Long-Term Patient-Level Meta-Analysis
Five year results from a patient-level meta-analysis of the totality of data available on the WATCHMAN Device, by Reddy, et al, has been published in the Journal of American College of Cardiology (JACC). This publication includes 5-year outcomes of PREVAIL, combined with the 5-year outcomes of PROTECT-AF, and demonstrated that LAAC with Watchman provided stroke reduction in non-valvular atrial fibrillation comparable to warfarin with additional reductions in major bleeding and mortality.
Reddy VY, Doshi SK, Kar S, et al. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J. Am Coll Cardiol. 2017; In Press.
Initial Commercial Experience Data
Post-FDA Approval, Initial US Clinical Experience with Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation
Initial US Clinical Experience evaluates the acute procedural performance and complication rates for all WATCHMAN cases performed in the US since FDA approval.
The authors conclude that despite a large fraction of previously-inexperienced operators, in the real world post-FDA approval experience of WATCHMAN LAAC, procedural success was high and complication rates low.
Reddy VR, Holmes DR, 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. 2016; Article in Press.
CAP 2 Registry
The Continued Access to PREVAIL (CAP2) Registry is a multi-center prospective non-randomized study allowing continued access to the WATCHMAN Device, following the PREVAIL trial, during regulatory review of the pre-market application for the WATCHMAN Device. The primary objective of the CAP registry was to collect additional safety and effectiveness data on the WATCHMAN Device in subjects with non-valvular atrial fibrillation who are deemed by their physicians to be suitable for warfarin therapy.
PREVAIL Clinical Trial
The goal of the PREVAIL trial was to assess the safety and efficacy of LAA closure for stroke risk reduction in patients with NVAF compared with long-term warfarin therapy.
The authors concluded that in this trial, LAA occlusion was non-inferior to warfarin for ischemic stroke risk reduction or SE >7 days’ post-procedure. Although non-inferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety was significantly improved. This trial provided additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke risk reduction in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy.
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.
The Continued Access to PROTECT AF (CAP) Registry was a multi-center prospective non-randomized study allowing continued access to the WATCHMAN Device, following the PROTECT AF trial, during regulatory review of the pre-market application for the WATCHMAN Device.
The primary objective of the CAP registry was to collect additional safety and effectiveness data on the WATCHMAN Device in subjects with non-valvular atrial fibrillation who are deemed by their physicians to be suitable for warfarin therapy.
Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011;123(4):417-424.
PROTECT AF Clinical Trial
The multicenter PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appendage closure with a filter device (Watchman) was non-inferior to warfarin for stroke risk reduction in atrial fibrillation.
In the Journal of the American Medical Association article (4-year results), the authors concluded that after 3.8 years of follow-up among patients with non-valvular AF at elevated risk for stroke, percutaneous LAA closure met criteria for both non-inferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as superiority for cardiovascular and all-cause mortality.
Reddy VY, Sievert H, Halperin J, et al; for the PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998.
Meta-analyses confirmed that in cases of left atrial thrombus in non-rheumatic AF patients approximately 90% of them are in the left atrial appendage (LAA). This study assessed the feasibility of implanting a device in the LAA in patients with atrial fibrillation (AF) to prevent thromboembolic stroke.
The authors concluded that preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible.
Sick PB, Schuler G, Hauptmann KE, et al. Initial worldwide experience with the WATCHMAN Left Atrial Appendage System for stroke prevention in atrial fibrillation. J Am Col Cardiol. 2007;49(13):1490-1495.
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.