Comparison of Different Vascular Closure Device in TAVI

National Taiwan University

Status: Completed

Conditions: Transcatheter Aortic Valve Implantation; Aortic Valve Stenosis

Treatments: Device: Vascular closure device (Angio-Seal, Progilde)

Study type: Interventional

Funder types: Other

Identifiers

NCT05491070

201711019RINC

Details and patient eligibility

About

Femoral artery approach for transcatheter aortic valve implantation (TAVI) is an ideal approach site. However the closure for femoral artery after transfemoral TAVI is challenging. We aimed to compared the efficacy and safety of Angio-Seal + Proglide vs. Dual Proglide for femoral arteriotomy closure following TAVI

Full description

Aortic stenosis (AS) is a common, potentially fatal condition that emerges as a substantial public health burden. The prevalence of AS is as high as 9.8% in those 80 years or older, with an overall prevalence of 2.8% in adults over 75 years of age. Several studies have demonstrated that the overall risk of sudden death in asymptomatic patients with aortic stenosis is around 2%. Once symptoms develop, there is an inexorable deterioration with a poor prognosis. Within 3 years of the onset of angina, syncope, or the symptoms of heart failure, 75% of symptomatic patients are dead unless the outflow obstruction is relieved. Therefore, the modality to solve AS is life saving for this patient group. Before 2002 when first-in-man transcatheter aortic valve implantation (TAVI) was performed, surgical aortic valve replacement (SAVR) is the only treatment of choice for patients with severe symptomatic aortic stenosis. As TAVI prevailed, TAVI has been demonstrated to be safe and effective in relieving AS in patients with high and intermediate surgical risk. Transfemoral approach is preferential approach of TAVI. As the device evolved, transfemoral TAVI procedure is moving to local anaesthetic with percutaneous procedure instead of surgical cut-down.

Femoral arteriotomy closure following TAVI remains challenging and, at times, may result in significant or even fatal complications. Even though the evolution of device and smaller device size, complications associated with the femoral access site are reported in 5-20% of patients undergoing TAVI. The incidence of access site-related vascular complications reinforces the need for the improvement of techniques that ensure effective and reproducible hemostasis with a safe and effective arteriotomy closure. The Perclose ProGlide (PP) suture-mediated closure device (Abbott Vascular, Santa Clara, CA, USA) has been widely utilized in a dual pre-close strategy, and successful closures may be obtained for up to 24F sheath. Moreover, the preclose technique has been shown not to increase the risk of CFA narrowing. Therefore, the preclose technique has been widely used in percutaneous endovascular procedures using large diameter arteriotomies, including TAVI and EVAR.

Nevertheless, failure of this device requiring further intervention has been described in 4-9% of cases. Adjunctive Angio-Seal technique has been postulated as feasible and safe or even considered as a bail-out strategy when the dual PP closure technique fails to obtain complete hemostasis. Therefore, the best strategy for femoral arteriotomy closure following TAVI remains to be studied.

In our hospital, we have performed either dual PP or one Perclose ProGlide with one Angio-Seal for femoral arteriotomy closure following TAVI. Both have been shown to be satisfactory for complete hemostasis. However, there was not study regarding complete hemostasis, long-term vessel outcome and clinical walking ability between these two procedures. Herein, we design a open-labeled randomized study to compare the efficacy of complete hemostasis and long-term vascular outcome between dual PP and one Perclose ProGlide with one Angio-Seal following TAVI.

Enrollment: 260 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 20 years old
• Severe aortic stenosis and suitable candidate for transfemoral transcatheter aortic valve implantation

Exclusion criteria

• Age < 20 years old
• Severe aortic stenosis not suitable for transfemoral transcatheter aortic valve implantation
• An initial plan for a surgical transfemoral cut-down approach

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Dual Proglide

Experimental group

Description:

Use Two Progilde for closure of femoral artery with large sheath in transfemoral TAVI

Treatment:

Device: Vascular closure device (Angio-Seal, Progilde)

Progilde + AngioSeal

Experimental group

Description:

Use Progilde + AngioSeal for closure of femoral artery with large sheath in transfemoral TAVI

Treatment:

Device: Vascular closure device (Angio-Seal, Progilde)