Table 1: Overview of studies about atrial shunt in patients affected by heart failure.

Reference

IASD

Population

Main inclusion criteria

Endpoints

Results

Sondegaard, et al. [23]

 

Corvia

n = 11 patients

·        HFpEF (EF < 45%),

·        ≥ 1 HF hospitalisation in the last 12 months or persistent NYHA class III/IV for at least 3 months

·        Baseline PCWP at rest ≥ 15 mmHg or PCWP during exercise ≥ 25 mmHg.

Primary endpoint: SADEs up to 30 days.

 

Secondary endpoints: procedural success and clinical benefit at 30 days.

No SADEs after 30 days;

Procedural success rate: 100%;

PCWP reduced by 28% (p = 0.005);

NYHA class was improved by two classes in two patients, one class in five patients, and worsened by one class in one patient.

 

Malek, et al. [19]

 

Corvia

n = 11 patients

·        LVEF ≥ 45% and at least one HF hospitalization within the prior year, or with persistent NYHA III class symptoms

·        PCWP at rest ≥ 15 mmHg or during exercise ≥ 25 mmHg.

Clinical and functional benefit at 1-year follow-up.

Survival rate: 100%;

Decrease of NYHA class (Class III/IV 45%/0% at 1 year vs. 82%/18% at baseline; p = 0.017);

NS improvement of 6MWT and QoL.

Hasenfuss, et al. [21]

 

Corvia

n = 68 patients

·        Symptomatic (NYHA class II/III/IV) HFpEF (EF > 40%)

·        PCWP at rest ≥ 15 mmHg or PCWP during exercise ≥ 25 mmHg.

Primary endpoint: MACCE at 6 months.

 

Secondary endpoint: clinical efficacy at 6 months.

No MACCE and sustained device patency at 6 months;

Mean PCWP reduced at 6 months (at rest p = 0.0124, during exercise p = 0.0255).

Del Trigo, et al. [20]

 

V-Wave

n = 10 patients

·        HFrEF (LVEF < 40%) or NYHA class III or IV

·        PCWP at rest ≥ 15 mmHg.

Safety or the procedure and potential efficacy up to 90 days.

Procedural success rate: 100%;

No procedural related SAE;

Patency at 30 days: 100%;

PCWP at rest reduced from 23 ± 5 to 17 ± 8 (p = 0.035); Improvement of NYHA class (from class III to class II in seven [78%] of nine patients, from class III to class I in one [11%] patient, and no change in one [11%] patient; p = 0.0004);

Improvement of QoF, as assessed by the DASI (from a mean score of 13 to 24.8; p = 0.016) and the KCCQ (from a mean score of 44.3 to 79.1; p = 0.0001);

Increase of 6MWT distance (from a mean of 244 m to 318 m; p = 0.016); one patient died (VT after 2 months)

Feldman T, et al. [11]

 

Corvia

n = 44 patients

(22 IASD, 22 control)

·        Symptomatic (NYHA class III or IV) HFpEF (EF ≥ 40%)

·        PCWP during exercise ≥ 25 mmHg or RAP gradient ≥ 5 mmHg.

Primary endpoints: ∆PCWP during exercise and at 30 days and MACCRE.

Secondary endpoints: ∆PCWP and ∆workload at peak exercise need for explantation, clinical efficacy at 30 days.

Procedural success rate: 95.5%; ∆PCWP during exercise significantly decreased (p = 0.028) and no MACCRE at 30 days; no need for explantation.

Paitazoglou C, et al. [12]

 

AFR

n = 53 patients

·        Symptomatic chronic HF (NYHA class III or IV)

·        HFrEF (LVEF 15-39%) or HFpEF (LVEF ≥ 40%) with elevated BNP (> 125 pg/mL)

·        PCWD or LVEDP ≥ 15 mmHg or PCWP ≥ 25 mmHg at exercise and CVP < 20 mmHg

Primary endpoint: incidence of SADEs at 3 months following implantation.

 

Secondary endpoints: SADEs between 3 and 12 months following implantation; left to right shunt through the AFR device at 12 months;

Improvement in symptoms and hemodynamic parameters during at 12 months.

1 patient with 2 documented SADEs after the procedure with bleeding at the puncture site and loss of consciousness with prolonged hospitalisation, which resolved without sequelae;

100% device patency at 1 year; improvement in terms of NYHA class (-1 ± 0.2 in HFrEF and -0.9 ± 0.2 at 1 year), distance in the 6MWT (+50.5 m ± 20 in HFrEF at 1 year), PCWP (-5 mmHg [-12.5, -1.5] in HFpEF already at 3 months) and QoL evaluated with the KCCQ (+21.5 ± 6.1 in HFrEF and +15.3 ± 4.8 in HFpEF at 1 year).

 

 

6MWT: 6-Minute Walk Test; AFR: Atrial Flow Regulator; BNP: Brain Natriuretic Peptide; CVP: Central Venous Pressure; DASI: Duke Activity Status Index; HFpEF: Heart Failure with Preserved Ejection Fraction; HFrEF: Heart Failure with Reduced Ejection Fraction; IASD: Inter-Atrial Shunt Device; KCCQ: Kansas City Cardiomyopathy Questionnaire; LVEDP: Left Ventricle End-Diastolic Pressure; LVEF: Left Ventricle Ejection Fraction; MACCE: Major Adverse Cardiovascular and Cerebrovascular Events; MACCRE: Major Adverse Cardiac, Cerebrovascular, and Renal Events; NS: Not Significant; NYHA: New York Heart Association; PCWP: Pulmonary Capillary Wedge Pressure; QoL: Quality of Life; SADEs: Sudden Adverse Device-related Events; SAEs: Sudden Adverse Events; VT: Ventricular Tachycardia.