Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure

Abstract

More than one-half of people with heart failure (HF) have a preserved left ventricular ejection fraction (HFpEF).1,2 Patients with HFpEF, commonly referred to as diastolic HF, have symptoms and/or signs of HF and a left ventricular ejection fraction (LVEF) >40% to 50%. The prevalence of HFpEF exceeds 3 million in the United States alone, and its prevalence seems to be increasing because of factors such as increased diagnostic awareness and greater longevity. The prognosis for patients hospitalized with HFpEF is poor, worsens with increasing age, and has not improved over time.3 Epidemiology studies have shown similar mortality rates in HF with reduced ejection fraction (HFrEF) and HFpEF; 1-year mortality is 26% in HFrEF compared with 22% in HFpEF. 4,5 Although pharmacological treatments may improve symptoms and reduce mortality in Advances in Clinical Trials© 2016 American Heart Association, Inc. Abstract-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. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02600234.(Circ Heart Fail. 2016;9:e003025.

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

“…Randomized trials, with blinded patients and physician assessors, are currently underway and are required to validate the utility of this novel therapy. 27 …”

<p>Diagnosis and Management of Patients with Heart Failure with Preserved Ejection Fraction (HFpEF): Current Perspectives and Recommendations</p>

“…109 The first randomized clinical trial (RCT) REDUCE LAP-HF I was conducted in 22 centres in the United States, Europe, and Australia on patients with NYHA class III or ambulatory class IV, LVEF≥40%, exercise PCWP≥25 mm Hg, and PCWP-right atrial pressure gradient≥5 mmHg. 110 Safety was assessed by major adverse cardiac, cerebrovascular, or renal events (MACCRE). Exploratory outcomes evaluated at 1 year were hospitalizations for HF, NYHA class, quality of life, a 6-minute walk test, and device patency.…”

The last frontier: transcatheter devices for percutaneous or minimally invasive treatment of chronic heart failure

“…Patients had significantly fewer HF symptoms and were able to exercise longer, resulting in a substantially better quality of life. Currently, the follow-up REDUCE LAP-HF trial (NCT01913613) and a randomised REDUCE LAP-HF I trial [ 43 ] are ongoing.…”