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Effect of Body Mass Index on Short- and Long-Term Outcomes After Transcatheter Aortic Valve Implantation

2012; Elsevier BV; Volume: 111; Issue: 2 Linguagem: Inglês

10.1016/j.amjcard.2012.09.022

ISSN

1879-1913

Autores

Robert M.A. van der Boon, Alaide Chieffo, Nicolas Dumonteil, Didier Tchetchè, Nicolas M. Van Mieghem, Gill Louise Buchanan, Olivier Vahdat, Bertrand Marcheix, Patrick W. Serruys, Jean Fajadet, Antonio Colombo, Didier Carrié, Ron T. van Domburg, Peter P.T. de Jaegere,

Tópico(s)

Cardiac Imaging and Diagnostics

Resumo

Better outcomes have been reported after percutaneous cardiac intervention in obese patients ("obesity paradox"). However, limited information is available on the effect of the body mass index on the outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the "obesity paradox" in patients undergoing TAVI. Better outcomes have been reported after percutaneous cardiac intervention in obese patients ("obesity paradox"). However, limited information is available on the effect of the body mass index on the outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the "obesity paradox" in patients undergoing TAVI. Transcatheter aortic valve implantation (TAVI) has become an established treatment of patients with aortic stenosis who are at high risk of surgical aortic valve replacement.1Leon M.B. Smith C.R. Mack M. Miller D.C. Moses J.W. Svensson L.G. Tuzcu E.M. Webb J.G. Fontana G.P. Makkar R.R. Brown D.L. Block P.C. Guyton R.A. Pichard A.D. Bavaria J.E. Herrmann H.C. Douglas P.S. 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Relation of body mass index to outcome in patients with known or suspected coronary artery disease.Am J Cardiol. 2007; 99: 1485-1490Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar, 9Powell B.D. Lennon R.J. Lerman A. Bell M.R. Berger P.B. Higano S.T. Holmes Jr., D.R. Rihal C.S. Association of body mass index with outcome after percutaneous coronary intervention.Am J Cardiol. 2003; 91: 472-476Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar, 10Hastie C.E. Padmanabhan S. Slack R. Pell A.C.H. Oldroyd K.G. Flapan A.D. Jennings K.P. Irving J. Eteiba H. Dominiczak A.F. Pell J.P. Obesity paradox in a cohort of 4880 consecutive patients undergoing percutaneous coronary intervention.Eur Heart J. 2010; 31: 222-226Crossref PubMed Scopus (172) Google Scholar, 11Byrne J. Spence M.S. Fretz E. Mildenberger R. Chase A. Berry B. Pi D. Janssen C. Klinke P. Hilton D. 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Brinkman W.T. Prince S.L. Ryan W.H. Mack M.J. Does body mass index affect outcomes for aortic valve replacement surgery for aortic stenosis?.Ann Thorac Surg. 2012; 93 ([discussion 746–747]): 742-746Abstract Full Text Full Text PDF PubMed Scopus (45) Google Scholar Patients who currently undergo TAVI are older and have more co-morbid conditions than those who undergo percutaneous coronary intervention or cardiac surgery.18Tamburino C. Barbanti M. Capodanno D. Mignosa C. Gentile M. Aruta P. Pistritto A.M. Bonanno C. Bonura S. Cadoni A. Gulino S. Di Pasqua MC. Cammalleri V. Scarabelli M. Mulè M. Immè S. Del Campo G. Ussia G.P. Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis.Am J Cardiol. 2012; 109: 1487-1493Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar, 19Wenaweser P. Pilgrim T. Kadner A. Huber C. Stortecky S. Buellesfeld L. Khattab A.A. Meuli F. Roth N. Eberle B. Erdös G. Brinks H. Kalesan B. Meier B. Jüni P. Carrel T. Windecker S. Clinical outcomes of patients with severe aortic stenosis at increased surgical risk according to treatment modality.J Am Coll Cardiol. 2011; 58: 2151-2162Crossref PubMed Scopus (131) Google Scholar, 20Nuis R.J. Dager A.E. van der Boon R.M. Jaimes M.C. Caicedo B. Fonseca J. Van Mieghem N.M. Benitez L.M. Umana J.P. O'Neill W.W. de Marchena E. de Jaegere P.P. Patients with aortic stenosis referred for TAVI: treatment decision, in-hospital outcome and determinants of survival.Neth Heart J. 2012; 20: 16-23Crossref PubMed Scopus (26) Google Scholar This, combined with the use of large indwelling delivery catheters, could expose obese patients to a particular high risk of perioperative complications. Currently, no information is available on an eventual protective or adverse effect of body weight on the procedural and long-term outcomes in patients undergoing TAVI, which was the subject of the present study. The Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC Plus) Initiative is a collaboration of 4 European institutions with established TAVI experience. The baseline patient characteristics, procedural details, and clinical outcomes data from a series of 944 consecutive patients were prospectively collected from San Raffaele Scientific Institute, Milan, Italy (n = 330); Clinique Pasteur, Toulouse, France (n = 224); Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands (n = 206); and Hôpital Rangueil, Toulouse, France (n = 184). After the Valve Academic Research Consortium (VARC) consensus document was made public, the VARC end point definitions were adopted, and the respective local databases were modified accordingly.21Leon M.B. Piazza N. Nikolsky E. Blackstone E.H. Cutlip D.E. Kappetein A.P. Krucoff M.W. Mack M. Mehran R. Miller C. Morel M. Petersen J. Popma J.J. Takkenberg J.J.M. Vahanian A. van Es G.-A. Vranckx P. Webb J.G. Windecker S. Serruys P.W. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.J Am Coll Cardiol. 2011; 57: 253-269Crossref PubMed Scopus (700) Google Scholar All data were then pooled into a dedicated global multicenter database, after which a post hoc analysis was performed. Patient eligibility for TAVI has been previously described and is comparable across the 4 centers.20Nuis R.J. Dager A.E. van der Boon R.M. Jaimes M.C. Caicedo B. Fonseca J. Van Mieghem N.M. Benitez L.M. Umana J.P. O'Neill W.W. de Marchena E. de Jaegere P.P. Patients with aortic stenosis referred for TAVI: treatment decision, in-hospital outcome and determinants of survival.Neth Heart J. 2012; 20: 16-23Crossref PubMed Scopus (26) Google Scholar, 22Godino C. Maisano F. Montorfano M. Latib A. Chieffo A. Michev I. Al-Lamee R. Bande M. Mussardo M. Arioli F. Ielasi A. Cioni M. Taramasso M. Arendar I. Grimaldi A. Spagnolo P. Zangrillo A. La Canna G. Alfieri O. Colombo A. Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.JACC Cardiovasc Interv. 2010; 3: 1110-1121Crossref PubMed Scopus (125) Google Scholar, 23Tchetche D. Dumonteil N. Sauguet A. Descoutures F. Luz A. Garcia O. Soula P. Gabiache Y. Fournial G. Marcheix B. Carrie D. Fajadet J. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population.EuroIntervention. 2010; 5: 659-665Crossref PubMed Scopus (130) Google Scholar All patients with symptomatic severe aortic stenosis who underwent TAVI had been judged to be at high operative risk by multidisciplinary heart team consensus. The body mass index (BMI) was defined as the weight in kilograms divided by the square of the height in meters. The weight and height of all the patients were collected at hospital admission before the TAVI procedure. Categorization of the BMI was adopted from the World Health Organization and National Institutes of Health and defined as underweight ( 30 kg/m2).24Expert Panel on the Identification, Evaluation, and Treatment of Overweight in Adults. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary.Am J Clin Nutr. 1998; 68: 899-917Abstract Full Text PDF PubMed Scopus (1144) Google Scholar The primary end point of the present study was all-cause mortality at 30 days and during follow-up. The secondary end points included death, myocardial infarction, cerebrovascular complications, vascular and bleeding complications, and acute kidney injury (AKI), in accordance with the VARC end point definitions.21Leon M.B. Piazza N. Nikolsky E. Blackstone E.H. Cutlip D.E. Kappetein A.P. Krucoff M.W. Mack M. Mehran R. Miller C. Morel M. Petersen J. Popma J.J. Takkenberg J.J.M. Vahanian A. van Es G.-A. Vranckx P. Webb J.G. Windecker S. Serruys P.W. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.J Am Coll Cardiol. 2011; 57: 253-269Crossref PubMed Scopus (700) Google Scholar After hospital discharge, mortality data were collected by contacting the civil registries or the referring physician or general practitioner. Follow-up data were complete for 99.5% of the patients who survived the first 30 days. Categorical variables are presented as frequencies with percentages and compared using the Pearson's chi-square test or Fisher's exact test, as appropriate. To assess the presence of a linear association between BMI and outcome, linear-by-linear association was used. Continuous variables are presented as the mean ± SD in the case of a normal distribution or median and interquartile range in the case of a skewed distribution and compared using analysis of variance. The normality of the distributions was assessed using the Shapiro-Wilks test. Superiority testing was only performed between the normal weight, overweight, and obese groups owing to the low sample size in the underweight group (n = 25). Univariate and multivariate logistic regression analysis was used to assess the effect of BMI on 30-day mortality. Cox proportional hazard regression analysis was performed to determine the relation between BMI (category) and mortality during follow-up. All BMI categories, except for the underweight category, were entered into the model, with the normal weight patients (BMI 18.5 to 24.9 kg/m2) as the reference group. Multivariate analysis was adjusted for all differences in baseline and procedural characteristics (age, gender, diabetes, chronic obstructive pulmonary disease, coronary disease, learning effect (first vs latter ½ of cohort), sheath size (18Fr or 19Fr vs >19Fr), percutaneous versus surgical access, peripheral vascular disease, logistic European System for Cardiac Operative Risk Evaluation (logistic EuroSCORE; [LES]), left ventricular ejection fraction ≤35%, and glomerular filtration rate ≤60 ml/min/1.73 m2). Additionally, univariate and multivariate (logistic or Cox) regression analysis was performed, with BMI as a continuous variable to determine the relation of an increase in 1 kg/m2 and the primary end point. Survival curves for time-to-event variables were constructed for patients who survived the first 30 days after TAVI (landmark analysis) using Kaplan-Meier estimates and compared using the log-rank test. A 2-sided α level of 0.05 was used for all superiority testing. All statistical analysis were performed using the Statistical Package for Social Sciences software, version 17.0 (SPSS, Chicago, Illinois). A total of 940 patients with complete information on weight and height were included in the present study. Four patients were excluded because of missing data for either height or weight. The baseline characteristics and procedural details of the population according to the 4 predefined BMI categories are summarized in Tables 1 and 2. Overall, 57% of the patients were either overweight or obese. The latter constituted 17% of the population. These patients were in general younger, with a greater prevalence of preserved left ventricular systolic and renal function but more diabetes. The first 2 characteristics explained the lower LES (18.7%, IQR: 10.9% to 26.4%]) in obese patients. No differences were seen in the procedural details among the different categories (Table 2).Table 1Baseline characteristicsVariableOverall (n = 940)BMI (kg/m2)p Value 30 (n = 159)Age (yrs)81.0 ± 7.0381.4 ± 6.581.7 ± 7.3∗Statistically significant from each other using Bonferroni's correction.80.8 ± 7.079.7 ± 6.4∗Statistically significant from each other using Bonferroni's correction.0.008Men506/940 (54%)8/25 (32%)205/384 (53%)228/372 (61%)65/159 (41%)<0.001Body mass index (kg/m2)26.26 ± 4.3417.50 ± 0.8822.54 ± 1.6127.06 ± 1.3433.38 ± 3.48<0.001New York Heart Association class III or IV761/938 (81%)18/24 (75%)305/383 (80%)299/372 (80%)139/159 (87%)0.09Logistic European System for Cardiac Operative Risk Evaluation20.9 (13.0–29.9)20.5 (11.9–29.1)21.0 (13.8–28.3)21.6 (12.9–30.3)18.7 (10.9–26.4)0.002Previous cerebrovascular accident147/940 (16%)2/25 (8%)61/384 (16%)64/372 (17%)20/159 (13%)0.41Previous myocardial infarction158/940 (17%)3/25 (12%)59/384 (15%)73/372 (20%)23/159 (15%)0.20Previous coronary bypass grafting207/940 (22%)3/25 (12%)69/384 (18%)100/372 (27%)35/159 (22%)0.013Previous percutaneous coronary intervention277/940 (30%)4/25 (16%)114/384 (30%)121/372 (33%)38/159 (24%)0.14Coronary artery disease425/940 (45%)6/25 (24%)164/384 (43%)193/372 (52%)62/159 (39%)0.007Diabetes mellitus268/940 (29%)6/25 (24%)86/384 (22%)107/372 (29%)69/159 (43%)<0.001Hypertension656/940 (70%)14/25 (56%)265/384 (69%)265/372 (71%)112/159 (70%)0.80Serum creatinine level (μmol/L)99.0 (72.4–125.7)83.1 (67.2–99.0)99.5 (74.1–124.9)101.3 (70.0–132.6)108.1 (87.3–128.8)0.06Glomerular filtration rate (ml/min/1.73 m2)†Glomerular filtration rate was calculated using the Modification of Diet in Renal Disease equation.57.6 (41.0–74.2)71.2 (54.8–87.6)56.9 (41.1–72.6)57.3 (39.3–75.3)59.9 (45.2–74.5)0.57Glomerular filtration rate <60 ml/min/1.73 m2591/937 (63%)20/25 (80%)275/383 (72%)221/372 (59%)75/157 (48%)<0.001Chronic obstructive pulmonary disease323/940 (34%)8/25 (32%)128/384 (33%)126/372 (34%)61/159 (38%)0.51Peripheral vascular disease234/936 (25%)8/24 (33%)96/383 (25%)100/370 (27%)30/159 (19%)0.14Permanent pacemaker105/940 (11%)0/2549/384 (13%)46/372 (12%)10/159 (6%)0.08EchocardiographyAortic valve annulus (mm)23.11 ± 2.1122.21 ± 2.3023.02 ± 2.2623.30 ± 1.9723.01 ± 1.950.15Left ventricular ejection fraction ≤35%160/940 (17.0)6/25 (24%)79/384 (21%)57/372 (15%)18/159 (11%)0.019Aortic valve area (cm2)0.71 ± 0.190.63 ± 0.180.68 ± 0.190.73 ± 0.20∗Statistically significant from each other using Bonferroni's correction.0.73 ± 0.19∗Statistically significant from each other using Bonferroni's correction.0.001Data are presented as mean ± SD, n (%), or median (interquartile range).∗ Statistically significant from each other using Bonferroni's correction.† Glomerular filtration rate was calculated using the Modification of Diet in Renal Disease equation. Open table in a new tab Table 2Procedural characteristicsVariableOverall (n = 940)BMI (kg/m2)p Value 30 (n = 159)Prosthesis type and size Medtronic CoreValve 26-mm152/940 (16%)8/25 (32%)59/384 (15%)59/372 (16%)26/159 (16%)0.96 Medtronic CoreValve 29-mm348/940 (43%)5/25 (20%)142/384 (37%)132/372 (36%)69/159 (43%)0.22 Medtronic CoreValve 31-mm5/940 (1%)0/250/3845/372 (1%)0/1590.025 Edwards Sapien 23-mm155/940 (17%)9/25 (36%)74/384 (19%)46/372 (12%)26/159 (16%)0.034 Edwards Sapien 26-mm274/940 (29%)3/25 (12%)106/384 (28%)127/372 (34%)38/159 (24%)0.032 Edwards Sapien 29-mm6/940 (1%)0/253/384 (1%)3/372 (1%)0/1590.53Sheath size 18Fr Medtronic500/940 (53%)11/25 (44%)200/384 (52%)196/372 (53%)93/159 (59%)0.37 18–19Fr Edwards242/940 (26%)9/25 (36%)106/384 (28%)88/372 (24%)39/159 (25%)0.44 >19Fr198/940 (21%)5/25 (20%)78/384 (20%)88/372 (24%)27/159 (17%)0.20Vascular access SurgicalFemoral artery94/940 (10%)2/25 (8%)41/384 (11%)38/372 (10%)13/159 (8%)0.67Subclavian artery57/940 (6%)0/2527/384 (7%)17/372 (5%)13/159 (8%)0.20Transapical89/940 (10%)3/25 (12%)38/384 (10%)40/372 (11%)5/159 (5%)0.11 PercutaneousFemoral artery696/940 (74%)20/25 (80%)277/384 (72%)275/372 (74%)124/159 (78%)0.37Transaortal4/940 (0.4%)0/251/384 (0.3%)2/372 (1%)1/159 (1%)0.78Therapy-specific results Concomitant percutaneous coronary intervention21/940 (2%)0/259/384 (2%)7/372 (2%)5/159 (3%)0.73 Postimplantation balloon dilation115/940 (12%)3/25 (12%)45/384 (12%)47/372 (13%)20/159 (13%)0.73 Valve-in-valve implantation31/940 (3%)1/25 (4%)13/384 (3%)12/372 (3%)5/159 (3%)0.87 Coronary obstruction3/940 (0.3%)0/251/384 (0.3%)1/372 (0.3%)1/159 (1%)0.51 Open table in a new tab Data are presented as mean ± SD, n (%), or median (interquartile range). The in-hospital outcomes (VARC definitions) are summarized in Table 3. Obese patients had a greater incidence of minor stroke (1.3% vs 0% and 0.3% in normal weight and overweight patients, respectively; p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, respectively, p = 0.028), and AKI stage I (23.3% vs 10.7% and 16.1%, respectively, p <0.001) Long-term follow-up data were complete for 99.5% of all patients, and follow-up ranged from 1 to 72 months (median 12, interquartile range 6 to 18). Kaplan-Meier estimates of survival after hospital discharge disclosed no difference in survival in the various patient categories (log-rank, p = 0.76; Figure 1).Table 3In-hospital outcomes according to Valve Academic Research Consortium (VARC) outcomesOverall (n = 940)BMI (kg/m2)p Value 30 (n = 159)Device success885/940 (94%)23/25 (92%)362/384 (94%)350/372 (94%)150/159 (94%)1.00All-cause 30-day or in-hospital death68/940 (7%)5/25 (20%)33/384 (9%)21/372 (6%)9/159 (6%)0.13Cerebrovascular complication Major stroke22/940 (2%)0/259/384 (2%)10/372 (3%)3/159 (2%)0.86 Minor stroke3/940 (0.3%)0/2501/372 (0.3%)2/159 (1%)0.03 Transient ischemic attack13/940 (1%)0/255/384 (1%)4/372 (1%)4/159 (3%)0.40Myocardial infarction Periprocedural ( 72 h)6/940 (1%)0/253/384 (1%)2/372 (1%)1/159 (1%)0.77Bleeding complications Life-threatening129/940 (14%)4/25 (16%)50/384 (13%)56/372 (15%)19/159 (12%)0.97 Major198/940 (21%)6/25 (24%)73/384 (19%)84/372 (23%)159/35 (22%)0.31 Minor102/940 (11%)3/25 (12%)43/384 (11%)37/372 (10%)19/159 (12%)0.96Vascular complications Major101/940 (11%)3/25 (12%)40/384 (10%)41/372 (11%)17/159 (11%)0.87 Minor107/940 (11%)4/25 (16%)35/384 (9%)43/372 (12%)25/159 (16%)0.028Acute kidney injury Stage I139/940 (15%)1/25 (4%)41/384 (10%)60/372 (16%)37/159 (23%)<0.001 Stage II34/940 (4%)1/25 (4%)12/384 (3%)12/372 (3%)9/159 (6%)0.21 Stage III43/939 (5%)2/25 (8%)17/383 (4%)19/372 (5%)5/159 (3%)0.67Total hospital stay (days)8.0 (5.5–10.5)7.0 (4.0–10.0)8.0 (5.5–10.5)8.0 (5.5–10.5)8.0 (5.5–10.5)0.84Red blood cell transfusion required363/937 (39%)12/25 (48%)143/382 (37%)144/371 (39%)64/159 (40%)0.53Prosthetic valve-associated complication (permanent pacemaker requirement)145/938 (16%)3/25 (12%)54/382 (14%)60/372 (16%)28/159 (18%)0.28Combined safety end point248/940 (26%)9/25 (36%)101/384 (26%)106/372 (29%)32/159 (20%)0.29 Open table in a new tab Univariate and multivariate analysis results of the association between the BMI and short- and long-term mortality are listed in Tables 4 and 5. When using BMI as a categorical variable (Table 4), no association between the BMI and 30-day and 1-year mortality was found. However, the BMI as a continuous variable was associated with a significant reduction of the risk of 30-day all-cause mortality, which remained significant after adjustment for baseline differences (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023). The BMI did not affect mortality after hospital discharge.Table 4Effect of Body Mass Index (Categorical) on short- and long-term mortalityOutcomeOR (95% CI)p ValueBMI 30 kg/m2All–cause 30-day mortality UnivariateExcluded†Excluded from analysis because of low sample size.Reference0.64 (0.36–1.12)0.64 (0.30–1.37)0.23 Multivariate‡Adjusted for all differences in baseline and procedural characteristics.Excluded†Excluded from analysis because of low sample size.Reference0.59 (0.32–1.08)0.67 (0.29–1.55)0.21Mortality during follow-up∗Landmark analysis included patients who did not die during hospitalization or within 30 days of index procedure. UnivariateExcluded†Excluded from analysis because of low sample size.Reference1.11 (0.71–1.73)0.89 (0.48–1.65)0.81 Multivariate‡Adjusted for all differences in baseline and procedural characteristics.Excluded†Excluded from analysis because of low sample size.Reference1.17 (0.72–1.89)1.34 (0.70–2.56)0.65CI = confidence interval; OR = odds ratio.∗ Landmark analysis included patients who did not die during hospitalization or within 30 days of index procedure.† Excluded from analysis because of low sample size.‡ Adjusted for all differences in baseline and procedural characteristics. Open table in a new tab Table 5Effect of Body Mass Index (BMI) on short- and long-term mortalityOutcomeOR/HR (95% CI)p ValueAll-cause 30-day mortality Univariate0.92 (0.87–0.98)0.011 Multivariate†Adjusted for all differences in baseline and procedural characteristics.0.93 (0.86–0.98)0.023Mortality during follow-up∗Landmark analysis included patients who did not die during hospitalization or within 30 days of index procedure. Univariate0.98 (0.94–1.03)0.47 Multivariate†Adjusted for all differences in baseline and procedural characteristics.1.01 (0.96–1.07)0.73CI = confidence interval; HR = hazard ratio; OR = odds ratio.∗ Landmark analysis included patients who did not die during hospitalization or within 30 days of index procedure.† Adjusted for all differences in baseline and procedural characteristics. Open table in a new tab CI = confidence interval; OR = odds ratio. CI = confidence interval; HR = hazard ratio; OR = odds ratio. The main finding of the present study was that obesity (BMI >30 kg/m2) is not associated with an increased risk of major perioperative complications during TAVI and that—after correction for differences in baseline characteristics—obesity is associated with a significant decrease in all-cause 30-day mortality. The BMI did not affect mortality after hospital discharge. Both underscore the "obesity paradox" in patients undergoing TAVI. These conclusions stem from a multicenter observation of 940 patients, of whom 16.9% were obese, underscoring the "obesity paradox." Intuitively, one would expect an increased operative risk in obese patients and, in particular, an increased risk of access site-related complications. We did not find a difference in the composite VARC safety end point and its individual components, except for minor vascular complications, minor stroke, and AKI stage I. The absence of a difference in major bleeding and vascular complications between obese and nonobese patients could not be explained by a different access site strategy, because no such difference was found among the 4 patient groups. It is acknowledged, however, that failure of the closure device during TAVI has been reported to occur in 7.4% and 9.4% of the patients, with a trend toward more failure in obese patients.25Van Mieghem N.M. Tchetche D. Chieffo A. Dumonteil N. Messika-Zeitoun D. van der Boon R.M.A. Vahdat O. Buchanan G.L. Marcheix B. Himbert D. Serruys P.W. Fajadet J. Colombo A. Carrié D. Vahanian A. de Jaegere P.P.T. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation.Am J Cardiol. 2012; 110: 1361-1367Abstract Full Text Full Text PDF PubMed Scopus (192) Google Scholar, 26Hayashida K. Lefèvre T. Chevalier B. Hovasse T. Romano M. Garot P. Mylotte D. Uribe J. Farge A. Donzeau-Gouge P. Bouvier E. Cormier B. Morice M.-C. True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications.JACC Cardiovasc Interv. 2012; 5: 207-214Crossref PubMed Scopus (104) Google Scholar The latter could be a reason for the greater frequency of minor vascular complications in the present cohort. The low number of patients with stroke, a minor stroke in particular, precluded any meaningful conclusion in relation to the association with obesity. With respect to AKI, it is unclear why obese patients had a greater incidence of AKI stage I after TAVI. No difference was seen in baseline renal insufficiency or in the use of contrast during TAVI. A relation between blood transfusion and AKI has recently been demonstrated.27Nuis R.-J.M. Van Mieghem N.M. Tzikas A. Piazza N. Otten A.M. Cheng J. van Domburg R.T. Betjes M. Serruys P.W. de Jaegere P.P.T. Frequency, determinants, and prognostic effects of acute kidney injury and red blood cell transfusion in patients undergoing transcatheter aortic valve implantation.Catheter Cardiovasc Interv. 2011; 77: 881-889Crossref PubMed Scopus (122) Google Scholar However, a different frequency of blood transfusion in the various patient groups was not likely, given the similar incidence of bleeding complications in the 4 groups. On multivariate analysis, we found a statistically significant reduction in 30-day all-cause mortality and, more specifically, that every BMI increase in 1 kg/m2 was associated with a 7% mortality reduction. Moreover, obesity did not have an adverse effect on mortality after hospital discharge. This is at variance with the findings in patients who undergo percutaneous coronary intervention, for whom a lower risk of late death has been reported for patients with moderate obesity.8Galal W. van Domburg R.T. Feringa H.H.H. Schouten O. Elhendy A. Bax J.J. Awara A.M.M. Klein J. Poldermans D. Relation of body mass index to outcome in patients with known or suspected coronary artery disease.Am J Cardiol. 2007; 99: 1485-1490Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar, 9Powell B.D. Lennon R.J. Lerman A. Bell M.R. Berger P.B. Higano S.T. Holmes Jr., D.R. Rihal C.S. Association of body mass index with outcome after percutaneous coronary intervention.Am J Cardiol. 2003; 91: 472-476Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar, 10Hastie C.E. Padmanabhan S. Slack R. Pell A.C.H. Oldroyd K.G. Flapan A.D. Jennings K.P. Irving J. Eteiba H. Dominiczak A.F. Pell J.P. Obesity paradox in a cohort of 4880 consecutive patients undergoing percutaneous coronary intervention.Eur Heart J. 2010; 31: 222-226Crossref PubMed Scopus (172) Google Scholar, 11Byrne J. Spence M.S. Fretz E. Mildenberger R. Chase A. Berry B. Pi D. Janssen C. Klinke P. Hilton D. 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The influence of optimal medical treatment on the "obesity paradox," body mass index and long-term mortality in patients treated with percutaneous coronary intervention: a prospective cohort study.BMJ Open. 2012; 2: e000535Crossref PubMed Scopus (73) Google Scholar, 28Sarno G. Räber L. Onuma Y. Garg S. Brugaletta S. van Domburg R.T. Pilgrim T. Pfäffli N. Wenaweser P. Windecker S. Serruys P. Impact of body mass index on the five-year outcome of patients having percutaneous coronary interventions with drug-eluting stents.Am J Cardiol. 2011; 108: 195-201Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar This discrepancy can be explained by several factors such as the definition of obesity and the duration of follow-up, but also by the specific features related to obese patients undergoing catheter-based cardiac interventions. Similar to the findings of Sarno et al,28Sarno G. Räber L. Onuma Y. Garg S. Brugaletta S. van Domburg R.T. Pilgrim T. Pfäffli N. Wenaweser P. Windecker S. Serruys P. Impact of body mass index on the five-year outcome of patients having percutaneous coronary interventions with drug-eluting stents.Am J Cardiol. 2011; 108: 195-201Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar who used the same definition of obesity in patients undergoing percutaneous coronary intervention, we found that obese patients were younger than the nonobese patients. In addition, the obese patients in the present study had a greater prevalence of preserved ventricular and renal function. The combination of these characteristics might have contributed and, even explain, the lower rate of all-cause mortality at 30 days, providing a possible explanation for the apparent paradox. The number of patients who were underweight (BMI <18.5 kg/m2) was too small to study the relation between underweight and outcome. Thus, the present study lacked the power to detect the previously reported U-shaped association between body weight and mortality.29Allison D.B. Faith M.S. Heo M. Kotler D.P. Hypothesis concerning the U-shaped relation between body mass index and mortality.Am J Epidemiol. 1997; 146: 339-349Crossref PubMed Scopus (180) Google Scholar, 30Romero-Corral A. Montori V.M. Somers V.K. Korinek J. Thomas R.J. Allison T.G. Mookadam F. Lopez-Jimenez F. Association of bodyweight with total mortality and with cardiovascular events in coronary artery disease: a systematic review of cohort studies.Lancet. 2006; 368: 666-678Abstract Full Text Full Text PDF PubMed Scopus (1221) Google Scholar The present study had several limitations that should be addressed. The PRAGMATIC Plus collaboration was a retrospective analysis of prospectively collected data. Despite care with data collection and the use of the VARC end point definitions, some degree of observation bias must be expected. Moreover, the clinical end points were not adjudicated by an independent clinical event committee. In addition, a number of variables that might confound the outcome (e.g., frailty) were not available for analysis and might have affected the robustness of the multivariate analysis, its interpretation, and the conclusions. Dr. Tchetche and Dr. Dumonteil are proctors for Edwards Lifesciences, Inc., Irvine, California and Medtronic CoreValve, Minneapolis, Minnesota. Dr. Marcheix is a proctor for Edwards Lifesciences. Dr. de Jaegere is a proctor for Medtronic CoreValve.

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