The ABLATE Trial: Safety and Efficacy of Cox Maze-IV Using a Bipolar Radiofrequency Ablation System
| Autor: | David Heimansohn, James Longoria, James L. Cox, MacK Stirling, Divyakant B. Gandhi, Robert L. Hooker, Michael J. Mack, Allen Morris, Patrick M. McCarthy, Christian W. Zemlin, Jonathan M. Philpott |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Pulmonary and Respiratory Medicine medicine.medical_specialty Time Factors medicine.medical_treatment law.invention Randomized controlled trial law Internal medicine Atrial Fibrillation medicine Humans Adverse effect Aged medicine.diagnostic_test business.industry Atrial fibrillation Equipment Design medicine.disease Ablation Confidence interval Treatment Outcome Pulmonary Veins Anesthesia Concomitant Ambulatory Catheter Ablation Electrocardiography Ambulatory Cardiology Female Surgery Cardiology and Cardiovascular Medicine business Electrocardiography Follow-Up Studies |
| Zdroj: | The Annals of Thoracic Surgery. 100:1541-1548 |
| ISSN: | 0003-4975 |
| DOI: | 10.1016/j.athoracsur.2015.07.006 |
| Popis: | Background The Cox Maze-IV procedure (CMP-IV) has replaced the Cox Maze-III procedure as the most common approach for the surgical treatment of atrial fibrillation (AF). The Food and Drug Administration-regulated AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE) trial sought to demonstrate the safety and efficacy of the CMP-IV performed with the Synergy ablation system (AtriCure, Inc, Cincinnati, OH). Methods Fifty-five patients (aged 70.5 ± 9.3 years), 92.7% of whom had nonparoxysmal AF, underwent CMP-IV to terminate AF during a concomitant cardiac surgical procedure. Lesions were created using the AtriCure Synergy bipolar radiofrequency ablation system. All patients were seen for follow-up visits after 30 days, 3 months, and 6 months, with 24-hour Holter monitoring at 6 months. Late evaluation was performed by 48-hour Holter monitoring at an average of 21 months. Results The primary efficacy endpoint, absence of AF (30 seconds or less) at 6-month follow-up off antiarrhythmic medications (Heart Rhythm Society definition), indicated 76% (38 of 50) were AF free (95% confidence interval: 62.6% to 85.7%). The primary safety endpoint, the rate of major adverse events within 30 days, was 9.1% (5 of 55; 95% confidence interval: 3.9% to 19.6%), with 3.6% mortality (2 of 55). Secondary efficacy endpoints included being AF free with antiarrhythmic drugs (6 months, 84%; 21 months, 75%), successful pulmonary vein isolation (100%), and AF burden at 6 and 21 months. The results, together with those for the secondary safety endpoint (6-month major adverse events), demonstrated that the Synergy system performs comparably to the cut-and-sew Cox Maze-III procedure. Conclusions The CMP-IV using the AtriCure Synergy system was safe and effective for cardiac surgical patients who had persistent and longstanding persistent AF. |
| Databáze: | OpenAIRE |
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