- Ischemic stroke remains a significant risk for patients with AF.
- Oral anticoagulants, while highly effective in reducing the risk of stroke, are associated with an increased risk of bleeding.
- Several non-pharmacologic approaches to LAA occlusion have evolved simultaneously, including endovascular occlusion, surgical suturing, stapling, and amputation. These methods have been shown to vary in their efficacy and safety.
- Percutaneous LAA occlusion has the potential to a have major, positive clinical impact on our treatment of certain subsets of patients with AF that are at risk for stroke.
- As this technology becomes clinically available to a broader population of patients, it is essential that physician stakeholders establish criteria for the performance of these procedures that will be used in granting initial and ongoing privileges.
- The FDA approval of the WATCHMAN device for percutaneous closure of the LAA represents an important addition to the physician’s armamentarium to help mitigate this problem.
|Centers for Medicare & Medicaid Services National Coverage Determination for Percutaneous Left Atrial Appendage Occlusion Therapy requires a CHADS2 score ≥2.a|
|Congestive HF||1||CHADS2 Score||Stroke Risk %|
(>140/90 or on medication)
|Age ≥75 y||1||2||4.0|
Maximum Score: 6
|Physicians performing this procedure must have a firm grasp of the underlying principles surrounding AF, including:|
|The medical management and clinical course of AF|
|Principles of rate and rhythm control|
|Current tools for assessing stroke risk, such as the CHA2DS2-VASc scoring system|
|The indications for and management of oral anticoagulant therapy and knowledge of the various agents available|
|Understanding the risks and benefits of antiarrhythmic agents used for rate and rhythm control|
|Understanding the bleeding risks of oral anticoagulants and the use of bleeding risk assessment tools such as the HAS-BLED score|
|Knowledge of indications, risks, and benefits of invasive surgical and catheter-based ablation techniques|
|Knowledge and understanding of shared decision making|
|Centers for Medicare & Medicaid Services National Coverage Determination for Percutaneous Left Atrial Appendage Occlusion Therapy requires a CHA2DS2-VASc score ≥3.a|
|Congestive HF||1||CHADS2 Score||Stroke Risk %|
|Age ≥75 y||2||1||1.3|
(prior MI, PAD, or aortic plaque)
|Age 65–74 y||1||7||9.6|
|Sex category (i.e., female sex)||1||8||12.5|
Maximum Score: 9
HAS-BLED Bleeding Risk Score
(systolic blood pressure >160)
|Abnormal renal and liver function|
(1 point each)
|1 or 2||0||1.13|
|Stroke (previous stroke)||1||1||1.02|
(<60% of time in therapeutic range)
|Elderly (age > 65)||1||4||8.7|
|Drugs or alcohol (1 point each)|
(drugs predisposing to bleeding
[antiplatelets, NSAIDs], alcohol
use [>8 drinks/week])
|1 or 2||≥5||≥12.5|
|Maximum Score: 9|
Key Institutional Requirements
|An aggregate of 50 structural heart disease or left-sided catheter ablations, at least 25 of which involve transseptal puncture through an intact septum, should be performed at the institution in the year leading to starting an LAA occlusion program and per year thereafter (see Table 1 for qualifying left-sided procedures).|
Note: The rationale is that not only the primary procedural specialist or physician team, but also ancillary staff, should be comfortable with the basic aspects of the procedure.
|The procedure should be performed in the cardiac catheterization laboratory, electrophysiology suite, or hybrid suite with continuous hemodynamic monitoring.|
|Fixed radiographic imaging systems with fluoroscopy, offering catheterization laboratory-quality imaging are required. The capability to acquire/record cine loops is strongly recommended.|
|Mobile C-Arm for fluoroscopic imaging is NOT acceptable.|
|Biplane imaging is helpful but not required.|
|The room should be adequately sized to accommodate echocardiographic and anesthesia equipment, in addition to the regular radiographic imaging system.|
|The interventional suite should be stocked with equipment for safe procedures and for handling complications such as device stabilization, retrieval, and managing pericardial effusions.|
|This equipment includes a variety of endovascular sheaths, diagnostic catheters, transseptal kits, wires, snares, bioptomes, vascular occluders, and pericardiocentesis equipment.|
|Cell–Saver technology for rapid processing of drained blood and re-transfusion in case of pericardial effusion and tamponade should be readily available.|
|Imaging Should Include:|
|Fluoroscopy—ideally biplane—for visualization of the relational anatomy in the right anterior oblique and left anterior oblique views|
Note: These views define the atrioventricular groove and septal planes, although it is recognized that a number of alternate fluoroscopic techniques can be effective and safe.
|Either transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE)|
|A hemodynamic system to allow for continuous pressure monitoring, which would allow for early recognition of hemodynamic deterioration, including tamponade|
|An echocardiography laboratory with the full array of transthoracic and TEE capabilities should be on site.|
|A TEE-capable machine and probe should be available in the procedure room.|
|Appropriate staff should be present during the procedure, which may include a cardiologist or cardiac anesthesiologist familiar with the procedural steps and subtleties of invasive echocardiography.|
|Three-dimensional echocardiography capability is helpful but not required.|
|Multidisciplinary team/Outpatient clinic|
|A cardiac surgeon, anesthesiologist, and perfusionist should be on site for surgical backup.|
|Cardiac surgery operating rooms should be readily available in the rare event of a major complication requiring surgical intervention.|
Table 1. LAA Occlusion Program Components – Summary
- Initial qualification
- 50 lifetime structural or left-sided catheter ablation procedures, at least 25 of which involved transseptal puncture through an intact septumb
- Clinical knowledge that includes a comprehensive understanding of stroke and bleeding risk in atrial fibrillation and appropriate treatment strategies
- Experience with catheter-based management of potential complications, including pericardiocentesis and embolized device retrieval
- Suitable training on the devices to be used
- Understanding of left atrial appendage anatomy and imaging
- Over a 2-year period, 25 procedures that involve transseptal puncture through an intact septum, 12 of which are LAA occlusion procedures
- Process for identifying whether additional training is required on the basis of technological or clinical changes
- 50 structural or left-sided catheter ablations/year, at least 25 of which involved transseptal puncture through an intact septum in the year leading to program initiation and per year thereafter
- Continuous intraprocedure availability of a physician with experience at transesophageal echocardiography in structural heart disease (a cardiologist, electrophysiologist, or cardiac anesthesiologist certified in echocardiography and with experience in guiding structural heart interventions may fulfill this role )
- Multidisciplinary team that includes necessary staff and expertise for preoperative evaluation, performing the LAA occlusion procedure, and acute and long-term post-procedure follow-up
- Active cardiothoracic surgery program with cardiac surgeons and perfusionists on site
- Cardiac catheterization laboratory, electrophysiology laboratory, or hybrid room with hemodynamic monitoring and high resolution imaging
Data Collection and Quality
- Submission of all cases to a national registry in timely fashion, including follow-up reporting as required
- Institutional multi-stakeholder process for evaluation of patient selection, outcomes, and quality
a Procedures using LAA occlusion devices are typically performed either by electrophysiologists, interventional cardiologists (adult or pediatric), or cardiovascular surgeons. This document uses the term “procedural specialist” to apply to members of any subspecialty who implant LAA occlusion devices. In some cases, a physician team will be composed of two operators. Therefore, the procedural volume criteria and ongoing proficiency requirements apply to at least one member of the team.
b LAA occlusion involving a transseptal catheterization that is primary (i.e., WATCHMAN or similar devices) or adjunctive to a percutaneous pericardial approach (i.e., LARIAT), percutaneous left ventricular assist device placement when such devices involve transseptal approach (i.e., Tandem Heart), endovascular catheter ablation within the left side of the heart, pulmonary vein stenting, balloon mitral valvuloplasty, percutaneous closure of prosthetic mitral paravalvular leaks using a transseptal approach, antegrade balloon aortic valvuloplasty, mitral valve repair using the MitraClip system or other technique involving transseptal puncture or closure, and diagnostic transseptal catheterization.
AF, atrial fibrillation; ASD, atrial septal defect; CT, computed tomography; FDA, The Food and Drug Administration; ICE, intracardiac echocardiography; INR, international normalized ratio; LAA, left atrial appendage; MDT, multidisciplinary team; PFO, patent foramen ovale; TEE, transesophageal echocardiography
This Guideline attempts to define principles of practice that should produce high-quality patient care. It is applicable to interventional cardiologists, primary care, and providers at all levels. This Guideline should not be considered exclusive of other methods of care reasonably directed at obtaining the same results. The ultimate judgment concerning the propriety of any course of conduct must be made by the clinician after consideration of each individual patient situation. Neither IGC, the medical associations, nor the authors endorse any product or service associated with the distributor of this clinical reference tool.