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Dedicated plug based closure for large bore access -The MARVEL prospective registry

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DOI

  • Herbert G Kroon, Erasmus University Medical Center Cancer Institute, Department of Obstetrics and Gynaecology, Erasmus University Medical Center.
  • ,
  • Pim A L Tonino, Catharina Hosp, Catharina Hospital, Dept Internal Med
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  • Mikko Savontaus, Department of Medical Physics, Turku PET Centre, Turku University Central Hospital and University of Turku, Turku
  • ,
  • Giovanni Amoroso, Onze Lieve Vrouw Hosp, Onze Lieve Vrouwe Gasthuis Hospital, Dept Surg
  • ,
  • Mika Laine, Department of Child Neurology, Children's Hospital, Helsinki University Hospital Helsinki, University of Helsinki, Helsinki, Finland.
  • ,
  • Evald H Christiansen
  • Stefan Toggweiler, Kantonsspital Luzern
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  • Jur Ten Berg, St Antonius Hosp, St. Antonius Hospital Utrecht
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  • Janarthanan Sathananthan, St. Paul's and Vancouver General Hospital
  • ,
  • Joost Daemen, Erasmus University Medical Center Cancer Institute, Department of Obstetrics and Gynaecology, Erasmus University Medical Center.
  • ,
  • Peter P de Jaegere, Erasmus University Medical Center Cancer Institute, Department of Obstetrics and Gynaecology, Erasmus University Medical Center.
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  • Guus B R G Brueren, Catharina Hosp, Catharina Hospital, Dept Internal Med
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  • Markus Malmberg, Department of Medical Physics, Turku PET Centre, Turku University Central Hospital and University of Turku, Turku
  • ,
  • Ton Slagboom, Onze Lieve Vrouw Hosp, Onze Lieve Vrouwe Gasthuis Hospital, Dept Surg
  • ,
  • Noriaki Moriyama, Department of Child Neurology, Children's Hospital, Helsinki University Hospital Helsinki, University of Helsinki, Helsinki, Finland.
  • ,
  • Christian J Terkelsen
  • Federico Moccetti, Kantonsspital Luzern
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  • Livia Gheorghe, St Antonius Hosp, St. Antonius Hospital Utrecht
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  • John Webb, St. Paul's and Vancouver General Hospital
  • ,
  • David Wood, St. Paul's and Vancouver General Hospital
  • ,
  • Nicolas M Van Mieghem, Erasmus University Medical Center Cancer Institute, Department of Obstetrics and Gynaecology, Erasmus University Medical Center.

OBJECTIVES: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.

BACKGROUND: The MANTA is a novel plug-based device for large bore arteriotomy closure.

METHODS: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.

RESULTS: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.

CONCLUSION: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.

Original languageEnglish
JournalCatheterization and Cardiovascular Interventions
Volume97
Issue6
Pages (from-to)1270-1278
ISSN1522-1946
DOIs
Publication statusPublished - May 2021

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