NEXUS Registry: An Outcomes Database Which Tracks Patient -Reported Outcomes After Percutaneous Coronary Intervention for Coronary Artery Disease Along With Surgical and Subcutaneous Ablation for the Management of Atrial Fibrillation.

This is a prospective cohort, time series analysis of the routine procedures associated with the catheterization and the electrophysiology lab through ten years post intervention. The goal is to demonstrate clinical effectiveness with cardiac service line with low-volume operators. A connection between NCDR with applied clinical research that directs continuous quality improvement goals and objectives is the ideal setting for value-based, quality care. The system of diagnosing, treating and tracking individuals with cardiovascular and pacing disease has many facets which could benefit from continuous quality improvement and outcomes analysis. The proposed Valley View NEXUS outcomes registry will bridge national data to local clinical data. Clinical registries are a methodically sound instrument for measuring and improving performance. Registries are efficacious for surveillance, measuring effectiveness of quality improvement initiatives, identifying determinates of quality of life and function while synergistically increasing the value of health care expenditures with respect to heart disease, stroke, and arrhythmias.

The ADVARRA formerly Schulman Institutional Review Board (IRB) reviewed our protocol, and authorized the study. Once informed consent was obtained, eligible adults scheduled for diagnostic angiography with possible PCI completed a baseline patient reported outcome assessment and again at designated follow-up intervals (six months and annually thereafter for up to ten years). Due to the urgent nature of STEMI- PCI procedures, it was determined that informed consent prior to PCI was prohibitive; however after consideration, the protocol was amended to capture baseline assessments immediately following PCI while the patient 's status was in hospital with use of the Seattle Angina Questionnaire (SAQ) and the Veterans Rand 12-Item Health Survey (VR-12). The SAQ is recognized as a disease specific questionnaire for coronary artery disease. The SAQ is a six item questionnaire that assesses patient's function, symptoms, and satisfaction. A higher score translates to better outcomes. The VR-12 is a twelve item questionnaire used to assess quality of life. A lower score translates to a higher quality of life in relation to a person's health and wellness. Combining data from a disease specific questionnaire, quality of life assessment, and the NCDR's CathPCI® Registry serves as a nexus between big data and the individual patient experience. From January 2015 through December 2017, twenty- two patients have been enrolled. Based on the data from the first six patients to provide scores both at baseline and month six and with a study design to have 90% power to detect a change in the overall SAQ score of 10 points at six months, it was determined 49 patients will need to be enrolled.

The aforementioned methodology will be applied for surgical and endocardial ablations for patients' with Afib. Presently, enrollment is open for Afib patients and data being captured will be analyzed to determine sample size. Patients who receive intervention for management Afib will complete the Atrial Fibrillation Effect on Quality -of-life (AFEQT) Questionnaire and the VR-12. Again the VR-12 is a twelve item questionnaire used to assess quality of life. A lower score translates to a higher quality of life in relation to a person's health and wellness. The AFEQT is recognized as a disease specific questionnaire for Afib. A higher score translates to worse symptoms and limitations in daily function associated with Afib. Combining the outcomes metric with NCDR's Afib Ablation Registry ® allows our institution demonstrative effective outcomes for low-volume operators.

The data validation process applies to both PCI and surgical and/or endocardial ablation and is as follows:

1. Quality Assurance Plan Training for staff that populates both data registries is ongoing. Staff will participate in the NCDR® applicable training modules. Documentation of training will be maintained in the study coordinator's office. Agreeing to participate with the NCDR®, an institution also agrees to random site monitoring and/or audits.
2. Data Checks All patients who agree to participate in NEXUS outcomes registry and subsequent statistical analysis will experience a complete date audit for both outcomes assessments and NCDR® data elements. NCDR® has algorithm limits for both CathPCI® Registry and Afib Ablation ® Registry. All registry elements require abstraction form Meditech source documents. Reports are titled Cardiology Procedure Note and Electrophysiology Procedure Note for PCI and Afib ablation, respectively. Quality/outcome metrics will be sampled in paper form -the sources documents. Information will then be populated into excel for scoring. All paper forms will be maintained for the life of the study.
3. Data Dictionary Complete Data Dictionaries are provided by NCDR® with data element numbers and associated limits and acceptable values for both Cath PCI ® and Afib Ablation ® Registry.
4. Standard Operating Procedures A complete NEXUS Registry Protocol will be on site held in the Cardiovascular Innovation & Research Institute at Valley View Hospital along with all regulatory information, lab certifications, training documents, IRB documents, license agreements, analytic agreements and process maps for informed consent for outcomes research. Note NCDR® registries obtained a waiver for informed consent.
5. Sample Size Assessment The number of patients necessary to demonstrate an effect for outcomes after PCI with low-volume operators is 49.