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CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
Atrial fibrillation ablation in patients with therapeutic international normalized ratios.
Pacing and Clinical Electrophysiology : PACE 2009 August
AIMS: Pulmonary vein antrum isolation (PVAI) plays a pivotal role in the comprehensive treatment of atrial fibrillation (AF). The need for effective anticoagulation bridging following PVAI is associated with significant vascular complication rates and increased costs. We investigated the safety of PVAI in patients with therapeutic international normalized ratios (INR) the day of the procedure.
METHODS: A case-control analysis was performed on patients who underwent PVAI with therapeutic INR (>2). Patients with normal preprocedure INR served as controls. The incidence of major and minor hematomas, fistulas, vascular injury, and cardiac perforation or tamponade were catalogued. PVAI was performed under fluoroscopic, electro-anatomical, and intracardiac echocardiographic guidance, with an open irrigation ablation technique.
RESULTS: A total of 194 patients (mean age 64 +/- 12) were included; 87 patients underwent PVAI with therapeutic INR (cases) and 107 with normal INR (controls). Persistent AF was more prevalent than paroxysmal AF in the therapeutic INR group. The mean INR for cases was 2.8 +/- 0.7 compared to 1.4 +/- 0.3 in the control group (P < 0.01). All procedures were completed without acute complications. Two major adverse events were observed, one in each arm. No significant difference in terms of minor (6.5% vs. 5.7%, P = 0.23) or major (0.93% vs. 1.15%, P = 0.49) vascular events or bleeding was detected between the therapeutic INR and the control group. The combined endpoint of major and minor complications did not differ among groups (9.35% vs. 8.05%, P = 0.19).
CONCLUSION: Atrial fibrillation ablation in patients with therapeutic INR on the day of a procedure appears to be safe and feasible. Expensive outpatient anti-coagulation bridging may be safely avoided in this type of population.
METHODS: A case-control analysis was performed on patients who underwent PVAI with therapeutic INR (>2). Patients with normal preprocedure INR served as controls. The incidence of major and minor hematomas, fistulas, vascular injury, and cardiac perforation or tamponade were catalogued. PVAI was performed under fluoroscopic, electro-anatomical, and intracardiac echocardiographic guidance, with an open irrigation ablation technique.
RESULTS: A total of 194 patients (mean age 64 +/- 12) were included; 87 patients underwent PVAI with therapeutic INR (cases) and 107 with normal INR (controls). Persistent AF was more prevalent than paroxysmal AF in the therapeutic INR group. The mean INR for cases was 2.8 +/- 0.7 compared to 1.4 +/- 0.3 in the control group (P < 0.01). All procedures were completed without acute complications. Two major adverse events were observed, one in each arm. No significant difference in terms of minor (6.5% vs. 5.7%, P = 0.23) or major (0.93% vs. 1.15%, P = 0.49) vascular events or bleeding was detected between the therapeutic INR and the control group. The combined endpoint of major and minor complications did not differ among groups (9.35% vs. 8.05%, P = 0.19).
CONCLUSION: Atrial fibrillation ablation in patients with therapeutic INR on the day of a procedure appears to be safe and feasible. Expensive outpatient anti-coagulation bridging may be safely avoided in this type of population.
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