Clinical impact of initial surgical aortic bioprosthetic valve size on mid-term outcomes of transcatheter valve-in-valve in Japanese patients

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Japanese patients with failed surgical aortic bioprosthetic valves undergoing transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) procedure, mean age 82.4 years, 46.4% female (n=185). Intervention: Transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) procedure vs. Comparison by initial surgical aortic valve size ≤21 mm versus >21 mm. Primary outcome: Overall 4-year survival (p=0.79).

Koichi Maeda; Satoru Domoto; Kei Torikai; Joji Ito; Yasuhiro Ichibori; Tohru Takaseya; Takeshi Onohara; Junji Yunoki; Hiromichi Sonoda; Hidenori Yoshitaka

doi:10.1007/s11748-026-02275-x

February 27, 2026General Thoracic and Cardiovascular SurgeryOpen Access

Clinical impact of initial surgical aortic bioprosthetic valve size on mid-term outcomes of transcatheter valve-in-valve in Japanese patients

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Key result

TAV-in-SAV in small surgical valves shows comparable 4-year survival to larger valves.

P=0.79
n=185

Figures

Why the study?

Clinical outcomes of TAV-in-SAV have been reported to be poor in patients initially implanted with small bioprosthetic valves, motivating evaluation of mid-term outcomes in this population.

Does TAV-in-SAV in patients with small initial surgical aortic valves (≤ 21 mm) result in comparable 4-year survival to those with larger valves (> 21 mm)?

Key Points

To evaluate mid-term outcomes of transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) procedures for small surgical aortic bioprosthetic valves.
Interventional multicenter study analyzing N=185 TAV-in-SAV procedures performed between January 2013 and March 2024 across 10 centers in Japan (NCT06826027).
Compared clinical outcomes between patients with small initial surgical valves (≤ 21 mm SAV, n=116) and larger valves (> 21 mm SAV, n=69), with primary evaluation of 4-year Kaplan–Meier overall survival.
Tracked hemodynamic parameters, procedural characteristics (transfemoral approach in 90.3%, Evolut platform in 81.1%), and clinical follow-up for a mean of 2.6 ± 1.7 years (maximum 7.7 years).
Overall 4-year Kaplan–Meier survival was 69.1% in the small valve group (≤ 21 mm) versus 79.6% in the non-small valve group (> 21 mm) (p = 0.79).
Freedom from cardiovascular mortality at 4 years reached 91.3% in the small valve group compared to 90.1% in the non-small valve group (p = 0.096).
Multivariate Cox analysis identified age as an independent predictor of all-cause mortality (HR 1.09, P = 0.0083), while severe patient-prosthesis mismatch occurred in 25.0% of the small group versus 12.3% of the non-small group (p = 0.052).

Study Design

Type

Observational (n=185)

Multicenter

Yes

Structured PICO

Does TAV-in-SAV in patients with small initial surgical aortic valves (≤ 21 mm) result in comparable 4-year survival to those with larger valves (> 21 mm)?

P

Population

185 Japanese patients with failed surgical bioprosthetic valves undergoing transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) procedures, mean age 82.4 years, 46.4% female.

I

Intervention

Transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) for initial small surgical aortic valves (≤ 21 mm label size).

C

Comparator

Transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) for initial non-small surgical aortic valves (> 21 mm label size).

O

Outcome

Overall 4-year survival estimated using the Kaplan–Meier method.hard clinical

Main Result

Absolute Event Rate: 69.1% vs 79.6%

p-value: p=0.79

TAV-in-SAV yields satisfactory mid-term survival in Japanese patients regardless of initial surgical valve size, suggesting it is a viable option even for those with small (≤ 21 mm) bioprostheses.

Limitations

Retrospective observational design with small cohort limiting statistical power and possibility of type II error
Lack of echocardiographic core laboratory may introduce inter-institution variability in assessments
Absence of CT data limited evaluation of anatomical risk factors
No adjudication of cardiovascular death, stroke, and hospitalization by clinical events committee
Retrospective study with a small cohort, limiting statistical power and significance
Lack of an echocardiographic core laboratory, which may have introduced inter-institution variation in hemodynamic assessments
Exclusion of patients due to anatomical limitations identified through preoperative screening without CT data collection
Lack of clinical events committee adjudication for cardiovascular death, stroke, and hospitalization

Implication

Supports TAV-in-SAV viability in ≤21 mm surgical valves; extends real-world mid-term evidence to Japanese cohorts.

Abstract

Clinical outcomes of transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) procedures have been reported to be poor in patients initially implanted with small bioprosthetic valves. The aim of this study was to evaluate mid-term outcomes of TAV-in-SAV for small SAVs using data from a Japanese multicenter registry. A total of 185 TAV-in-SAV procedures performed between January 2013 and March 2024 at 10 centers in Japan were analyzed. The primary endpoint was overall 4-year Kaplan–Meier survival. Clinical outcomes were also compared between initial ≤ 21 mm SAV (small group) vs. > 21 mm SAV (non-small group). The mean age was 82.4 years; 46.5% were female. One hundred sixteen (62.7%) patients were in the small group (≤ 21 mm SAV in 40 patients; > 21 mm SAV in 76 patients). The Evolut platform was used in 150 patients (81.1%), especially in the small group (103 patients, 88.8%). The 4-year survival in the small group (69.1%) was comparable to that in the non-small group (79.6%) (p = 0.79). Similarly, freedom from cardiovascular mortality at 4 years in the small group (91.3%) was comparable to that in the non-small group (90.1%) (p = 0.096). This multicenter retrospective study shows that TAV-in-SAV in Japanese patients yields satisfactory mid-term outcomes. Despite advanced age, overall and freedom from cardiovascular mortality at 4 years were comparable to previous international reports, with no significant difference by valve size. (ClinicalTrials.gov number, NCT06826027.)

Discussion

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Cite This Study

Maeda et al. (2026) conducted an observational in Japanese patients with failed surgical aortic bioprosthetic valves undergoing transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) procedure, mean age 82.4 years, 46.4% female (n=185). Transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) procedure vs. Comparison by initial surgical aortic valve size ≤21 mm versus >21 mm was evaluated on Overall 4-year survival (p=0.79). TAV-in-SAV in patients with small initial surgical valve sizes (≤21 mm) yielded comparable 4-year survival of 69.1% versus 79.6% in patients with >21 mm valves (p=0.79).

synapsesocial.com/papers/69a3d7baec16d51705d2df34 https://doi.org/10.1007/s11748-026-02275-x

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Clinical impact of initial surgical aortic bioprosthetic valve size on mid-term outcomes of transcatheter valve-in-valve in Japanese patients

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Clinical impact of initial surgical aortic bioprosthetic valve size on mid-term outcomes of transcatheter valve-in-valve in Japanese patients

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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