Impact of High Body Mass Index on Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation

Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI. Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI. 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Meta-analysis of effect of body mass index on outcomes after transcatheter aortic valve implantation. Am J Cardiol;119:308-316.Google Scholar However, besides this debated inverse relationship with BMI, a direct impact to vascular and bleeding complications after TAVI has not been well characterized. Within this framework, a relevant question arise as to whether high BMI affects the risk of vascular complications and bleeding associated with TAVI. We aimed to investigate the 30-day vascular and bleeding outcomes of patients with high versus normal BMI undergoing TAVI procedures. The current project is a planned analysis of the RISPEVA registry. Details on the registry are reported elsewhere.13Giordano A Corcione N Biondi-Zoccai G Berti S Petronio AS Pierli C Presbitero P Giudice P Sardella G Bartorelli AL Bonmassari R Indolfi C Marchese A Brscic E Cremonesi A Testa L Brambilla N Bedogni F Patterns and trends of transcatheter aortic valve implantation in Italy: insights from RISPEVA.J Cardiovasc Med. 2017; 18: 96-102Crossref Scopus (18) Google Scholar Briefly, RISPEVA is a prospective database addressing complications and outcomes after TAVI involving over 20 Italian centers performing TAVI. The study is registered online (clinicaltrials.gov ID: NCT02713932). Data were collected between March 2012 and July 2019. Centers contributing to this study have long-standing and high-volume experience in TAVI. Relevant baseline information, as well as vascular and bleeding outcomes at 30-days, were entered into prespecified electronic case report forms. This study received approval by the local ethics committee of all participating centers, and patients signed a written informed consent. The primary endpoint was addressed at 30 days and was predefined as the composite of access-related vascular and bleeding complications. Patients were classified according to the World Health Organization criteria such as normal weight, overweight, or obese according to their BMI (18.5 to 24.9 kg/m2, 25.0 to 29.9 kg/m2, and ≥30.0 kg/m2, respectively). High BMI was defined as ≥25 kg/m2. Clinical events were classified according to the Valve Academic Research Consortium-2 criteria.14Kappetein AP Head SJ Généreux P Piazza N van Mieghem NM Blackstone EH Brott TG Cohen DJ Cutlip DE van Es GA Hahn RT Kirtane AJ Krucoff MW Kodali S Mack MJ Mehran R Rodés-Cabau J Vranckx P Webb JG Windecker S Serruys PW Leon MB Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.EuroIntervention. 2012; 8: 782-795Crossref PubMed Scopus (160) Google Scholar Information on follow-up events was site-reported and adjudicated by a trained physician-investigator. Secondary endpoints were the individual components included in the primary outcome. All analyses have been performed in the propensity-matched population. Categorical variables are reported as n (%) and continuous variables as mean ± standard deviation. Categorical variables were compared by χ2 or Fisher's exact tests, as appropriate. Continuous data were analyzed by independent-samples t-test. An adjusted analysis based on propensity score (PS) was performed. PS is the probability that each individual patient is included in the high BMI or normal BMI group and was estimated via logistic regression based on the available baseline covariates.15Austin PC An introduction to propensity score methods for reducing the effects of confounding in observational studies.Multivariate Behav Res. 2011; 46: 399-424Crossref PubMed Scopus (5029) Google Scholar Potential confounders were entered into the PS model on the of known or of (p observed at was performed by a logistic or regression model with and and a by to G C D A review and for the 2018; PubMed Scopus Google Scholar that were used to the PS model are in data were in of variables or the was had a higher of that data were at used logistic logistic regression and mean as to in using the R We and the analyses were performed on each of was used to PS adjusted and for each endpoint and according to the A analysis using PS as was Full was performed to methods for a review and a 25: PubMed Scopus Google Scholar using PS were included in the survival analysis to estimate adjusted event for high and was used to the was the standardized mean between and adjusted and of the were estimated for all the baseline and after to and of for a indicate a A p was significant for all the p was and a was The adjusted analysis was performed using R and as survival and an of a total of 3776 subjects undergoing TAVI were matched with the and included in the analysis and outcome data of patients with high BMI were compared with of patients with normal All TAVI were performed via with local and characteristics at are reported in The baseline characteristics were in the matched with significant between the high versus normal BMI as by standardized and PS in between and and characteristics of patients with high versus normal = = ± ± Body mass index ± ± artery ± ± ± ± ± ± ± ± ± ± data ± ± ± ± ± ± ± ± ± ± ± ± vascular data and and characteristics vascular ± ± time ± ± as mean ± or n body mass = was using the Heart = standard score = of 30-day mortality in a Data as mean ± or n body mass = was using the Heart = standard score = of 30-day mortality The of the primary endpoint in the high BMI versus normal BMI is in 30-days, compared with normal BMI, high BMI a significantly greater risk of the composite primary endpoint (11.1% vs 8.8%, p = 0.03). This relationship significant after for high BMI versus normal BMI or bleeding complications rates were higher both in obese and overweight patients as compared with the normal BMI group An analysis of the primary endpoint at 30 days was The of composite of vascular and bleeding complications was significantly greater in the high BMI group within the 30 time frame A landmark analysis of the event at the 7 landmark the significant increased within 7 days of vascular or bleeding complications in the high versus normal BMI This not significant in the time between 7 and 30 days The between increased BMI values and events was using BMI as continuous a significant linear association with vascular complications at 30 days The 30-day primary outcome was in prespecified compared with normal BMI, the risk of the primary endpoint greater in the high BMI of of vascular and of A significant with and used was with patients having higher BMI and with at the risk of complications BMI was high By analysis, whether in over time have the results by the effect of high BMI in patients undergoing TAVI in the to to that for to 2019. were time with a significant in the of bleeding in the high versus normal BMI for both time CI to p = for to and CI to p = for without a significant p for complications or bleeding risk at 30-day follow-up with high versus normal BMI in prespecified = coronary artery CI = = = N = of events in each = 30-day follow-up a significantly increased risk of vascular complications in the high BMI was vs p = A significant increased risk of bleeding was observed in the high BMI vs p = was significant using propensity score as These bleeding were by a significant of bleeding vs p = The significant was by the propensity score as a outcomes at 30 days in subjects with high versus normal BMI undergoing = = adjusted score adjusted vascular vascular vascular or = body mass CI = = in a BMI = body mass CI = = The findings of this analysis of 3776 propensity-matched patients are as compared with normal BMI, high BMI values are associated with a greater 30-day risk of access-related vascular or bleeding the effect on these complications more within 7 days after a direct linear association is observed between BMI and the risk of vascular complications. The of high BMI and obesity in the TAVI has been of studies have that obesity as a in TAVI, to an W Li S Liao Y Zhao Z Che G Chen M Feng Y The 'obesity paradox' does exist in patients undergoing transcatheter aortic valve implantation for aortic stenosis: a systematic review and meta-analysis.Interact Cardiovasc Thorac Surg. 2017; 25: 633-642Crossref PubMed Scopus (17) Google A, Schiattarella GG, Toscano E, Gargiulo G, Giugliano G, Galderisi M, Losi M-A, Stabile E, Cirillo P, Imbriaco M, Grayburn PA, Trimarco B, Esposito G. Meta-analysis of effect of body mass index on outcomes after transcatheter aortic valve implantation. Am J Cardiol;119:308-316.Google A Lavie CJ Borer JS A S F A D JM Meta-analysis of the of body mass index to all-cause and cardiovascular mortality and in patients with heart J Cardiol. Full Text Full Text PDF PubMed Scopus Google Scholar, M G A M M H J B P P A A M K E Effect of body mass index on and and survival rates of transcatheter aortic valve implantation the National and J Cardiol. Full Text Full Text PDF PubMed Scopus Google Scholar, A N D Mieghem NM O B Serruys PW J A D van Domburg RT de Effect of body mass index on and long-term outcomes after transcatheter aortic valve J Cardiol. Full Text Full Text PDF PubMed Scopus Google Scholar reported rates of outcomes after TAVI in overweight and obese compared with normal weight or patients at study reported effect of high BMI on mortality and outcomes in patients with BMI 20 E S R S J R P Satler LF Pichard AD Waksman R Body mass index association with survival in aortic stenosis patients undergoing transcatheter aortic valve Cardiovasc 2016; PubMed Scopus Google Scholar The increased mortality in the groups by characteristics of this and the AP Head SJ Généreux P Piazza N van Mieghem NM Blackstone EH Brott TG Cohen DJ Cutlip DE van Es GA Hahn RT Kirtane AJ Krucoff MW Kodali S Mack MJ Mehran R Rodés-Cabau J Vranckx P Webb JG Windecker S Serruys PW Leon MB Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus Heart 2012; PubMed Scopus Google HJ HJ Patel H C A review of the of in and a 2011; PubMed Scopus Google Scholar to these high BMI to a and affects the outcomes over However, this to the of a effect of high BMI on TAVI outcomes of the after the TAVI procedure. Within this framework, the impact of high BMI on vascular access-related complications and bleeding has not been clarified. have to a of the and TAVI vascular and bleeding complications to in a of patients undergoing L A J P E J G and of after Valve A PubMed Scopus Google Scholar, T M H M K M of the used for transcatheter aortic valve PubMed Scopus (17) Google Scholar, Z W C T M M J L D J S of of on vascular complications and mortality in TAVI using the 2017; PubMed Scopus Google Scholar, MW K Matsouaka R Li Z Vemulapalli S A D Kirtane A AM and associated outcomes of vascular and bleeding complications in patients undergoing transcatheter aortic valve replacement: insights from the of of transcatheter valve Cardiovasc 2020; Google Scholar, S Bedogni F A Petronio AS A Bartorelli AL B C C T A Sardella G Bonmassari R M F G and of versus vascular in transcatheter aortic valve replacement: the RISPEVA Am Heart 2020; PubMed Scopus Google Scholar, Z J F A Bartorelli AL Bedogni F M F A B C K J A M T W W M D Berti S and of a to Patients at of Cardiovasc PubMed Scopus Google Scholar or that to the risk of vascular complications is a TAVI. Increased in and of vascular L E G F T F M for patient and Cardiovasc Med. 2018; PubMed Scopus Google Scholar weight to in and in that more the M MA HL JH Body mass index and the risk of artery in coronary 2018; Google Scholar in the associated with higher BMI has been reported in patients undergoing coronary and in for and is by the to the and the to the JJ Cohen M Jr., The current of results from the Am Coll Cardiol. 2001; 38: PubMed Scopus Google Scholar A high BMI has been associated with increased and Z J F A Bartorelli AL Bedogni F M F A B C K J A M T W W M D Berti S and of a to Patients at of Cardiovasc PubMed Scopus Google Scholar A of this study in a propensity matched of 3776 subjects undergoing TAVI is the of higher BMI to an of access-related vascular and bleeding complications. The analysis of the event a of the for the of vascular and bleeding complications in patients with high BMI undergoing TAVI. 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