| Literature DB >> 36039865 |
Sophie C Rier1, Suzan Vreemann2, Wouter H Nijhof3, Vincent J H M van Driel4, Ivo A C van der Bilt4.
Abstract
BACKGROUND: Cardiac magnetic resonance (CMR) provides excellent temporal and spatial resolution, tissue characterization, and flow measurements. This enables major advantages when guiding cardiac invasive procedures compared with X-ray fluoroscopy or ultrasound guidance. However, clinical implementation is limited due to limited availability of technological advancements in magnetic resonance imaging (MRI) compatible equipment. A systematic review of the available literature on past and present applications of interventional MR and its technology readiness level (TRL) was performed, also suggesting future applications.Entities:
Keywords: cardiac catheterization; interventional cardiovascular magnetic resonance; technology readiness level
Mesh:
Year: 2022 PMID: 36039865 PMCID: PMC9434707 DOI: 10.1177/17539447221119624
Source DB: PubMed Journal: Ther Adv Cardiovasc Dis ISSN: 1753-9447
TRL levels based on the US Government Accountability Office (GAO).
| TRL level based on US-GAO | Description based on US-GAO | Modified TRL level description as applied in this review |
|---|---|---|
| TRL 1 | Published research identifying problem/possible technology | Proposed hypothesis of using interventional CMR |
| TRL 2 | Papers of analytic studies. Supporting analyses providing
scientific | Preprocedural CMR used to guide interventions |
| TRL 3 | Proof of concept in laboratory, publication of results | |
| TRL 4 | Proof of concept and safety demonstrated in | |
| TRL 5 | Evidence of device being equivalent to predicate device (FDA
510(k)) ready for | |
| TRL 6 | Clinical trials conducted in small number of humans | Proven feasibility in single human case |
| TRL 7 | Clinical safety and effectiveness trials in operational
environment. Determination | Proven efficacy in single human case |
| TRL 8 | FDA 510(k) or equivalent approved | Proven feasibility and efficacy in series of humans |
| TRL 9 | The device is being marketed. Postmarketing studies | Widespread clinical translation |
CMR, cardiac magnetic resonance; GAO, Government Accountability Office; TRL, technology readiness level; FDA, Food and Drug Administration.
Figure 1.Flowchart depicting the selection of papers.
Figure 2.Flowchart depicting the various subcategories.
Cardiac procedures divided into subcategories with their respective TRLs.
| Procedure | TRL level | References |
|---|---|---|
| Electrophysiology | ||
| Right atrial flutter ablation | TRL 8 | Grotthoff |
| Left atrium ablation | TRL 5 | Grotthoff |
| Right ventricle ablation | TRL 5 | Dukkipati |
| Left ventricle ablation | TRL 5 | Toupin |
| AV-node ablation | TRL 5 | Schmidt |
| Congenital procedures | ||
| Diagnostic right and left heart catheterization | TRL 8 | Veeram Reddy |
| Ventricular septal defect closure, treatment of pulmonary artery stenosis and aortic coarctation | TRL 6 | Grant |
| Atrial septal defect closure | TRL 5 | Ratnayaka |
| Cavopulmonary shunt | TRL 5 | Ratnayaka |
| Valvular procedures | ||
| Transcatheter aortic valve replacement | TRL 5 | Kuehne |
| Pulmonary valve stenosis balloon dilatation | TRL 6 | Tzifa |
| Coronary procedures | ||
| Diagnostic catheterization | TRL 5 | Green |
| Percutaneous coronary intervention | TRL 5 | Spuentrup |
| Other procedures | ||
| Endomyocardial biopsy | TRL 5 | Behm |
| Intramyocardial injections | TRL 5 | Carlsson and Saeed,
|
| Pericardiocentesis | TRL 5 | Halabi |
TRL, technology readiness level.