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Yaojun Zhang,1,2 Christos V Bourantas,1 Vasim Farooq,1 Takashi Muramatsu,1 Roberto Diletti,1 Yoshinobu Onuma,1 Hector M Garcia-Garcia,1 Patrick W Serruys11Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; 2Division of Cardiovascular Diseases, Nanjing First Hospital, Nanjing Medical University, Nanjing, People's Republic of ChinaAbstract: Drug-eluting stents have reduced the risk of in-stent restenosis and have broadened the application in percutaneous coronary intervention in coronary artery disease. However, the concept of using a permanent metallic endovascular device to restore the patency of a stenotic artery has inherited pitfalls, namely the presence of a foreign body within the artery causing vascular inflammation, late complications such as restenosis and stent thrombosis, and impeding the restoration of the physiologic function of the stented segment. Bioresorbable scaffolds (BRS) were introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Currently, several BRSs are available, undergoing evaluation either in clinical trials or in preclinical settings. The aim of this review is to present the new developments in BRS technology, describe the mechanisms involved in the resorption process, and discuss the potential future prospects of this innovative therapy.Keywords: bioresorbable scaffold, drug-eluting stent, biodegradable, design, mechanism, coronary artery disease

To quantify with in vivo OCT and histology, the device/vessel interaction after implantation of the bioresorbable vascular scaffold (BVS). We evaluated the area and thickness of the strut voids previously occupied by the polymeric struts, and the neointimal hyperplasia (NIH) area covering the endoluminal surface of the strut voids (NIH(EV)), as well as the NIH area occupying the space between the strut voids (NIH(BV)), in healthy porcine coronary arteries at 2, 3 and 4 years after implantation of the device. Twenty-two polymeric BVS were implanted in the coronary arteries of 11 healthy Yucatan minipigs that underwent OCT at 2, 3 and 4 years after implantation, immediately followed by euthanasia. The areas and thicknesses of 60 corresponding strut voids previously occupied by the polymeric struts and the size of 60 corresponding NIH(EV) and 49 NIH(BV) were evaluated with both OCT and histology by 2 independent observers, using a single quantitative analysis software for both techniques. At 3 and 4 years after implantation, the strut voids were no longer detectable by OCT or histology due to complete polymer resorption. However, analysis performed at 2 years still provided clear delineation of these structures, by both techniques. The median [ranges] areas of these strut voids were 0.04 [0.03-0.16] and 0.02 [0.01-0.07] mm(2) by histology and OCT, respectively. The mean (±SD) thickness by histology and OCT was 220 ± 40 and 120 ± 20 μm, respectively. The median [ranges] NIH(EV) by histology and OCT was 0.07 [0.04-0.20] and 0.03 [0.01-0.08] mm(2), while the mean (±SD) NIH(BV) by histology and OCT was 0.13 ± 0.07 and 0.10 ± 0.06 mm(2). Our study indicates that in vivo OCT of the BVS provides correlated measurements of the same order of magnitude as histomorphometry, and is reproducible for the evaluation of certain vascular and device-related characteristics. However, histology systematically gives larger values for all the measured structures compared to OCT, at 2 years post implantation. [ABSTRACT FROM AUTHOR]

Although previous intravascular ultrasound (IVUS) radiofrequency-based analysis data showed acceptable reproducibility for plaque composition, measurements are not easily obtained, particularly that of lumen contour, because of the limited IVUS resolution. The purpose of this study was to compare a new measurement method (Shin's method) and the conventional measurement method for necrotic core and calcium content in atherosclerotic lesions using Virtual Histology-intravascular ultrasound (VH-IVUS). Fifty-seven patients with unstable angina who underwent elective percutaneous coronary intervention were included. Shin's method focuses on catheter contour, instead of lumen contour, and vessel contour. Patients ages ranged from 46 to 88 years, and 34 were men. A total of 1,401 frames from 59 culprit lesions were assessed. There were no significant differences in the mean area and volume of necrotic core and dense calcium between the two methods. Correlation coefficients (R) were >or=0.99 for all above mentioned parameters (P < 0.001). Between methods, the absolute differences in mean area and volume of necrotic core were 0.02 +/- 0.02 mm(2) and 0.34 +/- 0.29 mm(3), respectively, while for mean area and volume of dense calcium, the absolute differences were 0.04 +/- 0.07 mm(2) and 0.36 +/- 0.52 mm(3), respectively. The reproducibility of Shin's method was excellent. For area of the necrotic core and dense calcium, the means of the differences between the two measurements were nearly zero, and the reproducibility coefficients were within 1% of the means of the two measurements. Mean analysis time for both measurements was 26.8 +/- 6.7 min/segment in the conventional method and 3.3 +/- 0.6 min/segment in Shin's method. Shin's method for measurement of necrotic core and dense calcium using VH-IVUS demonstrated a good correlation with the conventional method and excellent reproducibility. Also, Shin's method required a significantly shorter analysis time than the conventional method. Therefore, Shin's method could replace the conventional method for necrotic core and calcium measurement in atherosclerotic lesions, and it might be useful in the catheterization laboratory for online clinical decision. [ABSTRACT FROM AUTHOR]

BACKGROUND: Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications. METHODS: To assess the frequency and outcomes associated with 'off-label' use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving System (CRS). Label status (on-label vs off-label) was determined by following (1) inclusion/exclusion criteria indicated in the 18F CRS safety and efficacy trial and (2) a patient selection matrix indicating anatomical boundaries to guide patient selection. Off-label use was defined as the presence of at least one exclusion criterion or 'non-acceptable' criteria based on the patient selection matrix. RESULTS: Off-label implantation was identified in 42 patients (67%)-40% had one, 19% had two and 8% had three or more off-label criteria. Baseline demographics were similar between the groups except for a higher logistic EuroSCORE in the on-label group (19.8 (11.2) vs 14.5 (7.3), p = 0.029). There was no significant difference in the procedural success rates between the on-label and off-label groups (91% vs 95%, respectively, p = 0.47). The frequency of angiographic moderate-severe aortic regurgitation, post-implant dilatation or implantation of a second valve was also similar between the groups. At 30 days, the cumulative death rate was 10%; there were four deaths in the 'on-label' and three deaths in the 'off-label' group. CONCLUSION: In this study we found that 'off-label' implantation of the CRS was common. Further studies are needed to evaluate the consequences of 'label status' for patients undergoing TAVI. [ABSTRACT FROM AUTHOR]

Objective: To assess the potential relation between plaque composition and vascular remodelling by using spectral analysis of intravascular ultrasound (IVUS) radiofrequency data. Methods and Results: 41 coronary vessels with non-significant (< 50% diameter stenosis by angiography), < or = 20 mm, non-ostial lesions located in non-culprit vessels underwent IVUS interrogation. IVUS radiofrequency data obtained with a 30 MHz catheter, were analysed with IVUS virtual histology software. A remodelling index (RI) was calculated and divided into three groups. Lesions with RI > or = 1.05 were considered to have positive remodelling and lesions with RI < or = 0.95 were considered to have negative remodelling. Lesions with RI > or = 1.05 had a significantly larger lipid core than lesions with RI 0.96-1.04 and RI < or = 0.95 (22.1 (6.3) v 15.1 (7.6) v 6.6 (6.9), p < 0.0001). A positive correlation between lipid core and RI (r = 0.83, p < 0.0001) and an inverse correlation between fibrous tissue and RI (r = -0.45, p = 0.003) were also significant. All of the positively remodelled lesions were thin cap fibroatheroma or fibroatheromatous lesions, whereas negatively remodelled lesions had a more stable phenotype, with 64% having pathological intimal thickening, 29% being fibrocalcific lesions, and only 7% fibroatheromatous lesions (p < 0.0001). Conclusions: In this study, in vivo plaque composition and morphology assessed by spectral analysis of IVUS radiofrequency data were related to coronary artery remodelling. [ABSTRACT FROM AUTHOR]

The multicenter EUROPA trial of 12,218 patients showed that perindopril decreased adverse clinical events in patients with established coronary heart disease. The PERSPECTIVE study, a substudy of the EUROPA trial, evaluated the effect of perindopril on coronary plaque progression as assessed by quantitative coronary angiography and intravascular ultrasound (IVUS). In total 244 patients (mean age 57 years, 81% men) were included. Evaluable paired quantitative coronary angiograms were obtained from 96 patients randomized to perindopril and from 98 patients to placebo. Concomitant treatment at baseline consisted of aspirin (90%), lipid-lowering agents (70%), and beta blockers (60%). The primary and secondary end point was the difference of minimum and mean lumen diameters (quantitative coronary angiography) or mean plaque cross-sectional area (IVUS) measured at baseline and 3-year follow-up between the perindopril and placebo groups. After a median follow-up of 3.0 years (range 1.9 to 4.1), no differences in change in quantitative coronary angiographic or IVUS measurements were detected between the perindopril and placebo groups (minimum and mean luminal diameters -0.07 +/- 0.4 vs -0.02 +/- 0.4 mm, p = 0.34; mean luminal diameter -0.05 +/- 0.2 vs -0.05 +/- 0.3 mm, p = 0.89; mean plaque cross-sectional area -0.18 +/- 1.2 vs -0.02 +/- 1.2 mm(2), p = 0.48). In conclusion, we found no progression in coronary artery disease by quantitative coronary angiography and IVUS with long-term administration of perindopril or placebo, possibly because most patients were on concomitant treatment with a statin. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to investigate whether the anatomical location of the disease carries prognostic implications in patients undergoing drug-eluting stent (DES) implantation for the left main coronary artery (LMCA) stenosis. Background: Liberal use of DES, compared with a bare metal stent (BMS), has resulted in an improved outcome in patients undergoing LMCA intervention. However, the overall event rate in this subset of patients remains high, and alternative tools to risk-stratify this population beyond conventional surgical risk status would be desirable. Methods: From April 2002 to June 2004, 130 patients received DES as part of the percutaneous intervention for LMCA stenoses in our institution. Distal LMCA disease (DLMD) was present in 94 patients. They were at higher surgical risk and presented with a greater coronary disease extent compared with patients without DLMD. Results: After a median of 587 days (range 368 to 1,179 days), the cumulative incidence of major adverse cardiac events (MACE) was significantly higher in patients with DLMD at 30% versus 11% in those without DLMD (hazard ratio [HR] 3.42, 95% confidence interval [CI] 1.34 to 9.7; p = 0.007), mainly driven by the different rate of target vessel revascularization (13% and 3%; HR 6, 95% CI 1.2 to 29; p = 0.02). After adjustment for confounders, DLMD (HR 2.79,95% CI 1.17 to 8.9; p = 0.032) and surgical risk status (HR 2.18,95% CI 1.06 to 4.5; p = 0.038) remained independent and complementary predictors of MACE. Conclusions: Distal LMCA disease carries independent prognostic implications, and it may help in selecting the most appropriate patient subset for LMCA intervention beyond the conventional surgical risk status in the DES era. [ABSTRACT FROM AUTHOR]

Background: Coronary microvascular dysfunction (CMD) is a prevalent condition among patients with cardiovascular risk factors, leading to a reduced quality of life and an increased risk of major adverse cardiovascular events. Novel invasive techniques have emerged to more accurately diagnose CMD. However, CMD's natural history remains poorly understood due to limited data. To address this knowledge gap, the Coronary Microvascular Disease Registry (CMDR) was established with the primary aim of standardizing comprehensive coronary functional testing and understanding of CMD., Design: CMDR is a prospective, multicenter registry enrolling an unlimited number of consecutive subjects who undergo comprehensive invasive hemodynamic assessment of the entire coronary arterial vasculature. Patients undergoing acetylcholine provocation test for coronary vasospasm will also be included. Follow-up assessments will be conducted at 30 days and annually for up to 5 years. The primary endpoint is Canadian Cardiovascular Society angina grade over time. Secondary endpoints, including all-cause mortality, cardiovascular death, acute myocardial infarction, stroke, hospitalizations, medication changes, and subsequent coronary interventions, will be analyzed to establish long-term safety and clinical outcomes in patients undergoing invasive CMD assessment., Summary: CMDR aims to characterize the clinical and physiologic profile of patients undergoing comprehensive invasive coronary functional testing, simultaneously providing crucial longitudinal information on the natural history and outcomes of these patients. This will shed light on CMD's course and clinical implications, which, in turn, holds the potential to significantly improve diagnostic and treatment strategies for CMD patients, ultimately leading to the enhancement of their overall prognosis and quality of life., Clinical Trial Registration: clinicaltrials.gov, NCT05960474., Competing Interests: Declaration of competing interest Brian C. Case, - Speaker: Asahi Intecc USA, Zoll Medical. Hector M. Garcia-Garcia – Institutional Grant Support: MedAlliance, Biotronik, Neovasc, Boston Scientific, Abbott, Shockwave, Chiesi, Philips, Spectrawave, Angiowave, InfraReDx, Medis, Pulse Medical, MedHub; Consultancy: Biotronik and Abbott; Speaker's fee: Abbott, Biotronik, Boston Scientific, InfraReDx. Hayder Hashim – Advisory Board, Speaker: Abbott Vascular, Boston Scientific, Philips IGT. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Transmural Systems Inc. All other authors – None., (Copyright © 2024. Published by Elsevier Inc.)

Spontaneous coronary artery dissection (SCAD) is a rare cause of ST-segment elevation myocardial infarction (STEMI), predominantly affecting women. Because primary percutaneous coronary intervention (PPCI) is reserved for a select group of patients, vulnerable and minority patients may experience delays in appropriate management and adverse outcomes. We examined the racial differences in the outcomes for patients with SCAD who underwent PPCI for STEMI. Records of patients aged ≥18 years who underwent PPCI for SCAD-related STEMI between 2016 and 2020 were identified from the National Inpatient Sample database. Clinical, socioeconomic, and hospital characteristics were compared between non-White and White patients. Weighted multivariate analysis assessed the association of race with inpatient mortality, length of stay (LOS), and hospitalization costs. The total weighted estimate of patients with SCAD-STEMI who underwent PPCI was 4,945, constituting 25% non-White patients. Non-White patients were younger (56 vs 60.7 years, p <0.001); had a higher prevalence of diabetes, acute renal failure, and obesity; and were more likely to be uninsured and be in the lowest income group. Inpatient mortality (7.7% vs 8.4%, p = 0.74) and hospitalization costs ($34,213 vs $31,858, p = 0.27) were similar for non-White and White patients, and the adjusted analysis did not show any association between the patients' race and inpatient mortality (odds ratio 0.60, 95% confidence interval [CI] 0.32 to 1.13, p = 0.11) or hospitalization costs (β [β coefficient]: 215, 95% CI -4,193 to 4,623, p >0.90). Similarly, there was no association between the patients' race and LOS (incident rate ratio 1.20, 95% CI 1.00 to 1.45, p = 0.054). The weighted multivariate analysis showed that age; clinical co-morbidities such as diabetes, acute renal failure, valvular dysfunction, and obesity; low-income status; and hospitalization in the western region were associated with adverse outcomes. In conclusion, our study does not show any differences in inpatient mortality, LOS, and hospitalization costs between non-White and White patients who underwent PPCI for SCAD-related STEMI., Competing Interests: Declaration of competing interest Dr. Garcia-Garcia receives institutional grant support from MedAlliance, Biotronik, Neovasc, Boston Scientific, Abbott, Shockwave, Chiesi, Philips, Spectrawave, Angiowave, InfraReDx, Medis, Pulse Medical, and MedHub; is a consultant of Biotronik and Abbott; and receives speaker's fee form Abbott, Biotronik, Boston Scientific, and InfraReDx. Dr. Chitturi is a consultant for Glass Health. Dr. Case is a speaker for Asahi Intecc USA, Zoll Medical. Dr. Waksman is on the advisory board of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; is a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receives grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; is part of the speakers bureau of AstraZeneca; and is an investor of MedAlliance and Transmural Systems Inc. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Many lesions in patients undergoing percutaneous coronary intervention (PCI) exhibit significant calcification. Several techniques have been developed to improve outcomes in this setting. However, their impact on coronary microcirculation remains unknown. The aim of this study is to evaluate the influence of plaque modification techniques on coronary microcirculation across patients with severely calcified coronary artery disease. In this multicenter retrospective study, consecutive patients undergoing PCI with either Rotablation (RA) or Shockwave-intravascular-lithotripsy (IVL) were included. Primary endpoint was the impairment of coronary microvascular resistances assessed by Δ angiography-derived index of microvascular resistance (ΔIMRangio) which was defined as the difference in IMRangio value post- and pre-PCI. Secondary endpoints included the development of peri procedural PCI complications (flow-limiting coronary dissection, slow-flow/no reflow during PCI, coronary perforation, branch occlusion, failed PCI, stroke and shock developed during PCI) and 12-month follow-up adverse events. 162 patients were included in the analysis. Almost 80% of patients were male and the left descending anterior artery was the most common treated vessel. Both RA and IVL led to an increase in ΔIMRangio (22.3 and 10.3; p = 0.038, respectively). A significantly higher rate of PCI complications was observed in patients with ΔIMRangio above the median of the cohort (21.0% vs. 6.2%; p = 0.006). PCI with RA was independently associated with higher ΔIMRangio values (OR 2.01, 95% CI: 1.01-4.03; p = 0.048). Plaque modification with IVL and RA during PCI increases microvascular resistance. Evaluating the microcirculatory status in this setting might help to predict clinical and procedural outcomes and to optimize clinical results., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Background: Hemoglobin (Hgb) drop without bleeding is common among patients undergoing transcatheter aortic valve replacement; however, the clinical implications of significant Hgb drop have not been fully evaluated., Methods and Results: Consecutive patients undergoing transcatheter aortic valve replacement at our institution from 2011 to 2021 were retrospectively reviewed. Three groups were assessed: no Hgb drop and no bleed (NoD-NoB [reference group]), Hgb drop with bleed, and Hgb drop and no bleed (D-NoB). Hgb drop was defined as ≥3 g/dL decrease from pre- to post-transcatheter aortic valve replacement. Outcomes of interest were in-hospital death and 1-year all-cause mortality. A total of 1851 cases with complete Hgb data were included: NoD-NoB: n=1579 (85.3%); D-NoB: n=49 (2.6%); Hgb drop with bleed: n=223 (12.6%). Compared with NoD-NoB, the D-NoB group was older (81.1 versus 78.9 years of age) with higher preprocedure Hgb (12.9 versus 11.7 g/dL). In-hospital death rate was higher among patients with D-NoB versus NoD-NoB (4.5% versus 0.8%, P <0.001) and similar to Hgb drop with bleed (4.5% versus 4.1%, P =0.999). Predictors of in-hospital death were D-NoB (odds ratio [OR], 3.45 [95% CI, 1.32-8.69]) and transfusion (OR, 10.6 [95% CI, 4.25-28.2]). Landmark survival analysis found that D-NoB experienced 1-year mortality rate comparable to NoD-NoB, whereas Hgb drop with bleed had higher midterm mortality (hazard ratio [HR], 3.2 [95% CI, 1.83-5.73]), and transfusion continued to impact mortality (HR, 2.5 [95% CI, 1.79-3.63])., Conclusions: Hgb drop without bleeding is common among patients undergoing transcatheter aortic valve replacement and may represent a higher risk of periprocedural death. Blood transfusion increases short- and midterm mortality risk in patients with and without bleeding, supporting a restrictive transfusion strategy.

Background: Quantitative flow ratio (QFR) and myocardial perfusion scintigraphy (MPS) are utilized for assessing coronary artery disease (CAD) significance. We aimed to analyze their concordance and prognostic impact., Aims: We aimed to analyze the concordance between QFR and MPS and their risk stratification., Methods: Patients with invasive coronary angiography and MPS were categorized as concordant if QFR ≤ 0.80 and summed difference score (SDS) ≥ 4 or if QFR > 0.80 and SDS < 4; otherwise, they were discordant. Concordance was classified by coronary territory involvement: total (three territories), partial (two territories), poor (one territory), and total discordance (zero territories). Leaman score assessed coronary atherosclerotic burden., Results: 2010 coronary territories (670 patients) underwent joint QFR and MPS analysis. MPS area under the curve for QFR ≤ 0.80 was 0.637. Concordance rates were total (52.5%), partial (29.1%), poor (15.8%), and total discordance (2.6%). Most concordance occurred in patients without significant CAD or with single-vessel disease (89.5%), particularly without MPS perfusion defects (91.5%). Leaman score (odds ratio [OR]: 0.839, 95% confidence interval [CI]: 0.805-0.875, p < 0.001) and MPS perfusion defect (summed stress score [SSS] ≥ 4) (OR: 0.355, 95% CI: 0.211-0.596, p < 0.001) were independent predictors for discordance. After 1400 days, no significant difference in death/myocardial infarction was observed based on MPS assessment, but Leaman score, functional Leaman score, and average QFR identified higher risk patients., Conclusions: MPS showed good overall accuracy in assessing QFR significance but substantial discordance existed. Predictors for discordance included higher atherosclerotic burden and MPS perfusion defects (SSS ≥ 4). Leaman score, QFR-based functional Leaman score, and average QFR provided better risk stratification for all-cause death and myocardial infarction than MPS., (© 2024 Wiley Periodicals LLC.)

Background: Recent clinical data indicate a different performance of biodegradable polymer (BP)-drug eluting stent (DES) compared to durable polymer (DP)-DES. Whether this can be explained by a beneficial impact of BP-DES stent design on the local hemodynamic forces distribution remains unclear., Objectives: To compare endothelial shear stress (ESS) distribution after implantation of ultrathin (us) BP-DES and DP-DES and examine the association between ESS and neointimal thickness (NIT) distribution in the two devices at 9 months follow up., Methods and Results: We retrospectively identified patients from the BIOFLOW II trial that had undergone OCT imaging. OCT data were utilized to reconstruct the surface of the stented segment at baseline and 9 months follow-up, simulate blood flow, and measure ESS and NIT in the stented segment. The patients were divided into 3 groups depending on whether DP-DES (N = 8, n = 56,160 sectors), BP-DES with a stent diameter of >3 mm (strut thickness of 80 μm, N = 6, n = 36,504 sectors), or BP-DES with a stent diameter of ≤3 mm (strut thickness of 60 μm, N = 8, n = 50,040 sectors) were used for treatment. The ESS, and NIT distribution and the association of these two variables were estimated and compared among the 3 groups., Results: In the DP-DES group mean NIT was 0.18 ± 0.17 mm and ESS 1.68 ± 1.66 Pa; for the BP-DES ≤3 mm group the NIT was 0.17 ± 0.11 mm and ESS 1.49 ± 1.24 Pa and for the BP-DES >3 mm group 0.20 ± 0.23 mm and 1.42 ± 1.24 Pa respectively (p < 0.001 for both NIT and ESS comparisons across groups). A negative correlation between NIT and baseline ESS was found, the correlation coefficient for all the stented segments was -0.33, p < 0.001., Conclusion: In this OCT sub-study of the BIOFLOW II trial, the NIT was statistically different between groups of patients treated with BP-DES and DP-DES. In addition, regions of low ESS were associated with increased NIT in all studied devices., Competing Interests: Declaration of competing interest Ron Waksman: Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors have no conflicts of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aims: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up., Methods and Results: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P < 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P < 0.001., Conclusion: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue., Competing Interests: Conflict of interest: H.M.G.-G., R.W., G.D.M., M.G., S.B., A.K., and M.B.L. were core laboratory members, and the remaining authors were investigators of the trial. H.M.G.-G. has grants or contracts from Medtronic, Biotronik, Abbott, Neovasc, Corflow, Alucentbio, Philips, and Chiesi (paid to institution), received consulting fees from Boston Scientific and ACIST, and participates in DSMB/advisory board of the VIVID study. R.W. has grants or contracts from Amgen, Biotronik, Boston Scientific, Medtronic, and Philips IGT; received consulting fees from Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; received honoraria from AstraZeneca; participates in DSMB/advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; and is an investor in MedAlliance and Transmural Systems Inc. J.T. reports grants and contracts from Abbott paid to his institution, speaker honoraria and support for attending meetings from Biotronik, and is an associate editor of Cardiovascular Biologics and Regenerative Medicine and Frontiers in Cardiovascular Medicine. J.E. reports personal fees/speaker honoraria from Abbott, Boston Scientific, Philips, and Shockwave, patents from Shared, and participation in advisory boards of Abbott and Phillips. The institution of J.F.I. receives grants or contracts from Terumo Corp, Biosensors, Concept Medical, Biotronik, Abbott Vascular, and Philips Volcano. J.F.I. reports consulting fees from Biotronik, Medtronic, Cordis, Terumo Corp., and ReCor Medical; speaker fees/honoraria from Terumo Corp, Biosensors, Medalliance, OrbusNeich, Concept Medical, Bristol Myers Squibb/Pfizer, Novartis, Cordis, AstraZeneca, and Philips Volcano; and support to attend meetings from Biotronik and Amgen. The institution of J.B. receives grants or contracts from Shockwave IVLS. J.B. receives consulting fees from Biotronik AG and Boston Scientific and speaker fees/honoraria from Biotronik AG, Boston Scientific, and Abbott Vascular, participates in the DSMB of Boston Scientific, and has a leadership or fiduciary role for Biotronik. G.G.T. reports consulting fees from Biotronik, Medtronic, Abbott, and Terumo and honoraria from Biotronik, Medtronic, Abbott, and Terumo. M.J. reports grant support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Infraredx; consulting fees from AlchiMedics SAS, Biotronik, TriCares, Veryan, and Shockwave; speaker fees/honoraria from Abbott Vascular, Biotronik, Boston Scientific, Edwards Lifesciences, Cardiac Dimensions, AstraZeneca, Recor Medical, and Shockwave; travel support from SIS Medical, Edwards Lifesciences, Boston Scientific, and Cardiac Dimensions; and participation in Steering Committees of Biotronik and Edwards Lifesciences. R.T. reports lecture fees from Biotronik. M.W. reports speaker honoraria and conference attendance support from Biotronik. G.O. reports lecturer honoraria from Abbott Vascular, Biotronik, and Cordis and is a DSMB member of the SCIENCE trial and a CEC-member of the BIOFREEDOM STEMI trial. M.H. reports grants/contracts from Biotronik, Cardiac Dimensions, OrbusNeich, and Philips; consulting fees from Biotronik, Cardiac Dimensions, Shockwave Medical, and OrbusNeich; honoraria/speaker fees from Biotronik, Cardiac Dimensions, Shockwave Medical, OrbusNeich, and Philips; and support to attend meetings/travel support from Biotronik, is a steering committee member of the BIOSOLVE and BIOMAG trials, and is a past president of EAPCI. All other authors have no conflict of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Nonhyperemic pressure ratios (NHPRs) have been proposed as alternatives to fractional flow reserve (FFR) without induction of hyperemia. More recently, imaging based-FFR estimation, especially coronary angiography-derived FFR (Angio-FFR) measurement, is proposed to estimate wire-based FFR. However, little is known about the diagnostic performance of these indices against conventional FFR., Aims: We aimed to assess and compare the diagnostic performance of both NHPRs and coronary Angio-FFR against wire-based conventional FFR., Methods: PubMed and Embase databases were systematically searched for peer-reviewed original articles up to 08/2022. The primary outcomes were the pooled sensitivity and specificity as well as the area under the curve (AUC) of the summary receiver-operating characteristic curve of those indices., Results: A total of 6693 records were identified after a literature search, including 37 reports for NHPRs and 34 for Angio-FFR. Overall, NHPRs have a lower diagnostic performance in estimating wire-based FFR with an AUC of 0.85 (0.81, 0.88) when compared with Angio-FFR of 0.95 (0.93, 0.97). When all four modalities of NHPRs (iFR, Pd/Pa, DPR, RFR) were compared, those had overlapping AUCs without major differences among each other. Similarly, when the two most commonly used Angio-FFR (QFR, FFR angio ) were compared, those had overlapping AUCs without major differences among each other., Conclusion: Angio-FFR may offer a better estimation of wire-based FFR than NHPRs. Our results support a wider use of Angio-FFR in the cardiac catheterization laboratory to streamline our workflow for coronary physiologic assessment., Classifications: FFR,, stable ischemic disease and non-ST elevation acute coronary syndrome., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Patients with ST-segment-elevation myocardial infarction but no coronary microvascular injury are at low risk of early cardiovascular complications (ECC). We aim to assess whether nonhyperemic angiography-derived index of microcirculatory resistance (NH-IMR angio ) could be a user-friendly tool to identify patients at low risk of ECC, potentially candidates for expedited care pathway and early hospital discharge., Methods: Retrospective analysis of 2 independent, international, prospective, observational cohorts included 568 patients with ST-segment-elevation myocardial infarction. NH-IMR angio was calculated based on standard coronary angiographic views with 3-dimensional-modeling and computational analysis of the coronary flow., Results: Overall, ECC (a composite of cardiovascular death, cardiogenic shock, acute heart failure, life-threatening arrhythmias, resuscitated cardiac arrest, left ventricular thrombus, post-ST-segment-elevation myocardial infarction mechanical complications, and rehospitalization for acute heart failure or acute myocardial infarction at 30 days follow-up), occurred in 54 (9.3%) patients. NH-IMR angio was significantly correlated with pressure/thermodilution-based index of microcirculatory resistance (r=0.607; P <0.0001) and demonstrated good accuracy in predicting ECC (area under the curve, 0.766 [95% CI, 0.706-0.827]; P <0.0001). Importantly, ECC occurred more frequently in patients with NH-IMR angio ≥40 units (18.1% versus 1.4%; P <0.0001). At multivariable analysis, NH-IMR angio provided incremental prognostic value to conventional clinical, angiographic, and echocardiographic features (adjusted-odds ratio, 14.861 [95% CI, 5.177-42.661]; P <0.0001). NH-IMR angio <40 units showed an excellent negative predictive value (98.6%) in ruling out ECC. Discharging patients with NH-IMR angio <40 units at 48 hours after admission would reduce the total in-hospital stay by 943 days (median 2 [1-4] days per patient)., Conclusions: NH-IMR angio is a valuable risk-stratification tool in patients with ST-segment-elevation myocardial infarction. NH-IMR angio guided strategies to early discharge may contribute to safely shorten hospital stay, optimizing resources utilization., Competing Interests: Dr Scarsini reports research grant from Abbott Vascular and Philips and speakers fee from Abbott. Dr Banning reports institutional research grant from Boston Scientific. Dr De Maria reports research grant from Miracor, Medtronic, Terumo, Abbott, Philips and consultant fee from Miracor. Dr Ribichini reports research grant from Abbott Vascular and Philips. Drs Kotronias, Marin, Channon, Banning, and De Maria acknowledge support/funding from the Oxford NIHR Biomedical Research center. The other authors report no conflicts.

Coronary atherosclerosis remains a leading cause of morbidity and mortality worldwide. The underlying pathophysiology includes a complex interplay of endothelial dysfunction, lipid accumulation and inflammatory pathways. Multiple structural and inflammatory features of the atherosclerotic lesions have become targets to identify high-risk lesions. Various intracoronary imaging devices have been developed to assess the morphological, biocompositional and molecular profile of the intracoronary atheromata. These techniques guide interventional and therapeutical management and allow the identification and stratification of atherosclerotic lesions. We sought to provide an overview of the inflammatory pathobiology of atherosclerosis, distinct high-risk plaque features and the ability to visualize this process with contemporary intracoronary imaging techniques., Competing Interests: PD: received research grants and speaker fees from Abbott Vascular; research grants, speaker fees and consultancy fees from Philips; and research grants from AstraZeneca. NvR: research grants from Abbott, Philpis, Biotronik and Medtronic. Speaker fee: Abbott, Bayer, Rainmed, Microport. HG-G: receives consulting fees from Boston Scientific, Abbott and institutional grants from Phillips, Biotronik, Abbott, MedAlliance, Corflow, Chiesi and Medis. JC: Advisory board Amgen en Novo Nordisk. Received research grants from ZonMw. R-JvG: reported grants and personal fees from Boston Scientific, grants and personal fees from Abbott Vascular, grants and personal fees from Astra Zeneca, grants and personal fees from Amgen, grants from InfraRedx. The other authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Los, Mensink, Mohammadnia, Opstal, Damman, Volleberg, Peeters, van Royen, Garcia-Garcia, Cornel, El Messaoudi and van Geuns.)

Background: Recent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse., Methods: The current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves., Results: A total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm 2 vs. 1.69 ± 0.45 mm 2 , p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038)., Conclusion: In this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated., Clinical Trial Registry: LRT 1.0: NCT02628899 LRT 2.0: NCT03557242., Competing Interests: Declaration of Competing Interest Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems. Puja Parikh – Consultant: Medtronic, Inc. Federico Asch – No personal disclosures. Director of the MedStar Health Academic Echocardiography Core Laboratory which has institutional contracts with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, Biotronik, LivaNova, and Foldax. Gaby Weissman – No personal disclosures. Director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Toby Rogers – Consultant: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott; Advisory board: Medtronic, Boston Scientific; Equity: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH. All other authors have no conflicts of interest to disclose., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown., Methods: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death., Results: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group., Conclusions: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.)., (Copyright © 2023 Massachusetts Medical Society.)

Background: To assess the reproducibility of coronary tissue characterization by an Artificial Intelligence Optical Coherence Tomography software (OctPlus, Shanghai Pulse Medical Imaging Technology Inc.)., Methods: 74 patients presenting with multivessel ST-segment elevation myocardial infarction (STEMI) underwent optical coherence tomography (OCT) of the infarct-related artery at the end of primary percutaneous coronary intervention (PPCI) and during staged PCI (SPCI) within 7 days thereafter in the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and angioX) Treatment-Duration study (ClinicalTrials.gov, NCT01433627). OCT films were run through the OctPlus software. The same region of interest between either side of the stent and the first branch was identified on OCT films for each patient at PPCI and SPCI, thus generating 94 pairs of segments. 42 pairs of segments were re-analyzed for intra-software difference. Five plaque characteristics including cholesterol crystal, fibrous tissue, calcium, lipid, and macrophage content were analyzed for various parameters (span angle, thickness, and area)., Results: There was no statistically significant inter-catheter (between PPCI and SPCI) or intra-software difference in the mean values of all the parameters. Inter-catheter correlation for area was best seen for calcification [intraclass correlation coefficient (ICC) 0.86], followed by fibrous tissue (ICC 0.87), lipid (ICC 0.62), and macrophage (ICC 0.43). Some of the inter-catheter relative differences for area measurements were large: calcification 9.75 %; cholesterol crystal 74.10 %; fibrous tissue 5.90 %; lipid 4.66 %; and macrophage 1.23 %. By the intra-software measurements, there was an excellent correlation (ICC > 0.9) for all tissue types. The relative differences for area measurements were: calcification 0.64 %; cholesterol crystal 5.34 %; fibrous tissue 0.19 %; lipid 1.07 %; and macrophage 0.60 %. Features of vulnerable plaque, minimum fibrous cap thickness and lipid area showed acceptable reproducibility., Conclusion: The present study demonstrates an overall good reproducibility of tissue characterization by the Artificial Intelligence Optical Coherence Tomography software. In future longitudinal studies, investigators may use discretion in selecting the imaging endpoints and sample size, accounting for the observed relative differences in this study., Competing Interests: Declaration of competing interest None., (Copyright © 2023 Elsevier Inc. All rights reserved.)