Elsevier

JACC: Heart Failure

Volume 11, Issue 8, Part 2, August 2023, Pages 1121-1130
JACC: Heart Failure

Clinical Research
No-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes From Multicenter Pilot Feasibility Studies

https://doi.org/10.1016/j.jchf.2023.01.024Get rights and content

Abstract

Background

Most approaches to the creation of an interatrial shunt require placement of a permanent implant to maintain patency.

Objectives

The goal of this study was to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF).

Methods

This was a multicenter, uncontrolled study of patients with HFpEF/HFmrEF and NYHA functional class ≥II, ejection fraction >40%, and pulmonary capillary wedge pressure (PCWP) during supine exercise ≥25 mm Hg with PCWP-to–right atrial gradient ≥5 mm Hg. Follow-up was through 6 months with imaging to assess shunt durability.

Results

A total of 28 patients were enrolled: mean age was 68 ± 9 years, and 68% were female. Baseline resting and peak exercise PCWP were 19 ± 7 mm Hg and 40 ± 11 mm Hg, respectively. All procedures displayed technical success with confirmation of left-to-right flow (shunt diameter 7.1 ± 0.9 mm). At 1 month, peak exercise PCWP decreased 5.4 ± 9.6 mm Hg (P = 0.011) with no change in right atrial pressure. There were no serious device or procedure-related adverse events through 6 months. Mean 6-minute walk distance increased 101 ± 71 meters (P < 0.001); Kansas City Cardiomyopathy Questionnaire Overall Summary Score increased 26 ± 19 points (P < 0.001); N-terminal pro–B-type natriuretic peptide decreased 372 ± 857 pg/mL (P = 0.018); and shunt patency was confirmed with unchanged diameter.

Conclusions

In these feasibility studies of a no-implant interatrial shunt, HFpEF/HFmrEF shunts exhibited stability with favorable safety and early efficacy signals. The results show promise toward this new approach for treating patients with HFpEF/HFmrEF and an appropriate hemodynamic profile. (Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction [ALLEVIATE-HF-1]; NCT04583527; Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction [ALLEVIATE-HF-2]; NCT04838353)

Section snippets

Study design

ALLEVIATE-HF-1 and ALLEVIATE-HF-2 were prospective, open-label, uncontrolled, nonrandomized studies. For ALLEVIATE-HF-1, patients were recruited at the Tbilisi Heart and Vascular Clinic (Tbilisi, Republic of Georgia). For ALLEVIATE-HF-2, patients were recruited at Dunedin Public Hospital (Dunedin, New Zealand), Monash Medical Centre (Clayton, Victoria, Australia), Flinders Medical Centre (Bedford Park, South Australia, Australia), and Centre hospitalier de l'Université de Montréal (Montreal,

Population sample and baseline characteristics

Between August 2020 and March 2022, a total of 28 patients were enrolled in the studies. Their mean age was 68 ± 9 years. A majority of the patients were female (n = 19 [68%]). Mean baseline left ventricular ejection fraction was 60.8% ± 8.4%, and body mass index was 36.1 ± 7.5 kg/m2. Enrolled patients were in NYHA functional class III (n = 20) and class II (n = 8). Mean 6MWT was 252 ± 67 meters, indicating impaired functional capacity. Baseline resting and peak exercise PCWP were 19 ± 7 mm Hg

Discussion

The ALLEVIATE-HF-1 and ALLEVIATE-HF-2 studies were first-in-human clinical studies conducted to evaluate the use of a no-implant approach to creating a sustained interatrial shunt. The results of these studies showed procedural success in all patients, with successful excision of atrial tissue and consistent creation of a 7-mm-diameter interatrial shunt with left-to-right shunt flow. All shunts maintained patency at 6 months with no change in size or in ratio of pulmonary to systemic blood

Conclusions

The ALLEVIATE-HF-1 and ALLEVIATE-HF-2 pilot feasibility studies collectively show initial signals of safety and efficacy of the no-implant approach to creating an interatrial shunt. At the 6-month follow-up visit, all patients had patent shunts that remained stable in size. In addition, there was a significant reduction in PCWP from baseline to 1 month, with promising clinical efficacy signals and no serious adverse events through 6 months. Although further validation is needed, these results

Funding Support and Author Disclosures

These studies were funded by Alleviant Medical. Dr Udelson has received consulting fees from Alleviant Medical, Merck, Cardurion, Reprieve CV, Medtrace, and GE. Dr Barker has received consulting fees from and is an advisory board/board member to Alleviant Medical. Dr Gooley has received consulting fees from Boston Scientific, Medtronic, and Abbott Vascular; and is an advisory board member to Boston Scientific and Medtronic. Dr Potter has received research funding and consulting fees from

Acknowledgment

The authors thank Jake Rosen for contributing an early draft of the manuscript.

References (17)

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