See the Proven Safety Profile of the WATCHMAN Implant
- This patient population (N=3822) included more WATCHMAN patients than in the PROTECT AF and PREVAIL clinical trials and CAP and CAP2 prospective registries combined (N=1877)1,2,4
- Half of all the procedures in the initial US commercial experience were performed by newly implanting physicians1
a Implant success is defined as deployment and release of the device into the left atrial appendage; no leak ≥5 mm.1
b Refinements were made to the WATCHMAN device and procedure in the early stages of the PROTECT AF trial. Thereafter, procedural and device-related safety events decreased. The procedural/device-related safety events in the second half of PROTECT AF were 4.8% (vs 9.9% in the first half), a level of safety similar to that seen in later studies.4
- The WATCHMAN NESTed study is a prospective, post-market surveillance analysis plan reflecting data on newly implanted WATCHMAN patients nested within the larger NCDR LAAO Registry.
- These data further confirm low rates of as complications seen in clinical studies and the initial U.S. Commercial Experience data previously published.
* Complication rate as reported from the WATCHMAN U.S. NESTed Post Approval Study defined as a report of death, ischemic stroke, systemic embolism, or device/procedure-related events necessitating cardiac surgery or major endovascular intervention within either 7-days post-implant or hospital discharge, whichever occurred later.
- Pericardial tamponade was the most frequent major procedural complication both in clinical studies and in the initial US commercial experience1
- The rate of pericardial tamponade for WATCHMAN implantation in the initial US commercial experience was 1.02%, comparable to the rate of pericardial tamponade in AF ablation (1.31-1.52%), another left-sided cardiac procedure1,5,6
- Approximately two-thirds of pericardial tamponade events in the initial US commercial experience were treated percutaneously, without the need for cardiac surgery1
- Reddy VY, Gibson DN, Kar S, et al. Post-FDA approval, initial US clinical experience with Watchman Left Atrial Appendage Closure for stroke prevention in atrial fibrillation. J Am Coll Cardiol. doi: 10.1016/j.jacc.2016.10.010.
- Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12.
- Boersma LV, Schmidt B, Betts TR, et al. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. European Heart Journal. 2016; pii:ehv730.
- WATCHMAN Left Atrial Appendage Closure (LAAC) Technology for Patients with Non-Valvular Atrial Fibrillation. Sponsor’s Executive Summary. FDA Circulatory Systems Devices Panel Meeting. October 8, 2014. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM417177.pdf. Accessed September 10, 2016.
- Cappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3:32-38.
- Deshmukh A, Patel NJ, Pant S, et al. In-hospital complications associated with catheter ablation of atrial fibrillation in the United States between 2000 and 2010: analysis of 93,801 procedures. Circulation. 2013;128:2104-2112.
WATCHMAN Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Access System
INDICATIONS FOR USE
The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:
- Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
- Are deemed by their physicians to be suitable for warfarin; and
- Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Do not use the WATCHMAN Device if:
- Intracardiac thrombus is visualized by echocardiographic imaging.
- An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
- The LAA anatomy will not accommodate a device. See Table 46 in the DFU.
- Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
- There are contraindications to the use of warfarin, aspirin, or clopidogrel.
- The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section) such that the use of the WATCHMAN Device is contraindicated.
- Device selection should be based on accurate LAA measurements obtained using fluoro and ultrasound guidance (TEE recommended) in multiple angles (e.g., 0°, 45°, 90°, 135°).
- Do not release the WATCHMAN Device from the core wire if the device does not meet all release criteria.
- If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE.
- The potential for device embolization exists with cardioversion <30 days following device implantation. Verify device position post-cardioversion during this period.
- Administer appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion.
- For single use only. Do not reuse, reprocess, or resterilize.
- The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.
- The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying the device.
- Use caution when introducing the WATCHMAN Access System to prevent damage to cardiac structures.
- Use caution when introducing the Delivery System to prevent damage to cardiac structures.
- To prevent damage to the Delivery Catheter or device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath.
- If using a power injector, the maximum pressure should not exceed 100 psi.
- In view of the concerns that were raised by the RE-ALIGN1 study of dabigatran in the presence of prosthetic mechanical heart valves, caution should be used when prescribing oral anticoagulants other than warfarin in patients treated with the WATCHMAN Device. The WATCHMAN Device has only been evaluated with the use of warfarin post-device implantation.
Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, AV fistula, Bruising, hematoma or seroma, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device thrombosis, Edema, Excessive bleeding, Fever, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection/pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device/improper seal of the appendage/movement of device from appendage wall, Myocardia erosion, Nausea, Oral bleeding, Pericardial effusion/tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency/failure, Surgical removal of the device, Stroke – Ischemic, Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions. There may be other potential adverse events that are unforeseen at this time.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
1. Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14.