Clinical Evidence

ClinicalEVIDENCE Newsletter

Newsletter #5 – November 2023

ClinicalEVIDENCE Newsletter 2023 #5 – November 2023

Welcome to the ClinicalEVIDENCE newsletter, your go to source for the latest clinical data on heart diseases, diagnostics, and monitoring.

Our aim is to provide you with cutting-edge information that will keep you up to-date on the most recent advancements in the field of heart failure management.

In this issue, we are excited to have the opportunity to share the key messages of the publication about the design of the PREEMPT-HF study.

We will also provide you with the highlights of the two HeartLogicTM abstracts presented at HFSA 2023 Congress.

Main takeaways of the PREEMPT-HF study & abstracts from the HFSA 2023 Congress

PREEMPT-HF study design and enrolment

Since 2017, the HeartLogic performance in clinical practice has been confirmed by several studies, but there is limited data on this index’s association and its constituent sensors with HF readmissions.

The PREcision Event Monitoring of PatienTs with Heart Failure using HeartLogic (PREEMPT-HF) trial was designed to assess the association of sensor data with 30-day readmission following an index hospitalization for HF.

The design and enrolment details of this study has been recently published by Boehmer et al. on ESC Heart Failure Journal.

PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT-HF) study design and enrolment

Study protocol:

  • PREEMPT-HF is a multinational, multi-center, post-market, prospective, non-randomized study of HF patients with an ICD or CRT-D device equipped with HeartLogic algorithm.
  • All patients (age > 18 years) with documented diagnosis of Heart Failure, implanted with an HeartLogic enable ICD or CRT-D device and enrolled in the LATITUDE remote monitoring system could be included in the study.
  • The HeartLogic feature was disable. Centers were blinded to the HeartLogic index and heart sounds trends on LATITUDE, and clinicians didn’t receive HeartLogic alerts.
  • Flowchart (Figure 1):
    • Baseline visit within 30 days post study enrollment has been performed for demographic, medical and physical assessment.
    • Interim Medical Chart Review at 6-months was required to assess study-related and adverse events:
      • All-cause hospitalization;
      • HF hospitalization (signs/symptoms of HF with unscheduled augmented HF therapy);
      • HF readmission (30 day): the subject is admitted for an all-cause hospitalization within 30 days post discharge from an HF hospitalization;
      • HF outpatient visit (signs/symptoms  of HF with unscheduled intravenous decongestive therapy).
  • Final Visit at 12-months and download of device sensor data into LATITUDE.
  • Study Exit.

Study objectives:

The primary objective is to evaluate if the pattern of sensor changes is different when an HeartLogic index hospitalization for HF is followed by a readmission (all cause and/or HF) within 30 days versus when it is not.

This analysis is exploratory, and no formal tests of the hypothesis are planned.

Additional objectives will be evaluated:

  • The association of sensor trends before a VT/VF event.
  • Phenomapping of HF events.
  • The association of sensor changes before a non-HF hospitalization.

Baseline and enrolment characteristics:

From June 2018 to June 2020, a total of 2183 patients were enrolled in the study (2155 usable patients).
The main baseline characteristics are reported in Table 1:

Characteristics

N=2155

Age, mean ± SD

67.3 ± 11.5

Male, N (%)

1569 (73%)

CRT-D, N (%)

1323 (61%)

NYHA, N (%)

  • Class I
  • Class II
  • Class III
  • Class IV

 

271 (13%)

1136 (53%)

707 (33%)

26 (1%)

HF hospitalization previous 12 months, N (%)

679 (32%)

Ischemic heart disease, N (%)

1069 (50%)

Dilated cardiomyopathy, N (%)

947 (44%)

NT-proBNP, median (Q1, Q3)

1734 (564, 3724)

ACE/ARBs/ARNI, N(%)

1734 (80%)

Beta-blockers, N (%)

1921 (89%)

Diuretics, N (%)

1381 (64%)

Anticoagulants, N (%)

1752 (81%)

Antiarrhythmics, N (%)

477 (22%)

Table 1: Baseline characteristics

Discussion:

The PREEMPT-HF study represents the largest study to date evaluating HeartLogic sensors in relationship to HF hospitalization and death. It is also the first large study to include ICD and CRT-D patients .

The results will inform the real-world performance of HeartLogic for several key outcomes that have not been evaluated previously.

Heart failure readmission:

Hospitalizations due to worsening HF are associated with high post-acute re-hospitalization and mortality. Considering the large sample size, PREEMPT-HF is expected to have sufficient events that allow to evaluate sensor changes preceding hospital readmission. These data could contribute to a better understanding of discharge readiness and an improved comprehension of sensor changes within the 30-days subsequent to hospital discharge.

Arrhythmias:

It is well known that arrhythmias are more common as HF progresses. Considering the association between arrhythmias and worsening heart failure, it is crucial to better understand the relation of HF-related sensor data and the risk of tachyarrhythmias and device therapy.

Phenomapping:

Heart failure is composite of multiple heterogeneous entities and different classification of acute worsening heart failure has been proposed. Physiological measurements underlying clinical classifications exhibit significant variation. PREEMPT-HF offers a large data set for using phenomapping techniques to identify subgroups of HF patients.

Real world data:

Patients in the PREEMPT-HF trial granted consent for their data to be linked with other data sources. The ability to connect extensive datasets with the sensor data collected from large patient groups and validate the findings from sensor data with multiple sources using data-driven approaches may lead to enhance the cost-effectiveness and reliability of device diagnostics in the future. 

Key findings:

  • The PREEMPT-HF trial will provide blinded sensor trend data from a large population of HF patients with ICD and CRT-D devices. 
  • Corresponding patient medical history and clinical event data will enable an exploration of relationships between physiological monitoring and index HF events in patient subgroups, 30-day hospital readmissions, and ventricular arrhythmias.
  • These data may help refine the clinical use of HL, aiming to improve patient outcomes.
Top of page

News from HFSA Congress

The Annual Scientific Meeting of HFSA (Heart Failure Society of America) took place in Cleveland (Ohio) from 6 to 9 October.

The congress is the opportunity to discover the latest findings on hear failure science, research, management and networking: 2 poster have been presented about two different HeartLogic studies DANLOGIC-HF and PREEMPT-HF.

Poster:

The design of a new HeartLogic study has been presented at HFSA congress by Dr. N. Dyrby Johansen (Copenhagen University Hospital).

Danish pragmatic randomized trial to evaluate the effect of HeartLogic-guided management on heart failure outcome (DANLOGIC-HF)

The DANLOGIC-HF (Figure 2) is a prospective, randomized study in clinical practice.

Objective:
To demonstrate impact of HeartLogic™-guided management on heart failure outcomes.

Population:
All patient in Denmark who have received an ICD o CRT-D device equipped with HeartLogic algorithm (approximately 1500 patients).

Randomization:
All eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or to the control group (with HeartLogic feature disabled).

Flowchart:
Patients will be followed as per standard care.
HeartLogic arm patients will be contacted , from the central trial site, at the time of any HeartLogic alerts for assessment and treatment decisions: all alerts will be managed according a prespecified management guide.

No mandatory follow-up visits are required, and data will be collected from:

  • Danish nationwide health registries;
  • LATITUDE remote monitoring system;
  • Case report forms (only for actions triggered by the alerts).

Primary endpoint:
The occurrence of a composite of hospitalization for heart failure or all-cause death (first event). 

The preliminary results of the PREEMPT-HF study have been presented by Dr. Sauer (Saint Luke’s Mid America Heart Institute Kansas City, Missouri).

Heart failure using HeartLogic trial (PREEMPT-HF)

The HeartLogic index has been found to be a sensitive predictor of worsening heart failure (HF), but there is a paucity of data on this index’s association with HF readmissions.

Aim:

The primary goal of the PREEMPT-HF trial was to evaluate the relationship between HeartLogic data and 30-day readmission following hospitalization for heart failure.

Results:

Between June 2018 and June 2020 a total of 2183 patients were enrolled in 103 sites.  During the follow-up period of 12 months, patients and clinicians were blinded to the HeartLogic index and alerts.

103 usable index hospitalization for heart failure were collected:

  • Readmission for heart failure (primary or secondary cause):
    21 (20%) times in 30 days of discharge
    37 (36%) times in 90 days of discharge
  • Unplanned all-cause readmissions:
    24 (23%) with in 30 days of discharge
    44 (43%) with in 90 days of discharge

Odds of Readmission if in alert state vs. out of alert state [95% CI]

  • Readmission for Heart Failure in 30 days: 3.05 [1.02, 9.10] 14 days prior to the index admission;
  • All-cause readmission in 30 days: 2.25 [0.84, 6.03] 14 days prior to the index admission;
  • Readmission for Primary Heart Failure in 90 days
    3.01 [1.29, 7.01] 7 days post discharge
    2.67 [1.16, 6.14] 14 days post discharge
Figure3 Figure 3: HeartLogic Index trends around hospitalizations for heart failure (HHF). * p>0.05, unpaired t-test

Conclusions:

  • Trends in the HeartLogic index were significantly different for patients who had readmissions.
  • These trends suggest that individuals at risk for readmission have had a more sustained worsening and/or insufficient intervention during the initial hospitalization for heart failure.

References:
Boehmer J. et al, “PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT-HF) study design and enrolment”. ESC Heart Fail. 2023 Sep 22

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