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Multicenter Study
. 2023 Aug;11(8 Pt 2):1121-1130.
doi: 10.1016/j.jchf.2023.01.024. Epub 2023 Apr 26.

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

James E Udelson  1 , Colin M Barker  2 , Gerard Wilkins  3 , Benjamin Wilkins  3 , Robert Gooley  4 , Siobhan Lockwood  4 , Brian J Potter  5 , Christopher U Meduri  6 , Peter S Fail  7 , Darrell J Solet  7 , Kari Feldt  6 , Jacob M Kriegel  8 , Tamaz Shaburishvili  9
Affiliations
Free article
Multicenter Study

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

James E Udelson et al. JACC Heart Fail. 2023 Aug.
Free article

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).

Keywords: heart failure; interatrial shunt; no-implant shunt; preserved ejection fraction; radiofrequency.

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Conflict of interest statement

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 Alleviant Medical; honoraria from Abbott; research funding from Bayer Canada, Boehringer Ingelheim Canada, and Novartis Canada; and has served as Principal Investigator of the ALLEVIATE-HF-2 study. Dr Meduri has received consulting fees from Alleviant Medical, Anteris Technologies, Boston Scientific, Medtronic, and VDyne; has received speaker fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic; is an advisory board member for Anteris Technologies and Cardiovalve; and is a proctor for Boston Scientific. Dr Fail has received consulting fees from BioVentrix and Alleviant Medical; speaker fees from Abbott Vascular, Boston Scientific, Medtronic; and has served as principal investigator of research studies for Ancora Heart and Corvia Medical. Dr Solet has received consulting fees from Abbott Medical and Alleviant Medical. Dr Felt has received consulting fees from Abbott Vascular, Alleviant Medical, Anteris Technologies, Pfizer Inc, and Orion Pharma. Dr Kriegel has received consulting fees from, is an advisory board/board member to, and serves as chief medical officer of Alleviant Medical. Dr Shaburishvili served as principal investigator of the ALLEVIATE-HF-1 study for Alleviant Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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