Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation

Abstract

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. 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 the 2 of in access Tchétché D Kroon H A S C Daemen J de Jaegere PP N Van Mieghem plug-based large-bore arteriotomy a Cardiovasc Interv. 14: PubMed Scopus Google Scholar and major R M A R of percutaneous arteriotomy closure using the device on vascular and bleeding complications after transcatheter aortic valve Cardiovasc Interv. PubMed Scopus Google Scholar In study and study demonstrated access site VC with MANTA in comparison with M Hartung P O D Wilde J Majunke N P R M M Kiefer P Noack T Leontyev S Sandri M J Kitamura M Borger AK S Desch S Holzhey D Thiele H of a plug-based versus a primary vascular closure device strategy for transfemoral transcatheter aortic valve replacement: the clinical 2022; PubMed Scopus Google P A T J P O H site complications after transfemoral aortic valve implantation a comparison of Manta and PubMed Scopus Google Scholar In the several and VC with M G Laine M S Ten Berg J Sathananthan J Daemen J de Jaegere PP M T N CJ L Webb J D Van Mieghem NM based closure for large access prospective Cardiovasc Interv. PubMed Scopus Google Scholar However, to VC been group that the ultrasound MANTA (US-MANTA) technique VC after TAVI in a N S T T P J O Laine M. 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Full Text Full Text PDF PubMed Scopus Google primary endpoint of this study was MANTA-related VC after VC was based on the Valve Academic Research Consortium 3 P Piazza N Alu MC T Hahn RT Pibarot P JJ Leipsic JA Blanke P Kapadia S A MJ Makkar R R JJ Reardon M J Van Mieghem NM Webb JG Cohen DJ Leon MB Academic Research Consortium endpoint for aortic valve clinical PubMed Scopus Google Scholar and MANTA-related VC was as the access VC that occurred of MANTA VC that was to MANTA of and aortic was as VC as MANTA-related VC. 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The of VCD failure in was the by the collagen failure analysis = showed the incidence of VC major VC and MANTA-related with 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 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, Tchétché D Kroon H A S C Daemen J de Jaegere PP N Van Mieghem plug-based large-bore arteriotomy a Cardiovasc Interv. 14: PubMed Scopus Google Scholar, R M A R of percutaneous arteriotomy closure using the device on vascular and bleeding complications after transcatheter aortic valve Cardiovasc Interv. PubMed Scopus Google Scholar In the comparison and comparison showed of MANTA-related VC in the US-MANTA analysis revealed technique as the predictor of MANTA-related VC. the of the of MANTA-related VC were the 2 and the of MANTA failure were also was by in the on the N S T T P J O Laine M. The efficacy of the MANTA following transfemoral transcatheter aortic valve Cardiovasc Interv. 2019; PubMed Scopus Google Scholar However, it was in also the the in the and collagen to the through the the US-MANTA technique reduce MANTA failure in In a with to the MANTA more to the to the to the collagen the to it in the reduce VCD failure to the incidence of MANTA-related the subgroup the efficacy of the US-MANTA technique was of and whereas the compared with the subgroup and compared with did from the of calcified on the of the In the of the of the with the technique as effective as with it to puncture the and using severely calcified for large-bore The impact of the on technique was However, the technique VC in who a of VC compared with 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 M S JJ JM D Williams MR Hahn RT Webb JG Svensson LG Cohen DJ PS Alu MC A Makkar RR Babaliaros V Thourani VH Leon MB Kodali SK outcomes of transcatheter aortic valve replacement with the 3 insights from the PARTNER and Cardiovasc Interv. PubMed Scopus Google US-MANTA technique reduce VC also the VCD failure the MANTA in the as MANTA and collagen is to the VCD failure it bleeding more significant complications was as the VC M G Laine M S Ten Berg J Sathananthan J Daemen J de Jaegere PP M T N CJ L Webb J D Van Mieghem NM based closure for large access prospective Cardiovasc Interv. PubMed Scopus Google K T B T M P D J A P B aortic valve implantation to vascular Cardiovasc Interv. PubMed Scopus Google J CR D Sorajja P M. for vascular complications in percutaneous transfemoral transcatheter aortic valve J Cardiol. 2019; 124: Full Text Full Text PDF PubMed Scopus Google Scholar In of MANTA failure, the to 2 MANTA N S T T P J O Laine M. The efficacy of the MANTA following transfemoral transcatheter aortic valve Cardiovasc Interv. 2019; PubMed Scopus Google M R S M R from a of the MANTA vascular closure Cardiovasc Interv. 2019; PubMed Scopus Google Scholar and of the 3 MANTA N S T T P J O Laine M. The efficacy of the MANTA following transfemoral transcatheter aortic valve Cardiovasc Interv. 2019; PubMed Scopus Google Scholar In a calcified the as a arteriotomy after a large-bore device and MANTA the to puncture the and to puncture the the of collagen failure of M R S M R from a of the MANTA vascular closure Cardiovasc Interv. 2019; PubMed Scopus Google Scholar severely calcified as the large-bore access site and the an approach. this study has with the the present study did the of the in using impact the study did the of patients in the US-MANTA group using MANTA without the technique of 2 and plug-based demonstrated a incidence of access VC with plug-based conventional plug-based VCD an The comparison VCD and plug-based VCD to further the efficacy of the US-MANTA study did for the we a from and is a clinical of and and has of to is a clinical of Laine from and from and The of to 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 the 2 of in access Tchétché D Kroon H A S C Daemen J de Jaegere PP N Van Mieghem plug-based large-bore arteriotomy a Cardiovasc Interv. 14: PubMed Scopus Google Scholar and major R M A R of percutaneous arteriotomy closure using the device on vascular and bleeding complications after transcatheter aortic valve Cardiovasc Interv. PubMed Scopus Google Scholar In study and study demonstrated access site VC with MANTA in comparison with M Hartung P O D Wilde J Majunke N P R M M Kiefer P Noack T Leontyev S Sandri M J Kitamura M Borger AK S Desch S Holzhey D Thiele H of a plug-based versus a primary vascular closure device strategy for transfemoral transcatheter aortic valve replacement: the clinical 2022; PubMed Scopus Google P A T J P O H site complications after transfemoral aortic valve implantation a comparison of Manta and PubMed Scopus Google Scholar In the several and VC with M G Laine M S Ten Berg J Sathananthan J Daemen J de Jaegere PP M T N CJ L Webb J D Van Mieghem NM based closure for large access prospective Cardiovasc Interv. PubMed Scopus Google Scholar However, to VC been group that the ultrasound MANTA (US-MANTA) technique VC after TAVI in a N S T T P J O Laine M. The efficacy of the MANTA following transfemoral transcatheter aortic valve Cardiovasc Interv. 2019; PubMed Scopus Google Scholar The present study to the and further the US-MANTA and conventional MANTA (C-MANTA) without

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