Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial

Autor: George Monir, Andrea Natale, Lee Ming Boo, Daniel P. Melby, Larry A. Chinitz, Anshul M. Patel, Robert Stagg, Craig Delaughter, Douglas N. Gibson, Francis E. Marchlinski, Robert S. Fishel, Charles A. Athill
Rok vydání: 2017
Předmět:
Male
medicine.medical_specialty
Time Factors
Radiofrequency ablation
medicine.medical_treatment
Drug Resistance
Action Potentials
030204 cardiovascular system & hematology
Cardiac Catheters
Pulmonary vein
law.invention
03 medical and health sciences
0302 clinical medicine
Heart Rate
Risk Factors
law
Physiology (medical)
Cardiac tamponade
Internal medicine
Atrial Fibrillation
medicine
Humans
Fluoroscopy
Prospective Studies
030212 general & internal medicine
Therapeutic Irrigation
Prospective cohort study
Aged
Ejection fraction
medicine.diagnostic_test
business.industry
Equipment Design
Middle Aged
Ablation
medicine.disease
United States
Catheter
Treatment Outcome
Pulmonary Veins
Catheter Ablation
Cardiology
Female
Cardiology and Cardiovascular Medicine
business
Anti-Arrhythmia Agents
Porosity
Zdroj: EP Europace. 20:f392-f400
ISSN: 1532-2092
1099-5129
DOI: 10.1093/europace/eux264
Popis: Aims THERMOCOOL SMARTTOUCH® SF Catheter is a new contact-force (CF)-sensing catheter with 56-hole porous tip designed for improved cooling and reduced fluid delivery compared with a standard 6-hole open-irrigated catheter. The SMART SF study examined the periprocedural safety, acute effectiveness, and procedural efficiency of the catheter for drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) ablation. Methods and results The prospective, open-label, non-randomized SMART-SF was conducted at 17 US sites. Circumferential pulmonary vein (PV) isolation was performed with confirmation of entrance block in all PVs. Stable ablation sites were identified using CARTO VISITAG™ Module. Primary adverse events (AEs; ≤1 week of index procedure), periprocedural AEs within 30 days of ablation procedure, acute effectiveness (confirmation of entrance block for targeted PVs), CF, and procedural parameters were assessed. Overall, 165 patients were enrolled (mean age, 62.7 years; male, 57.9%; white, 97%; left ventricular ejection fraction, 60.1 ± 7%; left atrium diameter, 38.8 ± 6 mm); 159 underwent radiofrequency ablation and comprised the safety cohort. Primary safety performance criteria were met: primary AE rate was 2.5% (4/159; cardiac tamponade [n = 2], thrombo-embolism [n = 1], transient ischaemic attack [n = 1]). All primary AEs resolved/improved within the 1-month follow-up period. Acute procedural effectiveness was attained in 96.2% (95% confidence interval: 92.0-98.6%) of patients. Procedure time, fluoroscopy time, and fluid delivered were observed in comparison to predecessor catheters. Conclusion In the SMART-SF trial, the predetermined safety performance goal was met, demonstrating the safety and acute effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter for PAF ablation.
Databáze: OpenAIRE
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