One‐year results of the first‐in‐man study investigating the Atrial Flow Regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study

Abstract

Aims Attenuating exercise‐induced elevated left atrial pressure with an atrial shunt device is under clinical investigation for treatment of symptomatic heart failure (HF). Methods and results PRELIEVE was a prospective, non‐randomised, multicentre, first‐in‐man study in symptomatic HF patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg during exercise. Here, we provide follow‐up data up to 1 year after implantation of the Atrial Flow Regulator (AFR) device. The AFR was successfully implanted in 53 patients (HFrEF n = 24 and HFpEF n = 29). Two patients were not enrolled due to an unsuccessful transseptal puncture. There was one device embolisation into the left atrium, which required surgical removal. One patient experienced a serious procedure‐related adverse event (post‐procedural bleeding and syncope). All patients with sufficient echocardiography readout confirmed device patency with left–right shunt both at 3 (n = 47/51, 92%) and 12 (n = 45/49, 92%) months. At 3 months, rest PCWP decreased by 5 (−12, 0) mmHg (P = 0.0003, median Q1, Q3). No patient developed a stroke, worsening of right heart function or significant increase of pulmonary artery pressure. Six (6/53, 11%) patients were hospitalised for worsening of HF and three (3/53, 6%) patients died. We observed improvements in New York Heart Association functional class, 6‐min walking distance and quality of life (Kansas City Cardiomyopathy Questionnaire) in certain patients. Conclusions Implantation of the AFR device in HF patients was feasible. No shunt occlusion, stroke or new right HF was observed during the 1‐year follow‐up, with clinical improvements in certain patients.

Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure: a systematic review and meta‐analysis

“…The included studies were published between 2014 and 2021 and evaluated four dedicated IASDs: the Corvia IASD II system, 20–22 the first‐ 23 and second‐generation 24 v‐Wave system, and the Occlutech Atrial Flow Regulator 25 . Table 1 depicts the main study characteristics 20–29 . Three studies (Corvia Feasibility, 20 REDUCE‐LAP HF, 21 and REDUCE‐LAP HF I 22 ) included patients with CHF with mildly‐reduced (41–49%) and preserved LVEF (≥ 50%), two studies (v‐Wave first generation 23 and PRELIEVE 25,29 ) included patients with an LVEF ≥ 15%, and one study included CHF patients irrespective of LVEF 24 .…”

May 2021 at a glance: focus on acute heart failure and heart failure with preserved ejection fraction

“…Atrial Flow Regulator reduced rest PCWP at 3 months by 5 (−12, 0) mmHg ( P = 0.0003, median Q1, Q3). No stroke, shunt occlusion, or new right HF was reported during the 1‐year follow‐up 25 …”

Interatrial shunting for the treatment of heart failure: an on‐demand, self‐regulating left atrial pressure lowering system

“…In this issue of the Journal, Paitazoglou and colleagues 9 add to this evidence by extending their prior observations supporting the feasibly, safety, and potential effectiveness of interatrial shunting in 53 HFrEF and HFpEF patients followed for 1 year after shunt implantation. (Their prior report included the first 36 patients followed for 3 months, in the AFR‐PRELIEVE study 7 …”