Audit of patients with severe acute pancreatitis admitted to an intensive care unit

Background

Severe acute pancreatitis (SAP) is a disease with high morbidity and mortality. We undertook a study of patients with SAP admitted to the intensive care unit (ICU) of a tertiary referral hospital.

Methods

Between 2002 and 2007, 50 patients with SAP were admitted in our intensive care unit (ICU). Data were collected from their medical records and their clinical profile, course and outcome were retrospectively analyzed. Patients were categorized into survivor and nonsurvivor groups, and were further classified based on interventions such as percutaneous drainage and surgical necrosectomy.

Results

SAP contributed 5?% of total ICU admissions during the study period. Median age of survivors (n?=?20) was 34 against 44?years in nonsurvivors (n?=?30). Median Acute Physiology and Chronic Health Evaluation (APACHE) II score in nonsurvivors was 16.5 (8?C32) vs. 12.5 (5?C20) in survivors (p?=?0.002). Patients with APACHE II score ??12 had mortality >80?% compared to 23?% with score <12 (p?<?0.001). Median Sequential Organ Failure Assessment (SOFA) scores on admission and on days 3, 7, 14, and 21 were significantly higher in nonsurvivors compared to survivors (p?<?0.05). Mean (SD) intraabdominal pressure was 23 (3.37) mmHg in nonsurvivors vs. 19.05 (2.51) in survivors (p?<?0.05). Patients with renal failure had significant mortality (p?<?0.001). Length of ICU stay, requirement for vasopressor, total parenteral nutrition, and the amount of blood and blood product transfusions differed significantly between patients with and without intervention.

Conclusions

APACHE II and SOFA scores and other clinical data correlated with outcome in SAP admitted to ICU.     

Key Barriers to Medication Adherence in Survivors of Strokes and Transient Ischemic Attacks

BACKGROUND

Even though medications can greatly reduce the risk of recurrent stroke, medication adherence is suboptimal in stroke survivors.

OBJECTIVE

To identify key barriers to medication adherence in a predominantly low-income, minority group of stroke and transient ischemic attack (TIA) survivors.

DESIGN

Cross-sectional study.

PARTICIPANTS

Six hundred stroke or TIA survivors, age ≥ 40 years old, recruited from underserved communities in New York City.

MAIN MEASURES

Medication adherence was measured using the 8-item Morisky Medication Adherence Questionnaire. Potential barriers to adherence were assessed using validated instruments. Logistic regression was used to test which barriers were independently associated with adherence. Models were additionally controlled for age, race/ethnicity, income, and comorbidity.

KEY RESULTS

Forty percent of participants had poor self-reported medication adherence. In unadjusted analyses, compared to adherent participants, non-adherent participants had increased concerns about medications (26 % versus 7 %, p?<?0.001), low trust in their personal doctor (42 % versus 29 %, p?=?0.001), problems communicating with their doctor due to language (19 % versus 12 %, p?=?0.02), perceived discrimination from the health system (42 % versus 22 %, p?<?0.001), difficulty accessing health care (16 % versus 8 %, p?=?0.002), and inadequate continuity of care (27 % versus 20 %, p?=?0.05). In the fully adjusted model, only increased concerns about medications [OR 5.02 (95 % CI 2.76, 9.11); p?<?0.001] and perceived discrimination [OR 1.85 (95 % CI 1.18, 2.90); p?=?0.008] remained significant barriers.

CONCLUSIONS

Increased concerns about medications (related to worry, disruption, long-term effects, and medication dependence) and perceived discrimination were the most important barriers to medication adherence in this group. Interventions that reduce medication concerns have the greatest potential to improve medication adherence in low-income stroke/TIA survivors.     

Elevated serum YKL-40 level predicts myocardial reperfusion and in-hospital MACE in patients with STEMI

Background

Macrophages in atherosclerotic plaques secrete YKL-40, a new biomarker of acute and chronic inflammation in patients with stable CAD. We hypothesized that YKL-40 may be a specific marker reflecting the burden of localized inflammation in myocardium and a predictor in patients with STEMI. In this study, we investigated the relationship of YKL-40 to in-hospital major adverse cardiac events (MACE), reperfusion parameters and its predictors in patients with STEMI.

Methods

In total, 80 patients with STEMI and no history of prior coronary artery disease (CAD), who underwent primary percutaneous coronary intervention (p-PCI), were enrolled consecutively. In addition, 30 patients with normal coronary arteries (NCA) were enrolled as a control group. Cardiac biomarker levels including creatinine kinase-MB fraction (CK-MB), troponin-I, admission glucose and inflammatory markers including leukocytes and YKL-40 levels were measured as admission values.

Results

In our study, YKL-40 levels correlated to high-sensitivity CRP levels (r?=?0.333, p?=?0.003), TIMI risk score (r?=?0.445, p?<?0.001), age (r?=?0.477, p?<?0.001), pain to balloon time (r?=?0.432, p?<?0.001), leukocyte and neutrophil count (r?=?0.386, p?<?0.001 and r?=?0.430, p?<?0.001, respectively), hemoglobin (r?=???0.345, p?=?0.002), admission and fasting blood glucose (r?=?0.388, p?<?0.001 and r?=?0.427, p?<?0.001), creatinine levels (r?=?0.395, p?<?0.001) and myocardial blush grade (r?=???0.334, p?=?0.004). When the patients were divided into two groups determined by presence or absence of MACE, the patients with MACE had significantly higher levels of YKL-40 in comparison to the patients without MACE and the control group (194?±?104, 114?±?61 and 110?±?53 μg/L, p?<?0.001, respectively). In multivariate logistic regression analysis in STEMI patients, only YKL-40 level (OR: 1.011, 95%CI: 1.002–1.019, p?=?0.011) and leukocyte count (OR: 1.264, 95%CI: 1.037–1.540, p?=?0.020) were the independent predictors for MACE. Sensitivity and specificity of YKL-40 to predict MACE, when 125 μg/l was accepted as a cut-off value, were 84% and 70%, respectively.

Conclusion

We found that serum YKL-40 is related to older age, increased admission glucose levels, leukocyte counts and decreased hemoglobin levels; YKL-40 level and leukocyte count independently predicted MACE.     

Incidence and predictors of hematological side effects in chronic HCV Egyptian patients treated with PEGylated interferon and ribavirin

Aim

The aim of this paper was to study the incidence and predictors of hematological abnormalities during treatment of chronic hepatitis C virus (HCV) patients with interferon and ribavirin.

Methods

One thousand and eighty-one chronic HCV patients who were treated with PEGylated interferon α-2a 180 μg (n?=?536) or α-2b 1.5 μg/kg (n?=?545) plus ribavirin for 48 weeks were included. Baseline demographic, laboratory, and histopathological data and, during treatment, hematological data were collected and analyzed using univariate and multivariate analyses to identify independent predictors of hematological side effects.

Results

During therapy, 168 of 1,018 (15.5 %) had moderate anemia (Hb?<10 and ≥8.5 g/dL) and 88 (8.1 %) had severe anemia (Hb?<8.5 g/dL). Two hundred and six patients (19.1 %) had moderate neutropenia (absolute neutrophil count (ANC)?<750 and ≥500/mm³); only 55 (5.1 %) had severe neutropenia (ANC?<500/mm³). Forty-three patients (4 %) had moderate (platelet <50,000 and ≥25,000/mm³) and 5 (1.4 %) had severe thrombocytopenia (platelet <25,000/mm³). Fibrosis stage, week 4 Hb level, and week 2 and 4 reduction level in Hb were independent predictors of moderate and severe anemia (p?<?0.001). Fibrosis stage and ANC at weeks 2 and 4 were predictors of neutropenia (p?<?0.001, 0.001, and 0.004, respectively). Fibrosis stage and platelet count at weeks 2 and 4 were predictors of thrombocytopenia (p?<?0.001, <0.001, and 0.005, respectively). There was no association between interferon type and anemia (p?=?0.57), neutropenia (p?=?0.6), or thrombocytopenia (p?=?0.79).

Conclusions

Fibrosis stage and week 2 and 4 hematological parameter reduction levels were independent predictors of hematological side effects, which are not related to interferon type.     

Combination of Sildenafil and Bosentan for Pulmonary Hypertension in a Human Ex Vivo Model

Purpose

Both sildenafil and bosentan have been used clinically to treat pulmonary arterial hypertension. As these substances target different pathways to modulate vasoconstriction, we investigated the combined effects of both drug classes in isolated human pulmonary vessels.

Methods

Segments of pulmonary arteries (PA) and veins (PV) were harvested from 51 patients undergoing lobectomy. Contractile force was determined isometrically in an organ bath. Vessels were constricted with norepinephrine (NE) to determine effects of sildenafil. They were constricted with ET-1 to assess effects of bosentan, and with NE and ET-1 to evaluate the combination of both substances.

Results

Sildenafil (1E-5 M) significantly reduced maximum constriction by NE of both PA (13.0?±?11.1 vs. 34.9?±?7.6 % relative to KCl induced constriction; n?=?6; p?<?0.001) and PV (81.2?±?34.2 vs 121.6?±?20.8 %; n?=?6; p?<?0.01) but did not affect basal tones. Bosentan (1E-5 M) significantly reduced maximum constriction of PV (56.6?±?21.5 vs. 172.1?±?30.0 %; n?=?6; p?<?0.01) by ET-1 and led to a small but insignificant decrease of basal tone (p?=?0.07). Bosentan almost completely abolished constriction of PA (1.0?±?0.9 vs. 74.7?±?25.7 %; n?=?6; p?<?0.001) by ET-1, but did not affect basal tone. Bosentan (1E-7 M) significantly attenuated combined ET-1/NE dose–response curves in PA (93.1?±?47.4 vs. 125.3?±?41.0 %; n?=?12; p?<?0.001) whereas the effect of sildenafil (1E-5 M) was less pronounced (103.6?±?20.2 %; p?<?0.05). Simultaneous administration of both substances showed a significantly greater reduction of maximum constriction in PA compared to individual administration (64.6?±?26.3 %; p?<?0.001).

Conclusions

Sildenafil only at its highest concentration was effective in suppressing NE induced pulmonary vessel contraction. Bosentan was able to completely suppress ET-1 induced contraction of PA and strongly attenuated contraction of PV. The present data suggest a benefit of sildenafil/bosentan combination therapy as they affect different pathways and may allow lower dosages.     

The relationship between defibrillation threshold and total mortality

Background

The relationship between the defibrillation threshold (DFT) and total mortality is unclear.

Methods

A university hospital prospectively maintained implantable defibrillator (ICD) database identified 508 patients who underwent ICD implantation and had DFT testing performed at implant. Patients were placed in one of three groups based on the implant DFT (high (≥20 J), moderate (19–11 J), or low DFT (≤10 J)).

Results

Sixty-seven patients had a high DFT, 216 had a moderate DFT, and 225 had a low DFT. The mean left ventricular ejection fraction (LVEF) was 0.25, 0.28, and 0.30 in the high, moderate, and low DFT groups, respectively, (p?=?0.04). There were significantly more patients with a subcutaneous electrode in the high DFT group (p?<?0.001), more patients taking amiodarone (p?<?0.001), and more patients on oral anticoagulation (p?=?0.04). There were a total of 140 deaths during the follow-up period (mean 3.2?±?1.7 years). There were 24 deaths in the high DFT group (35.8 %), 62 in the moderate DFT group (28.7 %), and 54 in the low DFT group (24.0 %) (p?=?0.05). Implant DFT was a significant predictor of mortality (p?=?0.01), as was age, LVEF (p?<?0.001), CAD (p?=?0.01), amiodarone use (p?=?0.02), and hematoma at implant (p?=?0.01). An elevated DFT was an independent predictor of mortality after controlling for all significant univariate variables (p?=?0.004).

Conclusions

A high-implant DFT predicts an adverse prognosis, even when an adequate ICD safety margin is present.     

Outcomes of rectal cancer treatment—influence of age?

Purpose

To evaluate how age influences the selection to different treatment modalities for rectal cancer and how these differences in approach affect the short- and long-term outcomes.

Methods

A single-center cohort of all 837 rectal cancer patients diagnosed between 1994 and 2006 was analyzed. Patients <75, 75–79, 80–84, and >85 years were compared.

Results

Treatment for cure was judged possible for 80.8, 77.9, 74.6, and 65.3 % of the four age groups (p?=?0.02), and radiochemotherapy was given to 22.9, 19.3, 10.2, and 2 % of the same groups (p?=?0.001). Local resection was performed for 3.7, 14.7, 13.6, and 24.5 % (p?<?0.001) and anterior resection for 66.6, 54.1, 56.8, and 49 % (p?<?0.001). The 5-year rates of local recurrence were 5.3, 8.3, 12.8, and 22.3 % (p?<?0.001), and overall survival was 70, 54, 45.9, and 29.8 % in the four groups treated with curative intent (p?<?0.001). Relative survival was 76.4, 72.6, 72.9, and 72.3 % (ns).

Conclusions

Age caused treatment to be modified; there was less surgery for patients over 85 years, less radiochemotherapy over 80 years, and less major radical surgery over 75 years. This strategy resulted in more local recurrences among the elderly, although no certain effect on relative survival was observed.     

Age impacts the pattern of care for elderly patients with rectal cancer

Purpose

This study analyzed the current approaches for rectal cancer treatment in elderly patients.

Methods

We retrospectively studied 240 rectal cancer patients who had undergone radiotherapy from 2000 to 2008. The ages of the patients ranged from 65 and 75 years (group A, n?=?127) and older than 75 years (group B, n?=?113). The distribution of the Charlson comorbidity index was similar between the two groups, but the ECOG performance status (PS) differed between the groups (66 % of the patients of group A were PS 0, and 40 % were PS 0 in group B (p?<?0.0001)). The tumor stages were comparable between groups.

Results

The median age of the patients was 74.3 years (range 65–90.6). Treatment was discussed during a multidisciplinary cancer team meeting before treatment for 55 % of the cases in group A and 73 % of the cases in group B (p?<?0.001), and treatment proposals were in accordance with guidelines in 96 % of the cases in group A and 76 % of the cases in group B (p?<?0.001). Group B patients received slightly less concurrent chemotherapy (35 vs. 30 % for group A; p?=?0.54), more hypofractionated radiotherapy (41 vs. 54 % for group A; p?=?0.064), less surgery (92 vs. 80 % for group A; p?=?0.014), and less adjuvant chemotherapy (34 vs. 10 % for group A; p?<?0.001). Finally, 80 % of the patients in group A and 60 % of the patients in group B received treatment in accordance with guidelines (p?=?0.007) and in the logistic regression model. Non-metastatic patients who were aged below 75 years were predicted for conformal management (HR?=?0.323; 95 % CI?=?0.152–0.684) irrespective of their performance status, comorbidity, or disease stage.

Conclusions

Treatment proposals and administered therapy differed according to age.     

Assessment of shoulder pain and shoulder disability in patients with implantable cardioverter–defibrillator

Purpose

Shoulder pain and disability is a common but overlooked disorder in patients with implantable cardioverter–defibrillators (ICD). We aimed to assess chronic shoulder pain and disability in patients with ICD.

Methods

Two hundred fifty-four patients (mean age, 66?±?12 years; 156 men) with ICD were included in the study. The Shoulder Pain and Disability Index (SPADI) was used for assessment of shoulder pain and disability.

Results

Of the patients, 131 (52 %) have shoulder pain and disability. The total mean SPADI score in patients with shoulder pain and disability was 33?±?18 and was significantly higher than in patients without shoulder pain and disability (11?±?2; p?<?0.001). Patients with three-lead ICD have significantly higher SPADI scores than patients with single-lead ICD (p?<?0.001). Number of leads correlated with pain score (p?=?0.001, r?=?0.253), disability score (p?=?0.006, r?=?0.174) and total SPADI score (p?=?0.001, r?=?0.213). In multivariate analysis, significant associates of shoulder pain and disability were evaluated, adjusting for age, sex, body mass index, procedure time, implantation time interval, limitation of shoulder activity and number of leads. Number of leads was the only predictor of shoulder pain and disability (OR 0.518, 95 % CI, 0.372–0.721; p?<?0.001).

Conclusions

Patients with ICD implantation frequently have chronic shoulder pain and disability. Patients with three leads suffer more shoulder pain and disability.     

Comparative-Effectiveness of Revascularization Versus Routine Medical Therapy for Stable Ischemic Heart Disease: A Population-Based Study

BACKGROUND

Randomized studies have shown optimal medical therapy to be as efficacious as revascularization in stable ischemic heart disease (IHD). It is not known if these efficacy results are reflected by real-world effectiveness.

OBJECTIVE

To evaluate the comparative effectiveness of routine medical therapy versus revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in stable IHD.

DESIGN

Observational cohort study.

PATIENTS

Stable IHD patients from 1 October 2008 to 30 September 2011, identified using a Registry of all angiography patients in Ontario, Canada.

INTERVENTION

Revascularization, defined as PCI/CABG within 90 days after index angiography.

MAIN MEASURES

Death, myocardial infarction (MI) or repeat PCI/CABG. Revascularization was compared to medical therapy using a) multivariable Cox-proportional hazard models with therapy strategy treated as a time-varying covariate; and b) a propensity score matched analysis. Post-angiography medication use was determined.

KEY RESULTS

We identified 39,131 stable IHD patients, of whom 15,139 were treated medically, and 23,992 were revascularized (PCI?=?15,604; CABG?=?8,388). Mean follow-up was 2.5 years. Revascularization was associated with fewer deaths (HR 0.76; 95 % CI 0.68–0.84; p?<?0.001) ,MIs (HR 0.78; 95 % CI 0.72–0.85; p?<?0.001) and repeat PCI/CABG (HR 0.59; 95 % CI 0.50–0.70; p?<?0.001) than medical therapy. In the propensity-matched analysis of 12,362 well–matched pairs of revascularized and medical therapy patients, fewer deaths (8.6 % vs 12.7 %; HR 0.75; 95 % CI 0.69–0.81; p?<?0.001) , MIs (11.7 % vs 14.4 %; HR 0.84; 95 % CI 0.77–0.93 p?<?0.001) and repeat PCI/CABG ( 17.4 % vs 24.1 %;HR 0.67; 95 % 0.63–0.71; p?<?0.001) occurred in revascularized patients, over the 4.1 years of follow-up. The revascularization patients had higher uptake of clopidogrel (70.3 % vs 27.2 %; p?<?0.001), β-blockers (78.2 % vs 76.7 %; p?=?0.010), and statins (94.7 % vs 91.5 %, p?<?0.001) in the 1-year post-angiogram.

CONCLUSIONS

Stable IHD patients treated with revascularization had improved risk-adjusted outcomes in clinical practice, potentially due to under-treatment of medical therapy patients.     

Identifying the Risks of Anticoagulation in Patients with Substance Abuse

BACKGROUND

Warfarin is effective in preventing thromboembolic events, but concerns exist regarding its use in patients with substance abuse.

OBJECTIVE

Identify which patients with substance abuse who receive warfarin are at risk for poor outcomes.

DESIGN

Retrospective cohort study. Diagnostic codes, lab values, and other factors were examined to identify risk of adverse outcomes.

PATIENTS

Veterans AffaiRs Study to Improve Anticoagulation (VARIA) database of 103,897 patients receiving warfarin across 100 sites.

MAIN MEASURES

Outcomes included percent time in therapeutic range (TTR), a measure of anticoagulation control, and major hemorrhagic events by ICD-9 codes.

RESULTS

Nonusers had a higher mean TTR (62 %) than those abusing alcohol (53 %), drugs (50 %), or both (44 %, p?<?0.001). Among alcohol abusers, an increasing ratio of the serum hepatic transaminases aspartate aminotransferase/alanine aminotransferase (AST:ALT) correlated with inferior anticoagulation control; normal AST:ALT?≤ 1.5 predicted relatively modest decline in TTR (54 %, p?<?0.001), while elevated ratios (AST:ALT 1.50–2.0 and > 2.0) predicted progressively poorer anticoagulation control (49 % and 44 %, p?<?0.001 compared to nonusers). Age-adjusted hazard ratio for major hemorrhage was 1.93 in drug and 1.37 in alcohol abuse (p?<?0.001 compared to nonusers), and remained significant after also controlling for anticoagulation control and other bleeding risk factors (1.69 p?<?0.001 and 1.22 p?=?0.003). Among alcohol abusers, elevated AST:ALT >2.0 corresponded to more than three times the hemorrhages (HR 3.02, p?<?0.001 compared to nonusers), while a normal ratio AST:ALT ≤ 1.5 predicted a rate similar to nonusers (HR 1.19, p?<?0.05).

CONCLUSIONS

Anticoagulation control is particularly poor in patients with substance abuse. Major hemorrhages are more common in both alcohol and drug users. Among alcohol abusers, the ratio of AST/ALT holds promise for identifying those at highest risk for adverse events.     

Glucocorticoid treatment impairs microvascular function in healthy men in association with its adverse effects on glucose metabolism and blood pressure: a randomised controlled trial

Aims/hypothesis

Glucocorticoids (GCs) are widely used anti-inflammatory agents that frequently induce side effects, including insulin resistance, diabetes and hypertension. Here, we investigated the contribution of microvascular dysfunction to the development of these adverse effects in healthy men.

Methods

In a randomised, placebo-controlled, dose–response intervention study, 32 healthy normoglycaemic men (age: 21?±?2 years; BMI: 21.9?±?1.7 kg/m²) were allocated to receive prednisolone 30 mg once daily (n?=?12), prednisolone 7.5 mg once daily (n?=?12) or placebo (n?=?8) for 2 weeks using block randomisation. A central office performed the treatment allocation, and medication was dispersed by the hospital pharmacy that was also blinded. Treatment allocation was kept in concealed envelopes. Participants, study personnel conducting the measures and assessing the outcome were blinded to group assignment. The study was conducted at a university hospital. Primary endpoint was prednisolone-induced changes in microvascular function, which was assessed by capillary microscopy. Insulin sensitivity was determined by hyperinsulinaemic–euglycaemic clamp and postprandial glycaemic excursions by standardised meal tests.

Results

Compared with placebo, prednisolone 7.5 mg and 30 mg decreased insulin-stimulated capillary recruitment by 9?±?4% and 17?±?3%, respectively (p?<?0.01). In addition, prednisolone 7.5 mg and 30 mg reduced insulin sensitivity (M value) by ?11.4?±?4.5 μmol kg^?1 min^?1 and ?25.1?±?4.1 μmol kg^?1 min^?1 (p?<?0.001) and increased postprandial glucose levels by 11?±?5% and 27?±?9% (p?<?0.001), respectively. Only high-dose prednisolone increased systolic blood pressure (6?±?1.2 mmHg, p?=?0.006). Prednisolone-induced changes in insulin-stimulated capillary recruitment were associated with insulin sensitivity (r?=?+0.76; p?<?0.001), postprandial glucose concentrations (r?=??0.52; p?<?0.03) and systolic blood pressure (r?=??0.62; p?<?0.001). Prednisolone increased resistin concentrations, which were negatively related to insulin-stimulated capillary recruitment (r?=??0.40; p?=?0.03). No effects were noted on adiponectin and leptin concentrations. Prednisolone treatment was well tolerated; none of the participants left the study.

Conclusions/interpretation

Prednisolone-induced impairment of insulin-stimulated capillary recruitment was paralleled by insulin resistance, increased postprandial glucose levels, hypertension and increased circulating resistin concentrations in healthy men. We propose that GC-induced impairments of microvascular function may contribute to the adverse effects of GC treatment on glucose metabolism and blood pressure.

Trial registration

isrctn.org ISRTCN 78149983

Funding

The study was funded by the Dutch Top Institute Pharma T1-106.     

Weight Loss Success in Metabolic Syndrome by Telephone Interventions: Results from the SHINE Study

BACKGROUND

The Diabetes Prevention Program (DPP) intensive lifestyle intervention resulted in significant weight loss, reducing the development of diabetes, but needs to be adapted to primary care provider (PCP) practices.

OBJECTIVES

To compare a DPP-translation using individual (IC) vs. conference (CC) calls delivered by PCP staff for the outcome of percent weight loss over 2 years.

DESIGN

Randomized clinical trial.

SETTING

Five PCP sites.

PARTICIPANTS

Obese patients with metabolic syndrome, without diabetes (IC, n?=?129; CC, n?=?128).

INTERVENTION

Telephone delivery of the DPP Lifestyle Balance intervention [16-session core curriculum in year 1, 12-session continued telephone contact in year 2 plus telephone coaching sessions (dietitians).

MAIN MEASURES

Weight (kg), body mass index (BMI), and waist circumference.

KEY RESULTS

Baseline data: age?=?52 years, BMI?=?39 kg/m², 75 % female, 85 % non-Hispanic White, 13 % non-Hispanic Black, and 48 % annual incomes <$40,000/year. In the intention-to-treat analyses at year 2, mean percent weight loss was ?5.6 % (CC, p?<?0.001) and ?1.8 % (IC, p?=?0.046) and was greater for CC than for IC (p?=?0.016). At year 2, mean weight loss was 6.2 kg (CC) and 2.2 kg (IC) (p?<?0.001). There was similar weight loss at year 1, but between year 1 and year 2 CC participants continued to lose while IC participants regained. At year 2, 52 % and 43 % (CC) and 29 % and 22 % (IC) of participants lost at least 5 % and 7 % of initial weight. BMI also decreased more for CC than IC (?2.1 kg/m² vs. ?0.8 kg/m² p?<?0.001). Waist circumference decreased by 3.1 cm (CC) and 2.4 cm (IC) at year 2. Completers (≥9 of 16 sessions; mean 13.3 sessions) lost significantly more weight than non-completers (mean 4.3 sessions).

CONCLUSIONS

PCP staff delivery of the DPP lifestyle intervention by telephone can be effective in achieving weight loss in obese people with metabolic syndrome. Greater weight loss may be attained with a group telephone intervention.     

Diabetes was the only comorbid condition associated with mortality of invasive pneumococcal infection in ICU patients: a multicenter observational study from the Outcomerea research group

Purposes

Streptococcus pneumoniae is a leading pathogen of severe community, hospital or nursing facility infections. We sought to describe characteristics of invasive pneumococcal infection (IPI) and pneumonia (due to the high mortality of intensive care-associated pneumonia) and to report outcomes according to various types of comorbidity.

Methods

Multicenter observational cohort study on the prospective Outcomerea database, including adult patients, with a hospital stay?<?48 h before ICU admission and a documented IPI within the first 72 h of ICU admission. Comorbid conditions were defined according to the Knaus and Charlson classification.

Results

Of the 20,235 patients, 5310 (26.4%) had an invasive infection, including 560/5,310 (10.6%) who had an IPI. The ICU 28-day mortality was 109/560 (19.8%). Four factors were independently associated with mortality: SOFA day 1–2: [hazard ratio (HR) 1.21; 95% confidence interval (95% CI) 1.15–1.27, p?<?0.001]; maximum lactate level day 1–2: (HR 1.07, 95% CI 1.02–1.12, p?=?0.006); diabetes mellitus: (HR 1.91, 95% CI 1.23–3.03, p?=?0.006) and appropriate antibiotics (HR 0.28, 95% CI 0.15–0.50, p?<?0.001). Comparable results were obtained when other comorbid conditions were forced into the model. Diabetes impact was more pronounced in case of micro- or macro-angiopathy (HR 4.17, 95%CI 1.68–10.54, p?=?0.003), in patients?≥?65 years old (HR 2.59, 95% CI 1.56–4.28, <?0.001) and in those with body mass index (BMI)?<?25 kg/m² (HR 2.11, 95% CI 1.10–4.06, p?=?0.025).

Conclusions

Diabetes mellitus was the only comorbid condition which independently influenced mortality in patients with IPI. Its impact was more pronounced in patients with complications, aged?≥?65 years and with BMI?<?25 kg/m².

     

Interaction of vitamin K antagonists with heparin affect monitoring by activated clotting times

Background

Unfractionated heparin is recommended during atrial fibrillation (AF) ablation to achieve activated clotting time (ACT) above 250–300 s to prevent clot. Many patients on therapeutic international normalised ratio (INR) undergo AF ablation procedures; however, it is unknown whether they require less heparin to achieve similar ACT levels.

Methods

During AF ablation, the ACT was measured before and 10 min after administration of i.v. unfractionated heparin in patients with and without anticoagulation. The association of INR, heparin, pre-procedure ACT and body weight with ACT after heparin administration was tested using multivariable linear regression models.

Results

The subjects of this study were 149 patients undergoing AF ablation, among them 40 (27%) with subtherapeutic INR?<?2, 79 (53%) with an INR between 2 and 3, and 30 (20%) patients with INR?>?3. Baseline ACT was associated with INR (r?=?0.33, p?<?0.001). After a mean of 8,685?±?2,015 U (range, 5,000–15,000 IU) unfractionated heparin, univariate predictors of ACT were baseline INR (p?<?0.001), heparin dose (p?=?0.012) and baseline ACT (p?=?0.027). In the multivariable model, baseline INR (part r?=?0.64, p?<?0.001) and heparin dose (part r?=?0.33, p?<?0.001) strongly predicted post-heparin ACT. Estimated from the regression model, the heparin dose reductions by approximately one third in those with an INR of 2–3 and by at least two thirds in those with an INR above 3 may be favourable. Over the following 3 months, no thromboembolism and acute bleeding were observed.

Conclusion

The INR was the strongest predictor of post-heparin ACT, even more important than the heparin dose itself. The reduction of heparin dose by one third if INR is between 2–3 and by two thirds if INR is above 3 may be favourable.     

Incidence,predictors, and clinical course of atrial tachyarrhythmias in patients with pulmonary hypertension

Background

The prevalence and predictors of atrial tachyarrhythmias (ATa) in patients with pulmonary hypertension (PH) is less well understood.

Methods

We performed a retrospective study including 311 patients with PH, confirmed by right heart catheterization in our center between 2007 and 2011. Baseline characteristics, clinical, echocardiographic, and hemodynamic data were collected and compared between patients with and without ATa.

Results

The mean age was 61?±?13 years with 64 % females. The mean pulmonary artery pressure (mPAP) was 46?±?20 mmHg, mean left ventricular ejection fraction (LVEF) was 55?±?13 %, and mean pulmonary capillary wedge pressure (PCWP) was 19?±?9 mmHg. Of the 311 patients with PH, 121 (39 %) patients had ATa. Patients with ATa were older (p?p?=?0.03), diabetes (p?=?0.015), coronary artery disease (p?p?p?=?0.001), impaired LVEF (p?=?0.02), and left atrial enlargement (p?p?=?0.022). In multivariate analysis using Cox-proportional hazard model, the independent predictors of mortality were age (HR 1.05; p?=?0.003), coronary artery disease (HR 2.34; p?=?0.047), LVEF (HR 0.793; p?=?0.023), and mPAP (HR 1.023; p?=?0.003).

Conclusion

ATa are common in patients with PH. Left heart disease, left atrial enlargement, and elevated PCWP but not right atrial enlargement or mPAP predict the occurrence of ATa in patients with PH.     

Immediate and medium-term outcomes of cryoballoon-based pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation: single-centre experience

Background

Pulmonary vein (PV) isolation with cryoballoon is a recently developed technique for the treatment of atrial fibrillation (AF) with acceptable mid-term results in terms of the success and safety. The purpose of our study is to identify the periprocedural complications, mid-term success rates and predictors of recurrence after AF ablation with cryoballoon.

Method

A total of 236 patients (54 % male, mean age 54.6?±?10.45 years and 79.6 % paroxysmal AF) with symptomatic AF underwent PV isolation with cryoballoon due to failure with ≥1 antiarrhythmic drug previously. Procedural success, complications and follow-up data were defined according to recent guidelines.

Results

Acute procedural success rate was 99.5 %. Mean procedural and fluoroscopy times were 72.5?±?5.3 and 14?±?3.5 min. At a median of 18 (6–27)?months follow-up, 80.8 % of paroxysmal AF patients and 50.0 % of persistent AF patients were free from AF recurrence. In multivariate regression analysis, body mass index (BMI) (hazard ratio (HR), 1.35; 95 % confidence interval (CI), 1.18–2.93, p?=?0.001), smoking (HR, 2.12; 95 % CI, 1.36–6.67, p?<?0.001), non-paroxysmal AF (HR, 1.26; 95 % CI, 1.12–2.56, p?=?0.024), duration of AF (HR, 1.42; 95 % CI, 1.18–2.61, p?=?0.015), left atrium (LA) diameter (HR, 2.42; 95 % CI, 1.64–5.88, p?<?0.001) and early AF recurrence (HR, 4.88; 95 % CI, 2.86–35.6, p?<?0.001) were independent predictors of AF recurrence following cryoablation.

Conclusion

Our results showed that AF ablation with cryoballoon is effective and safe. Non-paroxysmal AF, duration of AF, smoking, BMI, LA diameter and early recurrence were found to be the most powerful predictors and could be helpful to select patients for appropriate therapeutic strategy.     

Acute procedural and cryoballoon characteristics from cryoablation of atrial fibrillation using the first- and second-generation cryoballoon: a retrospective comparative study with follow-up outcomes

Purpose

There is limited data available on the safety and efficacy of the second-generation cryoballoon (CB-2) for cryoablation of atrial fibrillation (Cryo-AF). We evaluated the procedural, biophysical, and clinical outcomes of Cryo-AF in a large patient cohort using CB-2 as compared with the first-generation cryoballoon (CB-1).

Methods

Three-hundred and forty consecutive patients undergoing Cryo-AF with CB-1 (n?=?140) and CB-2 (n?=?200) were retrospectively evaluated.

Results

Paroxysmal AF was more prevalent in CB-1 (86 %) versus CB-2 (72 %) (p?=?0.001). During Cryo-AF, the mean balloon temperature was lower with CB-2 at 30 s (8 versus ?4 °C; p?p?p?=?0.542). With CB-2, time-to-nadir temperature was shorter (232 versus 209 s; p?p?p?=?0.036) despite reduced cryoablation time (61 versus 47 min; p?p?p?p?p?=?0.037).

Conclusions

With CB-2, acute and long-term PV isolation rates were higher despite shorter ablations, faster balloon cooling, and longer thaw times, with similar AE rates and freedom from AF.     

Predictors of left atrium appendage clot detection despite on-target warfarin prevention for atrial fibrillation

Background and purpose

The antithrombotic management of atrial fibrillation (AF) is currently based on clinical scores (CHADS₂ or CHA₂DS₂VASc). The prevalence of left atrium (LA) thrombi in effectively anticoagulated AF patients has been reported as being up to 7.7 %. We tried to correlate LA/LA appendage (LAA) thrombus detection with possible clinical predictors in warfarin-treated patients.

Methods

We performed trans-esophageal echocardiography on 430 patients (mean age, 60.3?±?9.8 years) receiving oral anticoagulant (OAC) therapy and undergoing pulmonary vein isolation. In 10/430 (2.3 %), an LA thrombus was found despite therapeutic OAC (mean INR 2.6?±?0.6; range, 2.0–3.8) over the previous 4 weeks.

Results

Two study groups were identified:

1. T-positive group?=?with LAA thrombus (10 patients)
2. T-negative group?=?without LAA thrombus (420 patients)

The T-positive patients had a higher CHADS₂ score (1.5?±?0.7 versus 0.7?±?0.8; p?=?0.004), a lower LVEF (54.7?±?9.5 % versus 60.2?±?7.4; p?=?0.02), and a larger LA size (LA diameter, 56?±?12.2 mm versus 46?±?6.5 mm; p? <?0.001and normalized LA volume: 140.2?±?66 ml/m² vs. 67?±?39 ml/m²; p?<?0.05). On multivariate analysis, a larger LA diameter and normalized LA volume (OR, 1.14; 95 % C.I., 1.04–1.26; p?=?0.006 and OR, 1.02; 95 % C.I., 1.01–1.03; p?=?0.001, respectively) and a higher CHA₂DS₂VASc score (OR, 2.4; 95 % C.I., 1.4–4.2; p?=?0.001) predicted left atrium appendage (LAA) thrombus. In another 42/430 (9.8 %) patients, an LA spontaneous echo-contrast (SEC) was detected. Thus, cumulatively, 52/430 (12.1 %) patients had either LAA thrombi (10 patients) or SEC (42 patients). LA diameter continued to predict the presence of either thrombi or SEC (OR, 1.14; 95 % C.I., 1.07–1.2; p?<?0.05).

Conclusions

We found a 2.3 % prevalence of LA thrombus (12.1 % when SEC was also considered). The thrombus was present despite on-target warfarin prevention. In addition to a higher CHA₂DS₂VASc score, a larger LA size was a strong predictor of clot detection.