TY - JOUR
T1 - Association between quality of life and procedural outcome after catheter ablation for atrial fibrillation a secondary analysis of a randomized clinical trial
AU - Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II) Investigators
AU - Terricabras, Maria
AU - Mantovan, Roberto
AU - Jiang, Chen Yang
AU - Betts, Timothy R.
AU - Chen, Jian
AU - Deisenhofer, Isabel
AU - Macle, Laurent
AU - Morillo, Carlos A.
AU - Haverkamp, Wilhelm
AU - Weerasooriya, Rukshen
AU - Albenque, Jean Paul
AU - Nardi, Stefano
AU - Menardi, Endrj
AU - Novak, Paul
AU - Sanders, Prashanthan
AU - Verma, Atul
AU - Verma, Atul
AU - Kalman, Jonathan
AU - Sanders, Prashanthan
AU - Thomas, Stuart
AU - Hayes, John
AU - Purerfellner, Helmut
AU - Rivero-Ayerza, Maximo
AU - Novak, Paul
AU - Champagne, Jean
AU - Macle, Laurent
AU - Parkash, Ratika
AU - Skanes, Allan
AU - Essebag, Vidal
AU - Roux, Jean Francois
AU - Morillo, Carlos A.
AU - Nery, Pablo
AU - Ayala-Paredes, Felix
AU - Molin, Franck
AU - Chen-Yang, Jiang
AU - Minglong, Chen
AU - Wu, Shu Lin
AU - Cao, Jiang
AU - Albenque, Jean Paul
AU - Babuty, Dominique
AU - Pisapia, André
AU - Cebron, Jean Pierre
AU - Halimi, Franck
AU - Poty, Hervé
AU - Chalvidan, Thierry
AU - Pasquie, Jean Luc
AU - Haverkamp, Wilhelm
AU - Deisenhofer, Isabel
AU - Zarse, Markus
AU - Kleemann, Thomas
AU - Sause, Armin
AU - Kuniss, Malte
AU - Nardi, Stefano
AU - Menardi, Endrj
AU - Mantica, Massimo
AU - Bongiorni, Maria Grazia
AU - Calzolari, Vittorio
AU - de Martino, Giuseppe
AU - Bellocci, Fulvio
AU - Kim, Young Hoon
AU - Jensen-Urstad, Mats
AU - Betts, Timothy R.
AU - Connelly, Derek
AU - Pepper, Christopher
PY - 2020/12/2
Y1 - 2020/12/2
N2 - IMPORTANCE Catheter ablation is effective in reducing atrial fibrillation (AF), but the association of ablation for AF with quality of life is unclear. OBJECTIVE To evaluate whether the procedural outcome of ablation for AF is associated with quality of life (QOL) measures. DESIGN, SETTING, AND PARTICIPANTS This was a prespecified secondary analysis of the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation-Part II (STAR AF II) prospective randomized clinical trial, which compared 3 strategies for ablation of persistent AF. This analysis included 549 of the 589 patients enrolled in the trial who underwent ablation. Enrollment occurred at 35 centers in Europe, Canada, Australia, China, and Korea from November 2010 to July 2012. Data for the current study were analyzed on December 11, 2019. INTERVENTIONS Patients underwent AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions. MAIN OUTCOMES AND MEASURES Quality of life was assessed at baseline and at 6, 12, and 18 months after ablation for AF using the 36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire. Scores were also converted to a physical health component score (PCS) and a mental health component score (MCS). Individual AF burden was calculated by the total time with AF from Holter monitors and the percentage of transtelephonic monitor recordings showing AF. RESULTS Among the 549 patients included in this secondary analysis, QOL was assessed in 466 (85%) at baseline and at 6, 12, and 18 months after ablation for AF. The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation. The AF burden significantly decreased from a mean (SD) of 82% (36%) before ablation to 6.6% (23%) after ablation (P <.001). Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P <.05 for both). Significant QOL improvement occurred in all 3 study arms and regardless of AF recurrence, defined as AF episodes lasting more than 30 seconds: for no recurrence, mean (SD) PCS increased from 66.5 (20.9) to 79.1 (19.4) and MCS from 35.3 (8.7) to 37.7 (7.7); for recurrence, mean (SD) PCS increased from 70.2 (20.4) to 86.4 (16.8) and MCS from 35.3 (8.6) to 37.1 (7.4) (P <.05 for all). When outcome was defined by AF burden reduction, in patients with less than 70% reduction in AF burden, the increase in PCS was significantly less than in those with greater than 70% reduction, and only 3 of 8 subscales showed significant improvement. CONCLUSIONS AND RELEVANCE In this secondary analysis, decreases in AF burden after ablation for AF were significantly associated with improvements in QOL. Quality of life changes were significantly associated with the percentage of AF burden reduction after ablation.
AB - IMPORTANCE Catheter ablation is effective in reducing atrial fibrillation (AF), but the association of ablation for AF with quality of life is unclear. OBJECTIVE To evaluate whether the procedural outcome of ablation for AF is associated with quality of life (QOL) measures. DESIGN, SETTING, AND PARTICIPANTS This was a prespecified secondary analysis of the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation-Part II (STAR AF II) prospective randomized clinical trial, which compared 3 strategies for ablation of persistent AF. This analysis included 549 of the 589 patients enrolled in the trial who underwent ablation. Enrollment occurred at 35 centers in Europe, Canada, Australia, China, and Korea from November 2010 to July 2012. Data for the current study were analyzed on December 11, 2019. INTERVENTIONS Patients underwent AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions. MAIN OUTCOMES AND MEASURES Quality of life was assessed at baseline and at 6, 12, and 18 months after ablation for AF using the 36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire. Scores were also converted to a physical health component score (PCS) and a mental health component score (MCS). Individual AF burden was calculated by the total time with AF from Holter monitors and the percentage of transtelephonic monitor recordings showing AF. RESULTS Among the 549 patients included in this secondary analysis, QOL was assessed in 466 (85%) at baseline and at 6, 12, and 18 months after ablation for AF. The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation. The AF burden significantly decreased from a mean (SD) of 82% (36%) before ablation to 6.6% (23%) after ablation (P <.001). Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P <.05 for both). Significant QOL improvement occurred in all 3 study arms and regardless of AF recurrence, defined as AF episodes lasting more than 30 seconds: for no recurrence, mean (SD) PCS increased from 66.5 (20.9) to 79.1 (19.4) and MCS from 35.3 (8.7) to 37.7 (7.7); for recurrence, mean (SD) PCS increased from 70.2 (20.4) to 86.4 (16.8) and MCS from 35.3 (8.6) to 37.1 (7.4) (P <.05 for all). When outcome was defined by AF burden reduction, in patients with less than 70% reduction in AF burden, the increase in PCS was significantly less than in those with greater than 70% reduction, and only 3 of 8 subscales showed significant improvement. CONCLUSIONS AND RELEVANCE In this secondary analysis, decreases in AF burden after ablation for AF were significantly associated with improvements in QOL. Quality of life changes were significantly associated with the percentage of AF burden reduction after ablation.
UR - http://www.scopus.com/inward/record.url?scp=85097310639&partnerID=8YFLogxK
U2 - 10.1001/jamanetworkopen.2020.25473
DO - 10.1001/jamanetworkopen.2020.25473
M3 - Article
C2 - 33275151
AN - SCOPUS:85097310639
SN - 2574-3805
VL - 3
JO - JAMA Network Open
JF - JAMA Network Open
IS - 12
M1 - e20225473
ER -