Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure

Filippini, Filippe Barcellos; Ribeiro, Henrique Barbosa; Bocchi, Edimar; Bacal, Fernando; Marcondes-Braga, Fabiana G.; Avila, Monica S.; Sturmer, Janine Daiana; Marchi, Mauricio Felippi de Sá; Kanhouche, Gabriel; Freire, Antônio Fernando; Cassar, Renata; Abizaid, Alexandre A.; Brito Jr, Fábio Sândoli de

doi:10.36660/abc.20220496

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Review Article • Arq. Bras. Cardiol. 120 (11) • Nov 2023 • https://doi.org/10.36660/abc.20220496 linkcopy

Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Innovations in devices during the last decade contributed to enhanced diagnosis and treatment of patients with cardiac insufficiency. These tools progressively adapted to minimally invasive strategies with rapid, widespread use. The present article focuses on actual and future directions of device-related diagnosis and treatment of chronic heart failure.

Heart Failure; Implantable Defibrillators; Cardiac Resynchronization Therapy Devices

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: Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure

Device	CardioMEMS	HeartPOD	V-LAP
Monitoring site	Pulmonary artery	Left atrium	Left atrium
Trial / Year of release	CHAMPION (2011)	HOMEOSTASIS (2010)	VECTOR-HF (2022)
Design	RCT; intention to treat; single-blinded	first-in-human	first-in-human
Inclusion	NYHA III, regardless of EF HFpEF and HFrEF	NYHA III-IVa HFpEF and HFrEF	NYHA III, EF> 15% HFrEF in 92%
Patients	n= 550 61 y.o., mostly with EF <40% (79%)	n=40 66 y.o., mean EF 32%	n=24 67 y.o., mean EF 31%
Follow-up	6 months	25 months	6 months
Outcomes	Reduction in HF hospitalization (HR 0.72; p=0.0002; NNT=8)	- Improvement of NYHA and EF (P<0.001 for both); - drop in LA pressure (P= 0.003)	- Improvement of NYHA in 40%; - No improvement in 6MWT or NT-proBNP
Additional data	GUIDE-HF (2021): n=1.022; FU 12 months; RCT - Inclusion: NYHA II or IV, regardless of EF - Results: negative 1a EP, despite reduction of mPAP - Pre-COVID analysis: reduction of death and HF -related events (HR 0.81; P= 0.049) MONITOR-HF (2023): n=348; FU 12 months; RCT - Inclusion: NYHA III, regardless of EF - Results: improved quality of life (p= 0.013); reduced HF hospitalizations (p= 0.0053); reduced mPAP (p< 0.0001)	LAPTOP-HF (2014): n=486; RCT - Inclusion: NYHA III, regardless of EF - RCT with high implant-related complications - Terminated prematurely by the Data and Safety Monitoring Board based on futility and transseptal complications	- Implant success: 100% - No device-related complications

Device	Corvia	v-WAVE	AFR
Indication	HFpEF and HFmrEF	HFpEF, HFmrEF and HFrEF	HFpEF, HFmrEF and HFrEF
Trial	REDUCE LAP-HF II, 2022	V-WAVE SHUNT (VW-SP-1), 2018	AFR PRELIEVE, 2021
Methods and Demographic data	- double-blinded RCT, sham-controlled - n=626. IASD (n=314) and sham (n=312), FU= 24 months - Inclusion: EF ≥ 40%, NYHA II- III, (PCWP) ≥ 25mmHg (exercise) - Patients: 72 y.o., NYHA III (77%), mean EF: 60%, female sex (62%)	- first-in-man, n=38, 6 centers, FU=12 months. - Inclusion: EF >15%, NYHA III-IVa - Patients: 66 y.o., ischemic cardiomyopathy (79%), NYHA III (97%), 79% with HFrEF (mean EF: 26%) and 21% with HFpEF (mean EF: 50%), male sex (92%)	- first-in-man , n=53, multicentric, FU=12 months - Inclusion: EF > 15%, NYHA III-IVa, PCWP ≥ 25 (exercise) ou ≥15 (rest) - Patients: 70 y.o., NYHA III (93%), HFrEF (n=24), HFpEF (n=29)
Results	- no difference in the 1ª EP of CV death, non-fatal ischemic stroke at 12 months - IASD did not reduce HF-related events or improve quality of life - NYHA significantly improved in the shunt group.	- improvement in NYHA, quality of life and 6MWT - in 12 months: occluded shunts (14%) and stenotic shunts (36%) - in those with a patent shunt at 12 months, there was less hospitalization due to HF (p= 0.008) and a reduction in PCWP (p= 0.01)	- success rate: 98% - improvement in NYHA, quality of life and 6MWT - shunt patency at 12 months: 100% - hospitalizations due to HF: 6/53 (3 HFrEF and 3 HFpEF) - total deaths: 3 (all HFrEF)
Additional Data	REDUCE LAP-HF I (2016): - n=64, NYHA II-IV, EF ≥ 40%, FU=12 months - reduction of iLVEdV, increase in iRVEdV, reduction in PCWP - improvement in NYHA, quality of life and 6MWT	RELIEVE-HF: (in progress) - n=605, RCT, double-blind - randomization 1:1 - FU: 1, 2 e 5 years	- 3-month FU: reduction in PCWP (p= 0.0003) - 1y FU: no shunt occlusion, stroke, or new HF was observed, with clinical improvements in certain patients
Size / Caliber	8 mm / 16 Fr	5 mm / 14 Fr	6, 8, and 10 mm / 12-14 Fr

Device	CardioFit	Barostim Neo	Harmony (HASS)
Indication	HFrEF	HFrEF	HFrEF or HFmrEF
Method of vagal stimulation	Bidirectional (efferent and afferent)	Afferent	Afferent
Electrode location	Cervical vagus nerve, 3 cm below the bifurcation of the carotid artery	Carotid sinus	Thoracic aorta
Trials	INOVATE-HF (2016): - n=707, FU= 16 months - Inclusion: EF ≤ 40%, NYHA III - did not change the 1a composite EP of death or HF-related events - improvement in NYHA, quality of life, and 6MWT (p< 0.05 for all) - no change in iLVEsV	HOPE4HF (2015): - n=146, FU= 6 months - Inclusion: EF ≤ 35%, NYHA III - Results: significant improvement in 6MWT, quality of life, NT pro-BNP, NYHA - no difference in hospitalization for HF (p= 0.08) BeAT-HF (2020): n=408, FU= 6 months - Inclusion: EF ≤ 35, NYHA II-III - Results: significant improvement in 6MWT, quality of life, NT pro-BNP (p< 0.01 for all)	ENDO-HF (in progress): - n=30, FU 6 months, phase II - Inclusion: EF ≥ 40%, NYHA II-III, NT pro-BNP > 300 pg/mL

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Sociedade Brasileira de Cardiologia - SBC Avenida Marechal Câmara, 160, sala: 330, Centro, CEP: 20020-907, (21) 3478-2700 - Rio de Janeiro - RJ - Brazil, Fax: +55 21 3478-2770 - São Paulo - SP - Brazil
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[TFN1001] RCT: randomized clinical trial; NYHA: functional class by the New York Heart Association; EF: ejection fraction; HFpEF: heart failure with preserved ejection fraction; HFrEF: heart failure with reduced ejection fraction; Y.O.: years old; HF: heart failure; RR: relative risk; NNT: number needed to treat; FU: follow-up (follow-up); mPAP: mean pulmonary arterial pressure; LA: left atrium; 6MWT: 6-minute walk test; NT-ProBNP: N-terminal fragment of type B natriuretic peptide.