The novel Occlutech Figulla PFO N single layer device appears to be safe, feasible and useful for PFO closure despite a 50% reduction of the meshwire, no distal hub and an improved flexibility of the left atrial disc.
Peripheral arterial disease (PAD) is one of the most common manifestations of systemic atherosclerosis. The prevalence of unrecognized PAD is high, leading to a lack of opportunity to detect subjects at a high risk for cardiovascular events. Inflammatory processes play an important role in the disease initiation as well as in the disease progression. Vascular cell adhesion molecule 1 (VCAM-1), a biomarker of endothelial dysfunction, appears to be an important mediator in inflammatory processes. Therefore, we hypothesized that in patients with PAD, circulating VCAM-1 might be elevated due to its function in mediating adhesion of immune cells to the vascular endothelium in the process of endothelial dysfunction and inflammation, and, therefore, applicable as a diagnostic biomarker. A total of 126 non-consecutive patients were enrolled in this study, of whom 51 patients had typical clinical manifestations of PAD and as controls 75 patients with no history of PAD or cardiovascular disease. All serum samples were obtained either during hospitalization or during out-patient visits and analyzed for VCAM-1 by the ELISA. Compared with controls, median levels of VCAM-1 were significantly elevated in patients suffering from PAD (953 vs. 1352 pg/ml;
p
< 0.001). Furthermore, VCAM-1 appeared to be highly discriminative for the detection of PAD (AUC = 0.76; CI 0.67–0.83). We could not observe dynamics related to increasing disease stages according to Rutherford classes in patients with apparent PAD. VCAM-1 was shown to be a potential discriminator and biomarker for the severity of systemic atherosclerosis. In a logistic regression analysis, VCAM-1 was robustly associated with the diagnosis of PAD, even after correction for clinically relevant cofounders (namely age, arterial hypertension, diabetes and LDL levels). Thusly, VCAM-1 might serve as a biomarker for PAD screening and detection.
Objectives. The transvascular closure of patent
foramen ovale (PFO) with self-expanding devices carries the risk
of left atrial thrombus formation related to material protruding
into the left atrium. Thus, we developed a novel device with flat
left atrial disc geometry. We evaluated feasibility, handling, and
biocompatibility in a porcine animal model.
Methods. Implantation of an Occlutech Figulla PFO
device was performed in 10 mini pigs using fluoroscopy and
intra-cardiac ultrasound after transseptal puncture of the
interatrial septum. Angiographic follow-up was performed after six
and twelve weeks. Results. Implantation was
successful in 100%. There were no further implant related
complications. One procedure related death occurred, as one animal
died of ventricular tachycardia due to mispunture of the
interatrial septum. Angiographic studies showed no residual shunt
during follow-up. Histopathological evaluation could demonstrate
partial neoendothelialization after 6 weeks with completion after
12 weeks. The devices were incorporated into connective tissue
containing fibro muscular cells. An only mild inflammatory
reaction was detected locally related to the polyester fibers.
Conclusion. In terms of feasibility and handling,
the new device does not seem to be inferior to other presently
used implantation systems. Good biocompatibility was demonstrated
with rapid and complete neoendothelialization.
Circulatory support with IABP increases microcirculatory flow in the smallest vessels of the sublingual mucosa. Our data support the hypothesis that intra-aortic balloon counter-pulsation increases coronary and microvascular perfusion, thus, improving microcirculation even in hemodynamically stable patients. The use of IABP may increase safety of complex PCI and decrease the risk of deleterious complications.
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