Clinical Pathways Guided by Remotely Monitoring Cardiac Device Data: The Future of Device Heart Failure Management?

Research examining the utility of cardiac device data to manage patients with heart failure (HF) is rapidly evolving. COVID-19 has reignited interest in remote monitoring, with manufacturers each developing and testing new ways to detect acute HF episodes, risk stratify patients and support self-care. As standalone diagnostic tools, individual physiological metrics and algorithm-based systems have demonstrated utility in predicting future events, but the integration of remote monitoring data with existing clinical care pathways for device HF patients is not well described. This narrative review provides an overview of device-based HF diagnostics available to care providers in the UK, and describes the current state of play with regard to how these systems fit in with current HF management.

Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial.

BACKGROUND: For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure. METHODS: IRONMAN was a prospective, randomised, open-label, blinded-endpoint trial done at 70 hospitals in the UK. Patients aged 18 years or older with heart failure (left ventricular ejection fraction ≤45%) and transferrin saturation less than 20% or serum ferritin less than 100 µg/L were eligible. Participants were randomly assigned (1:1) using a web-based system to intravenous ferric derisomaltose or usual care, stratified by recruitment context and trial site. The trial was open label, with masked adjudication of the outcomes. Intravenous ferric derisomaltose dose was determined by patient bodyweight and haemoglobin concentration. The primary outcome was recurrent hospital admissions for heart failure and cardiovascular death, assessed in all validly randomly assigned patients. Safety was assessed in all patients assigned to ferric derisomaltose who received at least one infusion and all patients assigned to usual care. A COVID-19 sensitivity analysis censoring follow-up on Sept 30, 2020, was prespecified. IRONMAN is registered with ClinicalTrials.gov, NCT02642562. FINDINGS: Between Aug 25, 2016, and Oct 15, 2021, 1869 patients were screened for eligibility, of whom 1137 were randomly assigned to receive intravenous ferric derisomaltose (n=569) or usual care (n=568). Median follow-up was 2·7 years (IQR 1·8-3·6). 336 primary endpoints (22·4 per 100 patient-years) occurred in the ferric derisomaltose group and 411 (27·5 per 100 patient-years) occurred in the usual care group (rate ratio [RR] 0·82 [95% CI 0·66 to 1·02]; p=0·070). In the COVID-19 analysis, 210 primary endpoints (22·3 per 100 patient-years) occurred in the ferric derisomaltose group compared with 280 (29·3 per 100 patient-years) in the usual care group (RR 0·76 [95% CI 0·58 to 1·00]; p=0·047). No between-group differences in deaths or hospitalisations due to infections were observed. Fewer patients in the ferric derisomaltose group had cardiac serious adverse events (200 [36%]) than in the usual care group (243 [43%]; difference -7·00% [95% CI -12·69 to -1·32]; p=0·016). INTERPRETATION: For a broad range of patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric derisomaltose administration was associated with a lower risk of hospital admissions for heart failure and cardiovascular death, further supporting the benefit of iron repletion in this population. FUNDING: British Heart Foundation and Pharmacosmos.

Spironolactone effect on the blood pressure of patients at risk of developing heart failure: an analysis from the HOMAGE trial.

AIMS: Uncontrolled blood pressure (BP) increases the risk of developing heart failure (HF). The effect of spironolactone on BP of patients at risk of developing HF is yet to be determined. To evaluate the effect of spironolactone on the BP of patients at risk for HF and whether renin can predict spironolactone's effect. METHODS AND RESULTS: HOMAGE (Heart OMics in Aging) was a prospective multicentre randomized open-label blinded endpoint (PROBE) trial including 527 patients at risk for developing HF randomly assigned to either spironolactone (25-50 mg/day) or usual care alone for a maximum of 9 months. Sitting BP was assessed at baseline, Months 1 and 9 (or last visit). Analysis of covariance (ANCOVA), mixed effects models, and structural modelling equations was used. The median (percentile25-75) age was 73 (69-79) years, 26% were female, and >75% had history of hypertension. Overall, the baseline BP was 142/78 mmHg. Patients with higher BP were older, more likely to have diabetes and less likely to have coronary artery disease, had greater left ventricular mass (LVM), and left atrial volume (LAV). Compared with usual care, by last visit, spironolactone changed SBP by -10.3 (-13.0 to -7.5) mmHg and DBP by -3.2 (-4.8 to -1.7) mmHg (P < 0.001 for both). A higher proportion of patients on spironolactone had controlled BP <130/80 mmHg (36 vs. 26%; P = 0.014). Lower baseline renin levels predicted a greater response to spironolactone (interactionP = 0.041). CONCLUSION: Spironolactone had a clinically important BP-lowering effect. Spironolactone should be considered for lowering blood pressure in patients who are at risk of developing HF.

Ambulatory intravenous furosemide for decompensated heart failure: safe, feasible, and effective.

AIMS: This study aims to establish the feasibility, safety, and efficacy of outpatient intravenous (IV) diuretic treatment for the management of decompensated heart failure (HF) for patients enrolled in the HeartFailure@Home service. METHODS AND RESULTS: We retrospectively analysed the clinical episodes of decompensated HF for patients enrolled in the HeartFailure@Home service, managed by ambulatory IV diuretic treatment either at home or on a day-case unit. A control group consisting of HF patients admitted to hospital for IV diuretics (standard-of-care) was also evaluated. In total, 203 episodes of decompensated HF (n = 154 patients) were evaluated. One hundred and fourteen episodes in 79 patients were managed exclusively by the ambulatory IV diuretic service-78 (68.4%) on a day-case unit and 36 (31.6%) domiciliary; 84.1% of patient episodes under the HF@Home service were successfully managed entirely in an out-patient setting without hospitalization. Eleven patients required admission in order to administer higher doses of IV diuretics than could be provided in the ambulatory setting. During follow-up, there were 20 (17.5%) 30 day re-admissions with HF or death in the ambulatory IV group and 29 (32.6%) in the standard-of-care arm (P = 0.02). There was no difference in 30 day HF readmissions between the two groups (14.9% ambulatory vs. 13.5% inpatients, P = 0.8), but 30 day mortality was significantly lower in the ambulatory group (3.5% vs. 21.3% inpatients, P < 0.001). CONCLUSIONS: Outpatient ambulatory management of decompensated HF with IV diuretics given either on a day case unit or in a domiciliary setting is feasible, safe, and effective in selected patients with decompensated HF. This should be explored further as a model in delivering HF services in the outpatient setting during COVID-19.

Lockdown, slow down: impact of the COVID-19 pandemic on physical activity-an observational study.

AIMS: In response to the COVID-19 pandemic, the UK was placed under strict lockdown measures on 23 March 2020. The aim of this study was to quantify the effects on physical activity (PA) levels using data from the prospective Triage-HF Plus Evaluation study. METHODS: This study represents a cohort of adult patients with implanted cardiac devices capable of measuring activity by embedded accelerometery via a remote monitoring platform. Activity data were available for the 4 weeks pre-implementation and post implementation of 'stay at home' lockdown measures in the form of 'minutes active per day' (min/day). RESULTS: Data were analysed for 311 patients (77.2% men, mean age 68.8, frailty 55.9%. 92.2% established heart failure (HF) diagnosis, of these 51.2% New York Heart Association II), with comorbidities representative of a real-world cohort.Post-lockdown, a significant reduction in median PA equating to 20.8 active min/day was seen. The reduction was uniform with a slightly more pronounced drop in PA for women, but no statistically significant difference with respect to age, body mass index, frailty or device type. Activity dropped in the immediate 2-week period post-lockdown, but steadily returned thereafter. Median activity week 4 weeks post-lockdown remained significantly lower than 4 weeks pre-lockdown (p≤0.001). CONCLUSIONS: In a population of predominantly HF patients with cardiac devices, activity reduced by approximately 20 min active per day in the immediate aftermath of strict COVID-19 lockdown measures. TRIAL REGISTRATION NUMBER: NCT04177199.

Substantial decline in hospital admissions for heart failure accompanied by increased community mortality during COVID-19 pandemic.

AIMS: We hypothesized that a decline in admissions with heart failure during COVID-19 pandemic would lead to a reciprocal rise in mortality for patients with heart failure in the community. METHODS AND RESULTS: We used National Heart Failure Audit data to identify 36 974 adults who had a hospital admission with a primary diagnosis of heart failure between February and May in either 2018, 2019, or 2020. Hospital admissions for heart failure in 2018/19 averaged 160/day but were much lower in 2020, reaching a nadir of 64/day on 27 March 2020 [incidence rate ratio (IRR): 0.40, 95% confidence interval (CI): 0.38-0.42]. The proportion discharged on guideline-recommended pharmacotherapies was similar in 2018/19 compared to the same period in 2020. Between 1 February-2020 and 31 May 2020, there was a 29% decrease in hospital deaths related to heart failure (IRR: 0.71, 95% CI: 0.67-0.75; estimated decline of 448 deaths), a 31% increase in heart failure deaths at home (IRR: 1.31, 95% CI: 1.24-1.39; estimated excess 539), and a 28% increase in heart failure deaths in care homes and hospices (IRR: 1.28, 95% CI: 1.18-1.40; estimated excess 189). All-cause, inpatient death was similar in the COVID-19 and pre-COVID-19 periods [odds ratio (OR): 1.02, 95% CI: 0.94-1.10]. After hospital discharge, 30-day mortality was higher in 2020 compared to 2018/19 (OR: 1.57, 95% CI: 1.38-1.78). CONCLUSION: Compared with the rolling daily average in 2018/19, there was a substantial decline in admissions for heart failure but an increase in deaths from heart failure in the community. Despite similar rates of prescription of guideline-recommended therapy, mortality 30 days from discharge was higher during the COVID-19 pandemic period.

The impact of COVID-19 on the management of heart failure: a United Kingdom patient questionnaire study.

AIMS: The coronavirus disease 2019 (COVID-19) pandemic has created significant challenges to healthcare globally, necessitating rapid restructuring of service provision. This questionnaire survey was conducted amongst adult heart failure (HF) patients in the United Kingdom (UK), to understand the impact of COVID-19 upon HF services. METHODS AND RESULTS: The survey was conducted by the Pumping Marvellous Foundation, a UK HF patient charity. 'Survey Monkey' was used to disseminate the questionnaire in the Pumping Marvellous Foundation 's online patient group and in 10 UK hospitals (outpatient hospital and community HF clinics). There were 1050 responses collected (693/1050-66% women); 55% (579/1050) were aged over 60 years. Anxiety level was significantly higher regarding COVID-19 (mean 7 ± 2.5 on anxiety scale of 0 to 10) compared with anxiety regarding HF (6.1 ± 2.4; P < 0.001). Anxiety was higher amongst patients aged ≤60 years about HF (6.3 ± 2.2 vs. 5.9 ± 2.5 in those aged >60 years; P = 0.005) and COVID-19 (7.3 ± 2.3 vs. 6.7 ± 2.6 those aged >60 years; P < 0.001). Sixty-five per cent of respondents (686/1050) reported disruption to HF appointments (cancellation or postponement) during the lockdown period. Thirty-seven per cent reported disruption to medication prescription services, and Thirty-four per cent reported inability to access their HF teams promptly. Thirty-two per cent expressed reluctance to attend hospital (25% stated they would only attend hospital if there was no alternative, and 7% stated that they would not attend hospital at all). CONCLUSIONS: The COVID-19 pandemic has caused significant anxiety amongst HF patients regarding COVID-19 and HF. Cancellation or postponement of scheduled clinic appointments, investigations, procedures, prescription, and monitoring services were implicated as sources of anxiety.

Protecting the most vulnerable during COVID-19 and beyond: a case report on the remote management of heart failure patients with cardiac implantable electronic devices.

BACKGROUND: Heart failure (HF) patients with cardiac implantable electronic devices (CIEDs) represent an important cohort. They are at increased risk of hospitalization and mortality. We outline how remote-only management strategies, which leverage transmitted health-related data, can be used to optimize care for HF patients with a CIED during the COVID-19 pandemic. CASE SUMMARY: An 82-year-old man with HF, stable on medical therapy, underwent cardiac resynchronization therapy implantation in 2016. Modern CIEDs facilitate remote monitoring by providing real-time physiological data (thoracic impedance, heart rate and rhythm, etc.). The 'Triage Heart Failure Risk Score' (Triage-HFRS), available on Medtronic CIEDs, integrates several monitored physiological parameters into a risk prediction model classifying patients as low, medium, or high risk of HF events within 30 days. In November 2019, the patient was enrolled in an innovative clinical pathway (Triage-HF Plus) whereby any 'high' Triage-HF risk status transmission prompts a phone call-based virtual consultation. A high-risk alert was received via remote transmission on 11 March, triggering a phone call assessment. Upon reporting increasing breathlessness, diuretics were initiated. The prescription was remotely issued and delivered to the patient's home. This approach circumvented the need for all face-to-face reviews, delivering care in an entirely remote manner. DISCUSSION: The challenges posed by COVID-19 have prompted us to think differently about how we deliver care for patients, both now and following the pandemic. Contemporary CIEDs facilitate the ability to remotely monitor HF patients by providing rich physiological data that can help identify individuals at elevated risk of decompensation using automated device-generated alerts.