Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction

David M Kaye, Mark C Petrie, Scott McKenzie, Gerd Hasenfuβ, Filip Malek, Martijn Post, Robert N Doughty, Jean-Noël Trochu, Finn Gustafsson, Irene Lang, Adam Kolodziej, Ralf Westenfeld, Martin Penicka, Mark Rosenberg, Jörg Hausleiter, Philip Raake, Guillaume Jondeau, Martin W Bergmann, Tim Spelman, Huseyin Aytug, Piotr Ponikowski, Chris Hayward, REDUCE LAP-HF study investigators, David M Kaye, Mark C Petrie, Scott McKenzie, Gerd Hasenfuβ, Filip Malek, Martijn Post, Robert N Doughty, Jean-Noël Trochu, Finn Gustafsson, Irene Lang, Adam Kolodziej, Ralf Westenfeld, Martin Penicka, Mark Rosenberg, Jörg Hausleiter, Philip Raake, Guillaume Jondeau, Martin W Bergmann, Tim Spelman, Huseyin Aytug, Piotr Ponikowski, Chris Hayward, REDUCE LAP-HF study investigators

Abstract

Aims: Impaired left ventricular diastolic function leading to elevated left atrial pressures, particularly during exertion, is a key driver of symptoms and outcomes in heart failure with preserved ejection fraction (HFpEF). Insertion of an interatrial shunt device (IASD) to reduce left atrial pressure in HFpEF has been shown to be associated with short-term haemodynamic and symptomatic benefit. We aimed to investigate the potential effects of IASD placement on HFpEF survival and heart failure hospitalization (HFH).

Methods and results: Heart failure with preserved ejection fraction patients participating in the Reduce Elevated Left Atrial Pressure in Patients with Heart Failure study (Corvia Medical) of an IASD were followed for a median duration of 739 days. The theoretical impact of IASD implantation on HFpEF mortality was investigated by comparing the observed survival of the study cohort with the survival predicted from baseline data using the Meta-analysis Global Group in Chronic Heart Failure heart failure risk survival score. Baseline and post-IASD implant parameters associated with HFH were also investigated. Based upon the individual baseline demographic and cardiovascular profile of the study cohort, the Meta-analysis Global Group in Chronic Heart Failure score-predicted mortality was 10.2/100 pt years. The observed mortality rate of the IASD-treated cohort was 3.4/100 pt years, representing a 33% lower rate (P = 0.02). By Kaplan-Meier analysis, the observed survival in IASD patients was greater than predicted (P = 0.014). Baseline parameters were not predictive of future HFH events; however, poorer exercise tolerance and a higher workload-corrected exercise pulmonary capillary wedge pressure at the 6 months post-IASD study were associated with HFH.

Conclusions: The current study suggests IASD implantation may be associated with a reduction in mortality in HFpEF. Large-scale ongoing randomized studies are required to confirm the potential benefit of this therapy.

Keywords: HFpEF; Heart failure; Interatrial shunt; Medical device; Survival.

© 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Kaplan–Meier survival curves representing the observed and predicted outcome for the heart failure with preserved ejection fraction cohort.
Figure 2
Figure 2
Bar graphs represent baseline (pre‐interatrial shunt device) peak exercise haemodynamic parameters in relation to subsequent heart failure hospitalization (HFH) events. PA, pulmonary artery; PCWP, pulmonary capillary wedge pressure.
Figure 3
Figure 3
Bar graphs represent peak exercise haemodynamic parameters 6 months after interatrial shunt device (n = 60) implantation in relation to subsequent heart failure hospitalization (HFH) events. PA, pulmonary artery; PCWP, pulmonary capillary wedge pressure.
Figure 4
Figure 4
Bar graph represents the New York Heart Association (NYHA) class distribution of heart failure with preserved ejection fraction patients prior to and after interatrial shunt device implantation. ***P < 0.001 vs. baseline and +P < 0.05 vs. 12 months.

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