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Propensity‐matched comparison of large‐bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real‐world experience
Author(s) -
Medranda Giorgio A.,
Case Brian C.,
Zhang Cheng,
Rappaport Hank,
Weissman Gaby,
Bernardo Nelson L.,
Satler Lowell F.,
BenDor Itsik,
Rogers Toby,
Waksman Ron
Publication year - 2021
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.29786
Subject(s) - medicine , valve replacement , vascular closure device , fibrous joint , surgery , propensity score matching , aortic valve , stenosis , femoral artery
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). 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. 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. 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. 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.