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. 2025 Aug 27;9(10):100482.
doi: 10.1016/j.shj.2025.100482. eCollection 2025 Oct.

Outcomes of Iatrogenic Atrial Septal Defect Closure After Transseptal Transcatheter Mitral Valve Replacement in the Mitral Implantation of Transcatheter Valves (MITRAL) Trial

Atefeh Ghorbanzadeh  1 , Conor Lane  1 , Abdullah Al-Abcha  1 , Alan Ortega-Macias  2 , Mackram Eleid  1 , Dee Dee Wang  3 , Isaac George  4 , Susheel Kodali  5 , Carl L Tommaso  6 , Philip Krause  6 , Ronald Berger  6 , Igor Palacios  7 , Raj Makkar  8 , Lowell Satler  9 , Tatiana Kaptzan  2 , Brad Lewis  2   10 , Jeremy Thaden  1 , Jae Oh  1 , Rebecca T Hahn  5 , Chet Rihal  1 , Mayra Guerrero  1
Affiliations

Outcomes of Iatrogenic Atrial Septal Defect Closure After Transseptal Transcatheter Mitral Valve Replacement in the Mitral Implantation of Transcatheter Valves (MITRAL) Trial

Atefeh Ghorbanzadeh et al. Struct Heart. .

Abstract

Background: The long-term hemodynamic consequences of iatrogenic atrial septum defect (iASD) after transseptal (TS) transcatheter mitral valve replacement (TMVR) are unknown. The objective of this study was to compare the clinical outcomes of patients who underwent iASD closure after TS TMVR in the MITRAL (Mitral Implantation of TRAnscatheter vaLves) trial.

Methods: The MITRAL trial enrolled high-surgical-risk patients with severe mitral annular calcification treated with valve-in-mitral annular calcification (ViMAC), failed surgical repair with annuloplasty ring treated with mitral valve-in-ring (MViR), or failed surgical mitral bioprosthesis treated with mitral valve-in-valve (MViV).

Results: Ninety-one patients were prospectively enrolled between February 2015 and December 2017, at 13 US sites (MViV ​= ​30, MViR ​= ​30, ViMAC ​= ​31). Seventy-five of them were treated with TS access (MViV ​= ​30, MViR ​= ​30, and ViMAC ​= ​15), of which 16 patients underwent iASD closure during or after the index procedure (MViV ​= ​3, MViR ​= ​7, ViMAC ​= ​6). Closure of the iASDs was left to the operator's discretion, and the reason in most patients was the presence of large left-to-right shunt. Patients who underwent closure of iASD were a sicker population at baseline with more severe symptoms (87.5% with New York Heart Association functional class III-IV, compared to 81.4% in non-iASD closure group, p ​= ​0.02), higher rate of recent heart failure hospitalization (68.8% vs. 30.5%; p ​= ​0.01) and lower 6-minute walk test distance (110 m vs. 214 m; p ​= ​0.002). These patients also had longer length of stay after TMVR compared with patients who did not undergo iASD closure (8 vs. 4 days, p < ​0.001). Despite these differences at baseline and requiring longer hospital stays, there was no significant difference in mortality, New York Heart Association class, 6-minute walk test distance, or heart failure hospitalization at 5 years.

Conclusions: Patients who underwent iASD closure were more symptomatic at baseline, had decreased functional exercise capacity and required longer length of stay after TMVR. Despite these differences at baseline, 5-year outcomes were similar between groups.

Keywords: Iatrogenic atrial septal defect; Transcatheter mitral valve replacement; Transseptal access.

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Conflict of interest statement

M. Guerrero has received institutional research grant support from Edwards Lifesciences. D. D. Wang is a consultant for Abbott, Boston Scientific, Edwards Lifesciences, Materialise, and NeoChord. She also receives research grant support from Boston Scientific assigned to her employer, Henry Ford Hospital. I. George has received consulting honoraria from Zimmer Biomet, AtriCure, Neptune Medical, AbbVie, Johnson & Johnson, and Boston Scientific; has served on advisory boards for Edwards Surgical, Medtronic Surgical, Trisol Medical, AbbVie, Johnson & Johnson, Foldax Medical, Zimmer Biomet, AbbVie, and Boston Scientific; holds equity in Valcare Medical, Durvena, CardioMech, VDyne, MitreMedical, and MITRx; and has received institutional funding to Columbia University from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. S. Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve; has received consulting fees from Admedus, TriCares, TriFlo, X-Dot, Micro Interventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and Moray Medical; and is a scientific advisory board member for Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, and Boston Scientific. R. Makkar has received grant support from and has research contracts with Edwards Lifesciences and St Jude Medical and has received consulting fees and honoraria from and is a speakers bureau member for Abbott Vascular, Cordis Corporation, and Medtronic. R. T. Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and is chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. C. Rihal has received institutional research grant support from Edwards Lifesciences. The other authors had no conflicts to declare.

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