Real‐world experience of suture‐based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience

Abstract

Objectives: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) -Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). Background: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. Methods: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports.Results: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group.Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

Large-bore arterial access closure after transcatheter aortic valve replacement: a systematic review and network meta-analysis

“…Nonetheless, VCD failures are not uncommon (1–8%), 11 , 22 , 33 are associated with major vascular complications and, in turn, with a higher risk of in-hospital and short-term death. 8 Major vascular complications after TAVR are associated with increased rates of in-hospital and short-term death, 5–7 reflecting the morbidity and mortality of a bleeding event and of vascular surgery performed in an emergency setting. Therefore, it is important to understand the difference between the available VCDs and to highlight any benefit to optimize the outcomes after TAVR.…”

“…In clinical practice, despite a trend towards smaller TAVR delivery systems, the ever-increasing operator experience and the wide use of VCDs, bleedings related to major vascular complications remain relatively common, even in a low-risk setting, 2 , 3 exerting a negative impact on mortality. 6 Considering that major vascular complications are often linked to VCDs failure, 7 , 8 in the present systematic review and network meta-analysis (NMA), we aimed at collecting and summarizing the available evidence on the performance of VCDs regarding clinical outcomes.…”

Balloon-Assisted Perclose Suture Delivery for Large-Bore Vascular Access Closure After Transcatheter Aortic Valve Replacement

“…2 Several mechanisms of Perclose failure have been reported, with malfunction of the sutures being the most common mechanism, accounting for 25% of cases. 3 In this article, we describe a method for optimization of suture-mediated closure with the Perclose ProGlide™ system, using balloon counterpressure to facilitate and confirm delivery of the suture knot to the vessel.…”

Comment: Comparison of radial versus femoral access using hemostatic devices following percutaneous coronary intervention

“… 3 , 4 A recently published review of post marketing surveillance of suture-based VCDs revealed 827 reports of major complications with Perclose ProGlide (Abbott Cardiovascular; Abbott Park, IL) and 175 reports of major complications with Prostar XL (Abbott Cardiovascular; Abbott Park, IL). 5 The authors concluded that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Also, it has been observed that because of limited experience of TFA in routine interventional cardiology practice where TRA is the default access, the incidence of groin and device closure complications has increased ("Campeau Radial Paradox,") 6 .…”