Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial

Maarten van Wiechen; D Tchétché; Joris Ooms; Thijmen Hokken; Herbert Kroon; Francesca Ziviello; A Ghattas; S Siddiqui; C Laperche; Ernest Spitzer; Joost Daemen; Peter de Jaegere; N Dumonteil; Nicolas van Mieghem

doi:10.1016/j.jcin.2020.09.052

Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial

Maarten van Wiechen, D Tchétché, Joris Ooms, Thijmen Hokken, Herbert Kroon, Francesca Ziviello, A Ghattas, S Siddiqui, C Laperche, Ernest Spitzer, Joost Daemen, Peter de Jaegere, N Dumonteil, Nicolas van Mieghem

Cardiology

Research output: Contribution to journal › Article › Academic › peer-review

79 Citations (Scopus)

Abstract

Objectives: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. Background: Vascular complications after TAVR are relevant and often associated with VCD failure. Methods: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site–related major or minor vascular complications at 30-days’ follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. Results: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site–related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. Conclusions: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.

Original language	English
Pages (from-to)	149-157
Number of pages	9
Journal	JACC: Cardiovascular Interventions
Volume	14
Issue number	2
DOIs	https://doi.org/10.1016/j.jcin.2020.09.052
Publication status	Published - 25 Jan 2021

Bibliographical note

Funding Information:
Dr. Tchétché has been a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and 4Tech. Dr. Daemen has received institutional research support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical, and PulseCath BV; and has received consultancy and speaker fees from Boston Scientific, ReCor, Pie Medical, Medtronic, and PulseCath BV. Dr. Dumonteil has received consultancy and proctoring fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Van Mieghem has received research grants and advisory fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Essential Medical/Teleflex, Medtronic, and PulseCath BV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Publisher Copyright:
© 2021 American College of Cardiology Foundation

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van Wiechen, M., Tchétché, D., Ooms, J., Hokken, T., Kroon, H., Ziviello, F., Ghattas, A., Siddiqui, S., Laperche, C., Spitzer, E., Daemen, J., de Jaegere, P., Dumonteil, N., & van Mieghem, N. (2021). Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial. JACC: Cardiovascular Interventions, 14(2), 149-157. https://doi.org/10.1016/j.jcin.2020.09.052

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title = "Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial",

abstract = "Objectives: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. Background: Vascular complications after TAVR are relevant and often associated with VCD failure. Methods: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site–related major or minor vascular complications at 30-days{\textquoteright} follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. Results: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site–related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. Conclusions: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.",

author = "{van Wiechen}, Maarten and D Tch{\'e}tch{\'e} and Joris Ooms and Thijmen Hokken and Herbert Kroon and Francesca Ziviello and A Ghattas and S Siddiqui and C Laperche and Ernest Spitzer and Joost Daemen and {de Jaegere}, Peter and N Dumonteil and {van Mieghem}, Nicolas",

note = "Funding Information: Dr. Tch{\'e}tch{\'e} has been a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and 4Tech. Dr. Daemen has received institutional research support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical, and PulseCath BV; and has received consultancy and speaker fees from Boston Scientific, ReCor, Pie Medical, Medtronic, and PulseCath BV. Dr. Dumonteil has received consultancy and proctoring fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Van Mieghem has received research grants and advisory fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Essential Medical/Teleflex, Medtronic, and PulseCath BV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} 2021 American College of Cardiology Foundation",

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doi = "10.1016/j.jcin.2020.09.052",

language = "English",

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van Wiechen, M, Tchétché, D, Ooms, J , Hokken, T , Kroon, H, Ziviello, F, Ghattas, A, Siddiqui, S, Laperche, C, Spitzer, E, Daemen, J , de Jaegere, P, Dumonteil, N & van Mieghem, N 2021, 'Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial', JACC: Cardiovascular Interventions, vol. 14, no. 2, pp. 149-157. https://doi.org/10.1016/j.jcin.2020.09.052

TY - JOUR

T1 - Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial

AU - van Wiechen, Maarten

AU - Tchétché, D

AU - Ooms, Joris

AU - Hokken, Thijmen

AU - Kroon, Herbert

AU - Ziviello, Francesca

AU - Ghattas, A

AU - Siddiqui, S

AU - Laperche, C

AU - Spitzer, Ernest

AU - Daemen, Joost

AU - de Jaegere, Peter

AU - Dumonteil, N

AU - van Mieghem, Nicolas

N1 - Funding Information: Dr. Tchétché has been a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and 4Tech. Dr. Daemen has received institutional research support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical, and PulseCath BV; and has received consultancy and speaker fees from Boston Scientific, ReCor, Pie Medical, Medtronic, and PulseCath BV. Dr. Dumonteil has received consultancy and proctoring fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Van Mieghem has received research grants and advisory fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Essential Medical/Teleflex, Medtronic, and PulseCath BV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: © 2021 American College of Cardiology Foundation

PY - 2021/1/25

Y1 - 2021/1/25

N2 - Objectives: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. Background: Vascular complications after TAVR are relevant and often associated with VCD failure. Methods: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site–related major or minor vascular complications at 30-days’ follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. Results: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site–related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. Conclusions: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.

AB - Objectives: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. Background: Vascular complications after TAVR are relevant and often associated with VCD failure. Methods: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site–related major or minor vascular complications at 30-days’ follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. Results: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site–related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. Conclusions: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.

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U2 - 10.1016/j.jcin.2020.09.052

DO - 10.1016/j.jcin.2020.09.052

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Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial

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