Michael Barbella, Managing Editor05.20.24
A transatlantic clinical trial, TAILORED-AF, compared an artificial intelligence (AI) software-guided (Volta AF-Xplorer) ablation procedure in combination with pulmonary vein isolation (PVI) to conventional ablation targeting PVI alone for the treatment of persistent atrial fibrillation (AF). Results indicated that a tailored cardiac ablation procedure supported by AI was a better treatment option for persistent and long-standing AF, challenging the current standard of care. Researchers presented these findings during the Heart Rhythm Society's annual meeting in Boston.
More than 37 million people worldwide are living with AF, the most common type of arrhythmia.1 Persistent AF occurs when an abnormal heart rhythm lasts for more than a week and longstanding persistent AF occurs when it extends greater than 12 months. Previous landmark studies looking at ablation strategies for persistent AF patients have demonstrated a lack of a consistent ablation strategy that is effective for patients, with a clinical success rate in past trials of 50%.2 While PVI remains the cornerstone ablation procedure for paroxysmal AF, the optimal procedure for persistent and long-standing persistent AF is unknown.
In recent years, AI has significantly impacted the field of cardiac electrophysiology. AI can provide an individualized non-invasive approach to determine targets of ablation in persistent AF and determine arrhythmia risk in patients with heart disease.3 The TAILORED-AF study, a randomized, two-arm clinical trial involving 26 centers in Europe and the United States, evaluated the effectiveness of an AI-guided cardiac ablation procedure compared to an ablation procedure with PVI alone for freedom of persistent AF. Patients were randomly assigned to receive the Anatomical arm (PVI-only) or the Tailored arm (AI-guided ablation with PVI) to assess the effectiveness of both treatment methods.
Researchers found the tailored arm was superior to the anatomical arm. Eighty-eight percent of patients in the tailored arm experienced freedom from AF 12 months post-procedure with or without antiarrhythmic drugs, while 70% of patients in the anatomical arm experienced freedom from AF. Additionally, 66% of patients in the tailored arm experienced acute termination of AF compared to 15% of patients in the anatomical arm. These results indicate that a more tailored approach, which includes AI-guided assessment, could represent a more effective procedure for patients with persistent and long-standing persistent AF than conventional methods.
"Atrial fibrillation is the most common arrhythmia and clinicians need more options, especially for hard-to-treat populations experiencing persistent AF,” said Isabel Deisenhofer, M.D., of the German Heart Center, Munich Department of Electrophysiology in Munich, Germany. “This is the first largescale trial to show the benefit of an ECG-driven 'PVI plus' procedure vs. standard-of-care in persistent AF patients. These results could have a real-world impact on how we treat persistent AF patients, especially those with longer AF duration."
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients and is the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal healthcare policies and standards. Incorporated in 1979 and based in Washington, D.C., it has a membership of more than 8,200 heart rhythm professionals from 94 countries.
References
1 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. International Journal of Stroke. 2021;16(2):217-221.
2 Verma, Atul, et al. "Approaches to catheter ablation for persistent atrial fibrillation." New England Journal of Medicine 372.19 (2015): 1812-1822.
3 Kabra R, Israni S, Vijay B, Baru C, Mendu R, Fellman M, Sridhar A, Mason P, Cheung JW, DiBiase L, Mahapatra S, Kalifa J, Lubitz SA, Noseworthy PA, Navara R, McManus DD, Cohen M, Chung MK, Trayanova N, Gopinathannair R, Lakkireddy D. Emerging role of artificial intelligence in cardiac electrophysiology. Cardiovasc Digit Health J. 2022 Sep 27;3(6):263-275.
More than 37 million people worldwide are living with AF, the most common type of arrhythmia.1 Persistent AF occurs when an abnormal heart rhythm lasts for more than a week and longstanding persistent AF occurs when it extends greater than 12 months. Previous landmark studies looking at ablation strategies for persistent AF patients have demonstrated a lack of a consistent ablation strategy that is effective for patients, with a clinical success rate in past trials of 50%.2 While PVI remains the cornerstone ablation procedure for paroxysmal AF, the optimal procedure for persistent and long-standing persistent AF is unknown.
In recent years, AI has significantly impacted the field of cardiac electrophysiology. AI can provide an individualized non-invasive approach to determine targets of ablation in persistent AF and determine arrhythmia risk in patients with heart disease.3 The TAILORED-AF study, a randomized, two-arm clinical trial involving 26 centers in Europe and the United States, evaluated the effectiveness of an AI-guided cardiac ablation procedure compared to an ablation procedure with PVI alone for freedom of persistent AF. Patients were randomly assigned to receive the Anatomical arm (PVI-only) or the Tailored arm (AI-guided ablation with PVI) to assess the effectiveness of both treatment methods.
Researchers found the tailored arm was superior to the anatomical arm. Eighty-eight percent of patients in the tailored arm experienced freedom from AF 12 months post-procedure with or without antiarrhythmic drugs, while 70% of patients in the anatomical arm experienced freedom from AF. Additionally, 66% of patients in the tailored arm experienced acute termination of AF compared to 15% of patients in the anatomical arm. These results indicate that a more tailored approach, which includes AI-guided assessment, could represent a more effective procedure for patients with persistent and long-standing persistent AF than conventional methods.
"Atrial fibrillation is the most common arrhythmia and clinicians need more options, especially for hard-to-treat populations experiencing persistent AF,” said Isabel Deisenhofer, M.D., of the German Heart Center, Munich Department of Electrophysiology in Munich, Germany. “This is the first largescale trial to show the benefit of an ECG-driven 'PVI plus' procedure vs. standard-of-care in persistent AF patients. These results could have a real-world impact on how we treat persistent AF patients, especially those with longer AF duration."
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients and is the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal healthcare policies and standards. Incorporated in 1979 and based in Washington, D.C., it has a membership of more than 8,200 heart rhythm professionals from 94 countries.
References
1 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. International Journal of Stroke. 2021;16(2):217-221.
2 Verma, Atul, et al. "Approaches to catheter ablation for persistent atrial fibrillation." New England Journal of Medicine 372.19 (2015): 1812-1822.
3 Kabra R, Israni S, Vijay B, Baru C, Mendu R, Fellman M, Sridhar A, Mason P, Cheung JW, DiBiase L, Mahapatra S, Kalifa J, Lubitz SA, Noseworthy PA, Navara R, McManus DD, Cohen M, Chung MK, Trayanova N, Gopinathannair R, Lakkireddy D. Emerging role of artificial intelligence in cardiac electrophysiology. Cardiovasc Digit Health J. 2022 Sep 27;3(6):263-275.