Femoral Micropuncture or Routine Introducer Study (FEMORIS)

Abstract

Objectives: The Micropuncture® 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture. Methods: This was a single-center, multiple-user trial. Four hundred and two patients undergoing possible or definite percutaneous coronary intervention (PCI) were randomized 1:1 to an 18-gauge versus a 21-gauge needle. Patients and personnel pulling the sheaths and performing the follow-up were blinded. The primary end point was a composite of access bleeding. Events were tabulated following sheath removal, ≤24 h after the procedure and at the follow-up (at 1-2 weeks). End points were blindly adjudicated. Results: The event rate overall was 12.4% and did not differ significantly between groups, although the 21-gauge needle was found to reduce events by more than one third. An exploratory subgroup analysis of prespecified variables indicated that: patients who did not undergo PCI or elective procedures, female patients and those with a final sheath size of ≤6 Fr all had a significant or near-significant reduction of complications with Micropuncture. Conclusions: Although no significant differences between the use of the 18- and 21-gauge needles were observed, there was a 50-75% reduction with Micropuncture in several subgroups. The study was terminated prematurely. Access site complications may be reduced by the use of the 21-gauge needle, particularly when the risk of bleeding is not high. Further multicenter data will be required to confirm these hypothesis-generating observations.

Differences in Complication Rates Between Large Bore Needle and a Long Micropuncture Needle During Epicardial Access

“…MP needle is much smaller at the tip with a smooth shaft to tip transition eliminating hang-ups during the access and is believed to be associated with less trauma during access. Ambrose et al 13 compared the LB needle with MP needle in patients undergoing cardiac catheterization through femoral arterial access and reported a significantly higher vascular event rate using the LB when compared with a MP needle (15.5% versus 9.4%).…”

Transarterial and transvenous access for neurointerventional surgery: report of the SNIS Standards and Guidelines Committee

“…In complex cases, it has been shown to reduce the number of attempts to successful cannulation, time to access, inadvertent vessel puncture, and access site complications in prospective randomized trials across multiple access sites and patient populations compared with arterial access based on fluoroscopic guidance, arterial palpation, or surface anatomical landmarks 6. The use of micropuncture access (21 g) versus standard access (18 g) has been shown in a prospective trial of over 400 patients to reduce access site complications in patients without an elevated bleeding risk 7. Furthermore, increasing arterial sheath size is associated with an increase in access site complications across multiple access sites 8–10.…”

Targeting the safe zone: A quality improvement project to reduce vascular access complications

“…Micropuncture has been shown to reduce vascular complications, but definitive data on its benefits is still lacking the recently published FEMORIS study, the first randomized trial to assess the effects of using a 21‐gauge needle on vascular complications, failed to document a significant benefit in outcomes with its use .…”