The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry.

BACKGROUND: Bioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry. METHODS AND RESULTS: In the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013 at the Amsterdam University Medical Centre-Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median follow-up of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term follow-up, the composite endpoint of TVF had occurred in 27 patients. The 4­year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days after device implantation in a patient who was not on dual anti-platelet therapy. CONCLUSION: In a patient population reflecting routine clinical practice, we found that cases of TVF continued to accrue beyond 2 years after Absorb BVS implantation.

Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: A weighted meta-analysis of seven randomised controlled trials including 5577 patients.

AIMS: Mid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent. METHODS AND RESULTS: Randomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1-3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11-1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88-4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99-8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11-1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20-2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91-1.46, p = 0.25] and cardiac death [OR 0.91; 95% CI 0.57-1.46, p = 0.71] were not significantly different between BVS and Xience. CONCLUSION: This meta-analysis shows a higher rate of target lesion failure and an almost threefold higher rate of device thrombosis in BVS compared with Xience, which extends beyond the first year. Device thrombosis did not lead to an overall increased (cardiac) mortality.

How to define bifurcation lesion complexity and how to successfully perform percutaneous treatment.

Historically, percutaneous coronary interventions (PCI) of bifurcation lesions have been associated with a lower procedural success rate, a higher complication rate, and less favorable clinical outcomes, compared to PCI of non-bifurcation lesions. However, percutaneous treatment of coronary bifurcation lesions have been improved over the past decade due to improvements in stent design and the introduction of specific bifurcation stent techniques. Some even argue that PCI of bifurcation lesions should no longer be considered as being complex. However, recent studies have shown that there are still certain bifurcation lesion subtypes which are at higher risk for adverse cardiac events after PCI. Future efforts, including the development of a dedicated bifurcation device, should be focused on this specific high-risk subgroup, including distal left main bifurcations.

[Cellular laser microscopy of corneal ulcer and infiltrate]. / Zelluläre Lasermikroskopie zur Detektion von Infiltraten und Ulzera der Hornhaut.

BACKGROUND: Corneal ulcers can be observed occasionally due to infections, wearing contact lenses or in dry eyes. Confocal microscopy represents a new tool for the differential diagnostic work-up of pathological processes and provides the possibility for dynamic healing control. METHODS: We report on the corneal morphological changes caused by corneal ulcers of varying aetiologies. Morphological changes and pathological processes in infiltrates as well as in ulcus corneae can be investigated by means of the confocal in vivo microscopy based on the confocal laser scanning microscope model Heidelberg Retina Tomograph II with the Rostock cornea module. RESULTS: Corneal infiltrates are characterised by inflammatory cell infiltration without other morphological changes. An advanced process like corneal ulcer is characterised by not only the tissue defects but also by oedematous structures of the entire cornea resulting in an increase in corneal thickness, increased cell density of leukocytes and of Langerhans cells. The scar tissue formation as well as epithelium regeneration are documented during the follow-up. Confocal detection of pathogens (acanthamoeba, fungus, etc.) was performed. CONCLUSION: The confocal microscopic data about micromorphological changes could be useful in the evaluation of defect geometry and healing processes of the cornea. Differential diagnostic distinction between bacterial, fungal or acanthamoeba genesis is possible.

[Three-dimensional confocal laser scanning microscopy of the corneal nerve structure]. / 3D-konfokale Laser-Scanning-Mikroskopie der kornealen epithelialen Nervenstruktur.

PURPOSE: The aim of this study was the evaluation of a technology for in vivo visualization of distribution and morphology of corneal nerves by means of 3D confocal laser scanning microscopy (3D-CLSM). METHOD: The anterior corneas of four human volunteers were examined by an in-house developed confocal laser scanning microscope based on a commercially available instrument (Heidelberg Retina Tomograph II, Heidelberg Engineering GmbH, Germany). Raw stacks were converted using ImageJ (NIH, USA) for 3D-reconstruction using AMIRA 3.1 (TGS Inc, USA). RESULTS: The spatial arrangement of epithelium, nerves and keratocytes was visualized by in vivo 3D-CLSM. After 3D-reconstruction of volunteers' corneas, volume rendering and selective oblique sections have been done to demonstrate the nerves in the central human cornea. 3D-imaging shows thick nerve bundles rising out of the deeper stroma. The nerves further divide, resulting in fibers that are arranged parallel to Bowman's layer and are partly interconnected. Branches rising up to the superficial cell layer cannot be visualized. Wound healing following refractive surgery can be evaluated. CONCLUSIONS: 3D-CLSM allows in vivo visualization and analysis of the spatial arrangement of the epithelium, nerves and keratocytes of the human cornea. The developed method provides a basis for further studies on the alterations of the cellular arrangement and epithelial innervation in corneal diseases. This may help to clarify gross variations of nerve fiber patterns under various clinical and experimental conditions.

Contribution to comprehension of image formation in confocal microscopy of cornea with Rostock cornea module.

AIM: To investigate the influence of refractive index of aqueous humour on imaging of corneal endothelium in confocal microscopy. To clarify the phenomenon of dark endothelial and bright epithelial cell membranes in confocal images of corneas. METHODS: Use of a novel digital confocal laser scanning microscope, a combination of the Heidelberg retina tomograph (HRT II) and the Rostock cornea module. Exchange of aqueous humour solution from domestic pigs against glycerol/water solutions (refractive indices eta = 1.337-1.47). Transelectron microscopy of endothelial and epithelial cell morphology. RESULTS: Under the terms of variable refractive indices no differences were observed for general imaging of endothelium. Bright cells were bordered by dark cell membranes in all experiments. Electron microscopy of endothelium and epithelium revealed differences in intracellular and cell membrane structure of both cell types. CONCLUSION: Source of specific confocal optical behaviour of endothelium does not come from interface conditions to aqueous humour, but may result from intracellular variations and ultrastructure of cell membranes.