Comparison of Different Vascular Closure Device in TAVI

Efficacy Comparison of Different Femoral Vascular Closure Method Following Percutaneous Transcatheter Aortic Valve Implantation

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: Vascular closure device (Angio-Seal, Progilde)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Proglide; Use Two Progilde for closure of femoral artery with large sheath in transfemoral TAVI	Device: Vascular closure device (Angio-Seal, Progilde); In transfemoral TAVI, vascular closure devices were used for femoral artery wound closure, progilde and angio-seal can be used in wound closure. We aimed to compared the efficacy and safety of different vascular closure device in TAVI
Experimental: Progilde + AngioSeal; Use Progilde + AngioSeal for closure of femoral artery with large sheath in transfemoral TAVI	Device: Vascular closure device (Angio-Seal, Progilde); In transfemoral TAVI, vascular closure devices were used for femoral artery wound closure, progilde and angio-seal can be used in wound closure. We aimed to compared the efficacy and safety of different vascular closure device in TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular complication	TAVI related major or minor vascular complication according to valve academic research consortium 3 criteria	during hospitalization for index procedure
Life threatening bleeding complication	TAVI related life threatening bleeding according valve academic research consortium 3 criteria	within 24hrs after the index procedure
Major or minor bleeding complication without life threatening condition	TAVI related major or minor bleeding according valve academic research consortium 3 without life threatening condition	within 24hrs after the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bail-out closure device use	additional closure device deployment for femoral access site to achieve hemostasis	within 10mins after the index procedure
Limb ischemia related to TAVI	Significant peripheral ischemia related to arteriotomy closure	within one year after TAVI
In-hospital serious vascular complications requiring percutaneous or surgical interventions	Vascular perforation or dissection, peripheral ischemia or acute limb ischemia, arteriovenous fistula, pseudoaneurysm, and access-site hematoma.	In the index hospitalization (up to 14 days)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Mao-Shin Lin, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 201711019RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No