Pilot phase experience of the International Quality Improvement Collaborative catheterization registry

Abstract

Objectives: To describe the development of a quality collaborative for congenital cardiac catheterization centers in low and middle-income countries (LMICs) including pilot study data and a novel procedural efficacy measure. Background: Absence of congenital cardiac catheterization registries in LMICs led to the development of the International Quality Improvement Collaborative Congenital Heart Disease Catheterization Registry (IQIC-CHDCR). As a foundation for this initiative, the IQIC is a collaboration of pediatric cardiac surgical programs from LMICs. Participation in IQIC has been associated with improved patient outcomes. Methods: A web-based registry was designed through a collaborative process. A pilot study was conducted from October through December 2017 at seven existing IQIC sites. Demographic, hemodynamic, and adverse event data were obtained and a novel tool to assess procedural efficacy was applied to five specific procedures. Procedural efficacy was categorized using ideal, adequate, and inadequate. Results: A total of 429 cases were entered. Twenty-five adverse events were reported. The five procedures for which procedural efficacy was measured represented 48% of cases (n = 208) and 71% had complete data for analysis (n = 146). Procedure efficacy was ideal most frequently in patent ductus arteriosus (95%) and atrial septal defect (90%) device closure, and inadequate most frequently in coarctation procedures (100%), and aortic and pulmonary valvuloplasties (50%). Conclusions: The IQIC-CHDCR has designed a feasible collaborative to capture catheterization data in LMICs. The novel tool for procedural efficacy will provide valuable means to identify areas for quality improvement. This pilot study and lessons learned culminated in the full launch of the IQIC-CHDCR.

Congenital Cardiac Catheterization in Low- and Middle-Income Countries

“…Additional data were collected for 5 common isolated procedures: aortic valvuloplasty, pulmonary valvuloplasty, atrial septal defect (ASD) device closure, patent ductus arteriosus (PDA) device closure, and aortic coarctation procedures in accordance with previous publications from the IQIC-CHDCR pilot study ( Table 1 ). 14 …”

“… 13 Leveraging these successes, the IQIC-Congenital Heart Disease Catheterization Registry (IQIC-CHDCR) was piloted in 2017 at 7 participating surgical sites with catheterization programs. 14 Feedback from the pilot phase was used to improve the database with the primary objective of harmonizing data elements with the U.S.-based Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry prior to the beginning of open enrollment for IQIC-CHDCR in 2019. 14 This study aims to describe the patient and procedural characteristics and outcomes of CHD cardiac catheterization in LMICs using the audited, cumulative data from the IQIC-CHDCR registry.…”

Health-related quality of life in postcardiac interventional catheterization patients with congenital heart disease: a mixed-methods study protocol from Pakistan

“… 31 Ideal=When all criteria meet, Inadequate=presence of any criteria described above. 26 AES, adverse event severity; AR, aortic regurgitation; ASD, atrial septal defect; AV, atrioventricular; LPA, left pulmonary artery; MPA, main pulmonary artery; PA, pulmonary artery; PDA, patent ductus arteriosus; PR, pulmonary regurgitation; PSEG, peak systolic ejection gradient; RVOT, right ventricular outflow tract; TR, tricuspid regurgitation. …”

“…31 A novel procedural efficacy variable (a composite of technical success and adverse events) will also be used to determine the effect of the procedure on HRQoL. Procedural efficacy will be classified as ideal, adequate and inadequate (table 1) as previously described, 26 this variable is available for common procedures including pulmonary and aortic valvuloplasty, atrial septal defect and patent ductus arteriosus device closure, and CoA stenting. For complex and uncommon procedures like ventricular septal defect device closure, we will collect the data on complications and adverse events (not as a composite measure) and will be factoring it on a case-tocase basis.…”

“…Our secondary aim is to determine the effects of different patients’ and procedure-related factors on their postprocedure HRQoL. Additionally, we seek to assess the effect of a novel procedure efficacy variable (a composite measure of technical success and adverse events) which will categorise the procedure efficacy as ideal, adequate and inadequate; for five common interventional cardiac catheterization procedures 26 on HRQoL. Furthermore, we will also inquire about the study population’s perceptions and experiences (through the qualitative interview) to gather their comprehensive perspective about HRQoL.…”