Progressive growth of coronary aneurysms after bioresorbable vascular scaffold implantation: Successful treatment with OCT-guided exclusion using covered stents.

The development and progressive enlargement over time of multiple saccular coronary artery aneurysms (CAA) after implantation of everolimus-eluting stent and bioresorbable vascular scaffolds (BVS) have been reported. CAA was successfully excluded by two overlapped covered stents expanded inside a long metallic drug-eluting stent to avoid dislodgment at the overlap point. Optical coherence tomography (OCT) was repeatedly performed to monitor CAA expansion and to guide treatment through precise measurement of aneurysm length and vessel size at the landing zone. At 10-month follow-up, coronary computed tomography angiography showed persistent CAA exclusion. To the best of our knowledge, this is the first report of this technique to exclude a long CCA segment.

Relationship between coronary plaque morphology of the left anterior descending artery and 12 months clinical outcome: the CLIMA study.

AIMS: The CLIMA study, on the relationship between coronary plaque morphology of the left anterior descending artery and twelve months clinical outcome, was designed to explore the predictive value of multiple high-risk plaque features in the same coronary lesion [minimum lumen area (MLA), fibrous cap thickness (FCT), lipid arc circumferential extension, and presence of optical coherence tomography (OCT)-defined macrophages] as detected by OCT. Composite of cardiac death and target segment myocardial infarction was the primary clinical endpoint. METHODS AND RESULTS: From January 2013 to December 2016, 1003 patients undergoing OCT evaluation of the untreated proximal left anterior descending coronary artery in the context of clinically indicated coronary angiogram were prospectively enrolled at 11 independent centres (clinicaltrial.gov identifier NCT02883088). At 1-year, the primary clinical endpoint was observed in 37 patients (3.7%). In a total of 1776 lipid plaques, presence of MLA <3.5 mm2 [hazard ratio (HR) 2.1, 95% confidence interval (CI) 1.1-4.0], FCT <75 µm (HR 4.7, 95% CI 2.4-9.0), lipid arc circumferential extension >180° (HR 2.4, 95% CI 1.2-4.8), and OCT-defined macrophages (HR 2.7, 95% CI 1.2-6.1) were all associated with increased risk of the primary endpoint. The pre-specified combination of plaque features (simultaneous presence of the four OCT criteria in the same plaque) was observed in 18.9% of patients experiencing the primary endpoint and was an independent predictor of events (HR 7.54, 95% CI 3.1-18.6). CONCLUSION: The simultaneous presence of four high-risk OCT plaque features was found to be associated with a higher risk of major coronary events.

Carotid Artery Stenting With Proximal Embolic Protection via a Transradial or Transbrachial Approach: Pushing the Boundaries of the Technique While Maintaining Safety and Efficacy.

PURPOSE: To compare the feasibility and safety of proximal cerebral protection to a distal filter during carotid artery stenting (CAS) via a transbrachial (TB) or transradial (TR) approach. METHODS: Among 856 patients who underwent CAS between January 2007 and July 2015, 214 (25%) patients (mean age 72±8 years; 154 men) had the procedure via a TR (n=154) or TB (n=60) approach with either Mo.MA proximal protection (n=61) or distal filter protection (n=153). The Mo.MA group (mean age 73±7 years; 54 men) had significantly more men and more severe stenosis than the filter group (mean age 71±8 years; 100 men). Stent type and CAS technique were left to operator discretion. Heparin and a dedicated closure device or bivalirudin and manual compression were used in TR and TB accesses, respectively. Technical and procedure success, crossover to femoral artery, 30-day major adverse cardiovascular/cerebrovascular events (MACCE; death, all strokes, and myocardial infarction), vascular complications, and radiation exposure were compared between groups. RESULTS: Crossover to a femoral approach was required in 1/61 (1.6%) Mo.MA patient vs 11/153 (7.1%) filter patients mainly due to technical difficulty in engaging the target vessel. Five Mo.MA patients developed acute intolerance to proximal occlusion; 4 were successfully shifted to filter protection. A TR patient was shifted to filter because the Mo.MA system was too short. CAS was technically successful in the remaining 55 (90%) Mo.MA patients and 142 (93%) filter patients. The MACCE rate was 0% in the Mo.MA patients and 2.8% in the filter group (p=0.18). Radiation exposure was similar between groups. Major vascular complications occurred in 1/61 (1.6%) and in 3/153 (1.96%) patients in the Mo.MA and filter groups (p=0.18), respectively, and were confined to the TB approach in the early part of the learning curve. Chronic radial artery occlusion was detected by Doppler ultrasound in 2/30 (6.6%) Mo.MA patients and in 4/124 (3.2%) filter patients by clinical assessment (p=0.25) at 8.1±7.5-month follow-up. CONCLUSION: CAS with proximal protection via a TR or TB approach is a feasible, safe, and effective technique with a low rate of vascular complications.

Patent Foramen Ovale Occlusion in Elderly Patients: Is It Worth It? A Large, Single-Center Retrospective Analysis.

Background: Patent foramen ovale (PFO) is often diagnosed in patients with cryptogenic stroke, aged > 60-65 years, but few data report the outcomes of PFO closure in elderly patients. Methods: Consecutive patients undergoing PFO closure at a single institution between January 2006 and December 2011 were included. Baseline clinical features and cerebral imaging data were collected, and a RoPE score was calculated for each patient. Procedural data were recorded as well as medical therapy upon discharge. All-cause death, ischemic stroke, TIA and systemic embolism recurrence at long-term follow-up were investigated, as well as new atrial fibrillation onset. Results: Overall, 462 patients were included, of whom 64 (13.8%) were aged ≥ 65 years. Female gender was slightly more prevalent in the younger group while hypertension was more frequent among elderly patients. Previous stroke/TIA was the indication for PFO closure in 95.3% of older patients and 80.4% of younger patients, whereas other indications were more frequent among younger patients. RoPE scores were lower in older patients (median RoPE score of 5 vs. 7), and atrial septal aneurysm was more frequently detected among elderly patients. All procedures were technically successful. Procedural or in-hospital complications equally occurred in 5 (7.8%) older patients (4 AF and 1 device embolization) and 30 (7.5%) young patients (29 AF or other supraventricular arrhythmias and 1 device embolization). The follow-up duration was longer among younger patients. All-cause mortality was higher in older patients (16 deaths vs. 4 at follow-up, log-rank p < 0.001), no recurrent strokes occurred, and 2 TIAs were reported among non-elderly patients. New-onset atrial fibrillation occurred in three elderly and eight young patients. Conclusions: PFO closure is a safe procedure in patients aged ≥ 65 years, associated with favorable long-term follow-up and the prevention of ischemic neurologic recurrences.

[A case of aortic stenosis in a young patient with familiar hypercholesterolemia, bicuspid aortic valve and heavy calcification of the ascending aorta]. / Un caso di stenosi aortica in un giovane paziente con ipercolesterolemia familiare, valvola bicuspide e severa calcificazione dell'aorta ascendente.

We report the case of a 28-year-old Caucasian patient symptomatic for low-threshold angina. Coronary angiography ruled out significant coronary stenosis. He was diagnosed with familial hypercholesterolemia and severe aortic stenosis in a setting of bicuspid valve disease. Preoperative evaluation showed diffuse atheromatous disease and severe calcification of the ascending aorta. The patient was treated by endarterectomy of the ascending aorta, non-coronary sinus enlargement patch and aortic valve replacement. This case report emphasizes the role of aortic valve disease in patients with familial hypercholesterolemia and highlights the complexity of surgical management of this condition.

Comparison between different approaches to evaluate fibrous cap thickness in sequential optical coherence tomography studies.

BACKGROUND: In this in-vivo human study we tested the reproducibility for optical coherence tomography (OCT) assessment of lumen area (LA) and plaque components measurements, such as lipid arc extension and fibrous cap thickness (FCt). METHODS: We tested the variability of LA, lipid arc and FCt assessments in two repeated OCT pullbacks from the same diseased coronary segment matched using fiduciary anatomical landmarks. In particular, for the reliability of minimal FCt measurement we compared four different approaches based on continuous (longitudinal) or segmental (spot) individuation of smaller thickness: 1) comparison of single minimal FCt individuated alongside all plaque extension in the two pullbacks (Longitudinal (L)-spot minimal FCt value); 2) comparison of the mean FCt values of the plaque in the two pullbacks (L-plot mean FCt value); 3) comparison between the single minimal FCt value obtained in the first pullback and the single FCt obtained in the matched CS of second pullback (L-spot CS matched FCt value); 4) comparison of measurements obtained by visual selection of CS with minimal FCt s in the two pullbacks (single-spot minimal FCt value). RESULTS: From the paired analyses of 20 non culprit lesions (accounting for a total of 387 matched CS), we found a suboptimal in-segment correlation for LA (Intra-Class Coefficient [ICC] 0.731), but a good in-segment correlation for lipid arc (ICC 0.963). Regarding FCt measurement, a high reproducibility was obtained applying continuous assessment; in particular, the best correlation was observed with L-spot minimal FCt value and the L-plot mean FCt (ICC 0.893 and 0.952, respectively) with small inter-pullback differences (confidence intervals less than 0.04 mm). CONCLUSIONS: In this methodological study we observed a good reproducibility for quantitative plaque measurements with OCT confirming its reliability for serial assessment. In particular, longitudinal measurement in multiple adjacent frames seems to be the more accurate and reproducible approach for sequential FCt assessment.

Patent foramen ovale closure with the Occlutech Figulla flex II device: A long-term (up to 10-years) follow-up.

BACKGROUND: Percutaneous closure represents the first line of treatment in patients with cryptogenic stroke and documented patent foramen ovale (PFO). Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany). METHODS: Consecutive patients undergoing PFO closure with a Figulla Flex II device at a single, high-volume Institution were included. Baseline clinical and procedural features were collected and patients were followed up for up to 10 years. The device's long-term safety was assessed, as well as mortality, recurrent cerebrovascular events, new-onset atrial fibrillation (AF) and residual shunt. RESULTS: Overall, 442 patients were included. The main indication for PFO closure was cryptogenic stroke/transitory ischemic attack (65.5%), followed by migraine (21.7%), silent lesions at MRI (10.8%), and decompression disease (2.0%). Atrial septal aneurysm was present in 20.8% of cases, Eustachian valve in 9.0%, Chiari network in 19.9%. The most frequently implanted device was the 23/25 mm (49.5% of cases). One procedural failure due to device embolization; in-hospital complications occurred in 15 cases (3.4%; 4 minor access site complications, 11 transient supraventricular tachycardias (SVT)/AF). After a follow-up of 9.2 years, 2 patients suffered recurrent TIA (with no residual R-L shunt detected). A moderate or severe residual shunt was observed in 3 patients after discharge. CONCLUSIONS: Figulla Flex II devices for PFO closure are associated with high procedural success and low incidence of adverse events even at long-term follow-up.

Intravascular Lithotripsy in Calcified Coronary Lesions: A Single-Center Experience in "Real-World" Patients.

Objectives: This study aims to describe the outcome of intravascular lithotripsy (IVL) when used with different indications and to assess the short- and long-term outcomes of IVL-facilitated percutaneous coronary intervention (PCI). Background: Intravascular lithotripsy can improve the results of PCI of calcified coronary lesions with a low rate of periprocedural complications. Methods: A total of 105 consecutive patients with 110 calcified lesions underwent IVL. A total of 87 de novo lesions were treated by IVL with the following indications: 25 before attempting other balloon-based devices (primary IVL), 51 after the failure of non-compliant balloon dilatation (secondary IVL), and 11 after stent implantation because of stent under expansion (bailout IVL). In 23 lesions, IVL was used for the treatment of in-stent restenosis (ISR). Effectiveness (angiographic success) and safety [major adverse cardiovascular events (MACEs) and IVL-related procedural complications] endpoints were assessed. Results: Angiographic success was achieved in 84.6% of lesions. Early MACEs were periprocedural MI only, ranging from 6.7 to 20% depending on MI definition. The flow-limiting dissections rate was 2.7%. A total of five (4.5%) IVL balloons ruptured during treatment with subsequent vessel perforation in 1 case. MACEs at 12 months were 13.3%, with TLR occurring in 8 lesions (12% primary IVL, 0% secondary IVL, 0% bailout IVL, and 21.7% IVL for ISR, p = 0.002). Conclusion: Treatment of calcified coronary lesions with IVL in a "real-world" setting can be performed with high success, low rate of procedural complications, and an acceptable MACEs rate. Target lesion failure may be more frequent when IVL is performed for the treatment of ISR due to calcium-mediated stent under expansion.

Transradial/brachial carotid artery stenting with proximal protection: technical instructions, acute results and long-term outcomes.

BACKGROUND: The aim of this study was to evaluate the feasibility, safety and efficacy of transradial/brachial (TR/TB) carotid artery stenting (CAS) with proximal cerebral protection (PCP) as a first line of treatment of carotid artery stenosis. METHODS: Among 556 patients with significant (>50% if symptomatic or >70% if asymptomatic by Doppler US) unilateral, lipid-rich carotid artery stenosis undergoing TR/TB CAS, 137 (24.5%) deemed at high-risk for periprocedural cerebral embolization were scheduled for PCP with Mo.MA Ultra or Mo.MA mono-balloon. In patients with very complex anatomy the standard technique was modified loading the Mo.MA catheter without mandrel on two-wire system (so called 'No MAndrel 2 wire' technique, No.MA2) to increase support and deliverability. Device, technical and procedural successes both acute and at follow-up were the main outcomes. RESULTS: Mean patients' age was 74±7 years (93% male), 15% were symptomatic and 59.6% owned 'high-surgical-risk' features. Stenosis degree was 85±7% with soft composition in all (by CT-angiography). TR and TB approach were selected in 92 (67%) and 45 (33%) patients, respectively. Target carotid axes were right, left bovine and left non bovine in 55%, 38% and 7% of patients. Procedures were successfully completed in all patients (intention-to-treat basis) with the standard Mo.MA Ultra system in 129 patients and the Mo.MA mono-balloon in 8 patients. No.MA2 technique was succesfully used in 16 patients as 'bailout' and in 27 patients as 'first line'). Device and technical success was 97% (133/137 patients) due to crossover to femoral access in 3 cases, and Mo.MA too short to engage the ECA in 1 patient. The procedural success was 96.7% (131/137, two minor strokes). Procedural time and fluoroscopy time were increased with No.MA2 technique. One major vascular complication occurred, in the TB group, while chronic radial occlusion was detected by Doppler ultrasound in 7/92 patients (7.1%) at 372±163 days of follow-up. The event-free survival was 91% and the stroke rate was 0%. CONCLUSIONS: TR/TB CAS with proximal protection is a feasible, safe and effective strategy and may be considered a first line strategy in all comer patients.

The Role of the Association Between Serum C-Reactive Protein Levels and Coronary Plaque Macrophage Accumulation in Predicting Clinical Events - Results from the CLIMA Registry.

The present investigation aims to study the interaction between systemic and intra-plaque inflammation in predicting cardiac events. We investigated C-reactive protein (CRP) levels as well as plaque inflammation with optical coherence tomography (OCT)-detected macrophages in the CLIMA study. 689 patients had admission CRP serum values reported, and high CRP values were defined as ≥ 2 mg/dl. The main study endpoint was a composite of cardiac death, myocardial infarction, and/or target vessel revascularization at 1-year follow-up. At multivariate Cox regression analysis, a large (hazard ratio [HR] 2.27, 95% confidence interval [CI] 1.2-4.3; p = 0.013) and superficial (HR 2.78, 95%CI 1.5-5.1; p = 0.001) macrophage arc was predicted of the main composite endpoint in patients with high CRP levels. Patients with large/superficial macrophage accumulation and low CRP levels were not at higher risk of adverse events. The presence of high CRP levels and large/superficial macrophage accumulation at OCT analysis identified patients at higher risk of clinical events.

Clinical outcomes of suboptimal stent deployment as assessed by optical coherence tomography: long-term results of the CLI-OPCI registry.

BACKGROUND: Intraprocedural optical coherence tomography (OCT) is a valuable tool for guidance of percutaneous coronary intervention, but long-term follow-up data are lacking. AIMS: The aim of this study was to address the long-term (7.5 years) clinical impact of quantitative OCT metrics of suboptimal stent implantation. METHODS: This retrospective study includes 391 patients with long-term follow-up (mean 2,737 days; interquartile range 1,301-3,143 days) from the multicentre Centro per la Lotta contro l'Infarto - Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) registry. OCT-assessed suboptimal stent deployment required the presence of at least one of the following pre-defined OCT findings: in-stent MLA <4.5 mm2, proximal or distal reference lumen narrowing with lumen area <4.5 mm2, significant proximal or distal edge dissection width ≥200 µm. RESULTS: One hundred and two patients (26.1%) with 138 stented lesions (27.7%) experienced a device-oriented cardiovascular event (DOCE). In-stent MLA <4.5 mm2 (38.1% vs 19.8%, p<0.001), in-stent lumen expansion <70% (29.5% vs 20.3%, p=0.032), proximal reference lumen narrowing <4.5 mm2 (6.5% vs 1.4%, p=0.004), and distal reference lumen narrowing <4.5 mm2 (12.9% vs 3.6%, p=0.001) were significantly more common in the DOCE vs non-DOCE group. OCT-assessed suboptimal stent deployment was an independent predictor of long-term DOCE (HR 2.17, p<0.001), together with bare metal stent implantation (HR 1.73, p=0.003) and prior revascularisation (HR 1.53, p=0.017). CONCLUSIONS: The presence of OCT-assessed suboptimal criteria for stent implantation was related to a worse clinical outcome at very long-term follow-up. This information further supports an OCT-guided strategy of stent deployment.

Relationship betweeen the amount and location of macrophages and clinical outcome: subanalysis of the CLIMA-study.

BACKGROUND: The ability of optical coherence tomography (OCT) to recognize intraplaque macrophage infiltration is now well acknowledged. This post-hoc analysis of the CLIMA study aimed to address the clinical impact of the circumferential extension of OCT-defined macrophages and their location at one year follow-up. METHODS: The multicentre CLIMA study enrolled 1003 patients undergoing OCT evaluation of the untreated proximal left anterior descending (LAD) coronary artery. Measurements of circumferential extension of macrophages and measurements of the distance from intima-lumen contour to macrophages string were performed at the plaque cross-section judged as containing the greatest amount of macrophages. The main study endpoint was a composite of cardiac death, myocardial infarction (MI) and/or target vessel revascularization (TVR). RESULTS: Patients with large macrophage arc (p = 0.001) and superficial macrophage arc (p < 0.001) showed a higher one-year incidence of the main one-year composite endpoint. Consistently hypertension (p = 0.018), family history of CAD (p = 0.046), diabetes mellitus (p = 0.036), lower ejection fraction (p = 0.009) and chronic kidney disease (p = 0.019) were more frequently found in patients experiencing the main composite endpoint. At multivariate Cox regression analysis, fibrous cap thickness < 75 µm (HR 2.51, 95% 1.46-4.32), presence of large (HR 1.97, 95%CI 1.16-3.35, p = 0.012) and superficial (HR 1.72, 95%CI 1.02-2.90; p = 0.040) macrophage arc remained independent predictors of the main composite endpoint. Large macrophage arc was associated with target LAD related MI. CONCLUSION: The present post-hoc analysis of the CLIMA showed that the circumferential extension of macrophages and their location are related to a composite endpoint of cardiac death, MI and/or TVR.

Adoption of a new automated optical coherence tomography software to obtain a lipid plaque spread-out plot.

PURPOSE: Near infrared spectroscopy-Intravascular ultrasound (NIRS-IVUS) provide a fully automated Lipid Core Burden Index (LCBI). Optical coherence tomography (OCT) is potentially capable of measuring lipid longitudinal extension in a dedicated two-dimensional LCBI spread-out plot. The present study has been designed to validate an automated approach to assess OCT images, able of providing a dedicated LCBI spread-out plot. METHODS: We compared results obtained with conventional (manual) OCT, with those obtained with a novel automated OCT algorithm and with NIRS-IVUS in consecutive 40 patients. Our goal was to calculate the lipid core longitudinal extension in a dedicated two-dimensional LCBI spread-out plot. Three groups were identified according to the studied lesions: (1) culprit lesions in ACS patients (n = 16), (2) non-culprit lesions in ACS patients (n = 12) and (3) lesions in stable patients (n = 12). OCT (either manual and automated) and NIRS-IVUS assessment showed for culprit ACS plaques a more complex anatomy. RESULTS: A strong trend for increased LCBI was found in the culprit ACS group, regardless of the adopted imaging modality (either NIRS-IVUS or automated OCT). A fair correlation was obtained for the maximum 4 mm LCBI measured by NIRS-IVUS and automated OCT (r = 0.75). The sensitivity and specificity of automated OCT to detect significant LCBI (> 400) were 90.5 and 84.2 respectively. CONCLUSION: We developed an OCT automated approach that can provide a dedicated lipid plaque spread-out plot to address plaque vulnerability. The automated OCT software can promote and improve OCT clinical applications for the identification of patients at risk of hard events.

Prevalence and quantitative assessment of macrophages in coronary plaques.

Although optical coherence tomography (OCT) proved to be able to identify macrophage clusters, there are no available data on the possibility to obtain reproducible measurements of their circumferential extension and location. The purpose of the present post-hoc analysis of the CLIMA study was to revise the clinical and demographic variables of patients having coronary plaques with macrophages and to investigate the reproducibility of their quantitative assessment. A total of 577 patients out of 1003 undergoing OCT showed macrophage accumulation. Three groups were identified; group 1 (426 patients) without macrophages, group 2 (296) patients with low macrophage content (less than median value [67°] of circumferential arc) and group 3 (281) with high macrophage content arc [> 67°]. Patients with macrophages (groups 2 and 3) showed a higher prevalence of family history for coronary artery disease and hypercholesterolemia and had a significantly larger body mass index. Furthermore, group 3 had more commonly triple vessel disease and higher value of LDL cholesterol levels compared to the two other groups. The inter-observer agreement for macrophage interpretation was good: R values were 0.97 for the circumferential arc extension, 0.95 for the minimum distance and 0.98 for the mean distance. A non-significant correlation between circumferential extension of macrophages and hsCRP values was found (R = 0.013). Quantitative assessment of macrophage accumulations can be obtained with high reproducibility by OCT. The presence and amount of macrophages are poorly correlated with hsCRP and identify patients with more advanced atherosclerosis and higher LDL cholesterol levels.

Clinical outcomes of calcified nodules detected by optical coherence tomography: a sub-analysis of the CLIMA study.

AIMS: The goal of the present post hoc analysis of the CLIMA registry was to establish the relationship between calcified nodules (CNs) with (CND) or without (CNWD) disruption of the superficial intimal fibrous layer and one-year occurrence of target lesion myocardial infarction (MI) and/or cardiac death. METHODS AND RESULTS: CND and CNWD were identified based on the presence or absence of superficial irregularities indicative of disruption of the intimal fibrous layer, with possible overlying local thrombus. In total, 222 CNs were found in the 1,776 non-culprit LAD plaques. CND had larger maximum calcific arc and smaller lumen area. Cardiac death and MI occurred in 20% of patients in the CND group versus 2.7% in the CNWD group and 3.3% in the group without CN (p<0.001). This figure was mainly due to the 13.3% incidence of cardiac death in the CND group versus 2.0% in the CNWD group and versus 2.2% in the group without CN (p<0.001). The presence of CND was confirmed as an independent predictor of events (HR 6.58, 95% CI: 2.7-15.8, p<0.001). CONCLUSIONS: The presence of CND was associated with a high one-year incidence of cardiac death and/or target lesion MI.

Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting.

OBJECTIVES: The aim of this study was to randomly compare the double-layer Roadsaver stent (RS) (Terumo, Tokyo, Japan) with the single-layer Carotid Wallstent (CW) (Boston Scientific, Santa Clara, California) in association with either distal embolic protection with the FilterWire (FW) device (Boston Scientific) or proximal protection with the Mo.Ma Ultra device (Medtronic, Santa Rosa, California) in patients with lipid-rich carotid plaques. BACKGROUND: The role of both stent type and brain protection during carotid artery stenting (CAS) remains unsettled. METHODS: A total of 104 consecutive patients with carotid artery stenosis were randomized to CAS with FW + RS (group 1, n = 27), FW + CW (group 2, n = 25), Mo.Ma + RS (group 3, n = 27), or Mo.Ma + CW (group 4, n = 25). The primary endpoint was the number of microembolic signals (MES) on transcranial Doppler among groups in the following CAS steps: 1 and 2) target vessel access; 3) lesion wiring; 4) pre-dilation; 5) stent crossing; 6) stent deployment; 7) stent dilation; and 8) device retrieval and deflation. RESULTS: No significant differences in baseline characteristics were found among the 4 groups. Compared with the FW device, the Mo.Ma Ultra device significantly reduced mean MES count (p < 0.0001) during lesion crossing, stent crossing, stent deployment, and post-dilation. Compared with the CW, the RS significantly reduced MES count (p = 0.016) in steps 6 to 8, including spontaneous MES (29% of patients). The combination of Mo.Ma + RS performed significantly better than Mo.Ma + CW (p = 0.043). Clinical major adverse cardiac and cerebrovascular events occurred in 3 patients (p = 0.51). After CAS, peak systolic velocity significantly decreased in all patients. In-stent restenosis developed in 1 patient (0.98%) at 6-month follow-up. The RS was an independent predictor of external carotid artery patency over time. CONCLUSIONS: In patients with high-risk, lipid-rich plaque undergoing CAS, Mo.Ma + RS led to the lowest microembolic signals count. (Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection; NCT02915328).

CT Perfusion Versus Coronary CT Angiography in Patients With Suspected In-Stent Restenosis or CAD Progression.

OBJECTIVES: The goal of this study was to assess the diagnostic performance of coronary computed tomography angiography (CTA) alone, adenosine-stress myocardial perfusion assessed by computed tomography (CTP) alone, and coronary CTA + CTP by using a 16-cm Z-axis coverage scanner versus invasive coronary angiography (ICA) and fractional flow reserve (FFR) as the clinical standard. BACKGROUND: Diagnostic performance of coronary CTA for in-stent restenosis detection is still challenging. Recently, CTP showed additional diagnostic power over coronary CTA in patients with suspected coronary artery disease. However, few data are available on CTP performance in patients with previous stent implantation. METHODS: Consecutive stable patients with previous coronary stenting referred for ICA were enrolled. All patients underwent stress myocardial CTP and rest CTP + coronary CTA. Invasive FFR was performed during ICA when clinically indicated. The diagnostic rate and diagnostic accuracy of coronary CTA, CTP, and coronary CTA + CTP were evaluated in stent-, territory-, and patient-based analyses. RESULTS: In the 150 enrolled patients (132 men; mean age 65.1 ± 9.1 years), the CTP diagnostic rate was significantly higher than that of coronary CTA in all analyses (territory based [96.7% vs. 91.1%; p < 0.0001] and patient based [96% vs. 68%; p < 0.0001]). When ICA was used as gold standard, CTP diagnostic accuracy was significantly higher than that of coronary CTA in all analyses (territory based [92.1% vs. 85.5%, p < 0.03] and patient based [86.7% vs. 76.7%, p < 0.03]). The concordant coronary CTA + CTP assessment exhibited the highest diagnostic accuracy values versus ICA (95.8% in the territory-based analysis). The diagnostic accuracy of CTP was significantly higher than that of coronary CTA (75% vs. 30.5%; p < 0.001). The radiation exposure of coronary CTA + CTP was 4.15 ± 1.5 mSv. CONCLUSIONS: In patients with coronary stents, CTP significantly improved the diagnostic rate and accuracy of coronary CTA alone compared with both ICA and invasive FFR as gold standard.

Comparison of the Effectiveness of Percutaneous Intervention of the Left-Main Coronary Artery With Everolimus-Eluting Stents in Women -Vs- Men.

Everolimus-eluting stents are largely used for left main (LM) percutaneous coronary interventions (PCI). Long-term follow-up of patients who underwent LM PCI in a real world clinical setting, in particular women, have been scarcely reported. Consecutive patients who underwent unprotected LM PCI with EES at a single Institution from December 2006 to April 2016 were included. Main outcome assessed was the occurrence of major adverse cardiovascular events (MACE) as a composite of death, myocardial infarction or target lesion revascularization at follow-up. Overall, 589 patients (20.8% women) were included in the present analysis. Women were older, had lower body mass index and more frequently hypertensive compared with men. Main clinical presentation was stable coronary artery disease (CAD); unstable angina was more frequently observed in women compared with men, whereas ST-elevation myocardial infarction was less frequent. After 69.7 ± 28.3 months of follow-up, 47 patients overall experienced MACE (1.43 per 100*patients/year). MACE rate was higher in women compared with male patients, with a rate of 2.49 and 1.17 per 100*patients/year, respectively (p = 0.015). The difference was driven mainly by higher mortality in women (0.89 vs 0.15 per 100*patients/years, p = 0.002). At multivariable Cox regression, female gender was independently associated with an increased risk of MACE at follow-up (hazard ratio 2.21, 95% confidence interval 1.20 to 4.08, p = 0.011). In conclusion, EES can be safely and effectively adopted for LM PCI.

A Long-Term Single-Center Registry of 6893 Patients Undergoing Elective Percutaneous Coronary Intervention With the Xience Everolimus-Eluting Stent.

BACKGROUND: The safety and effectiveness of the everolimus-eluting stent (EES) have been previously demonstrated. AIMS: To assess very long-term performance and outcomes of the EES in a real-world population. METHODS: This single-center registry prospectively enrolled 6893 patients (mean age, 66 ± 9.7 years; 81.4% men) undergoing elective coronary intervention with the EES over a decade. Clinical follow-up (FU) was performed at 1 year and then yearly thereafter. RESULTS: Multiple risk factors were present in 34%. Stable angina was the main stenting indication (78.1%), followed by unstable angina (5.3%) and positive stress test (16.6%) for 1-vessel (44%) or 2/3-vessel disease (56%). Multiple stents (stent/patient ratio: 2.1 ± 0.8) in >1 vessel were implanted in 36.9% (mean stent length, 43 ± 31.3 mm). At 1 year, 80% of patients were on dual-antiplatelet therapy, while only 3% were on therapy at 2 years. A low 1-year major adverse cardiac event (MACE) rate of 5.0% was observed; stent thrombosis (ST) occurred in 19 patients (0.3%), with a prevalence of early (n = 9) over late (n = 4) and very late events (n = 6; 0.08%). Clinically driven target- lesion revascularization/target-vessel revascularization (TLR/TVR) occurred in 3.3% at 1-year follow-up. Long-term FU (3 years) completed in 6210 patients (90.0%) showed a MACE rate of 5.9%, while very long-term FU (>5 years and up to 10 years), available in 3550 out of 4635 exposed patients (76.6%), showed a MACE rate of 8.6%. Independent MACE predictors were stented segment length (odds ratio [OR], 2.1; 95% confidence interval [CI] 1.57-2.82), small vessel stenting (OR, 1.34; 95% CI, 1.08-1.68), and multivessel disease (2-vessel disease: OR, 1.59; 95% CI, 1.21-2.08; 3-vessel disease: OR, 2.26; 95% CI, 1.72-2.97). CONCLUSIONS: This large, prospective registry confirms the very long-term safety and efficacy of the EES in unselected real-world and complex coronary lesions.

Biological profile of monocyte-derived macrophages in coronary heart disease patients: implications for plaque morphology.

The prevalence of a macrophage phenotype in atherosclerotic plaque may drive its progression and/or instability. Macrophages from coronary plaques are not available, and monocyte-derived macrophages (MDMs) are usually considered as a surrogate. We compared the MDM profile obtained from coronary artery disease (CAD) patients and healthy subjects, and we evaluated the association between CAD MDM profile and in vivo coronary plaque characteristics assessed by optical coherence tomography (OCT). At morphological analysis, MDMs of CAD patients had a higher prevalence of round than spindle cells, whereas in healthy subjects the prevalence of the two morphotypes was similar. Compared to healthy subjects, MDMs of CAD patients had reduced efferocytosis, lower transglutaminase-2, CD206 and CD163 receptor levels, and higher tissue factor (TF) levels. At OCT, patients with a higher prevalence of round MDMs showed more frequently a lipid-rich plaque, a thin-cap fibroatheroma, a greater intra-plaque macrophage accumulation, and a ruptured plaque. The MDM efferocytosis correlated with minimal lumen area, and TF levels in MDMs correlated with the presence of ruptured plaque. MDMs obtained from CAD patients are characterized by a morpho-phenotypic heterogeneity with a prevalence of round cells, showing pro-inflammatory and pro-thrombotic properties. The MDM profile allows identifying CAD patients at high risk.