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Background: For patients with severe aortic stenosis, transcatheter aortic valve implantation (TAVI) is a less invasive but equally effective treatment option compared with surgical aortic valve replacement (SAVR). In 2019, we reported low rates of TAVI in the UK compared with other countries in western Europe and highlighted profound geographical variation in TAVI care. Here, we provide contemporary data on access to aortic valve replacement by either TAVI or SAVR across clinical commissioning groups in England. Methods: We obtained aggregated data from the UK TAVI registry and the National Adult Cardiac Surgery Audit between 2019 and 2023. Rates of TAVI and SAVR procedures per million population were reported by clinical commissioning groups. The relationship between TAVI and SAVR rates was determined using Pearson correlation coefficients. Results: In 2022/23, the rates of TAVI and SAVR in England were 136 per million population and 60 per million population, respectively. The observed increase in TAVI rates since 2019/20 corresponded with a decline in SAVR rates. There remains substantial variation in access to both procedures, with an over tenfold variation in TAVI rates, and an over fourfold variation in SAVR rates across clinical commissioning groups in England. No relationship was identified between the rates of TAVI and those for SAVR (correlation coefficient 0.06). Conclusion: Geographical heterogeneity in access to TAVI persists over time, with the low rates of TAVI in many areas not compensated for by higher rates of SAVR, indicating an overall inequality in the treatment of severe aortic stenosis.

Objective Fluoropyrimidine chemotherapy is a first-line treatment for many gastrointestinal (GI) cancers, however, cardiotoxicity concerns may limit administration in patients with pre-existing cardiovascular disease (CVD). This study investigated the association of pre-existing CVD with use of fluoropyrimidine chemotherapy in tumour-eligible GI cancer patients.Methods and analysis National cancer registry data from the Virtual Cardio-Oncology Research Initiative from England between 2014 and 2018 was used to identify GI cancer patients eligible to receive fluoropyrimidine chemotherapy. Linkage to Hospital Episode Statistics and CVD registry data were used to ascertain prior CVD and outcomes. Primary outcome was first administration of fluoropyrimidine chemotherapy following cancer diagnosis. Cox proportional hazard models determined HR and 95% CIs for the association between initiation of fluoropyrimidine treatment and prior CVD.Results 112 726 eligible patients were identified (median age 71 years (IQR 62–80), 39.7% female). 33 026 (29.3%) had pre-existing CVD. 73 392 (65.1%) patients had a diagnosis of colorectal, 23 208 (20.6%) oesophageal, 14 788 (13.1%) gastric and 1338 (1.2%) small bowel cancer. Individuals with pre-existing CVD had a 27% reduced rate of receiving fluoropyrimidine chemotherapy (HR, 0.73; 95% CI 0.70 to 0.75) on multivariable analysis. Significantly reduced rates of fluoropyrimidine administration were found across all subtypes of pre-existing CVD.Conclusions GI cancer patients with all types of pre-existing CVD are less likely to receive fluoropyrimidine chemotherapy despite eligibility. This suggests widespread caution regarding administration of fluoropyrimidines across this population; further research is needed to assess whether such conservatism is justified.

Abstract Background Routine pre-discharge echocardiography (ECHO) is recommended post transcatheter aortic valve implantation (TAVI) as a baseline for future comparison. However, there is no clear guidance on the optimal timing of this study. Aim The purpose of this retrospective study was to investigate the safety and work-force efficiency of intraprocedural same-day ECHO versus next-day ECHO, following transfemoral TAVI. Methods and results In this retrospective study 100 consecutive patients who underwent intraprocedural ECHO only were compared with 100 consecutive patients undergoing both intraprocedural and routine next-day ECHO following elective transfemoral TAVI. All patients received the Sapien 3/Ultra transcatheter heart valve and were treated with a minimalist procedure with conscious sedation. The composite of in-hospital mortality, urgent ECHO and new tamponade after leaving the cath lab and before discharge was not different between the two groups (4 vs. 4%, P = 1). There was no paravalvular leak more than mild in any of the cases. Length of stay was similar (1 day). Conclusions Intraprocedural post-TAVI ECHO appears as safe as next day pre-discharge ECHO and obviates the need for a routine next day study, thereby reducing burden on echocardiography services and allows better utilisation of resources.

Abstract Background Institutions or clinicians (units) are often compared according to a performance indicator such as in-hospital mortality. Several approaches have been proposed for the detection of outlying units, whose performance deviates from the overall performance. Methods We provide an overview of three approaches commonly used to monitor institutional performances for outlier detection. These are the common-mean model, the ‘Normal-Poisson’ random effects model and the ‘Logistic’ random effects model. For the latter we also propose a visualisation technique. The common-mean model assumes that the underlying true performance of all units is equal and that any observed variation between units is due to chance. Even after applying case-mix adjustment, this assumption is often violated due to overdispersion and a post-hoc correction may need to be applied. The random effects models relax this assumption and explicitly allow the true performance to differ between units, thus offering a more flexible approach. We discuss the strengths and weaknesses of each approach and illustrate their application using audit data from England and Wales on Adult Cardiac Surgery (ACS) and Percutaneous Coronary Intervention (PCI). Results In general, the overdispersion-corrected common-mean model and the random effects approaches produced similar p-values for the detection of outliers. For the ACS dataset (41 hospitals) three outliers were identified in total but only one was identified by all methods above. For the PCI dataset (88 hospitals), seven outliers were identified in total but only two were identified by all methods. The common-mean model uncorrected for overdispersion produced several more outliers. The reason for observing similar p-values for all three approaches could be attributed to the fact that the between-hospital variance was relatively small in both datasets, resulting only in a mild violation of the common-mean assumption; in this situation, the overdispersion correction worked well. Conclusion If the common-mean assumption is likely to hold, all three methods are appropriate to use for outlier detection and their results should be similar. Random effect methods may be the preferred approach when the common-mean assumption is likely to be violated.

Background: Crossing of the interatrial septum (IAS) with the Edwards Sapien-3 transcatheter heart valve (THV) may fail, despite preparatory balloon septostomy. A planned buddy guidewire placed in the left ventricle may help facilitate crossing of the IAS and mitral bioprosthesis with the THV. Methods: A retrospective study of 12 consecutive patients undergoing transseptal, mitral valve-in-valve or valve-in-ring procedures using the Edwards Sapien-3 THV since 2018 with a planned buddy-wire technique. The primary endpoint was the composite of successful delivery of the buddy wire and deployment of the first intended Sapien 3 within the mitral valve without removal from the body, additional interatrial septal puncture, or placement of a further buddy wire. Secondary objectives included safety endpoints, as follows: access-site bleeding, tamponade, stroke, intraprocedural death, sustained ventricular arrhythmia, and 30-day vascular complications. Results: From January 2018 to March 2022, a total of 12 consecutive patients who underwent transseptal mitral valve-in-valve (9) or valve-in-ring (3) procedures were identified. Three patients (25%) required repeat septostomy on the buddy wire after initial THV crossing failure. Crossing of the IAS and successful deployment in the mitral valve with the THV was achieved in all cases, without removal from the body or need for an additional wire or septal puncture. No access-site bleeding, stroke, tamponade, ventricular arrhythmia, intraprocedural death, or 30-day vascular complication occurred. Conclusions: The planned buddy-wire technique was successful in all cases and facilitated successful crossing of the IAS and deployment of the THV in the mitral position without removal from the body, additional wires, or septal punctures, with no adverse events. Résumé: Contexte: Malgré une septostomie par ballonnet, le passage à travers le septum interatrial (SIA) d’une valve cardiaque implantée par cathéter (VCC) Sapien-3 d’Edwards peut se solder par un échec. Un fil-guide planifié, placé dans le ventricule gauche, pourrait aider à faciliter le passage de la VCC à travers le SIA et la bioprothèse mitrale. Méthodologie: Une étude rétrospective a été réalisée auprès de 12 patients consécutifs ayant subi une implantation mitrale transseptale dans le cas d’une bioprothèse mitrale (valve-in-valve) ou d’une annuloplastie chirurgicale (valve-in-ring) d’une VCC Sapien-3 d’Edwards avec la technique du fil-guide planifié, depuis 2018. Le critère d’évaluation principale composé comprenait le placement avec succès du fil-guide et le déploiement de la première valve Sapien-3 prévue dans la valve mitrale, sans devoir la sortir du corps, sans effectuer de ponction supplémentaire du septum interatrial et sans devoir placer de fil-guide supplémentaire. Les objectifs secondaires incluaient les critères d’innocuité suivants : saignement lié à l’accès vasculaire, tamponnade, accident vasculaire cérébral (AVC), décès en cours d’intervention, arythmie ventriculaire soutenue et complication vasculaire dans les 30 jours après l’intervention. Résultats: Entre janvier 2018 et mars 2022, un total de 12 patients consécutifs ayant subi une implantation mitrale transseptale pour une bioprothèse mitrale (neuf) ou pour une annuloplastie chirurgicale (trois) ont été recensés. Pour trois de ces patients (25 %), une deuxième septostomie, sur le fil-guide, a été nécessaire avec un échec initial du passage de la VCC. Le passage du SIA et le déploiement dans la valve mitrale avec la VCC ont été réussis dans tous les cas, sans devoir sortir la valve du corps, avoir recours à un fil supplémentaire ou effectuer une ponction du septum. Aucun cas de saignement lié à l’accès vasculaire, d'AVC, de tamponnade, d’arythmie ventriculaire, de décès en cours d’intervention ou de complication vasculaire dans les 30 jours après l’intervention n’est survenu. Conclusions: La technique du fil-guide a été couronnée de succès dans la totalité des cas, et a facilité le passage du SIA et le déploiement de la VCC en position mitral sans avoir besoin de sortir la valve du corps, d’avoir recours à des fils supplémentaires ou d’effectuer une ponction du septum; aucun effet indésirable n’est survenu.

Abstract Transfemoral transcatheter aortic valve implantation (TAVI) under conscious sedation is the most widely used method of implantation. Echocardiography is used to detect complications and to assess the implantation result. The aim of this paper is to provide a time-efficient protocol when transthoracic echocardiography (TTE) is used to guide TAVI procedures.

Background Intracoronary imaging (ICI) has been shown to improve survival after percutaneous coronary intervention (PCI). Whether this prognostic benefit is sustained across different indications remains unclear. Methods and Results All PCI procedures performed in England and Wales between April, 2014 and March 31, 2020, were retrospectively analyzed. The association between ICI use and in‐hospital major acute cardiovascular and cerebrovascular events; composite of all‐cause mortality, stroke, and reinfarction and mortality was examined using multivariable logistic regression analysis for different imaging‐recommended indications as set by European Association for Percutaneous Cardiovascular Interventions consensus. Of 555 398 PCI procedures, 10.8% (n=59 752) were ICI‐guided. ICI use doubled between 2014 (7.8%) and 2020 (17.5%) and was highest in left main PCI (41.2%) and lowest in acute coronary syndrome (9%). Only specific European Association for Percutaneous Cardiovascular Interventions imaging‐recommended indications were associated with reduced major acute cardiovascular and cerebrovascular events and mortality, including left main PCI (odds ratio [OR], 0.45 [95% CI, 0.39–0.52] and 0.41 [95% CI, 0.35–0.48], respectively), acute coronary syndrome (OR, 0.76 [95% CI, 0.70–0.82] and 0.70 [95% CI, 0.63–0.77]), and stent length >60 mm (OR, 0.75 [95% CI, 0.59–0.94] and 0.72 [95% CI, 0.54–0.95]). Stent thrombosis and renal failure were associated with lower mortality (OR, 0.69 [95% CI, 0.52–0.91]) and major acute cardiovascular and cerebrovascular events (OR, 0.77 [95% CI, 0.60–0.99]), respectively. Conclusions ICI use has more than doubled over a 7‐year period at a national level but remains low, with

Background There are limited data about how COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) and ORBITA (Objective Randomized Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) trials have impacted percutaneous coronary intervention (PCI) practices at regional or national level. We evaluated temporal trends in elective PCI rates for stable angina and, specifically, examined the impact of the COURAGE and ORBITA trials on PCI practices in England and Wales. Methods and Results We used national PCI data comprising >1.2 million patients undergoing PCI between January 2006 and December 2019. Patient demographics, procedural details, and clinical outcomes were analyzed, and temporal trends in PCI rates for stable angina were compared before and after the publication of the COURAGE and ORBITA trials. Of 1 245 802 PCI procedures, 430 248 (34.5%) were performed for stable angina. Over the study period, the number of elective PCI procedures per year (30 823 in 2006 to 34 103 in 2019) and per 100 000 population estimates (50.7 in 2006 to 58.4 in 2019) remained stable. The proportion of patients undergoing elective PCI without angina symptoms almost doubled from 5.1% to 9.7%. The incidence rate of elective PCI volume after the COURAGE trial, published in 2007, was not different from before the trial was published (incidence rate ratio, 1.06 [95% CI, 0.69–1.62]). It also remained stable after the publication of the ORBITA trial in 2017 (incidence rate ratio, 0.96 [95% CI, 0.74–1.23]). Conclusions In this nationwide analysis, rates of elective PCI for stable angina remained stable over 14 years. Publication of the COURAGE and ORBITA trials had no impact on elective PCI activity.

Developmental educators are often familiar with the benefits of learning communities and with the importance of incorporating research-based best practices into their developmental studies courses. Faculty may be less familiar with the educational applications based on the concepts of emotional intelligence (EI). Faculty at College of the Mainland created a learning community for incoming developmental freshman that incorporated the concepts of EI from the work of Golman along with principles from Chickering's (1991) "Seven Principles of Good Practice" and Boylan's (2002) "What Works: A Guide to Research-Based Best Practices in Developmental Education." Faculty found that the EI strategies provided a common language and a useful framework for planning instructional materials and activities.

Introduction. There is increasing evidence supporting the use of intracoronary imaging to optimize the outcomes of percutaneous coronary intervention (PCI). However, there are no studies examining the impact of imaging on PCI outcomes in cases utilising rotational atherectomy (RA-PCI). Our study examines the determinants and outcomes of using intracoronary imaging in RA-PCI cases including 12-month mortality. Methods. Using the British Cardiac Intervention Society database, data were analysed on all RA-PCI procedures in the UK between 2007 and 2014. Descriptive statistics and multivariate logistic regressions were used to examine baseline, procedural, and outcome associations with intravascular imaging. Results. Intracoronary imaging was used in 1,279 out of 8,417 RA-PCI cases (15.2%). Baseline covariates associated with significantly more imaging use were number of stents used, smoking history, previous CABG, pressure wire use, proximal LAD disease, laser use, glycoprotein inhibitor use, cutting balloons, number of restenosis attempted, off-site surgery, and unprotected left main stem (uLMS) PCI. Adjusted rates of in-hospital major adverse cardiac/cerebrovascular events (IH-MACCE), its individual components (death, peri-procedural MI, stroke, and major bleed), or 12-month mortality were not significantly altered by the use of imaging in RA-PCI. However, subgroup analysis demonstrated a signal towards reduction in 12-month mortality in uLMS RA-PCI cases utilising intracoronary imaging (OR 0.67, 95% CI 0.44–1.03). Conclusions. Intracoronary imaging use during RA-PCI is associated with higher risk of baseline and procedural characteristics. There were no differences observed in IH-MACCE or 12-month mortality with intracoronary imaging in RA-PCI.

Data were collected on patients admitted to the Queen Elizabeth Hospital Birmingham with type-1 myocardial infarction during 2016 and 2017 inclusively, who were treated by percutaneous intervention and had pre-discharge transthoracic echocardiography. The data were obtained from prospectively maintained hospital databases and records. Echocardiography was performed and reported contemporaneously by accredited echocardiographers. The purpose was to understand the prevalence and characteristics of mitral regurgitation (MR) after acute MI, including patients with ST-elevation (STEMI) and non-ST elevation MI (NSTEMI). MR was observed in 294/1000 patients with the following relative severities: mild = 76%, moderate = 21%, severe = 3% [1]. MR was graded by multiparametric quantification including proximal isolvelocity surface area (PISA), vena contracta (VC), effective regurgitant orifice area (EROA) and regurgitant volume (RVol). Amongst all patients with MR (n=294), PISA was performed in 89/294 (30%), VC 75/294 (26%), EROA in 53/294 (18%) and RVol in 26/294 (9%). Amongst patients with moderate or severe MR (n=70), PISA was performed in 57/70 (81%), VC in 55/70 (79%), EROA in 46/70 (66%) and RVol in 25/70 (36%). Characteristics of MR following acute MI were also assessed including frequency of reported leaflet thickness (259/294 = 88%) and mitral annular calcification (102/294 = 35%). Furthermore, the effect of MI on pre-existing MR was investigated and patients with pre-existing MR who continue to have MR after acute MI were found to have progression of MR by one grade in approximately 25% of cases. Finally, using Cox proportional hazards univariate analysis, significant factors associated with mortality in patients with MR post-MI include age (HR 1.065; 95% CI 1.035-1.096; p

Evidence about the effectiveness and safety of dog visits in pediatric oncology is limited. We conducted a randomized controlled trial (n=26) of dog visits versus usual care among pediatric oncology inpatients. Psychological functioning and microbial load from hand wash samples were evaluated. Parental anxiety was a secondary outcome. We did not observe a difference in the adjusted mean present functioning score (−3.0; 95% confidence interval [CI], −12.4 to 6.4). The difference in microbial load on intervention versus control hands was −0.04 (95% CI, −0.60 to 0.52) log10 CFU/mL, with an upper 95% CI limit below the prespecified noninferiority margin. Anxiety was lower in parents of intervention versus control patients. We did not detect an effect of dog visits on functioning; however, our study was underpowered by low recruitment. Visits improved parental anxiety. With hand sanitization, visits did not increase hand microbial levels. Clinicaltrials.gov NCT03471221. [ABSTRACT FROM AUTHOR]

• This analysis reports the effects of intravenous ferric derisomaltose (FDI) in a population of patients with heart failure and iron deficiency anemia in the IRONMAN trial. • Intravenous FDI was well-tolerated and improved quality of life and may reduce morbidity and mortality in patients with heart failure, anemia, and iron deficiency. • This will help shared decision-making in the management of patients with heart failure in countries where intravenous FDI is only licensed for the treatment of iron deficiency when accompanied by anemia. In some countries, intravenous ferric derisomaltose (FDI) is only licensed for treating iron deficiency with anemia. Accordingly, we investigated the effects of intravenous FDI in a subgroup of patients with anemia in the IRONMAN (Effectiveness of Intravenous (IV) Iron Treatment Versus Standard Care in Patients With Heart Failure and Iron Deficiency) trial. IRONMAN enrolled patients with heart failure, a left ventricular ejection fraction of ≤45%, and iron deficiency (ferritin <100 µg/L or transferrin saturation of <20%), 771 (68%) of whom had anemia (hemoglobin <12 g/dL for women and <13 g/dL for men). Patients were randomized, open label, to FDI (n = 397) or usual care (n = 374) and followed for a median of 2.6 years. The primary end point, recurrent hospitalization for heart failure and cardiovascular death, occurred less frequently for those assigned to FDI (rate ratio 0.78, 95% confidence interval 0.61–1.01; P =.063). First event analysis for cardiovascular death or hospitalization for heart failure, less affected by the coronavirus disease 2019 pandemic, gave similar results (hazard ratio 0.77, 95% confidence interval 0.62–0.96; P =.022). Patients randomized to FDI reported a better Minnesota Living with Heart Failure quality of life, for overall (P =.013) and physical domain (P =.00093) scores at 4 months. In patients with iron deficiency anemia and heart failure with reduced left ventricular ejection fraction, intravenous FDI improves quality of life and may decrease cardiovascular events. [Display omitted] [ABSTRACT FROM AUTHOR]

Abstract Background Patients with mental illness are frequently treated in primary care, where Primary Care Providers (PCPs) report feeling ill-equipped to manage their care. Team-based models of care improve outcomes for patients with mental illness, but multiple barriers limit adoption. Barriers include practical issues and psychosocial factors associated with the reorganization of care. Practice facilitation can improve implementation, but does not directly address the psychosocial factors or gaps in PCP skills in managing mental illness. To address these gaps, we developed Relational Team Development (RELATED). Methods RELATED is an implementation strategy combining practice facilitation and psychology clinical supervision methodologies to improve implementation of team-based care. It includes PCP-level clinical coaching and a team-level practice change activity. We performed a preliminary assessment of RELATED with a convergent parallel mixed method study in 2 primary care clinics in an urban Federally Qualified Health Center in Southwest, USA, 2017-2018. Study participants included PCPs, clinic staff, and patient representatives. Clinic staff and patients were recruited for the practice change activity only. Primary outcomes were feasibility and acceptability. Feasibility was assessed as ease of recruitment and implementation. Acceptability was measured in surveys of PCPs and staff and focus groups. We conducted semi-structured focus groups with 3 participant groups in each clinic: PCPs; staff and patients; and leadership. Secondary outcomes were change in pre- post- intervention PCP self-efficacy in mental illness management and team-based care. We conducted qualitative observations to better understand clinic climate. Results We recruited 18 PCPs, 17 staff members, and 3 patient representatives. We ended recruitment early due to over recruitment. Both clinics developed and implemented practice change activities. The mean acceptability score was 3.7 (SD=0.3) on a 4-point Likert scale. PCPs had a statistically significant increase in their mental illness management self-efficacy [change = 0.9, p-value=

Abstract Background Team-based models of care are efficacious in improving outcomes for patients with mental and physical illnesses. However, primary care clinics have been slow to adopt these models. We used iterative stakeholder engagement to develop an intervention to improve the implementation of team-based care for this complex population. Methods We developed the initial framework for Relational Team Development (RELATED) from a qualitative study of Primary Care Providers’ (PCPs’) experiences treating mental illness and a literature review of practice facilitation and psychology clinical supervision. Subsequently, we surveyed 900 Colorado PCPs to identify factors associated with PCP self-efficacy in management of mental illness and team-based care. We then conducted two focus groups for feedback on RELATED. Lastly, we convened an expert panel to refine the intervention. Results We developed RELATED, a two-part intervention delivered by a practice facilitator with a background in clinical psychology. The facilitator observes PCPs during patient visits and provides individualized coaching. Next, the facilitator guides the primary care team through a practice change activity with a focus on relational team dynamics. Conclusion The iterative development of RELATED using stakeholder engagement offers a model for the development of interventions tailored to the needs of these stakeholders. Trial registration Not applicable.

Transcatheter aortic valve implantation (TAVI) is a proven treatment for life-threatening aortic valve disease, predominantly severe aortic stenosis. However, even among developed nations, access to TAVI is not uniform. The Valve for Life initiative was launched by the European Association of Percutaneous Cardiovascular Interventions in 2015 with the objective of improving access to transcatheter valve interventions across Europe. The UK has been identified as a country with low penetration of these procedures and has been selected as the fourth nation to be included in the initiative. Specifically, the number of TAVI procedures carried out in the UK is significantly lower than almost all other European nations. Furthermore, there is substantial geographical inequity in access to TAVI within the UK. As a consequence of this underprovision, waiting times for TAVI are long, and mortality among those waiting intervention is significant. This article reviews these issues, reports new data on access to TAVI in the UK and presents the proposals of the UK Valve for Life team to address the current problems in association with the British Cardiovascular Intervention Society.

Background Excimer laser coronary atherectomy (ELCA) can be used as an adjunctive percutaneous coronary intervention treatment for challenging, heavily calcified lesions. Although previous studies have documented high rates of complication and restenosis, these predate the introduction of the smaller 0.9 mm laser catheter. As the coronary complexity has increased, there has been a renewed interest in the ELCA. This study investigates the indications, procedural characteristics, complications and outcomes of ELCA in a contemporary coronary interventional practice.Methods This single-centre study retrospectively analysed 50 patients treated with ELCA between January 2013 and January 2019.Results Patients had a mean age of 67.9±11.4 years with a male predominance (65.3%). 25 (50%) cases were performed in patients with stable angina. Failure to deliver the smallest available balloon/microcatheter was the most frequent indication in 32 (64%) cases for ELCA use. 30 (60%) of the procedures were performed via radial access. The 0.9 mm X-80 catheter was used in 41 (82%) of cases, delivering on average 9000±3929 pulses. ELCA-related complications included 2 coronary dissections and 1 perforation, all of which were covered with stents. No major complications could be directly attributed to the use of ELCA. There was one death and one case of stent thrombosis within 30 days of the procedure.Conclusion ELCA can be performed safely via the radial approach with a 0.9 mm catheter with a high success rate by suitably trained operators. The low procedure-related complications with contemporary techniques make this a very useful tool for complex coronary interventions, especially for difficult to dilate lesions and chronic total occlusion vessels.

Background Studies have reported significant reduction in acute myocardial infarction–related hospitalizations during the coronavirus disease 2019 (COVID‐19) pandemic. However, whether these trends are associated with increased incidence of out‐of‐hospital cardiac arrest (OHCA) in this population is unknown. Methods and Results Acute myocardial infarction hospitalizations with OHCA during the COVID‐19 period (February 1–May 14, 2020) from the Myocardial Ischaemia National Audit Project and British Cardiovascular Intervention Society data sets were analyzed. Temporal trends were assessed using Poisson models with equivalent pre–COVID‐19 period (February 1–May 14, 2019) as reference. Acute myocardial infarction hospitalizations during COVID‐19 period were reduced by >50% (n=20 310 versus n=9325). OHCA was more prevalent during the COVID‐19 period compared with the pre–COVID‐19 period (5.6% versus 3.6%), with a 56% increase in the incidence of OHCA (incidence rate ratio, 1.56; 95% CI, 1.39–1.74). Patients experiencing OHCA during COVID‐19 period were likely to be older, likely to be women, likely to be of Asian ethnicity, and more likely to present with ST‐segment–elevation myocardial infarction. The overall rates of invasive coronary angiography (58.4% versus 71.6%; P

The testing effect is when patient-reported outcomes (PRO) improve with repeated administration without intervention. The testing effect can confound interpretation of clinical trials using PROs as endpoints. This study investigated potential mechanisms. The parent study (n = 302) investigated a self-management intervention for depression. We qualitatively analyzed exit interview feedback from the 89 control group participants completing the last assessment. Participants reported several perceived benefits from control group participation including novel mechanisms (study participation was meaningful, emotional support, appreciating outreach), a possible negative testing effect and mechanisms previously identified (behavioral change).

Background: Bioprosthetic valve thrombosis (BPVT) is a rare but recognized complication causing valve dysfunction. In subacute valve thrombosis, systemic oral anticoagulation is recommended. However, there is little data comparing the efficacy of warfarin and novel oral anticoagulant (NOAC) therapy in this setting.Case Summary: A patient developed subacute BPVT 11 years post-implantation. The patient was initially treated with warfarin for a period of 6 months, with limited effect. Following replacement of warfarin with rivaroxaban, there was significant reversal of the BPVT, as represented by a reduction in transaortic maximal velocity (Vmax) from 4.1 to 3 m/s over 7 months.Discussion: Systemic oral anticoagulation can be an effective treatment for subacute valve thrombosis. Guidelines currently recommend warfarin as first line but NOACs can be considered in such patients and may be more effective than warfarin. Randomized controlled trials are required to further establish the optimal anticoagulation for patients with subacute BPVT.

Abstract Background Experts recommend that alcohol-related care be integrated into primary care (PC) to improve prevention and treatment of unhealthy alcohol use. However, few healthcare systems offer such integrated care. To address this gap, implementation researchers and clinical leaders at Kaiser Permanente Washington (KPWA) partnered to design a high-quality program of evidence-based care for unhealthy alcohol use: the Sustained Patient-centered Alcohol-related Care (SPARC) program. SPARC implements systems of clinical care designed to increase both prevention and treatment of unhealthy alcohol use. This clinical care for unhealthy alcohol use was implemented using three strategies: electronic health record (EHR) decision support, performance monitoring and feedback, and front-line support from external practice coaches with expertise in alcohol-related care (“SPARC implementation intervention” hereafter). The purpose of this report is to describe the protocol of the SPARC trial, a pragmatic, cluster-randomized, stepped-wedge implementation trial to evaluate whether the SPARC implementation intervention increased alcohol screening and brief alcohol counseling (so-called brief interventions), and diagnosis and treatment of alcohol use disorders (AUDs) in 22 KPWA PC clinics. Methods/Design The SPARC trial sample includes all adult patients who had a visit to any of the 22 primary care sites in the trial during the study period (January 1, 2015–July 31, 2018). The 22 sites were randomized to implement the SPARC program on different dates (in seven waves, approximately every 4 months). Primary outcomes are the proportion of patients with PC visits who (1) screen positive for unhealthy alcohol use and have documented brief interventions and (2) have a newly recognized AUD and subsequently initiate and engage in alcohol-related care. Main analyses compare the rates of these primary outcomes in the pre- and post-implementation periods, following recommended approaches for analyzing stepped-wedge trials. Qualitative analyses assess barriers and facilitators to implementation and required adaptations of implementation strategies. Discussion The SPARC trial is the first study to our knowledge to use an experimental design to test whether practice coaches with expertise in alcohol-related care, along with EHR clinical decision support and performance monitoring and feedback to sites, increase both preventive care—alcohol screening and brief intervention—as well as diagnosis and treatment of AUDs. Trial registration The trial is registered at ClinicalTrials.Gov: NCT02675777. Registered February 5, 2016, https://clinicaltrials.gov/ct2/show/NCT02675777.

Acute myocardial infarction (AMI) is a major cause of morbidity and mortality worldwide. Timely reperfusion with primary percutaneous coronary intervention (PPCI) remains the gold standard in patients presenting with ST-segment elevation myocardial infarction (STEMI), limiting infarct size, preserving left ventricular ejection fraction (LVEF), and improving clinical outcomes. Despite this, a significant proportion of STEMI patients develop post-infarct heart failure. We review the current understanding and up-to-date evidence base for therapeutic intervention of ischaemia-reperfusion injury (IRI), a combination of myocardial ischaemia secondary to acute coronary occlusion and reperfusion injury leading to further myocardial injury and cell death. Multiple treatment modalities have been shown to be cardioprotective and reduce IRI in experimental animal models. Recent phase II/III randomised controlled trials (RCT) have assessed multiple cardioprotective strategies ranging from ischaemic conditioning, therapeutic hypothermia and hyperoxaemia to pharmacological therapies. While several therapies have been shown to reduce infarct size in animal models or proof-of-concept studies, many larger scale trial results have proven inconsistent and disappointing. Hard clinical outcomes remain elusive. We discuss potential reasons for the difficulties in translation to clinical practice.

Abstract Background Most patients with alcohol use disorders (AUDs) never receive alcohol treatment, and experts have recommended management of AUDs in primary care. The Choosing Healthier Drinking Options In primary CarE (CHOICE) trial was a randomized controlled effectiveness trial of a novel intervention for primary care patients at high risk for AUDs. This report describes the conceptual and scientific foundation of the CHOICE model of care, critical elements of the CHOICE trial design consistent with the Template for Intervention Description and Replication (TIDieR), results of recruitment, and baseline characteristics of the enrolled sample. Methods The CHOICE intervention is a multi-contact, extended counseling intervention, based on the Chronic Care Model, shared decision-making, motivational interviewing, and evidence-based options for managing AUDs, designed to be practical in primary care. Outpatients who received care at 3 Veterans Affairs primary care sites in the Pacific Northwest and reported frequent heavy drinking (≥4 drinks/day for women; ≥5 for men) were recruited (2011–2014) into a trial in which half of the participants would be offered additional alcohol-related care from a nurse. CHOICE nurses offered 12 months of patient-centered care, including proactive outreach and engagement, repeated brief motivational interventions, monitoring with and without alcohol biomarkers, medications for AUDs, and/or specialty alcohol treatment as appropriate and per patient preference. A CHOICE nurse practitioner was available to prescribe medications for AUDs. Results A total of 304 patients consented to participate in the CHOICE trial. Among consenting participants, 90% were men, the mean age was 51 (range 22–75), and most met DSM-IV criteria for alcohol abuse (14%) or dependence (59%). Many participants also screened positive for tobacco use (44%), depression (45%), anxiety disorders (30-41%) and non-tobacco drug use disorders (19%). At baseline, participants had a median AUDIT score of 18 [Interquartile range (IQR) 14–24] and a median readiness to change drinking score of 5 (IQR 2.75–6.25) on a 1–10 Likert scale. Conclusion The CHOICE trial tested a patient-centered intervention for AUDs and recruited primary care patients at high risk for AUDs, with a spectrum of severity, co-morbidity, and readiness to change drinking. Trial registration The trial is registered at clinicaltrial.gov (NCT01400581).

Abstract RNA silencing constitutes an important antiviral mechanism in plants. Small RNA guided Argonaute proteins fulfill essential role in this process by acting as executors of viral restriction. Plants encode multiple Argonaute proteins of which several exhibit antiviral activities. A recent addition to this group is AGO2. Its involvement in antiviral responses is established predominantly by studies employing mutants of Arabidopsis thaliana. In the virological model plant, Nicotiana benthamiana, the contribution of AGO2 to antiviral immunity is much less certain due to the lack of appropriate genetic mutants. Previous studies employed various RNAi based tools to down-regulate AGO2 expression. However, these techniques have several disadvantages, especially in the context of antiviral RNA silencing. Here, we have utilized the CRISPR/Cas9 technology to inactivate the AGO2 gene of N. benthamiana. The ago2 plants exhibit differential sensitivities towards various viruses. AGO2 is a critical component of the plants’ immune responses against PVX, TuMV and TCV. In contrast, AGO2 deficiency does not significantly influence the progression of tombusvirus and CMV infections. In summary, our work provides unequivocal proof for the virus-specific antiviral role of AGO2 in a plant species other than A. thaliana for the first time.

Accreditation is a process by which programs demonstrate their academic quality; that is, they demonstrate that they are making decisions for programmatic changes based on: (1) a sound theoretical foundation; (2) clearly stated mission, goals, and objectives; (3) a comprehensive self-study and thoughtful use of best practices; and (4) consistent, systematic data collection and analysis (both baseline and comparative). This article is intended to provide an overview of the steps involved in achieving National Association for Developmental Education (NADE) accreditation.

Abstract Background As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants’ views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or “broad” fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic. Methods A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients’ views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. Results Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee’s output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers. Conclusions Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.

Sian W Ludman,1 Robert J Boyle2 1Paediatric Allergy Department, St Mary's Hospital, Imperial Healthcare NHS Trust, London, UK; 2Department of Paediatrics, Imperial College London, London, UKAbstract: Systemic allergic reactions to insect stings affect up to 5% of the population during their lifetime, and up to 32% of beekeepers. Such reactions can be fatal, albeit very rarely, and fear of a further systemic reaction (SR) can lead to significant anxiety and quality of life impairment. A recent Cochrane systematic review confirmed that venom immunotherapy (VIT) is an effective treatment for people who have had a systemic allergic reaction to an insect sting. VIT reduces risk of a further SR (relative risk 0.10, 95% confidence interval 0.03–0.28), but VIT also reduces risk of a future large local reaction, and significantly improves disease-specific quality of life. However, health economic analysis showed that VIT is generally not cost effective for preventing future SRs; most people are stung infrequently, most SRs resolve without long-term consequences, and a fatal outcome is extremely rare. VIT only becomes cost effective if one is stung frequently (eg, beekeepers) or if quality of life improvement is considered. Thus, for most people with insect sting allergy, anxiety and quality of life impairment should be the overriding consideration when making treatment decisions, highlighting the importance of a patient-centered approach. Areas which need to be explored in future research include efforts to improve the safety and convenience of VIT such as the use of sublingual immunotherapy; quality of life effects of venom allergy in children and adolescents as well as their parents; and the optimal duration of treatment.Keywords: anaphylaxis, quality of life

BACKGROUND: Sex-based outcome differences for women with ST-segment--elevation myocardial infarction (STEMI) have not been adequately addressed, and the role played by differences in prescription of potent P2Y12 inhibitors (P-P2Y12) is not well defined. This study explores the hypothesis that disparities in P-P2Y12 (prasugrel or ticagrelor) use may play a role in outcome disparities for women with STEMI. METHODS: Data from British Cardiovascular Intervention Society national percutaneous coronary intervention database were analyzed, and 168 818 STEMI patients treated with primary percutaneous coronary intervention from 2010 to 2020 were included. RESULTS: Among the included women (43 131; 25.54%) and men (125 687; 74.45%), P-P2Y12 inhibitors were prescribed less often to women (51.71%) than men (55.18%; P<0.001). Women were more likely to die in hospital than men (adjusted odds ratio, 1.213 [95% CI, 1.141--1.290]). Unadjusted mortality was higher among women treated with clopidogrel (7.57%), than P-P2Y12-treated women (5.39%), men treated with clopidogrel (4.60%), and P-P2Y12-treated men (3.61%; P<0.001). The strongest independent predictor of P-P2Y12 prescription was radial access (adjusted odds ratio, 2.368 [95% CI, 2.312--2.425]), used in 67.93% of women and 74.38% of men (P<0.001). Two risk adjustment models were used. Women were less likely to receive a P-P2Y12 (adjusted odds ratio, 0.957 [95% CI, 0.935--0.979]) with risk adjustment for baseline characteristics alone, when procedural factors including radial access were included in the model differences were not significant (adjusted odds ratio, 1.015 [95% CI, 0.991--1.039]). CONCLUSIONS: Women were less likely to be prescribed prasugrel or ticagrelor, were less likely to have radial access, and had a higher mortality when being treated for STEMI. Improving rates of P-P2Y12 use and radial access may decrease outcome disparities for women with STEMI. GRAPHIC ABSTRACT: A graphic abstract is available for this article. [ABSTRACT FROM AUTHOR]

BackgroundRecent recommendations suggest that in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and coexistent significant coronary artery disease, the latter should be treated before the index procedure; however, the evidence basis for such an approach remains limited. We performed a systematic review and meta‐analysis to study the clinical outcomes of patients with coronary artery disease who did or did not undergo revascularization prior to transcatheter aortic valve implantation. Methods and ResultsWe conducted a search of Medline and Embase to identify studies evaluating patients who underwent transcatheter aortic valve implantation with or without percutaneous coronary intervention. Random‐effects meta‐analyses with the inverse variance method were used to estimate the rate and risk of adverse outcomes. Nine studies involving 3858 participants were included in the meta‐analysis. Patients who underwent revascularization with percutaneous coronary intervention had a higher rate of major vascular complications (odd ratio [OR]: 1.86; 95% confidence interval [CI], 1.33–2.60; P=0.0003) and higher 30‐day mortality (OR: 1.42; 95% CI, 1.08–1.87; P=0.01). There were no differences in effect estimates for 30‐day cardiovascular mortality (OR: 1.03; 95% CI, 0.35–2.99), myocardial infarction (OR: 0.86; 95% CI, 0.14–5.28), acute kidney injury (OR: 0.89; 95% CI, 0.42–1.88), stroke (OR: 1.07; 95% CI, 0.38–2.97), or 1‐year mortality (OR: 1.05; 95% CI, 0.71–1.56). The timing of percutaneous coronary intervention (same setting versus a priori) did not negatively influence outcomes. ConclusionsOur analysis suggests that revascularization before transcatheter aortic valve implantation confers no clinical advantage with respect to several patient‐important clinical outcomes and may be associated with an increased risk of major vascular complications and 30‐day mortality. In the absence of definitive evidence, careful evaluation of patients on an individual basis is of paramount importance to identify patients who might benefit from elective revascularization.

BackgroundTranscatheter aortic valve implantation (TAVI) is indicated for patients with aortic stenosis who are intermediate‐high surgical risk. Although all‐cause mortality rates after TAVI are established, survival attributable to the procedure is unclear because of competing causes of mortality. The aim was to report relative survival (RS) after TAVI, which accounts for background mortality risks in a matched general population. Methods and ResultsNational cohort data (n=6420) from the 2007 to 2014 UK TAVI registry were matched by age, sex, and year to mortality rates for England and Wales (population, 57.9 million). The Ederer II method related observed patient survival to that expected from the matched general population. We modelled RS using a flexible parametric approach that modelled the log cumulative hazard using restricted cubic splines. RS of the TAVI cohort was 95.4%, 90.2%, and 83.8% at 30 days, 1 year, and 3 years, respectively. By 1‐year follow‐up, mortality hazards in the >85 years age group were not significantly different from those of the matched general population; by 3 years, survival rates were comparable. The flexible parametric RS model indicated that increasing age was associated with significantly lower excess hazards after the procedure; for example, by 2 years, a 5‐year increase in age was associated with 20% lower excess mortality over the general population. ConclusionsRS after TAVI was high, and survival rates in those aged >85 years approximated those of a matched general population within 3 years. High rates of RS indicate that patients selected for TAVI tolerate the risks of the procedure well.

BackgroundAortic valve predilation with balloon aortic valvuloplasty (BAV) is recommended before transcatheter aortic valve implantation (TAVI), despite limited data around the requirement of this preprocedural step and the potential risks of embolization. This study aimed to investigate the trends in practice and associations of BAV on short‐term outcomes in the UK TAVI registry. Methods and ResultsEleven clinical endpoints were investigated, including 30‐day mortality, myocardial infarction, aortic regurgitation, valve dysfunction, and composite early safety. All endpoints were defined as per the VARC‐2 definitions. Odd ratios of each endpoint were estimated using logistic regression, with data analyzed in balloon‐ and self‐expandable valve subgroups. Propensity scores were calculated using patient demographics and procedural variables, which were included in the models of each endpoint to adjust for measured confounding. Between 2007 and 2014, 5887 patients met the study inclusion criteria, 1421 (24.1%) of whom had no BAV before TAVI valve deployment. We observed heterogeneity in the use of BAV nationally, both temporally and by center experience; rates of BAV in pre‐TAVI workup varied between 30% and 97% across TAVI centers. All endpoints were similar between treatment groups in SAPIEN (Edwards Lifesciences Inc., Irvine, CA) valve patients. After correction for multiple testing, none of the endpoints in CoreValve (Medtronic, Minneapolis, MN) patients were significantly different between patients with or without predilation. ConclusionsPerforming TAVI without predilation was not associated with adverse short‐term outcomes post procedure, especially when using a balloon‐expandable prosthesis. Randomized trials including different valve types are required to provide conclusive evidence regarding the utility of predilation before‐TAVI.

Objective: Examine whether (1) childhood maltreatment is associated with subsequent obesity and depression in middle-age; (2) maltreatment explains the associations between obesity and depression; and (3) binge eating or body dissatisfaction mediate associations between childhood maltreatment and subsequent obesity. Methods: Data were obtained through a population-based survey of 4641 women (mean age = 52 years) enrolled in a large health plan in the Pacific Northwest. A telephone survey assessed child sexual and physical abuse, obesity (BMI greater than or equal to 30), depressive symptoms, binge eating, and body dissatisfaction. Data were analyzed using logistic regression models incorporating sampling weights. Results: Both child sexual and physical abuse were associated with a doubling of the odds of both obesity and depression, although child physical abuse was not associated with depression for the African American/Hispanic/American Indian subgroup. The association between obesity and depression (unadjusted OR = 2.82; 95% CI = 2.20-3.62) was reduced somewhat after controlling for sexual abuse (adjusted OR = 2.54; 1.96-3.29) and for physical abuse (adjusted OR = 2.63; 2.03-3.42). Controlling for potential mediators failed to substantially attenuate associations between childhood maltreatment and obesity. Conclusions: This study is the first to our knowledge that compares associations of child abuse with both depression and obesity in adults. Although the study is limited by its cross-sectional design and brief assessments, the fact that child abuse predicted two debilitating conditions in middle-aged women indicates the potential long-term consequences of these experiences. (Contains 4 tables.)

Randomized trial evidence and expert guidelines are mixed regarding the value of combined pharmacotherapy and psychotherapy as initial treatment for depression. This study describes long-term results of a randomized trial (N = 393) evaluating telephone-based cognitive-behavioral therapy (CBT) plus care management for primary care patients beginning antidepressant treatment versus usual care. In a repeated measures linear model with adjustment for baseline scores, the phone therapy group showed significantly lower mean Hopkins Symptom Checklist (HSCL) Depression Scale scores (L. Derogatis, K. Rickels, E. Uhlenhuth, & L. Covi, 1974) from 6 months to 18 months versus usual care, F(1, 336) = 11.28, p = 0.001. Average HSCL depression scores over the period from 6 months to 18 months were 0.68 (SD = 0.55) in the telephone therapy group and 0.85 (SD = 0.65) in the usual-care comparison group. Addition of a brief, structured CBT program can significantly improve clinical outcomes for the large number of patients beginning antidepressant treatment in primary care.