Anna Suling

Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial

Aims This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation. Methods and results Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) −3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of −10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095). Conclusion Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.

Prevalence of mental disorders in elderly people: the European MentDis_ICF65+ study.

BACKGROUND Except for dementia and depression, little is known about common mental disorders in elderly people. AIMS To estimate current, 12-month and lifetime prevalence rates of mental disorders in different European and associated countries using a standardised diagnostic interview adapted to measure the cognitive needs of elderly people. METHOD The MentDis_ICF65+ study is based on an age-stratified, random sample of 3142 older men and women (65-84 years) living in selected catchment community areas of participating countries. RESULTS One in two individuals had experienced a mental disorder in their lifetime, one in three within the past year and nearly one in four currently had a mental disorder. The most prevalent disorders were anxiety disorders, followed by affective and substance-related disorders. CONCLUSIONS Compared with previous studies we found substantially higher prevalence rates for most mental disorders. These findings underscore the need for improving diagnostic assessments adapted to the cognitive capacity of elderly people. There is a need to raise awareness of psychosocial problems in elderly people and to deliver high-quality mental health services to these individuals.

Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis

This on-treatment analysis was conducted to facilitate understanding of mechanisms underlying the increased risk of all-cause and cardiovascular mortality in heart failure patients with reduced ejection fraction and predominant central sleep apnoea randomised to adaptive servo ventilation versus the control group in the SERVE-HF trial. Time-dependent on-treatment analyses were conducted (unadjusted and adjusted for predictive covariates). A comprehensive, time-dependent model was developed to correct for asymmetric selection effects (to minimise bias). The comprehensive model showed increased cardiovascular death hazard ratios during adaptive servo ventilation usage periods, slightly lower than those in the SERVE-HF intention-to-treat analysis. Self-selection bias was evident. Patients randomised to adaptive servo ventilation who crossed over to the control group were at higher risk of cardiovascular death than controls, while control patients with crossover to adaptive servo ventilation showed a trend towards lower risk of cardiovascular death than patients randomised to adaptive servo ventilation. Cardiovascular risk did not increase as nightly adaptive servo ventilation usage increased. On-treatment analysis showed similar results to the SERVE-HF intention-to-treat analysis, with an increased risk of cardiovascular death in heart failure with reduced ejection fraction patients with predominant central sleep apnoea treated with adaptive servo ventilation. Bias is inevitable and needs to be taken into account in any kind of on-treatment analysis in positive airway pressure studies. SERVE-HF on-treatment results showed increased cardiovascular risk similar to the intention-to-treat analysis http://ow.ly/hoO130dx4s9

Serum Matrix Metalloproteinases as Quantitative Biomarkers for Myocardial Fibrosis and Sudden Cardiac Death Risk Stratification in Patients With Hypertrophic Cardiomyopathy

BACKGROUND Hypertrophic cardiomyopathy (HCM) is associated with an increased risk of sudden cardiac death due to ventricular tachycardia (VT), and myocardial fibrosis reflects an important risk factor. Several matrix metalloproteinases (MMPs) and procollagen N-terminal propeptides (PNPs) are involved in collagen turnover and discussed as fibrosis biomarkers. We aimed to identify biomarkers that correlate with myocardial fibrosis in late-gadolinium-enhancement cardiac magnetic resonance imaging (LGE-CMR) and/or cardiac events (syncope, VT) in HCM patients. METHODS AND RESULTS In 54 HCM patients (age 55.9 ± 14.3 y, 50% female) fibrosis was quantified by LGE-CMR. Serum concentrations of MMP-1, -2, -3, -9, and tissue inhibitor of MMP (TIMP) 1 were analyzed by means of enzyme-linked immunosorbent assay and PINP, PIIINP, and type I collagen C-terminal telopeptide (ICTP) concentrations by radioimmunoassay. MMP-9 was associated with fibrosis in LGE-CMR (mean increase 0.66 g/unit MMP9 [95% confidence interval [CI] 0.50-0.82]; P < .001) and with cardiac events in women (odds ratio [OR] 1.07 [1.01-1.12], P = .01) but not in men. Increased MMP-2 levels in women were associated with lower fibrosis (0.05 [-0.09 to -0.01]; P = .015). MMP-3 levels were positively associated with cardiac events (OR 1.13 [1.05-1.22]; P = .001) independently from fibrosis and sex. No association was detected for MMP-1, TIMP-1, PNPs, and ICTP. CONCLUSIONS These data suggest that MMP-9 is a useful biomarker for fibrosis and cardiac events in female HCM patients, whereas MMP-3 is associated with a higher event rate independent from fibrosis and sex.

Long-term biomechanical analysis of donor site morbidity after radial forearm free flap.

BACKGROUND Although the radial forearm free flap (RFF) is a commonly used microvascular graft for head and neck reconstruction, long-term biomechanical results regarding donor site morbidity are rare. PATIENTS AND METHODS In a prospective panel study, 32 patients were included. Biomechanical assessment was performed preoperatively, three months postoperatively and two years postoperatively. The primary endpoint of the study was grip strength. In addition, the Mayo wrist score, DASH score (disabilities of the arm, shoulder and hand score), fine motor skill strengths (tip pinch, key pinch, palmar pinch) and the range of motion were analysed. Primary defects were closed with local full-thickness skin grafts (FTSG) from the donor site forearm avoiding a secondary defect site. RESULTS In the long-term analysis, grip strength was reduced in both arms. A significant improvement over time was found only for the donor arm. A persistent deficit of tip pinch strength and dorsal extension was recorded. Persistent sensory limitations occurred in four cases. Patient contentment after two years of follow-up was high and daily life routine was not restricted. CONCLUSION Gross and fine motor skill limitations are reversible short-term effects after RFF harvesting and do not restrict daily routine in the long term. These findings substantiate the value of the RFF as a workhorse in reconstructive surgery.

Phenotyping of Sleep-Disordered Breathing in Patients With Chronic Heart Failure With Reduced Ejection Fraction-the SchlaHF Registry

Background Different sleep‐disordered breathing (SDB) phenotypes, including coexisting obstructive and central sleep apnea (OSA‐CSA), have not yet been characterized in a large sample of patients with heart failure and reduced ejection fraction (HFrEF) receiving guideline‐based therapies. Therefore, the aim of the present study was to determine the proportion of OSA, CSA, and OSA‐CSA, as well as periodic breathing, in HFrEF patients with SDB. Methods and Results The German SchlaHF registry enrolled patients with HFrEF receiving guideline‐based therapies, who underwent portable SDB monitoring. Polysomnography (n=2365) was performed in patients with suspected SDB. Type of SDB (OSA, CSA, or OSA‐CSA), the occurrence of periodic breathing (proportion of Cheyne‐Stokes respiration ≥20%), and blood gases were determined in 1557 HFrEF patients with confirmed SDB. OSA, OSA‐CSA, and CSA were found in 29%, 40%, and 31% of patients, respectively; 41% showed periodic breathing. Characteristics differed significantly among SDB groups and in those with versus without periodic breathing. There was a relationship between greater proportions of CSA and the presence of periodic breathing. Risk factors for having CSA rather than OSA were male sex, older age, presence of atrial fibrillation, lower ejection fraction, and lower awake carbon dioxide pressure (pco 2). Periodic breathing was more likely in men, patients with atrial fibrillation, older patients, and as left ventricular ejection fraction and awake pco 2 decreased, and less likely as body mass index increased and minimum oxygen saturation decreased. Conclusions SchlaHF data show that there is wide interindividual variability in the SDB phenotype of HFrEF patients, suggesting that individualized management is appropriate. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01500759.

Integrating patient reported measures as predictive parameters into decisionmaking about palliative chemotherapy: a pilot study

BackgroundSystemic treatment has proven to improve physical symptoms in patients with advanced cancer. Relationship between quality of life (QoL) or symptom burden (SYB) and treatment efficacy (tumour response and survival) is poorly described. Therefore, we evaluated the predictive value of pretreatment QoL and SYB on treatment outcomes.MethodsEligible patients had metastatic gastrointestinal cancers and were about to receive 1st/2nd line palliative chemotherapy. 47 patients were consecutively enrolled. QoL and SYB were assessed by EORTC QLQ-C30 and MSKCC MSAS questionnaires before treatment and after first response evaluation after 8–12 weeks. Logistic regression analysis of QoL and SYB for prediction of objective treatment efficacy was performed. Patients were categorized according to response rate (RR) based on RECIST1.1 and progression free survival (PFS). PFS was categorized by a ratio (individual PFS/expected PFS) in above median (ratio ≥ 1) or below median PFS (ratio < 1). QoL and SYB were analysed for RR groups (partial response, stable or progressive disease) and PFS ratio (PFSR).ResultsObjective response to chemotherapy and increase in PFS were associated with better pretreatment QoL and less SYB. Patients with future objective treatment efficacy (PFSR ≥ 1) evidenced clinically relevant better role/emotional/cognitive/social functioning and less fatigue and appetite loss at baseline in comparison to PFSR < 1 (>10 points difference). Lowest scores in all functioning scales at treatment start were seen in patients with future PFSR < 1. Global health status (EORTC), PSYCH subscale and global distress index (MSAS) predicted PFSR, even if adjusted for gender, age, cancer type, ECOG and line of treatment (p < 0.05). Interestingly, improved QoL and SYB (subjective benefit) were noted even in patients with worse pretreatment status and no objective tumour response.ConclusionFuture non-responders seem to show distinct QoL patterns before chemotherapy. This may facilitate early detection of patients deriving less or even no benefit from treatment regarding prolongation of survival. Even in patients with primarily progressive disease QoL and SYB may improve during treatment. Integration of QoL and SYB assessment into decision-making about palliative chemotherapy seem to be an important approach to improve patient outcome and should be further evaluated.

Anxiety Disorders in Old Age: Psychiatric Comorbidities, Quality of Life, and Prevalence According to Age, Gender, and Country

OBJECTIVES Previous estimates of the prevalence of anxiety disorders in late life vary greatly due to the lack of reliable diagnostic tools. This MentDis_ICF65+ study assessed 12-month prevalence rates of anxiety disorders and age- and gender-related differences in comorbidities, as well as impact on quality of life. DESIGN The study used a cross-sectional multicenter survey. PARTICIPANTS The study sample comprised 3,142 men and women aged 65 to 84 years, living in five European countries and Israel. MEASUREMENTS Anxiety disorders were assessed using computer-assisted face-to-face interviews with an age-appropriate diagnostic interview (CIDI65+). RESULTS The prevalence of anxiety disorders was 17.2%. Agoraphobia was the most frequent disorder (4.9%), followed by panic disorder (3.8%), animal phobia (3.5%), general anxiety disorder (3.1%), post-traumatic stress disorder (1.4%), social phobia (1.3%), and obsessive-compulsive disorder (0.8%). The prevalence rate of any anxiety disorder dropped by 40% to 47% in adults aged 75-84 years compared with those aged 65-74 years. Women were twice as likely to present with agoraphobia or general anxiety disorder as men. Only panic disorder and phobia were associated with comorbid major depression. The negative relationship with quality of life was limited to agoraphobia and generalized anxiety disorder. CONCLUSIONS The age-appropriate CIDI65+ led to higher prevalence rates of anxiety disorders in the elderly, yet to weaker associations with comorbidities and impaired quality of life compared with previous studies.

The effects of music therapy in patients with high-dose chemotherapy and stem cell support: a randomized pilot study.

Patients with high dose chemotherapy (HDC) with autologous stem cell transplantation (ASCT) are highly distressed. Psycho‐oncological support might be beneficial but is not routinely provided. Our aim was to investigate whether music therapy (MT) in addition to standard supportive treatment had any effect on quality of life, depression, anxiety, side effects of therapy, medication, and immunological changes during and within three months after HDC plus ASCT.

Functional donor site morbidity longer than one year after fibula free flap: A prospective biomechanical analysis

The fibula free flap is the workhorse procedure for osseous reconstruction. The objective of this study was to investigate long‐term functional outcomes of the harvesting site.