Heart failure & cardiomyopathies
Obesity, frail obesity, and outcomes after durable left ventricular assist device implantation: a pooled analysis of the MOMENTUM 3 trials
Authors' conclusion
In the HM3 era, obese and non-obese recipients had similar unadjusted 2-year outcomes; however, after adjustment for baseline case-mix, obesity was independently associated with a higher risk of both the primary endpoint and all-cause mortality, together with heart failure hospitalization, infection, and arrhythmia. Frailty was independently associated with adverse outcomes across nearly all endpoints and was highly prevalent among obese recipients; the combination of obesity and frailty was additive but not synergistic, with frail-obese patients carrying the highest absolute risk. Frailty, however, proved substantially reversible after LVAD support, and its improvement was associated with markedly better survival. Obesity and frailty should therefore be assessed together, rather than through BMI thresholds alone, with recognition that frailty status is dynamic after implantation and that improvement in frailty is associated with markedly better survival.
Study context
- Population
- HeartMate 3 (HM3) recipientsHM3 recipients pooled from the MOMENTUM 3 pivotal randomized trial and Continued Access Protocol · MOMENTUM 3 pivotal randomized trial 515 · Continued Access Protocol 1,685
- Participants
- 2,200 participants
- Comparison
- Obese vs non-obese patients, and the additive influence of co-existing frailty (‘frail obesity’)
- Obesen = 887
- Frail-obesen = 571
- Outcome
- Survival to transplant, recovery, or 24 months of support free of disabling stroke (modified Rankin score >3) or pump replacement reoperation (freedom from the primary endpoint)
- Follow-up
- 2-year
Methodological detailspivotal randomized trial and Continued Access Protocol, covariate adjustment
- Pivotal randomized trial and Continued Access Protocol
- Covariate adjustment
Pooled result
As reported in the abstract
HR for the primary endpoint
1.30
95% CI 1.07–1.58
By group
Further pooled results
| Outcome | Estimate | |
|---|---|---|
| Survival / all-cause mortality · 2-yearAfter covariate adjustment | HR for all-cause mortality 1.35 (95% CI 1.10–1.67) | |
| Primary endpoint, by frailtyFrailvs Non-obeseAdjusted; comparator not named in the abstract | HR for the primary endpoint 1.51 (95% CI 1.09–2.10) | |
| 0.512Ratio (log scale) |
Survival, by improvement in frailty
| Adjusted HR (95% CI) | ||
|---|---|---|
| Improvement in frailty | 0.14 (0.07–0.26) | |
| 0.050.21520Adjusted hazard ratio (log scale) |
| Outcome | Obese | Non-obese | P value |
|---|---|---|---|
| Survival / all-cause mortality · 2-yearUnadjusted survival | 79.9% | 81.2% | P = 0.57 |
- Survival / all-cause mortality: Obesity-by-frailty interaction not significant for mortality (P = .215)
- Survival, by improvement in frailty: associated with better survival; comparator not named in the abstract
Baseline characteristics of obese patients
- Obese patients
- n = 887, 40.3%
- Younger, less often with ischaemic aetiology, more frequently women, but more often with diabetes and hypertension, than non-obese patients
Heart failure hospitalization, infection and arrhythmia
- Obesity independently associated with a higher risk after covariate adjustment
Stroke, bleeding and early right heart failure
- Obesity not independently associated after covariate adjustment
Frailty among obese recipients
- Frailty among obese recipients
- 67.3% (571/849)
Overall mortality and non-haemocompatibilty-related morbidity endpoints, by frailty
- Frailty associated with a higher adjusted risk
Absolute risk in frail-obese patients
- Frail-obese patients carried the highest absolute risk of any subgroup
- Additive rather than synergistic risk
Frailty improved by at least one severity class, among frail-obese patients · 6 months
- Frail-obese patients with frailty improved by at least one severity class
- 75.9%
Original publication
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