Welcome to the LAAO Registry's on-demand session titled, The Details in the Documentation, CHADS-VASC Risk Score and Metric Impacts. The content in this session was developed and narrated by myself. I am Fernando Garcia Barbón, a Clinical Quality Advisor for the LAAO Registry. Before we begin speaking on the CHADS-VASC score in relation to the LAAO Registry, let's discuss the background of the risk score. The CHADS-VASC risk score is the most commonly used clinical prediction tool for estimating the risk of stroke in patients with a diagnosis of non-valvular atrial fibrillation. The score is used to determine whether a patient in atrial fibrillation requires anticoagulation therapy. The risk score has been part of the European Society of Cardiology Guidelines for AFib Management since 2012. In 2014, the American College of Cardiology, in conjunction with the American Heart Association and the Heart Rhythm Society, recommended the use of the risk score in the United States Guidelines. Why is the CHADS-VASC score part of the Registry's data collection? The main reason is the CHADS-VASC score is one of the requirements listed by CMS, which is the Center for Medicare and Medicaid Services, in their National Coverage Determination for LAAO procedures in patients with non-valvular AFib. The one criteria in the National Coverage Determination states the patient must have a CHADS-2 score equal or greater than 2 or a CHADS-VASC score equal or greater than 3 to meet that requirement. Capturing the CHADS-VASC score in the Registry ensures a vehicle for documenting and measuring that the CMS's requirement is met. It also helps to capture more data on the patient's pre-procedure history, stroke risk, and acuity. The CHADS-VASC score is divided into two separate scores. The original score was the CHADS-2 risk score, and the updated version is the CHADS-VASC risk score. The updated VASC part of the score was added to the original CHADS-2 score to capture additional stroke risk factors of age, female gender, and vascular disease. However, both scores are used to measure stroke risk in patients with non-valvular AFib. The CHADS-2 score awards one point for a history or new diagnosis of congestive heart failure, one point for a history of hypertension, one point if the patient's age is equal or greater than 75 years, one point for a history of diabetes, and two points for a history of stroke, TIA, or thromboembolic event. The score will only award two points even if more than one of these elements is coded. This is referring to history of stroke, TIA, or thromboembolic event. The CHADS-VASC score awards one point for a history or new diagnosis of congestive heart failure, which also includes left ventricular systolic dysfunction, one point for a history of hypertension, two points if the patient's age is equal or greater than 75 years, one point for a history of diabetes, one point for a history of diabetes, two points for a history of stroke, TIA, or thromboembolic event, one point for a history of vascular disease, one point if the patient's age is between 65 and 74, and one point if the patient is female. The CHADS-VASC risk score is part of Section C of the Data Collection Form, which captures history and risk factors. The risk score includes sequences 40-05 to 40-50. We will discuss the coding of each individual element, including target values, coding instructions, and what documentation can be used to code each element in the following slides. The first three elements of the section captures congestive heart failure, NYHA classification, and LV dysfunction, which for the purpose of the registry were separated into their own elements to gather more detailed information about the patient's history and acuity. The first element of the section is congestive heart failure in sequence 40-05. This element indicates if the patient has been diagnosed or has an active diagnosis of heart failure. The target value of this element is within 30 days prior to the start of the procedure, meaning that any documentation being used to code the element must be within 30 days prior to the procedure. The supporting definition as a reference source defines CHF as the presence of signs and symptoms of either right or left ventricular failure or both. These signs and symptoms may include increased central venous pressure, hepatomegaly, edema, exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rails, gallop rhythm, and pulmonary vein congestion. This element may be coded based on provider documentation of history, active diagnosis, or symptoms of heart failure. However, the documentation used to code the element must be within 30 days prior to the start of the procedure. In order to code YES to sequence 40-05, CHATS-VASC congestive heart failure, the following options are available. A provider documented their own CHATS-VASC assessment and they included heart failure as part of their assessment. A patient has been diagnosed with or had an episode of heart failure within 30 days prior to the procedure. A chronic or new diagnosis documented within 30 days prior to the procedure. Patient symptoms of heart failure exhibited pre-procedure or documented within 30 days prior to the procedure. A patient being medically treated for CHF with medications such as furosemide may be coded YES as their CHF is a chronic and current condition being treated. Or a documented NYHA of 2, 3, or 4 documented within 30 days prior to the procedure can be used to code CHATS-VASC CHF as YES as this is a functional evaluation regarding the patient's limitation in activities of daily living as a result of heart failure. The next element is sequence 40-10, New York Heart Association functional class or NYHA classification. It is important to remember this element will only become available to code if sequence 40-05 is coded YES. The element indicates the NYHA functional class of patients diagnosed with heart failure. The target value is the highest value on admission, meaning the documentation used to code the element may be older than 30 days. If multiple classes are documented, please code the most recent. The NYHA functional class is divided into class 1, 2, 3, and 4. The details regarding the classifications are available in the Registry's Data Dictionary. The following options are available to code this sequence. The provider documented their CHATS-VASC assessment and included CHF with the patient's NYHA class documented. Provider's office documentation of NYHA class from an office assessment. Like sequence 40-05 CHF, this element can also be coded based on patient symptoms exhibited and documented pre-procedure. Remember, a documented NYHA of 2, 3, or 4 documented within 30 days prior to the procedure can be used to code CHATS-VASC CHF as YES. Next up is sequence 40-15, LV dysfunction. This element indicates if the patient has been diagnosed with left ventricular dysfunction. LV dysfunction is defined as an LVEF of less than 40%. The element's target value is within 30 days prior to the start of the procedure. In order to code sequence 40-15 LV dysfunction, the following options are available. We can use a provider's documented CHATS-VASC assessment in which LV dysfunction was included, a documented diagnosis of LV dysfunction within 30 days prior to the procedure, or an LVEF of less than 40% that has been documented within 30 days prior to the procedure. The next element in the risk score is sequence 40-20 hypertension. This element indicates if the patient has been diagnosed with hypertension. The target value for this element is within 30 days prior to the start of the procedure. The CHATS-VASC score defines hypertension as resting blood pressure of more than 140 mmHg systolic and or more than 90 mmHg diastolic on at least two occasions between 30 days of the procedure. If the patient is currently on antihypertensive pharmacological treatment between 30 days prior to the procedure can also be used to code this element. In order to code sequence 40-20 hypertension, the following options are available. A provider documented CHATS-VASC assessment in which hypertension was included, a documented diagnosis or active history of hypertension, documentation of the patient being treated with antihypertensive pharmacologic therapy as part of their daily medication regimen, or a documented resting systolic blood pressure greater than 140 or diastolic blood pressure greater than 90 on at least two occasions within 30 days from the start of the procedure. Sequence 40-25 captures diabetes mellitus. This element indicates if the patient has been diagnosed with diabetes mellitus. CHATS-VASC defines diabetes as a fasting glucose level of 126 mg per deciliter or treatment with oral hypoglycemic agent and or insulin. The target value for this element is also within 30 days prior to the start of the procedure. In order to code sequence 40-25 diabetes mellitus, the following options are available. A provider documented CHATS-VASC assessment in which diabetes was included, a documented diagnosis or active history of diabetes. This includes patients with diet-controlled diabetes. However, it does not include patients diagnosed with pre-diabetes. Documentation of patient being treated with oral hypoglycemic or insulin pharmacologic therapy as part of their daily medication regimen or a fasting glucose level of 126 mg per deciliter within 30 days prior to the start of the procedure. The next element is stroke in sequence 40-30. This element indicates if the patient has been diagnosed with an ischemic stroke or a stroke of undetermined origin. Strokes of undetermined origin were added by the registry steering committee to ensure that all patient risk factors are included and none are missed when calculating the patient's score. This element is not to be coded for a history of hemorrhagic stroke. CHATS-VASC defines stroke as a focal neurologic deficit or sudden onset as diagnosed by a neurologist, lasting more than 24 hours and caused by ischemia. The target value for this element is any occurrence between birth and the start of the procedure. In order to code sequence 40-30, stroke, the following options are available. A provider's documented CHATS-VASC assessment, which included an ischemic stroke or a stroke of undetermined origin, or a documented history of an ischemic stroke or a stroke of undetermined origin at any time in the patient's life. Sequence 40-35 is TIA. This element indicates if the patient has been diagnosed with a transient ischemic attack or TIA. CHATS-VASC defines TIA as a focal neurologic deficit or sudden onset as diagnosed by a neurologist, lasting less than 24 hours. The target value for this element is any occurrence between birth and the start of the procedure. In order to code sequence 40-35, TIA, the following options are available. A provider's documented CHATS-VASC assessment, which included TIA, can be used, or a documented history of a TIA at any time in the patient's life. Sequence 40-40 captures history of a thromboembolic event. This element indicates if the patient has been diagnosed with a thromboembolic event. A thromboembolic event is defined as a thrombus formed in a blood vessel that breaks loose and travels to occlude another vessel. The target value for this element is any occurrence between birth and the start of the procedure. Some examples of thromboembolic events are pulmonary embolism, ischemic stroke, and peripheral embolisms, which are thromboembolic events taking place outside of the brain, heart, eyes, and lungs. In order to code sequence 40-40, thromboembolic event, the following options are available. We can use a provider's documented CHATS-VASC assessment, which included a form of thromboembolic event, or a documented history of a pulmonary embolism, ischemic stroke, a stroke of undetermined origin, or any peripheral embolism. When sequence 40-30, stroke, is coded yes, sequence 40-40, thromboembolic event, will also be coded as yes. Sequence 40-45 captures history of vascular disease. This element indicates if the patient has been diagnosed with vascular disease according to the CHATS-VASC definition. The target value for this element is any occurrence between birth and the start of the procedure. Vascular disease is defined as a history of prior myocardial infarction, peripheral arterial disease, or aortic plaque. The LAO Registry's Steering Committee added the conditions of CAD, PCI, CABG, and carotid disease for purposes of coding these elements. These conditions are not part of the original validated vascular disease criterion for the CHATS-VASC score, but were added to accommodate real-world documentation of patients' risk score. Sequence 40-50, vascular disease type, will only become available to code if sequence 40-45 is coded as yes. The element indicates the type of vascular disease used to award a point in the risk score. The choices are prior my, PAD, non-aortic plaque, CAD, PCI, CABG, and carotid disease. CAD, PCI, CABG, and carotid disease can only be coded if the provider specifically documented using any of these conditions in their CHATS-VASC assessment of the patient. Detailed definitions and criteria of each condition are available in the data dictionary on page 28 to page 30. In order to code sequence 40-45 and 40-50, vascular disease and type, the following options are available. We can use a provider's documented CHATS-VASC assessment which included vascular disease with a documented history of prior my, PAD, or non-aortic plaque that meets the criteria listed in the data dictionary. Like mentioned in the last slide, in order to code the added conditions of CAD, PCI, CABG, or carotid disease, the provider must specifically document using any of these conditions to award a point in their own CHATS-VASC assessment. Finding documentation of a history of these conditions is not sufficient to code. FAQs with ID number 24714 and 24694 have more details on these instructions. There are a few metrics that include and are affected by the CHATS-VASC assessment. The first metric is metric number one, which measures the proportion of patients undergoing left atrial appendage occlusion evaluated for stroke risk using the CHATS-VASC score. This metric measures the proportion of patients who have CHATS-VASC assessment captured. All patients are included in the denominator, and patients are included in the numerator if any of the CHATS-VASC elements are coded either yes or no. Patients will be excluded from the numerator or fall out of the metric if any of the CHATS-VASC elements are left blank. The second metric is metric number three, which measures the proportion of patients undergoing left atrial appendage occlusion procedure per FDA indications. This metric measures the number of LAO procedures in which a Watchman device was used that were performed per FDA indications. The FDA indications include a patient must have history of non-valvular AFib, patient must have an increased risk of stroke based on the CHATS-VASC scores, a patient must be deemed suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy. The metric evaluates the patient's CHATS-VASC score to determine if the FDA indication of increased risk of stroke is met. And the third metric is metric 25, which is one of our newer informational data metrics. Metric 25 measures the average CHATS-VASC score of the facility's population. This metric was developed to give facilities the opportunity to have a broader look at the population being treated in the programs. As all other informational data metrics, it will include all patients entered into the registry, but only the patients who have all CHATS-VASC elements coded either yes or no will be part of the calculation. The metric will exclude patients who had any elements of their CHATS-VASC score assessment left blank. The LAAO registry team would like to thank all of our participants for taking the time to review this presentation with us. Thank you.

CHADS-VASC risk score

LAAO Registry

non-valvular atrial fibrillation

anticoagulation therapy

CMS

data collection