Vineet Kumar1, Marc Wish1, Ganesh Venkataraman2, Kevin Bliden1, Manila Jindal1,3, Adam Strickberger1. 1. Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia. 2. Department of Electrophysiology, Colorado Heart & Vascular, Lakewood, Colorado. 3. Department of Internal Medicine, Howard University Hospital, Washington, District of Columbia.
Abstract
INTRODUCTION:Cryoballoon ablation is commonly used to treat atrial fibrillation (AF). Femoral vein hemostasis after cryoballoon ablation for AF is routinely achieved with manual pressure (MP) after reversal of heparin and reassessment of the activated clotting time, or with a figure-of-eight suture (F8). The purpose of this randomized trial was to compare these two techniques for femoral vein hemostasis after cryoballoon ablation for AF in a patient population predominantly on novel anticoagulants (NOAC). METHODS AND RESULTS: Seventy consecutive patients who underwent cryoballoon ablation were randomized to either the MP or F8 for femoral vein hemostasis. Clinical and procedural characteristics were similar between the groups with the majority of patients treated with a NOAC. The total time in the electrophysiology laboratory for the MP group and the F8 group (197 ± 37 minutes vs 167 ± 36 minutes, respectively; P = .02), and the time from sheath removal until the patient left the laboratory (28 ± 9 minutes vs 20 ± 5 minutes, respectively; P < .0001) were significantly less in the F8 group. Additional pressure for hemostasis in the recovery suite was required more often in the MP Group, as opposed to the F8 group (29% vs 3%; P = .003). No major bleeding occurred and the rate of minor hematomas was statistically similar. CONCLUSIONS: Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared with manual hemostasis, even amongst patients treated with a NOAC.
RCT Entities:
INTRODUCTION: Cryoballoon ablation is commonly used to treat atrial fibrillation (AF). Femoral vein hemostasis after cryoballoon ablation for AF is routinely achieved with manual pressure (MP) after reversal of heparin and reassessment of the activated clotting time, or with a figure-of-eight suture (F8). The purpose of this randomized trial was to compare these two techniques for femoral vein hemostasis after cryoballoon ablation for AF in a patient population predominantly on novel anticoagulants (NOAC). METHODS AND RESULTS: Seventy consecutive patients who underwent cryoballoon ablation were randomized to either the MP or F8 for femoral vein hemostasis. Clinical and procedural characteristics were similar between the groups with the majority of patients treated with a NOAC. The total time in the electrophysiology laboratory for the MP group and the F8 group (197 ± 37 minutes vs 167 ± 36 minutes, respectively; P = .02), and the time from sheath removal until the patient left the laboratory (28 ± 9 minutes vs 20 ± 5 minutes, respectively; P < .0001) were significantly less in the F8 group. Additional pressure for hemostasis in the recovery suite was required more often in the MP Group, as opposed to the F8 group (29% vs 3%; P = .003). No major bleeding occurred and the rate of minor hematomas was statistically similar. CONCLUSIONS: Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared with manual hemostasis, even amongst patients treated with a NOAC.
Authors: Julian Chun; Tilman Maurer; Andreas Rillig; Stefano Bordignon; Leon Iden; Sonia Busch; Daniel Steven; Roland R Tilz; Dong-In Shin; Heidi Estner; Felix Bourier; David Duncker; Philipp Sommer; Nils-Christian Ewertsen; Henning Jansen; Victoria Johnson; Livio Bertagnolli; Till Althoff; Andreas Metzner Journal: Herzschrittmacherther Elektrophysiol Date: 2021-11-04