Vascular Complications in Transcatheter Aortic Valve Replacement With Plug-Based vs Suture-Based Closure Devices

Area of Science:

• Cardiovascular Interventions
• Medical Device Technology
• Vascular Surgery

Background:

• Conflicting data exist on suture vs. plug-based vascular closure devices (VCDs) for large-bore catheter management during transcatheter aortic valve replacement (TAVR).
• Vascular complications (VCs) are a concern in TAVR procedures requiring large-bore access.
• Comparing the safety and efficacy of different VCDs is crucial for optimizing TAVR patient outcomes.

Purpose of the Study:

• To compare the rates of vascular complications (VCs) between the MANTA VCD (M-VCD) and ProGlide VCD (P-VCD) in patients undergoing TAVR.
• To evaluate the safety profile of M-VCD versus P-VCD in a large, real-world cohort.
• To determine if device type influences the incidence of major versus minor VCs post-TAVR.

Main Methods:

• A single-center, prospective registry study included patients undergoing TAVR for severe aortic stenosis (AS) from 2009-2022.
• Outcomes were compared between patients who received M-VCD (n=502) and P-VCD (n=813) for femoral access closure.
• Vascular complications were adjudicated according to VARC-2 criteria, distinguishing between major and minor events.

Main Results:

• In-hospital vascular complications were significantly more frequent with M-VCD (17.3%) compared to P-VCD (9.8%) (P < 0.001).
• The increased VCs in the M-VCD group were predominantly driven by a higher rate of minor VCs (15.1% vs 8.4%; P < 0.001).
• Rates of major VCs were low and not significantly different between the M-VCD and P-VCD groups (2.2% vs 1.5%; P = 0.33).

Conclusions:

• The MANTA VCD was associated with higher overall vascular complication rates in TAVR patients compared to the ProGlide VCD.
• This increased risk is mainly attributable to minor vascular complications, not major ones.
• Both M-VCD and P-VCD demonstrated low rates of major vascular complications in this TAVR cohort.