Culprit lesion plaque characterization and thrombus grading by high-definition intravascular ultrasound in patients with ST-segment elevation myocardial infarction.

BACKGROUND: Dedicated prospective studies investigating high-definition intravascular ultrasound (HD-IVUS)-guided primary percutaneous coronary intervention (PCI) are lacking. The aim of this study was to qualify and quantify culprit lesion plaque characteristics and thrombus using HD-IVUS in patients presenting with ST-segment elevation myocardial infarction (STEMI). METHODS: The SPECTRUM study is a prospective, single-center, observational cohort study investigating the impact of HD-IVUS-guided primary PCI in 200 STEMI patients (NCT05007535). The first 100 study patients with a de novo culprit lesion and a per-protocol mandated preintervention pullback directly after vessel wiring were subject to a predefined imaging analysis. Culprit lesion plaque characteristics and different thrombus types were assessed. An IVUS-derived thrombus score, including a 1-point adjudication for a long total thrombus length, long occlusive thrombus length, and large maximum thrombus angle, was developed to differentiate between low (0-1 points) and high (2-3 points) thrombus burden. Optimal cut-off values were obtained using receiver operating characteristic curves. RESULTS: The mean age was 63.5 (±12.1) years and 69 (69.0%) patients were male. The median culprit lesion length was 33.5 (22.8-38.9) mm. Plaque rupture and convex calcium were appreciated in 48 (48.0%) and 10 (10.0%) patients, respectively. Thrombus was observed in 91 (91.0%) patients (acute thrombus 3.3%; subacute thrombus 100.0%; organized thrombus 22.0%). High IVUS-derived thrombus burden was present in 37/91 (40.7%) patients and was associated with higher rates of impaired final thrombolysis in myocardial infarction flow (grade 0-2) (27.0% vs. 1.9%, p < 0.001). CONCLUSIONS: HD-IVUS in patients presenting with STEMI allows detailed culprit lesion plaque characterization and thrombus grading that may guide tailored PCI.

Optical coherence tomography-derived predictors of stent expansion in calcified lesions.

BACKGROUND: Severe coronary artery calcification is associated with stent underexpansion and subsequent stent failure. AIMS: We aimed to identify optical coherence tomography (OCT)-derived predictors of absolute (minimal stent area [MSA]) and relative stent expansion in calcified lesions. METHODS: This retrospective cohort study included patients who underwent percutaneous coronary intervention (PCI) with OCT assessment before and after stent implantation between May 2008 and April 2022. Pre-PCI OCT was used to assess calcium burden and post-PCI OCT was used to assess absolute and relative stent expansion. RESULTS: A total of 361 lesions in 336 patients were analyzed. Target lesion calcification (defined as OCT-detected maximum calcium angle ≥ 30°) was present in 242 (67.0%) lesions. Following PCI, median MSA was 5.37 mm2 in calcified lesions and 6.24 mm2 in noncalcified lesions (p < 0.001). Median stent expansion was 78% in calcified lesions and 83% in noncalcified lesions (p = 0.325). In the subset of calcified lesions, average stent diameter, preprocedural minimal lumen area, and total calcium length were independent predictors of MSA in multivariable analysis (mean difference 2.69 mm2 /mm2 , 0.52 mm2 /mm, and -0.28 mm2 /5 mm, respectively, all p < 0.001). Total stent length was the only independent predictor of relative stent expansion (mean difference -0.465% per mm, p < 0.001). Calcium angle, thickness, and the presence of nodular calcification were not significantly associated with MSA or stent expansion in multivariable analyses. CONCLUSION: Calcium length appeared to be the most important OCT-derived predictor of MSA, whereas stent expansion was mainly determined by total stent length.

Initial experience with orbital atherectomy in a tertiary centre in the Netherlands.

BACKGROUND: In January 2021, the Diamondback 360 orbital atherectomy (OA) system received CE mark approval and became available in Europe. The first procedure in Europe was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. AIMS: To report the procedural safety and efficacy of the initial experience with OA in a tertiary care institution in the Netherlands. METHODS: Patients with de novo severely calcified coronary artery disease who were treated with intended invasive imaging-guided OA were included in a prospective single-centre registry. Device success, defined as less than 50% stenosis after OA, and procedural success, defined as successful stent implantation with less than 50% residual stenosis, were evaluated. Calcium debulking effects were assessed by invasive imaging. Safety was assessed up to 30 days after the index procedure. RESULTS: Between February 2021 and June 2021, 29 patients with a total of 39 coronary arteries underwent OA. Target lesions were heavily calcified with a mean length of 32 mm and a calcium arc of 320 degrees. Invasive imaging was applied in all but one patient and 36 vessels. Superficial sanding was observed in almost all vessels (90%) and fracturing of deeper medial calcium in more than half of the vessels (63%), with a device success of 66% and procedural success of 94%. The mean stent symmetry index was 0.84, indicating good circular stent expansion. No primary safety events occurred during 30 days of follow-up. CONCLUSION: Our initial experience with OA for heavily calcified coronary lesions demonstrated favourable debulking effects and plaque modification, with high procedural success and clinical safety.

Validation of a simplified intravascular ultrasound core lab analysis method in stented coronary arteries.

OBJECTIVES: To validate a simplified core laboratory intravascular ultrasound (IVUS) analysis method based on frames with visually determined minimal lumen areas (MLAs) as compared with a comprehensive (per frame) analysis method. BACKGROUND: IVUS-guided percutaneous coronary intervention has proven to be superior to angiography-guided stenting. In clinical practice, cross-sections with visually determined MLA are measured to determine lesion severity or minimal stent area (MSA), however, its accuracy has not been compared with a comprehensive per frame analysis method. METHODS: A total of 50 stented coronary segments of anonymized core lab datasets were analyzed using a comprehensive analysis method and reanalyzed by two core lab analysts using the simplified method including a maximum of seven frames to be analyzed (the visually determined MSA, the first and last frame, and the MLA of each reference segment). The main parameters of interest were MSA, MLA in the reference segments, and plaque burden. RESULTS: The simplified method showed moderate agreement for measurement of the proximal MLA (7.51 ± 2.52 vs. 6.32 ± 1.88 mm2 , intraclass correlation coefficient [ICC] = 0.73), good agreement for the distal MLA (5.41 ± 1.85 vs. 5.11 ± 1.38 mm2 , ICC = 0.84) and plaque burden proximal (0.49 ± 0.12 vs. 0.50 ± 0.11, ICC = 0.88), and excellent agreement for the MSA (5.35 ± 1.05 vs. 5.32 ± 0.99 mm2 , ICC = 0.94) and plaque burden distal (0.47 ± 0.14 vs. 0.47 ± 0.12, ICC = 0.92), when compared with the comprehensive analysis method. Inter- and intraobserver analysis revealed good-to-excellent agreement for all parameters. CONCLUSIONS: Measuring poststenting IVUS cross-sections with visually determined MLAs by experienced core lab analysts is an accurate and reproducible method to identify MLAs.

Diagnostic accuracy of angiography-based vessel fractional flow reserve after chronic coronary total occlusion recanalization.

BACKGROUND: Angiography-based vessel fractional flow reserve (vFFR) demonstrated a strong correlation with invasive fractional flow reserve (FFR) in both a pre- and post-percutaneous coronary intervention (PCI) setting. However, the role of vFFR and its correlation with post-PCI FFR in chronic coronary occlusions (CTO) has not been evaluated yet. We sought to investigate the diagnostic performance of post-PCI vFFR with post-PCI FFR as a reference in patients undergoing successful CTO PCI. METHODS: Between March 2016 and April 2020, a total of 80 patients from the FFR-SEARCH (prospective registry) and FFR REACT (randomized controlled trial) studies underwent successful CTO recanalization with post-PCI FFR measurements. RESULTS: A total of 50 patients (median age 66 (interquartile range [IQR]: 56-74) years, 76% were male) were eligible for the analysis. Median post-PCI FFR was 0.89 (IQR: 0.84-0.94), while median post-PCI vFFR was 0.91 (IQR: 0.85-0.94) (p 0.10). Suboptimal physiological results, defined as FFR and vFFR <0.90, were identified in 26 (52%) and in 21 (42%) patients, respectively. A strong correlation (r = 0.82) was found between vFFR and FFR with a mean bias of 0.013 ± 0.051. Receiver-operating characteristics curve analysis revealed an excellent accuracy of vFFR in predicting FFR <0.90 (area under the curve: 0.97; 95% confidence interval: 0.93-1.00). CONCLUSION: Post-PCI vFFR shows a good correlation with post-PCI FFR and a high diagnostic accuracy for post-PCI FFR ≤0.90 in patients undergoing successful PCI of a CTO lesion.

Angiography-Based Fractional Flow Reserve: State of the Art.

PURPOSE OF REVIEW: Three-dimensional quantitative coronary angiography-based methods of fractional flow reserve (FFR) derivation have emerged as an appealing alternative to conventional pressure-wire-based physiological lesion assessment and have the potential to further extend the use of physiology in general. Here, we summarize the current evidence related to angiography-based FFR and perspectives on future developments. RECENT FINDINGS: Growing evidence suggests good diagnostic performance of angiography-based FFR measurements, both in chronic and acute coronary syndromes, as well as in specific lesion subsets, such as long and calcified lesions, left main coronary stenosis, and bifurcations. More recently, promising results on the superiority of angiography-based FFR as compared to angiography-guided PCI have been published. Currently available angiography -FFR indices proved to be an excellent alternative to invasive pressure wire-based FFR. Dedicated prospective outcome data comparing these indices to routine guideline recommended PCI including the use of FFR are eagerly awaited.

Correlation between 3D-QCA based FFR and quantitative lumen assessment by IVUS for left main coronary artery stenoses.

OBJECTIVES: We aimed to evaluate the feasibility of using three dimensional-quantitative coronary angiography (3D-QCA) based fractional flow reserve (FFR) (vessel fractional flow reserve [vFFR], CAAS8.1, Pie Medical Imaging) and to correlate vFFR values with intravascular ultrasound (IVUS) for the evaluation of intermediate left main coronary artery (LMCA) stenosis. BACKGROUND: 3D-QCA derived FFR indices have been recently developed for less invasive functional lesion assessment. However, LMCA lesions were vastly under-represented in first validation studies. METHODS: This observational single-center cohort study enrolled consecutive patients with stable angina, unstable angina, or non-ST-segment elevation myocardial infarction and nonostial, intermediate grade LMCA stenoses who underwent IVUS evaluation. vFFR was computed based on two angiograms with optimal LMCA stenosis projection and correlated with IVUS-derived minimal lumen area (MLA). RESULTS: A total of 256 patients with intermediate grade LMCA stenosis evaluated with IVUS were screened for eligibility; 147 patients met the clinical inclusion criteria and had a complete IVUS LMCA footage available, of them, 63 patients (63 lesions) underwent 3D-QCA and vFFR analyses. The main reason for screening failure was insufficient quality of the angiogram (51 patients,60.7%). Mean age was 65 ± 11 years, 75% were male. Overall, mean MLA within LMCA was 8.77 ± 3.17 mm2 , while mean vFFR was 0.87 ± 0.09. A correlation was observed between vFFR and LMCA MLA (r = .792, p = .001). The diagnostic accuracy of vFFR ≤0.8 in identifying lesions with MLA < 6.0 mm2 (sensitivity 98%, specificity 71.4%, area under the curve (AUC) 0.95, 95% confidence interval (CI) 0.89-1.00, p = .001) was good. CONCLUSIONS: In patients with good quality angiographic visualization of LMCA and available complete LMCA IVUS footage, 3D-QCA based vFFR assessment of LMCA disease correlates well to LMCA MLA as assessed by IVUS.

Polarimetric Signatures of Coronary Thrombus in Patients With Acute Coronary Syndrome.

BACKGROUND: Intravascular polarization-sensitive optical frequency domain imaging (PS-OFDI) offers a novel approach to measure tissue birefringence, which is elevated in collagen and smooth muscle cells, that in turn plays a critical role in healing coronary thrombus (HCT). This study aimed to quantitatively assess polarization properties of coronary fresh and organizing thrombus with PS-OFDI in patients with acute coronary syndrome (ACS).Methods and Results:The POLARIS-I prospective registry enrolled 32 patients with ACS. Pre-procedural PS-OFDI pullbacks using conventional imaging catheters revealed 26 thrombus-regions in 21 patients. Thrombus was manually delineated in conventional OFDI cross-sections separated by 0.5 mm and categorized into fresh thrombus caused by plaque rupture, stent thrombosis, or erosion in 18 thrombus-regions (182 frames) or into HCT for 8 thrombus-regions (141 frames). Birefringence of coronary thrombus was compared between the 2 categories. Birefringence in HCTs was significantly higher than in fresh thrombus (∆n=0.47 (0.37-0.72) vs. ∆n=0.25 (0.17-0.29), P=0.007). In a subgroup analysis, when only using thrombus-regions from culprit lesions, ischemic time was a significant predictor for birefringence (ß (∆n)=0.001 per hour, 95% CI [0.0002-0.002], P=0.023). CONCLUSIONS: Intravascular PS-OFDI offers the opportunity to quantitatively assess the polarimetric properties of fresh and organizing coronary thrombus, providing new insights into vascular healing and plaque stability.

Coronary lithotripsy - a state of the art review.

Lesion calcification is frequently encountered during percutaneous coronary intervention and has been directly linked to procedural complications and future cardiac events. Intravascular lithotripsy is a novel balloon-based modality that does not rely on barotrauma or debulking, but converts electrical energy into mechanical energy creating sonic pressure waves that selectively disrupt calcium. The present review provides an overview of its mechanism of action, the available evidence on its safety and efficacy and indications for use.

Vessel fractional flow reserve-based non-culprit lesion reclassification in patients with ST-segment elevation myocardial infarction: Impact on treatment strategy and clinical outcome (FAST STEMI I study).

BACKGROUND: Complete revascularization in patients with ST-segment elevation myocardial (STEMI) improves clinical outcome. Vessel fractional flow reserve (vFFR) has been validated as a non-invasive physiological technology to evaluate hemodynamic lesion significance without need for a dedicated pressure wire or hyperemic agent. This study aimed to assess discordance between vFFR reclassification and treatment strategy in intermediate non-culprit lesions of STEMI patients and to assess the clinical impact of this discordance. METHODS: This was a single-center, retrospective cohort study. From January 2018 to December 2019, consecutive eligible STEMI patients were screened based on the presence of a non-culprit vessel with an intermediate lesion (30-80% angiographic stenosis) feasible for offline vFFR analysis. The primary outcome was the percentage of non-culprit vessels with discordance between vFFR and actual treatment strategy. The secondary outcome was two-year vessel-oriented composite endpoint (VOCE), a composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and target vessel revascularization. RESULTS: A total of 441 patients (598 non-culprit vessels) met the inclusion criteria. Median vFFR was 0.85 (0.73-0.91). Revascularization was performed in 34.4% of vessels. Discordance between vFFR and actual treatment strategy occurred in 126 (21.1%) vessels. Freedom from VOCE was higher for concordant vessels (97.5%) as compared to discordant vessels (90.6%)(p = 0.003), particularly due to higher adverse event rates in discordant vessels with a vFFR ≤0.80 but deferred revascularization. CONCLUSIONS: In STEMI patients with multivessel disease, discordance between vFFR reclassification and treatment strategy was observed in 21.1% of non-culprit vessels with an intermediate lesion and was associated with increased vessel-related adverse events.

Association Between 3D-Angiography Based Fractional Flow Reserve and Non-Invasive Myocardial Ischemia Testing: The FAST ISCHEMIA Study.

BACKGROUND: In order to facilitate fractional flow reserve (FFR)-guided lesion assessment, several 3-dimensional (3D)-angiography-based physiological indices have been recently validated. Thus far, limited data are available on the association of these indices with conventional forms of ischemia testing. AIM: The aim of the study was to determine the association between 3D-angiography-based vessel-FFR (vFFR) and myocardial ischemia as assessed by exercise electrocardiography (ECG) testing, dobutamine stress echocardiography, single photon emission computed tomography myocardial perfusion imaging (SPECTMPI), and stress cardiovascular magnetic resonance imaging (stress CMR). METHODS: FAST ISCHEMIA is a retrospective, single-center cohort study including patients who underwent non-invasive myocardial ischemia testing and subsequent coronary angiography (≤3 months). A total of 145 patients (340 vessels) were analyzed. The overall patient-based sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of vFFR ≤0.80 in any vessel for ischemia was 64% (95% confidence interval [CI], 53-74), 71% (95% CI, 54-84), 83% (95% CI, 72-91), 46% (95% CI, 33-60), 2.16 (95% CI, 1.25-3.74), and 0.52 (95% CI, 0.36-0.74), respectively. Multivariable logistic regression showed that vFFR ≤0.80 was significantly associated with ischemia on a patient level (odds ratio, 8.13; 95% CI, 2.51-30.06; P<.001) and on a vascular territory level (odds ratio, 2.75; 95% CI, 1.17-6.44; P<.01). CONCLUSION: Our study suggests that vFFR ≤0.80 has a modest association with non-invasive myocardial ischemia testing using either exercise ECG or stress imaging modalities. After correcting for independent confounders, vFFR was independently associated with ischemia on a non-invasive myocardial ischemia detection test.

Long-term clinical outcomes in patients with non-ST-segment Elevation Acute Coronary Syndrome and ST-segment elevation myocardial infarction with thrombolysis in myocardial infarction 0 flow.

Background: Thrombolysis in Myocardial Infarction (TIMI) 0 flow often characterizes ST-segment Elevation Myocardial Infarction (STEMI) patients, but may also feature in non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS). Since recanalization usually occurs later in NSTE-ACS patients, the aim of this study was to assess whether patients presenting with NSTE-ACS and TIMI 0 flow have worse clinical outcomes as compared to patients presenting with STEMI and TIMI 0 flow. Methods: A single-center retrospective cohort study was conducted with patients treated for NSTE-ACS and STEMI with TIMI 0 flow at diagnostic angiogram between January 2015 and December 2019. The two patient groups were 1:1 matched using a propensity score logistic regression model. The primary outcome was Major Adverse Cardiac Events (MACE), a composite of all-cause mortality, any myocardial infarction, coronary artery bypass graft, urgent target vessel revascularization or stroke during long term follow-up. Results: The total population consisted of 1255 ACS patients, of which 249 NSTE-ACS and 1006 STEMI patients. After propensity score matching, 234 NSTE-ACS patients were matched with 234 STEMI patients. In this matched population, the mean age was 62.6 (±12.4) years and 75.2 % of the patients was male. The median follow-up time was 3.2 years. MACE rates during follow-up were similar between the two matched groups (HR = 0.84 [95 % CI 0.60 - 1.12] with p = 0.33) with cumulative event-free survival of 63.3 % in the NSTE-ACS group vs 59.3 % in the STEMI group at 6 year follow-up. Conclusion: In this retrospective study, a culprit lesion with TIMI 0 flow has similar clinical outcome in NSTE-ACS and STEMI patients. Further research is warranted to determine optimal the timing of PCI in NSTE-ACS patients with TIMI 0 flow.

Validation of Segmental Post-PCI Physiological Gradients With IVUS-Detected Focal Lesions and Stent Underexpansion.

BACKGROUND: Segmental postpercutaneous coronary intervention (PCI) pressure gradients may detect residual disease and potential targets for optimization. However, universal definitions of relevant segmental gradients are lacking. OBJECTIVES: This study sought to evaluate the diagnostic performance of post-PCI fractional flow reserve (FFR), distal coronary pressure-to-aortic pressure ratio (Pd/Pa), and diastolic pressure ratio (dPR) gradients to detect residual focal lesions and stent underexpansion as observed by intravascular ultrasound (IVUS). METHODS: Patients from the IVUS-guided optimization arm of the FFR REACT (FFR-guided PCI Optimization Directed by High-Definition IVUS Versus Standard of Care) trial with complete IVUS and FFR pullback data were included. Patients with angiographically successful PCI and post-PCI FFR <0.90 underwent FFR, Pd/Pa, and IVUS pullbacks. dPR was calculated offline using dedicated software. Segmental pressure gradients (distal, in stent, and proximal) in segments ≥5 mm were evaluated against IVUS-detected residual disease (distal or proximal focal lesions and stent underexpansion). RESULTS: A total of 139 vessels were included (mean post-PCI FFR: 0.83 ± 0.05, range 0.56-0.89). Focal distal and proximal lesions were detected by IVUS in 23 (17.4%) of 132 and 14 (12.6%) of 111 vessels, respectively, whereas stent underexpansion was present in 86 (61.9%) vessels. Diagnostic ability of segmental FFR gradients to predict IVUS-detected distal and proximal lesions was moderate-to-good (area under the curve [AUC]: 0.69 and 0.84, respectively) and poor to moderate for segmental Pd/Pa and dPR gradients (AUC ranging from 0.58 to 0.69). In-stent gradients had no discriminative ability to detect stent underexpansion (FFR AUC: 0.52; Pd/Pa AUC: 0.54; dPR AUC: 0.55). CONCLUSIONS: In patients with post-PCI FFR <0.90, segmental post-PCI pressure gradients have moderate discriminative ability to identify IVUS-detected focal lesions but no discriminative ability to identify IVUS-detected stent underexpansion.

Predictors of discordance between fractional flow reserve (FFR) and diastolic pressure ratio (dPR) in intermediate coronary lesions.

Background: Recently, non-hyperemic pressure ratios (NHPRs) have been validated as a reliable alternative to fractional flow reserve (FFR). However, a discordance between FFR and NHPRs is observed in 20-25% of cases. The aim of this study is to evaluate predictors of discordance between FFR and diastolic Pressure ratio (dPR). Methods: PREDICT is a retrospective, single center, investigator-initiated study including 813 patients (1092vessels) who underwent FFR assessment of intermediate coronary lesions (angiographic 30%-80% stenosis). dPR was calculated using individual pressure waveforms and dedicated software. Clinical, angiographic and hemodynamic variables were compared between patients with concordant and discordant FFR and dPR values. Results: Median age was 65 (IQR:59-73) years and 70% were male. Hemodynamically significant lesions, as defined by FFR ≤ 0.80, and dPR ≤ 0.89, were identified in 29.6% and 30.3% of cases, respectively. Overall, FFR and dPR values were discordant in 22.1% patients (17.4% of the vessels). Discordance was related to FFR+/dPR- and FFR-/dPR + in 11.8% and 10.3% of patients, respectively.In case of FFR-dPR discordance, a higher prevalence of left anterior descending arteries lesions was observed (70.5% vs. 53.1%, p < 0.001) and mean values of both FFR and dPR were significantly lower (FFR 0.81 ± 0.05 vs 0.85 ± 0.08, p < 0.001, and dPR 0.89 ± 0.04 vs 0.92 ± 0.08,p < 0.001) as compared to vessels with FFR and dPR concordance. Following multivariable adjustment, dPR delta (defined as the absolute difference between measured dPR to the cut-off value of 0.89) turned out to be the only independent predictor of discordance (OR = 0.74, 95% CI 0.68-0.79, p < 0.001). Conclusion: Our study suggests that FFR-to-dPR discordance occurs in approximately one-fifth of patients. Absolute dPR delta appears to be the only independent predictor of discordance.

Clinical and Vessel Characteristics Associated With Hard Outcomes After PCI and Their Combined Prognostic Implications.

Background Cardiac death or myocardial infarction still occurs in patients undergoing contemporary percutaneous coronary intervention (PCI). We aimed to identify adverse clinical and vessel characteristics related to hard outcomes after PCI and to investigate their individual and combined prognostic implications. Methods and Results From an individual patient data meta-analysis of 17 cohorts of patients who underwent post-PCI fractional flow reserve measurement after drug-eluting stent implantation, 2081 patients with available clinical and vessel characteristics were analyzed. The primary outcome was cardiac death or target-vessel myocardial infarction at 2 years. The mean age of patients was 64.2±10.2 years, and the mean angiographic percent diameter stenosis was 63.9%±14.3%. Among 11 clinical and 8 vessel features, 4 adverse clinical characteristics (age ≥65 years, diabetes, chronic kidney disease, and left ventricular ejection fraction <50%) and 2 adverse vessel characteristics (post-PCI fractional flow reserve ≤0.80 and total stent length ≥54 mm) were identified to independently predict the primary outcome (all P<0.05). The number of adverse vessel characteristics had additive predictability for the primary end point to that of adverse clinical characteristics (area under the curve 0.72 versus 0.78; P=0.03) and vice versa (area under the curve 0.68 versus 0.78; P=0.03). The cumulative event rate increased in the order of none, either, and both of adverse clinical characteristics ≥2 and adverse vessel characteristics ≥1 (0.3%, 2.4%, and 5.3%; P for trend <0.01). Conclusions In patients undergoing drug-eluting stent implantation, adverse clinical and vessel characteristics were associated with the risk of cardiac death or target-vessel myocardial infarction. Because these characteristics showed independent and additive prognostic value, their integrative assessment can optimize post-PCI risk stratification. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04684043. www.crd.york.ac.uk/prospero/. Unique Identifier: CRD42021234748.

Correlation of 3D Quantitative Coronary-Angiography Based Vessel FFR With Diastolic Pressure Ratio: A Single-Center Pooled Analysis of the FAST EXTEND and FAST II Studies.

BACKGROUND: Vessel fractional flow reserve (vFFR) has a high diagnostic accuracy in assessing functional lesion significance compared with FFR. Nonhyperemic pressure ratios (NHPRs) were noninferior to FFR to guide revascularization of intermediate lesions. Therefore, the diagnostic performance of vFFR compared with NHPR warrants interest. AIM: To evaluate the diagnostic performance of vFFR with a generic diastolic pressure ratio (dPR) as a reference. METHODS: The study population was derived from the FAST EXTEND and FAST II studies. Between January 2016 and September 2020, a total of 475 patients were enrolled. RESULTS: Median dPR was 0.92 (interquartile range [IQR], 0.87-0.95), median vFFR was 0.86 (IQR, 0.80-0.90). The sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy of vFFR ≤0.80 for dPR ≤0.89 were 66%, 92%, 79%, 85%, and 84%, respectively. Vessel FFR showed a good agreement with dPR (r=0.68), consistent among specific clinical lesion subsets and a high diagnostic accuracy for dPR ≤0.89 (area under the curve=0.89). Discordance between vFFR and dPR was observed in 78/492 cases (15.6%) and logistic regression analysis did not reveal any clinical, angiographic, or hemodynamic variables associated with vFFR and dPR discordance. CONCLUSION: Vessel FFR shows a good agreement with dPR and a high diagnostic accuracy for dPR ≤0.89.

Diagnostic Accuracy of Coronary Angiography-Based Vessel Fractional Flow Reserve (vFFR) Virtual Stenting.

3D coronary angiography-based vessel fractional flow reserve (vFFR) proved to be an accurate diagnostic alternative to invasively measured pressure wire based fractional flow reserve (FFR). The ability to compute post-PCI vFFR using pre-PCI vFFR virtual stent analysis is unknown. We aimed to assess the feasibility and diagnostic accuracy of pre-PCI vFFR virtual stenting analysis (residual vFFR) with post-PCI FFR as a reference. This is an observational, single-center retrospective cohort study including consecutive patients from the FFR-SEARCH registry. We blindly calculated residual vFFR from pre-PCI angiograms and compared them to invasive pressure-wire based post-PCI FFR. Inclusion criteria involved presentation with either stable or unstable angina or non-ST elevation myocardial infarction (NSTEMI), ≥1 significant stenosis in one of the epicardial coronary arteries (percentage diameter stenosis of >70% by QCA or hemodynamically relevant stenosis with FFR ≤0.80) and pre procedural angiograms eligible for vFFR analysis. Exclusion criteria comprised patients with ST elevation myocardial infarction (STEMI), coronary bypass grafts, cardiogenic shock or severe hemodynamic instability. Eighty-one pre-PCI residual vFFR measurements were compared to post-PCI FFR and post-PCI vFFR measurements. Mean residual vFFR was 0.91 ± 0.06, mean post-PCI FFR 0.91 ± 0.06 and mean post-PCI vFFR was 0.92 ± 0.05. Residual vFFR showed a high linear correlation (r = 0.84) and good agreement (mean difference (95% confidence interval): 0.005 (−0.002−0.012)) with post-PCI FFR, as well as with post-PCI-vFFR (r = 0.77, mean difference −0.007 (−0.015−0.0003)). Residual vFFR showed good accuracy in the identification of lesions with post-PCI FFR < 0.90 (sensitivity 94%, specificity 71%, area under the curve (AUC) 0.93 (95% CI: 0.86−0.99), p < 0.001). Virtual stenting using vFFR provided an accurate estimation of post-PCI FFR and post-PCI vFFR. Further studies are needed to prospectively validate a vFFR-guided PCI strategy.

Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study.

INTRODUCTION: Intravascular ultrasound (IVUS) improves clinical outcome in patients undergoing percutaneous coronary intervention (PCI) but dedicated prospective studies assessing the safety and efficacy of IVUS guidance during primary PCI are lacking. METHODS AND ANALYSIS: The SPECTRUM study is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enrol 200 patients presenting with ST-segment elevation myocardial infarct undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, postintervention and postoptimisation (if applicable), using a 40-60 MHz high-definition (HD) system. Baseline tissue characterisation includes the morphological description of culprit lesion plaque characteristics and thrombus as assessed with HD-IVUS. The primary endpoint is target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation). The secondary outcome of interest is IVUS-guided optimisation, defined as IVUS-guided additional balloon dilatation or stent placement. Other endpoints include clinical and procedural outcomes along with post-PCI IVUS findings. ETHICS AND DISSEMINATION: The protocol of this study was approved by the Ethics Committee of the Erasmus University Medical Center, Rotterdam, the Netherlands. Written informed consent is obtained from all patients. Study findings will be submitted to international peer-reviewed journals in the field of cardiovascular imaging and interventions and will be presented at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT05007535.

The prognostic value of angiography-based vessel fractional flow reserve after percutaneous coronary intervention: The FAST Outcome study.

BACKGROUND: Vessel Fractional Flow Reserve (vFFR) as assessed by three-dimensional quantitative coronary angiography has high correlation with pressure wire-based fractional flow reserve in both a pre- and post-PCI setting. The present study aims to assess the prognostic value of post-PCI vFFR on the incidence of target vessel failure (TVF), a composite endpoint of cardiac death, target vessel myocardial infarction and target vessel revascularization (TVR) at 5-year follow up. METHODS: Post-PCI vFFR was calculated after routine PCI in a total of 748 patients (832 vessels) with available orthogonal angiographic projections of the stented segment. RESULTS: Median age was 65 (IQR 55-74) years, 18.2% were diabetic, and 29.1% presented with stable angina. Median post-PCI vFFR was 0.91 (IQR 0.86-0.95). Vessels were categorized into tertiles based on post-PCI vFFR: low (vFFR <0.88), middle (vFFR 0.88-0.93), and upper (vFFR ≥0.94). Vessels in the lower and middle tertile were more often LADs and had smaller stent diameters (p<0.001). Vessels in the lower and middle tertile had a higher risk of TVF as compared to vessels in the upper tertile (24.6% and 21.5% vs. 17.1%; adjusted HR 1.84 (95%CI 1.15-2.95), p = 0.011, and 1.58 (95%CI 1.02-2.45), p = 0.040) at 5-years follow-up. Additionally, vessels in the lower tertile had higher rates of TVR as compared to vessels in the higher tertile (12.6% vs. 6.5%, adjusted HR 1.93 (95%CI 1.06-3.53), p = 0.033). CONCLUSION: Lower post-PCI vFFR values are associated with a significantly increased risk of TVF and TVR at 5-years follow-up.

Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: The INTERSECT registry.

BACKGROUND: New permanent pacemaker implantation (new-PPI) remains a compelling issue after Transcatheter Aortic Valve Replacement (TAVR). Previous studies reported the relationship between a short MS length and the new-PPI post-TAVR with a self-expanding THV. However, this relationship has not been investigated in different currently available THV. Therefore, the aim of this study was to investigate the association between membranous septum (MS)-length and new-PPI after TAVR with different Transcatheter Heart Valve (THV)-platforms. METHODS: We included patients with a successful TAVR-procedure and an analyzable pre-procedural multi-slice computed tomography. MS-length was measured using a standardized methodology. The primary endpoint was the need for new-PPI within 30 days after TAVR. RESULTS: In total, 1811 patients were enrolled (median age 81.9 years [IQR 77.2-85.4], 54% male). PPI was required in 275 patients (15.2%) and included respectively 14.2%, 20.7% and 6.3% for Sapien3, Evolut and ACURATE-THV(p â€‹< â€‹0.01). Median MS-length was significantly shorter in patients with a new-PPI (3.7 â€‹mm [IQR 2.2-5.1] vs. 4.1 â€‹mm [IQR 2.8-6.0], p â€‹= â€‹<0.01). Shorter MS-length was a predictor for PPI in patients receiving a Sapien3 (OR 0.87 [95% CI 0.79-0.96], p â€‹= â€‹<0.01) and an Evolut-THV (OR 0.91 [95% CI 0.84-0.98], p â€‹= â€‹0.03), but not for an ACURATE-THV (OR 0.99 [95% CI 0.79-1.21], p â€‹= â€‹0.91). By multivariable analysis, first-degree atrioventricular-block (OR 2.01 [95% CI 1.35-3.00], p = <0.01), right bundle branch block (OR 8.33 [95% CI 5.21-13.33], p = <0.01), short MS-length (OR 0.89 [95% CI 0.83-0.97], p â€‹< â€‹0.01), annulus area (OR 1.003 [95% CI 1.001-1.005], p â€‹= â€‹0.04), NCC implantation depth (OR 1.13 [95% CI 1.07-1.19] and use of Evolut-THV(OR 1.54 [95% CI 1.03-2.27], p â€‹= â€‹0.04) were associated with new-PPI. CONCLUSION: MS length was an independent predictor for PPI across different THV platforms, except for the ACURATE-THV. Based on our study observations within the total cohort, we identified 3 risk groups by MS length: MS length ≤3 â€‹mm defined a high-risk group for PPI (>20%), MS length 3-7 â€‹mm intermediate risk for PPI (10-20%) and MS length > 7 â€‹mm defined a low risk for PPI (<10%). Anatomy-tailored-THV-selection may mitigate the need for new-PPI in patients undergoing TAVR.