12-month results of a novel large access closure device: insights from the FRONTIER II Study
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1 12-month results of a novel large access closure device: insights from the FRONTIER II Study Presented by Dr Arne Schwindt MD St Franziskus Hospital - Münster, Germany
2 Dr Arne Schwindt MD I do not have any potential conflict of interest I have the following potential conflicts of interest to report: Honorarium: Institutional grant/research support: Consultant: Avinger, Biotronik, Boston Scientific, Cordis, Johnson & Johnson, Terumo Employment in industry: Owner of a healthcare company: Stockholder of a healthcare company: Other(s):
3 Frontier II CE-Mark Study Aim of the Studies: to evaluate the safety and performance of the VIVASURE CLOSURE DEVICE. 50+ patients undergoing large bore femoral percutaneous access for TAVI, EVAR and TEVAR, prospective, non-randomized in 7 European centres Assessment of puncture site with CCD at discharge, 30 days, 90 days and 1 year Primary endpoint: Safety: Incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation (as defined by VARC-2 1 ) is no worse than those associated with cut-down or suture based closure devices of 14.7% 1. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium Leon et al. European Heart Journal 2011
4 VIVASURE CLOSURE DEVICE - Overview Designed for large arteriotomies (12-24F) Synthetic absorbable low-profile implant Over the wire delivery Control of bleeding throughout delivery/deployment No sutures or collagen Used at conclusion of primary procedure (no pre-closure)
5 VIVASURE CLOSURE DEVICE - Overview Features Easy to use 3 simple steps for deployment No pre-placement One device per arteriotomy Controls blood loss throughout procedure Maintains wire access Seals from inside Fully absorbable in 180 days
6 Pre-clinical Pathology 162 days post-implant Porcine abdominal aorta luminal surface Implantation site Longitudinal histology Complete absorption Implantation site undifferentiated from native arterial wall No granuloma/scaring No perivascular fibrosis
7 Multi-centred European Study - Results The FRONTIER II study was a non-inferior, prospective, multi-centered, nonrandomized study to investigate the safety and performance of a new large hole closure device 58 subjects (66 closures) completed in 8 centers across Europe 35 TAVI patients 22 EVAR + 1 TEVAR patients No device related major vascular complications (VARC-2) 97% Technical success 55 subjects with 1 month follow-up; 51 with 3 Month follow-up and 42 with 12 month follow-up assessments completed no late minor or major device related vascular complications No clinically significant changes on Ultrasound/CT
8 Clinical Case TAVR (Edwards 16F SAPIEN 3) - 77 year old Male, Height 175 cm, Weight 63.3 kg Right Access via 18 F sheath Med: 15 mg q.d. rivaroxaban
9 EVAR - bilateral arteriotomy closures Pre-Implantation 2 days Post Implantation
10 Angiograms pre, peri and post procedure (Frontier II) Pre-Implantation Tamponade peri-procedure Post Implantation Control of bleeding during delivery Complete haemostasis No stenosis
11 CE Mark Study Clinical Case Follow-up Pre-procedure 1 mo. post-procedure
12 Conclusions The new Vivasure closure device offers a safe and dependable alternative to open surgical closure, pre-close suture mediated or collagen plug devices for percutaneous closure of large hole femoral arteriotomies The device has demonstrated its safety and effectiveness with excellent outcomes from discharge through 1, 3 and 12 month follow-up The device performed reliably with a low learning curve (3 simple steps for deployment) May be deployed in less than 1 minute with immediate haemostasis No groin fibrosis or scaring observed to 12 months Uses an synthetic implant which is fully absorbable within 180 days Minimal haemodynamic impact observed Device provides a real option for fully percutaneous closure with reduced hospital costs and procedure times.
BASELINE CHARACTERISTICS. Patients (n) 62. Age (years) 77.6 ± 7.4. Male gender (%) 59.7% Weight (kg) 81.7 ± 17.4
FRONTIER III Results of a study to assess a New Fully Absorbable Patch Based Large Hole Vascular Closure Device Michael Laule, MD 1, Arne Schwindt, MD 2, Peter Crean, MD 3, Matthew Thompson, MD 4, Andrej
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