TY - JOUR
T1 - Composite Index Tagging for PVI in Paroxysmal AF
T2 - A Prospective, Multicenter Postapproval Study
AU - SURPOINT Postapproval Trial Investigators
AU - Di Biase, Luigi
AU - Monir, George
AU - Melby, Daniel
AU - Tabereaux, Paul
AU - Natale, Andrea
AU - Manyam, Harish
AU - Athill, Charles
AU - Delaughter, Craig
AU - Patel, Anshul
AU - Gentlesk, Philip
AU - Liu, Christopher
AU - Arkles, Jeffrey
AU - McElderry, Hugh Thomas
AU - Osorio, Jose
N1 - Publisher Copyright:
© 2022 The Authors
PY - 2022/9
Y1 - 2022/9
N2 - Background: VISITAG SURPOINT (VS)–guided ablation of paroxysmal atrial fibrillation has demonstrated good short- and long-term success rates with low rates of complications in recent, predominantly European, studies. However, there is a lack of multicenter data from the United States. Objectives: This U.S. study evaluated the safety and effectiveness of VS ablation using a contact force–sensing catheter for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation. Methods: The prospective, nonrandomized VS postapproval study was conducted at 32 U.S. sites. Ablation consisted of pulmonary vein isolation with recommended VS index targets (anterior, roof, or ridge: 550; posterior or inferior: 380). Additional non–pulmonary vein triggers were ablated at the investigators’ discretion. Subjects were followed for 12 months, including a 3-month blanking period. The primary safety endpoint was the primary adverse event rate up to 7 days postablation. The primary effectiveness endpoint was 12-month freedom from atrial tachyarrhythmia recurrence and an additional set of failure modes based on stringent monitoring (weekly transtelephonic monitoring [TTM] [day 91 through month 5], monthly TTM [months 6 to 12], and any symptomatic cardiac episode using TTM, plus electrocardiogram [at discharge, 1 month, 3 months, 6 months, and 12 months] with 24-hour Holter monitoring [12 months]). Results: Of 283 patients enrolled, 261 had the catheter inserted and underwent ablation (safety cohort); 246 met all eligibility criteria (effectiveness cohort). Mean fluoroscopy time was 2.2 minutes. Mean amount of catheter-delivered fluid was 671 mL; only 18.0% of patients utilized a Foley catheter. Primary safety and effectiveness endpoints were met. The raw primary adverse event rate was 4.3% (14 events, n = 11). At 12 months, the Kaplan-Meier estimate of freedom from primary effectiveness failure was 76.4%; estimates of 12-month freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter recurrence were 81.5% and 92.7% per stringent monitoring and standard-of-care monitoring (excluding TTM), respectively. The first-pass isolation rate was 83.1%, represented by no acute reconnection after the 30-minute waiting period. Freedom from repeat ablation at 12 months was 94.0%. Conclusions: The VS postapproval study confirms reproducibility of clinical safety and effectiveness of the standardized VS paroxysmal atrial fibrillation ablation workflow with >80% 12-month freedom from atrial tachyarrhythmia recurrence and first-pass isolation rate of 83.1%. Procedures were performed with minimal fluoroscopy.
AB - Background: VISITAG SURPOINT (VS)–guided ablation of paroxysmal atrial fibrillation has demonstrated good short- and long-term success rates with low rates of complications in recent, predominantly European, studies. However, there is a lack of multicenter data from the United States. Objectives: This U.S. study evaluated the safety and effectiveness of VS ablation using a contact force–sensing catheter for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation. Methods: The prospective, nonrandomized VS postapproval study was conducted at 32 U.S. sites. Ablation consisted of pulmonary vein isolation with recommended VS index targets (anterior, roof, or ridge: 550; posterior or inferior: 380). Additional non–pulmonary vein triggers were ablated at the investigators’ discretion. Subjects were followed for 12 months, including a 3-month blanking period. The primary safety endpoint was the primary adverse event rate up to 7 days postablation. The primary effectiveness endpoint was 12-month freedom from atrial tachyarrhythmia recurrence and an additional set of failure modes based on stringent monitoring (weekly transtelephonic monitoring [TTM] [day 91 through month 5], monthly TTM [months 6 to 12], and any symptomatic cardiac episode using TTM, plus electrocardiogram [at discharge, 1 month, 3 months, 6 months, and 12 months] with 24-hour Holter monitoring [12 months]). Results: Of 283 patients enrolled, 261 had the catheter inserted and underwent ablation (safety cohort); 246 met all eligibility criteria (effectiveness cohort). Mean fluoroscopy time was 2.2 minutes. Mean amount of catheter-delivered fluid was 671 mL; only 18.0% of patients utilized a Foley catheter. Primary safety and effectiveness endpoints were met. The raw primary adverse event rate was 4.3% (14 events, n = 11). At 12 months, the Kaplan-Meier estimate of freedom from primary effectiveness failure was 76.4%; estimates of 12-month freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter recurrence were 81.5% and 92.7% per stringent monitoring and standard-of-care monitoring (excluding TTM), respectively. The first-pass isolation rate was 83.1%, represented by no acute reconnection after the 30-minute waiting period. Freedom from repeat ablation at 12 months was 94.0%. Conclusions: The VS postapproval study confirms reproducibility of clinical safety and effectiveness of the standardized VS paroxysmal atrial fibrillation ablation workflow with >80% 12-month freedom from atrial tachyarrhythmia recurrence and first-pass isolation rate of 83.1%. Procedures were performed with minimal fluoroscopy.
KW - SMARTTOUCH
KW - VISITAG SURPOINT
KW - atrial fibrillation
KW - contact force catheter
KW - paroxysmal atrial fibrillation
KW - pulmonary vein isolation
KW - radiofrequency ablation
UR - http://www.scopus.com/inward/record.url?scp=85137725642&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85137725642&partnerID=8YFLogxK
U2 - 10.1016/j.jacep.2022.06.007
DO - 10.1016/j.jacep.2022.06.007
M3 - Article
C2 - 36137711
AN - SCOPUS:85137725642
SN - 2405-500X
VL - 8
SP - 1077
EP - 1089
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 9
ER -