Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose‐lowering agents

Aims To compare starter insulins in the elderly subgroup of the DURABLE trial 24‐week initiation phase. Methods In a post‐hoc analysis of the ≥ 65 years subgroup enrolled in the DURABLE trial, we compared the safety and efficacy of lispro mix 25 (LM25: lispro 25%/insulin lispro protamine suspension 75%), n = 258, vs. glargine, n = 222, added to oral glucose‐lowering agents. Results Baseline glycated hemoglobin (HbA_1c) was similar (LM25 8.7 ± 1.2, glargine 8.8 ± 1.1%, P = 0.612). At 24‐weeks, LM25 patients had lower HbA_1c (7.0 ± 0.9 vs. 7.3 ± 0.9%, P < 0.001), greater HbA_1c reduction (?1.7 ± 1.2 vs. ?1.5 ± 1.1%, P < 0.001), and more patients reaching HbA_1c < 7.0% (55.6 vs. 41.0%, P = 0.005). LM25 patients were on more insulin (0.40 ± 0.19 vs. 0.33 ± 0.19 u/kg/day, P < 0.001) and experienced more weight gain (3.6 ± 3.6 vs. 1.8 ± 3.2 kg, P < 0.001). Additionally, LM25‐treated patients reported a higher mean overall hypoglycaemia rate than glargine patients (40.8 ± 47.6 vs. 31.1 ± 48.5 episodes/patient/year, P = 0.037), while nocturnal hypoglycaemia rates were similar. Over 24 weeks, incidence of severe hypoglycaemia was higher for LM25 (4.3% vs. 0.9%, P = 0.018); however, by 24‐week endpoint incidence was similar (0.8% vs. 0.0%P = 0.125). Conclusions In this elderly subgroup post‐hoc analysis, LM25 demonstrated a lower endpoint HbA_1c and a higher % of patients reaching HbA_1c target of < 7.0%, but with more weight gain and higher rates of hypoglycaemia compared to glargine.     

Long‐term outcomes of direct acting antivirals in post‐transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis

Long‐term functional outcomes of sofosbuvir‐based antiviral treatment were evaluated in a cohort study involving 16 Italian centres within the international compassionate use programme for post‐transplant hepatitis C virus (HCV) recurrence. Seventy‐three patients with cirrhosis (n=52) or fibrosing cholestatic hepatitis (FCH, n=21) received 24‐week sofosbuvir with ribavirin±pegylated interferon or interferon‐free sofosbuvir‐based regimen with daclatasvir/simeprevir+ribavirin. The patients were observed for a median time of 103 (82‐112) weeks. Twelve of 73 (16.4%) died (10 non‐FCH, 2 FCH) and two underwent re‐LT. Sustained virological response was achieved in 46 of 66 (69.7%): 31 of 47 (66%) non‐FCH and 15 of 19 (79%) FCH patients. All relapsers were successfully retreated. Comparing the data of baseline with last follow‐up, MELD and Child‐Turcotte‐Pugh scores improved both in non‐FCH (15.3±6.5 vs 10.5±3.8, P<.0001 and 8.4±2.1 vs 5.7±1.3, P<.0001, respectively) and FCH (17.3±5.9 vs 10.1±2.8, P=.001 and 8.2±1.6 vs 5.5±1, P=.001, respectively). Short‐treatment mortality was higher in patients with baseline MELD≥25 than in those with MELD<25 (42.9% vs 4.8%, P=.011). Long‐term mortality was 53.3% among patients with baseline MELD≥20 and 7.5% among those with MELD<20 (P<.0001). Among deceased patients 75% were Child‐Turcotte‐Pugh class C at baseline, while among survivors 83.9% were class A or B (P<.0001). Direct acting antivirals‐based treatments for severe post‐transplant hepatitis C recurrence, comprising fibrosing cholestatic hepatitis, significantly improve liver function, even without viral clearance and permit an excellent long‐term survival. The setting of severe HCV recurrence may require the identification of “too‐sick‐to‐treat patients” to avoid futile treatments.     

Non‐invasive ventilation of patients with acute asthma

A retrospective observational study of 21 patients admitted to the Intensive Care Unit (ICU) of Frankston Hospital with acute asthma between 2011 and 2014 was undertaken. We report the outcomes for three groups of patients; those that did (n = 7) or did not (n = 6) receive initial therapy with non‐invasive ventilation (NIV) together with those that received invasive ventilation (n = 8). Patients successfully managed with NIV alone experienced a shorter ICU and hospital stay versus those who required invasive ventilation.     

Five‐year outcome in COPD patients after their first episode of acute exacerbation treated with non‐invasive ventilation

Background and objective: Little is known about long‐term survival of patients surviving the first episode of type II respiratory failure requiring non‐invasive ventilation (NIV). We aimed to determine the 1‐, 2‐ and 5‐year survival, cause of death and potential prognostic indicators in this patient cohort. Methods: We retrospectively identified 100 sequential COPD patients (mean age 70, mean FEV₁ 37% predicted) treated with NIV for the first time. Mortality and data on hospital morbidity and potential prognostic factors were collected from patient records and a State Health Data Linkage Service. Results: Survival at 1, 2 and 5 years was 72%, 52% and 26%, respectively. Respiratory failure secondary to COPD was the commonest cause of death (56.8%), followed by cardiovascular events (25.7%). Readmission rate at 1 year was 60% for those who survived 2 years or more and 52% for those deceased within 2 years. Recurrent respiratory failure requiring NIV was observed in 31% of the cohort. Only advance age (P = 0.04), BMI (P = 0.014) and prior domiciliary oxygen use (P = 0.03) correlated with death within 5 years. Severity of respiratory failure did not correlate with mortality. Conclusions: The 2‐ and 5‐year mortality rates for patients with COPD surviving their first episode of respiratory failure requiring NIV are high. Physiological measures of the severity of respiratory failure at presentation do not predict subsequent survival and nor does the time interval between first and second admissions requiring NIV. Age, BMI and prior need for domiciliary oxygen are the main predictors of mortality at 5 years.     

AA genotype of IL‐8 −251A/T is associated with low PaO2/FiO2 in critically ill patients and with increased IL‐8 expression

Background and Objective: Interleukin‐8 (IL‐8) is a central chemokine in acute respiratory distress syndrome (ARDS), and the IL‐8 gene contains a functional single nucleotide polymorphism (SNP) ?251A/T in its promoter region. We hypothesized that IL‐8 ?251A/T SNP is associated with PaO₂/FiO₂ in critically ill patients. Methods: We conducted genetic‐association studies in intensive care units at academic teaching centres using a derivation septic shock cohort (vasopressin and septic shock trial (VASST), n = 467) and a validation post‐cardiopulmonary bypass surgery cohort (CPB, n = 739) of Caucasian patients. Patients in both cohorts were genotyped for IL‐8 ?251A/T. The primary outcome variable in both cohorts was the fraction of patients who had a PaO₂/FiO₂ < 200. IL‐8 mRNA expression was measured in genotyped lymphoblastoid cells in vitro. Results: The frequency of the patients with PaO₂/FiO₂ <200 was significantly greater in patients who had the AA genotype of ?251A/T than in patients who had the AT or TT genotypes in both VASST (AA = 60.8% vs AT and TT = 53.8% and 48.0%, P = 0.038) and the CPB cohort (AA = 37.0% vs AT and TT = 27.0% and 26.0%, P = 0.039). Patients having the AA genotype had a higher probability to remain on mechanical ventilation (P = 0.047) in the first 14 days. Lymphoblastoid cells having the AA genotype had significantly higher IL‐8 mRNA expression than cells having the AT or TT genotype (P = 0.022). Conclusions: Critically ill Caucasian patients who had the AA genotype of IL‐8 ?251A/T had an increased risk of PaO₂/FiO₂ <200. The AA genotype was associated with greater IL‐8 mRNA expression than the AT or TT genotypes.     

Cardiac Functional Reserve is Diminished in Growth Hormone‐Deficient Adults

Various studies have shown that patients with severe growth hormone deficiency (GHD) have diverse changes in left ventricular (LV) size or performance but so far there is no direct indication of cardiac reserve ability to maintain the circulation during peak exercise. We tested the hypothesis that patients with severe GHD have reduced cardiac reserve function compared with healthy controls. Eighteen patients with severe GHD were studied and compared with 18 age‐, sex‐, and body mass index (BMI)‐matched healthy controls. Peak cardiac power and cardiorespiratory fitness were investigated using noninvasive hemodynamic measurements during maximal cardiopulmonary exercise testing. Compared with matched controls, the cardiac power of GHD patients during exercise to volitional exhaustion was significantly reduced by 15% (mean ± SD: 4.4 ± 1.0 watts (W) vs. 5.2 ± 1.0 W, P= 0.02), despite attaining similar aerobic exercise peaks (VO_{2 max}, GHD: 2390 ± 822 mL/min vs. controls: 2461 ± 872 mL/min, P= 0.80) and similar peak respiratory exchange ratios. The lower peak cardiac power could not be accounted for by peripheral alterations because both groups reached similar peak exercise systemic vascular resistances. Patients with GHD also had lower cardiac chronotropic reserve (peak heart rate: 154 ± 21 bpm vs. 174 ± 11 bpm, P= 0.001) and a lower cardiac pressure‐generating capacity (systolic blood pressure [SBP] 160 ± 25 mmHg vs. 200 ± 15 mmHg, P < 0.0001). Using this robust noninvasive method of assessing functional cardiac pumping capacity we have for the first time shown that patients with severe GHD have a significantly impaired cardiac functional reserve associated with chronotropic incompetence and impaired pressure‐generating capacity.     

Difference in outcome among women and men after percutaneous mitral valvuloplasty

Objective : To analyze the differences in anatomical, clinical and echocardiographic characteristics of women and men undergoing PMV and to evaluate the relationship between sex, PMV success, and immediate and long‐term clinical outcome. Background : Rheumatic mitral stenosis (MS) is predominantly a disease of middle‐aged women. Percutaneous mitral valvuloplasty (PMV) has become the standard of care for suitable patients. However little is known about the relationship between sex, PMV success, and procedural outcome. Methods and results : We evaluated measures of procedural success and clinical outcome in consecutive patients (839 women and 176 men) who underwent PMV. Despite a lower baseline echocardiographic score (7.47 ± 2.15 vs. 8.02 ± 2.18, P = 0.002), women were less likely to achieve PMV success (69% vs. 83%, adjusted OR 0.44, 95% CI 0.27–0.74, P = 0.002), and had a smaller post‐procedural MV area (1.86 ± 0.7 vs. 2.07 ± 0.7 cm², P < 0.001). Overall procedural and in‐hospital complication rates did not differ significantly between women and men. However, women were significantly more likely to develop severe MR immediately post PMV (adjusted OR 2.41, 95% CI 1.0–5.83, P = 0.05) and to undergo MV surgery (adjusted HR 1.54, 95% CI 1.03–2.3, P = 0.037) after a median follow‐up of 3.1 years. Conclusions : Compared to men, women with rheumatic MS who undergo PMV are less likely to have a successful outcome and more likely to require MV surgery on long‐term follow‐up despite more favorable baseline MV anatomy. © 2010 Wiley‐Liss, Inc.     

Increased risk of nontuberculous mycobacterial infection in asthmatic patients using long-term inhaled corticosteroid therapy

Background and objective: The risk of pneumonia is increased among COPD patients using inhaled corticosteroids (ICS). However, there is uncertainty regarding the association between long‐term use of ICS and exacerbations of respiratory tract infections among asthmatic patients. Methods: A case‐control nested cohort study was performed to assess the association of asthma with nontuberculous mycobacterium (NTM) infection. Results: Among this cohort of 464 asthmatic patients, 14 experienced complications due to NTM infections, of which eight were caused by Mycobacterium avium‐intracellulare complex, three by M. kansasii, one by M. terrae and the remaining two by unclassifiable scotochromogens. Asthmatic patients with NTM infections were older (67.1 ± 8.6 vs 58.8 ± 12.3 years, P < 0.01) and had more severe airflow limitation (FEV₁%, 60.6 ± 10.3 vs 72.3 ± 18.3, P < 0.03) than those without NTM infections. All except one had received ICS treatment for more than 5 years, and 12 of the 14 patients used inhaled fluticasone propionate daily (four patients at a dose of 400 µg/day and eight patients at a dose >800 µg/day). Conclusions: These findings suggest that the risk of NTM infection may be greater in asthmatic patients who are older, have more severe airflow limitation and receive higher doses of ICS therapy.     

Post‐prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus

Aims To study whether post‐prandial insulin lispro (PL) could be used as a part of insulin therapy instead of premeal human regular insulin (HR) in prepubertal children with Type 1 diabetes mellitus (Type 1 DM). Patients and methods In this open, randomized cross‐over study patients used either PL or HR at breakfast and at dinner. After a 1‐month screening period, patients were randomized to treatment with PL or HR for 3 months and then they crossed over to the other insulin for an additional 3 months. The patients were 24 prepubertal children with Type 1 DM (median age 6.2 years, duration of diabetes 37 months). Home monitoring of 1‐day glucose profiles at meals (premeal, 1 h and 2 h after breakfast and after dinner) and HbA_1c were measured before randomization, before cross‐over, and at the last visit. Data on hypoglycaemic episodes were collected at each of the seven visits. The variables were compared between the two treatments. Results Of the patients 22/24 completed the study. There were no major differences in the glucose excursions between PL and HR after breakfast (mean ± sd : 1‐h PL 3.7 ± 4.7 vs. HR 2.9 ± 3.9 mmol/l, P = 0.3; 2‐h ?0.9 ± 5.4 vs. 0.3 ± 4.5 mmol/l, P = 0.2, respectively) or after dinner (1‐h PL ?2.5 ± 4.8 vs. HR ?0.4 ± 3.7 mmol/l, P = 0.07, 2‐h ?4.1 ± 5.2 vs. ?0.7 ± 5.0 mmol/l, P = 0.05, respectively). Mean change of HbA_1c was similar in both treatment groups (PL 0.2 ± 0.8% vs. HR ?0.4 ± 0.7%, P = 0.1). The frequency of hypoglycaemic episodes was 4.9 per patient per month during treatment with PL, and 4.4 during HR (P = 0.3). Conclusion Treatment with post‐prandial lispro as a meal insulin is as effective and safe as traditional treatment with regular insulin in young children. Diabet. Med. 18, 654–658 (2001)     

Childhood measles contributes to post‐bronchodilator airflow obstruction in middle‐aged adults: A cohort study

Background and objective

Chronic obstructive pulmonary disease (COPD) has potential origins in childhood but an association between childhood measles and post‐bronchodilator (BD) airflow obstruction (AO) has not yet been shown. We investigated whether childhood measles contributed to post‐BD AO through interactions with asthma and/or smoking in a non‐immunized middle‐aged population.

Methods

The population‐based Tasmanian Longitudinal Health Study (TAHS) cohort born in 1961 (n = 8583) underwent spirometry in 1968 before immunization was introduced. A history of childhood measles infection was obtained from school medical records. During the fifth decade follow‐up (n = 5729 responses), a subgroup underwent further lung function measurements (n = 1389). Relevant main associations and interactions by asthma and/or smoking on post‐BD forced expiratory volume in 1 s/forced vital capacity (FEV₁/FVC; continuous variable) and AO (FEV₁/FVC < lower limit of normal) were estimated by multiple regression.

Results

Sixty‐nine percent (n = 950) had a history of childhood measles. Childhood measles augmented the combined adverse effect of current clinical asthma and smoking at least 10 pack‐years on post‐BD FEV₁/FVC ratio in middle age (z‐score: −0.70 (95% CI: −1.1 to −0.3) vs −1.36 (−1.6 to −1.1), three‐way interaction: P = 0.009), especially for those with childhood‐onset asthma. For never‐ and ever‐smokers of <10 pack‐years who had current asthma symptoms, compared with those without childhood measles, paradoxically, the odds for post‐BD AO was not significant in the presence of childhood measles (OR: 12.0 (95% CI: 3.4–42) vs 2.17 (0.9–5.3)).

Conclusion

Childhood measles infection appears to compound the associations between smoking, current asthma and post‐BD AO. Differences between asthma subgroups provide further insight into the complex aetiology of obstructive lung diseases for middle‐aged adults.

     

Acute respiratory distress syndrome in patients with hematological malignancies

Abstract

Background

We investigated the clinical course and mortality of acute respiratory distress syndrome (ARDS) in patients with hematological malignancies.

Methods

Sixty-eight patients with hematological malignancies and ARDS admitted to medical intensive care unit (ICU) of a university hospital were analyzed semi-prospectively in the study.

Results

The most common etiology of ARDS was pneumonia. The ratio of partial pressure of oxygen in arterial blood to fractional concentration of inspired oxygen (PO₂/FiO₂) was 104 (74–165). Ten patients (15%) received non-invasive mechanical ventilation (NIV), 21 (31%) received invasive mechanical ventilation (MV), and 36 (53%) received both NIV and invasive MV. ICU mortality was 77% in the cohort. None of the variables with relevance to the underlying hematological disease was associated with mortality. The presence of two or more organ failures was the only independent risk factor for mortality (P = 0.045), whereas NIV was associated with low mortality (P = 0.001). The Kaplan–Meier curve of mortality, with respect to the type of MV support, demonstrated that NIV was associated with the lowest mortality (P < 0.001).

Conclusion

The mortality of ARDS in critically ill patients with hematological malignancies is quite high. The presence of multi-organ failure is independently associated with high mortality whereas the use of NIV is independently associated with low mortality.     

Asthma management and asthma control in São Paulo,Brazil and Uppsala,Sweden: a questionnaire‐based comparison

Background and Aims: The Global Initiative Against Asthma (GINA) was developed to meet the global challenge of asthma. GINA has been adopted in most countries and comparison of asthma management in different parts of the world may be of help when assessing the global dissemination of the guideline. The overall goals in GINA include that asthma patients should be free of symptoms, acute asthma attacks and activity limitations. The aim of the present study was to compare asthma management and asthma control in São Paulo, Brazil and Uppsala, Sweden. Materials and Methods: Information was collected from asthmatics in São Paulo and Uppsala with a questionnaire. The questionnaire dealt with the following issues: symptoms, smoking, self‐management, hospital visits, effect on school/work and medication. Results: The São Paulo patients were more likely to have uncontrolled asthma (36% vs 13%, P < 0.001), having made emergency room visits (57% vs 29%, P < 0.001) and having lost days at school or work because of their asthma (46% vs 28%, P = 0.03) than the asthmatics from Uppsala. There were no difference in the use of inhaled corticosteroids, but the Brazilian patients were more likely to be using theophylline (18% vs 1%, P = 0.001) and less likely to be using long‐acting beta‐2 agonists (18% vs 37%, P < 0.001). Conclusion: We conclude that the level of asthma control was lower among the patients from São Paulo than Uppsala. Few of the patients in either city reached the goals set up by GINA. Improved asthma management may therefore lead to health–economic benefits in both locations. Please cite this paper as: Skorup P, Rizzo LV, Machado‐Boman L and Janson C. Asthma management and asthma control in São Paulo, Brazil and Uppsala, Sweden: a questionnaire‐based comparison. The Clinical Respiratory Journal 2009; 3: 22–28.     

Tracheostomy placement in infants with bronchopulmonary dysplasia: Safety and outcomes

Optimizing the timing and safety for the placement of a tracheostomy in infants with bronchopulmonary dysplasia (BPD) has not been determined. The purpose of the present study was to describe the data from a single institution about the efficacy and safety of tracheostomy placement in infants with BPD needing long‐term respiratory support. We established a service line for the comprehensive care of infants with BPD and we collected retrospective clinical data from this service line. We identified patients that had a trachostomy placed using the local Vermont‐Oxford database, and obtained clinical data from chart reviews. We identified infants who had a tracheostomy placed for the indication of severe BPD only. Safety and respiratory efficacy was assessed by overall survival to discharge and the change in respiratory supportive care from just before placement to 1‐month post‐placement. Twenty‐two patients (750 ± 236 g, 25.4 ± 2.1 weeks gestation) had a tracheostomy placed on day of life 177 ± 74 which coincided with a post‐conceptual age of 51 ± 10 weeks. At placement these infants were on high settings to support their lung disease. The mean airway pressure (MAP) was 14.3 ± 3.3 cmH₂O, the peak inspiratory pressure was 43.7 ± 8.0 cmH₂O, and the FiO₂ was 0.51 ± 0.13. The mean respiratory severity score (MAP × FiO₂) 1 month after tracheostomy was significantly (P = 0.03) lower than prior to tracheostomy. Survival to hospital discharge was 77%. All patients with tracheostomies that survived were discharged home on mist collar supplemental oxygen. In conclusion, the high survival rate in these patients with severe BPD and the decreased respiratory support after placement of a tracheostomy suggests that high ventilatory pressures should not be a deterrent for placement of a tracheostomy. Future research should be aimed at determining optimal patient selection and timing for tracheostomy placement in infants with severe BPD. Pediatr Pulmonol. 2013; 48:245–249. © 2012 Wiley Periodicals, Inc.     

In‐patient rehabilitation in haemophilic subjects with total knee arthroplasty

Summary. Total knee arthroplasty (TKA) is a major orthopaedic surgery intervention, indicated for severe haemophilic arthropathy. The aim of our study was to analyse rehabilitation outcome in haemophilic patients after TKA. A consecutive series of 21 patients (23 knees) was retrospectively evaluated. The mean age was 37 ± 8 years (range 22–55). Physiotherapy treatment was performed twice a day for 5 days week^?1, for 3 h day^?1. Assessment included knee range of motion (ROM), Visual Analogue Scale (VAS) for pain evaluation, Western Ontario and McMaster University (WOMAC) Score for functional outcome, Medical Research Council Scale (MRC) for quadriceps muscle strength evaluation, incidence of adverse events and a self‐reported questionnaire. The patients’data were recorded before surgery (t0), at Rehabilitation Unit admission (t1), before discharge (t2) and at follow‐up (t3), 11–48 months after rehabilitation. Western Ontario and McMaster University Score (ref. score: 0–96) was 56.7 ± 12 at t0 and 6.2 ± 6 at t3 (t3 vs. t0: P < 0.001). Visual Analogue Scale (ref. score: 0–10) decreased from 5.0 ± 2 at t1 to 2.1 ± 2 at t2 (t2 vs. t1: P < 0.05) and to 0.1 ± 0 at t3 (t3 vs. t2: P < 0.05). Flexion degrees increased from 43.4 ± 21° at t1 to 80.2 ± 15° at t2 (t2 vs. t1: P < 0.001) and to 95.0 ± 15° at t3 (t3 vs t2: P < 0.05). According to MRC (ref. score: 0–5), quadriceps muscle strength increased from 2.3 ± 0.6 at t1 to 3.6 ± 0.5 at t2 (t2 vs. t1: P < 0.05). Adverse events were found in four patients. Patients’ satisfaction on their outcome at follow‐up was referred as good by 72% of patients or excellent by 28% of patients. Postsurgical intensive rehabilitation in haemophilic patients resulted effective, safe and feasible.     

Serial intravascular ultrasound analysis comparing double kissing and classical crush stenting for coronary bifurcation lesions

Background : Compared with the classical crush, double kissing (DK) crush improved outcomes in patients with coronary bifurcation lesions. However, there is no serial intravascular ultrasound (IVUS) comparisons between these two techniques. Objectives : This study aimed to analyze the mechanisms of the two crush stenting techniques using serial IVUS imaging. Methods : A total of 54 patients with IVUS images at baseline, post‐stenting and eight‐month follow‐up were classified into classical (n = 16) and DK (n = 38) groups. All patients underwent final kissing balloon inflation (FKBI). Unsatisfactory kissing (KUS) was defined as the presence of wrist or >20% stenosis during FKBI at the side branch (SB) ostium. The vessels at bifurcation lesions were divided into the proximal main vessel (MV) stent, the crushed segment, the distal MV stent, the SB ostium and the SB stent body. Results : KUS and incomplete crushing were commonly observed in the classical group (62.5%, 81.3%), compared with DK group (18.0%, 39.5%, P < 0.001 and P = 0.004). The post‐stenting stent symmetry in the classical group was 71.85 ± 7.69% relative to 85.93 ± 6.09% in DK group (P = 0.022), resulting in significant differences in neointimal hyperplasia (NIH, 1.60 ± 0.21 mm² vs. 0.85 ± 0.23 mm², P = 0.005), late lumen loss (1.31 ± 0.81 mm² vs. 0.55 ± 0.70 mm², P = 0.013), and minimal lumen area (MLA, 3.57 ± 1.52 mm² vs. 4.52 ± 1.40 mm^2, P = 0.042) at the SB ostium between two groups. KUS was positively correlated with the incomplete crush and was the only predictor of in‐stent‐restenosis (ISR) at the SB ostium. Conclusion : DK crush was associated with improved quality of the FKBI and larger MLA. KUS predicted the occurrence of ISR. © 2011 Wiley Periodicals, Inc.     

Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit

BackgroundTo compare the application of non-invasive ventilation (NIV) versus continuous positive airway pressure (CPAP) in the treatment of patients with cardiogenic pulmonary edema (CPE) admitted to an intensive care unit (ICU).MethodsIn a prospective, randomized, controlled study performed in an ICU, patients with CPE were assigned to NIV (n=56) or CPAP (n=54). Primary outcome was intubation rate. Secondary outcomes included duration of ventilation, length of ICU and hospital stay, improvement of gas exchange, complications, ICU and hospital mortality, and 28-day mortality. The outcomes were analyzed in hypercapnic patients (PaCO₂ > 45 mmHg) with no underlying chronic lung disease.ResultsBoth devices led to similar clinical and gas exchange improvement; however, in the first 60 min of treatment a higher PaO₂/FiO₂ ratio was observed in the NIV group (205±112 in NIV vs. 150±84 in CPAP, P=.02). The rate of intubation was similar in both groups (9% in NIV vs. 9% in CPAP, P=1.0). There were no differences in duration of ventilation, ICU and length of hospital stay. There were no significant differences in ICU, hospital and 28-d mortality between groups. In the hypercapnic group, there were no differences between NIV and CPAP.ConclusionsEither NIV or CPAP are recommended in patients with CPE in the ICU. Outcomes in the hypercapnic group with no chronic lung disease were similar using NIV or CPAP.     

Nasopharyngeal oxygen with intermittent nose‐close and abdomen‐compression: A novel resuscitation technique in a piglet model

Objective: To evaluate the efficacy of a simple and novel cardiopulmonary resuscitation (CPR) technique, nasopharyngeal oxygen with intermittent nose‐close and abdomen‐compression (NPO₂‐NC‐AC) in an animal model. Design: Prospective piglet study. Setting: In an animal physiology laboratory of a medical university. Piglets: Six healthy piglets <14 days old. Interventions: Spontaneous breathing of the anesthetized piglets (n = 6) was medically ceased until severe bradycardia (<20 beat/min). NPO₂‐NC‐AC CPR trial was then initiated by delivering NPO₂ at 1.0–1.5 L/kg/min and intermittently performing the NC‐AC maneuver: (1) NC for inspiration, occluded nostrils for 1 sec; and (2) AC for expiration, released nostrils, and compressed the abdomen for 1 sec. NC‐AC was repeated at a rate of 30/min for 5 min. This CPR trial was repeated three times in each piglet. Cardiopulmonary variables were monitored, recorded, and compared. Measurements and Main Results: A total of 18 CPR trials were performed. All of these acute life‐threatening asphyxia events rapidly improved within 1 min of CPR. Cardiopulmonary variables recovered to the baseline levels and oxygenation continually increased. The intratracheal pressure (P_tr) values of positive end expiratory pressure and peak inspiratory pressure values were 4.3 ± 0.8 cmH₂O and 26.2 ± 4.1 cmH₂O, respectively. Chest wall movement was observed when the P_tr reached 17.5 ± 3.1 cmH₂O. All six piglets fully recovered after 63.8 ± 7.2 min of experiment without additional support. Conclusions: NPO₂‐NC‐AC is a simple and effective CPR technique for severe acute cardiopulmonary asphyxia in piglets. It may be clinically applicable for supportive or rescue use. Pediatr Pulmonol. 2013; 48:288–294. © 2012 Wiley Periodicals, Inc.     

Impact of a prolonged delivery inflation time for optimal drug‐eluting stent expansion

Purpose: We examined the importance of prolonged inflation time for optimal sirolimus‐eluting stent (SES) or paclitaxel‐eluting stent (PES) expansion. Methods: Eighty‐one de novo lesions deployed single SES or PES between April 2007 and March 2008 were divided into four groups; group 1: 21 SES deployed at 20 atm × 60 sec, group 2: 20 SES deployed with 2‐step inflation at 20 atm × 60 sec following 20 atm × 20 sec, group 3: 20 PES deployed same as group 1, group 4: 20 PES deployed same as group 2. The minimal lumen diameter (MLD) and stent expansion ratio (SER; stent cross‐ sectional area at lesion/balloon cross‐sectional area which was calculated according to the compliance chart at the same atmosphere as stent deployment) were compared between group 1 and group 2 in SES, between group 3 and group 4 in PES. Results: The MLD of post 60 sec was significantly higher than that of post 20sec (2.84 ± 0.28 mm in group 1, 2.76 ± 0.33 mm in group 2 vs. 2.54 ± 0.33 mm in group 2; P = 0.003, 0.045, respectively and 2.94 ± 0.28 mm in group 3, 3.00 ± 0.34 mm in group 4 vs. 2.69 ± 0.35 mm in group 4; P = 0.022, 0.007, respectively). The SER of post 60 sec was significantly higher than that of post 20 sec (79.3% ± 8.5% in group 1, 80.8% ± 7.8% in group 2 vs. 71.1% ± 10.2% in group 2; P = 0.014, 0.011, respectively and 81.1% ± 7.9% in group 3, 84.3% ± 9.9% in group 4 vs. 72.6% ± 10.5% in group 4, P = 0.011, 0.001, respectively). Conclusion: The prolonged delivery inflation for 60 sec may result in a more optimal stent expansion. It is therefore considered to be a useful method for deploying drug‐eluting stent. © 2008 Wiley‐Liss, Inc.     

Clinical Efficacy of Phosphodiesterase‐5 Inhibitor Tadalafil in Eisenmenger Syndrome—A Randomized,Placebo‐controlled,Double‐blind Crossover Study

Objectives. In a randomized double‐blind crossover trial, we compared the efficacy of phosphodiesterase‐5 (PDE‐5) inhibitor tadalafil with placebo in patients of Eisenmenger Syndrome (ES). The primary end point was the change in 6‐minute walk test distance (6 MWD). Secondary end points were the effect of the drug on systemic oxygen saturation (SO₂), pulmonary vascular resistance (PVR), systemic vascular resistance (SVR), effective pulmonary blood flow (EPBF), and World Health Organization (WHO) functional class. Background. ES is a disorder with limited treatment options. Uncontrolled studies have shown PDE‐5 inhibitors to be beneficial in patients of ES. Methods. Twenty‐eight symptomatic adult patients of ES with weight ≥30 kg in WHO class II and III were enrolled. Patients were given 40 mg of tadalafil or matching placebo for 6 weeks followed by crossover to the other drug after a washout period of 2 weeks. Assessment of WHO class, exercise capacity by 6 MWD, and various hemodynamic parameters by cardiac catheterization was done at baseline, after 6 weeks and at the end of the study. Results. All patients completed the study. There was significant increase in 6 MWD following drug administration compared with baseline (404.18 ± 69.54 m vs. 357.75 ± 73.25 m, P < .001). Compared with placebo, tadalafil produced significant decrease in PVR (?7.32 ± 1.58, P < .001), resulting in significant increase in EPBF (0.12 ± 0.05, P= .03), SO₂ % (1.72 ± 0.58, P= .007), and WHO functional class (1.96 ± 0.18 vs. 2.14 ± 0.44, P= .025), with no significant change in SVR (P= NS). Conclusion. In this first short‐term placebo‐controlled trial of tadalafil in patients of ES, the drug was well tolerated and significantly improved exercise capacity, functional class, SO₂, and pulmonary hemodynamics. http://www.clinicaltrial.gov/ct2/show/NCT01200732?term=NCT01200732&rank=1     

A first‐in‐man study of the reitan catheter pump for circulatory support in patients undergoing high‐risk percutaneous coronary intervention

Objectives : To investigate the safety of a novel percutaneous circulatory support device during high‐risk percutaneous coronary intervention (PCI). Background : The Reitan catheter pump (RCP) consists of a catheter‐mounted pump‐head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion. Methods : Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 ± 9; LVEF 34% ± 11%; jeopardy score 8 ± 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose? sutures. PCI was performed via the radial artery. Outcomes included in‐hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal. Results : The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 ± 1,424 rpm maintained an aortic gradient of 9.8 ± 2 mm Hg. Although fHb increased, there was no significant hemolysis (4.7 ± 2.4 mg/dl pre vs. 11.9 ± 10.5 post, P = 0.04, reference 20 mg/dl). Platelets were unchanged (pre 257 ± 74 × 10⁹ vs. 245 ± 63, P = NS). Renal function improved (cre pre 110 ± 27 μmol/l vs. 99 ± 28, P = 0.004). The RCP was not used in one patient following femoral introducer sheath related aortic dissection. All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal. Conclusions : The RCP can be used safely in high‐risk PCI patients. This device may be an alternative to other percutaneous systems when substantial cardiac support is needed. © 2009 Wiley‐Liss, Inc.