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1.
Varunsiri Atti Venkat Vuddanda Mohit K. Turagam Praveen Vemula Zubair Shah Himakar Nagam Srikanth Yandrapalli Mohammad-Ali Jazayeri Scott Koerber Juan Viles Gonzalez Andrea Natale Luigi Di Biase Dhanunjaya R. Lakkireddy 《Journal of interventional cardiac electrophysiology》2018,53(2):207-215
Background
Catheter ablation is proven to be an effective strategy for drug refractory ventricular tachycardia (VT) in ischemic cardiomyopathy. However, the appropriate timing of VT ablation and identifying the group of patients that may receive the greatest benefit remains uncertain. There is limited data on the effect on prophylactic catheter ablation (PCA) in the prevention of implantable cardioverter defibrillator (ICD) therapy, electrical storm, and mortality.Methods
We performed a comprehensive literature search through November 1, 2017, for all eligible studies comparing PCA + ICD versus ICD only in eligible patients with ischemic cardiomyopathy. Clinical outcomes included all ICD therapies including ICD shocks and electrical storm. Additional outcomes included all-cause mortality, cardiovascular mortality, and complications.Results
Three randomized controlled trials (RCTs) (N?=?346) met inclusion criteria. PCA was associated with a significantly lower ICD therapies (OR 0.49; CI 0.28 to 0.87; p?=?0.01) including ICD shocks [OR 0.38; CI 0.22 to 0.64; p?=?0.0003) and electrical storm (OR 0.55; CI 0.30 to 1.01; p?=?0.05) when compared with ICD only. There was no significant difference in all-cause mortality (OR 0.77; CI 0.41 to 1.46; p?=?0.42), cardiovascular mortality (OR 0.49; CI 0.16 to 1.50; p?=?0.21), and major adverse events (OR 1.45; CI 0.52 to 4.01; p?=?0.47) between two groups.Conclusion
These results suggest prophylactic catheter ablation decreases ICD therapies, including shocks and electrical storm with no improvement in overall mortality. There is a need for future carefully designed randomized clinical trials.2.
3.
Purpose of Review
Clear guidelines on when to select a subcutaneous ICD (S-ICD) over a transvenous ICD (TV-ICD) are lacking. This review will provide an overview of the most recent clinical data on S-ICD and TV-ICD therapy by pooling comparison studies in order to aid clinical decision making.Recent Findings
Pooling of observational-matched studies demonstrated an incidence rate ratio (IRR) for device-related complication of 0.90 (95% CI 0.58–1.42) and IRR for lead-related complications of 0.15 (95% CI 0.06–0.39) in favor of S-ICD. The IRR for device infections was 2.00 (95% CI 0.95–4.22) in favor of TV-ICD. Both appropriate shocks (IRR 0.67 (95% CI 0.42–1.06)) and inappropriate shocks (IRR 1.17 (95% CI 0.77–1.79)) did not differ significantly between both groups.Summary
With randomized data underway, the observational data demonstrate that the S-ICD is associated with reduced lead complications, but this has not yet resulted in a significant reduction in total number of complications compared to TV-ICDs. New technologies are expected to make the S-ICD a more attractive alternative.4.
Mohammed Shurrab Yazan Zayed Sankar D. Navaneethan Nour Yadak Abeer Yaseen Anna Kaoutskaia Waad Qamhia Zakaria Hamdan Saleem Haj-Yahia Douglas S. Lee David Newman Jeff S. Healey Paula Harvey Eugene Crystal 《Journal of interventional cardiac electrophysiology》2018,53(1):123-129
Purpose
The efficacy of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) in patients with chronic kidney disease (CKD) remains unclear. The aim of this meta-analysis is to explore the association between ICD/CRT and mortality in CKD patients.Methods
An electronic search was conducted using MEDLINE. We included studies that reported outcomes of interest in CKD patients stratified by the presence of ICD, CRT, or none. The primary outcome was all-cause mortality. Outcomes were pooled using random effects model. Odds ratios (OR) were reported for dichotomous variables.Results
The literature search resulted in 11 studies (observational studies) including 21,136 adult patients: seven studies compared ICD vs. no ICD and four studies compared CRT vs. ICD. All-cause mortality was significantly lower in the ICD group in comparison to that in the no ICD group (OR 0.66 (95% confidence interval [CI] 0.45; 0.98), P?=?0.04). Among dialysis-only patients, all-cause mortality was significantly lower in the ICD group (OR 0.49 (95% CI 0.38; 0.64), P?<?0.001). All-cause mortality was significantly lower in the CRT group in comparison to that in the ICD group (OR 0.73 (95% CI 0.57; 0.92), P?=?0.01).Conclusions
The use of ICDs is associated with lower all-cause mortality in observational studies of CKD patients. CRT use was also associated with lower all-cause mortality in CKD patients in comparison to ICDs. A randomized controlled trial is required to definitively define the role of ICDs/CRTs in CKD patients.5.
Purpose of Review
There has been confusion following the 2013 American College of Cardiology/American Heart Association (ACC/AHA) Lipid guidelines on the role of non-statin medications for cardiovascular prevention.Recent Findings
Several recent large trials have also now shown that lowering LDL with non-statins reduces cardiovascular events. In ASCVD patients on statins, adding ezetimibe or a PCSK9 inhibitor led to reductions in CV events in the IMPROVE IT, FOURIER, and most recently the ODYSSEY-OUTCOMES trials. Additional novel therapies reducing LDL and other atherogenic lipoproteins are in development during this exciting time in this field.Summary
With recent evidence, the 2017 ACC Expert Consensus Decision pathway calls for initial therapy with statins, monitoring LDL levels, and then adding ezetimibe and/or PCSK9 inhibitors to further lower LDL-C to targets based on the patient’s risk.6.
Background
Idiopathic pulmonary fibrosis (IPF) is an incurable, debilitating disease which impairs lung function and eventually leads to death. Currently, there is a lack of effective modifying therapies and treatments for IPF as the underlying epidemiological mechanism is not clearly understood. This leads to difficulty in diagnosing and managing IPF, which results in a high incurment of disease-associated cost. Even though IPF poses a substantial economic burden, there is a lack of research available on cost triggers and healthcare utilization, which can be a barrier to future economic evaluations of new medicines for IPF.Objectives
We aimed to conduct a systematic literature review (SLR) to identify the key cost-generating events of IPF and to gather any related costing information.Results
The data showed that the main events triggering high resource use in patients were the symptoms of IPF progression along with comorbidities and lung transplantations. These events result in a high economic impact through the use of medications, health care professionals, and hospital stays.Conclusion
More research is needed to identify the direct, and indirect, relationships between IPF events and the costs they generate. This would help to further evaluate the area of need for future health technologies and to understand what events should be targeted to reduce the global economic burden of IPF.7.
Purpose of Review
Recent evidence has suggested that implantable defibrillator (ICD) in non-ischemic cardiomyopathy (NICM) may not offer mortality benefit in the presence of guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy (CRT).Recent Findings
Despite significant benefits of GDMT and CRT, current evidence is derived from ICD trials that rely predominantly on reduced left ventricular ejection fraction alone (LVEF). The majority of patients with sudden cardiac death (SCD) have LVEF >?30% indicating that LVEF by itself is an inadequate predictor of SCD. The Danish study to assess the efficacy of ICD in patients with non-ischemic systolic heart failure on mortality (DANISH) highlights the importance of better risk stratifying NICM patients for ICD implantation.Summary
Assessment of life expectancy, comorbidities, presence of advanced heart failure, etiology of NICM, and the presence of myocardial fibrosis can help risk stratify ICD beyond LVEF. Genetics and biomarkers can be of further assistance in risk stratification.8.
Purpose of review
Eosinophilic granulomatosis with polyangiitis (EGPA) is a systemic disseminated vasculitis associated with extravascular granulomas in patients suffering from asthma and tissue eosinophilia. Current therapies to achieve remission and prevent relapse include glucocorticoids and immunosuppressants like cyclophosphamide.Recent findings
With the right treatment, clinical prognosis is favorable, so concerted efforts have been made in recent years to find new alternatives for treating severe EGPA. Monoclonal antibodies such as omalizumab, rituximab, and mepolizumab are among these new options.Summary
This review summarizes the pathogenesis and clinical manifestations of EGPA and critically examines current and emerging therapies.9.
Adam Wright Skye Aaron Diane L. Seger Lipika Samal Gordon D. Schiff David W. Bates 《Journal of general internal medicine》2018,33(11):1868-1876
Background
Drug-drug interaction (DDI) alerts in electronic health records (EHRs) can help prevent adverse drug events, but such alerts are frequently overridden, raising concerns about their clinical usefulness and contribution to alert fatigue.Objective
To study the effect of conversion to a commercial EHR on DDI alert and acceptance rates.Design
Two before-and-after studies.Participants
3277 clinicians who received a DDI alert in the outpatient setting.Intervention
Introduction of a new, commercial EHR and subsequent adjustment of DDI alerting criteria.Main Measures
Alert burden and proportion of alerts accepted.Key Results
Overall interruptive DDI alert burden increased by a factor of 6 from the legacy EHR to the commercial EHR. The acceptance rate for the most severe alerts fell from 100 to 8.4%, and from 29.3 to 7.5% for medium severity alerts (P?<?0.001). After disabling the least severe alerts, total DDI alert burden fell by 50.5%, and acceptance of Tier 1 alerts rose from 9.1 to 12.7% (P?<?0.01).Conclusions
Changing from a highly tailored DDI alerting system to a more general one as part of an EHR conversion decreased acceptance of DDI alerts and increased alert burden on users. The decrease in acceptance rates cannot be fully explained by differences in the clinical knowledge base, nor can it be fully explained by alert fatigue associated with increased alert burden. Instead, workflow factors probably predominate, including timing of alerts in the prescribing process, lack of differentiation of more and less severe alerts, and features of how users interact with alerts.10.
11.
Abhinav Sood Krista Dobbie W. H. Wilson Tang 《Current treatment options in cardiovascular medicine》2018,20(5):43
Purpose of review
This review illustrates the dynamic role of palliative care in heart failure management and encapsulates the commonly utilized pharmacologic and non-pharmacologic therapeutic strategies for symptom palliation in heart failure. In addition, we provide our experience regarding patient care issues common to the domain of heart failure and palliative medicine which are commonly encountered by heart failure teams.Recent findings
Addition of palliative care to conventional heart failure management plan results in improvement in quality of life, anxiety, depression, and spiritual well-being among patients.Summary
Palliative care should not be confused with hospice care. Palliative care teams should be involved early in the care of heart failure patients with the aims of improving symptom palliation, discussing goals of care and improving quality of life without compromising utilization of evidence-based heart failure therapies. A consensus on the appropriate timing of involvement and evidence for many symptom palliation therapies is still emerging.12.
Martin Grett Martin Christ Hans-Joachim Trappe 《Herzschrittmachertherapie & Elektrophysiologie》2016,27(4):390-395
Background
Little is known about the incidence and risk factors for progression to pacemaker dependency or the need for cardiac resynchronization in typical patients with an implanted defibrillator with regard to an alternative implantation of a subcutaneous ICD (S-ICD).Study design and methods
After retrospective analysis of 291 patients with first implantation of a transvenous single chamber ICD (VVI-ICD) from 2010–2016 and excluding those with an indication for pacemaker or lack of follow-up data, 121 patients were included and investigated with regard to the following endpoints: need for pacemaker stimulation, upgrade for cardiac resynchronization (CRT), and secondary occurrence and effectiveness of antitachycardia pacing (ATP). We compared the results with those of fundamental S?ICD studies and tried to determine risk factors on the basis of medical history and pre-implant data.Results
The study population and the rate of endpoints were significantly different to those of fundamental S?ICD studies. Within a 2.2-year follow-up, 14.9?% of the patients developed a need for pacemaker stimulation and 0.8?% the need for cardiac resynchronization. Excluding patients who at implantation were already at high risk for pacemaker dependency, 7.4?% remained with a reached endpoint. We identified atrial fibrillation and bundle-branch-block as risk factors. All episodes of ventricular tachycardia (VT) could be terminated by ATP in 9.9?% of the patients. They more often had ischemic heart disease and a secondary prophylactic indication for an ICD.Conclusion
The low rate of conversions from S?ICD to a transvenous ICD in case of pacemaker-dependency as stated in fundamental S?ICD studies should not be transferred to other typical collectives of ICD recipients. The latter group is at significantly higher risk for developing pacemaker-dependency.13.
Purpose of Review
Gastroparesis remains a difficult-to-treat disease with limited therapeutic options. Though patients often have a common syndrome of stereotypic symptoms, the underlying pathophysiology is heterogeneous, often leading to variable treatment responses. Due to limitations in medical and surgical therapies, endoscopic options have been increasingly explored. These options can be broadly categorized into pyloric-directed therapy, non-pyloric-directed therapy, and nutritional support. In this review, we will highlight current and emerging endoscopic options, such as gastric per-oral endoscopic myotomy (G-POEM).Recent Findings
Early retrospective studies on G-POEM offer encouraging results up to one year out, with an acceptable safety profile. Other pyloric-directed therapies, such as pyloric dilation and stenting, have also been explored.Summary
While emerging endoscopic therapeutic options are encouraging, efficacy will likely depend on a better characterization of underlying pathophysiology and improved patient selection. Future prospective, controlled studies are needed.14.
Background
The prognosis of specific subgroups of patients has been significantly improved by a personalized medicine due to histological differentiation, discovery of new oncogene driver mutations in adenocarcinomas and the introduction of targeted therapies.Objective
Minimally invasive endoscopic methods as well as surgical procedures are available for obtaining histological and cytological material for molecular diagnostics. The various diagnostic options with their advantages and disadvantages are described.Material and methods
A literature search was carried out in PubMed.Results
In every patient it should be possible for clinically practical reasons to perform molecular diagnostic investigations on biopsies, which are as small as possible. Endoscopic transbronchial needle aspiration (TBNA) has a high sensitivity and represents the diagnostic method of choice. If radiologically suspicious mediastinal lymph nodes are present and the cytological result is negative, surgical evaluation is still necessary.Discussion
In the future the aim will be to find further molecular alterations that make a targeted therapy possible and which can be used as prognostic biomarkers or to predict therapy response. Research into entirely noninvasive methods, such as analysis of circulating tumor cells is ongoing.15.
Background
Little is known about self-help associations and their possibilities. Obstacles often prevent early contacts between affected people.Objectives
The psychosocial support given by self-help associations in different phases is evaluated.Materials and methods
Based on the experience of the Deutsche ILCO and from cooperation with other organizations and institutions, various dimensions of self-help groups are investigated.Results
On the professional side, there is a lack of knowledge and of attitude. Suitable structures are rare.Conclusions
The removal of barriers and development of effective structures are overdue.16.
George Z. Retsch-Bogart Jill M. Van Dalfsen Bruce C. Marshall Cynthia George Joseph M. Pilewski Eugene C. Nelson Christopher H. Goss Bonnie W. Ramsey 《Journal of general internal medicine》2014,29(3):714-723
BACKGROUND
Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study.OBJECTIVE
To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success.DESIGN
Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams.PARTICIPANTS
CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network.APPROACH
Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research.KEY RESULTS
Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research.CONCLUSIONS
Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.17.
Giovanni B. Gaeta Massimo Puoti Nicola Coppola Teresa Santantonio Raffaele Bruno Antonio Chirianni Massimo Galli 《Infection》2018,46(2):183-188
Aim
This paper is aimed at providing practical recommendations for the management of acute hepatitis C (AHC).Methods
This is an expert position paper based on the literature revision. Final recommendations were graded by level of evidence and strength of the recommendations.Results
Treatment of AHC with direct-acting antivirals (DAA) is safe and effective; it overcomes the limitations of INF-based treatments.Conclusions
Early treatment with DAA should be offered when available.18.
Travis I. Lovejoy Benjamin J. Morasco Michael I. Demidenko Thomas H. A. Meath Steven K. Dobscha 《Journal of general internal medicine》2018,33(1):24-30
Background
Little is known about pain care offered to patients discontinued from long-term opioid therapy (LTOT) by their prescriber due to aberrant behaviors versus other reasons.Objective
This study aimed to compare rates of non-opioid analgesic pharmacotherapy initiation and clinician referrals for non-pharmacologic pain treatment, complementary and integrative pain therapies, and specialty mental health and substance use disorder treatment between patients discontinued from opioid therapy due to aberrant behaviors versus other reasons.Design
The design included retrospective manual electronic health record review and administrative data abstraction.Participants
Patients were sampled from a national cohort of US Department of Veterans Affairs patients prescribed continuous opioid therapy in 2011 who subsequently discontinued opioid therapy in 2012. The study sample comprised 509 patients discontinued from LTOT by opioid-prescribing clinicians.Main Measures
The primary independent variable was reason for discontinuation of LTOT (aberrant behaviors versus other reasons). Pain care dichotomous outcomes included clinician use of an opioid taper; initiating new non-opioid analgesic pharmacotherapy; and referrals for non-pharmacologic pain treatment, complementary and integrative pain therapies, and specialty mental health and substance use disorder treatment.Key Results
We observed low rates of opioid taper (15% of patients), initiations of new or modifications of existing non-opioid analgesic pharmacotherapy (45% of patients), and clinician referrals for non-pharmacologic pain treatment (58% of patients) and complementary and integrative therapies (25% of patients). Patients discontinued due to aberrant behaviors, relative to patients discontinued for other reasons, were more likely to receive opioid tapers (adjusted OR?=?5.60, 95% CI?=?2.10–14.93), receive new non-opioid analgesic medications or dose changes to an existing non-opioid analgesic medications (adjusted OR?=?2.61, 95% CI?=?1.59–4.29), or be referred for specialty substance use disorder treatment (adjusted OR?=?7.39, 95% CI?=?3.76–14.53).Conclusions
These findings highlight the variability in referral rates for different types of non-opioid pain treatments and challenges accessing specific types of pain care.19.
Purpose of Review
To review recent advances in the treatment of Crohn’s disease.Recent Findings
Several key advances are highlighted, including the increasing role of treatment algorithms and where new therapies can be used most effectively, the appropriate use of therapeutic drug monitoring, optimal management of post-surgical patients, and the role of multi-disciplinary clinics.Summary
The last several years have seen a number of exciting developments in the field of Crohn’s therapy. This review covers research advances including updated treatment algorithms focusing on identifying patient risk as well as the role of drug monitoring in managing the disease. We also review the optimal management of post-surgical patients as well as new biologics and biosimilars. Finally, we describe innovations in care delivery including multi-disciplinary clinics and emerging evidence from developing therapeutics.20.