Underweight and obesity as outcome predictors after transcatheter aortic valve implantation: insights from the DOUBLE-CHOICE trial

Q: What are the key findings of this study?

Obesity (BMI ≥30 kg/m²) was independently associated with lower 30-day composite complication rates after TAVI, whereas underweight increased risk.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Symptomatic severe aortic stenosis undergoing transfemoral TAVI (n=752). Intervention: Obesity (BMI ≥ 30 kg/m²) and underweight (BMI < 20 kg/m²) vs. Non-obese (BMI < 30 kg/m²) and non-underweight (BMI ≥ 20 kg/m²). Primary outcome: 30-day composite of all-cause mortality, vascular complications (VARC-3 major/minor), bleeding complications (VARC-3 type 1-4), infections requiring antibiotic therapy, and neurologic events (NeuroARC type 1-3) (OR 0.48, 95% CI 0.30-0.75, p=0.002).

Q: What does this research mean for the field?

In patients undergoing transcatheter aortic valve implantation, obesity is independently associated with lower 30-day adverse event risk, whereas underweight strongly predicts increased 30-day procedural complications. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To determine whether obesity and underweight independently predict 30-day clinical outcomes following transcatheter aortic valve implantation.

Maria Buske; Mohamed Abdel‐Wahab; Joerg Ender; Steffen Desch; Niklas Lankisch; Helene Schrader; Sebastian von der Emde; Philipp Lauten; Tanja K. Rudolph; Tobias Geisler; Steffen Maßberg; Matti Adam; Stephan Ernst Baldus; Samuel Sossalla; Michael Joner; Helge Möllmann; Alexander Wolf; Won-Keun Kim; Michael Andrew Borger; Thilo Noack; Andreas Boening; Sabine Bleiziffer; Sven Hohenstein; Holger Thiele; Holger Thiele

doi:10.1007/s00392-026-03042-x

Key result

Obesity linked to ~52% lower odds of 30-day complications after TAVI, whereas underweight increases risk.

OR 0.48
95% CI 0.30-0.75
P=0.002
n=752

Why the study?

After TAVI, higher BMI has been linked to lower mortality while underweight predicts adverse outcomes, but whether these associations reflect a true biological effect or residual confounding, frailty, and patient selection remains uncertain.

Does baseline obesity (BMI ≥30 kg/m²) or underweight (BMI <20 kg/m²) predict the 30-day composite outcome of mortality, vascular/bleeding complications, infections, and neurologic events in patients undergoing transfemoral TAVI?

Key Points

To determine whether obesity and underweight independently predict 30-day clinical outcomes following transcatheter aortic valve implantation.
Prespecified subgroup analysis of the multicenter, randomized, open-label 2×2 factorial DOUBLE-CHOICE trial across 10 German sites in 752 patients undergoing transfemoral TAVI.
Categorized patients by body mass index into obese (BMI ≥ 30 kg/m², n = 192), non-obese (BMI < 30 kg/m², n = 560), and underweight (BMI < 20 kg/m², n = 23).
Assessed a primary composite endpoint at 30 days of all-cause mortality, vascular complications, bleeding, infections requiring antibiotics, and neurologic events using multivariable logistic regression adjusted for age, sex, frailty, and comorbidities.
Obese patients experienced lower rates of the 30-day primary endpoint than non-obese patients (15.2% vs. 27.6%; p < 0.001; adjusted OR 0.48, 95% CI 0.30–0.75; p = 0.002).
Underweight patients experienced a significantly higher rate of the primary composite endpoint compared with non-underweight patients (55.0% vs. 23.4%; p = 0.003; adjusted OR 3.74, 95% CI 1.30–9.52; p = 0.005).
Comparing obese to non-obese patients, rates were lower for infections requiring antibiotics (5.7% vs. 12.5%; p = 0.01), neurologic events (4.0% vs. 9.1%; p = 0.03), and vascular complications (4.6% vs. 10.4%; p = 0.02), while all-cause mortality did not differ significantly (1.0% vs. 2.7%; p = 0.26).

Study Design

Type

Cohort (n=752)

Blinding

Open-label

Randomization

1:1:1:1 factorial randomization in parent trial (non-randomized BMI exposure groups)

Multicenter

Yes

Structured PICO

Does baseline obesity (BMI ≥30 kg/m²) or underweight (BMI <20 kg/m²) predict the 30-day composite outcome of mortality, vascular/bleeding complications, infections, and neurologic events in patients undergoing transfemoral TAVI?

P

Population

752 older adults with symptomatic severe aortic stenosis undergoing transfemoral TAVI across 10 German centers in the DOUBLE-CHOICE trial, followed for 30 days.

E

Exposure

Transfemoral TAVI Evaluated across baseline BMI categories: obesity (BMI ≥30 kg/m²) and underweight (BMI <20 kg/m²). Background trial randomized patients in a 2x2 factorial design to minimalist approach (local anesthesia without sedation, avoidance of urinary catheterization, central venous lines, and additional arterial lines) vs standard of care anesthesia (local anesthesia with conscious sedation titrated to RASS 0 to -2) and ACURATE neo2 vs Evolut Pro/Pro+/FX valves.

C

Comparator

Reference BMI categories undergoing transfemoral TAVI: non-obese patients (BMI <30 kg/m², n=560) and non-underweight patients (BMI ≥20 kg/m², n=729).

O

Outcome

30-day composite of all-cause mortality, vascular complications (major/minor per VARC-3 criteria), bleeding complications (VARC-3 type 1–4), infections requiring antibiotic therapy, and neurologic events (NeuroARC type 1–3), adjudicated by an independent Clinical Event Committee.composite

Main Result

Odds Ratio: 0.48 (95% CI 0.3–0.75)

Absolute Event Rate: 15.2% vs 27.6%

p-value: p=0.002

In this prespecified subgroup analysis of the randomized DOUBLE-CHOICE TAVI trial, obesity (BMI ≥30 kg/m²) was independently associated with lower 30-day composite adverse events, whereas underweight (BMI <20 kg/m²) identified a high-risk phenotype with a more than threefold increased odds of 30-day complications driven by major vascular and bleeding events.

Limitations

Subgroup analysis of a randomized trial not powered to detect BMI-related differences, raising the possibility of type I error
Small underweight group (n=23), resulting in limited precision of estimates
Use of a pragmatic BMI <20 kg/m² threshold that deviates from the WHO definition (<18.5 kg/m²)
BMI does not capture body composition, nutritional status, or inflammatory burden, leaving likely residual confounding
Exclusion of patients unsuitable for minimalist anesthesia or either valve strategy may limit generalizability and accentuate selection bias
Substantial missing data on femoral artery dimensions and sheath-to-femoral artery ratio (SFAR)
Follow-up limited to 30-day outcomes without long-term risk assessment
Selection mechanisms and residual confounding may explain the inverse association between obesity and adverse outcomes rather than a true biological protective effect.
Patients deemed unsuitable for a minimalist approach without sedation were excluded, limiting the inclusion of the most vulnerable individuals.
Detailed measures of body composition (such as muscle mass and metabolic reserve) were not captured in the trial.
Small sample size in the underweight subgroup (n=23).
Proposed access-related mechanisms for increased risk in underweight patients (such as reduced perivascular soft tissue) could not be directly confirmed in the dataset.

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Implication

Obesity-associated lower TAVI complications should not change practice; extends obesity paradox observations while confirming underweight risk.

Abstract

Background An “obesity paradox” has been described after transcatheter aortic valve implantation (TAVI), suggesting lower mortality in patients with higher body mass index (BMI) despite greater comorbidity. In contrast, underweight consistently predicts adverse outcomes. Whether these associations reflect a true biological effect or are primarily driven by residual confounding, frailty, and patient selection remains uncertain. Methods This prespecified subgroup analysis included eligible patients from the randomized DOUBLE-CHOICE trial comparing two transcatheter heart valves and two anesthesia strategies (minimalist approach with local anesthesia only vs. standard care with conscious sedation). The primary endpoint was a 30-day composite of all-cause mortality, vascular and bleeding complications, infections requiring antibiotic therapy, and neurologic events. Associations were evaluated using multivariable logistic regression adjusted for age, sex, frailty, diabetes, hypertension, chronic kidney disease, and anesthesia strategy. Results Among 752 patients (BMI ≥ 30 kg/m 2 , n = 192; BMI < 30 kg/m 2 , n = 560), obese patients had lower rates of the 30-day primary endpoint (15.2% vs. 27.6%; p < 0.001). After multivariable adjustment, obesity remained independently associated with lower risk (adjusted OR 0.48, 95% CI 0.30–0.75; p = 0.002). In contrast, underweight (BMI < 20 kg/m 2 ; n = 23) was associated with a higher incidence of the primary endpoint (55.0% vs. 23.4%; p = 0.003) and remained an independent predictor after adjustment (adjusted OR 3.74, 95% CI 1.30–9.52; p = 0.005). Conclusion In this randomized TAVI population, obesity was independently associated with favorable 30-day outcomes, whereas underweight identified a small but high-risk subgroup with substantially increased procedural risk. These findings identify underweight as a potential high-risk phenotype requiring further investigation in future studies incorporating more detailed measures of frailty and body composition.

Discussion

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Cite This Study

Buske et al. (2026) conducted a cohort in Symptomatic severe aortic stenosis undergoing transfemoral TAVI (n=752). Obesity (BMI ≥ 30 kg/m²) and underweight (BMI < 20 kg/m²) vs. Non-obese (BMI < 30 kg/m²) and non-underweight (BMI ≥ 20 kg/m²) was evaluated on 30-day composite of all-cause mortality, vascular complications (VARC-3 major/minor), bleeding complications (VARC-3 type 1-4), infections requiring antibiotic therapy, and neurologic events (NeuroARC type 1-3) (OR 0.48, 95% CI 0.30-0.75, p=0.002). Obesity (BMI ≥30 kg/m²) was independently associated with lower 30-day composite complication rates after TAVI, whereas underweight increased risk.

synapsesocial.com/papers/6af73ac79badce7b6084daa7 https://doi.org/10.1007/s00392-026-03042-x

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Underweight and obesity as outcome predictors after transcatheter aortic valve implantation: insights from the DOUBLE-CHOICE trial

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Underweight and obesity as outcome predictors after transcatheter aortic valve implantation: insights from the DOUBLE-CHOICE trial

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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