Kenneth A Ellenbogen, Ali Khoynezhad, Mark La Meir, Carlo de Asmundis, Jayanthi Koneru, John Johnkoski, Kevin Rist, Mubashir Mumtaz, Michael G Link, Joris R de Groot, Antoine H G Driessen, Mark Y Lee, Steven J Hoff, David Bello, Gansevoort Dunnington, Susan Eisenberg, Margot Vloka, Benedict J Taylor, Stephen D Jones, Jonathan M Philpott, Thomas M Beaver, William M Miles, Junaid H Khan, Steven Kang, Gaurang D Gandhi, Eric J Okum, Nitish Badhwar, Tina Baykaner, Anson M Lee, Paul A Vesco, J Michael Smith, Sydney Gaynor, Ken Frazier, Randall Lee, Vigneshwar Kasirajan
{"title":"持续性或长期持续性心房颤动的双重心外膜和心内膜手术（DEEP）。","authors":"Kenneth A Ellenbogen, Ali Khoynezhad, Mark La Meir, Carlo de Asmundis, Jayanthi Koneru, John Johnkoski, Kevin Rist, Mubashir Mumtaz, Michael G Link, Joris R de Groot, Antoine H G Driessen, Mark Y Lee, Steven J Hoff, David Bello, Gansevoort Dunnington, Susan Eisenberg, Margot Vloka, Benedict J Taylor, Stephen D Jones, Jonathan M Philpott, Thomas M Beaver, William M Miles, Junaid H Khan, Steven Kang, Gaurang D Gandhi, Eric J Okum, Nitish Badhwar, Tina Baykaner, Anson M Lee, Paul A Vesco, J Michael Smith, Sydney Gaynor, Ken Frazier, Randall Lee, Vigneshwar Kasirajan","doi":"10.1161/CIRCEP.125.013692","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Despite advances in endocardial catheter ablation (ECA) for persistent atrial fibrillation (PersAF), undertreatment persists, especially in ECA nonresponders and in longstanding PersAF (LSPersAF), with disappointing ablation results. These patients need effective clinical treatment options.</p><p><strong>Methods: </strong>The DEEP (Dual Epicardial and Endocardial Procedure) was a prospective, multicenter, single-arm, investigational device exemption trial to establish the safety and effectiveness of a combined epicardial/endocardial ablation procedure with left atrial appendage exclusion for PersAF/LSPersAF. Eligibility included age 18 to 75 years; symptomatic PersAF/LSPersAF refractory to ≥1 Class I/III antiarrhythmic drug; and ≤2 previous failed ECAs. Two-stage hybrid ablation included ECA performed at 91 to 121 days after the epicardial first stage (including left atrial appendage exclusion), followed by a 90-day blanking and 90-day antiarrhythmic drug optimization period. Primary effectiveness was defined as freedom from documented atrial fibrillation/atrial flutter/atrial tachycardia episodes >30 seconds through the 12-month follow-up, absent Class I/III antiarrhythmic drugs, except previously failed antiarrhythmic drugs at doses not exceeding those previously failed. Primary safety was defined as a composite of device/procedure-related serious adverse events within 30 days of epicardial ablation and 7 days of ECA.</p><p><strong>Results: </strong>Ninety patients enrolled from February 2015 to December 2020; 83.3% (75/90) were male and mean±SD age was 63.4±7.7 years. AF classification was 83.3% (75/90) PersAF/16.7% (15/90) LSPersAF, and 47.8% (43/90) had prior ECA. The composite serious adverse events rate was 6.7% (6/90 [95% CI, 2.5%-13.9%]; <i>P</i><0.001 versus safety goal), including 3 patients experiencing serious adverse events within 30 days of the epicardial procedure and 3 patients within 7 days of the endocardial procedure, all of whom were anticoagulated at the time of the event. Primary effectiveness through 12 months was 71.8% (61/85 [95% CI, 62.2%-81.3%]; <i>P</i>=0.0134 versus performance goal) and was 62.4% (53/85 [95% CI, 52.1%-72.7%]) through 2 years.</p><p><strong>Conclusions: </strong>A collaborative hybrid ablation approach to treating PersAF/LSPersAF is safe and effective.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02393885.</p>","PeriodicalId":10319,"journal":{"name":"Circulation. 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These patients need effective clinical treatment options.</p><p><strong>Methods: </strong>The DEEP (Dual Epicardial and Endocardial Procedure) was a prospective, multicenter, single-arm, investigational device exemption trial to establish the safety and effectiveness of a combined epicardial/endocardial ablation procedure with left atrial appendage exclusion for PersAF/LSPersAF. Eligibility included age 18 to 75 years; symptomatic PersAF/LSPersAF refractory to ≥1 Class I/III antiarrhythmic drug; and ≤2 previous failed ECAs. Two-stage hybrid ablation included ECA performed at 91 to 121 days after the epicardial first stage (including left atrial appendage exclusion), followed by a 90-day blanking and 90-day antiarrhythmic drug optimization period. Primary effectiveness was defined as freedom from documented atrial fibrillation/atrial flutter/atrial tachycardia episodes >30 seconds through the 12-month follow-up, absent Class I/III antiarrhythmic drugs, except previously failed antiarrhythmic drugs at doses not exceeding those previously failed. Primary safety was defined as a composite of device/procedure-related serious adverse events within 30 days of epicardial ablation and 7 days of ECA.</p><p><strong>Results: </strong>Ninety patients enrolled from February 2015 to December 2020; 83.3% (75/90) were male and mean±SD age was 63.4±7.7 years. AF classification was 83.3% (75/90) PersAF/16.7% (15/90) LSPersAF, and 47.8% (43/90) had prior ECA. The composite serious adverse events rate was 6.7% (6/90 [95% CI, 2.5%-13.9%]; <i>P</i><0.001 versus safety goal), including 3 patients experiencing serious adverse events within 30 days of the epicardial procedure and 3 patients within 7 days of the endocardial procedure, all of whom were anticoagulated at the time of the event. Primary effectiveness through 12 months was 71.8% (61/85 [95% CI, 62.2%-81.3%]; <i>P</i>=0.0134 versus performance goal) and was 62.4% (53/85 [95% CI, 52.1%-72.7%]) through 2 years.</p><p><strong>Conclusions: </strong>A collaborative hybrid ablation approach to treating PersAF/LSPersAF is safe and effective.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02393885.</p>\",\"PeriodicalId\":10319,\"journal\":{\"name\":\"Circulation. 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Dual Epicardial and Endocardial Procedure (DEEP) for Persistent or Longstanding Persistent Atrial Fibrillation.
Background: Despite advances in endocardial catheter ablation (ECA) for persistent atrial fibrillation (PersAF), undertreatment persists, especially in ECA nonresponders and in longstanding PersAF (LSPersAF), with disappointing ablation results. These patients need effective clinical treatment options.
Methods: The DEEP (Dual Epicardial and Endocardial Procedure) was a prospective, multicenter, single-arm, investigational device exemption trial to establish the safety and effectiveness of a combined epicardial/endocardial ablation procedure with left atrial appendage exclusion for PersAF/LSPersAF. Eligibility included age 18 to 75 years; symptomatic PersAF/LSPersAF refractory to ≥1 Class I/III antiarrhythmic drug; and ≤2 previous failed ECAs. Two-stage hybrid ablation included ECA performed at 91 to 121 days after the epicardial first stage (including left atrial appendage exclusion), followed by a 90-day blanking and 90-day antiarrhythmic drug optimization period. Primary effectiveness was defined as freedom from documented atrial fibrillation/atrial flutter/atrial tachycardia episodes >30 seconds through the 12-month follow-up, absent Class I/III antiarrhythmic drugs, except previously failed antiarrhythmic drugs at doses not exceeding those previously failed. Primary safety was defined as a composite of device/procedure-related serious adverse events within 30 days of epicardial ablation and 7 days of ECA.
Results: Ninety patients enrolled from February 2015 to December 2020; 83.3% (75/90) were male and mean±SD age was 63.4±7.7 years. AF classification was 83.3% (75/90) PersAF/16.7% (15/90) LSPersAF, and 47.8% (43/90) had prior ECA. The composite serious adverse events rate was 6.7% (6/90 [95% CI, 2.5%-13.9%]; P<0.001 versus safety goal), including 3 patients experiencing serious adverse events within 30 days of the epicardial procedure and 3 patients within 7 days of the endocardial procedure, all of whom were anticoagulated at the time of the event. Primary effectiveness through 12 months was 71.8% (61/85 [95% CI, 62.2%-81.3%]; P=0.0134 versus performance goal) and was 62.4% (53/85 [95% CI, 52.1%-72.7%]) through 2 years.
Conclusions: A collaborative hybrid ablation approach to treating PersAF/LSPersAF is safe and effective.
期刊介绍：
Circulation: Arrhythmia and Electrophysiology is a journal dedicated to the study and application of clinical cardiac electrophysiology. It covers a wide range of topics including the diagnosis and treatment of cardiac arrhythmias, as well as research in this field. The journal accepts various types of studies, including observational research, clinical trials, epidemiological studies, and advancements in translational research.
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