Thank you for viewing this educational presentation, introducing data elements that are new to the EP device implant registry version 3.0. The intra- or post-procedure events section is abstracted for every lab visit. Sequence 9001 captures the intra- and post-procedure events of the patient for each device lead lab visit. For sequence 9002, events occurred, yes is selected when there's documentation that a specific event occurred between the start of the procedure and next procedure or discharge. Procedure is defined as a device or lead procedure. No is selected when there's no supporting documentation indicating a specific event occurred within the target value of between the start of the procedure and next procedure or discharge. Some intra- or post-procedure event entries have child fields that become available when yes is selected in sequence 9002. Set to no is a feature that allows users to set sequence 9002 to no while still coding yes for any event that occurred during the lab visit. This structure ensures comprehensive tracking of clinical events while reducing the overall data abstraction effort. Three bleeding events are newly available for selection in version 3.0, bleeding at access site, bleeding gastrointestinal, and bleeding retroperitoneal. The criteria for capturing a bleeding event is the same for all three. The only differentiation being the location of the bleed. Each individual bleeding event is captured when there is a confirmed bleeding event associated with the selection location documented in the medical record and in conjunction with any one of the following, a hemoglobin drop of greater than or equal to 3 grams per deciliter or a transfusion of whole blood or packed red blood cells or a procedural intervention or surgery at the bleeding site to reverse, stop, or correct the bleeding. Please note that bleeding access site specifically seeks to capture significant external bleeding events at the percutaneous or access site. An event entitled vascular complications has been added to the intra-post procedure event list. The intent is to collect a vascular complication when it is attributable to the current procedure and required an intervention. Some examples include access site occlusions, peripheral embolizations, dissections, pseudo-aneurysms, and AV fistulas. An intervention required to treat the complication, meeting the full definition, is not limited to, but might include a fibrin injection, angioplasty, or surgical repair. Lastly, it should be noted that prolonged pressure does not qualify as an intervention. However, ultrasonic guided compression to treat a diagnosed pseudo-aneurysm would qualify. A retroperitoneal bleed or hematoma requiring transfusion is not considered a vascular complication. When a vascular complication is collected, the location, neck, chest, or groin, is available for selection in sequence 15784. When applicable according to the documentation, more than one location can be chosen as this is a select-all data element. Sequence 15783, intervention type, then seeks to capture the intervention type utilized to treat the vascular complication, either endovascular repair, surgical repair, or thrombin injection. When more than one intervention occurs, please select the highest level intervention performed. In ascending order, that would be thrombin injection, endovascular repair, and surgical repair, representing the highest level intervention. An intra-post-procedure diagnosis of pericardial effusion, or documentation that indicates that there is fluid in the pericardial space, supports coding yes to pericardial effusion. The registry is then interested in learning if the pericardial effusion identified in sequence 9002 necessitated treatment with an intervention such as a pericardiocentesis. When there is documented evidence that the patient experienced cardiac tamponade to the extent that fluid in the pericardial space was significant enough to cause hemodynamic instability, ultimately resulting in an unplanned or emergent intervention, please code yes in sequence 9002 to cardiac tamponade. The intervention type is then available for abstraction in sequence 15788. Percutaneous drainage is coded when the patient requires pericardiocentesis, and open cardiac surgery is coded when treatment of the cardiac tamponade requires surgical intervention, such as with a pericardial window. Device embolization is collected in instances in which the patient experienced device embolization, defined in this context as the full dislodgement of a device from its original position and introduced into the circulatory system. Thank you for taking the time to view this presentation.

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EP device implant registry

intra-procedure events

bleeding complications

pericardial effusion

device embolization