Closure devices versus manual compression to achieve hemostasis post-patent foramen ovale closure.

Abstract

Objectives: Venous access plays a crucial role in various interventional cardiology procedures, including percutaneous patent foramen ovale (PFO) closure. Traditionally, manual compression has been the standard method for achieving hemostasis following venous access. However, this approach may be associated with potential complications such as puncture site bleedings. The aim of the study was to compare the safety and efficacy of different venous closure techniques.

Methods: The authors conducted a single-center observational study of 220 patients undergoing PFO closure. The study quasi-randomized participants to 1 of 3 methods: Z-suture closure, Perclose ProGlide suture-mediated closure (Abbott), and manual compression. The primary outcome was the occurrence of bleeding events, classified according to the standardized Bleeding Academic Research Consortium (BARC) classification system.

Results: Bleeding events were not significantly different between the closure groups. Of the patients who received manual compression, 14.2% (n = 17) experienced BARC bleeding events of 2 or higher. In the Z-suture group, 14.5% (n = 7) of patients had BARC bleeding events of 2 or higher. In the ProGlide group, 15% (n = 8) of patients experienced such events (P = .9). Only 1 patient in the manual compression group experienced a severe bleeding event (BARC 3). However, no cases of BARC 4 or 5 occurred in any of the closure groups.

Conclusions: The Z-suture and ProGlide methods are safe and efficient for venous occlusion after percutaneous PFO closure compared with manual compression.