Assessment of change in symptoms, such as via a symptom score, was not provided. Defining who was an “athlete” depended on documentation and adjudication. The retrospective design highlights some limitations and future areas of study. This potential side effect of ablation can be symptomatic and should be discussed with patients preprocedure. The elevated heart rate post-ablation usually resolves in most patients, but seems to be a persistent manifestation of autonomic modulation post-ablation in athletes. It supports consideration of early ablation in symptomatic athletes, especially at the paroxysmal stage. This is the largest and most detailed study to date of an athletic population undergoing catheter ablation for AF. In the eight patients with pre- and post-procedure ETTs, exercise capacity was essentially unchanged, although heart rate recovery at 1 minute was significantly reduced. Resting heart rate at 1 year was increased by approximately 10 bpm compared to preablation in the 39 patients with data available. Longer diagnosis-to-ablation time was associated with arrhythmia recurrence, and pulmonary vein isolation within 2 years of diagnosis was significantly associated with lower recurrence. Arrhythmia-free survival was similar between competitive and noncompetitive, endurance versus nonendurance athletes. Rate of arrhythmia recurrence was the same in the matched cohort of nonathletes left atrial (LA) diameters and volumes were also similar. Accounting for multiple procedures, success improved to 86%, 76%, and 56% in respective groups by the end of follow-up. Single-procedure success was 75%, 68%, and 33% at 1 year for paroxysmal, persistent, and long-standing persistent AF, respectively. The study cohort was comprised of 144 athletes (93% men mean age, 50 years 72% endurance sports 67% paroxysmal, 26% persistent, and 6% long-standing persistent AF). The athlete cohort was compared to a matched group of nonathletes from the original database. Resting heart rate was assessed by electrocardiograms (ECGs) in sinus rhythm pre- and post-procedure. All patients underwent evaluation for pulmonary stenosis 3-6 months post-procedure. Arrhythmia recurrence was defined as >30 seconds of atrial arrhythmia recorded after the usual 3-month post-ablation blanking period and procedure success was defined as freedom from antiarrhythmics. Diagnosis to ablation time was defined as time from initial AF diagnosis to ablation. Exercise treadmill tests (ETTs) had to be performed within 5 years of the ablation. Only first-time ablation patients were included, but the ablation approach was not limited to isolation of the pulmonary veins-additional lines were “typically” performed. Ablation was performed with the cryoballoon in two patients and radiofrequency ablation in the rest. Two of the exclusion criteria were age >65 years old and body mass index (BMI) >30 mg/m 2. An “athlete” was defined as someone: 1) competing in a structured training program, or 2) exercising frequently and vigorously (>6.0 METs). (subsidiary of Teleflex Inc.Athletes were identified from a single-center database of consecutive patients undergoing catheter ablation for AF over a 15-year period. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = FOZ and Original Applicant = Arrow Internation, Inc. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. states: CO, FL, IL, NC, PA, SC, and TX.ġ A record in this database is created when a firm initiates a correction or removal action. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow.ĭistributed in the following U.S. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow.ģ. If you have affected stock, quarantine so that the affected products can beĢ. Notification letters were sent to consignees with the following instructions: 1. Class 2 Device Recall ARROW ENDURANCE" Extended Dwell Peripheral Catheter SystemĬatheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZĪRROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-BĬatalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019) Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)Ĭertain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
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