Pulse Medical has attended TCT 2023 from 23 to 26 October in San Francisco. Series of computational physiological assessment and PCI planning systems, angio-based μFR® (AngioPlus Core) system, CCTA-based CT-μFR (CtaPlus®) system and intravascular imaging-based OFR (OctPlus®) and UFR (IvusPlus®) system, attracted experts worldwide to share the new trend of functional imaging guided precision PCI and discuss clinical applications and business cooperation. Several product-related clinical findings were presented during the conference.
Dr. Simone Biscaglia from AOU Ferrara (Italy) released the AQVA II study result, which has been published on JACC. AQVA II is a multi-centre, randomized, controlled clinical trial, enrolling 473 patients with indications to PCI and at least one CHIP criteria. This study aims to demonstrate the superiority of physiology-guided PCI over conventional angiography-based PCI, and the non-inferiority of μFR (AngioPlus system from Pulse Medical) compared with FFR. Results showed that physiology-guided PCI is superior to angiography-guided PCI, with higher post-PCI FFR and more patients with optimal post-PCI FFR. μFR-guidance and FFR-guidance are equally effective. In μFR guided group, the procedure time is significantly shorter, and contrast media usage is lower.
Dr. Simone Fezzi from the University of Verona, Italy, presented the results of a study on behalf of a team that used μFR-derived functions to assess the changes on FFR and iFR in patients undergoing TAVI. As a retrospective, single-centre study, 136 vessels from 67 patients were included for pre-and post-FFR and iFR. During the evaluation, the study used multiple measures of μFR to determine the physiological patterns of CAD. The results showed that diffuse CAD without major gradients is the prevalent pattern of disease in patients with SAS undergoing TAVI. FFR decrease after TAVI correlated with a higher local disease severity (major drops), while iFR changes gave more unpredictable results.
Also, Dr Simone Fezzi presented the results of a study that used μFR-derived functions to investigate the interaction between the physiological pattern of CAD and PCI outcomes of patients undergoing PCI with BRS. As a retrospective, single-center study, 188 vessels from 129 patients were included for pre-and post μFR. The results showed that patients with predominantly focal disease had significantly better functional PCI results than predominantly diffuse disease. The physiological distribution of CAD (μFR PPGi) was significantly associated with post-PCI μFR, whereas the local severity of CAD (dμQFR/ds) was a significant determinant of percentage μFR increase after PCI.
"Comparison of FFR and μFR after successful PCI in patients with CTO", released by Dr. Jiasheng Yin from Zhongshan Hospital Fudan University. The study tries to explore the correlation between μFR and FFR after successful CTO recanalization and DES implantation, with 83 CTO lesions from 80 patients enrolled. There are significant differences between angiography-based μFR and FFR after successful CTO-PCI. Multivariate regression showed that collateral circulation grade was an independent risk factor contributing to these differences.
Also, Dr. Yin released the results of the prognosis value of μFR after stent implantation on CTO-PCI. 231 patients with 237 CTO-PCI lesions were enrolled. Target vessel failure (TVF) was the primary endpoint. The study result shows that most patients' post-PCI μFR was more than 0.90, with the median of 0.97. Post-PCI μFR was an independent predictor of TVF with the best cut-off value of ≤0.92. So Post-PCI μFR can predict the incidence of adverse events after successful stent implantation in CTO lesions.
Dr. Fukuishi Yuta from Kobe University Graduate School of Medicine in Japan, on behalf of the team, presented the results of "a validation of the diagnostic accuracy of μFR in patients with severe aortic stenosis undergoing TAVR (Transcatheter Aortic Valve Replacement)". As a single-center retrospective study, 38 vessels treated with TAVR in 25 patients were included. Pre-TAVR μFR was used as the primary endpoint, and post-TAVR invasive FFR ≤0.8 was used as a reference standard of ischemia. The accuracy of Pre-TAVR μFR was 84.2%, and the analysis speed was significantly fast. The results of the study indicated single-view μFR is a feasible option for evaluating comorbid CADs in patients with severe AS undergoing TAVR.
Dr. Pengcheng Sun from Pulse Medical, on behalf of Professor Chenguang Li and Professor Jinying Zhou from Zhongshan Hospital and Fuwai Hospital in China, presented the results of a study that used angio-derived microvascular resistance (AMR function of μFR system) to predict vessel-territory microvascular obstruction in anterior-wall STEMI after primary PCI. 117 STEMI cases with LAD were included as culprit vessel and followed up by CMR at 1-month. The results showed AMR is a feasible functional index in cath lab and post-PPCI AMR and ΔAMR are significantly associated with MVO at 1- month after STEMI.
Dr. Miao Chu from Shanghai Jiao Tong University China and the University of Oxford, UK, on behalf of Professor Shengxian Tu and the team, presented a study about the atherosclerotic plaque characterization between CCTA and OCT. The study included 23 vessels from the retrospective cohort and 18 vessels from the prospective cohort and analyzed the lesion with OFR(OctPlus) and CT-μFR(CtaPlus) systems from Pulse Medical. After comparing the lumen quantification, plaque quantification and plaque composition, the results demonstrated that CCTA-derived plaque volume and plaque burden powered by CT-μFR system correlated well with OCT. Further, there were good correlations for fibrous and calcified tissues measured on CT-μFR and OFR, while moderate correlation for lipidic tissue.
Also, Dr. Miao Chu presented the histological validation of AI-based plaque characterization on intravascular optical coherence tomography. Aiming to evaluate and compare plaque characterization by the AI model (OFR system from Pulse Medical) versus cardiologists, the study involved 25 co-registered histology and OCT frames for paired validation. The results showed a good agreement between the developed AI model and histology. AI outperformed human-based assessment, especially for inexperienced operators.
Dr. Anniek Ziedses des Plantes from Erasmus University Medical Center, Netherlands, on behalf of the team, presented the study that used diagnostic accuracy of ultrasonic flow ratio to predict FFR after PCI. As a post-hoc analysis of the FFR REACT trail, the study involved 115 vessels with FFR measurements and UFR computation (IvusPlus system from Pulse Medical). Compared to post-PCI MLA to predict post-PCI FFR ≤ 0.90, post-PCI UFR owns significantly higher AUC, which indicates the addition of post-PCI UFR to traditional IVUS-derived parameters such as MLA allows for more accurate estimation of the haemodynamic significance of residual disease after PCI.
Professor Ning Guo from The First Affiliated Hospital of Xi’an Jiaotong University, China, presented a case of left main and multivessel coronary artery disease. With the evaluation of the μFR system, professors optimized the PCI strategy for each vessel. Professor Guo indicated that physiology modalities like μFR are helpful to optimize acute stent outcomes. It should be strongly considered when performing PCI in patients with complex lesions and clinical characteristics. In addition, stent implantation in the main vessel and DCB dilatation in the SB ostium guided by IVUS and μFR might be a feasible strategy to treat bifurcation lesions.
Dr. Pruthvi C revaiah from CORRIB Research Centre for Advanced Imaging and Core Lab (University of Galway, Ireland) released the series results comparing the diagnostic performance of μFR vs. UFR vs. OFR for pre and post PCI. μFR (AngioPluse system, angio-based FFR), UFR (IvusPlus), OFR (OctPlus) from Pulse Medical all have the high diagnostic performance compared to FFR. The results showed that 2D μFR (using only 1 projection) and OFR had a high agreement (96%) with each other (both for pre and post PCI). And 2D μFR also had a high agreement (97%) with UFR.
Dr. Pruthvi C revaiah also reported the studies validating the values of Post-PCI OFR and UFR in assessing the suboptimal PCI outcomes, and in evaluating the stent parameters and its relation to physiological outcomes. The results showed that UFR/OFR pull-back curves can do the precise.
hemodynamic assessment of suboptimal results, and the identification and treatment of correctable lesions (focal and mixed lesions) will improve physiological results.
The results of evaluating stent parameters showed that patients with suboptimal post PCI physiological results have lower MSA and higher stent gradient. There is a weak positive correlation between MSA and UFR and a moderate positive correlation between MSA and OFR. Meanwhile, patients with SEI of ≤90 had higher in-stent UFR drop.
Aiming to deliver innovative and valuable solutions to improve patient outcomes, Pulse Medical is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease.