Issue link: https://beckershealthcare.uberflip.com/i/777561
Brief Statement Arctic Front ™ and Arctic Front Advance ™ Cardiac CryoAblation Catheter Systems Indications: The Arctic Front ™ and Arctic Front Advance ™ cardiac cryoablation catheter systems are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. Contraindications: Use of either Arctic Front ™ or Arctic Front Advance ™ cryoballoons is contraindicated: 1. In the ventricle because of the danger of catheter entrapment in the chordae tendineae 2. In patients with one or more pulmonary vein stents 3. In patients with cryoglobulinemia 4. In patients with active systemic infections 5. In conditions where the manipulation of the catheter within the heart would be unsafe (e.g., intracardiac mural thrombus) Warnings/Precautions: Do not resterilize this device for purpose of reuse. Use only the 12 Fr FlexCath ™ steerable sheath family with the Arctic Front Advance ™ cryoballoon because using another sheath may damage the catheter or balloon segment. Do not inflate the balloon inside the sheath. Always verify with fluoroscopy or by using the proximal shaft visual marker that the balloon is fully outside the sheath before inflation to avoid catheter damage. Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary veins stenosis. Do not connect the cryoballoon to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. The catheter contains pressurized refrigerant during operation; release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue; this may lead to tissue injury. Do not advance the balloon beyond the guide wire to reduce the risk of tissue damage. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency, or premature failure of the prosthetic valve. Always inflate the balloon in the atrium then position it at the pulmonary vein ostium to avoid vascular injury. Do not ablate in the tubular portion of the pulmonary vein. Use continuous phrenic nerve pacing throughout each cryoablation application in the right pulmonary veins. To avoid nerve injury, place a hand on the abdomen in the location of the diaphragm to assess for changes in the strength of the diaphragmatic contraction or loss of capture. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed. The Arctic Front ™ and Arctic Front Advance ™ cryoballoons were not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility. Potential Complications: Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Anemia; Anxiety; Atrial flutter; Back pain; Bleeding from puncture sites; Blurred vision; Bradycardia; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/ pressure; Cold feeling; Cough; Death; Diarrhea; Dizziness; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; Hemoptysis; Hypotension/Hypertension; Light headedness; Myocardial infarction; Nausea/vomiting; Nerve injury; Pericardial effusion; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Tachycardia; Transient ischemic attack; Urinary infection; Vasovagal reaction; Visual changes. Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/ or consult the Medtronic website at www.medtronic.com. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. References 1 Fürnkranz A, Brugada J, Albenque JP, et al. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. December 2014;25(12):1314-1320. 2 Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. New Engl J Med. June 9, 2016;374(23):2235-2245. 3 Kuck KH, Fürnkranz A, Chun KR, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. Published online July 5, 2016. 4 Kuck KH, et al. The Fire and Ice Trial: Impact of Catheter Ablation Technologies on Patient Demographic-Based Clinical outcome and Healthcare Costs. Late-breaking Clinical Trial Presentation at APHRS 2016 October 13; Seoul, Korea. (Abstract). 5 Rahman F, Kwan GF, Benjamin EJ. Global epidemiology of atrial fibrillation. Nat Rev Cardiol. November 2014;11(11):639-654. 6 Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. May 2011;4(3):313-320. 7 Raviele A, Natale A, Calkins H, et al. Venice Chart international consensus document on atrial fibrillation ablation: 2011 update. J Cardiovasc Electrophysiol. August 2012;23(8):890-923. 8 2015 ACC/AHA/HRS Advanced Training Statement on Clinical Cardiac Electrophysiology. http://circep.ahajournals.org/ content/early/2015/09/16/HAE.0000000000000014.full. pdf+html 9 Medtronic data on file. medtronic.com UC201702199a EN ©2016 Medtronic. Minneapolis, MN. All Rights Reserved. Printed in USA. 11/2016 Medtronic 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Toll-free in USA: 800.633.8766 Worldwide: +1.763.514.4000 Trial Overview 1,2 Multicenter, prospective, 1:1 randomized, non-inferiority, parallel group, open, blinded-endpoint study comparing the efficacy and safety of pulmonary vein isolation using Arctic Front ™ catheters (n = 374) versus ThermoCool ® point-by-point radiofrequency catheters with CARTO ® 3D mapping system (n = 376) in patients with paroxysmal atrial fibrillation. The trial was conducted at 16 centers in 8 countries. Primary Endpoints Primary Efficacy Endpoint: Time to first documented recurrence of atrial fibrillation (AF) > 30 sec/atrial tachycardia (AT)/atrial flutter (AFL), prescription of AAD, or repeat ablation (a blanking period of 3 months was maintained after the index procedure) Primary Safety Endpoint: Time to first all-cause death, all-cause stroke/TIA or treatment-related serious AEs Secondary Analyses2 Sites reported time to first and number of all-cause hospitalizations, including: § Cardiovascular-related hospitalizations (e.g., repeat ablations and direct current cardioversions) § Hospitalizations defined as a prolonged stay of ≥ 2 nights post index ablation Secondary Outcomes Cardiovascular Hospitalizations: Radiofrequency: 203 events in 135 patients (135/376; 35.9%) Cryo: 139 events in 89 patients (89/374; 23.8%) Kaplan Meier Log-Rank p-value < 0.01 † Repeat Ablation: Radiofrequency: 70 events in 66 patients (66/376; 17.6%) Cryo: 49 events in 44 patients (44/374; 11.8%) Kaplan Meier Log-Rank p-value = 0.03 † † Log-rank test comparing radiofrequency vs. cryo Health Economic Analysis Methods 4 Trial-period Health Economic Supplementary Analysis from a Payer Perspective § Based on Healthcare Utilization (HCU) data collected during the trial – HCUs that were shown to be significantly different between cryoballoon and RFC are included (hospitalizations, repeat ablations, cardioversions). § Total HCU costs were calculated by multiplying trial collected HCUs by standard unit costs. § Analyses were performed for three diverse healthcare systems (Germany, UK, U.S.). § Total cost differences per patient were calculated by: (Total Costs for the RF group divided by total RF patients) — (Total Costs Cryo for the group divided by total number of Cryo patients). Cost Assignment Methods § ICD-10 diagnosis and procedure codes were retrospectively assigned to each HCU. § Coder was blinded to the therapy randomization, but had full access to the study HCU data. § ICD-10 codes were mapped to country specific DRGs which determined the payer costs. Medtronic and the Medtronic logo are trademarks of Medtronic. ™ Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.