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Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study

Abstract

Objectives

Vascular closure devices can accelerate haemostasis after arteriotomy, but induce scarring. The aim of the study was to prospectively analyse the feasibility of a novel biodegradable arterial closure device (CD).

Methods

Two hundred fifty-five patients (183 male; age 36–98 years) with an access vessel diameter >3 mm received the biodegradable CD after endovascular therapy. Technical success rate, time-to-haemostasis (TTH) and time-to-ambulation (TTA) were measured. Puncture site complications were categorized as minor (local hematoma, minor bleeding) or major (pseudoaneurysm, embolization, dissection, thrombotic occlusion, hematoma/major bleeding requiring surgery, access site infection).

Results

Technical success was achieved in 98.8 % (252 cases); device failure occurred in three cases (1.2 %). The average TTH and TTA were 11.3 ± 26.9 s and 73.0 ± 126.3 min. The major complication rate was 1.6 %, with three pseudoaneurysms and one retroperitoneal bleeding. The minor complication rate was 2.0 %, with five small hematomas. Neither cardiovascular risk factors nor access vessel characteristics had statistically significant influence on adverse events. Re-puncture was uncomplicated in 32 cases after 155.0 ± 128.8 days.

Conclusions

Handling of the new biodegradable CD is safe. The complication rates are tolerably low and comparable to other CDs. Post-procedural sonography showed no significant palpable subcutaneous changes in the access site.

Key Points

VCDs can increase time efficiency and patient comfort after intervention.

In this prospective single-centre-study, biodegradable CD was safe and easily applicable.

Its major and minor complication rates are comparable to other CDs.

Its mean time-to-haemostasis and time-to-ambulation were 11.3 ± 26.9 s and 73.0 ± 126.3 min.

Post-procedural sonography showed no significant palpable subcutaneous changes at the access site.

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Abbreviations

BMI:

Body mass index

CFA:

Common femoral artery

CHD:

Coronary heart disease

FISH:

Femoral introducer sheath & stasis

PAOD:

Peripheral arterial occlusive disease

SFA:

Superficial femoral artery

TTA:

Time to ambulation

TTH:

Time to haemostasis

VAS:

Visual analogue scale

VCD:

Vascular closure device

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Acknowledgments

The scientific guarantor of this publication is Dr. Marcus Treitl. The authors of this manuscript declare relationships with the following companies: M. Treitl is a consultant for Medtronic and Biotronik. The other authors declare that they have no conflict of interest. The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article. The authors state that this work has not received any funding. One of the authors kindly provided statistical advice for this manuscript. Institutional review board approval was obtained.

Written informed consent was obtained from all subjects (patients) in this study. Some study subjects or cohorts were reported at the 2014 RSNA meeting. Methodology: prospective, observational, performed at one institution.

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Correspondence to Karla M. Treitl.

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Treitl, K.M., Ali, A. & Treitl, M. Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study. Eur Radiol 26, 2359–2368 (2016). https://doi.org/10.1007/s00330-015-4023-6

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Keywords

  • Vascular closure device
  • Biodegradable implants
  • Time-to-haemostasis
  • Time-to-ambulation
  • Endovascular techniques