Real-world five-year outcomes of FlexyRap® cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease.

BACKGROUND: The use of biodegradable polymer drug-eluting stents (BP-DES) has been proven to minimize restenosis and stent thrombosis. The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap® DES in the real world. AIM: To assess the safety and effectiveness of FlexyRap® DES at the 5-year follow-up in real-world settings. METHODS: Findings from a retrospective, multi-center, observational, post-market clinical follow-up study of patients treated with FlexyRap® DES for de novo coronary artery disease (CAD) were reported. During the 12-mo follow-up, the primary endpoint was target lesion failure, which was defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization. RESULTS: The data of 500 patients received with FlexyRap® DES was obtained at the completion of the surveillance timeline of 5-year. After the implantation of FlexyRap® DES, the device success rate was 100%. Adverse events that led to major bleeding, permanent disability, or death were not experienced in the patients. The major adverse cardiac event rate at 12-mo, 3-year, and 5-year follow-up was 1 (0.2%), 0 (0%), and 1 (0.2%) respectively with 0 (0%) cardiovascular death, 2 (0.4%) TV-MI, and 0 (0%) TLR compositely. Furthermore, late stent thrombosis was found in 2 (0.4%) patients at the follow-up of 12-mo, very late stent thrombosis was observed in 2 patients (0.4%) at 3-year follow-up. CONCLUSION: FlexyRap® DES was proved to be safe and efficacious in real-world patients with de novo CAD, indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.

Reconstructing the Intrinsic Statistical Properties of Intermittent Locomotion Through Corrections for Boundary Effects.

Locomotion characteristics are often recorded within bounded spaces, a constraint which introduces geometry-specific biases and potentially complicates the inference of behavioural features from empirical observations. We describe how statistical properties of an uncorrelated random walk, namely the steady-state stopping location probability density and the empirical step probability density, are affected by enclosure in a bounded space. The random walk here is considered as a null model for an organism moving intermittently in such a space, that is, the points represent stopping locations and the step is the displacement between them. Closed-form expressions are derived for motion in one dimension and simple two-dimensional geometries, in addition to an implicit expression for arbitrary (convex) geometries. For the particular choice of no-go boundary conditions, we demonstrate that the empirical step distribution is related to the intrinsic step distribution, i.e. the one we would observe in unbounded space, via a multiplicative transformation dependent solely on the boundary geometry. This conclusion allows in practice for the compensation of boundary effects and the reconstruction of the intrinsic step distribution from empirical observations.

First in man study of a new semi-open cell design Zephyr cobalt-chromium stent in large vessels and conduits.

OBJECTIVES: We present a first-in-man clinical use of a new hybrid design stent in stenosed large vessels. Its unique C and S polylinks prevent foreshortening without compromising its strength. Its thin profile permits use of smaller introducer sheaths. BACKGROUND: Stent angioplasty is widely employed in large vessel and conduit stenosis. These procedures are associated with difficulties due to large stent profiles, stent fractures, foreshortening and recoil. Cobalt chromium stents have high tensile strengths compared to stainless steel stents. METHODS: A retrospective analysis of feasibility and safety of a new Cobalt chromium stent in large vessels namely aorta, pulmonary arteries and outflow conduits was done from two institutions. Demographic patient details, procedural results, complications and medium term follow-up were analyzed. Stent recoil, foreshortening, fractures were assessed. RESULTS: Twenty patients including three with aortic coarctations, seven with stenosed conduits and 10 with pulmonary artery stenosis underwent stent angioplasty using 23 stents. Three stents were deployed to expand further a previously implanted stent. Procedure was successful in all patients, lumen increased by 150-300%, gradients reduced in all patients. There was no stent recoil, foreshortening or fractures. There were no complications. At a follow up of 3-27 months, there were no stent related complications and the gradients remained stable. CONCLUSIONS: The new Zephyr stent was useful in a wide variety of stenotic lesions involving large vessels including those that were previously stented. Lack of stent recoil and foreshortening seems to be an advantage for this new stent that needs validation in larger multicenter studies.

One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India.

BACKGROUND: Biodegradable polymer drug-eluting stents (BP-DES) have shown to reduce restenosis rates and have low rates of stent thrombosis. The present postmarketing surveillance assessed 1-year clinical outcomes of patients who had received NeoHexa DES in real practice. AIM: To investigate 1-year clinical outcomes of Neohexa DES in real practice. METHODS: Data obtained from a single-center cohort of patients who had received NeoHexa stents as part of routine treatment of coronary artery disease (CAD) were retrospectively investigated. The primary study endpoint was the rate of major adverse cardiac events (MACEs) defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) during the follow-up at 1 mo, 6 mo, and 1 year after the index procedure. RESULTS: A total of 129 patients with 172 lesions were enrolled. The most common comorbid conditions were hypertension (49.61%) and diabetes mellitus (39.53%). Procedural success was achieved in all patients, and no in-hospital MACE was reported. The incidence of composite MACE at 30 d, 6 mo, and 1 year was 0.78%, 3.94%, and 4.87%, respectively. The rate of possible and probable late stent thrombosis was 0.78%. The cumulative incidences of death, MI, and TLR at 1 year were 2.44%, 0.81%, and 1.63%, respectively. CONCLUSION: The relatively low rates of MACE and stent thrombosis in this study support safety and performance of NeoHexa stents, suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.

Novel growth stent for the permanent treatment of vessel stenosis in growing children: an experimental study.

Stent implantation in stenotic vessels of infants and small children is problematic because there is no ideal stent model that is small enough to be easily introduced into the infant femoral vein or artery and, at the same time, large enough to be dilated during growth to adult vessel diameters. To overcome this problem, we designed a new stent, the growth stent. This growth stent is a balloon-expandable metal stent. Two longitudinal halves are connected with bioabsorbable sutures so that a circular stent is created. It was postulated that after absorption of the sutures the stent would not impede growth. Twenty of these stents were implanted in the aorta, pulmonary arteries, and inferior vena cava of piglets (average weight 6.9 kg). After 18 weeks (14-23 weeks) and a mean weight gain of 59 kg, none of the stented vessels showed any significant stenosis or pressure gradient, documented by angiography and catheter pullback. During fluoroscopy, the two halves of the stent were clearly separated in all animals. The growth stent has the potential to be nonrestrictive during vessel growth, and thus is a promising new device for the permanent treatment of stenotic vessels in infancy and childhood.

Duct-Occlud for Occlusion of Patent Ductus Arteriosus.

The Duct-Occlud Occlusion System (ATG Co., Malta, Europe) is the only coil-type device that has been specifically designed to close the patent ductus arteriosus (PDA). The Duct-Occlud coil has no Dacron feathers. Occlusion of the PDA is achieved by precise positioning and implantation of a large number of densely packed coils with configuration appropriate for the PDA. A principle feature of the delivery system is retrievability, which facilitates both repositioning of a suboptimally placed device and exchange for a larger or more appropriate device. Standard and reinforced devices are available for closure of PDA with minimum diameter up to 4 mm. Clinical studies have demonstrated device safety and efficacy.