2Department of Interventional Cardiology, Lankenau Heart Institute, Main Line Health Wynnewood, Pennsylvania, USA
3Department of Cardiothoracic Surgery, Lankenau Heart Institute, Main Line Health Wynnewood, Pennsylvania, USA
Abstract
Background: The association of body mass index (BMI) and an “obesity paradox” with cardiovascular risk prediction is controversial. This study aimed to evaluate the impact of elevated BMI on the outcome of transcatheter aortic valve replacement (TAVR) for aortic stenosis.
Methods: This retrospective study included 1019 patients with a BMI of ≥18.5 kg/m2 divided into 3 groups: 1) normal BMI (18.5-24.9 kg/m2), 2) overweight (25-29.9 kg/m2), and 3) obese (≥30 kg/m2). Propensity score matching was used to compare normal BMI with overweight and normal BMI with obese.
Results: The median age of the cohort was 82 years, and 348 patients had a normal BMI, while 319 and 352 patients were overweight and obese, respectively. After 1 : 1 propensity score matching, 258 and 192 pairs between normal BMI and overweight, and normal BMI and obese patients, respectively, were analyzed. Both overweight and obese patients had higher post-transaortic mean gradients and lower indexed effective orifice areas compared to normal BMI patients. During a median follow-up of 25 (range: 0.1-72) months, all-cause mortality was similar between overweight or obese patients and patients with a normal BMI. However, in a subgroup analysis of patients with moderate/severe chronic lung disease, all-cause mortality was significantly higher in obese patients compared with normal BMI patients (hazard ratio = 3.49, 95% confidence interval, 1.21-10.0, P = .021).
Conclusions: In this study, the “obesity paradox” was not observed in patients undergo-ing TAVR; rather, in patients with significant lung disease, obesity may be associated with worse mid-term outcomes after TAVR.
Highlights
- Approximately one-third of patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis were overweight and another one-third were obese.
- Overweight and obese patients had different baseline characteristics, including younger age and lower surgical risk, compared with patients with normal body mass index (BMI).
- After adjustment, mid-term outcomes after TAVR were similar except for higher mortality in obese patients with moderate/severe chronic lung disease compared to normal BMI patients with the same condition.
Introduction
Overweight and obesity, often defined by body mass index (BMI), are known cardiovascular risk factors and are associated with several systemic metabolic disorders such as dyslipidemia and diabetes, as well as decreased life expectancy in the general population.1 However, being overweight or obese may be associated with improved survival and clinical outcomes in certain clinical settings, which is known as the “obesity paradox.”2,
Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for symptomatic severe aortic stenosis with comparable or superior outcomes to surgical aortic valve replacement in patients at any surgical risk.11,
Methods
Patients and Methods
This retrospective observational study included 1045 consecutive TAVR with newer generation transcatheter heart valves for severe native aortic stenosis performed between January 2018 and December 2022 at our institution. To evaluate the effect of elevated BMI compared to normal BMI, 26 patients with a BMI of <18.5 were excluded, resulting in a total of 1019 patients analyzed. These patients were divided into 3 BMI groups according to the World Health Organization (WHO) classification: 1) normal BMI (18.5-24.9 kg/m2), 2) overweight (25-29.9 kg/m2), and 3) obese (≥ 30 kg/m2).
Primary outcome was all-cause mortality, and other outcomes of interest included periprocedural outcomes and the composite of all-cause mortality, stroke, and rehospitalization for heart failure. Definitions, terminology, and reported outcomes were consistent with the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies (STS/ACC TVT) Registry and the VARC-3 (Valve Academic Research Consortium 3) criteria.15 Only the Sapien (Edwards Lifesciences, Irvine, CA, USA) and Evolut (Medtronic Inc., Minneapolis, MN, USA) valves were used during the study period, and the Sapien 3/3 Ultra and Evolut Pro/Pro+/FX were considered newer generation valves. The decision for TAVR was made by a dedicated cardiac team based primarily on age and surgical risk according to the STS Predicted Risk of Mortality (STS-PROM). In addition, patient anatomy and specific factors such as frailty were considered in the decision-making process. Artificial intelligence–assisted technologies, such as large language models, chatbots, or image creators, were not used in the production of submitted work in this study.
Statistical Analysis
Since all continuous values analyzed in this study were not normally distributed, as determined by the Shapiro–Wilk test, they are presented as median (interquartile range). In addition to the crude analysis across 3 groups, a propensity score matching procedure was used to control for confounding in the comparison between normal BMI and overweight patients and between normal BMI and obese patients. For continuous variables, the Kruskal–Wallis test was used to compare 3 groups for crude analysis, and the Mann–Whitney
Nearest neighbor matching was performed based on the calculated propensity scores. Specifically, a 1 : 1 matching ratio with a margin of 0.1 SDs of the logit of the propensity score was used without replacement. Propensity scores were calculated using the 24 variables listed in
Results
Prior to Propensity Score Matching
Baseline and procedural characteristics, as well as periprocedural outcomes across the 3 groups before propensity score matching, are shown in Baseline and Procedural Characteristics and Procedural Outcomes Before Propensity Score Matching Median (interquartile range), or n (%). * † ‡30-day data or in-hospital data if 30-day data is not available. BMI, body mass index; NA, not applicable; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality.
Normal BMI
Overweight
Obese
Age, years
85 (79-89)
82 (78-87)*
79 (73-83)*†
<.001
Female
171 (49)
136 (43)
179 (51)
.083
Height, m
1.68 (1.60-1.75)
1.68 (1.60-1.78)
1.68 (1.60-1.78)
.825
Weight, kg
62 (56-71)
77 (68-85)*
98 (86-109)*†
<.001
New York Heart Association III/IV
169 (49)
161 (50)
193 (55)
.236
STS-PROM
4.0 (2.8-6.5)
3.3 (2.1-5.6)*
3.3 (2.1-4.5)*
<.001
Hypertension
316 (91)
290 (91)
324 (92)
.814
Dyslipidemia
313 (90)
287 (90)
312 (89)
.808
Diabetes
80 (23)
103 (32)*
164 (47)*†
<.001
Chronic lung disease
29 (8.3)
69 (10)
18 (13)
.107
Liver disease
10 (2.9)
12 (3.8)
15 (4.3)
.611
Creatinine, mg/dL
1.1 (0.8-1.5)
1.1 (0.9-1.4)
1.1 (0.9-1.6)
.259
Creatinine
89 (26)
61 (19)
105 (30)†
.006
Dialysis
13 (3.7)
14 (4.4)
14 (4.0)
.911
Cerebrovascular accident
39 (11)
43 (13)
14 (13)
.670
Peripheral artery disease
78 (22)
83 (26)
69 (20)
.139
Coronary artery disease
159 (46)
168 (53)
160 (45)
.107
Atrial fibrillation
140 (40)
116 (36)
127 (36)
.454
Prior pacemaker/defibrillator
46 (13)
45 (14)
49 (14)
.939
Hemoglobin, g/dL
11.9 (10.4-13.1)
12.5 (11.1-13.6)*
12.7 (11.1-14.8)*
<.001
Anemia
235 (68)
185 (58)*
184 (52)*
<.001
Albumin, g/dL
3.7 (3.4-4.0)
3.8 (3.5-4.0)
3.8 (3.5-3.9)
.448
Albumin < 3.5 g/dL
92 (26)
79 (25)
72 (20)
.160
Left ventricular ejection fraction, %
61 (55-68)
63 (55-68)
63 (54-68)
.870
Left ventricular ejection fraction < 40%
43 (12)
33 (10)
35 (9.9)
.551
Aortic valve area, cm2
0.70 (0.60-0.80)
0.71 (0.60-0.84)
0.80 (0.67-0.90)*†
<.001
Indexed aortic valve area, cm2
0.41 (0.35-0.49)
0.38 (0.33-0.45)*
0.37 (0.31-0.43)*†
<.001
Transaortic mean gradient, mm Hg
41 (35-50)
41 (35-50)
42 (37-48)
.672
Mitral regurgitation
66 (19)
36 (11)*
28 (8.0)*
<.001
Tricuspid regurgitation ≥ moderate
55 (16)
45 (14)
33 (9.4)*
.033
Non-elective procedure
40 (11)
29 (9.0)
26 (7.4)
.171
Non-transfemoral access
32 (9.2)
29 (9.1)
21 (6.0)
.207
Transcatheter heart valve
NA
Sapien 20 mm
1 (0.3)
0
0
23 mm
44 (13)
35 (11)
38 (11)
26 mm
78 (22)
87 (27)
90 (26)
29 mm
50 (14)
57 (18)
76 (22)
Evolut 23 mm
8 (2.3)
6 (1.9)
6 (1.7)
26 mm
65 (19)
47 (15)
60 (17)
29 mm
83 (24)
62 (19)
62 (18)
34 mm
19 (5.5)
25 (7.8)
20 (5.7)
Mortality‡
5 (1.4)
7 (2.2)
8 (2.3)
.682
Major cardiac structural complication
5 (1.4)
4 (1.3)
1 (0.3)
.250
Major vascular complication
5 (1.4)
7 (2.2)
8 (2.3)
.682
Minor vascular complication
16 (4.6)
14 (4.4)
17 (4.8)
.964
Overt bleeding
17 (4.9)
20 (6.3)
20 (5.7)
.736
Need for second valve
1 (0.3)
3 (0.9)
0
.079
Acute stroke
9 (2.6)
7 (2.2)
6 (1.7)
.724
Acute kidney injury
7 (2.0)
4 (1.3)
9 (2.6)
.476
New permanent pacemaker implantation‡
43 (14)
42 (15)
57 (19)
.283
Transaortic mean gradient, mm Hg‡
8.0 (6.0-11)
9.7 (7.0-13)*
11 (8.0-14)*†
<.001
Transaortic mean gradient ≥ 20 mm Hg‡
6 (1.7)
10 (3.2)
27 (7.7)*
<.001
Effective orifice area, cm2
‡
1.83 (1.48-2.24)
1.80 (1.45-2.22)
1.80 (1.44-2.13)
.525
Indexed effective orifice area, cm2/m2
‡
1.07 (0.86-1.35)
0.96 (0.77-1.17)*
0.83 (0.67-1.03)*†
<.001
Aortic regurgitation ≥ moderate‡
9 (2.6)
4 (1.3)
4 (1.1)
.257
The overall periprocedural mortality was 1.9% with no significant differences between the 3 groups. Postprocedural transaortic mean gradient was highest and indexed effective orifice area was lowest in obese patients.
Normal Body Mass Index Versus Overweight After Propensity Score Matching
The propensity score C-statistic was 0.66 (95% confidence interval, 0.62-0.70). Propensity score matching resulted in 258 matched patient pairs for analysis ( Baseline and procedural characteristics and procedural outcomes after 1:1 propensity score matching, normal BMI versus overweight Median (interquartile range), or n (%). *30-day data or in-hospital data if 30-day data is not available. BMI, body mass index; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality.
Normal BMI
Overweight
Age, years
84 (78-88)
83 (79-88)
.644
Female
117 (45)
121 (46)
.791
Height, m
168 (160-175)
168 (160-178)
.671
Weight, kg
63 (56-71)
76 (68-85)
<.001
New York Heart Association III/IV
127 (49)
129 (50)
.930
STS-PROM
3.7 (2.4-6.0)
3.5 (2.2-5.9)
.393
Hypertension
232 (90)
235 (91)
.764
Dyslipidemia
231 (90)
230 (89)
>.999
Diabetes
72 (28)
75 (29)
.845
Chronic lung disease
21 (8.1)
20 (7.8)
>.999
Liver disease
9 (3.5)
10 (3.9)
>.999
Creatinine, mg/dL
1.0 (0.8-1.4)
1.1 (0.9-1.4)
.218
Creatinine
58 (23)
49 (19)
.385
Dialysis
8 (3.1)
14 (5.4)
.276
Cerebrovascular accident
30 (12)
34 (13)
.689
Peripheral artery disease
60 (23)
65 (25)
.681
Coronary artery disease
131 (51)
132 (51)
>.999
Atrial fibrillation
97 (38)
95 (37)
.927
Prior pacemaker/defibrillator
30 (12)
36 (14)
.510
Hemoglobin, g/dL
12.0 (10.7-13.3)
12.1 (10.7-13.4)
.977
Anemia
170 (66)
162 (63)
.520
Albumin, g/dL
3.8 (3.5-4.0)
3.7 (3.4-4.0)
.757
Albumin < 3.5 g/dL
63 (24)
66 (26)
.839
Left ventricular ejection fraction, %
63 (55-68)
63 (55-68)
.701
Left ventricular ejection fraction < 40%
33 (13)
27 (11)
.492
Aortic valve area, cm2
0.70 (0.60-0.80)
0.72 (0.60-0.84)
.216
Indexed aortic valve area, cm2
0.42 (0.35-0.48)
0.38 (0.33-0.45)
.001
Transaortic mean gradient, mm Hg
42 (35-50)
41 (35-50)
.925
Mitral regurgitation
37 (14)
34 (13)
.798
Tricuspid regurgitation ≥ moderate
39 (15)
38 (15)
>.999
Procedural characteristics
Non-elective procedure
22 (8.5)
27 (11)
.548
Non-transfemoral access
23 (8.9)
25 (9.7)
.880
Mortality*
2 (0.8)
7 (2.7)
.179
Major cardiac structural complication
3 (1.2)
4 (1.6)
>.999
Major vascular complication
4 (1.6)
5 (1.9)
>.999
Minor vascular complication
12 (4.7)
17 (6.6)
>.999
Overt bleeding
14 (5.4)
17 (6.6)
.711
Need for second valve
0
3 (1.2)
.247
Acute stroke
9 (3.5)
5 (1.9)
.416
Acute kidney injury
5 (1.9)
4 (1.6)
>.999
New permanent pacemaker implantation*
30 (13)
35 (16)
.514
Transaortic mean gradient, mm Hg*
8.0 (6.0-11)
9.0 (6.8-13)
.021
Transaortic mean gradient ≥ 20 mm Hg*
4 (1.6)
5 (2.0)
.991
Effective orifice area, cm2
*
1.84 (1.48-2.28)
1.80 (1.48-2.25)
.881
Indexed effective orifice area, cm2/m2
*
1.07 (0.87-1.36)
0.97 (0.77-1.19)
<.001
Aortic regurgitation ≥ moderate*
6 (2.3)
4 (1.6)
.754
The postprocedural transaortic mean gradient was significantly higher in the overweight group compared to the normal BMI group. In addition, while the effective orifice area was comparable, the indexed effective orifice area was significantly lower in the overweight group. Other major periprocedural outcomes were comparable between groups (Table 2). During follow-up, all-cause mortality (hazard ratio = 0.97, 95% confidence interval, 0.72-1.31) and the composite outcome (hazard ratio = 1.13, 95% confidence interval, 0.84-1.47) were similar between the normal BMI and overweight groups. In addition, no subgroup analyses showed significant differences in all-cause mortality (
Normal Body Mass Index Versus Obese After Propensity Score Matching
The propensity score C-statistic was 0.79 (95% confidence interval, 0.76-0.82). Propensity score matching resulted in 192 matched patient pairs for analysis ( Baseline and procedural characteristics and procedural outcomes after 1:1 propensity score matching, normal BMI versus obesity Median (interquartile range), or n (%). *30-day data or in-hospital data if 30-day data is not available. BMI, body mass index; NA, not applicable; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality.
Normal BMI
Obese
Age, years
82 (77-86)
82 (77-86)
.193
Female
99 (52)
98 (51)
>.999
Height, m
168 (160-175)
168 (160-175)
.791
Weight, kg
62 (56-71)
94 (86-107)
<.001
New York Heart Association III/IV
96 (50)
96 (50)
>.999
STS-PROM
3.6 (2.4-5.6)
3.3 (2.3-4.6)
.893
Hypertension
178 (93)
177 (92)
>.999
Dyslipidemia
173 (90)
171 (89)
.867
Diabetes
62 (32)
66 (34)
.745
Chronic lung disease
18 (9.4)
15 (7.8)
.716
Liver disease
9 (4.7)
8 (4.2)
>.999
Creatinine, mg/dL
1.0 (0.8-1.4)
1.1 (0.9-1.5)
.421
Creatinine
43 (22)
55 (29)
.198
Dialysis
8 (4.2)
7 (3.6)
>.999
Cerebrovascular accident
20 (10)
25 (13)
.526
Peripheral artery disease
40 (21)
36 (19)
.701
Coronary artery disease
90 (47)
91 (47)
>.999
Atrial fibrillation
76 (40)
70 (37)
.599
Prior pacemaker/defibrillator
23 (12)
24 (13)
>.999
Hemoglobin, g/dL
12.2 (10.9-13.4)
12.3 (10.8-13.3)
.923
Anemia
116 (60)
113 (59)
.835
Albumin, g/dL
3.8 (3.5-4.0)
3.7 (3.5-3.9)
.379
Albumin < 3.5 g/dL
44 (23)
41 (21)
.806
Left ventricular ejection fraction, %
63 (58-69)
63 (55-68)
.655
Left ventricular ejection fraction < 40%
21 (11)
20 (10)
>.999
Aortic valve area, cm2
0.71 (0.60-0.80)
0.80 (0.69-0.90)
<.001
Indexed aortic valve area, cm2
0.42 (0.35-0.49)
0.38 (0.32-0.44)
<.001
Transaortic mean gradient, mm Hg
42 (35-49)
42 (36-48)
.628
Mitral regurgitation
21 (11)
19 (9.9)
.868
Tricuspid regurgitation ≥ moderate
20 (10)
22 (12)
.870
Non-elective procedure
14 (7.3)
18 (9.4)
.580
Non-transfemoral access
14 (7.3)
15 (7.8)
>.999
Mortality*
3 (1.6)
4 (2.1)
>.999
Major cardiac structural complication
2 (1.0)
1 (0.5)
>.999
Major vascular complication
3 (1.6)
4 (2.1)
>.999
Minor vascular complication
6 (3.1)
8 (4.2)
.785
Overt bleeding
9 (4.7)
10 (5.2)
>.999
Need for second valve
0
0
NA
Acute stroke
5 (2.6)
2 (1.0)
.446
Acute kidney injury
3 (1.6)
6 (3.1)
.500
New permanent pacemaker implantation*
23 (14)
35 (21)
.107
Transaortic mean gradient, mm Hg*
8.0 (6.0-11)
10 (7.9-13)
<.001
Transaortic mean gradient ≥ 20 mm Hg*
2 (1.0)
15 (7.8)
.003
Effective orifice area, cm2
*
1.87 (1.48-2.22)
1.80 (1.50-2.12)
.607
Indexed effective orifice area, cm2/m2
*
1.07 (0.89-1.32)
0.83 (0.70-1.04)
<.001
Aortic regurgitation ≥ moderate*
4 (2.1)
2 (1.0)
.681
The postprocedural transaortic mean gradient was significantly higher in the obese group compared to the normal BMI group. The rate of mean gradient ≥20 mm Hg was also higher in the obese group. In addition, the indexed effective orifice area was significantly lower in the obese group. Other major periprocedural outcomes were comparable between groups (Table 3). During follow-up, all-cause mortality (hazard ratio = 0.87, 95% confidence interval, 0.62-1.24) and the composite outcome (hazard ratio = 0.98, 95% confidence interval, 0.72-1.34) were similar between the normal BMI and obese groups. However, in a subgroup analysis of patients with moderate/severe chronic lung disease, all-cause mortality was significantly higher in obese patients compared with normal BMI patients (hazard ratio = 3.49, 95% confidence interval, 1.21-10.0,
Discussion
The main findings of this study were as follows: 1) approximately one-third of patients with severe aortic stenosis undergoing TAVR at our institution in the United States were overweight, and another one-third were obese according to the WHO BMI classification, 2) these patients have different baseline characteristics, mainly being younger, with lower STS-PROM scores, and higher prevalence of diabetes, 3) an unadjusted analysis showed that obesity was associated with lower all-cause mortality compared with normal BMI, 4) however, after adjustment for confounders, there were no significant differences in early and late outcomes after TAVR, except for echocardiographic hemodynamics, between normal BMI and overweight or between normal weight and obese groups, 5) in patients with moderate/severe chronic lung disease, obesity was associated with higher all-cause mortality compared with normal BMI. The prevalence of overweight and obesity in our cohort aligns with a previous report from the STS/ACC TVT registry,16 with a prevalence of overweight and obesity of 34% and 30%, respectively, but the prevalence of obesity is slightly higher than in the FRANCE-2 registry (19%)13 and RISPEVA registry (18%).14
Several studies have examined the impact of BMI on TAVR outcomes, yielding mixed results. The methodology for examining the obesity paradox is also debated. While the issue is still contentious, numerous studies have observed worse clinical outcomes after TAVR in underweight patients.16-
Two large studies using the United States National Inpatient Sample reported conflicting results regarding BMI and in-hospital outcomes. Alharbi et al23 found no significant difference in mortality among different BMI groups in 77 319 TAVR cases, while Patel et al24 found lower mortality in overweight, obese, and morbidly obese patients in 42 315 cases. However, the remarkably high prevalence of obesity (81% and 82%) raises questions about the accuracy and generalizability of their findings. In studies that examined both short- and mid-term outcomes, the RESPIVA study14 and a study by Boukhris et al17 (n = 412) found no association between overweight/obesity and survival rates compared with normal weight. In contrast, Sharma et al16 analyzed data from 31 929 patients who underwent TAVR between 2011 and 2015 from the STS/ACC TVT Registry, and found that overweight patients [hazard ratio = 0.88 (0.81-0.95)] and those with class I obesity [0.84 (0.72-0.98)] and class II obesity [0.80 (0.72-0.89)] had a decreased risk of mortality at 1 year. Similarly, the FRANCE-2 registry13 observed superior survival at 1 year in overweight and obese patients. In addition, a recent meta-analysis showed that obese patients had a lower rate of 30-day mortality, and both overweight and obese patients had lower rates of 1-year mortality compared with normal-weight patients, while the incidence of post-procedural acute kidney injury was higher in obese patients, and overweight and obese patients were more likely to require permanent pacemaker implantation. The results of our study are inconsistent with these studies, which support the existence of an “obesity paradox” in mortality. These discrepancies may be explained in part by changes in TAVR outcomes over time. For example, in the aforementioned STS/ACC TVT registry and FRANCE-2 registry, 30-day and 1-year mortality rates were 4.9-7.4% and 18-26%, and 7.0-11% and 13-20%, respectively, in patients with a normal or higher BMI. In contrast, the RESPIVA study, a more recent study, showed a 30-day mortality rate of 1.3-2.8%, and during a mean follow-up of approximately 11 months, the mortality rate was 12-15%, which is consistent with our results. In fact, overall survival after TAVR has improved due to improvements in techniques and devices, as well as expansion of the indication to lower-risk cohorts.25 Similarly, the validity of the aforementioned study-level meta-analysis for current practice would be weakened by several factors: the lack of patient-level data, which hinders the assessment of baseline heterogeneity among BMI groups; non-standardized definitions of obesity and BMI groups with varying cutoffs; and the inclusion of only high-risk cohorts and older-generation devices in some studies. Despite the relatively small sample size and potential issues with statistical power, our study found no statistical trends in mortality after propensity score adjustment between normal and elevated BMI groups, which may actually reflect current real-world practice. On the other hand, in patients with moderate/severe chronic lung disease, we found increased all-cause mortality with obesity compared with normal BMI. Indeed, increased BMI has been suggested to be associated with decreased forced vital capacity and forced expiratory volume in 1 second,26 which may adversely affect patients with significant chronic lung disease undergoing TAVR for severe aortic stenosis. Further research is needed to update knowledge of the obesity paradox in TAVR outcomes and to examine potential effect modification by comorbidities. This will help refine optimal risk stratification and improve patient management and potentially clinical outcomes for patients undergoing TAVR.
Study Limitations
This study has several important limitations. First, it is a single-center retrospective study with a modest sample size, especially after propensity score matching, and a relatively short observation period. Despite efforts to reduce confounding by propensity score matching, unmeasured confounders such as frailty, central or peripheral obesity,27,
Conclusion
In conclusion, approximately one-third of the patients undergoing TAVR for severe native aortic stenosis were overweight and one-third were obese. In this study, the “obesity paradox” was not observed in patients undergoing TAVR; rather, in patients with significant lung disease, obesity may be associated with worse mid-term outcomes after TAVR.
Supplementary Materials
Footnotes
References
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