The Valve Academic Research Consortium-2 has defined body mass index (BMI) <20 as indicative of frailty, which may be one of the co-morbidities not captured by traditional risk factors after transcatheter aortic valve replacement (TAVR). This study aimed to assess the impact of low BMI on clinical outcomes after TAVR. A total of 777 consecutive patients scheduled for TAVR were classified into 3 groups as BMI <20 (n = 56), 20 to 24.9 (n = 322), and ≥25 (n = 399). Procedural complications and clinical outcomes were compared among the 3 groups. They were also analyzed according to propensity-matching model A (BMI <20 [n = 50] vs ≥20 [n = 50]), model B (BMI <20 [n = 50] vs 20 to 24.9 [n = 50]), and model C (BMI <20 [n = 47] vs ≥25 [n = 47]). The differences in baseline characteristics among the 3 groups were adequately adjusted in 3 matched models. Valve Academic Research Consortium-2–defined end points and other complications were similar among the 3 groups in each model. Kaplan-Meier curves indicated no significant differences in cumulative 30-day survival (BMI <20 [91.0%] vs 20 to 24.9 [86.3%], p = 0.33; BMI <20 [91.0%] vs ≥25 [91.4%], p = 0.91, respectively) and 1-year survival (BMI <20 [74.3%] vs 20 to 24.9 [71.8%], p = 0.71; BMI <20 [74.3%] vs ≥25 [77.0%], p = 0.71; respectively). These survival rates were also similar in each of the 3 matched models. In conclusion, BMI <20 was not associated with increased early or midterm mortality. BMI <20 alone may not constitute an additional co-morbidity factor in patients who underwent TAVR.
After the initial first-in-man procedures and the substantial clinical experience subsequently acquired, transcatheter aortic valve replacement (TAVR) has developed into an alternative therapeutical strategy in patients with severe aortic stenosis considered inoperable or high-risk candidates for surgical aortic valve replacement. The recently updated Valve Academic Research Consortium (VARC)-2 guidelines have emphasized the importance of additional risk factors such as porcelain aorta, frailty, cirrhosis of the liver, hostile chest, or other anatomical problems and co-morbidities that were not captured by traditional preoperative risk models. According to these criteria, body mass index (BMI) <20 kg/m 2 and/or weight loss of 5 kg/y are additional risk factors indicative of frailty. Frailty is generally recognized as a geriatric syndrome of impaired resilience to stressors that carries a high risk for adverse health outcomes. Therefore, the syndrome of frailty and its predictive value should be stringently evaluated in the TAVR population. However, there are currently no available data to confirm the suspicion that BMI <20 may be associated with worse prognosis or increased procedural complications after TAVR. The aim of this study was, consequently, to investigate the relation between BMI <20 and clinical outcomes in patients after TAVR.
Methods
A total of 777 consecutive patients with symptomatic severe AS who underwent TAVR were analyzed in 2 French centers (230 in Henri-Mondor University Hospital from December 2007 to May 2012 and 547 at the Institut Cardiovasculaire Paris Sud, Générale de Santé, from October 2006 to May 2012). Of these, 112 and 288 patients in each 2 centers were enrolled from January 2010 to October 2011 as the national FRench Aortic National CoreValve and Edwards 2 (FRANCE-2) registry data. Patients were selected for TAVR when considered unsuitable or high risk for SAVR by consensus between individual centers and Heart Team discussion. Enrolled patients were classified into 3 groups based on their BMI as follows: BMI <20 (n = 56), 20 to 24.9 (n = 322), and ≥25 (n = 399). Thereafter, the groups were subdivided into model A (BMI <20 vs ≥20), model B (BMI <20 vs 20 to 24.9), and model C (BMI <20 vs ≥25) using propensity-matching analysis. Clinical data, patient characteristics, echocardiographic data, procedural variables, length of hospital stay, and in-hospital and all-cause mortality rates were examined for each group. In addition, similar analysis was done between the BMI groups <18.5 (n = 16) and 18.5 to 20 (n = 40) to clarify the clinical difference in patients with low BMI. Information regarding the possible occurrence and/or causes of death was obtained from the treating hospital or by phoning directly the patient or the patient’s family. The medical ethics committee at both hospitals approved this study protocol. Detailed data of TAVR series have already been reported. Both the commercially available valves were used, namely the Edwards SAPIEN or SAPIEN XT (Edwards; Edwards Lifesciences, Irvine, California) balloon-expandable prosthesis and the Medtronic CoreValve Revalving System (CoreValve; Medtronic, Minneapolis, Minnesota) self-expandable prosthesis. The devices were delivered through the transfemoral, transapical, transsubclavian, transaortic, or transcarotid routes. The transfemoral approach was the primary choice and was carried out percutaneously in most patients using a preclosing technique (Prostar XL; Abbott, Inc., Chicago, Illinois). Procedural success and complications during TAVR were evaluated according to the VARC-2 criteria.
All statistical analyses were performed using SPSS software, version 19 (SPSS Inc., Chicago, Illinois). Continuous variables were expressed as mean ± standard deviation or median (interquartile range), depending on variable distribution. Categorical data were expressed as percentages of the total. Comparisons among the 3 BMI groups were performed using Pearson’s bivariate test and the chi-square test for categorical covariates and 1-way analysis of variance for continuous covariates. Propensity matching was selected as a method to provide a more valid comparison in model A (BMI <20 vs ≥20), model B (BMI <20 vs 20 to 24.9), and model C (BMI <20 vs ≥25). Propensity scores were calculated for each patient using multivariate logistic regression based on the following covariates: age, gender, valve type, approach routes, and other baseline variables. Baseline variables applied in each matching models included the factors affecting cumulative mortality after TAVI on the basis of the univariate analysis with p values <0.20. The discrimination and calibration abilities of the propensity score models A, B, and C were adequately assessed by means of C statistics (0.76, 0.73, and 0.80, respectively) and the Hosmer-Lemeshow test (p = 0.96, 0.38, and 0.97, respectively). The Kaplan-Meier method was used to estimate cumulative mortality rates in each BMI group. Survival differences in each group were compared with the log-rank test. All statistical tests were 2 sided, and a p value <0.05 was considered to be significant.
Results
A number of differences emerged among the 3 BMI groups with respect to age, gender, and prevalence of other baseline patient characteristics including echocardiographic data ( Table 1 ). Consequently, the mean value of logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) and Society of Thoracic Surgeons Predictive Risk of Mortality was significantly different among the 3 groups. Procedural characteristics and VARC-2–defined and other procedural complications are listed in Table 2 . Types of selected valves and approach routes were equally distributed in the 3 groups. Although no significant differences were observed in most complications among the 3 groups, a trend toward a lower incidence of major vascular complication (14.3% vs 7.5% vs 6.0%; p = 0.079) was observed across the 3 groups. The matching models A and B were assigned to each group of 50 patients between the BMI groups <20 and ≥20 and between the groups <20 and 20 to 24.9, respectively. Model C was assigned to each group of 47 patients between BMI <20 and ≥25. After propensity score matching, baseline patient characteristics in all 3 matching models were closely adjusted except for body size characteristics and aortic valve area ( Table 3 ). Procedure-related clinical outcomes were also compared in each propensity-matching model, but no significant differences were evidenced between the models ( Table 4 ). In the low BMI subset, there were no significant differences between the BMI groups <18.5 (n = 16) and 18.5 to 20 (n = 40) concerning the postprocedural variables that included the rates of procedural success (100% vs 92.5%, p = 0.55), major vascular complication (12.5% vs 15.0%, p >0.99), and major bleeding (6.3% vs 20%, p = 0.42). Clinical follow-up was obtained in 100% of patients with a median follow-up of 217 days (interquartile range 66 to 459 days). Cumulative early (30 days) and late (up to 2 years) survival rates of the whole cohort of patients and matched patients were compared between the groups BMI <20 and ≥20 ( Figure 1 ). There were no differences in the rates of early survival between the study groups (BMI <20 [91.0%] vs ≥20 [89.1%], p = 0.66), and these results remained unchanged after propensity matching (BMI <20 [89.9%] vs ≥20 [84.0%], p = 0.37). Cumulative 1-year survival rates were equivalent between patients with BMI <20 and ≥20 (74.3% vs 74.7%, p = 0.97) and remained similar even after propensity matching (BMI <20 [71.1%] vs ≥20 [60.3%], p = 0.54). If the groups were subdivided into 2 groups as BMI <20 and 20 to 24.9 and BMI <20 and ≥25, the results of early survival rates were similar in overall cohort (BMI <20 [91.0%] vs 20 to 24.9 [86.3%], p = 0.33; BMI <20 [91.0%] vs ≥25 [91.4%], p = 0.91, respectively) and were not attenuated in propensity-matching models (BMI <20 [89.9%] vs 20 to 24.9 [88.0%], p = 0.76; BMI <20 [91.4%] vs ≥25 [97.9%], p = 0.17, respectively). These results were not changed concerning 1-year survival rates of overall (BMI <20 and 20 to 24.9 [74.3% vs 71.8%, p = 0.71]; BMI <20 and ≥25 [74.3% vs 77.0%, p = 0.71]) and of propensity-matched models (BMI <20 [73.1%] vs 20 to 24.9 [65.1%], p = 0.61; BMI <20 [71.4%] vs ≥25 [82.7%], p = 0.33, respectively). Similar 30-day and 1-year survival rates were found between the BMI groups <18.5 and 18.5 to 20 (93.8% vs 90.0%, p = 0.67; and 87.5% vs 75.0%, p = 0.36, respectively).
| Variable | Body Mass Index (kg/m 2 ) | p value | ||
|---|---|---|---|---|
| <20 (n=56) | 20-24.9 (n=322) | 25 (n=399) | ||
| Baseline clinical characteristics | ||||
| Age (yrs) | 85.0 ± 6.7 | 84.0 ± 6.7 | 82.7 ± 6.5 | 0.005 |
| Male | 18 (32.1%) | 151 (46.9%) | 208 (52.1%) | 0.015 |
| Body mass index (kg/m 2 ) | 18.7 ± 1.2 | 23.0 ± 1.4 | 29.1 ± 3.7 | <0.001 |
| Body surface area (m 2 ) | 1.5 ± 0.13 | 1.7 ± 0.16 | 1.83 ± 0.17 | <0.001 |
| Diabetes mellitus | 5 (8.9%) | 56 (17.4%) | 118 (29.6%) | 0.001 |
| Dyslipidemia | 19 (33.9%) | 149 (46.3%) | 227 (56.9%) | 0.001 |
| Hypertension | 37 (66.1%) | 217 (67.4%) | 301 (75.4%) | 0.039 |
| New York Heart Association (III / IV) | 47 (83.9%) | 243 (75.5%) | 335 (84.0%) | 0.013 |
| Peripheral artery disease | 8 (14.3%) | 96 (29.8%) | 117 (29.3%) | 0.051 |
| Chronic kidney disease | 42 (75.0%) | 226 (70.2%) | 232 (58.1%) | 0.001 |
| Hemodialysis | 1 (1.8%) | 8 (2.5%) | 10 (2.5%) | 0.95 |
| Previous myocardial infarction | 5 (8.9%) | 47 (14.6%) | 60 (15.0%) | 0.47 |
| Previous stroke | 6 (10.7%) | 36 (11.2%) | 34 (8.5%) | 0.48 |
| Previous cardiac surgery | 6 (10.7%) | 41 (12.7%) | 77 (19.3%) | 0.031 |
| Chronic obstructive pulmonary disease | 17 (30.4%) | 74 (23.0%) | 114 (28.6%) | 0.19 |
| Permanent pacemaker | 10 (17.9%) | 49 (15.2%) | 59 (14.8%) | 0.68 |
| Logistic EuroSCORE | 23.6 ± 11.3 | 23.8 ± 13.2 | 20.9 ± 11.1 | 0.004 |
| STS score | 10.9 ± 7.3 | 8.9 ± 7.0 | 8.4 ± 6.5 | 0.039 |
| Echocardiographic data | ||||
| Ejection fraction, % | 49.2 ± 14.9 | 50.6 ± 15.0 | 51.2 ± 13.9 | 0.58 |
| Ejection fraction < 40% | 18 (32.1%) | 89 (27.6%) | 107 (26.8%) | 0.70 |
| Aortic valve area (cm 2 ) | 0.58 ± 0.19 | 0.63 ± 0.16 | 0.68 ± 0.17 | <0.001 |
| Corrected aortic valve area (cm 2 /m 2 ) | 0.38 ± 0.12 | 0.38 ± 0.10 | 0.38 ± 0.10 | 0.94 |
| Mean gradient (mmHg) | 53.3 ± 21.5 | 48.1 ± 17.9 | 45.7 ± 16.9 | 0.004 |
| Aortic regurgitation grade ≥2 | 8 (14.3%) | 51 (15.8%) | 59 (14.8%) | 0.91 |
| Mitral regurgitation grade ≥2 | 10 (17.9%) | 61 (18.9%) | 61 (15.4%) | 0.42 |
| Pulmonary artery pressure (mmHg) | 48.6 ± 13.6 | 49.2 ± 15.8 | 46.8 ± 14.3 | 0.10 |
| Pulmonary artery pressure ≥40mmHg | 38 (67.9%) | 207 (64.3%) | 247 (61.9%) | 0.62 |
| Variable | Body Mass Index (kg/m 2 ) | p Value | ||
|---|---|---|---|---|
| <20 (n=56) | 20-24.9 (n=322) | 25 (n=399) | ||
| Procedural variables | ||||
| Medotronic CoreValve | 27 (48.2%) | 117 (37.6%) | 167 (41.9%) | 0.14 |
| Edwards Sapien valve | 29 (51.8%) | 205 (63.7%) | 232 (58.1%) | |
| Approach site | ||||
| Transfemoral | 41 (73.2%) | 198 (61.5%) | 269 (67.4%) | 0.11 |
| Non-transfemoral | 15 (26.8%) | 124 (38.5%) | 130 (32.6%) | |
| Post-procedural variables | ||||
| Procedural success | 53 (94.6%) | 293 (91.0%) | 372 (93.2%) | 0.43 |
| Contrast media (ml) | 166.8 ± 91.2 | 153.2 ± 77.2 | 157.1 ± 69.4 | 0.52 |
| Procedure time (min) | 88.5 ± 44.2 | 86.4 ± 52.3 | 82.7 ± 39.7 | 0.62 |
| In hospital stay (day) | 10.3 ± 7.5 | 11.0 ± 8.6 | 11.4 ± 8.4 | 0.65 |
| Intensive care unit stay (day) | 4.9 ± 4.0 | 5.2 ± 4.7 | 5.4 ± 4.4 | 0.89 |
| VARC -2 defined complication | ||||
| Myocardial infarction | 0 (0%) | 1 (0.3%) | 2 (0.5%) | 0.82 |
| Disabling stroke | 3 (5.4%) | 14 (4.3%) | 9 (2.3%) | 0.21 |
| Major vascular complication | 8 (14.3%) | 24 (7.5%) | 24 (6.0%) | 0.079 |
| Life-threatening bleeding | 4 (7.1%) | 38 (11.8%) | 25 (8.8%) | 0.31 |
| Major bleeding | 9 (16.1%) | 26 (8.1%) | 33 (8.3%) | 0.97 |
| Acute kidney injury | 6 (10.7%) | 53 (16.5%) | 67 (16.8%) | 0.51 |
| Other procedural complication | ||||
| New pacemaker implantation | 5 (8.9%) | 35 (10.9%) | 46 (11.5%) | 0.84 |
| 2 valve implantation | 1 (1.8%) | 6 (1.9%) | 15 (3.8%) | 0.28 |
| Transfusion > 4 units | 2 (3.6%) | 30 (9.3%) | 27 (6.8%) | 0.22 |
| Cardiac tamponade | 3 (5.4%) | 13 (4.0%) | 11 (2.8%) | 0.47 |
| Annulus rupture | 1 (1.8%) | 5 (1.6%) | 2 (0.5%) | 0.32 |
| Vascular surgery | 5 (8.9%) | 12 (3.7%) | 16 (4.0%) | 0.19 |
| Any cardiac surgery | 1 (1.8%) | 11 (3.4%) | 8 (2.0%) | 0.46 |
| Propensity matching model | Model A | p Value | Model B | p Value | Model C | p Value | |||
|---|---|---|---|---|---|---|---|---|---|
| Patients | Body Mass Index | Body Mass Index | Body Mass Index | ||||||
| <20 (n=50) | ≥20 (n=50) | <20 (n=50) | 20-24.9 (n=50) | <20 (n=47) | ≥25 (n=47) | ||||
| Baseline clinical characteristics | |||||||||
| Age (yrs) | 85.1 ± 7.0 | 84.2 ± 7.4 | 0.56 | 85.2 ± 6.9 | 83.7 ± 6.2 | 0.23 | 85.1 ± 7.1 | 85.9 ± 5.0 | 0.57 |
| Male | 16 (32.0%) | 16 (32.0%) | >0.99 | 16 (32.0%) | 19 (38.0%) | 0.53 | 14 (29.8%) | 16 (34.0%) | 0.66 |
| Body mass index (kg/m 2 ) | 18.7 ± 1.1 | 25.8 ± 3.1 | <0.001 | 18.8 ± 1.1 | 23.0 ± 1.3 | <0.001 | 18.8 ± 1.1 | 28.7 ± 3.4 | <0.001 |
| Body surface area (m 2 ) | 1.5 ± 0.12 | 1.7 ± 0.16 | <0.001 | 1.5 ± 0.13 | 1.6 ± 0.15 | <0.001 | 1.5 ± 0.13 | 1.8 ± 0.17 | <0.001 |
| Diabetes mellitus | 5 (10.0%) | 7 (14.0%) | 0.76 | 5 (10.0%) | 7 (14.0%) | >0.99 | 5 (10.6%) | 6 (12.8%) | >0.99 |
| Dyslipidemia | 19 (38.0%) | 15 (30.0%) | 0.40 | 18 (36.0%) | 21 (42.0%) | 0.54 | 19 (40.4%) | 20 (42.6%) | 0.83 |
| Hypertension | 34 (68.0%) | 33 (66.0%) | 0.83 | 32 (64.0%) | 30 (60.0%) | 0.68 | 32 (68.1%) | 32 (68.1%) | >0.99 |
| New York Hear Association (III / IV) | 42 (84.0%) | 44 (88.0%) | 0.56 | 41 (82.0%) | 42 (84.0%) | 0.79 | 39 (83.0%) | 39 (83.0%) | >0.99 |
| Peripheral artery disease | 8 (16.0%) | 9 (18.0%) | >0.99 | 8 (16.0%) | 7 (14.0%) | >0.99 | 8 (17.0%) | 12 (25.5%) | 0.45 |
| Chronic kidney disease | 36 (72.0%) | 33 (66.0%) | 0.52 | 37 (74.0%) | 35 (70.0%) | 0.66 | 33 (70.2%) | 31 (66.0%) | 0.66 |
| Hemodialysis | 1 (2.0%) | 2 (4.0%) | >0.99 | 1 (2.0%) | 0 (0.0%) | >0.99 | 1 (2.1%) | 1 (2.1%) | >0.99 |
| Previous myocardial infarction | 5 (10.0%) | 10 (20.0%) | 0.26 | 5 (10.0%) | 7 (14.0%) | 0.76 | 5 (10.6%) | 9 (19.1%) | 0.39 |
| Previous stroke | 5 (10.0%) | 5 (10.0%) | >0.99 | 5 (10.0%) | 4 (8.0%) | >0.99 | 5 (10.6%) | 8 (17.0%) | 0.37 |
| Previous cardiac surgery | 6 (12.0%) | 6 (12.0%) | >0.99 | 6 (12.0%) | 6 (12.0%) | >0.99 | 6 (12.8%) | 4 (8.5%) | 0.74 |
| Chronic obstructive pulmonary disease | 16 (32.0%) | 11 (22.0%) | 0.26 | 15 (30.0%) | 20 (40.0%) | 0.30 | 15 (31.9%) | 17 (36.2%) | 0.66 |
| Permanent pacemaker | 6 (12.0%) | 8 (16.0%) | 0.77 | 5 (10.0%) | 3 (6.0%) | 0.72 | 6 (12.8%) | 7 (14.9%) | >0.99 |
| Logistic EuroSCORE | 24.1 ± 11.4 | 21.2 ± 11.0 | 0.19 | 24.2 ± 11.6 | 22.7 ± 13.2 | 0.55 | 24.7 ± 11.5 | 24.2 ± 13.5 | 0.82 |
| STS score | 11.3 ± 7.6 | 9.0 ± 6.0 | 0.40 | 10.5 ± 6.7 | 9.5 ± 7.4 | 0.50 | 10.9 ± 7.0 | 9.6 ± 7.2 | 0.35 |
| Echocardiographic data | |||||||||
| Ejection fraction (%) | 49.3 ± 15.3 | 49.4 ± 13.6 | 0.97 | 49.1 ± 14.9 | 46.8 ± 14.4 | 0.44 | 48.7 ± 5.8 | 52.9 ± 14.0 | 0.19 |
| Ejection fraction < 40% | 15 (30.0%) | 15 (30.0%) | >0.99 | 15 (30.0%) | 18 (36.0%) | 0.52 | 14 (29.8%) | 10 (21.3%) | 0.34 |
| Aortic valve area (cm 2 ) | 0.58 ± 0.20 | 0.68 ± 0.19 | 0016 | 0.58 ± 0.20 | 0.63 ± 0.17 | 0.19 | 0.58 ± 0.19 | 0.70 ± 0.21 | <0.001 |
| Corrected aortic valve area (cm 2 /m 2 ) | 0.38 ± 0.13 | 0.40 ± 0.11 | 0.40 | 0.38 ± 0.13 | 0.38 ± 0.11 | 0.93 | 0.38 ± 0.12 | 0.41 ± 0.12 | 0.30 |
| Mean gradient (mmHg) | 52.8 ± 22.0 | 48.5 ± 13.2 | 0.25 | 52.8 ± 22.1 | 47.1 ± 14.3 | 0.13 | 53.9 ± 22.8 | 47.4 ± 16.0 | 0.11 |
| Aortic regurgitation grade ≥2 | 7 (14.0%) | 10 (20.0%) | 0.60 | 7 (14.0%) | 7 (14.0%) | >0.99 | 7 (14.9%) | 9 (19.1%) | 0.79 |
| Mitral regurgitation grade ≥2 | 9 (18.0%) | 10 (20.0%) | >0.99 | 10 (20.0%) | 10 (20.0%) | >0.99 | 8 (17.0%) | 8 (17.0%) | >0.99 |
| Pulmonary artery pressure (mmHg) | 48.2 ± 13.5 | 48.7 ± 13.7 | 0.87 | 46.8 ± 14.3 | 46.8 ± 14.3 | 0.10 | 46.8 ± 14.3 | 46.8 ± 14.3 | 0.10 |
| Pulmonary artery pressure ≥40mmHg | 33 (66.0%) | 35 (70.0%) | 0.67 | 33 (66.0%) | 34 (68.0%) | 0.83 | 32 (68.1%) | 30 (63.8%) | 0.66 |
| Propensity matching model | Model A | p Value | Model B | p Value | Model C | p Value | |||
|---|---|---|---|---|---|---|---|---|---|
| Patients, n | Body Mass Index | Body Mass Index | Body Mass Index | ||||||
| <20 (n=50) | ≥20 (n=50) | <20 (n=50) | 20-24.9 (n=50) | <20 (n=47) | ≥25 (n=47) | ||||
| Procedural variables | |||||||||
| Medtronic CoreValve, | 25 (50.0%) | 30 (60.0%) | 0.32 | 23 (50.0%) | 23 (60.0%) | >0.99 | 24 (51.1%) | 25 (53.2%) | 0.84 |
| Edwards Sapien valve | 25 (50.0%) | 20 (40.0%) | 27 (50.0%) | 27 (40.0%) | 23 (48.9%) | 22 (46.8%) | |||
| Approach routes | |||||||||
| Transfemoral | 36 (72.0%) | 40 (80.0%) | 0.35 | 37 (74.0%) | 36 (72.0%) | 0.82 | 36 (76.6%) | 33 (70.2%) | 0.48 |
| Non-transfemral | 14 (18.0%) | 10 (20.0%) | 13 (26.0%) | 14 (28.0%) | 11 (23.4%) | 14 (29.8%) | |||
| Post-procedural variables | |||||||||
| Procedural success | 47 (94.0%) | 46 (92.0%) | 0.70 | 47 (94.0%) | 44 (88.0%) | 0.30 | 44 (93.6%) | 43 (91.5%) | >0.99 |
| Contrast media (ml) | 168.0 ± 96.3 | 172.0 ± 74.5 | 0.84 | 167.5 ± 96.3 | 147.7 ± 79.6 | 0.33 | 165.6 ± 97.7 | 169.8 ± 81.1 | 0.84 |
| Procedure time (min) | 90.0 ± 45.2 | 95.2 ± 57.8 | 0.68 | 89.4 ± 44.6 | 87.9 ± 56.2 | 0.91 | 89.1 ± 44.8 | 83.2 ± 31.9 | 0.56 |
| In hospital stay (day) | 10.4 ± 7.8 | 11.2 ± 7.6 | 0.59 | 9.7 ± 6.2 | 12.2 ± 8.7 | 0.71 | 10.2 ± 7.8 | 12.5 ± 8.4 | 0.19 |
| Intensive care unit stay (day) | 5.1 ± 4.1 | 6.1 ± 4.8 | 0.60 | 5.1 ± 4.3 | 5.7 ± 5.5 | 0.11 | 4.4 ± 2.2 | 4.1 ± 3.9 | 0.83 |
| VARC-2 defined complication | |||||||||
| Myocardial infarction | 0 (0.0%) | 0 (0.0%) | >0.99 | 0 (0.0%) | 1 (2.0%) | >0.99 | 0 (0.0%) | 0 (0.0%) | >0.99 |
| Disabling stroke | 3 (6.0%) | 1 (2.0%) | 0.62 | 2 (4.0%) | 0 (0.0%) | 0.50 | 1 (2.1%) | 0 (0.0%) | 0.50 |
| Major vascular complication | 8 (16.0%) | 4 (8.0%) | 0.36 | 7 (14.0%) | 5 (10.0%) | 0.76 | 7 (14.9%) | 4 (8.5%) | 0.52 |
| Life-threatening bleeding | 3 (6.0%) | 5 (10.0%) | 0.72 | 4 (8.0%) | 5 (10.0%) | >0.99 | 4 (8.5%) | 3 (6.4%) | >0.99 |
| Major bleeding | 9 (18.0%) | 8 (16.0%) | >0.99 | 8 (16.0%) | 4 (8.0%) | 0.36 | 7 (14.9%) | 6 (12.8%) | >0.99 |
| Acute kidney injury | 6 (12.0%) | 10 (20.0%) | 0.41 | 6 (12.0%) | 7 (14.0%) | >0.99 | 6 (12.8%) | 6 (12.8%) | >0.99 |
| Other procedural complication | |||||||||
| New pacemaker implantation | 4 (8.0%) | 11 (22.0%) | 0.091 | 3 (6.0%) | 7 (14.0%) | 0.32 | 3 (6.4%) | 8 (17.0%) | 0.20 |
| 2 valve implantation | 1 (2.0%) | 1 (2.0%) | 0.62 | 1 (2.0%) | 3 (6.0%) | 0.62 | 1 (2.1%) | 4 (8.5%) | 0.36 |
| Transfusion > 4 units | 1 (2.0%) | 5 (10.0%) | 0.20 | 1 (2.0%) | 3 (6.0%) | 0.62 | 2 (4.3%) | 3 (6.4%) | >0.99 |
| Cardiac tamponade | 3 (6.0%) | 1 (2.0%) | 0.62 | 3 (6.0%) | 1 (2.0%) | 0.62 | 3 (6.4%) | 3 (6.4%) | >0.99 |
| Annulus rupture | 1 (2.0%) | 0 (0.0%) | >0.99 | 1 (2.0%) | 0 (0.0%) | >0.99 | 1 (2.1%) | 0 (0.0%) | >0.99 |
| Vascular surgery | 5 (10.0%) | 2 (4.0%) | 0.47 | 4 (8.0%) | 1 (2.0%) | 0.36 | 4 (8.5%) | 4 (8.5%) | >0.99 |
| Any cardiac surgery | 1 (2.0%) | 1 (2.0%) | >0.99 | 1 (2.0%) | 1 (2.0%) | >0.99 | 1 (2.1%) | 2 (4.3%) | >0.99 |
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