The NEW WIND is coming!
μFR+RWS, the new era of PCI
From 14th-17th May, Pulse Medical attended the EuroPCR 2024 in Paris, and achieved a great success. 3 Late-Breaking Trials released, 1 bustling symposium, and 1 crowded booth, series of novel techniques from Pulse Medical, incl. μFR® (AngioPlusTM system), CT-μFR (CtaPlus system), RWS (Radial Wall Strain), OFR, UFR, and IVUS system, attracted great attentions from experts worldwide.
Closing Ceremony: a new wind for PCI
Prof. William Wijns gave a presentation “A new wind for PCI, angiography-based computational physiology, AI and PCI for vulnerability plaque” at the closing ceremony.
With no extra efforts from the angiogram, the needed information to understand where the obstacle stenosis on the epicardial side, in the microvascular side, and vulnerable plaque can be provided by one angiographic view based μFR and RWS. Besides the precise pre-PCI assessment, μFR can also help to evaluate the post-PCI residual ischemia, and also identify the epicardial CAD endotypes (focal, diffuse, serial, or mixed pattern) for planning an optimized PCI strategy before stenting. RWS can provide the plaque vulnerability assessment regarding to the likelihood of plaque rupture. Combined μFR & RWS can reduce the risk of deferred revascularization, and help to identify which area need to be imaged and potentially benefit from preventive PCI. These create a new wind for PCI, and the new era of computational physiology and plaque vulnerability is coming!
Late-Breaking Trials
Auto-μFR validation: Prof. Shengxian Tu from Shanghai Jiao Tong University, China, published the validation of Fully-auto μFR (without any manual interaction during analysis). With 330 vessels from 306 patients enrolled, the feasibility of auto μFR was 98.2%, and the accuracy was 84.9%. The mean analysis time was only 23 sec/vessel. The auto μFR can provide high feasibility and diagnostic performance for identifying stenosis induced ischemia, and has the potential to facilitate the adoption of physiology in routine workflow.
Auto-CT-μFR validation: Prof. Shengxian Tu published result of prospective CAREER study, and the validation of Fully-auto CT-μFR (without any manual interaction during analysis). With 706 vessels from 260 patients, the diagnostic accuracy of CT-μFR was 89.6%, and with comparable accuracy with μFR in non-extensively calcified lesions. The Fully-auto CT-μFR analysis feasibility was 97.2%, with accuracy of 83.0% and mean analysis time of 1.60 min/patient. CT-μFR can reduce the on-site identification of hemodynamically significant stenosis, reducing unnecessary ICA.
Long-term prognostic value of μFR+RWS: Dr. Jiayue Huang from Shanghai Jiao Tong University, China, released the 1st large-scale validation of RWS and μFR prognostic value in western population. Blinded μFR (2349 NT vessels) & RWS (1394 NT vessels) analysis were performed in all non-target vessels in TARGET AC study, and μFR<0.90 and RWS≥13% were both the effective predictors for 5-year clinical outcomes. Derived solely from a single angiographic view in the same analysis procedure, μFR & RWS can provide “ONE-STOP” physiology and plaque vulnerability assessment, and bear great potential for improved risk stratification and patient outcomes.
Symposium: AI-powered coronary physiology & vulnerable plaque
Prof. Shengxian Tu presented the methodology and validation of μFR and RWS. Single view derived μFR paving the application of physiology in routine workflow. Previous studies already validated the high accuracy (~93%) & high feasibility (>95%) & comparable accuracy of 2D & 3D μFR. Post-PCI μFR can assess the residual ischemia for main vessel and side branches, and predict the future clinical outcomes. RWS has already been validated to identify vulnerable plaque defined by OCT, and can predicts intermediate lesion progression, subsequent AMI, and long-term TVF. Both of these novel techniques are good predictor for long-term prognosis.
Dr. Simone Fezzi from University of Verona, Italy, shared a case of vulnerable plaque with fast progression leading to NSTEMI. A severe progression of non-culprit lesion in RCA at 9 months after primary deferred PCI. Retrospective μFR & RWS analysis showed that at baseline, μFR=0.90 (negative hemodynamic significance). But the RWS showed a large hotspot (=27.%), which was higher than cutoff (≥13%). RWS “hot spots” detection might potentially improve risk stratification and empower secondary prevention strategies.
Dr. Junqing Yang from Guangdong Provincial People's Hospital, China, shared a case of vulnerable plaque identified by both RWS and OFR. There’s an intermediate lesion in LAD, μFR=0.86 and OFR=0.89, both negative hemodynamic significance. RWS=10.9% and LCR=0.134 both indicate the low vulnerability. After comprehensive assessment, patient was safely deferred.
Prof. Michael Joner from German Heart Centre Munich, Germany, shared the study of plaque tissue change after RMS implantation. Based on BIOMAG I study (117 vessels from 116 patients), OFR plaque characterization analysis showed, fibrous tissue was significantly increased with the increasing of LLL (post-PCI and 12M). Decreasing of lipid tissue and increasing of fibrous tissue between pre and 12M indicate the favorable healing of vessel wall and the plaque stabilization.
Other Research results
Dr.Pruthvi Chenniganahosahalli Revaiah presented a study to evaluate the use of UFR and OFR to identify residual ischemia post-PCI. OFR and UFR analyses based on ASET JAPAN PILOT Study showed, UFR& OFR have good ability to predict IVUS/OCT defined focal lesions. Residuallesion post PCI are more frequent in vessel with sub-optimal physiologicaloutcomes (UFR/OFR≤0.90).
Dr. Simone Fezzi presented the study about μFR-derived physiological patterns after PCI and long-term outcomes. With 516 patients (615 vessels) enrolled, Focal pattern (μFR PPGi≥0.68) had less post-PCI μFR≤0.91, and higher μFR increase, and focal and diffuse pattern had non-significant clinical outcomes difference. Post-PCI μFR≤0.91 group had significant higher VOCE and TVR rate.
Dr. Bernardo Cortese shared the study of μFR assessment after DCB angioplasty for de-novo disease. Based on 270 consecutive patients enrollment with 3~9M follow-up (PICCOLETO VI), no significant different Late μFR loss (post-PCI vs. 5M follow-up) btw PCB (paclitaxel-coated balloons) and SCB (sirolimus-coated balloon), with a NS trend toward better of PCB.
Dr. PAOLUCCI L. presented the study using OFR to assess the physiology and morphology after IVL treatment with severe calcification lesion. Calcification phenotypes (nodular vs. concentric vs. eccentric) were identified by OFR plaque characterization. OFR increased progressively after IVL and stenting (0.72vs. 0.86 vs. 0.90, p<0.01). OFR-derived MLA gain was higher in focal lesion compared to diffuse lesion.
Booth visiting
150+ visitors came to our booth and experienced the novel techniques (μFR, RWS, CT-μFR, OFR, UFR, IVUS) from Pulse Medical.
Quoted from Prof. William Wijns in the closing ceremony, “This wind is going to translate into a lot of power. We are actually moving into the new era of computational physiology and AI empowered imaging. You can still step on the train, but don’t wait too long, because it’s about to take off!”