Original-clinicalAcute and long-term efficacy and safety of catheter cryoablation of the cavotricuspid isthmus for treatment of type 1 atrial flutter
Introduction
The incidence of cavotricuspid isthmus–dependent atrial flutter (AFL) has been estimated at more than 200,000 in the United States, with a prevalence of 800,000.1, 2 Radiofrequency (RF) catheter ablation is safe and effective treatment of AFL, with cure rates greater than 95%.3, 4 In studies using large-tip RF ablation catheters, acute efficacy ranged from 88% to 93%, long-term 6-month efficacy from 87% to 97%, and complications from 2.7% to 3.6%.3, 4 RF catheter ablation of AFL has been shown to improve quality of life and to reduce recurrence of atrial fibrillation (AF) and frequency of hospitalization compared with medical therapy.5
Catheter cryoablation has been used to treat supraventricular arrhythmias, with comparable efficacy and potentially fewer complications compared with RF catheter ablation.6, 7, 8, 9, 10, 11 Unlike RF catheter ablation, catheter-based cryoablation does not cause coagulum formation or endocardial charring.6, 7, 8, 9, 10, 11 It does not cause pain, potentially reducing the amount of sedation required during ablation.7, 8, 9, 10 However, the efficacy of catheter-based cryoablation for treatment of AFL has not been systematically evaluated in a large clinical trial. In this report, the acute and 6-month follow-up results in a total of 160 patients treated with catheter-based cryoablation are presented.
Section snippets
Methods
This prospective, multicenter study was designed to evaluate the safety and efficacy of the CryoCor catheter-based cryoablation system (CryoCor, Inc., San Diego, CA.), which has been previously described in detail.6, 7, 10, 11, 12 In brief, the system consists of a 10Fr, 6.5-mm metal-tip catheter and cryogenerator that produces a nadir temperature of –90°C. The primary end-points of this study were demonstration of acute safety and efficacy, defined by adverse event rates and success in
Results
One hundred sixty patients were enrolled in the study and treated (Table 1). Patients had a mean age of 63.1 ± 9.3 years and mean left ventricular ejection fraction of 54.6% ± 10.4%; 122 (76.3%) were male. One hundred four (65%) patients had concomitant arrhythmias, including 94 (58.75%) with AF. The majority had typical AFL (78.75%), most of the remainder had reverse typical AFL (13.8%) or both types of AFL (5.6%), and a small percentage was unreported (1.9%). At the time of ablation, 57
Short-term safety and efficacy of cryoablation of AFL
This large 160-patient study confirmed the acute safety and efficacy of catheter-based cryoablation for treatment of cavotricuspid isthmus–dependent AFL. Acute success, defined as bidirectional cavotricuspid isthmus block, was achieved in 87.5% of patients. This is similar to published studies using large-tip RF ablation catheters with high-power generators, with reported results ranging from 88% to 93%.3, 4 Only 4 (2.5%) patients in this study suffered serious adverse events that were ascribed
Conclusion
Catheter cryoablation of AFL in this study was highly effective in short-term and in long-term follow-up over 6 months. The occurrence of serious adverse events appears similar to that observed with RF catheter ablation. Catheter-based cryoablation may have specific safety advantages over RF catheter ablation and may be associated with less perceived pain during ablation.
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2010, Catheter Ablation of Cardiac Arrhythmias: Expert Consult - Online and PrintMRI of Right Atrial Function after Catheter Ablation of Atrial Flutter
2010, Academic Radiology
This study was sponsored by CryoCor, Inc., San Diego, CA. Dr. Feld is a consultant and member of the Scientific Advisory Board for CryoCor, Inc.
For a list of the Cryoablation Atrial Flutter Efficacy (CAFÉ) Trial Investigators, see the Appendix.