What is the clinical evidence from this study?

Study design: Cohort. Population: Severe mitral regurgitation or mitral stenosis (n=86). Intervention: Unsuccessful initial TMVR deployment vs. Successful initial TMVR deployment. Primary outcome: Early mortality (within 30 days) (p=0.10).

What question did this study set out to answer?

This study aims to evaluate the outcomes and complications related to rescue procedures in patients with unsuccessful transcatheter mitral valve replacement deployment.

July 27, 2026Journal of Cardiothoracic Surgery0 citationsOpen Access

Outcomes of rescue procedures in patients undergoing unsuccessful deployment of transcatheter mitral valve replacement

CNChikashi NakaiInterventional / Structural Cardiology JLJunyi LiuInterventional / Structural Cardiology MZMEI XING ZUOAlbany Medical Center Hospital

Key Result

Unsuccessful initial deployment of transcatheter mitral valve replacement was associated with a numerically higher but not statistically significant early mortality rate of 29.4% compared to 13.0% for successful deployment.

Key Points

This study aims to evaluate the outcomes and complications related to rescue procedures in patients with unsuccessful transcatheter mitral valve replacement deployment.
Single institution study conducted from March 2016 to December 2024 with 86 high-risk patients
Comparison of outcomes between 17 patients with unsuccessful TMVR and 69 with successful TMVR
Assessment of postoperative complications, early mortality, and survival rates over a median follow-up of 10 months.
70.6% of patients in the unsuccessful group underwent additional valve deployment, achieving 75.0% success with valve-in-valve implantation
Early mortality was 29.4% in the unsuccessful group compared to 13.0% in the successful group, with no significant difference (p = 0.10)
Cumulative survival rate at 12 months was 50.5% for the unsuccessful group and 60.0% for the successful group, with no significant difference in mid-term outcomes (p = 0.34).

Study Design

Type

Cohort (n=86)

Multicenter

Structured PICO

Does unsuccessful initial TMVR deployment compared to successful deployment worsen early mortality and mid-term survival in high-risk surgical patients?

Population

86 high-surgical-risk patients with severe mitral regurgitation or stenosis undergoing balloon-expandable transcatheter mitral valve replacement, followed for a median of 10 months.

Exposure

Unsuccessful first TMVR deployment requiring rescue procedures (e.g., additional valve deployment, surgical explantation, or medical management).

Comparator

Successful first TMVR deployment.

Outcome

Early mortality and mid-term cumulative survival (at 12 months).hard clinical

Unsuccessful initial TMVR deployment requires complex rescue procedures and is associated with numerically higher early mortality and significantly higher cardiac mortality, though limited by small sample size.

Main Result

Absolute Event Rate: 29.4% vs 13%

p-value: p=0.10

Limitations

Retrospective single-center design and modest sample size may limit statistical power and generalizability
Device iterations and procedural experience evolved over the study period
Long-term follow-up was incomplete for some patients
Lack of statistical significance in mortality may reflect the relatively small case number in the unsuccessful group
Lack of measurement and sizing from preoperative computer tomography

Abstract

Perivalvular leak (PVL), valve embolization, and migration of valve in mitral position are critical complications of transcatheter mitral valve replacement (TMVR). To date, rescue strategies, and outcomes following unsuccessful initial TMVR deployment remain poorly documented. Between March 2016 and December 2024, 86 patients with high risk of open-heart surgery underwent TMVR with a balloon expandable valve at a single institution. 19.8% (17/86) of patients experienced unsuccessful first TMVR (unsuccessful group) due to valve embolization, migration, significant PVL, or pericardial effusion, whereas 80.2% (69/86) had successful first TMVR (successful group). We evaluated postoperative outcomes comparing unsuccessful to successful groups. Among 17 patients with unsuccessful first TMVR, 70.6% (12/17) underwent additional valve deployment, with successful valve-in-valve implantation in 75.0% (9/12). 17.6% (3/17) developed valve embolization in left atrium after transcatheter rescue procedures or additional valve deployment failed, subsequently 66.7% (2/3) required emergent surgical explantation of embolized valves, 33.3% (1/3) was managed medically due to prohibitive surgical risk. Surgical patients were discharged home without complications. Early mortality in unsuccessful group was 29.4% (5/17) and 13.0% (9/69) in successful group. There was no significant difference in early mortality between the 2 groups ( p = 0.10). Median follow-up term was 10 months. Cumulative survival rate in 12 months was 50.5% in unsuccessful group, and 60.0% in successful group. Mid-term outcomes were similar between the 2 groups ( p = 0.34). The study was underpowered to detect differences in all-cause mortality, but unsuccessful deployment was associated with substantially higher numerical early mortality and significantly higher cardiac mortality.

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