INTERVENE-HF: feasibility study of individualized, risk stratification-based, medication intervention in patients with heart failure with reduced ejection fraction

Abstract

Aims: Determine the feasibility of implementing a heart failure (HF) management strategy that (i) uses a device-based, remote, dynamic, multimetric risk stratification model to predict the risk of HF events and (ii) uses a standardized, centrally administered, ambulatory medication intervention protocol to reproducibly and safely decrease elevated risk scores.

Methods and results: Prospective, non-randomized, single-arm, multicenter feasibility study (Intervene-HF) was conducted in HF patients implanted with a cardiac resynchronization therapy with implantable cardio defibrillator (CRT-D) with TriageHF risk score feature. Certified HF nurses (CHFN) in the Medtronic Care Management Services Program implemented an ambulatory medication intervention strategy by following a standardized guided action pathway triggered by risk-based alert. When CHFN received notification of increased risk score (HF care alert), they implemented a 3 day course of diuretic up-titration (PRN) previously prescribed by a physician. Safety was monitored daily. Recovery after PRN was defined as ≥70% recovery of impedance toward baseline levels. Sixty-six patients followed for 8.2 ± 3.9 months had 49 HF care alerts. Twenty-three of 49 alerts did not receive PRN due to protocol-mandated criteria. Twenty-six of 49 alerts received PRN, 22 were completed, and 19 led to impedance recovery. Four interventions were stopped for safety without leading to an adverse event (AE). One of 26 PRNs was followed by a HF event. Eighty-five per cent (22/26) of PRNs were completed without an AE; 69% (18/26) met the recovery criteria.

Conclusions: The Intervene-HF study supports the feasibility of testing, in a large randomized clinical trial, an ambulatory medication intervention strategy that is physician-directed, CHFN-implemented, and based on individualized device risk stratification.

Trial registration: ClinicalTrials.gov NCT02698241.

Keywords: Congestive; Heart failure; Remote metric.

Conflict of interest statement

Drs Zile, Costanzo, Butler, Stapleton, Sadhu, Jimenez served as consultants to Medtronic. Zhang, Ippolito, Sharma, Warman, Hobbs, and Streeter are Medtronic Inc. employees.

© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Figures

Figure 1

Intervene‐HF study information flow chart. This strategy entails a physician‐directed, nurse‐implemented, ambulatory, medication intervention described in detail in the manuscript text.

Figure 2

Guided PRN medication intervention pathway. Patients were assessed by certified heart failure nurses to determine whether the increased risk could/should be intervened upon using the ‘patient assessment’ algorithm shown. If a PRN medication intervention was appropriate to be instituted, the ‘PRN medication intervention’ algorithm was followed by certified heart failure nurses.

Figure 3

Schematic representation of guided action pathway. A heart failure care alert based on integrated TriageHF risk score and peripheral biometric data were used by CHFNs to implement PRNs and monitor safety and attainment of recovery criterion (recovery criterion presented in Figure4). CHFNs interaction with and notification of clinical provider team is also denoted. BP, blood pressure; CHFNs, certified heart failure nurses.

Figure 4

Recovery criterion resulting from PRNs. Recovery criterion after PRN medication intervention was based on the presence of a ≥70% recovery of impedance (daily impedance) toward baseline values (reference impedance). HF, heart failure.

Figure 5

Consort diagram: enrolment, screening, and follow‐up. The number of patients enrolled, screen/eligibility failed, length of follow‐up, completed follow‐up, and exited patients are listed. HF, heart failure.

Figure 6

Consort diagram: HF care alerts and PRN interventions. The number of HF care alerts occurring in the number of patients, their PRN medication interventions, impedance recoveries, and outcomes are listed. HF, heart failure.