ClinicalEVIDENCE Newsletter

In May Dr. Feijen et al (Leiden University Medical Centre, Leiden, The Netherland) published on Journal of Cardiac Failure an analysis about the clinical benefit provided by the use of HeartLogic on top of standard care and device telemonitoring in HF patients.

“Fewer worsening heart failure events with HeartLogicᵀᴹ on top of standard of care: a propensity-matched cohort analysis.”

A multicenter retrospective propensity-matched cohort analysis was performed in HF patients with and ICD and compared HeartLogic to conventional telemonitoring in term of HF events.

• Primary endpoint was the number of worsening HF events defined as a composite of hospital admission for HF and an unplanned ambulatory HF visit (lifestyle advice and/or diuretic therapy increase)
• Secondary endpoints were the number of HF hospitalizations and the scheduled ambulatory HF visits requiring actions.

Propensity score matching yielded 127  matched pairs with highly similar baseline characteristics. All patients were followed-up for 365 days.

• The median number of worsening HF events was 1 (IQR 0-3) in HeartLogic group and 2 (IQR 0-4) in control group (p=0.004). (Panel a)
• There was nonsignificant trend toward a lower number of HF hospitalizations in the HeartLogic group (P=0.096).
• The number of HF hospitalization days was significantly higher in the control group, with 8 (IQR 5-12) hospitalization days compared to 5 (IQR2-7) days in the HeartLogic group (P=0.025). (Panel b)
• There was a significantly higher number of ambulatory visits for intensifying diuretics in the control group (2; IQR0 - 3) compared to 1 (IQR0 - 2) in the HeartLogic group (P=0.0001).

Integrating the HeartLogic algorithm into a well-equipped heart failure care pathway on top of standard care is associated with clinical benefits characterized by fewer worsening HF events and shorter hospitalizations related to fluid retention.

568 consecutive HF patient with reduced LVEF who had received an ICD or CRT-D device endowed with the HeartLogic algorithm and followed up in accordance with the standard practice of the participating centers were include in the analysis.

The objectives of the study are:

• to compare the incidence of HeartLogic alerts between CRT and non-CRT patients;
• to evaluate the frequency of HeartLogic alerts in relation to the presence of co-morbidities;
• to investigate the investigated the impact of the presence of co-morbidities on the performance of the HeartLogic Index.

The study endpoints consisted of cardiovascular hospitalizations requiring at least one overnight stay and the combination of cardiovascular hospitalizations and death.

During a median follow-up of 26 months 1200 HeartLogic alerts (0.71 alerts/patient-year) occurred in 370 patients and overall, the time IN the alert state was 13% of the total observation period.

The rate of cardiovascular hospitalizations or death was 0.48/patient-year with the HeartLogic IN alert state and 0.04/patient-year OUT of alert state, with an incidence rate ratio of 13.35 (95%CI: 8.83-20.51, p<0.001).

Among patient characteristics, atrial fibrillation (AF) at implantation and chronic kidney disease (CKD) independently predicted alerts. HeartLogic alerts were not associated with CRT vs. non-CRT device implantation (HR:1.03, 95%CI:0.82-1.30, p=0.775). (Figure below)

• The burden of HeartLogic alerts appears similar between CRT and non-CRT patients, while patients with AF and CKD seem more exposed to alerts.
• The ability of the HeartLogic algorithm to identify periods of significantly increased risk of clinical events was confirmed both in the overall population and in patients stratified by device type, CKD and AF.
• At multivariate analysis, the time IN the HeartLogic alert state >13% was associated with the occurrence of cardiovascular hospitalization or death.

• AF at implantation and CKD independently predict HeartLogic alerts.
• HeartLogic algorithm identifies patients during periods of increased risk of clinical events regardless of the type of device, AF or CKD.

In the past months, some Congresses of most important cardiac societies took place, bringing to light a large amount of new scientific evidence.

Among the vast number of new findings presented, we’d like to delve into the key messages regarding HeartLogic and Remote support that have been presented at EHRA and ESC-HF congresses.

“Prediction of all-cause mortality using a multisensory implantable defibrillator algorithm for HF monitoring”

has been presented by Dr. D’Onofrio (Monaldi Hospital, Naples, Italy) as Moderated Poster.

This analysis evaluated whether remotely monitored data from HeartLogic could be used to identify patients at high risk for mortality.

The study endpoint was death due to any cause.

The HeartLogic was activated in 568 patients and during a median follow-up of 26 months 55 patients died (46 in the group with alerts), 33 deaths were from cardiovascular causes.

The rate of death during IN-alert state periods was 0.25 death/patient-year, while the rate during OUT of the alert state periods was 0.02 death/patient-year.

The occurrence of any alert episode was associated with an increased risk of death [hazard ratio (HR): 2.08, 95% confidence interval (CI): 1.16–3.73, P = 0.039] and a time IN alert ≥20% was associated with death (HR: 4.07, 95%CI: 2.19-7.54, p<0.001).

• This analysis demonstrated that the occurrence of HeartLogic IN-alerts is significantly associated with mortality due to any cause.
• The rate of fatal events is substantially higher with the HeartLogic in the alert state.

The full-length paper is available on Heart Rhythm. 2023 Mar 24:S1547-5271(23)00331-4 https://doi.org/10.1016/j.hrthm.2023.03.026

“Combination of device-detected heart failure status and sleep-disordered breathing for the prediction of atrial fibrillation occurrence”

has been presented by Dr. Vitali (University of Ferrara, Italy) as ePoster.

This analysis explored the association between sleep apnea and the HF status using HeartLogic and the incidence of AF in patients with implantable defibrillators (ICD).

411 consecutive patients implanted with ICD o CRT-D device endowed with HeartLogic have been enrolled in the analysis and observed for a median follow-up of 26 months.

The HF status was measured by the HeartLogic Index, and the ICD-measured Respiratory Disturbance Index (RDI) was computed to identify severe SA.

The endpoints were: daily AF burden of ≥5minutes, ≥6hours and ≥23hours. 

Figure shows the time-dependent Cox model: the IN-alert HF state was independently associated with AF regardless of the daily burden threshold: HR from 2.17 for ≥5 min/day to 3.43 for ≥23 h/day (p<0.01), while the occurrence of severe SA was associated only with AF burden ≥5 min/day (hazard ratio 1.55 [95%CI:1.11-2.16], p=0.001). 

• The occurrence of AF is independently associated with the ICD-measured HF status and with severe SA. ​
• The coexistence of HeartLogic alerts and severe SA occurs rarely but is associated with a very high rate of AF occurrence.

“Remote support during cardiac implantable electrical device follow-up:  preliminary experience in clinical practice”

has been presented by Dr. D’Onofrio (Monaldi Hospital, Naples, Italy) as ePoster.

In this analysis, authors described the preliminary experience of remote industry employed allied professionals (IEAPs)  support using Heart Connect™ during CIED follow-up in clinical practice.

During observation period a total of 34 follow-up visits were performed.

The remote connection was successfully established in all cases and the communication remained stable for the entire duration of all visits, except for 2 cases in which a loss of connection occurred (not restored in 1 case). 

The sound and video quality during two-way communication were rated good or excellent in 31 (91%) cases.

Routine CIED checks were performed during the visits and programming changes were done during 7 (21%) visits (pacing and sensing parameters, tachycardia detection and therapies).

The remote support allowed to successfully complete the visit in 33 (97%) cases, without requiring additional medical or technical support. In all these cases, the support was judged to be equally effective compared to the on-site support, without causing delays or organizational difficulties.

• Remote support during CIED follow-up using Heart Connect seems feasible, effective and well accepted. 

“Performance of a multiparametric implantable cardioverter-defibrillator algorithm for heart failure risk stratification and management: the multicentric Spanish RE-HEART Registry”

has been presented as ePoster.

The aim of this analysis was to evaluate the risk stratification ability of the algorithm in ICD and CRT-D patients in clinical practice.

392 patients were enrolled in 19 centers and followed for a median observation period of 17  months.

The index crossed the threshold value 436 times (0.78 alerts/patient-year) in 195 patients and the time in the alert state was 10% of the total observation period.

• 242 (56%) alerts were deemed clinically meaningful, being associated with HF events, signs or symptoms of HF and the corrective therapies delivered or other conditions (e.g., hospital admissions for non-HF conditions, arrhythmias’ onset, changes in drug or dietary regimen).
• 194 (44%) alerts were unexplained (0.34 alerts/patient-year).

• HeartLogic identified patients during periods of significantly increased risk of HF events.
• The use of the algorithm allowed relevant clinical conditions to be identified remotely, with a low rate of unexplained alerts.

“Clinical impact of remote heart failure management using a multiparametric implantable cardioverter-defibrillator alert: the multicentric Spanish RE-HEART Registry”

has been presented as Rapid Fire presentation.

Authors evaluated the impact of the RE-HEART standardized follow-up protocol implemented by nursing staff and based on remote management of alerts on the clinical outcome of ICD and CRT-D patients.

The standardized protocol used by all centers has been already presented in a previous publication¹.

• Primary endpoints: HF hospitalizations or deaths.
• Secondary endpoints: HF outpatient visits.

HF events occurred during the 12-month period before the adoption of the protocol were compared with those occurred in the following 12 months.

The HeartLogic algorithm was activated in 392 HF patients who had received an ICD or CRT-D device.

• The adoption of the RE-HEART protocol significantly improved the clinical outcome of HF patients who had received a remotely monitored ICD or CRT-D device.
• The adoption of the protocol allowed a prompt intervention in case of suspected worsening HF and promoted remote management.