Welcome to this learning activity titled CATH PCI Registry Metric No. 40, Risk-Standardized Bleeding. The content in this educational presentation was developed by myself. I am John Giroud, and I will also be narrating each lesson. Bleeding remains one of the most common complications of PCI and is associated with an increased short- and long-term risk of morbidity and mortality, as well as increased health care costs. The CATH PCI Registry Risk-Standardized Bleeding Metric is a predictive measure designed to provide risk-adjusted feedback on complications, inform clinical decision-making, and direct the use of bleeding avoidance strategies, such as radial access, anticoagulation with bivalorudin, and use of vascular closure devices to improve the safety of PCI. The objectives of this presentation are to examine Metric 40 model specifications, eligibility, and clinical implications, demonstrate understanding of metric criteria through case scenarios, and interpret Metric 40 results on the dashboard. Welcome to Lesson 1 of Metric 40 Risk-Standardized Bleeding, in which we will cover Metric 40 eligibility, model specifications, and clinical implications. We will begin by reviewing model eligibility at the facility level to understand the requirements for performance results to be aggregated and populated on the dashboard. At the facility level, the data submission must pass NCDR data inclusion thresholds and obtain green submission status for a given quarter. Your facility must have at least one patient with a pre-PCI hemoglobin or post-PCI hemoglobin value to be eligible for analysis. At the patient level, there are several variables that dictate whether the patient is eligible to be included or excluded in the Metric 40 risk model. Included are patients with a PCI procedure performed during the episode of care. Excluded are patients who died within 24 hours of the PCI procedure, defined by the time lapsed from procedure start date and time until the patient discharge date and time. Additionally, patients who underwent coronary artery bypass grafting during the episode of care are also excluded. It is important to note that only indexed PCI procedures are included when patients have multiple PCI procedures during their episode of care. This means that the procedure variable for subsequent PCI procedures during the same episode of care are excluded from the risk model. Now that we have discussed facility and patient level eligibility, let's turn our attention to the Metric 40 model specifications that outline what is considered an observed bleeding event. It is important to recognize that there are five separate events, or outcomes as defined in the language of the metric, qualify as an observed bleeding event in the risk standardized bleeding metric. Any one of these five events are true, assuming model eligibility, an observed bleeding event is reported. Let's begin with the first event, bleeding events that occur either during PCI or within 72 hours of PCI. Here we have a snapshot of the data elements that impact whether outcome number one results in an observed bleeding event. For the data dictionary, for any given bleeding site or source, we'll only code yes if there is a confirmed documented bleeding event associated with a hemoglobin drop of greater than or equal to three grams per deciliter, packed red blood cell transfusion, or an intervention or surgery to stop the bleeding. Let's suppose this patient had a documented hematoma at their access site post PCI and a pre to post hemoglobin drop of 3.5 grams per deciliter. Definition for bleeding hematoma at access site is met. Yes is now coded in sequence number 9002. Event date and time is then coded in sequence number 9003. Date and time will determine if the bleeding event identified and coded occurred either during the procedure or within 72 hours of the end of the procedure, meets outcome number one, qualifying the PCI procedure as an observed bleeding event. Let's now briefly cover outcome number two, hemorrhagic stroke and outcome number three, tamponade. As with bleeding events, the target value for all other intra and post procedure events is also any occurrence between start of procedure and until next procedure or discharge. Either a hemorrhagic stroke, cardiac tamponade occur as defined in sequence number 9001 to meet the target value, yes is coded in sequence number 9002, PCI procedure will qualify as an observed bleeding event. Like outcome number one, bleeding within 72 hours, event date and time coded in sequence number 9003, either hemorrhagic stroke or cardiac tamponade occurs does not play a role in the metric criteria. The correct outcome identifies an observed bleeding event when a patient receives a blood transfusion. Verify further, outcome number four identifies an observed bleeding event, right blood cell transfusion is coded yes. Either transfusion PCI equals yes or transfusion surgical equals yes. Patient has a pre-procedure hemoglobin of greater than eight grams per deciliter. This model determines if the pre-procedure hemoglobin greater than eight grams per deciliter based on the value captured in sequence 6030 hemoglobin. Fifth and final outcome identifies a PCI procedure as an observed bleeding event when there is a decrease from pre-PCI to post-PCI of greater than or equal to four grams per deciliter. But there are some important considerations to discuss. Take a minute to break this down. Patient has an absolute hemoglobin decrease from pre-PCI to post-PCI of greater than or equal to four grams per deciliter. Either their pre-procedure hemoglobin is less than 16 or a mechanical support device was not used during the procedure, the model considers this a bleeding event. Discuss this in another way. A hemoglobin drop of greater than or equal to four grams per deciliter. Procedure hemoglobin greater than or equal to 16 removes bleeding outcome number five from the scenario. Not exclude the procedure as an observed bleeding event when any other outcome is met. Hemoglobin drop of greater than or equal to four grams per deciliter with a mechanical support device use also removes bleeding outcome number five from the scenario. It does not exclude the procedure as an observed bleeding event when any other outcome number one, two, three, or four is met. This concludes lesson one of metric 40 risk standardized bleeding in which we examine metric 40 eligibility, model specifications, and clinical implications. Thank you for your participation. For more information, visit www.FEMA.gov

CATH PCI Registry Metric No. 40

Risk-Standardized Bleeding

John Giroud

Percutaneous Coronary Intervention

Bleeding Complications