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©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
Efficacy and safety of interatrial shunt treatment for heart failure: A systematic review and meta-analysis
Allahdad Khan, Shree Rath, Noor Fatima, Umair Hayat, Prachi Dawer, Hamza Khan, Waseef Ullah, Zahir Ud Din, Alina Sehar, Ibrahim Nagmeldin Hassan
Allahdad Khan, Department of Medicine, Nishtar Medical University, Multan 60650, Punjab, Pakistan
Shree Rath, Division of Medicine, Department of Medicine, All India Institute of Medical Sciences Bhubaneswar, Bhubaneswar 751012, India
Noor Fatima, Department of Medicine, Gomal Medical College, Dera Ismail Khan 29111, Pakistan
Umair Hayat, Hamza Khan, Waseef Ullah, Zahir Ud Din, Department of Medicine, Lady Reading Hospital, Peshawar 25000, Pakistan
Prachi Dawer, Department of Medicine, University College of Medical Sciences, New Delhi 110095, India
Alina Sehar, Department of Medicine, University of Alabama, Huntsville, AL 35899, United States
Ibrahim Nagmeldin Hassan, Department of Medicine, University of Khartoum, Faculty of Medicine, Khartoum 11111, Sudan
Author contributions: Khan A performed visualization and validation; Khan A and Rath S carried out the supervision, performed the formal analysis of data; Khan A, Rath S, Fatima N and Hayat U performed conceptualization, data curation, and project administration; Fatima N and Hayat U performed formal analysis, methodology, and software; Khan A, Rath S, Fatima N, Dawer P, Khan H, and Hassan IN wrote the original draft; Ullah W, Ud Din Z, Sehar A, and Hassan IN carried out writing, reviewing, and editing; all of the authors read and approved the final version of the manuscript to be published.
Conflict-of-interest statement: The authors declare no conflicts of interest related to this manuscript.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Ibrahim Nagmeldin Hassan, MBBS, Department of Medicine, Univer
sity of Khartoum, Faculty of Medicine, ElQasr Avenue, Khartoum 11111, Sudan.
ibrahimnagmmrcp@gmail.com
Received: July 15, 2025
Revised: July 31, 2025
Accepted: September 10, 2025
Published online: October 26, 2025
Processing time: 101 Days and 11.9 Hours
BACKGROUND
Heart failure (HF), especially in patients with preserved ejection fraction and mid-range ejection fraction, remains a significant global health burden. Interatrial shunt devices (IASDs), which allow blood flow from the left to the right atrium, offer a novel treatment approach by reducing left atrial pressure and alleviating symptoms.
AIM
To evaluate the efficacy and safety of IASDs in patients with HF through a systematic review and meta-analysis.
METHODS
We performed a systematic review and meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, analyzing studies up to April 2025. Randomized controlled trials and observational studies comparing interatrial shunt therapy with control groups were included. Data on clinical outcomes were analyzed using Review Manager software.
RESULTS
Nine studies involving 1689 patients were included. IASDs significantly improved cardiac output [mean difference (MD): 0.72, 95%CI: 0.13-1.32, P = 0.02], right atrial pressure (RAP) (MD: 0.70, 95%CI: 0.14-1.26, P = 0.01), and 6-minute walk distance (MD: 71.63, 95%CI: 24.13-119.13, P = 0.003). There were no significant differences in major adverse cardiac events, myocardial infarction, ischemic stroke, or new-onset atrial fibrillation. However, all-cause mortality [risk ratio (RR): 1.49, 95%CI: 1.02-2.18, P = 0.04] and cardiovascular death (RR: 1.66, 95%CI: 1.01-2.74, P = 0.05) were significantly higher in the shunt group.
CONCLUSION
IASDs offer significant short-term improvements in cardiac output, RAP, and exercise capacity in HF patients. However, long-term safety concerns, particularly regarding mortality, necessitate further research and careful patient selection.
Core Tip: Interatrial shunt devices represent a novel, device-based approach for managing heart failure, particularly in patients with preserved and mid-range ejection fraction. This systematic review and meta-analysis evaluated their efficacy and safety across multiple clinical outcomes. While short-term benefits were observed in exercise capacity, cardiac output, and right atrial pressure, increased all-cause and cardiovascular mortality raise concerns about long-term safety. These findings highlight the need for cautious patient selection and further high-quality randomized trials.
