Morcos, Ramez

AbstractBackgroundThere is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles.ObjectivesTo assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States.MethodsWe queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure.ResultsThe final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG).ConclusionsNeedle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training.

Peripheral arterial disease (PAD) refers to partial or complete occlusion of one or more non-coronary arteries that leads to compromised blood flow and ischemia. Numerous processes are involved in arterial stenosis, however, atherosclerosis remains the most common etiology. PAD constitutes a major health economic problem, and it is estimated that over 200 million people around the world suffer from PAD, with at least 20% having some degree of claudication. The purpose of this review is to compare and contrast the guidelines on PAD published in 2005, 2011 and 2016 in terms of new recommendations and level of evidence for practicing clinicians.