BACKGROUND:Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived ...from routine coronary angiography (FFRangio) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFRangio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFRangio.
METHODS:Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFRangio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFRangio for predicting pressure wire–derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity.
RESULTS:Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFRangio values correlated well with FFR measurements (r=0.80, P<0.001) and the Bland–Altman 95% confidence limits were between −0.14 and 0.12. The device success rate for FFRangio was 99%.
CONCLUSIONS:FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire–derived FFR. FFRangio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique IdentifierNCT03226262.
BACKGROUND—Fractional flow reserve (FFR)-guided coronary artery bypass graft (CABG) surgery has been associated with lower number of graft anastomoses, lower rate of on-pump surgery, and higher graft ...patency rate as compared with angiography-guided CABG surgery. However, no clinical benefit has been reported to date.
METHODS AND RESULTS—Consecutive patients (n=627) treated by CABG between 2006 and 2010 were retrospectively included. In 198 patients, at least 1 stenosis was grafted according to FFR (FFR-guided group), whereas in 429 patients all stenoses were grafted based on angiography (angiography-guided group). The 2 coprimary end points were overall death or myocardial infarction and major adverse cardiovascular events (composite of overall death, myocardial infarction, and target vessel revascularization) up to 6-year follow-up. In the FFR-guided group, patients were significantly younger (66 57–73 versus 70 63–76; P<0.001), more often male (82% versus 72%; P=0.008), and less often diabetic (21% versus 30%; P=0.023). Clinical follow-up (median, 85 66–104 months) was analyzed in 396 patients after 1:1 propensity-score matching for these 3 variables. The rate of overall death or myocardial infarction was significantly lower in the FFR-guided (n=31 16% versus n=49 25%; hazard ratio, 0.59 95% confidence interval, 0.38–0.93; P=0.020) as compared with the angiography-guided group. Major adverse cardiovascular events rate was also numerically lower in the FFR-guided than in the angiography-guided group (n=42 21% versus n=52 26%; hazard ratio, 0.77 95% confidence interval, 0.51–1.16; P=0.21).
CONCLUSIONS—FFR-guided CABG is associated with a significant reduction in the rate of overall death or myocardial infarction at 6-year follow-up as compared with angiography-guided CABG.
Diffuse disease has been identified as one of the main reasons leading to low post-PCI fractional flow reserve (FFR) and residual angina after PCI. Coronary pressure pullbacks allow for the ...evaluation of hemodynamic coronary artery disease (CAD) patterns. The pullback pressure gradient (PPG) is a novel metric that quantifies the distribution and magnitude of pressure losses along the coronary artery in a focal-to-diffuse continuum.
The primary objective is to determine the predictive capacity of the PPG for post-PCI FFR.
This prospective, large-scale, controlled, investigator-initiated, multicenter study is enrolling patients with at least 1 lesion in a major epicardial vessel with a distal FFR ≤ 0.80 intended to be treated by PCI. The study will include 982 subjects. A standardized physiological assessment will be performed pre-PCI, including the online calculation of PPG from FFR pullbacks performed manually. PPG quantifies the CAD pattern by combining several parameters from the FFR pullback curve. Post-PCI physiology will be recorded using a standardized protocol with FFR pullbacks. We hypothesize that PPG will predict optimal PCI results (post-PCI FFR ≥ 0.88) with an area under the ROC curve (AUC) ≥ 0.80. Secondary objectives include patient-reported and clinical outcomes in patients with focal vs. diffuse CAD defined by the PPG. Clinical follow-up will be collected for up to 36 months, and an independent clinical event committee will adjudicate events.
Recruitment is ongoing and is expected to be completed in the second half of 2023.
This international, large-scale, prospective study with pre-specified powered hypotheses will determine the ability of the preprocedural PPG index to predict optimal revascularization assessed by post-PCI FFR. In addition, it will evaluate the impact of PPG on treatment decisions and the predictive performance of PPG for angina relief and clinical outcomes.
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•An analysis of legal frameworks and four case studies shows the State role in GI.•GIs are a development tool whose uses vary with the local context.•GIs can be used as a tool for agricultural ...modernization.•Local government involvement facilitates negotiation on GI orientation.
This paper investigates the way Geographical Indications (GIs) are implemented by national and local governments in Indonesia and Vietnam. The two States are active at all stages of GI development, from the selection of the products candidates for GI registration to the supervision of the GI implementation. Thanks to the involvement of national experts from public agencies in the establishment of the Codes of Practices (CoP), they are able to push for the substitution of traditional local techniques with “good practices” (i.e., mostly those recommended by research centers worldwide). Thus, they put GIs at the service of agricultural modernization when GIs apply more conventionally to specific products based on traditional know-how.
However, the implementation of the CoPs and thus the achievement of this objective of modernization depend on the perceived interest of producers in the whole GI dynamic. Indeed, the cases studied in Indonesia and Vietnam highlight the variable level of participation of local producers in the GI. In the four studied cases, the CoPs are mainly based on expert knowledge which differs from the actual practices of farmers and processors. Moreover, GIs are implemented in order to create or reinforce reputations rather than legally protecting preexisting ones. For these two reasons, producers’ motivation to invest in GI certification is weak, which makes difficult the necessary collective involvement.
In both countries, the involvement of local governments in GI construction and management modifies the situation. Thanks to their knowledge of local situations and stakes, they are more likely than national experts to identify the most strategic supply chains at local level, enable participatory approaches in GI construction and facilitate the involvement of local producers in the GI managing group. But if competences have been given to local governments in the Indonesian and Vietnamese legal frameworks, the distribution of roles between central and provincial governments in GIs are not clearly enough specified. The nature and the importance of local public intervention differ from one case to another.
Finally, this paper recognizes the legitimacy of State intervention in GI development, at least as long as producers’ awareness of GIs is still low. However, this State intervention should not only let enough space for producers in GI governance, but also design a frame for arousing their interest and adhesion and for facilitating their collective involvement. That may be facilitated by a concrete and clearly established decentralization of competences in national policies.
The transcarotid (TC) vascular access for transcatheter aortic valve implantation (TAVI) has emerged as the first-choice alternative to the transfemoral access, in patients unsuitable for the latter. ...The use of both the left and right common carotid arteries (CCAs) for TC-TAVI has been described, but the optimal side is subject to debate. We conducted this pilot study to compare the level of vessel tortuosity and plaque burden from either the left CCA to the aortic annulus, or the right CCA to the aortic annulus, considering them as surrogates for technical and procedural complexity.
Consecutive patients who underwent TC-TAVI between 2018 and 2021 in our institution were included. Using three-dimensional reconstruction, pre-TAVI neck and chest computed tomography angiography exams were reviewed to assess the tortuosity index (TI), sum of angles metric, as well as plaque burden, between each CCA and the aortic annulus.
We included 46 patients who underwent TC-TAVI. No significant difference regarding the mean TIs between the left and right sides (respectively 1.20 and 1.19, p = 0.82), the mean sum of angles (left side: 396°, right side: 384°, p = 0.27), and arterial plaque burden (arterial plaque found in 30% of left CCAs and 45% of right CCAs, p = 0.19) was found.
We found no convincing data favoring the use of one particular access side over the other one. The choice of the CCA side in TC-TAVI should to be made on a case-by-case basis, in a multidisciplinary fashion, and may also depend on the operators' experience.
The recent pandemic launched an acceleration in adopting telemedicine by cardiovascular health and triggered the flourishing of technological advancements, such as the metaverse, which is a novel ...interactive mix of digital worlds that leverages augmented reality with virtual reality. The CardioVerse represents a theoretical term for the embracement of the metaverse by cardiovascular medicine, encompassing the endless possibilities as well as the challenges that it holds and introduces new dimensions to disease education, prevention and diagnosis. Its applications are numerous, notably in enhancing medical visits, assisting cardiovascular interventions and reshaping the way medical education is provided. Although obstacles are expected in diverse domains such as security, technical, legislative and regulatory, the utilization of non-fungible tokens as a security asset for patient data appears as potential solution.
Different studies have shown circadian variation of ischemic burden among patients with ST-Elevation Myocardial Infarction (STEMI), but with controversial results. The aim of this study was to ...analyze circadian variation of myocardial infarction size and in-hospital mortality in a large multicenter registry.
This retrospective, registry-based study was based on data from AMIS Plus, a large multicenter Swiss registry of patients who suffered myocardial infarction between 1999 and 2013. Peak creatine kinase (CK) was used as a proxy measure for myocardial infarction size. Associations between peak CK, in-hospital mortality, and the time of day at symptom onset were modelled using polynomial-harmonic regression methods.
6,223 STEMI patients were admitted to 82 acute-care hospitals in Switzerland and treated with primary angioplasty within six hours of symptom onset. Only the 24-hour harmonic was significantly associated with peak CK (p = 0.0001). The maximum average peak CK value (2,315 U/L) was for patients with symptom onset at 23:00, whereas the minimum average (2,017 U/L) was for onset at 11:00. The amplitude of variation was 298 U/L. In addition, no correlation was observed between ischemic time and circadian peak CK variation. Of the 6,223 patients, 223 (3.58%) died during index hospitalization. Remarkably, only the 24-hour harmonic was significantly associated with in-hospital mortality. The risk of death from STEMI was highest for patients with symptom onset at 00:00 and lowest for those with onset at 12:00.
As a part of this first large study of STEMI patients treated with primary angioplasty in Swiss hospitals, investigations confirmed a circadian pattern to both peak CK and in-hospital mortality which were independent of total ischemic time. Accordingly, this study proposes that symptom onset time be incorporated as a prognosis factor in patients with myocardial infarction.
Objectives
We sought to develop an automatic method for correcting common errors in phasic pressure tracings for physiology‐guided interventions on coronary and valvular stenosis.
Background
...Effective coronary and valvular interventions rely on accurate hemodynamic assessment. Phasic (subcycle) indexes remain intrinsic to valvular stenosis and are emerging for coronary stenosis. Errors, corrections, and clinical implications of fluid‐filled catheter phasic pressure assessments have not been assessed in the current era of ubiquitous, high‐fidelity pressure wire sensors.
Methods
We recruited patients undergoing invasive coronary physiology assessment. Phasic aortic pressure signals were recorded simultaneously using a fluid‐filled guide catheter and 0.014″ pressure wire before and after standard calibration as well as after pullback. We included additional subjects undergoing hemodynamic assessment before and after transcatheter aortic valve implantation. Using the pressure wire as reference standard, we developed an automatic algorithm to match phasic pressures.
Results
Removing pressure offset and temporal shift produced the largest improvements in root mean square (RMS) error between catheter and pressure wire signals. However, further optimization <1 mmHg RMS error was possible by accounting for differential gain and the oscillatory behavior of the fluid‐filled guide. The impact of correction was larger for subcycle (like systole or diastole) versus whole‐cycle metrics, indicating a key role for valvular stenosis and emerging coronary pressure ratios.
Conclusions
When calibrating phasic aortic pressure signals using a pressure wire, correction requires these parameters: offset, timing, gain, and oscillations (frequency and damping factor). Automatically eliminating common errors may improve some clinical decisions regarding physiology‐based intervention.
Background Several parameters of cardiovascular physiology and pathophysiology exhibit circadian rhythms. Recently, a relation between infarct size and the time of day at which it occurs has been ...suggested in experimental models of myocardial infarction. The aim of this study is to investigate whether circadian rhythms could cause differences in ischemic burden in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Methods In 353 consecutive patients with STEMI treated by PPCI, time of symptom onset, peak creatine kinase (CK), and follow-up at 30 days were obtained. We divided 24 hours into 4 time groups based on time of symptom onset (00:00-05:59, 06:00-11:59, 12:00-17:59, and 18:00-23:59). Results There was no difference between the groups regarding baseline patients and management's characteristics. At multivariable analysis, there was a statistically significant difference between peak CK levels among patients with symptom onset between 00:00 and 05:59 when compared with peak CK levels of patients with symptom onset in any other time group (mean increase 38.4%, P < .05). Thirty-day mortality for STEMI patients with symptom onset occurring between 00:00 and 05:59 was significantly higher than any other time group ( P < .05). Conclusion This study demonstrates an independent correlation between the infarct size of STEMI patients treated by PPCI and the time of the day at which symptoms occurred. These results suggest that time of the day should be a critical issue to look at when assessing prognosis of patients with myocardial infarction.
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