Publications
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Fisser C, Bureck J, Gall L, et al., 2021, Ventricular Arrhythmias in Heart Failure Patients with reduced Ejection Fraction and central Sleep Apnea. An Analysis of the SERVE-HF Major Sub-study, Publisher: GEORG THIEME VERLAG KG, Pages: S18-S18, ISSN: 0934-8387
Cowie MR, Schoepe J, Wagenpfeil S, et al., 2021, Patient factors associated with titration of medical therapy in patients with heart failure with reduced ejection fraction: data from the QUALIFY international registry, ESC Heart Failure, Vol: 8, Pages: 861-871, ISSN: 2055-5822
AimsFailure to prescribe key medicines at evidence-based doses is associated with increased mortality and hospitalization for patients with Heart Failure with reduced Ejection Fraction (HFrEF). We assessed titration patterns of guideline-recommended HFrEF medicines internationally and explored associations with patient characteristics in the global, prospective, observational, longitudinal registry.Methods and resultsData were collected from September 2013 through December 2014, with 7095 patients from 36 countries [>18 years, previous HF hospitalization within 1–15 months, left ventricular ejection fraction (LVEF) ≤ 40%] enrolled, with dosage data at baseline and up to 18 months from 4368 patients. In 4368 patients (mean age 63 ± 17 years, 75% male) ≥ 100% target doses at baseline: 30.6% (ACEIs), 2.9% (ARBs), 13.9% (BBs), 53.8% (MRAs), 26.2% (ivabradine). At final follow-up, ≥100% target doses achieved in more patients for ACEI (34.8%), BB (18.0%), and ivabradine (30.5%) but unchanged for ARBs (3.2%) and MRAs (53.7%). Adjusting for baseline dosage, uptitration during follow-up was more likely with younger age, higher systolic blood pressure, and in absence of chronic kidney disease or diabetes for ACEIs/ARBs; younger age, higher body mass index, higher heart rate, lower LVEF, and absence of coronary artery disease for BBs. For ivabradine, uptitration was more likely with higher resting heart rate.ConclusionsThe international QUALIFY Registry suggests that few patients with HFrEF achieve target doses of disease-modifying medication, especially older patients and those with co-morbidity. Quality improvement initiatives are urgently required.
Halliday B, Owen R, Gregson J, et al., 2021, Myocardial remodelling after withdrawing therapy for heart failure in patients with recovered dilated cardiomyopathy: insights from TRED-HF, European Journal of Heart Failure, Vol: 23, Pages: 293-301, ISSN: 1388-9842
Aims: To characterize adverse ventricular remodelling after withdrawing therapy in recovered dilated cardiomyopathy (DCM). Methods and results: TRED-HF was a randomized controlled trial with a follow-on single-arm cross-over phase that examined the safety and feasibility of therapy withdrawal in patients with recovered DCM over 6 months. The primary endpoint was relapse of heart failure defined by (i) a reduction in left ventricular (LV) ejection fraction >10% and to <50%, (ii) >10% increase in LV end-diastolic volume and to above the normal range, (iii) a twofold rise in N-terminal pro-B-type natriuretic peptide and to >400 ng/L, or (iv) evidence of heart failure. LV mass, LV and right ventricular (RV) global longitudinal strain (GLS) and extracellular volume were measured using cardiovascular magnetic resonance at baseline and follow-up (6 months or relapse) for 48 patients. LV cell and extracellular matrix masses were derived. The effect of withdrawing therapy, stratified by relapse and genotype, was investigated in the randomized and follow-on phases. In the randomized comparison, withdrawing therapy led to an increase in mean LV mass [5.4 g/m2; 95% confidence interval (CI) 1.3–9.5] and cell mass (4.2 g/m2; 95% CI 0.5–8.0) and a reduction in LV (3.5; 95% CI 1.6–5.5) and RV (2.4; 95% CI 0.1–4.7) GLS. In a non-randomized comparison of all patients (n = 47) who had therapy withdrawn in either phase, there was an increase in LV mass (6.2 g/m2; 95% CI 3.6–8.9; P = 0.0001), cell mass (4.0 g/m2; 95% CI 1.8–6.2; P = 0.0007) and matrix mass (1.7 g/m2; 95% CI 0.7–2.6; P = 0.001) and a reduction in LV GLS (2.7; 95% CI 1.5–4.0; P = 0.0001). Amongst those who had therapy withdrawn and did not relapse, similar changes were observed (n = 28; LV mass: 5.1 g/m2, 95% CI 1.5–8.8, P = 0.007; cell mass: 3.7 g/m2, 95% CI 0.3–7.0, P = 0.03; matrix mass: 1.7 g/m2, 95% CI 0.4–3.0, P = 0.02; LV GLS: 1.7, 95% CI
Wong KY, Davies B, Adeleke Y, et al., 2021, Hospital admissions for stroke and bleeding in Hounslow following a quality improvement initiative, Open Heart, Vol: 8, ISSN: 2053-3624
Objective Atrial fibrillation (AF) is the most common arrhythmia. Undiagnosed and poorly managed AF increases risk of stroke. The Hounslow AF quality improvement (QI) initiative was associated with improved quality of care for patients with AF through increased detection of AF and appropriate anticoagulation. This study aimed to evaluate whether there has been a change in stroke and bleeding rates in the Hounslow population following the QI initiative.Methods Using hospital admissions data from January 2011 to August 2018, interrupted time series analysis was performed to investigate the changes in standardised rates of admission with stroke and bleeding, following the start of the QI initiative in October 2014.Results There was a 17% decrease in the rate of admission with stroke as primary diagnosis (incidence rate ratio (IRR) 0.83; 95% CI 0.712 to 0.963; p<0.014). There was an even larger yet not statistically significant decrease in admission with stroke as primary diagnosis and AF as secondary diagnosis (IRR 0.75; 95% CI 0.550 to 1.025; p<0.071). No significant changes were observed in bleeding admissions. For each outcome, an additional regression model including both the level change and an interaction term for slope change was created. In all cases, the slope change was small and not statistically significant.Conclusion Reduction in stroke admissions may be associated with the AF QI initiative. However, the immediate level change and non-significant slope change suggests a lack of effect of the intervention over time and that the decrease observed may be attributable to other events.
Whitelaw S, Pellegrini DM, Mamas MA, et al., 2021, Barriers and facilitators of the uptake of digital health technology in cardiovascular care: a systematic scoping review., European Heart Journal Digital Health, Vol: 2, Pages: 62-74, ISSN: 2634-3916
Digital health technology (DHT) has the potential to revolutionize healthcare delivery but its uptake has been low in clinical and research settings. The factors that contribute to the limited adoption of DHT, particularly in cardiovascular settings, are unclear. The objective of this review was to determine the barriers and facilitators of DHT uptake from the perspective of patients, clinicians, and researchers. We searched MEDLINE, EMBASE, and CINAHL databases for studies published from inception to May 2020 that reported barriers and/or facilitators of DHT adoption in cardiovascular care. We extracted data on study design, setting, cardiovascular condition, and type of DHT. We conducted a thematic analysis to identify barriers and facilitators of DHT uptake. The search identified 3075 unique studies, of which 29 studies met eligibility criteria. Studies employed: qualitative methods (n = 13), which included interviews and focus groups; quantitative methods (n = 5), which included surveys; or a combination of qualitative and quantitative methods (n = 11). Twenty-five studies reported patient-level barriers, most common of which were difficult-to-use technology (n=7) and a poor internet connection (n=7). Six studies reported clinician-level barriers, which included increased workload (n=4) and a lack of integration with electronic medical records (n=3).Twenty-four studies reported patient-level facilitators, which included improved communication with clinicians (n=10) and personalized technology (n=6). Four studies reported clinician-level facilitators, which included approval and organizational support from cardiology departments and/or hospitals (n=3) and technologies that improved efficiency (n=3). No studies reported researcher-level barriers or facilitators. In summary, internet access, user-friendliness, organizational support, workflow efficiency, and data integration were reported as important factors in the uptake of DHT by patients and clinicians. These f
Jensen MT, Treskes RW, Caiani EG, et al., 2021, ESC working group on e-cardiology position paper: use of commercially available wearable technology for heart rate and activity tracking in primary and secondary cardiovascular prevention-in collaboration with the European Heart Rhythm Association, European Association of Preventive Cardiology, Association of Cardiovascular Nursing and Allied Professionals, Patient Forum, and the Digital Health Committee., Eur Heart J Digit Health, Vol: 2, Pages: 49-59
Commercially available health technologies such as smartphones and smartwatches, activity trackers and eHealth applications, commonly referred to as wearables, are increasingly available and used both in the leisure and healthcare sector for pulse and fitness/activity tracking. The aim of the Position Paper is to identify specific barriers and knowledge gaps for the use of wearables, in particular for heart rate (HR) and activity tracking, in clinical cardiovascular healthcare to support their implementation into clinical care. The widespread use of HR and fitness tracking technologies provides unparalleled opportunities for capturing physiological information from large populations in the community, which has previously only been available in patient populations in the setting of healthcare provision. The availability of low-cost and high-volume physiological data from the community also provides unique challenges. While the number of patients meeting healthcare providers with data from wearables is rapidly growing, there are at present no clinical guidelines on how and when to use data from wearables in primary and secondary prevention. Technical aspects of HR tracking especially during activity need to be further validated. How to analyse, translate, and interpret large datasets of information into clinically applicable recommendations needs further consideration. While the current users of wearable technologies tend to be young, healthy and in the higher sociodemographic strata, wearables could potentially have a greater utility in the elderly and higher-risk population. Wearables may also provide a benefit through increased health awareness, democratization of health data and patient engagement. Use of continuous monitoring may provide opportunities for detection of risk factors and disease development earlier in the causal pathway, which may provide novel applications in both prevention and clinical research. However, wearables may also have potential adverse
Singhal A, Cowie MR, 2021, Heart failure in men, TRENDS IN UROLOGY & MENS HEALTH, Vol: 12, Pages: 15-20, ISSN: 2044-3730
Mullens W, Auricchio A, Martens P, et al., 2021, Optimized Implementation of cardiac resynchronization therapy - a call for action for referral and optimization of care A joint position statement from the Heart Failure Association (HFA), European Heart Rhythm Association (EHRA), and European Association of Cardiovascular Imaging (EACVI) of the European Society of Cardiology (Retraction of Vol 23, Pg 1324, 2021), EUROPACE, Vol: 25, ISSN: 1099-5129
Chen Y, Postmus D, Cowie MR, et al., 2021, Using joint modelling to assess the association between a time-varying biomarker and a survival outcome: an illustrative example in respiratory medicine, EUROPEAN RESPIRATORY JOURNAL, Vol: 57, ISSN: 0903-1936
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- Citations: 5
McCambridge J, Keane C, Walshe M, et al., 2020, The prehospital patient pathway and experience of care with acute heart failure: a comparison of two health care systems, ESC Heart Failure, Vol: 8, Pages: 1076-1084, ISSN: 2055-5822
AimsThis study aimed to analyse community management of patients during the symptomatic period prior to admission with acute decompensated heart failure (ADHF).Methods and resultsWe conducted a prospective, two-centre, two-country observational study evaluating care pathways and patient experience in patients admitted to hospital with ADHF. Quantitative and qualitative data were gathered from patients, carers, and general practitioners (GPs). From the Irish centre, 114 patients enrolled, and from the English centre, 50 patients. Symptom duration longer than 72 h prior to hospitalization was noted among 70.4% (76) Irish and 80% (40) English patients, with no significant difference between those with a new diagnosis of HF [de novo HF (dnHF)] and those with known HF [established HF (eHF)] in either cohort. For the majority, dyspnoea was the dominant symptom; however, 63.3% (31) of these Irish patients and 47.2% (17) of these English patients did not recognize this as an HF symptom, with no significant difference between dnHF and eHF patients. Of the 46.5% (53) of Irish and 38% (19) of English patients reviewed exclusively by GPs before hospitalization, numbers prescribed diuretics were low (11.3%, six; and 15.8%, three, respectively); eHF patients were no more likely to receive diuretics than dnHF patients. Barriers to care highlighted by GPs included inadequate access to basic diagnostics, specialist support and up-to-date patient information, and lack of GP comfort in managing HF.ConclusionThe aforementioned findings, consistent across both health care jurisdictions, show a clear potential to intervene earlier and more effectively in ADHF or to prevent the need for hospitalization.
Zannad F, Cowie MR, 2020, VERTIS-CV More Evidence That Sodium Glucose Cotransporter 2 Inhibition Brings Rapid and Sustained Heart Failure Benefit, CIRCULATION, Vol: 142, Pages: 2216-2218, ISSN: 0009-7322
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- Citations: 2
Cowie MR, Fisher M, 2020, SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control, NATURE REVIEWS CARDIOLOGY, Vol: 17, Pages: 761-772, ISSN: 1759-5002
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- Citations: 276
Mullens W, Auricchio A, Martens P, et al., 2020, Optimized implementation of cardiac resynchronization therapy: a call for action for referral and optimization of care A joint position statement from the Heart Failure Association (HFA), European Heart Rhythm Association (EHRA), and European Association of Cardiovascular Imaging (EACVI) of the European Society of Cardiology, EUROPEAN JOURNAL OF HEART FAILURE, Vol: 22, Pages: 2349-2369, ISSN: 1388-9842
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- Citations: 77
Pandiaraja M, Brimicombe J, Cowie M, et al., 2020, Screening for atrial fibrillation: improving efficiency of manual review of handheld electrocardiograms †., Engineering Proceedings, Vol: 2, Pages: 1-7, ISSN: 2673-4591
Atrial fibrillation (AF) is a common irregular heart rhythm associated with a five-fold increase in stroke risk. It is often not recognised as it can occur intermittently and without symptoms. A promising approach to detect AF is to use a handheld electrocardiogram (ECG) sensor for screening. However, the ECG recordings must be manually reviewed, which is time-consuming and costly. Our aims were to: (i) evaluate the manual review workload; and (ii) evaluate strategies to reduce the workload. In total, 2141 older adults were asked to record their ECG four times per day for 1-4 weeks in the SAFER (Screening for Atrial Fibrillation with ECG to Reduce stroke) Feasibility Study, producing 162,515 recordings. Patients with AF were identified by: (i) an algorithm classifying recordings based on signal quality (high or low) and heart rhythm; (ii) a nurse reviewing recordings to correct algorithm misclassifications; and (iii) two cardiologists independently reviewing recordings from patients with any evidence of rhythm abnormality. It was estimated that 30,165 reviews were required (20,155 by the nurse, and 5005 by each cardiologist). The total number of reviews could be reduced to 24,561 if low-quality recordings were excluded from review; 18,573 by only reviewing ECGs falling under certain pathological classifications; and 18,144 by only reviewing ECGs displaying an irregularly irregular rhythm for the entire recording. The number of AF patients identified would not fall considerably: from 54 to 54, 54 and 53, respectively. In conclusion, simple approaches may help feasibly reduce the manual workload by 38.4% whilst still identifying the same number of patients with undiagnosed, clinically relevant AF.
Cowie MR, 2020, Sodium-glucose cotransporter-2 inhibitors: where and when?, FUTURE CARDIOLOGY, Vol: 17, Pages: 403-406, ISSN: 1479-6678
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- Citations: 1
Ladeiras-Lopes R, Baciu L, Grapsa J, et al., 2020, Social media in cardiovascular medicine: a contemporary review., Eur Heart J Digit Health, Vol: 1, Pages: 10-19
Social media increasingly impact both the private and professional lives of the majority of the population, including individuals engaged in cardiovascular healthcare and research. Healthcare providers across the world use social media platforms such as Twitter or Facebook to find medical and scientific information, to follow scientific meetings, to discuss individual clinical cases with colleagues, and to engage with patients. While social media provide a means for fast, interactive and accessible communication without geographic boundaries, their use to obtain and disseminate information has limitations and the potential threats are not always clearly understood. Governance concerns include a lack of rigorous quality control, bias due to the pre-selection of presented content by filter algorithms, and the risk of inadvertent breach of patient confidentiality. This article provides information and guidance regarding the role and use of social media platforms in cardiovascular medicine, with an emphasis on the new opportunities for the dissemination of scientific information and continuing education that arise from their responsible use.
Cowie MR, 2020, DAPA-HF: does dapagliflozin provide "bang for your buck" as a treatment for HFrEF?, European Journal of Heart Failure, Vol: 22, Pages: 2157-2159, ISSN: 1388-9842
Halliday B, Vazir A, Owen R, et al., 2020, Heart rate as a marker of relapse during withdrawal of heart failure therapy in patients with recovered dilated cardiomyopathy: an analysis from TRED-HF, European-Society-of-Cardiology (ESC) Congress, Publisher: OXFORD UNIV PRESS, Pages: 1057-1057, ISSN: 0195-668X
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- Citations: 1
Nielsen JC, Kautzner J, Casado-Arroyo R, et al., 2020, Remote monitoring of cardiac implanted electronic devices: legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report, EUROPACE, Vol: 22, Pages: 1742-+, ISSN: 1099-5129
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- Citations: 18
Cowie MR, 2020, Building the new digital world: launch of the European Heart Journal - Digital Health., Eur Heart J Digit Health, Vol: 1
Tanner FC, Brooks N, Fox KF, et al., 2020, ESC Core Curriculum for the Cardiologist, EUROPEAN HEART JOURNAL, Vol: 41, Pages: 3605-3692, ISSN: 0195-668X
Cowie MR, Lamy A, Levy P, et al., 2020, Health economic evaluation of rivaroxaban in the treatment of patients with chronic coronary artery disease or peripheral artery disease, Cardiovascular Research, Vol: 116, Pages: 1918-1924, ISSN: 0008-6363
AIMS: In the COMPASS trial, rivaroxaban 2.5 mg twice daily (bid) plus acetylsalicylic acid (ASA) 100 mg once daily (od) performed better than ASA 100 mg od alone in reducing the rate of cardiovascular disease, stroke, or myocardial infarction (MI) in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). A Markov model was developed to assess the cost-effectiveness of rivaroxaban plus ASA vs. ASA alone over a lifetime horizon, from the UK National Health System perspective. METHODS AND RESULTS: The base case analysis assumed that patients entered the model in the event-free health state, with the possibility to experience ≤2 events, transitioning every three-month cycle, through acute and post-acute health states of MI, ischaemic stroke (IS), or intracranial haemorrhage (ICH), and death. Costs, quality-adjusted life-years (QALYs), life years-all discounted at 3.5%-and incremental cost-effectiveness ratios (ICERs) were calculated. Deterministic and probabilistic sensitivity analyses were conducted, as well as scenario analyses. In the model, patients on rivaroxaban plus ASA lived for an average of 14.0 years with no IS/MI/ICH, and gained 9.7 QALYs at a cost of £13 947, while those receiving ASA alone lived for an average of 12.7 years and gained 9.3 QALYs at a cost of £8126. The ICER was £16 360 per QALY. This treatment was cost-effective in 98% of 5000 iterations at a willingness-to-pay threshold of £30 000 per QALY. CONCLUSION: This Markov model suggests that rivaroxaban 2.5 mg bid plus ASA is a cost-effective alternative to ASA alone in patients with chronic CAD or PAD.
Cowie MM, 2020, Heart Failure hospitalisation reduction with remote pulmonary artery pressure monitoring: results of the first 100 United Kingdom patients of the CardioMEMS HF System OUS Post-Market Study, Publisher: WILEY, Pages: 83-83, ISSN: 1388-9842
Diaz TD, Marin CM, Kall Y, et al., 2020, Cardiac autonomic nerves stimulation improves hemodynamics and clinical status in advanced heart failure patients, Publisher: WILEY, Pages: 38-38, ISSN: 1388-9842
Yadegarfar ME, Gale CP, Dondo TB, et al., 2020, Association of treatments for acute myocardial infarction and survival for seven common comorbidity states: a nationwide cohort study, BMC Medicine, Vol: 18, Pages: 1-12, ISSN: 1741-7015
BackgroundComorbidity is common and has a substantial negative impact on the prognosis of patients with acute myocardial infarction (AMI). Whilst receipt of guideline-indicated treatment for AMI is associated with improved prognosis, the extent to which comorbidities influence treatment provision its efficacy is unknown. Therefore, we investigated the association between treatment provision for AMI and survival for seven common comorbidities.MethodsWe used data of 693,388 AMI patients recorded in the Myocardial Ischaemia National Audit Project (MINAP), 2003–2013. We investigated the association between comorbidities and receipt of optimal care for AMI (receipt of all eligible guideline-indicated treatments), and the effect of receipt of optimal care for comorbid AMI patients on long-term survival using flexible parametric survival models.ResultsA total of 412,809 [59.5%] patients with AMI had at least one comorbidity, including hypertension (302,388 [48.7%]), diabetes (122,228 [19.4%]), chronic obstructive pulmonary disease (COPD, 89,221 [14.9%]), cerebrovascular disease (51,883 [8.6%]), chronic heart failure (33,813 [5.6%]), chronic renal failure (31,029 [5.0%]) and peripheral vascular disease (27,627 [4.6%]).Receipt of optimal care was associated with greatest survival benefit for patients without comorbidities (HR 0.53, 95% CI 0.51–0.56) followed by patients with hypertension (HR 0.60, 95% CI 0.58–0.62), diabetes (HR 0.83, 95% CI 0.80–0.87), peripheral vascular disease (HR 0.85, 95% CI 0.79–0.91), renal failure (HR 0.89, 95% CI 0.84–0.94) and COPD (HR 0.90, 95% CI 0.87–0.94). For patients with heart failure and cerebrovascular disease, optimal care for AMI was not associated with improved survival.ConclusionsOverall, guideline-indicated care was associated with improved long-term survival. However, this was not the case in AMI patients with concomitant heart failure or cerebrovascular disease. There is therefore a need fo
Zakeri R, Morgan JM, Phillips P, et al., 2020, Prevalence and prognostic significance of device-detected subclinical atrial fibrillation in patients with heart failure and reduced ejection fraction, INTERNATIONAL JOURNAL OF CARDIOLOGY, Vol: 312, Pages: 64-70, ISSN: 0167-5273
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- Citations: 5
Miro O, Rossello X, Platz E, et al., 2020, Risk stratification scores for patients with acute heart failure in the Emergency Department: A systematic review, EUROPEAN HEART JOURNAL-ACUTE CARDIOVASCULAR CARE, Vol: 9, Pages: 375-398, ISSN: 2048-8726
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- Citations: 24
Kim D, Hayhoe B, Aylin P, et al., 2020, Health service use by patients with heart failure living in a community setting: a cross-sectional analysis in North West London, British Journal of General Practice, Vol: 70, Pages: e563-e572, ISSN: 0960-1643
Background: The complex nature of heart failure (HF) management, often involving multidimensional care, is widely recognised, but overall health service utilisation by HF patients has not previously been described.Aim: To describe overall health service use by community-dwelling adults with HF.Design and Setting: Cross-sectional analysis of prevalent HF cases between 2015 and 2018 using an administrative dataset covering primary care, secondary care, and ‘other’ (community, mental health, and social care) services in North West London (NWL).Methods: Healthcare use of each service was described overall and by individual components of secondary care (e.g. outpatient appointments) and ‘other’ services (e.g. nursing contacts). Usage patterns were identified using k-means cluster analysis using all distinct contacts for the whole study period and visualised by a heatmap. Results: There were 39 301 patients with a prevalent diagnosis of HF between 1 January 2015 and 31 December 2018. 90% used health services during the study period, most commonly outpatient services, GP consultations, unplanned A&E visits and community services. Use of cardiology-specific services ranged from around 3% (cardiology-related community care) to around 20% (outpatient cardiology visits). GP consultations decreased by 11% over our study period. Five clusters of patients were identified, each with significantly different care usage patterns and patient characteristics.Conclusions: HF patients make heavy but heterogeneous use of services. Relatively low and falling use of GP consultations, and apparently low uptake of community rehabilitation services by patients with HF, is concerning and suggests challenges in primary care access and integration of care.
Singhal A, Cowie MR, 2020, The role of wearables in heart failure., Current Heart Failure Reports, Vol: 17, Pages: 125-132, ISSN: 1546-9530
PURPOSE OF REVIEW: This review discusses how wearable devices-sensors externally applied to the body to measure a physiological signal-can be used in heart failure (HF) care. RECENT FINDINGS: Most wearables are marketed to consumers and can measure movement, heart rate, and blood pressure; detect and monitor arrhythmia; and support exercise training and rehabilitation. Wearable devices targeted at healthcare professionals include ECG patch recorders and vests, patches, and textiles with in-built sensors for improved prognostication and the early detection of acute decompensation. Integrating data from wearables into clinical decision-making has been slow due to clinical inertia and concerns regarding data security and validity, lack of evidence of meaningful impact, interoperability, regulatory and reimbursement issues, and legal liability. Although few studies have assessed how best to integrate wearable technologies into clinical practice, their use is rapidly expanding and may support improved decision-making by patients and healthcare professionals along the whole patient pathway.
Wachter R, Shah SJ, Cowie MR, et al., 2020, Angiotensin receptor neprilysin inhibition versus individualized RAAS blockade: design and rationale of the PARALLAX trial, ESC Heart Failure, Vol: 7, Pages: 856-864, ISSN: 2055-5822
AIMS: Although the effect of the angiotensin receptor blocker neprilysin inhibitor (ARNI) sacubitril/valsartan on heart failure (HF) hospitalizations and cardiovascular death has been evaluated, its effects on functional capacity in patients with HF and ejection fraction (EF) >40% has yet to be determined. In addition, no prior studies have compared sacubitril/valsartan with angiotensin-converting enzyme inhibitor therapy. We sought to compare the effect of ARNI to background-medication-based individualized comparators (BMICs) on N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity [6 min walk distance (6MWD)], symptoms, and quality of life [Kansas City Cardiomyopathy Questionnaire (KCCQ)] in patients with HF and EF >40% in a randomized clinical trial. METHODS: PARALLAX is a prospective, randomized, controlled, double-blind multicentre clinical trial in patients with chronic symptomatic HF with EF >40%, New York Heart Association (NYHA) class II-IV symptoms, elevated natriuretic peptides, and evidence of structural heart disease. Eligible patients are randomized to sacubitril/valsartan vs. BMIC for cardiovascular and related co-morbidities. BMIC includes (i) enalapril, (ii) valsartan, and (iii) placebo depending on the type of medical therapy prior to enrolment. The primary endpoints are the change in plasma NT-proBNP concentration from baseline to 12 weeks and the change from baseline in 6MWD distance at 24 weeks. The secondary endpoints assess quality of life and symptom burden. CONCLUSIONS: PARALLAX will determine if sacubitril/valsartan compared with standard medical therapy for co-morbidities improves NT-proBNP levels, exercise capacity, quality of life, and symptom burden in HF patients with EF >40%.
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