Endothelialization of Amplatzer PFO Occluder Device 12 Months After Implantation: First-in-Human Angioscopic Assessment.

The current guidelines recommend at least 6 months of antithrombotic and antibiotic prophylaxis following atrial septal occluding device placement using the phrase "until endothelialization." However, neo-endothelialization has not been assessed in vivo in humans. Considering the atrial septal defect occluding device, several autopsy cases and device extraction cases only demonstrated insufficient endothelialization beyond 6 months after implantation caused endocarditis and thrombosis. Accordingly, we have successfully developed a method for determining device endothelialization using angioscopy. This method helped us evaluate the endothelialization of a 25 mm Amplatzer PFO occluder device (Abbott) in a 40-year-old man 12 months after implantation. This is the first report evaluating the PFO occluder device in vivo.

Consensus document on the standard of coronary angioscopy examination and assessment from the Japanese Association of Cardiovascular Intervention and Therapeutics.

Coronary angioscopy (CAS) is a unique diagnostic device that allows direct visualization of the vascular luminal surface in living patients. CAS contributes to elucidate the pathology of coronary artery disease. This consensus document provides a standard for CAS examination and assessment.

Optical coherence tomography and coronary angioscopy assessment of healed coronary plaque components.

PURPOSE: Histopathological or intracoronary image assessment of healed plaques (HPs) has been reported. However, the lesion characteristics of HPs remains undetermined yet. We assessed the healed plaque components in patients with coronary artery lesions using multiple imaging modalities. METHODS: We enrolled 33 stable angina pectoris (SAP) patients with 36 native coronary culprit lesions with angiography severe stenosis and without severe calcification undergoing pre-intervention optical coherence tomography (OCT) and coronary angioscopy (CAS). HPs were defined as layered phenotype on OCT. Lesion morphologies and plaque characteristics of HPs were assessed using OCT and CAS. RESULTS: HPs were observed in 19 lesions (52.8%). HP lesions had higher frequent B2/C lesions (89.4% vs. 52.9%, p = 0.02), worse pre-PCI coronary flow (corrected thrombolysis in myocardial infarction count 21.6 ± 13.5 vs. 13.8 ± 6.2, p = 0.047) and greater lumen-area stenosis (79.6 ± 10.6% vs. 68.0 ± 21.6%, p = 0.047) than non-HP lesions. HP lesions had higher prevalence of OCT-thin-cap fibroatheroma (TCFA) (31.6% vs. 0.0%, p = 0.02), OCT-macrophage (89.5% vs. 41.2%, p = 0.004), and CAS-red thrombus (89.5% vs. 41.2%, p = 0.004) than non-HP lesions. The combination of 3 features including OCT-TCFA, macrophages, and CAS-red thrombus showed higher predictive valuer for HPs on OCT than each single variable. Post-PCI irregular tissue protrusion was more frequently observed in lesions with HPs than in those without (52.6% vs. 13.3%, p = 0.03). CONCLUSIONS: SAP lesions with HPs might have more frequent vulnerable plaques with intraplaque inflammation and thrombus than those without, suggesting that layered phenotype on OCT might reflect not only healing process but also potential risks for future coronary events.

Endothelialization of a Venous Stent at 1 Month Post Implantation: First-in-Human Angioscopic Assessment.

This is the first report to evaluate endothelialization in vivo; the evidence of endothelialization on the venous stent in the early phase suggests that antithrombotic therapy could be stopped in some patients with high risk of bleeding in the chronic phase.

Different vascular healing process between bioabsorbable polymer-coated everolimus-eluting stents versus bioresorbable vascular scaffolds via optical coherence tomography and coronary angioscopy (the ENHANCE study: ENdothelial Healing Assessment with Novel Coronary tEchnology).

Recent clinical trials have raised concerns about the safety and efficacy of ABSORB™ bioresorbable vascular scaffolds (BVS). The difference in the vascular healing process between SYNERGY™ bioabsorbable polymer-coated everolimus-eluting stents (BP-EES) and BVS remains unclear. The aim of the ENHANCE study was to compare vascular healing on BP-EES versus BVS by optical coherence tomography (OCT) and coronary angioscopy (CAS) at 4- and 12-month follow-ups. This is a prospective, non-randomized, single center clinical trial. Thirteen eligible patients with multivessel disease were enrolled. BP-EES and BVS were simultaneously implanted in the same patients, but in different coronary vessels. Imaging follow-up with both OCT and CAS was completed in 11 patients at 12 months. Neointimal coverage rates were similar between the two groups based on OCT measurements. The neointimal thickness of BP-EES was significantly thicker at the 12th month than at the 4th month, whereas the neointimal thickness of BVS did not change between the measurements taken at the 4th and 12th month. Existence of intra-stent thrombus was significantly higher in the BVS group, compared to the BP-EES group. On the other hand, CAS revealed that red-thrombi and yellow-plaque were more frequently observed in BVS at 4 months and up to 12-month follow-ups than in BP-EES. These findings suggested that the evidence of instability remained up to 12 months in the vascular healing with BVS, compared to that with BP-EES. Vascular healing of the stented wall was recognized at the very early phase after BP-EES implantation. However, vascular healing with BVS was still incomplete after 12 months.

Endothelialization of an Amplatzer Septal Occluder Device 6 Months Post Implantation: Is This Enough Time? An In Vivo Angioscopic Assessment.

The current guidelines recommend a minimum of 6 months of antithrombotic and antibiotic prophylaxis following septal occluding device placement for transcatheter closure of atrial septal defect. Full neoendothelialization is thought to be completed within 6 months of device implantation; however, there is no method available that can assess the level of neoendothelialization in vivo. This report therefore evaluates endothelialization in vivo and demonstrates that 6 months of postimplantation prophylactic therapy may not provide sufficient time for adequate endothelialization. Further investigations are warranted to determine the optimal duration of these treatments after atrial septal defect closure.

Intravascular Ultrasound and Angioscopy Assessment of Coronary Plaque Components in Chronic Totally Occluded Lesions.

BACKGROUND: The in vivo lesion morphologies and plaque components of coronary chronic total occlusion (CTO) lesions remain unclear.Methods and Results:We investigated 57 consecutive CTO lesions in 57 patients with stable angina pectoris undergoing elective percutaneous coronary intervention with intravascular ultrasound (IVUS) and coronary angioscopy (CAS) examination. All CTO lesions were classified according to the proximal angiographic lumen pattern; tapered-type (T-CTO) and abrupt-type (A-CTO). The differences in the intracoronary images of these lesion types were evaluated according to the location within the CTO segment. A total of 35 lesions (61.4%) were T-CTO. T-CTO lesions had higher frequencies of red thrombi (proximal 71.4%; middle 74.3%; distal 31.4%; P<0.001) and bright-yellow plaques (yellow-grade 2-3) (48.6%; 74.3%; 2.9%; P<0.001) at the proximal or middle than at the distal subsegment; A-CTO lesions showed no significant differences among the 3 sub-segments. At the middle subsegment, T-CTO lesions showed higher frequencies of positive remodeling (51.4% vs. 18.2%, P=0.01) and bright-yellow plaques (74.3% vs. 13.6%, P<0.001) compared with A-CTO lesions. Multivariate analysis identified bright-yellow plaque as an independent predictor (odds ratio, 7.25; 95% confidence interval, 1.25-42.04; P=0.03) of the occurrence of periprocedural myocardial necrosis. CONCLUSIONS: The combination of IVUS and CAS analysis may be useful for identifying lesion morphology and plaque components, which may help clarify the pathogenetic mechanism of CTO lesions.

Passively Driven Probe Based on Miniaturized Propeller for Intravascular Optical Coherence Tomography.

Optical coherent tomography (OCT) has enabled clinical applications ranging from ophthalmology to cardiology that revolutionized in vivo medical diagnostics in the last few decades, and a variety of endoscopic probes have been developed in order to meet the needs of various endoscopic OCT imaging. We propose a passive driven intravascular optical coherent tomography (IV-OCT) probe in this paper. Instead of using any electrically driven scanning device, the probe makes use of the kinetic energy of the fluid that flushes away the blood during the intravascular optical coherence tomography imaging. The probe converts it into the rotational kinetic energy of the propeller, and the rotation of the rectangular prism mounted on the propeller shaft enables the scanning of the beam. The probe is low cost, and enables unobstructed stable circumferential scanning over 360 deg. The experimental results show that the probe scanning speed can exceed 100 rotations per second (rps). Spectral-domain OCT imaging of a phantom and porcine cardiac artery are demonstrated with axial resolution of 13.6 µm, lateral resolution of 22 µm, and sensitivity of 101.7 dB. We present technically the passively driven IV-OCT probe in full detail and discuss how to optimize the probe in further.

Vena Cavoscopy in the Assessment of Intraluminal Vena Caval Tumor Involvement.

OBJECTIVE: To improve confirmation of complete tumor thrombus removal in advanced malignancy, we report on our experience using intraoperative vena cavoscopy using a flexible cystoscope to confirm complete thrombus resection. Patients with renal cell carcinoma or testicular cancer associated with inferior vena caval tumor involvement benefit from surgical resection of the primary tumor and the tumor thrombus. Intraoperative assessment of the vena cava represents a technical challenge, particularly when the thrombus is friable and involves the hepatic veins, or there is caudal extension of thrombus toward the bifurcation. MATERIAL AND METHODS: From 2006 to 2014, 36 patients underwent tumor thrombectomy and vena cavoscopy. When residual caval thrombus was suspected, a flexible cystoscope was inserted into the vena cava for direct visual inspection of the caval lumen. Perioperative outcomes including residual tumor, changes in management, and postoperative complications were analyzed. RESULTS: All patients underwent endoscopy of the caval lumen without complications. Eight of 36 (22%) patients were found to have residual tumor thrombus visualized during cavoscopy. Five of these patients had evidence of residual mass and caval invasion within the caval lumen that ultimately resulted in cavectomy. Two patients had residual tumor thrombus that was bluntly removed. One patient was found to have significant involvement of the hepatic veins. CONCLUSION: Vena cavoscopy using a flexible cystoscope is a practical technique that may be utilized intraoperatively to ensure clearance of residual thrombus burden within the inferior vena cava and to assess for caval invasion.

Potential mechanisms of in-stent occlusion in the femoropopliteal artery: an angioscopic assessment.

Although stent implantation has become widespread for the treatment of patients with peripheral artery disease with femoropopliteal (FP) lesions, in-stent restenosis, especially in-stent occlusion (ISO), remains as a major concern for refractory recurrence. Furthermore, the mechanisms of ISO in FP lesions have not been well elucidated. We performed angioscopy for 6 lesions (bare-metal stent: 3, drug-eluting stent: 3) from 5 patients (mean age 74 ± 10 years, male 40 %) with ISO in the FP artery immediately after wire-passing or thrombus aspiration. The presence of thrombus as well as the presence and location of organic stenosis were evaluated. Median duration from stent implantation to angioscopic evaluation was 1099.5 (514.5-2272.5) days, while the duration from recurrence of symptoms to angioscopic evaluation was 45 (5.75-60) days. Mixed thrombi were observed in all stents. Organic stenosis was detected at the proximal edge of the stents in 5 lesions. Organic stenosis was observed at the overlapping segment of the stent in one lesion. The distal edge of the stents could be evaluated in 3 lesions, and all of them showed organic stenosis at the site. Mixed thrombi and organic stenosis were observed in all stents. Partial development of organic stenosis in a stent followed by thrombus formation may be the potential mechanism of the development of ISO in the FP artery though the sample size of this study was small and it had no serial angioscopic data so that we should consider it as preliminary one at best.

Angioscopic assessment of early phase arterial repair after paclitaxel-coated nitinol drug-eluting stent implantation in the superficial femoral artery.

BACKGROUND: Although durable clinical outcomes have been reported, arterial repair after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation in the superficial femoral artery (SFA) remains unclear. METHODS AND RESULTS: Angioscopic evaluation was performed in SFA intra-stent surfaces 80±29 (range, 49-135) days or 84±18 (range, 52-112) days following Zilver PTX (20 stents in 10 patients; mean age, 72±8 years; 40% men) or bare metal stent (BMS; 14 stents in 9 patients; mean age, 70±7 years; 67% men) implantation, respectively. Neointimal coverage (NIC) was graded as 0, stent struts exposed; grade 1, struts bulging into the lumen, but still transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of yellow plaque and thrombus were investigated. Dominant NIC was significantly different between Zilver PTX (grade 0, 35%; grade 1, 20%; grade 2, 25%; grade 3, 20%) and BMS (grade 0, 7%; grade 1, 0%; grade 2, 14%; grade 3, 79%; P=0.001). NIC heterogeneity was less frequently observed in Zilver PTX (40% vs. 86%, P=0.009). Prevalence of yellow plaque or thrombus (75% vs. 79%, P=0.57) or thrombus (75% vs. 79%, P=0.57) were similar between Zilver PTX and BMS. CONCLUSIONS: Early phase arterial repair was different between Zilver PTX and BMS.

Intravascular imaging tools in the cardiac catheterization laboratory: comprehensive assessment of anatomy and physiology.

Intravascular imaging modalities have an imperative role in contemporary cardiovascular research. Currently, there are several invasive imaging modalities available in the cardiac catheterization laboratory and new technologies are under development. In the current review, we aimed to provide an update on the research applications of contemporary intravascular imaging tools in the cardiac catheterization laboratory. For the purpose of this review, we separately discuss imaging tools for assessment of epicardial disease (fractional flow reserve and hyperemic stenosis resistance), microvascular function (coronary flow reserve, hyperemic microvascular resistance, and index of microcirculatory resistance), endothelial function, atherosclerotic plaque and vascular remodeling (intravascular ultrasound, optical coherence tomography, angioscopy, and near-infrared spectroscopy), and finally the emerging modalities (palpography and wall shear stress profiling).

Angioscopic assessment of arterial repair following biodegradable polymer-coated biolimus A9-eluting stent implantation. - Comparison with durable polymer-coated sirolimus-eluting stent-.

BACKGROUND: Second-generation drug-eluting stents (DES) are expected to show better arterial repair than older DES. We angioscopically compared the biodegradable polymer-coated biolimus A9-eluting stent (BES) and durable polymer-coated sirolimus-eluting stent (SES) to explore differences in arterial repair. METHODS AND RESULTS: Angioscopy was performed 9 ± 1 months after 15 BES and 16 SES were implanted initially in the native coronary artery. Heterogeneity of neointimal coverage (NIC) as well as the dominant NIC grade was examined. NIC was defined as: grade 0 = fully visible struts; grade 1 = struts bulging into the lumen, but covered; grade 2 = embedded, but translucent struts; grade 3 = invisible struts. Heterogeneity was judged when the NIC grade varied ≥ 1. In-stent late loss (0.06 ± 0.23 vs. 0.07 ± 0.18 mm, P = 0.80), and dominant NIC grade (1.5 ± 0.8 vs. 1.3 ± 0.7, P = 0.45) were similar for BES and SES. Within the stents, NIC was more heterogeneous in SES than in BES (P = 0.035). 80% of BES showed homogeneous NIC, while 56% of SES had heterogeneous NIC. CONCLUSIONS: BES showed limited late loss similar to that for SES. Nonetheless, the NIC with BES was more homogeneous than that with SES. Biodegradable polymer-coated BES may have an advantage in homogeneous NIC.

Virtual angioscopy assessment for acute type B aortic dissection endovascular repair.

INTRODUCTION: Virtual angioscopy 3D reconstruction (VA) based on Multidetector computed tomography (m-CT) can be an important tool in endovascular aortic repair assessment. Here, we present a case of an acute type B aortic dissection, evaluated with preoperative virtual angioscopy 3D reconstruction (VA). CASE REPORT: A 60 years-old-man presented with type B acute aortic dissection. Due to renal malperfusion and uncontrolled hypertension TEVAR and renal stenting was performed based on m-CT and VA images. DISCUSSION: Aortic dissection endovascular repair requires an accurate evaluation based on M-CT or magnetic resonance angiography (MRA). VA is a CT-based 3D reconstruction that provides a sort of information comparable to intravascular ultrasound (IVUS) that can be very helpful when it is not available and has many other potential applications in vascular surgery.