We herein present a case study of a patient with heart failure with a preserved ejection fraction and severe symptoms who underwent interatrial shunt device implantation and follow-up at a tertiary care heart failure clinic. The interatrial shunt device implantation was successful. No adverse events occurred, and the device prevented hospitalization for heart failure during long-term follow-up.

• Keywords
• Heart failure with preserved ejection fraction, adverse outcomes, case report, hospitalization for heart failure, interatrial shunt device, long-term follow-up,
• MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Cardiac Catheterization MeSH
• Heart Failure * surgery   MeSH
• Heart Atria * surgery   MeSH
• Stroke Volume MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH

AIMS: Impaired left ventricular diastolic function leading to elevated left atrial pressures, particularly during exertion, is a key driver of symptoms and outcomes in heart failure with preserved ejection fraction (HFpEF). Insertion of an interatrial shunt device (IASD) to reduce left atrial pressure in HFpEF has been shown to be associated with short-term haemodynamic and symptomatic benefit. We aimed to investigate the potential effects of IASD placement on HFpEF survival and heart failure hospitalization (HFH). METHODS AND RESULTS: Heart failure with preserved ejection fraction patients participating in the Reduce Elevated Left Atrial Pressure in Patients with Heart Failure study (Corvia Medical) of an IASD were followed for a median duration of 739 days. The theoretical impact of IASD implantation on HFpEF mortality was investigated by comparing the observed survival of the study cohort with the survival predicted from baseline data using the Meta-analysis Global Group in Chronic Heart Failure heart failure risk survival score. Baseline and post-IASD implant parameters associated with HFH were also investigated. Based upon the individual baseline demographic and cardiovascular profile of the study cohort, the Meta-analysis Global Group in Chronic Heart Failure score-predicted mortality was 10.2/100 pt years. The observed mortality rate of the IASD-treated cohort was 3.4/100 pt years, representing a 33% lower rate (P = 0.02). By Kaplan-Meier analysis, the observed survival in IASD patients was greater than predicted (P = 0.014). Baseline parameters were not predictive of future HFH events; however, poorer exercise tolerance and a higher workload-corrected exercise pulmonary capillary wedge pressure at the 6 months post-IASD study were associated with HFH. CONCLUSIONS: The current study suggests IASD implantation may be associated with a reduction in mortality in HFpEF. Large-scale ongoing randomized studies are required to confirm the potential benefit of this therapy.

• Keywords
• HFpEF, Heart failure, Interatrial shunt, Medical device, Survival,
• MeSH
• Time Factors MeSH
• Ventricular Function, Left physiology   MeSH
• Hospitalization trends   MeSH
• Humans MeSH
• Survival Rate trends   MeSH
• Follow-Up Studies MeSH
• Prospective Studies MeSH
• Prostheses and Implants * MeSH
• Aged MeSH
• Atrial Pressure physiology   MeSH
• Cardiac Catheterization methods   MeSH
• Heart Failure mortality   physiopathology   surgery   MeSH
• Heart Atria physiopathology   surgery   MeSH
• Stroke Volume physiology   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Australia epidemiology   MeSH
• Europe epidemiology   MeSH
• New Zealand epidemiology   MeSH

OBJECTIVES: This study sought to define the invasive hemodynamic correlates of peak oxygen consumption (Vo2) in both supine and upright exercise in heart failure with preserved ejection fraction (HFpEF) and evaluate its diagnostic role as a method to discriminate HFpEF from noncardiac etiologies of dyspnea (NCD). BACKGROUND: Peak Vo2 is depressed in patients with HFpEF. The hemodynamic correlates of reduced peak Vo2 and its role in the clinical evaluation of HFpEF are unclear. METHODS: Consecutive patients with dyspnea and normal EF (N = 206) undergoing both noninvasive upright and invasive supine cardiopulmonary exercise testing were examined. Patients with invasively verified HFpEF were compared with those with NCD. RESULTS: Compared with NCD (n = 72), HFpEF patients (n = 134) displayed lower peak Vo2 during upright and supine exercise. Left heart filling pressures during exercise were inversely correlated with peak Vo2 in HFpEF, even after accounting for known determinants of O2 transport according to the Fick principle. Very low upright peak Vo2 (<14 ml/kg/min) discriminated HFpEF from NCD with excellent specificity (91%) but poor sensitivity (50%). Preserved peak Vo2 (>20 ml/kg/min) excluded HFpEF with high sensitivity (90%) but had poor specificity (49%). Intermediate peak Vo2 cutoff points were associated with substantial overlap between cases and NCD. CONCLUSIONS: Elevated cardiac filling pressure during exercise is independently correlated with reduced exercise capacity in HFpEF, irrespective of body position, emphasizing its importance as a novel therapeutic target. Noninvasive cardiopulmonary testing discriminates HFpEF and NCD at high and low values, but additional testing is required for patients with intermediate peak Vo2.

• Keywords
• HFpEF, diagnosis, exercise, heart failure, hemodynamics,
• MeSH
• Adult MeSH
• Dyspnea etiology   MeSH
• Hemodynamics MeSH
• Middle Aged MeSH
• Humans MeSH
• Aged MeSH
• Oxygen Consumption * MeSH
• Cardiac Catheterization MeSH
• Heart Failure complications   diagnosis   physiopathology   MeSH
• Case-Control Studies MeSH
• Supine Position MeSH
• Stroke Volume * MeSH
• Pressure MeSH
• Exercise Tolerance MeSH
• Exercise Test methods   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, N.I.H., Extramural MeSH

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.

• Keywords
• heart failure, hemodynamics, physiology, therapeutics,
• MeSH
• Time Factors MeSH
• Equipment Design MeSH
• Adult MeSH
• Ventricular Function, Left MeSH
• Prosthesis Implantation * MeSH
• Quality of Life MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Aged MeSH
• Atrial Pressure physiology   MeSH
• Cardiac Catheterization * MeSH
• Heart Failure physiopathology   therapy   MeSH
• Heart Atria MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Research Support, Non-U.S. Gov't MeSH