What question did this study set out to answer?

The study aims to compare the long-term clinical outcomes of transcatheter and surgical aortic valve replacement.

January 10, 2026

Ten-Year outcomes of transcatheter versus surgical aortic valve replacement: extended follow-up from the OBSERVANT study

GCGiuliano CostaInterventional Cardiology MBMarco BarbantiUniversità degli Studi di Enna Kore SRStefano RosatoStructural Heart Disease

Key Result

At 10 years, TF-TAVR was associated with a higher risk of all-cause mortality (HR 1.39) and MACCE (HR 1.33) compared to SAVR, but lower risk of repeat aortic intervention (SHR 0.33).

Key Points

The study aims to compare the long-term clinical outcomes of transcatheter and surgical aortic valve replacement.
Conducted propensity score matching between SAVR and TF-TAVR patients
Evaluated all-cause mortality and major adverse cardiac and cerebrovascular events at 10 years
Used administrative databases for objective outcome adjudication
TF-TAVR showed a higher risk of all-cause mortality (HR 1.39) and MACCE (HR 1.33) at 10 years compared to SAVR
No significant differences in rehospitalization for heart failure or cardiac reasons
TAVR had a lower risk of repeat aortic intervention (SHR 0.33) at 10 years

Structured PICO

Does transfemoral TAVR compared to SAVR improve 10-year mortality and MACCE in patients with severe aortic stenosis?

Population

7,618 patients (5,707 SAVR and 1,911 TAVR) with severe aortic stenosis treated in Italian clinical practice between December 2010 and June 2012, analyzed as 650 propensity-matched pairs.

Intervention

Transfemoral transcatheter aortic valve replacement (TF-TAVR) using early generation devices

Comparator

Surgical aortic valve replacement (SAVR)

Outcome

All-cause mortality and major adverse cardiac and cerebrovascular events (MACCE) at 10 yearscomposite

At 10-year follow-up in real-world practice, early-generation TAVR was associated with higher mortality and MACCE but lower repeat aortic intervention compared to SAVR.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Abstract OBJECTIVES To compare long-term clinical outcomes of patients undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the Italian clinical practice and enrolled in the multicentre OBSERVANT (Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment) Study. METHODS Propensity score matching was used to compare patients undergoing SAVR or transfemoral (TF) TAVR with similar baseline characteristics. The primary end-points were all-cause mortality and major adverse cardiac and cerebrovascular events (MACCE) at 10 years. Prespecified secondary end-points included cerebrovascular accidents, repeat aortic intervention, repeat hospitalization due to cardiac reasons and heart failure. All outcomes were adjudicated through a linkage with administrative databases. RESULTS From the entire cohort (n = 5707 SAVR and n = 1911 TAVR treated between December 2010 and June 2012), 650 matched pairs of patients were considered. At 10 years, TF-TAVR was associated with a higher risk of all-cause mortality Hazard ratio (HR) 1.39, 95% confidence interval (CI) 1.22–1.59; p 0.001 and MACCE (HR 1.33, 95% CI 1.18–1.51; p 0.001) compared to SAVR. Secondary end-points did not differ for rehospitalization for heart failure (p = 0.443) or cardiac reasons (p = 0.552), and for cerebrovascular events (p = 0.573), but TAVR had a significantly lower risk of repeat aortic intervention Sub-distributional HR (SHR), 0.33; 95% CI, 0.12–0.91; p = 0.024 at 10 years. CONCLUSIONS At 10 years, early generation TAVR had significantly higher risk of all-cause mortality and MACCE, but lower risk of repeat aortic intervention in clinical practice.

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