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May 3, 2022 Circulation. 2022;145:e895–e1032. DOI: 10.1161/CIR.0000000000001063 e916

CLINICAL STATEMENTS AND GUIDELINES 2.	 Right-heart catherization in patients in acute HF. The ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial found that routine use of PA catheter monitoring for patients with HF did not provide benefit.3 However, invasive hemodynamic evaluation or monitoring can be useful to guide management in carefully selected patients with acute HF who have persistent symptoms despite treatment. This includes patients whose fluid status, perfusion, or systemic or pulmonary vascular resistance is uncertain whose systolic blood pressure (SBP) remains low, or is associated with symptoms, despite initial treatment; whose renal function is worsening with therapy; or who require parenteral vasoactive agents. 3.	 There has been no established role for routine or periodic invasive hemodynamic measurements in the management of HF. Most drugs used to treat HF are prescribed on the basis of their ability to improve symptoms or survival rather than their effect on hemodynamic variables. The initial and target doses of these drugs are generally selected on the basis of controlled trial experience rather than changes produced in cardiac output or pulmonary capillary wedge pressure.3,4

4.	 Patients with HF should not undergo routine endomyocardial biopsy because of the risk of complications that include perforation, cardiac tamponade, and thrombus formation, as well as limited diagnostic yield.5,6

4.6 Wearables and Remote Monitoring

(Including Telemonitoring and Device Monitoring) Recommendation for Wearables and Remote Monitoring (Including Telemonitoring and Device Monitoring) Referenced studies that support the recommendation are summarized in the Online Data Supplements.

COR LOE Recommendation

2b B-R 1.	 In selected adult patients with NYHA class III HF and history of a HF hospitalization in the past year or elevated natriuretic peptide levels, on maximally tolerated stable doses of GDMT with optimal device therapy, the usefulness of wireless monitoring of PA pressure by an implanted hemodynamic monitor to reduce the risk of subsequent HF hospitalizations is uncertain.1–4

Value Statement: Uncertain Value

(B-NR) 2.	 In patients with NYHA class III HF with a HF hospitalization within the previous year, wireless monitoring of the PA pressure by an implanted hemodynamic monitor provides uncertain value.4–7 Synopsis

HF is a chronic condition punctuated by periods of instability. Despite close longitudinal monitoring via in-person visits, event rates remain high, affording a potential role for remote monitoring strategies to improve clinical outcomes. Strategies tested in randomized trials include an implantable PA pressure sensor (CardioMEMS), noninvasive telemonitoring, or monitoring via existing implanted electronic devices (ICDs or CRT-Ds). Results from a single randomized trial,1–3 and subsequent observational studies,8–10 support consideration of an implantable PA sensor in selected patients with HF to reduce the risk of HF hospitalization. In contrast, a recent trial testing a PA pressure sensor did not meet its primary endpoint.4 Results from previous clinical trials do not support the alternative remote monitoring strategies (eg, noninvasive telemonitoring or remote monitoring of physiological parameters such as patient activity, thoracic impedance, heart rate) for this purpose.11–18

Recommendation-Specific Supportive Text

1.	 The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure patients) trial reported a significant 28% reduction of HF-related hospitalizations after 6 months in patients randomized to an implanted PA pressure monitor compared with a control group.1 Patients had to have a HF hospitalization in the previous year and be on stable doses of a beta blocker and angiotensin-converting enzyme inhibitor (ACEi) (or angiotensin (II) receptor blocker [ARB]) if tolerated. The clinical benefit persisted after longer term follow-up and was seen in both subjects with reduced3 and preserved2 LVEF. However, CHAMPION was a nonblinded trial, and there was differential contact of study personnel with patients in the treatment arm, raising methodological concerns about the opportunity for bias to have influenced its results.19–21 In the recent GUIDE-HF (Haemodynamic-GUIDEed management of Heart Failure) study, hemodynamic-guided management of patients with NYHA class II to IV heart failure did not significantly reduce the composite endpoint rate of mortality and total HF events.4 The usefulness of noninvasive telemonitoring11,12,22,23 or remote monitoring of physiological parameters13–18 (eg, patient activity, thoracic impedance, heart rate) via implanted electrical devices (ICDs or CRT-Ds) to improve clinical outcomes remains uncertain. Further study of these approaches is needed before they can be recommended for routine clinical care. 2.	 Three model-based studies5–7 have evaluated the cost-effectiveness of wireless PA pressure monitoring using data from the CHAMPION-HF1 study of

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