Safety
These documents describe an IRB-approved research study and clinical safety workflow that allows patients with pacemakers/ICDs (CIEDs) to undergo clinically indicated MRI with standardized monitoring, device programming, and follow-up, while…
Read MoreThis patient-facing educational handout explains the process, risks, and safeguards involved when patients with legacy (non–MRI-conditional) pacemakers or implantable cardioverter defibrillators (ICDs) undergo MRI imaging. It is designed to support…
Read MoreThis patient-facing educational resource explains the Convergent Hybrid Ablation procedure for atrial fibrillation, a two-stage treatment option designed for patients with persistent or long-standing AF who continue to have symptoms…
Read MoreThis patient-facing educational handout provides clear, step-by-step guidance to help reduce infection risk and support optimal recovery for patients undergoing implantable cardiac device procedures. Designed for use before pacemaker, ICD,…
Read MorePresentations and Graphics: In this slideshow presentation, the learner will explore the mission and history of the FDA and Center for Device and Radiological Health (CDRH), how the CDRH and FDA contribute to a device’s classification, approval, and post-approval maintenance, and an overview of the Total Product Lifecycle Advisory Program Pilot.
Read MorePresentations and Graphics: In this presentation, the learner will explore the purpose and structure of a medical device advisory committee, how they function, and recent guidance.
Read MorePresentations and Graphics: Slideshow presentation that explores collaborative communities, early feasibility studies, and the EP EFS initiative.
Read MorePresentations and Graphics: Slideshow presentation that explore what an investigational device exemption is, significant risk versus non-significant risk device studies, and how IRB’s and the FDA factor in to decisions around device studies.
Read MorePresentations and Graphics: Succinct presentation slides exploring heart rhythm device recalls, FDA’s roles and responsibilities relating to recalls, and recall communications. Also includes risk assessment and mitigation for recalled devices.
Read MoreData/Registries: Aims: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. Methods and results: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0–60) days and 21 (15, 29.5; range: 2–63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0–42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. Conclusion: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energyrather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.
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