. 2023 Dec 4;2(6Part B):101206. doi: 10.1016/j.jscai.2023.101206

Table 3.

A comprehensive summary of the current novel device-based therapies in the treatment of chronic heart failure.

Device	Mechanism	Response	Inclusion criteria	Pivotal evidence^a	Clinical outcome	FDA approval
Remote monitoring
CardioMEMS	Continuous pulmonary artery pressure monitoring	Detects intracardiac pressure before clinical decompensation	• HF hospitalization within 12 mo • Elevated BNP or NT-proBNP	CHAMPION³⁵ GUIDE-HF³⁶	↓ HFH ↓↓ HFH and mortality with concomitant optimal GDMT use	✓
Cordella	Continuous pulmonary artery pressure monitoring			PROACTIVE-HF^a	N/A
Cardiovascular implantable electronic devices
Cardiac resynchronization therapy (CRT)	Biventricular pacing	Decreases ventricular dyssynchrony Improves LV function Induces reverse ventricular remodeling	• NYHA II-IV, LVEF $\leq$ 35%, LBBB with QRS $\geq$ 150 ms • LVEF 36-50% with high degree or complete heart block • NYHA II-IV symptomatic HFrEF with non-LBBB pattern with QRS $\geq$ 150 ms • Genetic arrhythmogenic cardiomyopathy with high-risk features of SCD • High burden of ventricular pacing	MIRACLE³⁷ COMPANION³⁸ CARE-HF³⁹ REVERSE⁴⁰ MADIT-CRT⁴¹ RAFT⁴²	↑ 6MWD, QoL, LVEF, LV remodeling ↓ NYHA class, HFH & mortality	✓
Cardiac contractility modulation
OPTIMIZER Smart CE system	Delivery of nonexcitatory electrical signals to RV septal wall during absolute myocardial refractory period	Enhance myocardial contractility Augment myocardial calcium handling and gene expression	• NYHA III-IV, LVEF 25-45%, in NSR who remain symptomatic despite maximally tolerated GDMT and are CRT ineligible	FIX-HF-5C⁴³ CCM-REG⁴⁴	↑ Peak VO₂, 6MWD, QoL ↓ NYHA class, HFH, & mortality	✓
Autonomic modulation therapy
Barostim NEO System	Pulsed electrical stimulation of carotid sinus	Baroreceptor activation Reduction in sympathetic tone Increase in parasympathetic vagal tone	• NYHA II-III, LVEF $\leq$ 35% with NT-proBNP <1600 pg/mL who remain symptomatic despite maximally tolerated GDMT and are CRT ineligible	BeAT-HF⁴⁵	↑ Functional status, QoL, 6MWD ↓ NT-proBNP MANCE free rate 97%	✓
Enopace (Harmony System)	Pulsed electrical stimulation of descending aorta		• Chronic HF with NYHA II-III symptoms on maximally tolerated GDMT	ENDO-HF^a	N/A
MobiusHD	Endovascular implant designed to reshape carotid sinus		• LVEF $\leq$ 40% with NYHA II-III symptoms despite maximally tolerated GDMT, NT-proBNP $\geq$ 400 pg/mL, 6MWD 150-400 m	HF-FIM^a	N/A
Transcatheter interventions for valvular heart disease
MitraClip	Percutaneous, transcatheter, edge-to-edge repair via clip approximation of valve leaflets	Reduces severe functional mitral regurgitation	• Moderate-to-severe or severe symptomatic MR, LVEF 20-50% with NYHA II-IV despite optimal GDMT	COAPT⁴⁶	↓ annualized HFH and all-cause mortality through 5 y follow-up ↓ Severity of FMR	✓
TriClip		Reduces severe functional tricuspid regurgitation	• Severe symptomatic TR with NYHA II-IV symptoms on stable GDMT ≥30 d, intermediate or greater risk of M&M with tricuspid valve surgery	TRILUMINATE⁴⁷	↑ QoL ↓ Severity of TR ⇔ HFH or death MACE rate 1.7%
Implant-based interatrial shunt devices
IntraAtrial Shunt Device (IASD)	Device-based shunt implanted into the interatrial septum	Decrease left atrial pressure by providing pressure-dependent left-to-right atrial flow AFR: provides bidirectional atrial flow	• NYHA II-III symptoms, LVEF $\geq$ 40% with diastolic dysfunction, exercise PCWP $\geq$ 25 mm Hg while exceeding RAP $\geq$ 5 mm Hg	REDUCE-LAP-HF II⁴⁸ RESPONDER-HF^a	⇔ HFH or death
V-wave shunt system			• NYHA II-IV symptoms with chronic HF, on maximally tolerated GDMT o If NYHA II → at least one HFH and BNP >300 pg/ml or NT-proBNP $\geq$ 1500 pg/mL o If NYHA III-IV → at least one HFH or BNP >300 pg/mL or NT-proBNP $\geq$ 1500 pg/mL	RELIEVE-HF^a	↑ QoL (first 97 patients)
Atrial Flow Regulator (AFR)			• NYHA III-IV symptomatic HFrEF & HFpEF patients with resting PCWP ≥15 mm Hg or ≥25 mm Hg during exercise	PRELIEVE⁴⁹ FROST-HF^a AFteR^a	↑ QoL, 6MWD ↓ NT-proBNP, PCWP, NYHA class
APTURE Transcatheter Shunt System	Shunt implanted between left atrium and coronary sinus	Decrease left atrial pressure via left atrial to coronary sinus shunting	• NYHA II (with history of NYHA III) or NYHA III-IV symptoms and HFH or diuretic intensification or qualifying increased in BNP or NT-proBNP • On stable GDMT for 3 mo • Resting PCWP ≥15 mm Hg or ≥25 mm Hg during exercise	ALt FLOW US^a	↑ QoL, health status ↓ NT-proBNP, PCWP, NYHA class
Implant-free interatrial shunt devices
Alleviant System	Radiofrequency ablation-based interatrial shunt (RAIAS) therapy to create an interatrial shunt without permanent implant placement	Decrease left atrial pressure by allowing for left-to-right atrial flow	• Symptomatic HFpEF/HFmrEF with LVEF $\geq$ 40 mm Hg, NYHA II-IV, exercise LAP $\geq$ 25 mm Hg, exercise PVR <1.8 WU	ALLAY-HF^a	N/A
NoYA System			• Chronic symptomatic HF with NYHA II-IV symptoms or HFH within the last year • On stable maximally tolerated GDMT • mLAP or resting PCWP ≥15 mm Hg, and mLAP or PCWP-RAP ≥5 mm Hg	NoYA RAISE Trial II^a	N/A

6MWD, 6 minute walk distance; BNP, B-type natriuretic peptide; FMR, functional mitral regurgitation; FDA, Food and Drug Administration; GDMT, goal-directed medical therapy; HF, heart failure; HFH, heart failure hospitalization; HFmrEF, heart failure with mildly reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; LAP, left atrial pressure; LBBB, left bundle branch block; LV, left ventricular; LVEF, left ventricular ejection fraction; MACE, major adverse cardiac events; MANCE, major adverse neurological and cardiovascular events; M&M, morbidity and mortality; MR, mitral regurgitation; N/A, not applicable; NSR, normal sinus rhythm; NT-proBNP, N-terminal pro-brain natriuretic peptide; NYHA, New York Heart Association; PCWP, pulmonary capillary wedge pressure; PVR, pulmonary vascular pressure; QoL, quality of life; RAP, right atrial pressure; RV, right ventricular; SCD, sudden cardiac death; TR, tricuspid regurgitation.

Ongoing.