) undergoing flexible bronchoscopy, who were part of a larger multicenter, randomized, double-blind study. METHODS: Patients received fentanyl citrate (50 mcg) followed by fospropofol at initial (4.88mg/kg) and supplemental (1.63mg/kg) doses. The primary end point was sedation success (3 consecutive Modified Observer's Assessment of Alertness/Sedation scores of ≤4 and procedure completion without alternative sedative or assisted ventilation). Treatment success, time to fully alert, patient and physician satisfaction, and safety/tolerability were also evaluated. RESULTS: In the elderly patients subset (n=61), sedation success was 92%, the mean time to fully alert was 8.0±10.9 min, and memory retention was 72% during recovery, and these were comparable with the younger patients subgroup (age, <65 y). Sedation-related adverse events occurred in 23% of the elderly and 18% of the younger patients (age, <65 y) group. Hypoxemia occurred in 26% of the elderly and 18% of the younger patients group, but no escalation of care was required. CONCLUSIONS: Fospropofol provided safe and effective sedation, rapid time to fully alert, and high satisfaction in this elderly subset undergoing flexible bronchoscopy, which was comparable with outcomes in younger patients.

A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy.

BACKGROUND: Fospropofol disodium is a water-soluble prodrug of propofol with unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, multicenter study evaluated the use of fospropofol in patients undergoing flexible bronchoscopy. METHODS: Patients >or= 18 years of age were randomized (2:3) to receive fospropofol, 2 mg/kg or 6.5 mg/kg, after pretreatment with fentanyl, 50 microg. Supplemental doses of each were given per protocol. The primary end point was sedation success, which was defined as follows: three consecutive Modified Observer's Assessment of Alertness/Sedation scores of

Real-time endobronchial ultrasound-guided transbronchial lymph node aspiration.

BACKGROUND: Accurate staging of lung cancer requires noninvasive and pathologic examination of intrathoracic lymphadenopathy, which determines both the treatment options and prognosis. The gold standard for mediastinal staging has been mediastinoscopy. Other options include video-assisted thoracoscopic surgery, blind transbronchial needle aspiration, and endoscopic ultrasound-guided fine-needle aspiration. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has recently been introduced. Here we report the use of EBUS-TBNA as a diagnostic modality for mediastinal adenopathy and staging modality for lung cancer. METHODS: This was a retrospective analysis of 152 consecutive patients who underwent EBUS-TBNA with undiagnosed intrathoracic adenopathy or cancer staging as the primary indications. The procedures occurred between January 2005 and June 2006 at a single academic medical center. Of the 152 patients, 117 were included in the final statistical analysis after excluding those with benign disease diagnosed by EBUS-TBNA. Rapid on-site cytopathologic examination was used in all cases. RESULTS: Malignancy was identified in 113 patients, of which 67 (59.3%) had non-small cell lung carcinoma, and 20 (17.7%) underwent surgical resection. Four patients had benign diagnoses at surgical pathology. Only 1 surgical patient was found to have nodal metastasis at a lymph node station previously biopsied by EBUS-TBNA (negative predictive value, 97%). Compared with radiologic staging, EBUS-TBNA down-staged 18 of 113 (15.9%) and up-staged 11 (9.7%). Sensitivity was 98.7%, with 100% specificity. No major complications were associated with the procedure. CONCLUSIONS: EBUS-TBNA is useful in accessing mediastinal and hilar lymph nodes for the diagnosis and staging of non-small cell lung cancer and other disorders of the mediastinum. Thoracic surgeons and pulmonologists are well positioned to use this tool in everyday practice.

A pilot study of narrow-band imaging compared to white light bronchoscopy for evaluation of normal airways and premalignant and malignant airways disease.

BACKGROUND: The objectives of this study were to characterize the appearance of normal, dysplastic, and frankly malignant airway lesion appearance under narrow-band imaging (NBI), and to determine if NBI, when used in conjunction with white light (WL) bronchoscopy, could improve detection of dysplasia and malignancy. PATIENTS AND METHODS: This was a prospective, partially blinded study at a university teaching hospital. Bronchoscopy was performed on 22 patients with known or suspected bronchial dysplasia or malignancy. Full airway examination was performed first under WL bronchoscopy and then under NBI. Directed endobronchial biopsies of likely dysplastic, malignant, and normal (control) areas were then performed and sent for examination by a pathologist blinded to the gross description of the lesion. Pathology interpretations were then compared to the corresponding WL and NBI images. RESULTS: There were one malignant and four dysplastic lesions in 22 patients detected by NBI when findings by WL imaging were considered normal. In cases when the WL appearance was abnormal, NBI did not improve the diagnostic yield. The increased rate of detection of dysplasia and malignancy by NBI was statistically significant (p = 0.005). CONCLUSION: NBI identified dysplasia or malignancy that was not detected by WL inspection in 23% of subjects. Further studies are needed to determine the efficacy of NBI in detection of premalignant airways lesions in an at-risk population.

Unusual presentations of pulmonary sarcoidosis: cases from the medical university of South Carolina.

Sarcoidosis is a multisystem granulomatous disease that can affect any organ in the body, but most commonly the lung. Any part of the thorax may be affected by sarcoidosis, including the lung parenchyma, airways, and mediastinal and hilar lymph nodes. When the parenchyma is involved, sarcoidosis has a predilection for the bronchovascular bundles and subpleural locations. On occasion, the presentation of pulmonary sarcoidosis may be atypical. Atypical presentations may result in a delay in diagnosis as well as unnecessary treatment or diagnostic testing. We discuss four patients with an unusual presentation of thoracic sarcoidosis seen at our Sarcoidosis Clinic.

Successful real-time endobronchial ultrasound-guided transbronchial needle aspiration of a hilar lung mass obtained by traversing the pulmonary artery.

The utility and safety of transbronchial needle aspiration is well described. Serious complications from transbronchial needle aspiration are exceedingly rare. The addition of endoscopic ultrasonographic techniques in the form of endoscopic ultrasonography and, more recently, endobronchial ultrasonography has added valuable information regarding lymphatic anatomy of the hilum and mediastinum. In addition, the use of real-time ultrasound gives the operator visual feedback of needle placement and proximity to major surrounding structures such as the heart and great vessels. Here, the authors present the case of a 74-year-old man with a left hilar mass who underwent biopsy by means of intentional traverse of the pulmonary artery.

Hemodynamic changes during hemodialysis: role of nitric oxide and endothelin.

BACKGROUND: Etiology of dialysis induced hypotension and hypertension remains speculative. There is mounting evidence that nitric oxide (NO) and endothelin (ET-1) may play a vital role in these hemodynamic changes. We examined the intradialytic dynamic changes in NO and ET-1 levels and their role in the pathogenesis of hypotension and rebound hypertension during hemodialysis (HD). METHODS: The serum nitrate + nitrite (NT), fractional exhaled NO concentration (FENO), L-arginine (L-Arg), NGNG-dimethyl-L-arginine (ADMA) and endothelin (ET-1) profiles were studied in 27 end-stage renal disease (ESRD) patients on HD and 6 matched controls. The ESRD patients were grouped according to their hemodynamic profile; Group I patients had stable BP throughout HD, Group II had dialysis-induced hypotension, and Group III had intradialytic rebound hypertension. RESULTS: Pre-dialysis FENO was significantly lower in the dialysis patients compared to controls (19.3 +/- 6.3 vs. 28.6 +/- 3.4 ppb, P < 0.002). Between the experimental groups, pre-dialysis FENO was significantly higher in Group II (24.1 +/- 6.7 ppb) compared to Group I (17.8 +/- 5.6 ppb) and Group III (16.1 +/- 4.2 ppb; P < 0.05). Post-dialysis, FENO increased significantly from the pre-dialysis values (19.3 +/- 6.3 vs. 22.6 +/- 7.9 ppb; P=0.001). Pre-dialysis NT (34.4 +/- 28.2 micromol/L/L) level was not significantly different from that of controls (30.2 +/- 12.3 micromol/L/L). Serum NT decreased from 34.4 +/- 28.2 micromol/L/L at initiation of dialysis to 10.0 +/- 7.4 micormol/L/L at end of dialysis (P < 0.001). NT concentration was comparable in all the three groups at all time points. Pre-dialysis L-Arg (105.3 +/- 25.2 vs. 93.7 +/- 6.0 micromol/L/L; P < 0.05) and ADMA levels were significantly higher in ESRD patients (4.0 +/- 1.8 vs. 0.9 +/- 0.2 micromol/L/L; P < 0.001) compared to controls. Dialysis resulted in significant reduction in L-Arg (105.3 +/- 25.2 vs. 86.8 +/- 19.8 micromol/L/L; P < 0.005) and ADMA (4.0 +/- 1.8 vs. 1.6 +/- 0.7 micromol/L/L; P < 0.001) concentrations. Pre-dialysis ET-1 levels were significantly higher in ESRD patients compared to the controls (8.0 +/- 1.9 vs. 12.7 +/- 4.1 pg/mL; P < 0.002), but were comparable in the three study groups. Post-dialysis ET-1 levels did not change significantly in Group I compared to pre-dialysis values (14.3 +/- 4.3 vs.15.0 +/- 2.4 pg/mL, P=NS). However, while the ET-1 concentration decreased significantly in Group II (12.0 +/- 4.0 vs. 8.7 +/- 1.8 pg/mL, P < 0.05), it increased in Group III from pre-dialysis levels (12.8 +/- 3.8 vs. 16.7 +/- 4.5 pg/mL, P=0.06). CONCLUSION: Pre-dialysis FENO is elevated in patients with dialysis-induced hypotension and may be a more reliable than NT as a marker for endogenous NO activity in dialysis patients. Altered NO/ET-1 balance may be involved in the pathogenesis of rebound hypertension and hypotension during dialysis.