Original Title: Sistemas de estimación del flujo coronario y de la perfusión miocárdica mediante software de análisis de angiografías

Authors' objectives: To evaluate the diagnostic efficacy of angiography image analysis software for the estimation of coronary flow and myocardial perfusion in patients with suspected ischemic heart disease.

Authors' results and conclusions: Results Out of 720 retrieved references in the literature search, nine systematic reviews were included, seven with a metanalysis, one with a pooled data analysis, and a last one with an economic evaluation. The included studies assessed the diagnostic accuracy of the software through efficacy variables, such as sensitivity, specificity, and false positive/negative rates in comparison to the current clinical reference standard (invasive coronary angiography). FFRCT parameter was measured in five studies using the software HeartFlow®, cFFR® Siemens, Toshiba Medical Systems (currently Canon Medical Systems®) and DeepVessel FFR™, via computerized tomography for image acquisition. The parameters FFRangio, QFR, vFFR, caFFR and μFFR were measured in five studies with the softwares Medis QFR®, CathWorks FFRangio® System, CAAS® vFFR Workstation, μFR® AngioPlus Core, Flashangio™ caFFR System, VFAI™ and AngioFFR™, via non-invasive angiography for image acquisition. Four studies reported vessel- and patient-level data; and five, vessel-level data. Eight studies assessed the diagnostic accuracy of the software using the modalities of machine learning and computational fluid dynamics, and one study only by machine learning. The quality assessment identified four studies of critically low quality and five of low quality. Conclusions The analysed evidence, although limited, indicates that the use of advanced software in the diagnostic pathway could improve image processing and operational efficiency in the diagnosis of ischemic heart disease. In addition, it would also allow for better clinical management of the patient and maximize diagnostic precision. To consolidate the diagnostic value of the software, larger, homogeneous, and long-term prospective studies are required that directly compare hemodynamic parameters and software in computational fluid dynamics and machine learning modalities. Likewise, it is necessary to evaluate technical efficacy at the vessel and patient level, incorporating analyses of efficiency, safety, organizational aspects, and the patient's perspective.

Authors' recommendations: In view of evidence gaps, multicentre randomised controlled trials with a sufficient number of patients should be conducted to evaluate the use of software for analysing angiographic images compared with other invasive and non-invasive technologies, in order to establish a broader body of evidence addressing the following aspects: - Homogenisation of baseline patient characteristics and CAD severity. - Standardisation of vascular bed imaging acquisition procedures to ensure comparable technical quality and enable comparisons between different software applications. - Direct comparisons between different software applications and modalities (CFD vs. ML, off-site vs. on-site), as well as haemodynamic parameters, to identify potential differences in diagnostic accuracy. - Standardised assessment of data at the patient and/or individual coronary vessel level to ensure that diagnostic accuracy can be compared across different software applications. Similarly, specific studies should be conducted, or these aspects should be incorporated into existing studies, to assess the economic, safety and organisational implications, as well as the patient perspective, regarding the use of angiographic image analysis software in patients with suspected CAD.

Authors' methods: A systematic literature search was conducted including SRs, CPGs, and HTA reports covering the last 10 years. The databases Medline (Ovid), Embase, Cochrane Library, WOS, and INAHTA were consulted, along with resources such as ClinicalTrials, ICTPR, GuiaSalud, ECRI-guidelines, and SEC, as well as the main websites of international agencies: NICE, CDA-AMC, AHRQ, IQWIG, HIQA, and RedETS. Additionally, a targeted search for conference proceedings was performed to monitor the most recent technological innovations and software tools in the sector. Study selection, data extraction, and quality analysis were performed independently by two reviewers. The synthesis of results was carried out qualitatively. Study quality was evaluated using the AMSTAR-2 tool for systematic reviews.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/sistemas-de-estimacion-del-flujo-coronario-y-de-la-perfusion-miocardica-mediante-software-de-analisis-de-angiografias/

Year Published: 2026

URL for published report: https://www.aetsa.org/download/publicaciones/22_2025_AETSA_-Sistema-de-estimacion-flujo-coronario_web.pdf

Requestor: Spanish Health Ministry

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

DOI: 10.52766/ACIN7444

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: <p>Andalusian Agency for Health Technology Assessment (AETSA)</p>