ProGlide-AngioSeal versus ProGlide-FemoSeal for vascular access hemostasis posttranscatheter aortic valve implantation

Catheter Cardiovasc Interv. 2024 Nov;104(6):1251-1259. doi: 10.1002/ccd.31259. Epub 2024 Oct 8.

Abstract

Background: The hybrid strategy combining plug-based and suture-based vascular closure devices (VCD) was introduced as a promising technique for vascular access hemostasis after transcatheter aortic valve implantation (TAVI) with satisfactory outcomes. However, data comparing two plug-based VCDs each in the combination with a suture-based VCD, namely ProGlide/AngioSeal (P/AS) with ProGlide/FemoSeal (P/FS) VCDs, is still lacking.

Aims: To compare the 30-day outcome of the hybrid strategy using P/AS versus P/FS for vascular access site closure after TAVI.

Methods: A retrospective single-center observational study included 608 patients recruited from a prospective TAVI registry between 2016 and 2022. The composite endpoint was defined as any VCD-related major vascular complications and/or bleeding more than type 1 according to Valve Academic Research Consortium criteria.

Results: The current study reported a significantly higher rate of composite endpoint in P/AS group, which was driven by a higher rate of major bleeding (5.4% vs. 1.4%, p = 0.036). We also found a higher rate of VCD-related minor bleeding in P/AS group (16.3% vs. 8.1%, p = 0.013). Successful access site hemostasis was achieved in 71.7% of P/AS group versus 83.1% in P/FS group (p = 0.006). The presence of anterior wall calcification at the access site was significantly associated with the composite endpoint (adj odds ratio 2.49; 95% confidence interval (1.08-5.75), p = 0.032).

Conclusion: The hybrid strategy for large bore vascular access closure using P/FS showed a potentially better 30-day outcomes compared with P/AS. The presence of anterior calcification at the access site carries a significant risk of VCD-related complications.

Keywords: TAVI; femoral access site; vascular access closure device.

Publication types

  • Observational Study
  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery
  • Catheterization, Peripheral* / adverse effects
  • Female
  • Femoral Artery / diagnostic imaging
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control
  • Hemostatic Techniques* / adverse effects
  • Hemostatic Techniques* / instrumentation
  • Humans
  • Male
  • Punctures*
  • Registries*
  • Retrospective Studies
  • Risk Factors
  • Suture Techniques / adverse effects
  • Time Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / instrumentation
  • Treatment Outcome
  • Vascular Closure Devices*