Comprehensive review of the CB2 ablation best practice guide will provide a detailed technique for achieving safer and more effective outcomes for CB2 atrial fibrillation ablation.
BACKGROUND Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drugrefractory atrial fibrillation (AF).OBJECTIVE The purpose of this study was to assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF.METHODS STOP Persistent AF (ClinicalTrials.gov Identifier: NCT03 012841) was a prospective, multicenter, single-arm, Food and Drug Administration-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes ,6 months). The primary efficacy endpoint was 12-month freedom from 30 seconds of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at .40% and ,13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life) and SF (Short Form)-12 questionnaires.
RESULTSOf 186 total enrollments, 165 subjects (70% male; age 65 6 9 years; left atrial diameter 4.2 6 0.6 cm; body mass index 31 6 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 6 46 minutes, 102 6 41 minutes, and 19 6 16 minutes, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% confidence [CI] 46.7%-62.1%) freedom from AF, AFL, or AT. There was 1 primary safety event, translating to a rate of 0.6% (95% CI 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months postablation (P ,.001).
CONCLUSIONThe STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes ,6 months.
Since the evaluation of the cryoballoon in the Sustained Treatment Of Paroxysmal Atrial Fibrillation trial, more than 350,000 patients with atrial fibrillation have been treated. Several studies have reported improved outcomes using the second-generation cryoballoon, and recent publications have evaluated modifications, refinements, and improvements in procedural techniques. Here, peer-reviewed articles published since the first cryoballoon best practices review were summarized against the technical practices of physicians with a high level of experience with the cryoballoon (average ≥6 years of experience in ≥900 cases). This summary includes a comprehensive literature review along with practical usage guidance from physicians using the cryoballoon to facilitate safe, efficient, and effective outcomes for patients with atrial fibrillation.
Background:
Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce.
Methods:
The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible.
Results:
A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 17 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was −49±8 °C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months.
Conclusions:
The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI.
REGISTRATION:
URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT03645577.
In a canine model, effective PV isolation could be found even in the shortest duration dosing cohort (TTE + 60 s). One complication (phrenic nerve injury) was observed in the longest duration dosing group (2 × 180 s). Further studies will be required to correlate these results to a 28-mm cryoballoon (more commonly used in the cryoablation of a human LA); however, to date, this is the first reporting of a successful cryoablation using TTE + 60 s dosing (approximately 90 s total duration of freezing).
Since the 1995 publication of its Core Cardiovascular Training Statement (COCATS), the American College of Cardiology (ACC) has played a central role in defining the knowledge, experiences, skills, and behaviors expected of all clinical cardiologists upon completion of training. Subsequent updates have incorporated major advances and revisions-both in content and structure-including, most recently, a further move toward competency (outcomes)based training, and the use of the 6-domain competency structure promulgated by the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Medical Specialties, and endorsed by the American Board of Internal Medicine (ABIM). A similar structure has been used by ACC to describe the aligned general cardiovascular lifelong learning competencies that all practicing cardiologists are expected to maintain. Many hospital systems also now use the 6-domain structure as part of medical staff privileging and peer-review professional competence assessments.Whereas COCATS has focused on general clinical cardiology, ACC Advanced Training Statements define selected competencies that go beyond those expected of all cardiologists and require training beyond a standard 3-year cardiovascular disease fellowship. This includes sub-subspecialties for which there is an ABIM addedqualification designation, such as clinical cardiac electrophysiology (CCEP). The Advanced Training Statements also describe key experiences and outcomes necessary to maintain or expand competencies during practice.
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