Efficacy and safety of interatrial shunt treatment for heart failure: A systematic review and meta-analysis

Table 1 Study characteristics of the included studies

Ref.	Device	Study design	Device	Left ventricular ejection fraction	New York Heart Association class	Participants control	Participants IASD	Follow-up
Søndergaard et al[17], 2014	IASD	Pilot trial	IASD	≥ 45%	III/IV	11	11	1 month
Kaye et al[4], 2016	IASD	Single-arm study	IASD	≥ 40%	II/IV	64	64	12 months
Del Trigo et al[18], 2016	V-wave	Cohort study	V-wave	≤ 40%	III/IV	10	10	3 months
Feldman et al[10], 2018	IASD	Phase 2, randomized control trial	IASD	≥ 40%	III/IV	22	21	1 months
Rodés-Cabau et al[19], 2024	V-wave	Non-randomized control trial (single-arm open-label study)	V-wave	> 15%	III/IV	38	36	12 months
Paitazoglou et al[7], 2021	AFR device	Prospective, multicentre, open-label, non-randomised pilot	AFR device	≥ 15%	III/IV	36	36	3 months
Stone et al[20], 2024	Ventura shunt	Randomized, double-blind, placebo procedure–controlled, multicenter trial	Ventura shunt	30.2% (≤ 40%) in 206 patients and preserved 55.8% (> 40%) in 302 patients	II–IVa	258	250	2 years
Gustafsson et al[21], 2024	IASD system II (Corvia Medical)	Multicenter, randomized, double blind, sham-controlled trial	IASD system II (Corvia Medical)	≥ 50%	II/III	312	309	2 years
Fioretti et al[12], 2025	APTURE shunt	Open-label, single-arm, nonrandomized trial	APTURE shunt	> 40%	II–IV	106	95	2 years

AFR: Atrial flow regulator; IASD: Interatrial shunt device.

Table 2 Demographic details of included studies

Ref.	Age, mean ± SD (years)	Male sex (%)	Body mass index (kg/m2)	Coronary artery disease (%)	Hypertension (%)	Diabetes mellitus (%)	Atrial fibrillation/flutter (%)	Left ventricular ejection fraction, mean ± SD (%)
Søndergaard et al[17], 2014	70 ± 11.9	45	Not reported	36	91	45	36	57 ± 9
Kaye et al[4], 2016	69 ± 8	35	33 ± 6	36	81	33	36	47 ± 7
Del Trigo et al[18], 2016	62 ± 8	90	31 ± 5	90	70	70	70	25 ± 8
Feldman et al[10], 2018	69.6 ± 8.3/70.0 ± 9.2 (treatment/control)	63.6/36.4	35.2 ± 6.4/35.1 ± 9.1	22.7% (5/22)	81.8/90.9	54.5/54.4	59.1/54.5	59.9 ± 9.0/58.5 ± 6.9
Rodés-Cabau et al[19], 2024	66 ± 9	92	30 ± 6	79	84	68	53	50 ± 9 (HFpEF), 26 ± 7 (HFrEF)
Paitazoglou et al[7], 2021	67.3 ± 8.6	58.3	30.7 ± 6.7	55.6	66.7	52.8	47.2	51.5 ± 6 (HFpEF), 31.9 ± 7 (HFrEF)
Stone et al[20], 2024	73 ± 7.5	62.8	30.2 ± 5.6	64.7	83.6	49	64.7	45.4 ± 18.9 vs 45.3 ± 17.9
Gustafsson et al[21], 2024	71.67 ± 8.17	38.5	31.9 ± 2.3	16.1	88.2	36.9	62.1	HFrEF (7.1) vs HFpEF (92.9)
Fioretti et al[12], 2025	70.9 ± 8.47	49.5% (47/95)	33.7 ± 7.0	56.8% (54/95)	87.4 % (83/95)	40.0% (38/95)	58.9% (56/95)	62.50 ± 8.00

HFpEF: Heart failure with preserved ejection fraction; HFrEF: Heart failure with preserved ejection fraction.