Objective and Design: The search for improved stenting technologies to treat peripheral artery disease is trending toward biodegradable self-expanding shape-memory stents that, as of now, still suffer from the acute trade-off between deliverability and luminal stability: Higher deliverability leads to lower lumen stability, vessel recoil, and stent breakage. This study was aimed at the development and testing of a self-expanding bioresorbable poly(l,l-lactide-co-ε-caprolactone) stent that was designed to produce confident self-expansion after efficient crimping, as well as quick bioresorption, and sufficient radial force. Materials and Methods: Bench tests were employed to measure shape-memory properties, radial force, and hydrolytic degradation of the stent. The porcine model was employed to study deliverability, lumen stability, biocompatibility, and stent integrity. A total of 32 stents were implanted in the iliac arteries of 16 pigs with 15 to 180 day follow-up periods. The stented vessels were studied by angiography and histological evaluation. Results: Recovery of the diameter of the stent due to shape-memory effect was equal to 90.6% after 6Fr crimping and storage in refrigeration for 1 week. Radial force measured after storage was equal to 0.7 N/mm. Technical success of implantation in pigs (after the delivery implemented by pusher) was 94%. At 180 days, no implanted stents were found to be fragmented: All of the devices remained at the site of implantation with no stent migration and all stents retained their luminal support. Only moderate inflammation and neoepithelialization were detected by histological assessment at 60, 90, 120, and 180 days. Lumen loss at 180 days was less than 25% of the vessel diameter. Conclusions: The stent with the mechanical and chemical properties described in this study may present the optimal solution of the trade-off between deliverability and luminal stability that is necessary for designing the next generation stent for endovascular therapy of peripheral arterial disease.
The aim of the study was to assess the quality of life in patients after endovascular prophylaxis (inferior vena cava filter) and PATE conservative (drug) therapy. Materials and Methods. The authors examined efficacy of treatment and assessed the quality of life in 226 patients with deep vein thrombosis, IVC thrombosis, and PATE. All the patients underwent medical treatment at the Ulyanovsk Regional Clinical Hospital in 2006–2016. Patients with IVC filter (n=91) were included in the main group. Experimental group consisted of patients undergoing conservative treatment (n=135). Hospital patients underwent some diagnostic measures, including Doppler ultrasound, X-ray computed tomography, and echocardiography. MOS 36-Item Short Form Health Survey was used to study the effect of long-term complications on the patients’ quality of life. Results. The number of complaints per patient was higher in the experimental group (6.67) than in the main group (4.13). However, instrumental research methods showed that IVC filter caused secondary complications in 31.11 % of patients from the main group. In the long-term follow-up, patients from the experimental group rated a number of their health parameters on the mental status scales reliably higher (“social functioning” – 8.1 in the main group and 25.4 in the experimental group, “role-emotional functioning” – 25.3 in the main group and 33.3 in the experimental group, “mental status” – 57.8 in the main group and 70.2 in the experimental group). Conclusion. Despite a greater number of subjective complaints from the patients of the experimental group, the patients of the main group had more long-term complications, which affected patients’ quality of life, namely social functioning, role-emotional functioning and mental status. Keywords: vascular surgery, IVC filter, pulmonary thromboembolism, floating deep vein thrombosis of the lower extremities. Цель исследования – оценить качество жизни пациентов после эндоваскулярной профилактики (имплантации кава-фильтра) и консервативной (медикаментозной) терапии ТЭЛА. Материалы и методы. Было проведено исследование эффективности лечения и оценка качества жизни 226 пациентов, находившихся на лечении в период с 2006 по 2016 г. в ГУЗ Ульяновская областная клиническая больница с диагнозами «тромбоз глубоких вен», «тромбоз НПВ», «ТЭЛА». Пациенты, которым была проведена имплантация кава-фильтров, составили основную группу (91 чел.); пациенты, получавшие консервативное лечение, – группу сравнения (135 чел.). В стационаре проводился комплекс диагностических мероприятий, включавший ультразвуковую доплерографию, рентгеновскую компьютерную томографию, эхокардиографию. Для изучения влияния отдаленных осложнений на качество жизни пациентов проводилось анкетирование с использованием опросника MOS 36-Item Short Form Health Survey. Результаты. Количество жалоб на одного пациента было больше в группе сравнения (6,67), чем в основной (4,13). Однако инструментальные методы исследования показали, что кава-фильтр стал причиной вторичных осложнений у 31,11 % пациентов основной группы. В отдаленные сроки наблюдения пациенты из группы сравнения достоверно выше оценивали ряд показателей своего здоровья по шкалам психического состояния («социальное функционирование» – 8,1 в основной группе и 25,4 в группе сравнения, «ролевое функционирование, обусловленное эмоциональным состоянием» – 25,3 в основной группе и 33,3 в группе сравнения, «психическое здоровье» – 57,8 в основной группе и 70,2 в группе сравнения). Выводы. Несмотря на большее количество субъективных жалоб у пациентов группы сравнения, объективно у пациентов основной группы отмечалось большее число отдаленных осложнений, которые сказывались на качестве жизни пациентов по шкалам «социального функционирования», «ролевого функционирования, обусловленного эмоциональным состоянием» и «психического здоровья». Ключевые слова: сосудистая хирургия, кава-фильтр, тромбоэмболия лёгочных артерий, флотирующий тромбоз глубоких вен нижних конечностей.
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