One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction

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

Left atrial enlargement is associated with pulmonary vascular disease in heart failure with preserved ejection fraction

Aims: Elevated left atrial (LA) pressure is a pathophysiologic hallmark of heart failure with preserved ejection fraction (HFpEF). Chronically elevated LA pressure leads to LA enlargement, which may impair LA function and increase pulmonary pressures. We sought to evaluate the relationship between LA volume and pulmonary arterial haemodynamics in patients with HFpEF. Methods and results: Data from 85 patients (aged 69 ± 8 years) who underwent exercise right heart catheterisation and echocardiography were retrospectively analysed. All had symptoms of heart failure, LVEF ≥50% and haemodynamic features of HFpEF. Patients were divided into LAVI-based tertiles (≤34mL/m2, >34 to ≤45mL/m2, >45mL/m2). A subgroup analysis was performed in patients with recorded LA global reservoir strain (n=60), with reduced strain defined as ≤24%. Age, sex, BSA and LVEF were similar between volume groups. LA volume was associated with blunted increases in cardiac output with exercise (ΔCO) (Padjusted < .001), higher resting mean pulmonary artery pressure (mPAP) (Padjusted = .003), with similar wedge pressure (PCWP) (Padjusted = 1). Pulmonary vascular resistance (PVR) increased with increasing LA volume (Padjusted < .001). Larger LA volumes featured reduced LA strain (Padjusted < .001), with reduced strain associated with reduced pulmonary vascular resistance-compliance (RC) time (0.34 [0.28–0.40] vs 0.38 [0.33–0.43], P = .03). Conclusion: Increasing LA volume may be associated with more advanced pulmonary vascular disease in HFpEF, featuring higher pulmonary vascular resistance and pulmonary pressures. Reduced LA function, worse at increasing LA volumes, is associated with a disrupted pulmonary resistance-compliance relationship, further augmenting impaired pulmonary haemodynamics

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Rationale and Design of the Randomized Trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I)

Heart failure with preserved ejection fraction (HFpEF), a major public health problem with high morbidity and mortality rates, remains difficult to manage because of a lack of effective treatment options. Although HFpEF is a heterogeneous clinical syndrome, elevated left atrial pressure-either at rest or with exertion-is a common factor among all forms of HFpEF and one of the primary reasons for dyspnea and exercise intolerance in these patients. On the basis of clinical experience with congenital interatrial shunts in mitral stenosis, it has been hypothesized that the creation of a left-to-right interatrial shunt to decompress the left atrium (without compromising left ventricular filling or forward cardiac output) is a rational, nonpharmacological strategy for alleviating symptoms in patients with HFpEF. A novel transcatheter interatrial shunt device has been developed and evaluated in patients with HFpEF in single-arm, nonblinded clinical trials. These studies have demonstrated the safety and potential efficacy of the device. However, a randomized, placebo-controlled evaluation of the device is required to further evaluate its safety and efficacy in patients with HFpEF. In this article, we give the rationale for a therapeutic transcatheter interatrial shunt device in HFpEF, and we describe the design of REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I), the first randomized controlled trial of a device-based therapy to reduce left atrial pressure in HFpEF