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Vascular Complications in Transcatheter Aortic Valve Replacement Using 14 vs. 18 French Plug-Based Percutaneous

Tobias Lerchner1, Norvydas Zapustas2, Melchior Seyfarth2

  • 1Doctoral Programs, Witten-Herdecke University, 58455 Witten, Germany.

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Summary

This study found no significant difference in vascular complications between 14F and 18F plug-based vascular closure devices (Pb-VCDs) during transcatheter aortic valve replacement (TAVR). Real-world data suggests similar safety profiles for both Pb-VCD sizes in TAVR procedures.

Keywords:
14 FrenchTAVRaccess site complicationsplug-based vascular closurestructural heart

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Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Device Technology

Background:

  • Plug-based vascular closure devices (Pb-VCDs) are standard for transfemoral transcatheter aortic valve replacement (TAVR) access site closure.
  • Concerns exist regarding higher vascular complication rates with larger 18F Pb-VCDs compared to 14F devices.
  • Limited real-world data exists on the safety of 14F Pb-VCDs in routine clinical practice.

Purpose of the Study:

  • To compare the safety and efficacy of 14F versus 18F Pb-VCDs for vascular access site closure during TAVR.
  • To evaluate the incidence of major and minor vascular complications associated with different Pb-VCD sizes.
  • To assess secondary outcomes including bleeding events, hospital stay, and mortality.

Main Methods:

  • Retrospective, propensity score-matched comparison of patients undergoing TAVR.
  • Analysis of data from March 2019 to December 2020, comparing 14F and 18F Pb-VCD utilization.
  • Primary endpoints: major and minor vascular complications (VARC-3 criteria). Secondary endpoints: bleeding, length of stay, in-hospital mortality.

Main Results:

  • 85 matched pairs of patients (14F Pb-VCD vs. 18F Pb-VCD) were analyzed.
  • No significant difference in major vascular complications (3.5% vs. 0.0%, p=0.25).
  • Similar rates for minor vascular complications (12.9% vs. 14.1%, p=1.00), bleeding events, hospital stay, and mortality.

Conclusions:

  • This real-world study demonstrates no significant difference in VARC-3 defined vascular complications between 14F and 18F Pb-VCDs in TAVR.
  • Observed complication rates suggest comparable safety profiles for both device sizes.
  • Prospective controlled trials are needed to validate these findings.