Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study.
Atrial fibrillation and atrial flutter are common cardiac arrhythmias associated with an increased risk of stroke in patients with additional risk factors. Anticoagulation ameliorates stroke risk, but because these arrhythmias may occur intermittently without symptoms, initiation of prophylactic therapy is often delayed until electrocardiographic documentation is obtained. The IMPACT study is a multicenter, randomized trial of remote surveillance technology in patients with implanted dual-chamber cardiac resynchronization therapy defibrillator (CRT-D) devices designed to test the hypothesis that initiation and withdrawal of oral anticoagulant therapy guided by continuous ambulatory monitoring of the atrial electrogram improve clinical outcomes by reducing the combined rate of stroke, systemic embolism, and major bleeding compared with conventional clinical management. For those in the intervention group, early detection of atrial high-rate episodes (AHRE) generates an automatic alert to initiate anticoagulation based on patient-specific stroke risk stratification. Subsequently, freedom from AHRE for predefined periods prompts withdrawal of anticoagulation to avoid bleeding. Patients in the control arm are managed conventionally, the anticoagulation decision prompted by incidental detection of atrial fibrillation or atrial flutter during routine clinical follow-up. The results will help define the clinical utility of wireless remote cardiac rhythm surveillance and help establish the critical threshold of AHRE burden warranting anticoagulant therapy in patients at risk of stroke. In this report, we describe the study design and baseline demographic and clinical features of the initial cohort (227 patients).
Ip
John
J
Thoracic and Cardiovascular Healthcare Foundation, Lansing, MI 48910, USA. jip@tciheart.com
Waldo
Albert L
AL
Lip
Gregory Y H
GY
Rothwell
Peter M
PM
Martin
David T
DT
Bersohn
Malcolm M
MM
Choucair
Wassim K
WK
Akar
Joseph G
JG
Wathen
Mark S
MS
Rohani
Pooyan
P
Halperin
Jonathan L
JL
D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D001282:Atrial Flutter / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002304:Cardiac Pacing, Artificial; D015331:Cohort Studies; D017147:Defibrillators, Implantable; D004562:Electrocardiography / Q000379:methods; D004617:Embolism / Q000209:etiology; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013686:Telemetry
D000925:Anticoagulants