In a real-world, post-approval analysis, the WATCHMAN implant has demonstrated high rates of procedural success and low rates of major complications for patients with NVAF who are seeking an alternative to long-term warfarin therapy.
U.S. Commercial Implant Success Rate
*Procedural Success defined as deployment and release of the device into the LAA with no leak greater than 5mm
WATCHMAN U.S. NESTed Post Approval Study
Primary composite safety endpoint: 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
Implant Success Rates in Clinical Studies and Initial US Commercial Experience
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)4
Half of all the procedures in the initial US commercial experience were performed by newly implanting physicians4
Denotations (see current site Safety page)
*Implant success is defined as deployment and release of the device into the left atrial appendage; no leak >5 mm.
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.6
WATCHMAN Demonstrates Low Major Complication Rate in Real-World Setting
The WATCHMAN procedure has proven safety, with a 1.5% major complication rate in the highest-risk patients studied to date.5
WATCHMAN U.S. NESTed Post Approval Study
Safety Primary Endpoint
Real-World Data: NESTed SAP (LAAO Registry Major Procedural Complications within 7 days)
Primary Safety (N=1000)
1.5% (15 pts, 17 events)
*Primary composite safety endpoint: 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.
*Procedural success defined as deployment and release of the device into the left atrial appendage (LAA) with no leak greater than 5 mm.
†CHA2DS2-VASc score: Congestive heart failure=1, Hypertension (SBP >160)=1, Age >75 yrs=2, Diabetes mellitus=1, Prior stroke, TIA, or thromboembolism=2, Vascular disease (PAD, MI)=1, Age 65-74 yrs=1, Sex category (female)=1.
‡HAS-BLED score: Hypertension=1, Abnormal renal/liver function (1 pt each)=1 or 2, Hemorrhagic stroke=1, Bleeding history or disposition=1, Labile INRs=1, Elderly=1, Current drugs (medication) or alcohol use (1 pt each)=1 or 2.
- Boersma LVA, et al. EHJ (2016); 37 (31): 2465-2474.
- Phillips K P, et al. (2019). IJC Heart & Vasculature 2019; 23 (100358).
- Reddy, V.Y., et al. J Am Coll Cardiol 2013; 61(25): 2551-2556.
- Reddy VY, et al. JACC 2017; 69(3): 253-261.
- Ellenbogen KA, et al. Heart Rhythm. 2019; 16(5): S310.
- Holmes, D.R., Jr., et al. J Am Coll Cardiol 2014; 64(1): 1-12.
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.
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.
Do not use the WATCHMAN Device if: Intracardiac thrombus is present. 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 47 (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 echocardiographic imaging guidance (TEE recommended) in multiple angles (e.g., 0º, 45º, 90º, 135º). 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-ALIGN 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 the WATCHMAN Implant or implantation procedure include but are not limited to: Air embolism, Airway trauma, Allergic reaction to contrast media, anesthetic, WATCHMAN Implant material, or medications, Altered mental status, Anemia requiring transfusion, Anesthesia risk, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, Bruising, hematoma or seroma near the catheter insertion site, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Death, Decreased hemoglobin, Deep vein thrombosis, Device embolism, Device fracture, Device thrombosis, Edema, Embolism, Excessive bleeding, Fever, Fistula, 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, Myocardial 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 – Hemorrhagic, Stroke – Ischemic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular or vascular damage, Vasovagal reactions
There may be other potential adverse events that are unforeseen at this time.
Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14.