Differences between Japan and France in transcatheter aortic valve implantation: insights from the TOTO-TAVI study

Q: What are the key findings of this study?

TAVI in Japan resulted in a comparable in-hospital death rate compared to France (0.6% vs 1.3%; p=0.068) despite smaller patient anatomy and higher operative risk.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) (n=6193). Intervention: TAVI in Japan vs. TAVI in France. Primary outcome: In-hospital death (p=0.068).

Q: What does this research mean for the field?

In-hospital and three-year all-cause mortality following transcatheter aortic valve implantation are comparable between Japanese and French patients despite marked differences in anatomical size and baseline operative risk. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Juri Iwata; Kentaro Hayashida; Ziad Arow; Akiko Masumoto; Hikaru Tsuruta; Takashige Yamada; Hideyuki Shimizu; Masaki Ieda; Chiara de Biase; Nicolas Dumonteil; Didier Tchétché

doi:10.4244/aij-d-26-00018

October 1, 2026AsiaInterventionOpen Access

Differences between Japan and France in transcatheter aortic valve implantation: insights from the TOTO-TAVI study

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Key result

TAVI yields comparable in-hospital mortality in Japan versus France despite higher patient risk.

P=0.068
n=6,193

Why the study?

The number of TAVI procedures is increasing worldwide, but studies comparing regional differences in clinical outcomes remain scarce.

Does transcatheter aortic valve implantation (TAVI) result in different in-hospital and 3-year clinical outcomes between patients in Japan and France despite regional differences in anatomy and baseline risk?

Key Points

To compare clinical outcomes, periprocedural safety, and 3-year mortality following transcatheter aortic valve implantation between patients in Japan and France.
Evaluated the primary endpoint of in-hospital death alongside periprocedural complications, 3-year all-cause mortality, and country-specific multivariable risk factors for composite adverse outcomes.
In-hospital mortality did not differ significantly between Japan and France (0.6% vs 1.3%; p=0.068), while cardiovascular death (0.2% vs 1.0%; p=0.003), major bleeding (1.3% vs 3.2%; p<0.001), and new pacemaker implantation (7.9% vs 15.3%; p<0.001) were lower in Japan.
Three-year all-cause mortality showed no significant difference between the Japanese and French cohorts (22.5% vs 23.5%; HR 0.678, 95% CI: 0.114-4.033; p=0.583).
Multivariable analysis identified no statistically significant independent risk factors for composite in-hospital death, stroke, and bleeding in Japan, whereas female sex (OR 1.310, 95% CI: 1.028-1.669; p=0.029) and bicuspid annulus (OR 1.825, 95% CI: 1.228-2.711; p=0.003) independently increased risk in France.

Study Design

Type

Cohort (n=6,193)

Blinding

Unblinded

Multicenter

Yes

Structured PICO

Does transcatheter aortic valve implantation (TAVI) result in different in-hospital and 3-year clinical outcomes between patients in Japan and France despite regional differences in anatomy and baseline risk?

P

Population

6,193 older adults (mean age ~84 years, 49.4% female) with severe aortic stenosis undergoing native valve TAVI in Japan (n=1,422) and France (n=4,771), followed for up to 3 years.

E

Exposure

Transcatheter aortic valve implantation (TAVI) performed in Japan (n=1,422) using balloon-expandable (SAPIEN 3, SAPIEN 3 Ultra RESILIA; 79.0%) or self-expanding valves (Evolut R/PRO/PRO+/FX 15.5%, Navitor/Navitor Vision 5.5%), predominantly via transfemoral approach (98.7%) under local anaesthesia (97.8%).

C

Comparator

Transcatheter aortic valve implantation (TAVI) performed in France (n=4,771) using balloon-expandable (SAPIEN 3, SAPIEN 3 Ultra; 33.1%) or self-expanding valves (Evolut R/PRO/PRO+/FX 63.4%, Navitor 3.5%), predominantly via transfemoral approach (97.8%) under local anaesthesia (96.8%).

O

Outcome

In-hospital death, defined according to Valve Academic Research Consortium (VARC)-3 criteria.hard clinical

Main Result

Absolute Event Rate: 0.6% vs 1.3%

p-value: p=0.068

Limitations

Observational, unblinded, and non-randomised registry design susceptible to unmeasured confounding
Significant differences in the types of transcatheter heart valves used between Japan and France
Echocardiographic data were not adjudicated by an independent core laboratory
Inability to perform propensity score matching due to substantial baseline differences between cohorts
Post-TAVI computed tomography data and calcium scores were unavailable
Missing 3-year survival status data required multiple imputation
Inability to perform propensity score matching due to substantial baseline differences between the Japanese and French cohorts resulting in too few matched patients
Unavailable post-TAVI computed tomography data, precluding detailed assessment of calcium scores
Differences in valve types used between the two regions (e.g., SAPIEN 3 Ultra used in France but not Japan), precluding post-TAVI paravalvular leakage assessment by echocardiography
Use of multiple imputation for missing 3-year survival status and date of death data, which carries potential selection bias and low reproducibility
Lack of registry data on technical factors affecting pacemaker implantation, such as membranous septum length, depth of valve placement, and placement angle
Follow-up period limited to 3 years

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Implication

Despite Japanese TAVI patients having significantly smaller body size, smaller aortic anatomy, and higher operative risk scores than French patients, both cohorts achieved comparably low in-hospital mortality and equivalent 3-year survival.

Abstract

Background: The number of transcatheter aortic valve implantation (TAVI) procedures is increasing worldwide. However, studies comparing regional differences remain scarce. Aims: This study aimed to compare clinical outcomes after TAVI between Japan and France using a database compiled from two large hospitals. Methods: The TOTO-TAVI study included patients who underwent TAVI in Japan and France. The primary endpoint was in-hospital death. Periprocedural safety outcomes and 3-year all-cause mortality were also evaluated. A subgroup analysis was performed to assess the independent TAVI risk for each country. Results: Among 6,967 patients who underwent TAVI between 2016 and 2024, 1,422 in Japan and 4,771 in France were included. Although patients in Japan showed a significantly smaller body size, a smaller aortic valve, and a higher operative risk than those in France, the in-hospital death rate was comparable between the two groups (0.6% vs 1.3%; p=0.068). The new pacemaker implantation rate was lower in Japan than in France. There was no significant difference in 3-year all-cause mortality between Japan and France (22.5% vs 23.5%, hazard ratio 0.678, 95% confidence interval: 0.114-4.033; p=0.583). For the subgroup analysis, there were no statistically significant independent risk factors for composite outcomes, including in-hospital death, stroke, and bleeding, in Japan; however, in France, female sex, higher body mass index, lower haemoglobin levels, previous coronary artery bypass grafting and cerebrovascular disease, bicuspid annulus, and general anaesthesia were independent risk factors. Conclusions: Despite differences in patient backgrounds, in-hospital and 3-year mortality were comparable between Japan and France, suggesting that procedural safety and medium-term prognosis after TAVI were established regardless of procedural risks.

Discussion

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Cite This Study

Iwata et al. (2026) conducted a cohort in Severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) (n=6,193). TAVI in Japan vs. TAVI in France was evaluated on In-hospital death (p=0.068). TAVI in Japan resulted in a comparable in-hospital death rate compared to France (0.6% vs 1.3%; p=0.068) despite smaller patient anatomy and higher operative risk.

synapsesocial.com/papers/6adfeb2da8f7ee114eb18212 https://doi.org/10.4244/aij-d-26-00018

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Differences between Japan and France in transcatheter aortic valve implantation: insights from the TOTO-TAVI study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Differences between Japan and France in transcatheter aortic valve implantation: insights from the TOTO-TAVI study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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