Risk factors of complications during noninvasive mechanical ventilation -assisted flexible bronchoscopy.

PURPOSE: Flexible bronchoscopy (FB) causes airway narrowing and may cause respiratory failure (RF). Noninvasive mechanical ventilation (NIV) is used to treat RF. Until recently, little was known about noninvasive mechanical ventilation assisted flexible bronchoscopy (NIV-FB) risk and complications. MATERIALS AND METHODS: A retrospective analysis of NIV-FB performed in 20 consecutive months (July 1, 2018-February 29, 2020) was performed. Indications for: FB and NIV, as well as impact of comorbidities, blood gas results, pulmonary function test results and sedation depth, were analyzed to reveal NIV-FB risk. Out of a total of 713 FBs, NIV-FB was performed in 50 patients with multiple comorbidities, acute or chronic RF, substantial tracheal narrowing, or after previously unsuccessful FB attempt. RESULTS: In three cases, reversible complications were observed. Additionally, due to the severity of underlining disease, two patients were transferred to the ICU where they passed away after >48h. In a single variable analysis, PaO2 69 â€‹± â€‹18.5 and 49 â€‹± â€‹9.0 [mmHg] (p â€‹< â€‹0.05) and white blood count (WBC) 10.0 â€‹± â€‹4.81 and 14.4 â€‹± â€‹3.10 (p â€‹< â€‹0.05) were found predictive for complications. Left heart disease indicated unfavorable NIV-FB outcome (p â€‹= â€‹0.046). CONCLUSIONS: NIV-FB is safe in severely ill patients, however procedure-related risk should be further defined and verified in prospective studies.

Effects of trans-endocardial delivery of bone marrow-derived CD133+ cells on angina and quality of life in patients with refractory angina: A sub-analysis of the REGENT-VSEL trial.

BACKGROUND: The REGENT-VSEL trial demonstrated a neutral effect of transendocardial injection of autologous bone marrow (BM)-derived CD133+ in regard to myocardial ischemia. The current sub-analysis of the REGENT VSEL trial aims to assess the effect stem cell therapy has on quality of life (QoL) in patients with refractory angina. METHODS: Thirty-one patients (63.0 ± 6.4 years, 70% male) with recurrent CCS II-IV angina, despite optimal medical therapy, enrolled in the REGENT-VSEL single center, randomized, double-blinded, and placebo-controlled trial. Of the 31 patients, 16 individuals were randomly assigned to the active stem cell group and 15 individuals were randomly assigned to the placebo group on a 1:1 basis. The inducibility of ischemia, (≥ one myocardial segment) was confirmed for each patient using Tc-99m SPECT. QoL was measured using the Seattle Angina Questionnaire. Each patient completed the questionnaire prior to treatment and at the time of their outpatient follow-up visits at 1, 4, 6, and 12 months after cell/placebo treatment. RESULTS: The main finding of the REGENT-VSEL trial sub-analysis was that transendocardial injection of autologous BM-derived CD133+ stem cells in patients with chronic refractory angina did not show significant improvement in QoL in comparison to the control group. Moreover, there was no significant difference between cell therapy and placebo in a number of patients showing improvement of at least 1 Canadian Cardiovascular Society class during the follow-up period. CONCLUSIONS: Intra-myocardial delivery of autologous CD133+ stem cells is safe and feasible but does not show a significant improvement in the QoL or angina pectoris symptoms in patients with chronic myocardial ischemia.

Day and time of admissions to intensive care units - does it matter?

BACKGROUND: The literature data pertaining to the significance of day and time of ICU admission for outcomes of patients are inconsistent. The issue has not been analysed in Poland to date. The aim of the study was to gather information about differences between patients admitted to ICU outside regular working hours (off-hours) and those admitted during working hours (on-hours). METHODS: Analysis involved 20,651 patients from the Silesian Registry of Intensive Care Units carried out since 2010. The findings demonstrated that 34.8% of patients were admitted to ICUs during on-hours (between 8.00 a.m. and 3 p.m. on weekdays) and 65.2% were admitted during off-hours (outside regular working hours). The incidence of admissions and data of patients in both groups were compared in terms of the population characteristics and treatment outcomes. RESULTS: The incidence of admissions (calculated per each 24 hours of treatment) was found to be almost twice as high during on-hours, as compared to off-hours (14.5 vs. 6.9 patients/day). Patients admitted to the ICU during on-hours were less likely to be admitted from the surgical department (19.1% vs. 31.0%, P < 0.001), and more likely to be admitted from the emergency department (25.3% vs. 14.2%, P < 0.001). The incidence of off-hours admissions of cancer patients was lower (5.3% vs. 10.8%, P < 0.001), as compared with patients with alcohol dependence syndrome (10.3% vs. 6.9%, P < 0.001). Patients admitted during off-hours were in more severe conditions and had higher APACHE II scores (on average, 23.8 ± 8.8 vs. 21.8 ± 8.8, P < 0.001); their mortality rates were higher compared to the remaining population (46.8% vs. 39.4%, P < 0.001). CONCLUSIONS: Patients admitted to ICUs during off-hours are in more severe general condition and their treatment outcomes are worse, as compared to patients admitted to ICU during on-hours.

Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial.

RATIONALE: New therapies for refractory angina are needed. OBJECTIVE: Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND RESULTS: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD]: 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit: 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score: -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit: -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume: -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume: -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months. CONCLUSION: Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.