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.
RCT Entities:
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.
Authors: Chul Seung Lee; Sung-Hoon Yoon; Seung-Min Lee; In Kyu Lee; Jang Young Kim; Hyun Min Cho; Min Ki Kim Journal: World J Surg Date: 2020-04 Impact factor: 3.352
Authors: Sanjit S Jolly; Sulaiman AlRashidi; Marc-André d'Entremont; Omar Alansari; Bradley Brochu; Laura Heenan; Elizabeth Skuriat; Jessica Tyrwhitt; Michael Raco; Michael Tsang; Nicholas Valettas; James L Velianou; Tej Sheth; Matthew Sibbald; Shamir R Mehta; Natalia Pinilla-Echeverri; Jon David Schwalm; Madhu K Natarajan; Andrew Kelly; Elie Akl; Sarah Tawadros; Mercedes Camargo; Walaa Faidi; John Bauer; Rachel Moxham; James Nkurunziza; Gustavo Dutra; Jose Winter Journal: JAMA Cardiol Date: 2022-09-18 Impact factor: 30.154