Author + information
- Christopher R. Ellis,
- Moore Shoemaker,
- Arvindh Kanagasundram,
- George Crossley,
- Juan Estrada,
- Sharon Shen,
- Pablo Saavedra,
- Sherry Bowman and
- Sean Whalen
Background: Optimal dosing of dabigatran in patients undergoing left atrial (LA) ablation procedures for atrial fibrillation (AF) or LA flutter is unknown. Retrospective data suggest increased bleeding risk with continuous dabigatran, and increased embolic risk when interrupted. We sought to confirm safety and efficacy of interrupted dabigatran dosing for patients undergoing LA ablation per FDA labeling on drug discontinuation prior to invasive procedures.
Methods: Patients having ablation for AF or LA flutter were enrolled in a prospective controlled single arm study. Peri-procedural dabigatran was withheld a minimum of 24 hrs pre-procedure if GFR > 50ml/min, and 72 Hrs if GFR < 50ml/min. First dose of dabigatran was administered 4-6 hours post sheath pull with continued BID dosing for 90 days. The primary endpoint was a composite of major bleeding (identified source and reduction in Hgb level of > 2 gm/dL, transfusion of 2 or more units, or symptomatic bleeding in a critical organ) and any peri-procedural thromboembolic event within 90 days.
Results: 101 patients with paroxysmal (n=72) or persistent AF (n=26), or LA flutter (n=3) undergoing ablation at Vanderbilt Hospital from October 28, 2013, to August 30, 2015 were consented. Prospective 90 day follow up was complete in 94 subjects (mean age 61yr, 72% male). CHADS 2 score was 0-2 in 75%, and HAS-BLED score 0-1 in 74%. Average baseline hematocrit was 42.8%, and Creatinine was 0.96 mg/dL. Median LA size was 4.3cm, Mean LVEF 56.8%, BMI 32 and baseline ACT 120s. Mean case time was 244 min with total RF time 72 min and fluoroscopy time 27.5min. Mean heparin dose to achieve ACT 300-350s was 14,270 un, there was a trend to higher heparin dose required in patients on Factor Xa inhibitors at baseline versus dabigatran (14,440un v 12,886un, p=0.055). Time to dabigatran after sheath pull was 328 min. There was 1 major bleed (1 pericardial effusion), no thromboembolic events (0). At 90 days 6 subjects discontinued therapy due to GI side effects. No groin complications were observed.
Conclusions: Interrupted peri-procedural dabigatran for AF or LA flutter ablation in accordance with FDA insert labeling demonstrates a favorable bleeding and thromboembolic risk profile.
Poster Hall, Hall C
Friday, March 17, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Arrhythmias and Clinical EP: AF Ablation
Abstract Category: 6. Arrhythmias and Clinical EP: Other
Presentation Number: 1150-083
- 2017 American College of Cardiology Foundation