In an era driven by immediate answers and positive results, it is reassuring to examine the long-term follow-up of low-incidence outcomes. Piotrowski et al. evaluated the post-approval complication profiles of the Gore Cardioform and Gore Helex devices over a 10-year period, using data from the Manufacturer and User Facility Device Experience (MAUDE) database [1]. Given the large number of devices deployed to date, the authors confirmed a low incidence of both device-related and non-device-related events—with no reported cases of erosion.

It is in situations characterized by low event rates and extended follow-up periods that large-scale databases play a vital role in addressing important clinical questions. A notable example is the study by Stefanescu Schmidt et al., which investigated the incidence of procedural and long-term adverse events following percutaneous patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder, stratified by aortic rim distance [2]. Using Ontario's health administrative databases housed at the Institute for Clinical Evaluative Sciences (ICES) [3], the authors compiled 1394 patient-years of follow-up data. Their findings demonstrate that implantation of the Amplatzer PFO device is safe—even in patients with a short aortic rim thereby successfully challenging, in a substantiated manner, conventional beliefs and longstanding opinions.

Answering such complex questions, involving the interplay of low incidence and delayed event manifestation, is critical. These insights can influence a) procedural strategies (such as device type or sizing), b) the development and refinement of devices, and c) paradigm shifts in device design (e.g., transitioning from double-disc designs to suture-mediated alternatives [4]). In this regard, the U.S. trails behind its Canadian and European counterparts.