Original Title: Tratamiento de la comunicación interventricular (CIV) congénita con dispositivos de inserción percutánea y perventricular

Authors' objectives: This report evaluates the effectiveness, safety, preferences and values of patients and efficiency of surgical treatment of congenital VSD using percutaneous and periventricular insertion devices versus standard surgery.

Authors' results and conclusions: Outcomes prioritised as key were classified into efficiency-effectiveness and safety outcomes. For the quantitative analysis of efficiency-effectiveness and safety, 16 prospective and retrospective comparative studies were selected, of which 13 were conducted in China. Efficiency-effectiveness. No statistically significant differences were observed for the outcomes analysed: reoperation for significant residual shunt, mortality, and the appearance of acute myocardial infarction, stroke, or pulmonary thromboembolism. Safety. No statistically significant differences were observed except for in two outcomes: surgical reintervention for bleeding control (RR=0.18; 95% IC: 0.05 to 0.63) and patients requiring blood transfusions (RR=0.05; 95% IC: 0.01 to 0.22), in favour of device insertion techniques. Patient preferences and values. 4 studies were reviewed in full and discarded because their external validity was seriously compromised or they addressed aspects other than that of the research. Identification of social costs. Two semi-structured interviews were conducted with two couples of parents of patients with VSD from the Menudos Corazones Foundation, whose children had been operated on using standard surgery. The main social costs borne by these families were identified. Efficiency. The systematic review did not provide any studies that met the inclusion criteria. For the patients’ lifetime horizon, the CUA offered 30.04 quality-adjusted life years (QALY) with the percutaneous technique, compared with 30.01 QALY for standard surgery and 29.84 QALY for the periventricular technique. The incremental cost-utility ratio (ICUR) for percutaneous insertion versus the standard surgical approach for the NHS perspective was -792,920€/QALY, percutaneous insertion being considered a dominant option. From a social perspective, the ICUR obtained was -861,940€/QALY. Deterministic sensitivity analyses did not impact dominance and Monte Carlo simulations obtained more than 60% dominant results for the percutaneous technique versus a surgical strategy. The periventricular approach versus standard surgery represents a strategy of lower cost and lower health benefits, both for the NHS and from a social perspective.

Authors' methods: This report has been compiled using the GRADE methodology, for which health professionals and parents of patients with VSD were involved. They worked with and agreed on the relative importance of the outcomes which were included in the report. Three systematic reviews were carried out with specific searches focused on effectiveness and safety, knowing the preferences and values of the patients in relation to the treatment of VSD and the efficiency of the surgical alternatives under study. Once the inclusion and exclusion criteria were defined, a peer review was implemented. Specific templates were created and validated for the extraction of relevant efficiency and safety information. When conditions permitted, quantitative synthesis of the results was performed by meta-analysis using the Review Manager program. Through semi-structured interviews with parents of patients with VSD, social costs associated with the defect were identified. A cost-utility analysis (CUA) was created to evaluate the efficiency of the alternatives analysed from a social perspective, by constructing a decision tree model with a time horizon of the entire life expectancy of the patients. The results were contrasted by deterministic and probabilistic sensitivity analysis.

Project Status: Completed

Year Published: 2021

URL for published report: https://www.iacs.es/wp-content/uploads/2022/04/02_2017_IACS_CIV-Informe.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

DOI: 10.46994/ets_21

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es