Vascular closure after TAVI: assessing the safety and efficacy of a collagen-based device in a real-world population
Key result
MANTA closure in transfemoral TAVI yields an ~8% device failure rate.
- n=299
Why the study?
Transfemoral TAVI carries high vascular complication rates from large-bore access, and real-world safety and efficacy data for the MANTA collagen plug-based closure device were needed.
Is the MANTA collagen-based device safe and effective for large calibre arteriotomy closure in patients undergoing transfemoral TAVI?
Key Points
- To assess the real-world safety and efficacy of the MANTA collagen plug-based closure device for large-bore arteriotomy following transfemoral transcatheter aortic valve implantation.
- Retrospectively analyzed 299 consecutive patients who received transfemoral TAVI access closure with the MANTA device at a single center between March 2020 and May 2022.
- Evaluated primary safety endpoints (closure device failure, access-related vascular complications, and bleeding) and the secondary endpoint (periprocedural all-cause mortality) using VARC-3 criteria.
- Closure device failure occurred in 8.4% of patients (n=25), with only 1 patient requiring bailout surgical closure; overall vascular complications occurred in 11.4% (n=34) and bleeding in 4.3% (n=13).
- Smaller minimal femoral artery diameter (6.6 ± 1.1 mm vs 7.7 ± 1.4 mm, p<0.001) and a higher sheath-to-femoral artery diameter ratio (0.76 ± 0.15 vs 0.68 ± 0.14, p=0.02) were significantly associated with device failure.
- Periprocedural all-cause mortality occurred in 2.3% of patients (n=7), and closure device failure did not prolong the median hospital stay (4.00 vs 4.00 days, p=0.36).
Study Design
Type
Cohort (n=299)
Multicenter
No
Structured PICO
Is the MANTA collagen-based device safe and effective for large calibre arteriotomy closure in patients undergoing transfemoral TAVI?
P
Population
299 consecutive patients (mean age 81.1 years, 50.5% female) undergoing transfemoral TAVI access closure with the MANTA device.
E
Exposure
MANTA collagen plug-based device for large calibre arteriotomy closure during transfemoral TAVI
O
Outcome
Rates of closure device failure, and access-related vascular and bleeding complications defined according to VARC 3 criteriasafety
In a real-world cohort, the MANTA device demonstrated acceptable safety and efficacy for femoral arteriotomy closure after TAVI, with infrequent device failure that rarely led to severe complications.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Martinho et al. present an interesting single-center observational study on the largest real-world experience with the MANTA device. The aim of the study was to evaluate the safety and efficacy profile of the device in a consecutive unselected cohort of patients referred for TF-TAVI.”
MAMohamed Abdel-WahabInterventional cardiologist, Heart Center Leipzig
“The greatest weakness of the MANTA-based technique lies in the fact that vessel access is lost after deployment of the collagen plug, making further direct escalation via the primary access route practically impossible. This major limitation renders the use of MANTA an 'all or nothing' approach, with an obligatory binary outcome (success or failure).”
MAMohamad AlkhouliInterventional cardiologist, Mayo Clinic Rochester
“The [Manta] device was designed when the sheath sizes were very large and the vascular complication rates were high. Patients themselves are lower risk and have healthier vessels. The TAVR sheaths and delivery systems have improved, and the current collagen-based [plug] systems have not caught up with that progression. They're trying to solve a problem that was there 5 or 8 years ago.”
Implication
Acceptable real-world MANTA complication rates after TAVI support continued selective use; leaves open need for randomized comparisons to other devices.
Abstract
Background Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic stenosis. However, the high rates of vascular complications (5-20%) associated with the large-bore access hinder clinical outcomes. There are several options available for access site closure, including MANTA, a dedicated collagen plug-based device that showed promising results in recent trials. Purpose We sought to evaluate the safety and efficacy of large calibre arteriotomy closure with MANTA during transfemoral TAVI in a real-world cohort. Methods We retrospectively analysed all consecutive patients who underwent transfemoral TAVI access closure with the MANTA device in our centre between March 2020 and May 2022. The primary safety endpoints were the rates of closure device failure, and access-related vascular and bleeding complications. The secondary endpoint was periprocedural all-cause mortality. All endpoints were defined according to the Valve Academic Research Consortium (VARC) 3 criteria. Results A total of 299 patients were included, mean age of 81.09 ± 6.34 years, 50.5% females, median EuroSCORE II of 3.11% [IQR 2.08–4.75]. Approximately two-thirds were under antithrombotic treatment (36.4% on oral anticoagulation and 33.0% on antiplatelet therapy). Closure device failure occurred in 8.4% cases (n=25), nevertheless only one required bailout surgical closure. Vascular complications occurred in 11.4% (n=34), most minor and related to the access site (9.0%, n=27): arterial occlusion (5.0%, n=15), haematomas (3.0%, n=9) and pseudoaneurysms (1.0%, n=3). Bleeding complications occurred in 4.3% (n=13), most VARC type 1 (3.3%, n=10). Both smaller minimal femoral artery diameter (6.6 ± 1.1 mm vs 7.7 ± 1.4mm, p<0.001) and bigger sheath to femoral artery diameter ratio (0.76 ± 0.15 vs 0.68 ± 0.14, p=0.02) were associated with device failure. The secondary endpoint occurred in 7 patients (2.3%), both from cardiovascular (aortic dissection, n=3; ischemic stroke; n=2) and non-cardiovascular causes (sepsis, n=2). Device failure did not prolong the index hospitalization (4.00, IQR 3.00-5.00 days vs 4.00, IQR 3.00-5.00; p=0.36). Conclusions In a large real-world cohort, MANTA was a safe and effective solution for femoral arteriotomy closure after TAVI. Device failure was infrequent, rarely associated with severe complications and did not lengthen the hospital stay.
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Cite This Study
Grine et al. (2023) conducted a cohort in symptomatic severe aortic stenosis (n=299). MANTA device was evaluated on closure device failure. In patients undergoing transfemoral TAVI, access closure with the MANTA device resulted in an 8.4% rate of device failure, 11.4% vascular complications, and 4.3% bleeding complications.