Underweight and Obesity as Predictors of 30-Day Outcomes After Transcatheter Aortic Valve Implantation: Insights From the DOUBLE-CHOICE Trial

M. Buske (Leipzig)1, M. Abdel-Wahab (Leipzig)1, J. Ender (Leipzig)2, S. Desch (Leipzig)1, N. Lankisch (Leipzig)1, H. Schrader (Leipzig)3, P. Lauten (Bad Berka)4, T. K. Rudolph (Bad Oeynhausen)5, T. Geisler (Tübingen)6, S. Massberg (München)7, M. Adam (Köln)8, S. Baldus (Köln)9, S. T. Sossalla (Gießen)10, M. Joner (München)11, H. Möllmann (Dortmund)12, A. Wolf (Wuppertal)13, W.-K. Kim (Gießen)10, M. A. Borger (Leipzig)14, T. Noack (Leipzig)14, M. Sander (Gießen)15, A. Böning (Gießen)16, S. Bleiziffer (Bad Oeynhausen)17, S. Hohenstein (Leipzig)18, H. Thiele (Leipzig)1, H.-J. Feistritzer (Leipzig)1
1Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 2Herzzentrum Leipzig / Klinik für Anästhesie Leipzig, Deutschland; 3Herzzentrum Leipzig Kardiologie Leipzig, Deutschland; 4Zentralklinik Bad Berka GmbH Klinik für Kardiologie und Internistische Intensivmedizin Bad Berka, Deutschland; 5Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; 6Universitätsklinikum Tübingen Innere Medizin III, Kardiologie und Kreislauferkrankungen Tübingen, Deutschland; 7LMU Klinikum der Universität München Medizinische Klinik und Poliklinik I München, Deutschland; 8Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 9Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland; 10Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland; 11Deutsches Herzzentrum München Klinik für Herz- und Kreislauferkrankungen München, Deutschland; 12Kath. St. Paulus Gesellschaft Klinik für Innere Medizin I Dortmund, Deutschland; 13Helios Universitätsklinikum Wuppertal - Herzzentrum Medizinische Klinik 3 - Kardiologie Wuppertal, Deutschland; 14Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland; 15Universitätsklinikum Giessen und Marburg GmbH Gießen, Deutschland; 16Universitätsklinikum Gießen und Marburg GmbH Klinik für Herz-, Kinderherz- und Gefäßchirurgie Gießen, Deutschland; 17Herz- und Diabeteszentrum NRW Klinik für Thorax- und Kardiovaskularchirurgie Bad Oeynhausen, Deutschland; 18Herzzentrum Leipzig - Universität Leipzig Leipzig Heart Institute Leipzig, Deutschland

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 higher comorbidity. In contrast, underweight consistently predicts adverse outcomes.

Objectives:
To evaluate the impact of obesity (BMI ≥30 kg/m²) and underweight (BMI <20 kg/m²) on 30-day clinical outcomes after transfemoral TAVI and to reassess the obesity paradox after multivariable adjustment.

Methods:
This prespecified subgroup analysis included all patients of the randomized DOUBLE-CHOICE trial, comparing two transcatheter heart valves and two anaesthesia strategies (minimalist approach including local anaesthesia only without sedation vs. standard-of-care with sedation). The primary endpoint for the comparison of anaesthesia strategies 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 the anaesthesia strategy, to further assess the obesity paradox.

Results:
Among 738 patients (BMI ≥30: 193; <30: 545), obese patients showed lower event rates for the 30-day composite endpoint (15.2% vs 27.6%, p<0.001). After multivariable adjustment, obesity remained independently associated with lower risk of the primary composite endpoint (adjusted OR 0.48, 95% CI 0.30–0.75, p=0.002), whereas age, sex, frailty, diabetes, hypertension, renal function and the anaesthesia strategy were not significant predictors. Paradoxically, frailty was more common among obese patients (61.7% vs 53.2%, p=0.042).

In contrast, underweight (n=23) was strongly associated with excess risk: The primary endpoint occurred in 55.0% vs 23.4% (p=0.003), major vascular complications in 27.8% vs 2.3% (p<0.001), and bleeding in 26.3% vs 6.3% (p<0.001), respectively.  

Conclusion:
In this randomized TAVI population, obesity was independently associated with lower rates of adverse outcomes at 30 days, whereas underweight conferred markedly increased procedural and vascular risk. The apparent “obesity paradox” persisted after multivariable adjustment, suggesting that obesity may reflect greater physiological reserves in this elderly population. Conversely, underweight represents a high-risk phenotype that may benefit from tailored procedural and peri-interventional management.