Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation
2022; Elsevier BV; Volume: 180; Linguagem: Inglês
10.1016/j.amjcard.2022.06.046
ISSN1879-1913
AutoresHirokazu Miyashita, Noriaki Moriyama, Sebastian Dahlbacka, Tommi Vähasilta, Tiina Vainikka, Mikko Jalanko, Juho Viikilä, Mika Laine,
Tópico(s)Venous Thromboembolism Diagnosis and Management
ResumoDespite the development of device technology and operators' experience, access site vascular complications (VCs) remain one of the major concerns after transcatheter aortic valve implantation (TAVI). MANTA (Teleflex, Wayne, Pennsylvania) is a large-bore vascular closure device (VCD) with promising incidence of VC. Previously, we demonstrated that the ultrasound-guided MANTA (US-MANTA) technique further improved the outcomes compared with conventional MANTA (C-MANTA) without ultrasound guidance. The present study was established to prove the effectiveness of the technique in a larger population. In this study, we included 1,150 patients (335 patients with C-MANTA and 815 with US-MANTA) who received MANTA after TAVI from April 2017 to September 2021. The primary endpoint was MANTA-related VC. Overall VC, VCD failure, and bleeding complications were also assessed based on the Valve Academic Research Consortium 3 criteria. MANTA-related VC occurred in 12.5% in the C-MANTA group and 6.8% in the US-MANTA group (p = 0.001). VCD failure rate were 7.5% and 3.9%, respectively (p = 0.012). Valve Academic Research Consortium 3 major and minor VC were more frequent in C-MANTA group (major: 7.8% vs 4.4%, p = 0.023; minor: 8.1% vs 4.4%, p = 0.022). Multivariate analysis revealed US-MANTA as the negative predictor of MANTA-related VC (odds ratio 0.57, 95% confidence interval 0.36 to 0.89, p = 0.013). However, subgroup analysis showed the efficacy of the US-MANTA technique was limited to the patients without severely calcified puncture site (Pinteraction = 0.048). In conclusion, the US-MANTA technique was an effective strategy to reduce VC after transfemoral TAVI compared with C-MANTA. Despite the development of device technology and operators' experience, access site vascular complications (VCs) remain one of the major concerns after transcatheter aortic valve implantation (TAVI). MANTA (Teleflex, Wayne, Pennsylvania) is a large-bore vascular closure device (VCD) with promising incidence of VC. Previously, we demonstrated that the ultrasound-guided MANTA (US-MANTA) technique further improved the outcomes compared with conventional MANTA (C-MANTA) without ultrasound guidance. The present study was established to prove the effectiveness of the technique in a larger population. In this study, we included 1,150 patients (335 patients with C-MANTA and 815 with US-MANTA) who received MANTA after TAVI from April 2017 to September 2021. The primary endpoint was MANTA-related VC. Overall VC, VCD failure, and bleeding complications were also assessed based on the Valve Academic Research Consortium 3 criteria. MANTA-related VC occurred in 12.5% in the C-MANTA group and 6.8% in the US-MANTA group (p = 0.001). VCD failure rate were 7.5% and 3.9%, respectively (p = 0.012). Valve Academic Research Consortium 3 major and minor VC were more frequent in C-MANTA group (major: 7.8% vs 4.4%, p = 0.023; minor: 8.1% vs 4.4%, p = 0.022). Multivariate analysis revealed US-MANTA as the negative predictor of MANTA-related VC (odds ratio 0.57, 95% confidence interval 0.36 to 0.89, p = 0.013). However, subgroup analysis showed the efficacy of the US-MANTA technique was limited to the patients without severely calcified puncture site (Pinteraction = 0.048). In conclusion, the US-MANTA technique was an effective strategy to reduce VC after transfemoral TAVI compared with C-MANTA. IntroductionTranscatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis.1Mack MJ Leon MB Thourani VH Makkar R Kodali SK Russo M Kapadia SR Malaisrie SC Cohen DJ Pibarot P Leipsic J Hahn RT Blanke P Williams MR McCabe JM Brown DL Babaliaros V Goldman S Szeto WY Genereux P Pershad A Pocock SJ Alu MC Webb JG Smith CR PARTNERTranscatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med. 2019; 380: 1695-1705Crossref PubMed Scopus (2231) Google Scholar,2Popma JJ Deeb GM Yakubov SJ Mumtaz M Gada H O'Hair D Bajwa T Heiser JC Merhi W Kleiman NS Askew J Sorajja P Rovin J Chetcuti SJ Adams DH Teirstein PS Zorn 3rd, GL Forrest JK Tchétché D Resar J Walton A Piazza N Ramlawi B Robinson N Petrossian G Gleason TG Oh JK Boulware MJ Qiao H Mugglin AS Reardon MJ Evolut Low Risk Trial InvestigatorsTranscatheter aortic-valve replacement with a self-expanding valve in low-risk patients.N Engl J Med. 2019; 380: 1706-1715Crossref PubMed Scopus (1716) Google Scholar The vast majority of TAVI are performed through transfemoral approach. Despite the effort to reduce access site vascular complications (VCs) after TAVI, it remains one of the major concerns with a significant impact on clinical outcomes.3Ullery BW Jin R Kirker EB Hayes G Siwek L Brevig J Hodson RW Spinelli KJ Trends in vascular complications and associated treatment strategies following transfemoral transcatheter aortic valve replacement.J Vasc Surg. 2020; 72 (e5): 1313-1324Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar,4Généreux P Webb JG Svensson LG Kodali SK Satler LF Fearon WF Davidson CJ Eisenhauer AC Makkar RR Bergman GW Babaliaros V Bavaria JE Velazquez OC Williams MR Hueter I Xu K Leon MB PARTNER Trial Investigators. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic transcatheter Valve) trial.J Am Coll Cardiol. 2012; 60: 1043-1052Crossref PubMed Scopus (386) Google Scholar Recently, novel plug-based MANTA (Teleflex, Wayne, Pennsylvania) has been introduced. The efficacy of MANTA has been demonstrated by several studies,5Van Mieghem NM Latib A van der Heyden J van Gils L Daemen J Sorzano T Ligthart J Witberg K de Kroon T Maor N Mangieri A Montorfano M de Jaegere PP Colombo A Roubin G. Percutaneous plug-based arteriotomy closure device for large-bore access: A multicenter prospective study.JACC Cardiovasc Interv. 2017; 10: 613-619Crossref PubMed Scopus (67) Google Scholar, 6Wood DA Krajcer Z Sathananthan J Strickman N Metzger C Fearon W Aziz M Satler LF Waksman R Eng M Kapadia S Greenbaum A Szerlip M Heimansohn D Sampson A Coady P Rodriguez R Krishnaswamy A Lee JT Ben-Dor I Moainie S Kodali S Chhatriwalla AK Yadav P O'Neill B Kozak M Bacharach JM Feldman T Guerrero M Nanjundappa A Bersin R Zhang M Potluri S Barker C Bernardo N Lumsden A Barleben A Campbell J Cohen DJ Dake M Brown D Maor N Nardone S Lauck S O'Neill WW Webb JG SAFE MANTA Study InvestigatorsPivotal clinical study to evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device.Circ Cardiovasc Interv. 2019; 12e007258Crossref PubMed Scopus (54) Google Scholar, 7Dumpies O Kitamura M Majunke N Hartung P Haag A Wilde J Desch S Sandri M Crusius L Noack T Kiefer P Leontyev S Borger M Thiele H Holzhey D Abdel-Wahab M Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: initial experience from a large European center.Cardiovasc Revasc Med. 2022; 37: 34-40Crossref PubMed Scopus (6) Google Scholar, 8Gheorghe L Brouwer J Mathijssen H Nijenhuis VJ Rensing BJ Swaans MJ Chan Pin Yin DR Heijmen RH De Kroon T Sonker U Van der Heyden JA Ten Berg JM Early outcomes after percutaneous closure of access site in transfemoral transcatheter valve implantation using the novel vascular closure device collagen plug-based MANTA.Am J Cardiol. 2019; 124: 1265-1271Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar, 9Moriyama N Lindström L Laine M. Propensity-matched comparison of vascular closure devices after transcatheter aortic valve replacement using MANTA versus ProGlide.EuroIntervention. 2019; 14: e1558-e1565Crossref PubMed Scopus (45) Google Scholar whereas 2 studies did not show the differences between 2 types of VCDs in access site-related VC10van Wiechen MP Tchétché D Ooms JF Hokken TW Kroon H Ziviello F Ghattas A Siddiqui S Laperche C Spitzer E Daemen J de Jaegere PP Dumonteil N Van Mieghem NM. Suture- or plug-based large-bore arteriotomy closure: a pilot randomized controlled trial.JACC Cardiovasc Interv. 2021; 14: 149-157Crossref PubMed Scopus (31) Google Scholar and major VC.11De Palma R Settergren M Rück A Linder R Saleh N. Impact of percutaneous femoral arteriotomy closure using the MANTATM device on vascular and bleeding complications after transcatheter aortic valve replacement.Catheter Cardiovasc Interv. 2018; 92: 954-961Crossref PubMed Scopus (35) Google Scholar In contrast, 1 randomized study and 1 retrospective study demonstrated significantly higher access site VC with MANTA in comparison with suture-based VCD.12Abdel-Wahab M Hartung P Dumpies O Obradovic D Wilde J Majunke N Boekstegers P Müller R Seyfarth M Vorpahl M Kiefer P Noack T Leontyev S Sandri M Rotta Detto Loria J Kitamura M Borger MA Funkat AK Hohenstein S Desch S Holzhey D Thiele H CHOICE-CLOSURE InvestigatorsComparison of a pure plug-based versus a primary suture-based vascular closure device strategy for transfemoral transcatheter aortic valve replacement: the CHOICE-CLOSURE randomized clinical trial.Circulation. 2022; 145: 170-183Crossref PubMed Scopus (16) Google Scholar,13Hoffmann P Al-Ani A von Lueder T Hoffmann J Majak P Hagen O Loose H Kløw NE Opdahl A. Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide.CVIR Endovasc. 2018; 1: 20Crossref PubMed Scopus (26) Google Scholar In the MARVEL registry, several anatomic and baseline characteristics predicted VC with MANTA.14Kroon HG Tonino PAL Savontaus M Amoroso G Laine M Christiansen EH Toggweiler S Ten Berg J Sathananthan J Daemen J de Jaegere PP Brueren GBRG Malmberg M Slagboom T Moriyama N Terkelsen CJ Moccetti F Gheorghe L Webb J Wood D Van Mieghem NM Dedicated plug based closure for large bore access -The MARVEL prospective registry.Catheter Cardiovasc Interv. 2021; 97: 1270-1278Crossref PubMed Scopus (9) Google Scholar However, technical solutions to avoid VC have been scarcely proposed; our group reported that the ultrasound (US)-guided MANTA (US-MANTA) technique reduced VC after TAVI in a small retrospective study.15Moriyama N Dahlbacka S Vähäsilta T Vainikka T Aho P Viikilä J Lammintausta O Laine M. The efficacy of the ultrasound-navigated MANTA deployment following transfemoral transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 2564-2566Crossref PubMed Scopus (13) Google Scholar The present study aimed to extend the study's size and further compare the US-MANTA and conventional MANTA (C-MANTA) techniques without US.MethodsThis registry-based study included all consecutive patients who underwent transfemoral TAVI and received MANTA for a large-bore arteriotomy closure from April 2017 to September 2021 at Helsinki University Central Hospital (n = 1,182), and 32 patients were excluded (Figure 1). The baseline characteristics, clinical, and procedural data were prospectively collected as part of a dedicated institutional database. The study protocol conformed to the Declaration of Helsinki and was approved by the institutional review board. The data that support the findings of this study are available from the corresponding author on reasonable request.During the study period, our institution used MANTA as a VCD for transfemoral TAVI arteriotomy closure. For the first 335 consecutive cases, we used MANTA in the conventional method: an operator determines the distance of the subcutaneous track from skin level to the endoluminal arterial space using a dedicated dilator, and during the closure, the toggle is released at the predetermined deployment level. The rest of the patients received the US-MANTA technique, as previously reported.15Moriyama N Dahlbacka S Vähäsilta T Vainikka T Aho P Viikilä J Lammintausta O Laine M. The efficacy of the ultrasound-navigated MANTA deployment following transfemoral transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 2564-2566Crossref PubMed Scopus (13) Google Scholar The assistant operator scans the common femoral artery (CFA) to identify the position of the toggle in situ, with US in a longitudinal view. While the US image is maintained, the operator withdraws the MANTA to a predetermined depth + 1 cm. The toggle is released at this level, and the opening movement is confirmed in the image. If the predetermined deployment level is not considered reliable, a new deployment depth is visually determined by confirming the toggle location inside the vessel. The assembly was pulled back slowly with a 45° or more angle between the skin surface and the MANTA sheath while maintaining the toggle in the center of the US image. After confirming that the toggle is attached to the vessel wall in parallel, the operator maintains the pulling force while monitoring the color code of the tension gauge (green code) until the collagen pad gets close to the vessel wall. Although the MANTA is available in 2 sizes on the basis of the size of the large-bore device, only the 18-Fr device was used in this study.All transfemoral TAVI procedures were planned after contrast-enhanced multidetector computed tomography (MDCT) and coronary angiography examinations. All patients were evaluated as eligible for transfemoral TAVI by a multidisciplinary heart team on the basis of the guidelines at the time. If eligible patients had previous femoral vascular closure within 30 days16Nelson PR Kracjer Z Kansal N Rao V Bianchi C Hashemi H Jones P Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).J Vasc Surg. 2014; 59: 1181-1193Abstract Full Text Full Text PDF PubMed Scopus (190) Google Scholar or any previous surgical cutdown, the other femoral side was used. Pre-existing antiplatelet therapy was continued before and after the TAVI procedure. Direct oral anticoagulants were stopped for 24 hours before the procedure. Vitamin-K antagonists were continued, aiming at an international normalized ratio between 2 and 2.5 on the day of the procedure. Most transfemoral TAVI were performed under local anesthesia with conscious sedation. All femoral arterial access was punctured using US guidance in both US-MANTA and C-MANTA groups. Activated clotting time was controlled below 250 seconds by administrating protamine, and systolic blood pressure was lowered below 120 mmHg at the end of the procedure.For the iliofemoral artery assessment, a 3-dimensional MDCT image was retrospectively reconstructed from raw DICOM data using 3mensio Structure Heart software (3mensio Medical Imaging BV, Bilthoven, The Netherlands). A curved multiplanar reconstruction centerline was generated to assess the cross-sectional image.17Okuyama K Jilaihawi H Kashif M Takahashi N Chakravarty T Pokhrel H Patel J Forrester JS Nakamura M Cheng W Makkar RR. Transfemoral access assessment for transcatheter aortic valve replacement: evidence-based application of computed tomography over invasive angiography.Circ Cardiovasc Imaging. 2014; 8e001995PubMed Google Scholar The following measurements were obtained in all patients on the side of delivery sheath placement at the level of the CFA: minimum, mean, and maximum lumen diameter of the vessel at the minimum lumen diameter (MLD) level of the targeted CFA and degree of calcification based on MANTA femoral artery calcification score (MFACS).14Kroon HG Tonino PAL Savontaus M Amoroso G Laine M Christiansen EH Toggweiler S Ten Berg J Sathananthan J Daemen J de Jaegere PP Brueren GBRG Malmberg M Slagboom T Moriyama N Terkelsen CJ Moccetti F Gheorghe L Webb J Wood D Van Mieghem NM Dedicated plug based closure for large bore access -The MARVEL prospective registry.Catheter Cardiovasc Interv. 2021; 97: 1270-1278Crossref PubMed Scopus (9) Google Scholar CFA depth was determined as the distance between the skin and the center point of the CFA, as described previously.18Durand E Penso M Hemery T Levesque T Moles G Tron C Bouhzam N Bettinger N Wong S Dacher JN Eltchaninoff H. Standardized measurement of femoral artery depth by computed tomography to predict vascular complications after transcatheter aortic valve implantation.Am J Cardiol. 2021; 145: 119-127Abstract Full Text Full Text PDF PubMed Scopus (3) Google ScholarThe primary endpoint of this study was MANTA-related VC at 30 days after TAVI. VC was defined based on the Valve Academic Research Consortium 3 (VARC-3) criteria,19Généreux P Piazza N Alu MC Nazif T Hahn RT Pibarot P Bax JJ Leipsic JA Blanke P Blackstone EH Finn MT Kapadia S Linke A Mack MJ Makkar R Mehran R Popma JJ Reardon M Rodes-Cabau J Van Mieghem NM Webb JG Cohen DJ Leon MB VARC-3 Writing CommitteeValve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.Eur Heart J. 2021; 42: 1825-1857Crossref PubMed Scopus (112) Google Scholar and MANTA-related VC was defined as the access site-related VC that occurred because of MANTA usage. VC that was not related to MANTA (e.g., iliac artery rupture because of delivery sheath and aortic dissection) was classified as overall VC but not as MANTA-related VC. The institutional vascular surgeon and the heart team determined if the complication was related to the MANTA usage. MANTA-related VC was categorized into 4 categories (vascular injury, distal embolism, unplanned endovascular or surgical intervention, and VCD failure) based on the VARC-3 criteria.19Généreux P Piazza N Alu MC Nazif T Hahn RT Pibarot P Bax JJ Leipsic JA Blanke P Blackstone EH Finn MT Kapadia S Linke A Mack MJ Makkar R Mehran R Popma JJ Reardon M Rodes-Cabau J Van Mieghem NM Webb JG Cohen DJ Leon MB VARC-3 Writing CommitteeValve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.Eur Heart J. 2021; 42: 1825-1857Crossref PubMed Scopus (112) Google Scholar Also, MANTA-related VC was classified based on the timing of the failure: VC that developed in the catheterization laboratory or operating room, in-hospital VC, and postdischarge VC. Based on the VARC-3 criteria, overall VC, VCD failure, and bleeding complications were also assessed. MANTA failures were classified based on the mechanism of the failure (Supplementary Figure 1).15Moriyama N Dahlbacka S Vähäsilta T Vainikka T Aho P Viikilä J Lammintausta O Laine M. The efficacy of the ultrasound-navigated MANTA deployment following transfemoral transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 2564-2566Crossref PubMed Scopus (13) Google ScholarCategorical variables are presented as counts and percentages and were compared using the chi-square test or Fischer's exact test, if needed. Continuous variables are presented as the mean ± SD and were compared using the t test or Wilcoxon rank-sum test on the basis of their distributions. Logistic regression analysis, including baseline, MDCT, and procedural covariates, was used to obtain the odds ratio (OR) and 95% confidence interval (CI) for developing MANTA-related VC. Variables with a p value 30), CFA MLD (≤6.0 vs >6.0 mm), MFACS ( 33.8 mm), and sheath to femoral artery ratio (SFAR) (≤1.05 vs >1.05). For the BMI, CFA diameter, and SFAR subgroups, thresholds were based on previous studies.10van Wiechen MP Tchétché D Ooms JF Hokken TW Kroon H Ziviello F Ghattas A Siddiqui S Laperche C Spitzer E Daemen J de Jaegere PP Dumonteil N Van Mieghem NM. Suture- or plug-based large-bore arteriotomy closure: a pilot randomized controlled trial.JACC Cardiovasc Interv. 2021; 14: 149-157Crossref PubMed Scopus (31) Google Scholar,20Hayashida 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 MC. Transfemoral aortic valve implantation new criteria to predict vascular complications.JACC Cardiovasc Interv. 2011; 4: 851-858Crossref PubMed Scopus (405) Google Scholar For the subgroup of CFA depth, the median value was used to divide the patients into 2 subgroups. A p <0.05 was considered statistically significant, and all statistical tests were 2-tailed statistical analyses that were performed using JMP version 14.2 (SAS Institute Inc., Cary, North Carolina).ResultsBetween April 2016 and September 2021, 1,182 consecutive patients were treated with transfemoral TAVI and received MANTA for large-bore arteriotomy closure, and 32 patients were excluded from the analysis (Figure 1). In total, 1,150 patients were analyzed in this study. Baseline clinical characteristics of both groups are presented in Table 1. C-MANTA group had more women, higher STS score, more frequent chronic kidney disease, higher rate of previous percutaneous coronary intervention, previous peripheral artery disease, and previous stroke. Although there were significant differences in vitamin-K antagonist and direct oral anticoagulant use between the 2 groups, overall oral anticoagulant usage was not significantly different.Table 1Baseline characteristicsVariablesAll (n = 1150)C-MANTA (n =335)US-MANTA (n = 815)p-ValueSDMatched C-MANTA (n = 299)Matched US-MANTA (n = 299)p-ValueSDAge (years)79.8 ± 6.979.9 ± 6.879.8 ± 6.90.800.0179.7 ± 6.879.2 ± 7.70.490.069Female550 (48%)178 (53%)372 (46%)0.0210.15157 (53%)147 (49%)0.410.067BMI (kg/m2)27.0 ± 5.227.0 ± 4.826.9 ± 5.30.800.0227.0 ± 4.827.0 ± 5.80.950.067STS PROM3.8 ± 2.34.4 ± 3.33.6 ± 1.8<0.0010.333.8 ± 2.33.9 ± 2.00.460.061Hypertension1041 (91%)306 (91%)735 (90%)0.540.04272 (91%)274 (92%)0.770.024Dyslipidemia*Defined as presenting LDL cholesterol ≥ 140 mg/dl, triglyceride ≥ 150 mg/dl, HDL cholesterol <40 mg/dl, or taking cholesterol-lowering medicine. APG = aortic valve pressure gradient; APT = antiplatelet therapy; AV = aortic valve velocity; BMI = body mass index; C-MANTA = conventional MANTA; CABG = coronary artery bypass grafting; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; DAPT = dual antiplatelet therapy; eGFR = estimated glomerular filtration rate; LVEF = left ventricle ejection fraction; DOAC = direct oral anticoagulant; OAC = oral anticoagulant; PAD = peripheral artery disease; PCI = percutaneous coronary intervention; SAPT = single antiplatelet therapy; SD = standardized difference; STS PROM = Society of Thoracic Surgeons predicted risk of mortality; US-MANTA = ultrasound-guided MANTA.854 (74%)241 (71.9%)613 (75%)0.250.07213 (71%)224 (75%)0.310.083Diabetes mellitus331 (29%)96 (29%)235 (29%)0.950.00479 (26%)73 (24%)0.570.046Atrial fibrillation444 (39%)136 (41%)308 (38%)0.370.06117 (39%)113 (38%)0.740.028CKD330 (38%)145 (43%)295 (36%)0.0250.15119 (40%)123 (41%)0.740.027COPD239 (21%)77 (23%)162 (20%)0.240.07664 (21%)66 (22%)0.840.016Prior PCI288 (25%)99 (30%)189 (23%)0.0240.1583 (28%)83 (28%)1.000Prior CABG115 (10%)25 (7.5%)90 (11%)0.070.1220 (6.7%)32 (11%)0.080.14Prior non-CABG77 (6.7%)22 (6.6%)55 (6.8%)0.910.00717 (5.7%)26 (8.7%)0.150.047Prior PAD120 (10%)52 (16%)68 (8.3%)<0.0010.2234 (11%)41 (14%)0.390.071Prior stroke102 (8.9%)43 (13%)59 (7.2%)0.0020.1928 (9.4%)24 (8.0%)0.560.047Examination dataHemoglobin (g/L)128.0 ± 15.1128.7 ± 14.5127.7 ± 15.40.280.067129.5 ± 14.2127.0 ± 15.10.0410.17Platelet (x103/μL)213.2 ± 70.0218.5 ± 70.6211.0 ± 70.00.100.11217.3 ± 69.5213.9 ± 68.40.540.049Creatinine (µmol/L)95.3 ± 55.092.4 ± 30.796.5 ± 62.30.250.08390.4 ± 27.794.8 ± 43.50.140.12eGFR (ml/min/1.73 m2)64.2 ± 19.662.6 ± 17.964.9 ± 20.30.060.7463.6 ± 17.363.5 ± 19.40.930.005LVEF (%)57.5 ± 11.256.7 ± 12.157.8 ± 10.80.110.09657.0 ± 12.158.0 ± 10.90.300.087Peak AV (m/s)4.18 ± 0.634.16 ± 0.684.19 ± 0.600.540.0474.17 ± 0.684.18 ± 0.580.880.016mean APG (mmHg)43.9 ± 14.043.4 ± 14.544.1 ± 13.90.410.06843.5 ± 14.343.4 ± 12.80.930.007MedicationSAPT555 (48%)149 (45%)406 (50%)0.100.11135 (45%)143 (48%)0.510.054DAPT98 (8.5%)27 (8.1%)71 (8.7%)0.720.02425 (8.4%)33 (11%)0.270.020Oral anticoagulant427 (37%)129 (39%)298 (37%)0.540.040110 (37%)110 (37%)1.000Vitamin-K antagonist202 (18%)91 (27%)111 (14%)<0.0010.3479 (26%)44 (15%)<0.0010.29DOAC227 (20%)38 (11%)189 (23%)<0.0010.3231 (10%)66 (22%)<0.0010.32OAC + APT54 (4.7%)21 (6.3%)33 (4.1%)0.110.1017 (5.7%)13 (4.4%)0.450.061OAC mono373 (32%)108 (32%)265 (32%)0.930.00693 (31%)97 (32%)0.730.029 Defined as presenting LDL cholesterol ≥ 140 mg/dl, triglyceride ≥ 150 mg/dl, HDL cholesterol 1 cm361 (31%)113 (34%)248 (30%)0.2796 (32%)96 (32%)1.00MFACS0.94 ± 1.070.97 ± 1.120.93 ± 1.040.570.93 ± 1.130.97 ± 1.090.63MFACS ≥399 (8.6%)35 (11%)64 (7.9%)0.1530 (10%)28 (9.4%)0.89Anterior calcification99 (8.6%)27 (8.1%)72 (8.8%)0.6725 (8.4%)32 (11%)0.33Posterior calcification563 (49%)164 (49%)399 (49%)>0.99140 (47%)147 (49%)0.57Procedural characteristicsRight approach1060 (92%)314 (94%)746 (92%)0.21280 (94%)269 (90%)0.10Sheath size (Fr)15.7 ± 1.916.7 ± 1.715.3 ± 2.0<0.00116.7 ± 1.715.4 ± 2.1<0.001Effective sheath OD (mm)7.4 ± 0.57.5 ± 0.47.4 ± 0.6<0.0017.5 ± 0.57.4 ± 0.50.011THV typeSAPIEN 3519 (45%)127 (38%)392 (48%)0.002112 (38%)151 (51%)0.001Evolut R/Pro196 (17%)29 (8.7%)167 (21%)<0.00129 (9.7%)58 (19%)<0.001ACURATE neo385 (34%)165 (49%)220 (27%)<0.001146 (49%)73 (24%)<0.001LOTUS18 (1.6%)0 (0%)18 (2.2%)0.0030 (0%)10 (3.3%)0.002Allegra23 (2.0%)14 (4.2%)9 (1.1%)0.00212 (4.0%)3 (1.0%)0.020Portico9 (0.8%)0 (0%)9 (1.1%)0.070 (0%)4 (1.3%)0.12C-MANTA = conventional MANTA; CFA = common femoral artery; LD = lumen diameter; MFACS = MANTA femoral artery calcification score; MLD = minimum lumen diameter; OD = outer diameter; SFAR = sheath to femoral artery ratio; THV = transcatheter heart valve; US-MANTA = ultrasound-guided MANTA. Open table in a new tab MANTA-related VC occurred more frequently in the C-MANTA group (13% vs 6.8%, p = 0.001) (Table 3). In addition, both major and minor MANTA-related VC rates were higher in C-MANTA group (major: 6.6% vs 3.4%, p = 0.018; minor: 8.1% vs 4.4%, p = 0.022). Overall VARC-3 major complication (7.8% vs 4.4%, p = 0.023), minor complication (8.1% vs 4.4%, p = 0.022), major or life-threatening bleeding (11% vs 5.9%, p = 0.002), and MANTA failure (7.5% vs 3.9%, p = 0.012) occurred more frequently in the C-MANTA group. The 30-day all-cause mortality was not significantly different between the 2 groups. A detailed description of MANTA failure is presented in Supplementary Table 1. The incidence of each component of the types of VC was similar between the 2 groups. In addition, the incidence of the breakdowns of the vascular injury was not significantly different. In terms of the timing of MANTA-related VC, 48% and 44% (p = 0.70) of MANTA-related VC developed in the catheter laboratory or operating room, and 52% and 53% (p = 0.97) occurred during the hospitalization after the TAVI procedure. A total of 2 patients (2.1%) had postdischarge VC in the US-MANTA group. A total of 50% and 58% (p = 0.97) of MANTA-related VC ended up receiving surgical treatment, and 4.8% and 1.8% of patients (p = 0.50) had endovascular treatment. MANTA failure types were also classified (Supplementary Table 1). The most common failure mechanism was type 1, followed by type 5 in both groups. Multivariate analysis revealed US-guided and MFACS ≥3 as predictors of MANTA-related VC (Table 4).Table 3Clinical endpointsAll (n = 1150)C-MANTA (n =335)US-MANTA (n = 815)p-ValueMatched C-MANTA (n =299)Matched US-MANTA (n = 299)p
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