Propensity-matched comparison of large-bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real-world experience.

MedStar author(s):
Citation: Catheterization & Cardiovascular Interventions. 98(3):580-585, 2021 09.PMID: 34051039Institution: MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Advanced Cardiac Catheterization Research Fellowship | Interventional Cardiology FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Valve Stenosis | *Catheterization, Peripheral | *Transcatheter Aortic Valve Replacement | *Vascular Closure Devices | Aged | Aortic Valve Stenosis/dg [Diagnostic Imaging] | Aortic Valve Stenosis/su [Surgery] | Aortic Valve/dg [Diagnostic Imaging] | Aortic Valve/su [Surgery] | Catheterization, Peripheral/ae [Adverse Effects] | Femoral Artery/dg [Diagnostic Imaging] | Femoral Artery/su [Surgery] | Hemostatic Techniques/ae [Adverse Effects] | Humans | Male | Retrospective Studies | Transcatheter Aortic Valve Replacement/ae [Adverse Effects] | Treatment OutcomeYear: 2021Local holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006ISSN:
  • 1522-1946
Name of journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & InterventionsAbstract: BACKGROUND: The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse.CONCLUSIONS: In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations. Copyright (c) 2021 Wiley Periodicals LLC.METHODS: This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality.OBJECTIVE: Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR).RESULTS: We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p = 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p = .316), and no patients had major vascular complications.All authors: Ben-Dor I, Bernardo NL, Case BC, Medranda GA, Rappaport H, Rogers T, Satler LF, Waksman R, Weissman G, Zhang COriginally published: Catheterization & Cardiovascular Interventions. 2021 May 29Fiscal year: FY2022Fiscal year of original publication: FY2021Digital Object Identifier: ORCID: Date added to catalog: 2021-06-28
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 34051039 Available 34051039

Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006

BACKGROUND: The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse.

CONCLUSIONS: In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations. Copyright (c) 2021 Wiley Periodicals LLC.

METHODS: This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality.

OBJECTIVE: Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR).

RESULTS: We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p = 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p = .316), and no patients had major vascular complications.

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