Subcutaneous or Transvenous Defibrillator Therapy Knops, Reinoud E; Olde Nordkamp, Louise R A; Delnoy, Peter-Paul H M ...
The New England journal of medicine,
08/2020, Letnik:
383, Številka:
6
Journal Article
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The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing ...these systems has been based primarily on observational studies.
We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.
A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval CI, 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).
In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).
Objective
To explore the prescribing patterns of selective serotonin reuptake inhibitors (SSRIs) before, during and after pregnancy in six European population‐based databases.
Design
Descriptive drug ...utilisation study.
Setting
Six electronic healthcare databases in Denmark, the Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK.
Population
All women with a pregnancy ending in a live or stillbirth starting and ending between 2004 and 2010.
Methods
A common protocol was implemented across databases to identify SSRI prescriptions issued (UK) or dispensed (non‐UK) in the year before, during or in the year following pregnancy.
Main outcome measures
The percentage of deliveries in which the woman received an SSRI prescription in the year before, during or in the year following pregnancy. We also compared the choice of SSRIs and changes in prescribing over the study period.
Results
In total, 721 632 women and 862 943 deliveries were identified. In the year preceding pregnancy, the prevalence of SSRI prescribing was highest in Wales 9.6%; 95% confidence interval (CI95), 9.4–9.8% and lowest in Emilia Romagna (3.3%; CI95, 3.2–3.4%). During pregnancy, SSRI prescribing had dropped to between 1.2% (CI95, 1.1–1.3%) in Emilia Romagna and 4.5% (CI95, 4.3–4.6%) in Wales. The higher UK pre‐pregnancy prescribing rates resulted in higher first trimester exposures. After pregnancy, SSRI prescribing increased most rapidly in the UK. Paroxetine was more commonly prescribed in the Netherlands and Italian regions than in Denmark and the UK.
Conclusions
The higher SSRI prescribing rates in the UK, compared with other European regions, raise questions about differences in the prevalence and severity of depression and its management in pregnancy across Europe.
Objectives
Human age‐dependent telomere attrition and telomere shortening are associated with several age‐associated diseases and poorer overall survival. The aim of this study was to determine ...longitudinal leucocyte telomere length dynamics and identify factors associated with temporal changes in telomere length.
Design and Methods
Leucocyte telomere length was measured by quantitative polymerase chain reaction in 8074 participants from the Prevention of Renal and Vascular End‐stage Disease (PREVEND) study, an ongoing community‐based prospective cohort study initiated in 1997. Follow‐up data were available at two time‐points up to 2007. Leucocyte telomere length was measured, on between one and three separate occasions, in a total of 16 783 DNA samples. Multilevel growth models were created to identify the factors that influence leucocyte telomere dynamics.
Results
We observed an average attrition rate of 0.47 ± 0.16 relative telomere length units (RTLUs) per year in the study population aged 48 (range 39–60) years at baseline. Annual telomere attrition rate increased with age (P < 0.001) and was faster on average in men than in women (P for interaction 0.043). The major independent factors determining telomere attrition rate were active smoking (approximately tripled the loss of RTLU per year, P < 0.0001) and multiple traits of the metabolic syndrome (waist–hip ratio, P = 0.007; blood glucose level, P = 0.045, and HDL cholesterol level, P < 0.001).
Conclusions
Smoking and variables linked to the metabolic syndrome are modifiable lifestyle factors that accelerate telomere attrition in humans. The higher rate of cellular ageing may mediate the link between smoking and the metabolic syndrome to an increased risk of several age‐associated diseases.
The Antarctic Ice Sheet (AIS) is out of equilibrium with the current anthropogenic‐enhanced climate forcing. Paleoenvironmental records and ice sheet models reveal that the AIS has been tightly ...coupled to the climate system during the past and indicate the potential for accelerated and sustained Antarctic ice mass loss into the future. Modern observations by contrast suggest that the AIS has only just started to respond to climate change in recent decades. The maximum projected sea level contribution from Antarctica to 2100 has increased significantly since the Intergovernmental Panel on Climate Change (IPCC) 5th Assessment Report, although estimates continue to evolve with new observational and theoretical advances. This review brings together recent literature highlighting the progress made on the known processes and feedbacks that influence the stability of the AIS. Reducing the uncertainty in the magnitude and timing of the future sea level response to AIS change requires a multidisciplinary approach that integrates knowledge of the interactions between the ice sheet, solid Earth, atmosphere, and ocean systems and across time scales of days to millennia. We start by reviewing the processes affecting AIS mass change, from atmospheric and oceanic processes acting on short time scales (days to decades), through to ice processes acting on intermediate time scales (decades to centuries) and the response to solid Earth interactions over longer time scales (decades to millennia). We then review the evidence of AIS changes from the Pliocene to the present and consider the projections of global sea level rise and their consequences. We highlight priority research areas required to improve our understanding of the processes and feedbacks governing AIS change.
Plain Language Summary
The Antarctic Ice Sheet (AIS) is an important component of the global climate system. Human activities have caused the atmosphere and especially the oceans to warm. However, the full effect of human caused climate change on the AIS has not currently been realized because the ice sheet responds on a range of time scales and to many different Earth processes. Modern observations show that West Antarctica has been melting at an accelerating rate since the 2000s, while the data for East Antarctica are less clear. Environmental records preserve the history of the climate and AIS, which extend beyond the instrumental record and reveal how the AIS responded to past climate warming. Estimates of how much the AIS will contribute to sea level rise by the Year 2100 have changed as a result of new information on how the AIS evolved in the past and research into the interactions between the ice sheet, solid Earth atmosphere, and ocean systems. This review brings together our knowledge of the major processes and feedbacks affecting the AIS and the evidence for how the ice sheet changed since the Pliocene. We consider the future estimates and consequences of global sea level rise from melting of the AIS and highlight priority research areas.
Key Points
The AIS is a highly dynamic component of the Earth system, evolving on a broad range of temporal and spatial scales
Paleoenvironmental evidence highlights the centennial to millennial response time scales of the AIS to atmospheric‐ocean forcing
Coupling feedbacks in Earth system components are required to reduce the uncertainty in AIS's contribution to past and future sea level rise
A search for mixing between active neutrinos and light sterile neutrinos has been performed by looking for muon neutrino disappearance in two detectors at baselines of 1.04 and 735 km, using a ...combined MINOS and MINOS+ exposure of 16.36×10^{20} protons on target. A simultaneous fit to the charged-current muon neutrino and neutral-current neutrino energy spectra in the two detectors yields no evidence for sterile neutrino mixing using a 3+1 model. The most stringent limit to date is set on the mixing parameter sin^{2}θ_{24} for most values of the sterile neutrino mass splitting Δm_{41}^{2}>10^{-4} eV^{2}.
Large-scale losses of seagrass beds have been reported for decades and lead to numerous restoration programs. From worldwide scientific literature and 20 years of seagrass restoration research in the ...Wadden Sea, we review and evaluate the traditional guidelines and propose new guidelines for seagrass restoration.
Habitat and donor selection are crucial: large differences in survival were found among habitats and among donor populations. The need to preferably transplant in historically confirmed seagrass habitats, and to collect donor material from comparable habitats, were underlined by our results. The importance of sufficient genetic variation of donor material and prevention of genetic isolation by distance was reviewed. The spreading of risks among transplantation sites, which differed in habitat characteristics (or among replicate sites), was positively evaluated. The importance of ecosystem engineering was shown in two ways: seagrass self-facilitation and facilitation by shellfish reefs. Seagrass self-facilitative properties may require a large transplantation scale or additional measures.
To evaluate the diagnostic performance of four different tests in order to differentiate between Cushing's disease (CD) and pseudo-Cushing's syndrome (PCS).
In this prospective study, a total of 73 ...patients with clinical features of hypercortisolism and insufficient suppression of serum cortisol after 1 mg overnight dexamethasone and/or an elevated excretion of cortisol in 24-h urine samples were included. The circadian rhythm of serum cortisol levels as well as midnight serum cortisol (MserC) levels were assessed in all 73 patients. Late-night salivary cortisol (LNSC) concentrations were obtained in 44 patients. The dexamethasone-CRH (Dex-CRH) test was performed in 54 patients.
FIFTY-THREE PATIENTS WERE DIAGNOSED WITH CD AND SUBSEQUENTLY TREATED. TWENTY PATIENTS WERE CLASSIFIED AS HAVING PSC. SERUM CORTISOL CIRCADIAN RHYTHM: the diurnal rhythmicity of cortisol secretion was retained in PCS. A cortisol midnight:morning ratio of >0.67 is highly suggestive of CD (positive predictive value (PPV) 100% and negative predictive value (NPV) 73%). MserC concentration >243 nmol/l has a PPV of 98% in predicting true CD (NPV 95%). LNSC level >9.3 nmol/l predicted CD in 94% of patients (NPV 100%). Dex-CRH test: after 2 days of dexamethasone suppression, a CRH-stimulated cortisol level >87 nmol/l (T=15 min) resulted in a PPV of 100% and an NPV of 90%.
The Dex-CRH test as well as a single measurement of cortisol in serum or saliva at late (mid-) night demonstrated high diagnostic accuracy in differentiating PCS from true CD.
To provide an overview of current clinical results of irreversible electroporation (IRE), a novel, nonthermal tumor ablation technique that uses electric pulses to induce cell death, while preserving ...structural integrity of bile ducts and vessels.
All in-human literature on IRE reporting safety or efficacy or both was included. All adverse events were recorded. Tumor response on follow-up imaging from 3 months onward was evaluated.
In 16 studies, 221 patients had 325 tumors treated in liver (n = 129), pancreas (n = 69), kidney (n = 14), lung (n = 6), lesser pelvis (n = 1), and lymph node (n = 2). No major adverse events during IRE were reported. IRE caused only minor complications in the liver; however, three major complications were reported in the pancreas (bile leak n = 2, portal vein thrombosis n = 1). Complete response at 3 months was 67%-100% for hepatic tumors (93%-100% for tumors o 3 cm). Pancreatic IRE combined with surgery led to prolonged survival compared with control patients (20 mo vs 13 mo) and significant pain reduction.
In cases where other techniques are unsuitable, IRE is a promising modality for the ablation of tumors near bile ducts and blood vessels. This articles gives an extensive overview of the available evidence, which is limited in terms of quality and quantity. With the limitations of the evidence in mind, IRE of central liver tumors seems relatively safe without major complications, whereas complications after pancreatic IRE appear more severe. The available limited results for tumor control are generally good. Overall, the future of IRE for difficult-to-reach tumors appears promising.
RNA viruses within infected individuals exist as a population of evolutionary-related variants. Owing to evolutionary change affecting the constitution of this population, the frequency and/or ...occurrence of individual viral variants can show marked or subtle fluctuations. Since the development of massively parallel sequencing platforms, such viral populations can now be investigated to unprecedented resolution. A critical problem with such analyses is the presence of sequencing-related errors that obscure the identification of true biological variants present at low frequency. Here, we report the development and assessment of the Quality Assessment of Short Read (QUASR) Pipeline (http://sourceforge.net/projects/quasr) specific for virus genome short read analysis that minimizes sequencing errors from multiple deep-sequencing platforms, and enables post-mapping analysis of the minority variants within the viral population. QUASR significantly reduces the error-related noise in deep-sequencing datasets, resulting in increased mapping accuracy and reduction of erroneous mutations. Using QUASR, we have determined influenza virus genome dynamics in sequential samples from an in vitro evolution of 2009 pandemic H1N1 (A/H1N1/09) influenza from samples sequenced on both the Roche 454 GSFLX and Illumina GAIIx platforms. Importantly, concordance between the 454 and Illumina sequencing allowed unambiguous minority-variant detection and accurate determination of virus population turnover in vitro.
Key points
For correct application and interpretation of cerebral autoregulation (CA) measurements in research and in clinical care, it is essential to understand differences and similarities between ...dynamic and steady‐state CA.
The present study found no correlation between dynamic and steady‐state CA indices in healthy older adults.
There was variability between individuals in all (steady‐state and dynamic) autoregulatory indices, ranging from low (almost absent) to highly efficient CA in this healthy population.
These findings challenge the assumption that assessment of a single CA parameter or a single set of parameters can be generalized to overall CA functioning. Therefore, depending on specific research purposes, the choice for either steady‐state or dynamic measures or both should be weighed carefully.
The present study aimed to investigate the relationship between dynamic (dCA) and steady‐state cerebral autoregulation (sCA). In 28 healthy older adults, sCA was quantified by a linear regression slope of proportionate (%) changes in cerebrovascular resistance (CVR) in response to proportionate (%) changes in mean blood pressure (BP) induced by stepwise sodium nitroprusside (SNP) and phenylephrine (PhE) infusion. Cerebral blood flow (CBF) was measured at the internal carotid artery (ICA) and vertebral artery (VA) and CBF velocity at the middle cerebral artery (MCA). With CVR = BP/CBF, Slope‐CVRICA, Slope‐CVRVA and Slope‐CVRiMCA were derived. dCA was assessed (i) in supine rest, analysed with transfer function analysis (gain and phase) and autoregulatory index (ARI) fit from spontaneous oscillations (ARIBaseline), and (ii) with transient changes in BP using a bolus injection of SNP (ARISNP) and PhE (ARIPhE). Comparison of sCA and dCA parameters (using Pearson's r for continuous and Spearman's ρ for ordinal parameters) demonstrated a lack of linear correlations between sCA and dCA measures. However, comparisons of parameters within dCA and within sCA were correlated. For sCA slope‐CVRVA with Slope‐CVRiMCA (r = 0.45, P < 0.03); for dCA ARISNP with ARIPhE (ρ = 0.50, P = 0.03), ARIBaseline (ρ = 0.57, P = 0.03) and PhaseLF (ρ = 0.48, P = 0.03); and for GainVLF with GainLF (r = 0.51, P = 0.01). By contrast to the commonly held assumption based on an earlier study, there were no linear correlations between sCA and dCA. As an additional observation, there was strong inter‐individual variability, both in dCA and sCA, in this healthy group of elderly, in a range from low to high CA efficiency.
Key points
For correct application and interpretation of cerebral autoregulation (CA) measurements in research and in clinical care, it is essential to understand differences and similarities between dynamic and steady‐state CA.
The present study found no correlation between dynamic and steady‐state CA indices in healthy older adults.
There was variability between individuals in all (steady‐state and dynamic) autoregulatory indices, ranging from low (almost absent) to highly efficient CA in this healthy population.
These findings challenge the assumption that assessment of a single CA parameter or a single set of parameters can be generalized to overall CA functioning. Therefore, depending on specific research purposes, the choice for either steady‐state or dynamic measures or both should be weighed carefully.
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