What is the clinical evidence from this study?

Study design: Other. Population: Heart Failure With Preserved Ejection Fraction (HFpEF) (n=64). Intervention: Interatrial shunt device (IASD) vs. Baseline. Primary outcome: 6-minute walk distance at 12 months (p=0.001).

What does this research mean for the field?

Interatrial shunt device implantation in patients with heart failure with preserved ejection fraction is safe and results in sustained clinical improvements, including increased 6-minute walk distance, at 1 year. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

November 17, 2016Open Access

One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction

Key Result

Interatrial shunt device implantation in patients with heart failure with preserved ejection fraction resulted in sustained improvements in 6-minute walk distance from 331 m to 363 m at 1 year.

Structured PICO

Does transcatheter insertion of an interatrial shunt device improve clinical outcomes and hemodynamics in patients with heart failure with preserved ejection fraction?

Population

64 patients with symptomatic heart failure with preserved ejection fraction (LVEF ≥40%, NYHA class II-IV) and elevated pulmonary capillary wedge pressure (≥15 mm Hg at rest or ≥25 mm Hg during supine bicycle exercise). Excluded: moderate or greater right heart dysfunction, significant valvular disease.

Intervention

Transcatheter insertion of an interatrial shunt device (IASD)

Outcome

1-year outcomes including New York Heart Association class, quality of life (Minnesota Living with Heart Failure score), 6-minute walk distance, echocardiographic parameters, and invasive hemodynamics (workload corrected exercise PCWP)

Transcatheter insertion of an interatrial shunt device in patients with HFpEF is safe and provides sustained clinical and hemodynamic benefits at 1 year.

Main Result

Absolute Event Rate: 363% vs 331%

p-value: p=0.001

Limitations

Nonrandomized open-label study design
Key clinical outcome variables were of a subjective or effort-dependent nature
Cannot exclude the possibility of a placebo effect
Missing information at some observation points
Only a subgroup of patients underwent hemodynamic assessment at 12 months

Abstract

Background— Heart failure with preserved ejection fraction has a complex pathophysiology and remains a therapeutic challenge. Elevated left atrial pressure, particularly during exercise, is a key contributor to morbidity and mortality. Preliminary analyses have demonstrated that a novel interatrial septal shunt device that allows shunting to reduce the left atrial pressure provides clinical and hemodynamic benefit at 6 months. Given the chronicity of heart failure with preserved ejection fraction, evidence of longer-term benefit is required. Methods and Results— Patients (n=64) with left ventricular ejection fraction ≥40%, New York Heart Association class II–IV, elevated pulmonary capillary wedge pressure (≥15 mm Hg at rest or ≥25 mm Hg during supine bicycle exercise) participated in the open-label study of the interatrial septal shunt device. One year after interatrial septal shunt device implantation, there were sustained improvements in New York Heart Association class ( P <0.001), quality of life (Minnesota Living with Heart Failure score, P <0.001), and 6-minute walk distance ( P <0.01). Echocardiography showed a small, stable reduction in left ventricular end-diastolic volume index ( P <0.001), with a concomitant small stable increase in the right ventricular end-diastolic volume index ( P <0.001). Invasive hemodynamic studies performed in a subset of patients demonstrated a sustained reduction in the workload corrected exercise pulmonary capillary wedge pressure ( P <0.01). Survival at 1 year was 95%, and there was no evidence of device-related complications. Conclusions— These results provide evidence of safety and sustained clinical benefit in heart failure with preserved ejection fraction patients 1 year after interatrial septal shunt device implantation. Randomized, blinded studies are underway to confirm these observations. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT01913613.

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