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

Abstract

AimsTo assess the feasibility and efficacy of interatrial shunt devices (IASD) for the treatment of chronic heart failure (CHF). Methods and resultsMEDLINE and the Cochrane Central Register of Controlled Trials from inception until April 2021 were searched for prospective studies investigating dedicated transcatheter IASD for the treatment of CHF. Standardised mean differences were calculated for the within‐group changes before and after implantation of the IASD. The pre‐defined primary outcome was change in 6‐min walking distance (6MWD) from baseline to 12 months. Other outcomes were change in New York Heart Association class, health‐related quality of life (HRQoL), echocardiographic and haemodynamic data, device performance and safety. Subgroup analyses were crude univariable meta‐regression analyses. Six studies (five single‐arm open‐label studies, one sham‐controlled trial) were included. In these, 226 patients underwent IASD implantation using four different devices. From baseline to 12 months, 6MWD increased by 28.1 m [95% confidence interval (CI) 10.9–45.3] with no evidence for a difference between devices (P for interaction = 0.66) and patients with left ventricular ejection fraction (LVEF) >40% or ≤40% (P for interaction = 0.21). At 12 months, HRQoL improved by 17.7 points (95% CI 10.8–24.6) and pulmonary capillary wedge pressure (PCWP) decreased by 2.0 mmHg (95% CI −3.6 to −0.4). There were no changes in LVEF or N‐terminal pro brain natriuretic peptide during follow‐up. Shunt patency ranged from 50% for the first‐generation v‐Wave to 100% for the Corvia IASD II and the second‐generation v‐Wave system, respectively. The summary risk of serious adverse device‐related effects was 8% (95% CI 1–20) at 12 months. ConclusionsInteratrial shunt device implantation in CHF is feasible and associates with improved submaximal exercise capacity (measured by 6MWD) and HRQoL, and reductions in PCWP.

Do the Current Guidelines for Heart Failure Diagnosis and Treatment Fit with Clinical Complexity?

“…In acute HF patients, right ventricular preload haemodynamic parameters impact renal venous pressure and kidney function [60,63]. Recently, life quality and exercise tolerance improvement have been associated with PCWP reduction after interatrial shunt device implantation (IASD), in patients with HF and LVEF ≥40% [64]. Those patients showed a reduction in mortality after IASD implantation [65].…”

Atrial Flow Regulator for Postcapillary Pulmonary Hypertension

“…A meta-analysis of 6 studies on a total of 226 patients explored the feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure (3 different devices). 10 The authors concluded that the implantation of these devices in patients with chronic HF is feasible and is associated with improved submaximal exercise capacity, improved health-related quality of life, and reduction in PAWP. 10 …”

“… 10 The authors concluded that the implantation of these devices in patients with chronic HF is feasible and is associated with improved submaximal exercise capacity, improved health-related quality of life, and reduction in PAWP. 10 …”

November 2021 at a glance: focus on prevention, comorbidities, cardiogenic shock and novel devices

“…A meta‐analysis including six studies and 226 patients who received an interatrial shunt device showed an increase in 6‐min walking distance by 28.1 m, an improvement in quality of life and a decrease in pulmonary capillary wedge pressure 29 …”