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Abstract Aims The CardioMEMS HF System Post‐Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic‐guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia. Methods and results COAST is a prospective, international, multicentre, open‐label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic‐guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system‐related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72–88%] than the previous 12 months (0.27 vs. 1.52 events/patient‐year, respectively, P

Abstract Aims Evaluate whether UK National Institute for Health & Care Excellence (NICE) chronic heart failure (HF) guidelines can be safely and effectively refined through specialist referral management. Methods and results All referrals to a UK centre 1/3/2019–30/5/2019 and 1/6/2020–31/7/2020 were reviewed by HF specialists. Patients were triaged to specialist assessment in HF clinic, according to the NICE HF diagnostic pathway [urgency based on N‐terminal pro brain natriuretic peptide (NTproBNP) levels], or the referrer given remote Advice & Guidance (A&G), to aid primary care management. Standardized triage criteria for recommending primary care management were (i) presentation inconsistent with HF, (ii) competing comorbidity/frailty meant specialist assessment in clinic not in patient's best interests, (iii) recent assessment for same condition, or (iv) patient had known HF. Following triage patients managed in the primary care were categorized as low or high risk of adverse outcomes. Outcome measures were 90 day all‐cause and HF hospital admission and mortality rates. Four hundred and eighty‐six patients had the median age of 80 (74–86) years, and 253 (52%) were male. Two hundred and six (42%) had NTproBNP > 2000 pg/mL. Primary care management was recommended for 128 patients (26%): 105 (22%) A&G alone and 23 input from community HF nurse specialists. Primary care management was recommended due to the following: presentation inconsistent with HF 53 (42%), more important competing comorbidity/frailty 35 (27%), recent assessment 17 (13%), and known HF 23 (18%). Patients managed in primary care had higher rates of all‐cause hospitalization (30% vs. 19%; P = 0.018) and death (7% vs. 2%; P = 0.0054) than those seen in HF clinic. Of those managed in primary care, 50 (39%) were determined to be at low risk and 78 (61%) at high risk. High‐risk patients were older (87 vs. 80 years; P = 0.0026), had much higher NTproBNP (2666 vs. 697 pg/mL; P

Objective To understand human factors (HF) contributing to disturbances during invasive cardiac procedures, including frequency and nature of distractions, and assessment of operator workload.Methods Single centre prospective observational evaluation of 194 cardiac procedures in three adult cardiac catheterisation laboratories over 6 weeks. A proforma including frequency, nature, magnitude and level of procedural risk at the time of each distraction/interruption was completed for each case. The primary operator completed a National Aeronautical and Space Administration (NASA) task load questionnaire rating mental/physical effort, level of frustration, time-urgency, and overall effort and performance.Results 264 distractions occurred in 106 (55%) out of 194 procedures observed; 80% were not relevant to the case being undertaken; 14% were urgent including discussions of potential ST-elevation myocardial infarction requiring emergency angioplasty. In procedures where distractions were observed, frequency per case ranged from 1 to 16 (mean 2.5, SD ±2.2); 43 were documented during high-risk stages of the procedure. Operator rating of NASA task load parameters demonstrated higher levels of mental and physical workload and effort during cases in which distractions occurred.Conclusions In this first description of HF in adult cardiac catheter laboratories, we found that fewer than half of all procedures were completed without interruption/distraction. The majority were unnecessary and without relation to the case or list. We propose the introduction of a ‘sterile cockpit’ environment within catheter laboratories, as adapted from aviation and used in surgical operating theatres, to minimise non-emergent interruptions and disturbances, to improve operator conditions and overall patient safety.

Purpose: To determine the prognostic implications of changes towards hyponatremia at varying time-points in the treatment of patients undergoing cardiac resynchronisation therapy (CRT). Methods: A retrospective series of 249 patients was studied from 2002 to 2013. The population was categorized on the basis of serum sodium profile at baseline, at 1 month and at 6 month follow up visits following successful CRT implantation. The composite endpoint was all-cause mortality and heart failure hospitalisation (defined by the need for intravenous diuretic therapy) following CRT implantation. Results: A total of 249 patients (67.8 ± 12.5 years; NYHA class III/IV 75; LVEF 27.2 ± 8.8%) were followed up for a median of 5.5 years. Hyponatremia at baseline, 1 month or 6 months follow up did not predict the composite endpoint. 26% of patients showed hyponatremia at baseline prior to CRT implantation, while it was present in 19.9% of patients 1 month (p = 0.003) and in 16% (p 7.0 mmol/l) (HR 1.61 [1.05–2.46], p = 0.03) at baseline were associated with an increased risk of unplanned heart failure hospitalisation and all-cause mortality after CRT implantation. Conclusions: A change towards hyponatremia when observed 6 months after CRT implantation may predict a worse clinical outcome. Additionally, renal impairment and higher diuretic doses are associated with an increased risk of mortality in the population analysed.