title: Role of insertable cardiac monitors in anticoagulation therapy in patients with atrial fibrillation at high risk of bleeding.
abstract: OBJECTIVE
  We aimed to ascertain whether an insertable cardiac monitor (ICM)-guided rhythm-control strategy and assessment of atrial fibrillation (AF) burden may allow safe withdrawal and obviate long-term use of oral anticoagulants (OACs) in AF patients at high bleeding risk.
  
  
  RESULTS
  We implanted ICMs in 70 patients with AF with high risk of stroke (CHADS2 ≥2, CHA2DS2-VASc score ≥2) and bleeding (HAS-BLED score ≥3) after restoration of normal sinus rhythm (NSR) for continuous rhythm monitoring and optimization of antiarrhythmic drugs (AADs) when necessary. Patients were categorized into: (i) Group A (NSR/low AF burden, <1%), (ii) Group B (moderate/variable AF burden), and (iii) Group C (high AF burden, always AF). At patients' insistence, OACs were discontinued after proper counselling only if they maintained NSR/low AF burden for ≥3 consecutive months. All patients (age 73.3 ± 11.7 years; 53% male) were followed clinically and with ICM monitoring for 23.5 ± 10.5 months for outcomes including stroke, bleeding, death, device malfunction or infection, and AADs' adverse effects. Patients in Group A (n = 43), Group B (n = 20), and Group C (n = 7) had similar CHADS2 (2.09 ± 0.65, 2.05 ± 0.51, and 2.14 ± 0.38, respectively), CHA2DS2-VASc (3.05 ± 1.05, 2.85 ± 0.99, and 2.42 ± 0.53, respectively), and HAS-BLED (3.02 ± 1.01, 3.40 ± 0.68, and 3.00 ± 0.58, respectively) scores (P > 0.05). In 53 (76%) patients (Group A = 41 and Group B = 12) who maintained NSR/low AF burden, OACs were discontinued without adverse events. Severe bleeding occurred in 4 of 17 (24%) patients who remained on OACs.
  
  
  CONCLUSIONS
  In AF patients with high bleeding risk, ICM-guided rhythm control with AADs and assessment of AF burden may allow safe discontinuation of OACs.
authors.affiliation: Coventry Cardiology Associates, Easton Hospital, Easton, PA, USA.
authors.forename: Daniel A N
authors.initials: DA
authors.lastname: Mascarenhas
authors.affiliation: Easton Hospital, Easton, PA, USA.
authors.forename: Mohammad U
authors.initials: MU
authors.lastname: Farooq
authors.affiliation: Medtronic Diagnostics and Monitoring Research, Mounds View, MN, USA.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Ziegler
authors.affiliation: Cardiovascular and Heart Rhythm Consultants, 30 West 60th Street, Suite 1U, New York, NY 10023, USA bkantharia@yahoo.com.
authors.forename: Bharat K
authors.initials: BK
authors.lastname: Kantharia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000628:therapy*; D015716:Electrocardiography, Ambulatory / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000517:prevention & control; D014481:United States
chemical_list: D000889:Anti-Arrhythmia Agents; D000925:Anticoagulants
keywords: Antiarrhythmic drugs; Atrial fibrillation; Bleeding; Insertable cardiac monitors; Oral anticoagulation; Stroke