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) not clarified. RISPEVA, a multicenter prospective database TAVI stratified by was used for this analysis. Patients were classified as normal or (obese overweight) according to the World Health Organization criteria. A comparison 30-day outcomes between groups performed using propensity scores methods. total 3776 matched subjects their baseline characteristics included. Compared with BMI, had significantly greater composite (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 1.61]; p = 0.03). Complications rates higher both obese (11.3%) overweight (10.5%), compared weight (8.8%). By landmark event analysis, effect versus these appeared more pronounced within 7 days after procedure. significant linear association increased observed at time frame (p In conclusion, TAVI, experience complications. These findings indicate that independent predictor TAVI. 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Meta-analysis implantation. Cardiol;119:308-316.Google However, besides debated inverse direct well characterized. Within framework, relevant question arise whether affects We aimed investigate procedures. current project planned analysis RISPEVA registry. Details registry elsewhere.13Giordano Corcione Biondi-Zoccai Berti Petronio AS Pierli Presbitero Giudice Sardella Bartorelli AL Bonmassari Indolfi Marchese Brscic Cremonesi Testa Brambilla Bedogni Patterns trends Italy: insights RISPEVA.J Med. 18: 96-102Crossref (18) Briefly, addressing involving over 20 Italian centers performing study registered online (clinicaltrials.gov ID: NCT02713932). Data collected March 2012 July 2019. Centers contributing have long-standing high-volume Relevant information, 30-days, entered into prespecified electronic case forms. This received approval local ethics committee all participating centers, signed written informed consent. primary endpoint addressed 30 predefined access-related criteria such weight, overweight, (18.5 24.9 kg/m2, 25.0 29.9 ≥30.0 respectively). High defined ≥25 kg/m2. Clinical events Valve Academic Research Consortium-2 criteria.14Kappetein AP Head SJ Généreux Piazza Mieghem NM Blackstone EH Brott TG Cohen DJ Cutlip DE Es GA Hahn Kirtane AJ Krucoff MW Kodali Mack Mehran Rodés-Cabau Vranckx Webb JG Windecker Serruys PW Leon MB Updated standardized definitions implantation: consensus document.EuroIntervention. 2012; 8: 782-795Crossref (160) Information follow-up site-reported adjudicated trained physician-investigator. Secondary endpoints individual components included outcome. All analyses propensity-matched population. Categorical variables n (%) continuous mean ± standard deviation. χ2 Fisher's exact tests, appropriate. Continuous data analyzed independent-samples t-test. 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After that, Rubin's rule derive pooled odds ratio (OR) estimates confidence intervals (CIs) (primary secondary), method. further sensitivity covariate used. bias.17Stuart EA Matching causal inference: look forward.Stat Sci. 2010; 1-21Crossref (2316) Weights 2 cumulative curves (1 low BMI). Log rank test compare curves. Covariate balancing assessed exploring differences unadjusted populations distribution PS. Standardized covariates before assess pre-match imbalance post-match balance. 10.0% given relatively small imbalance. value <0.05 considered statistically analyses. For subgroup analyses, interaction calculated <0.10 significant. 4.0 some related packages, mice, matchthem packages. From initial cohort 5856 patients, full procedure (Figure 1). Demographic, clinical, those BMI. procedures femoral access anesthesia. Clinical, echocardiographic procedural presentation 1. balanced population no cohorts, expressed frequency active control.Table 1Baseline BMIBMI (kg/m2)Variable≥25(n 2405)18.5-24.9(n 1371)p Age (years)82.2 7981 520.86 Women1386 (57.6%)816(59.5%)0.91 (kg/m2)29.06 3.6422.42 1.97<0.001 Coronary Disease826 (34.3%)469 (34.2%)0.93 Diabetes mellitus716 (29.8%)391(28.5%)0.41 Smoker220 (9.1%)127 (9.3%)0.90 Dyslipidemia1354 (56.3%)754 (55.0%)0.43 Arterial Hypertension2031 (84.4%)1160 (84,6%)0.89 Chronic kidney disease686 (28.5%)395 (28.8%)0.85 STS score6.1 5.76.2 6.00.86 Euroscore (logistic)17.4 12.918.9 13.00.36 Frailty score3.73 4.13.78 4.60.72 NYHA class0.74 I57 (2.4%)26 (1.9%) II719 (29.9%)400 (29.2%) III1462 (60.8%)850 (62%) IV167 (6.9%)95 (6.9%) Hemoglobin (g/dl)12.0 1.612.0 1.60.86 Platelet count (x103/µl)208.6 71.2209.4 76.60.74Echocardiographic Left ventricular end-diastolic diameter (mm)50.6 12.949.5 12.90.72 end-systolic (mm)33.4 10.133.3 9.60.81 ejection fraction (%)53.06 10.652.7 11.30.36 Peak gradient (mm Hg)77.4 2376.9 22.40.52 Mean Hg)48.9 17.548.1 14.80.16 Annular area (mm2)401.2 137.8402.3 138.90.80Computed tomography Tortuosity0.67 Mild2216 (92.1%)1258 (91.8%) Moderate severe189 (7.9%)113 (8.2%) Calcium (access site)0.18 Mild2138 (88.9%)1199 (87.5%) severe267 (11.1%)172 (12.5%) Porcelain aorta243 (10.1%)164 (12.0%)0.07Procedural ProGlide closure device1279 (53.2%)736 (53.7%)0.76 Prosthesis type0.76 Sapien882 (36.7%)492 (35.9%) Corevalve807 (33.6%)506 (36.9%) Portico304 (12.6%)142 (10.4%) Other412 (17.1%)231 (16.8%) Contrast media (ml)169.5 97.2169.6 105.30.97 Fluoroscopy (min)24.7 36.325.1 17.40.76Data SD, (%). BMI= index; grading mild ≤ 1 cm, ≤180˚, moderate > ≤180), severe 180˚; Hospital Risk Score (HFRS).NYHA= New York Association; SD deviation; Society Thoracic Surgeons score. Open table new tab (HFRS). NYHA= incidence presented Figure 2. At yielded remained adjustment comparing 2).Vascular 2). overall conducted. day 3). point displayed periprocedural groups. difference became numerical but explored window relation confirmed measure, identified 4). also subgroups. When group, regardless diabetes, gender, chronic disease, type device (VCD), sheath size degree calcifications. gender VCD noted, male females treated Prostar being greatest 5). multivariate tested changes TAVR practice might influenced years 2013 2016 2017 Results comparable across periods increase frames: OR 1.25 [95% 1.04 1.50], 0.01 1.21 1.02 1.43], 0.02 to2019, interaction.Figure 5Vascular CAD disease; interval; CKD Fr French; number group; ratio.View Large Image ViewerDownload Hi-res image Download (PPT) found (9.8% 7.8%, 0.03) (Table (5.9% 4.4%, 0.03), nominally covariate. driven markedly minor (4.3% 2.5%, 0.005) treating covariate.Table 2Individual TAVIVariableHigh BMI(n 2405)Normal 1371)Propensity CI]p valuePropensity valueAny complication239 (9.8%)107 (7.8%)1.29 [1.02-1.64]0.031.29 [1.12-1.49]<0.001Major complications87 (3.6%)36 (2.6%)1.39 [0.93-2.06]0.101.40 [0.94-2.07]0.09Minor complications149 (6.2%)71 (5.2%)1.20 [0.90-1.61]0.201.90 [0.94-1.61]0.20Any bleeding141(5.9%)61 (4.4%)1.39 [1.01-1.92]0.031.33 [0.98-1.81]0.06Life threatening major bleeding38 (1.6%)27 (2.0%)0.79 [0.48-1.31]0.370.88 [0.51-1.51]0.60Minor bleeding103 (4.3%)34 (2.5%)1.75 [1.18-2.60]0.0051.79 [1.20-2.67]<0.001BMI ratio. salient large-scale that: 1) complications; 2) occurs frequently earlier, afterwards; 3) prognostic role field subject intense debate. 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Another recent neutral worst < kg/m2.21Koifman Kiramijyan Negi SI Didier Escarcega RO Minha Gai Torguson Okubagzi Ben-Dor I replacement.Catheter Interv. 88: 118-124Crossref (26) low-BMI could explained frail smaller peripheral site sizes.22Kappetein document.Eur 33: 2403-2418Crossref (712) Scholar,23Roberts HC Denison Martin HP Syddall Cooper Sayer AA measurement grip strength epidemiological studies: towards standardised approach.Age Ageing. 40: 423-429Crossref (1203) According previous findings, exert favorably time. observation lead misleading interpretation universal beneficial timing early Although technical improvements led progressive downsizing introducers prostheses, continue occur consistent TAVI.24Navarese EP Grisafi Spinoni EG Menunni MG Rognoni Ratajczak Podhajski Koni Kubica Patti Safety Efficacy Different Antithrombotic Strategies Transcatheter Implantation: Network Meta-Analysis.Thromb Haemost. 2021; (In press)https://doi.org/10.1055/a-1496-8114Crossref (4) 26Koehler Buege Schleiting Seyfarth Tiroch Vorpahl Changes eSheath outer dimensions transfemoral replacement.Biomed Res Int. 2015572681Crossref 27Dimitriadis Scholtz Ensminger SM Piper Bitter Wiemer Vlachojannis Börgermann Faber Horstkotte Gummert Impact types approaches Proglide device.PLoS One. 12e0183658Crossref (9) 28Sherwood Xiang Vora AN Fanaroff Harrison JK Thourani VH Holmes Pineda Peterson ED Rao SV Incidence, temporal trends, Surgeons/American College Cardiology therapies registry.Circ 13e008227PubMed 29Berti Giordano Iadanza Reimers Spaccarotella Trani Attisano Marella Cenname Medda Tomai Tarantini Navarese safety XL devices registry.J Assoc. 9e018042Crossref (7) 25Navarese Zhang Andreotti Farinaccio Rupji Wilczek Stepinska Witkowski Grygier Kukulski Wanha Wojakowski Lesiak Dudek Zembala MO Development Validation Practical Model Identify Bleeding TAVR.JACC 14: 1196-1206https://doi.org/10.1016/j.jcin.2021.03.024Crossref Therefore, identifying patient-related factors can contribute pivotal step planning BMIs pose challenges gaining access.30Biasco Ferrari Pedrazzini Faletra Moccetti Petracca Access sites TAVI: criteria, aspects, outcomes.Front 5: 88Crossref (32) Excess contributes patients' anatomy physiology ways render challenging invasive procedure.31Kim Kim Lee WJ Lim WH Seo JB SH Zo puncture angiography under fluoroscopy guidance.Medicine. 97: e0070PubMed Failure due fat panniculus already revascularization need intraortic balloon counterpulsation, determined inability advance secure deep artery.32Ferguson 3rd, Freedman RJ Stone GW Miller MF Joseph DL Ohman EM intra-aortic counterpulsation: Benchmark Registry.J 1456-1462Crossref (262) quality impairment during fluoroscopy-based procedures, radiation dose prolonged times.25Navarese finding conducted drive excess offered better understanding mechanistic underpinnings aggregate, contributed identify stages differently sensitive BMI: later stages. Based frames interventional operator. contrast, appears tempered days, impediments caused operating above ranges. aspect limited affected patients. finding, entire just obese, should referred continuum risk. predicted corroborates hypothesis. guidewire protection contralateral vessel access-site applied most our rate reduced high-BMI worth nothing female high. align XL, use reduction 30-days.29Berti Similarly, Manta, collagen-based technology XL.33De Palma Settergren Rück Linder Saleh arteriotomy MANTA(TM) 92: 954-961Crossref (29) No MANTA studies.34Biancari Romppanen Savontaus Siljander Mäkikallio Piira OP Piuhola Vilkki Ylitalo Vasankari Airaksinen JKE Niemelä implantation.Int 263: 29-31Abstract (42) powered head-to-head will clarify optimal setting. Taken together, call investigations improve Accordingly, implementation ultrasound-guided may reduce high-risk design, presenting limitations common non-randomized prone unmeasured confounders. On other hand, obtained collection forms support hypothesis scope inference done individuals. Thus, future needed suggest potential period Dr proctor Abbott. Sherwood declares honoraria Medtronic Boston scientific. remaining authors disclosures report. reports consulting fees/honoraria Abbott, Astra-Zeneca, Amgen, Bayer, Sanofi-Aventis; grants outside submitted work. declare following financial interests/personal relationships competing interests: Sergio Abbott Vascular includes: advisory. Matthew W. Structural Disease Management speaking lecture fees. Eliano P. EPN SB conceived rationale wrote first draft. co-authors providing important intellectual content critical revision manuscript. .docx (.6 MB) Help docx files