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Análise histológica e histomorfométrica de carótidas após o implante de stent de cromocobalto sem e com revestimento de polímero : modelo experimental porcinoGrudtner, Marco Aurelio January 2009 (has links)
Introdução: Apesar dos avanços significativos no tratamento endovascular das doenças arteriais coronarianas e periféricas, a reestenose intra-stent continua sendo o principal limitante a médio prazo desses procedimentos. O mecanismo da reestenose intra-stent é principalmente a hiperplasia intimal, já que o stent impede a retração elástica aguda e resiste ao remodelamento geométrico negativo tardio. A hiperplasia intimal ocorre basicamente em resposta à formação de trombo local, à inflamação e às dissecções intimais e mediais secundárias à injúria causada pelo stent, sendo o grau de resposta intimal a base dos efeitos a longo prazo. O uso de stents com hastes menores e revestidos com drogas ou polímeros tem sido considerado uma nova alternativa para a prevenção da reestenose intra-stent. Objetivo: Analisar a resposta arterial ao implante de stent de cromo-cobalto sem e com revestimento de polímero Camouflage® em artérias carótidas de suínos, utilizando os seguintes parâmetros histológicos: grau de endotelização, conteúdo de células musculares lisas, grau de angiogênese, conteúdo de fibrina, grau de inflamação e injúria; além da análise histomorfométrica. Método: Stents balões-expansíveis de cromo-cobalto ( 8 stents CC Flex e 5 stents CC Flex Proactive) de 4 x 16 mm foram implantados em artérias carótidas comuns de oito suínos jovens, sendo um stent liberado em cada artéria. Após 30 dias, as artérias contendo os stents foram removidas, fixadas e coradas pelos métodos de hematoxilina/eosina e Verhoeff/Van Giesson. O segmento arterial contendo o stent foi dividido em 3 blocos distintos: proximal, médio e distal. Os cortes histológicos foram obtidos utilizando-se micrótomo de impacto (Polycut S, Leica, Alemanha) equipado com navalha de tungstênio de 16 cm, tipo D (Leica, Alemanha), com 5 ^m de espessura. A navalha de tungstênio mantém as hastes dos stents intactas nas secções transversas, minimizando os artefatos potenciais causados pela retirada dos stents. A avaliação foi realizada através de critérios histológicos e histomorfométricos. Resultados: Todos os stents foram implantados com sucesso e sem dificuldades técnicas. A análise histológica em 30 dias evidenciou alto grau de endotelização em todos os segmentos avaliados e leve à moderada infiltração de células musculares na íntima. Observou-se baixo grau de angiogênese em cerca de 50% dos segmentos avaliados e ausência completa de deposição de fibrina em pelo menos 80%, com distribuição semelhante entre os grupos. A resposta inflamatória e o grau de injúria causadas pelas hastes dos stents também foram discretas e similares entre os grupos e não houve correlação entre resposta inflamatória e injúria e desses parâmetros com a área de neoíntima. O grau de obstrução neo-intimal identificada neste período foi pequeno (15,1% +/- 8,38 CC Flex x 15,5%+/- 5,39 CC Flex ProActive) e estatisticamente não significativo entre os grupos (p=0,785). Conclusão: Os achados deste estudo experimental sugerem que o uso de stents de cromo-cobalto revestidos com polímero Camouflage® em artérias carótidas de suínos parece estar associado, pelo menos no curto prazo, a uma resposta histológica semelhante àquela encontrada após o implante de stents de cromo-cobalto não revestidos. Neste período não se observou uma menor hiperplasia intimal em virtude do revestimento de polímero. / Introduction: Despite all the advances in the endovascular treatment of coronary and peripheral artery diseases, in-stent restenosis is still the main limiting factor of these procedures in the medium and long-term. The mechanism of in-stent restenosis is mainly the intimal hyperplasia, as the stent prevents acute elastic recoil and later negative geometric arterial remodeling. Intimal hyperplasia occurs basically in response to the formation of local thrombus, inflammation and intimal and medial dissections secondary to the injury caused by the stent, with the degree of intimal response being the cause of long-term effects. Coating drug-eluting stents with polymers and drugs with thinner struts have been considered a new alternative for in-stent restenosis prevention. Objective: Analyse the arterial response to the cobalt-chromium stent implant with and without polymer coating Camouflage® in carotid arteries of pigs, using the following histological parameters: degree of endothelialization, smooth muscle cells (SMC) content, degree of angiogenesis, intimal fibrin content, degree of inflammation and injury; plus histomorphometric analysis. Method: Cobaltchromium balloon-expandable stents (8 CC Flex stents and 5 CC Flex Proactive), 4 x 16 mm, were deployed in common carotid arteries of 8 young pigs, with one stent being deployed in each artery. After 30 days, the arteries containing the stents were removed and underwent fixation and staining using the hematoxilin/eosin and Verhoeff /Van Giesson methods. The arterial segment containing the stent was divided into 3 distinct portions: proximal, middle and distal. The histological sections were obtained using impact microtome (Polycut S, Leica, Germany), equipped with a 16 cm, type D, 5 ^m thick tungsten knife (Leica, Germany). The tungsten knife maintains the stent shaft intact in cross sections, minimizing the potential artifacts caused by stent removal. The evaluation was carried out using histological and histomorfometric criteria. Results: All the stents were deployed with success and with no technical difficulties. The histological analysis performed after 30 days showed a high level of endothelialization in all the evaluated portions and mild to moderate infiltration of the SMC in the intima layer. A low level of angiogenesis of about 50% of the evaluated portions was observed and a complete absence of fibrin deposition in at least 80% of the portions, with similar distribution among the groups. The inflammatory response and the level of injury caused by the struts of the stents were also minimum and this was similar among the groups. There was no correlation between inflammatory response and injury and between the two latter parameters and the neo-intima area. The level of neo-intimal obstruction identified in this period was small (15,1% +/- 8,38 CC Flex x 15,5%+/- 5,39 CC Flex ProActive ) and no statistical significance between the groups (p=0,785). Conclusion: The findings of this experimental study suggest the use of balloonexpandable cobalt-chromium stents coated with polymer Camouflage® in carotid arteries of pigs seems to be associated, at least in the short-term, with a similar histological response to that found in the implantation of non-coated cobalt-chromium stents. In this period, a lower intimal hyperplasia was not observed with polymer coating stents.
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Análise histológica e histomorfométrica de carótidas após o implante de stent de cromocobalto sem e com revestimento de polímero : modelo experimental porcinoGrudtner, Marco Aurelio January 2009 (has links)
Introdução: Apesar dos avanços significativos no tratamento endovascular das doenças arteriais coronarianas e periféricas, a reestenose intra-stent continua sendo o principal limitante a médio prazo desses procedimentos. O mecanismo da reestenose intra-stent é principalmente a hiperplasia intimal, já que o stent impede a retração elástica aguda e resiste ao remodelamento geométrico negativo tardio. A hiperplasia intimal ocorre basicamente em resposta à formação de trombo local, à inflamação e às dissecções intimais e mediais secundárias à injúria causada pelo stent, sendo o grau de resposta intimal a base dos efeitos a longo prazo. O uso de stents com hastes menores e revestidos com drogas ou polímeros tem sido considerado uma nova alternativa para a prevenção da reestenose intra-stent. Objetivo: Analisar a resposta arterial ao implante de stent de cromo-cobalto sem e com revestimento de polímero Camouflage® em artérias carótidas de suínos, utilizando os seguintes parâmetros histológicos: grau de endotelização, conteúdo de células musculares lisas, grau de angiogênese, conteúdo de fibrina, grau de inflamação e injúria; além da análise histomorfométrica. Método: Stents balões-expansíveis de cromo-cobalto ( 8 stents CC Flex e 5 stents CC Flex Proactive) de 4 x 16 mm foram implantados em artérias carótidas comuns de oito suínos jovens, sendo um stent liberado em cada artéria. Após 30 dias, as artérias contendo os stents foram removidas, fixadas e coradas pelos métodos de hematoxilina/eosina e Verhoeff/Van Giesson. O segmento arterial contendo o stent foi dividido em 3 blocos distintos: proximal, médio e distal. Os cortes histológicos foram obtidos utilizando-se micrótomo de impacto (Polycut S, Leica, Alemanha) equipado com navalha de tungstênio de 16 cm, tipo D (Leica, Alemanha), com 5 ^m de espessura. A navalha de tungstênio mantém as hastes dos stents intactas nas secções transversas, minimizando os artefatos potenciais causados pela retirada dos stents. A avaliação foi realizada através de critérios histológicos e histomorfométricos. Resultados: Todos os stents foram implantados com sucesso e sem dificuldades técnicas. A análise histológica em 30 dias evidenciou alto grau de endotelização em todos os segmentos avaliados e leve à moderada infiltração de células musculares na íntima. Observou-se baixo grau de angiogênese em cerca de 50% dos segmentos avaliados e ausência completa de deposição de fibrina em pelo menos 80%, com distribuição semelhante entre os grupos. A resposta inflamatória e o grau de injúria causadas pelas hastes dos stents também foram discretas e similares entre os grupos e não houve correlação entre resposta inflamatória e injúria e desses parâmetros com a área de neoíntima. O grau de obstrução neo-intimal identificada neste período foi pequeno (15,1% +/- 8,38 CC Flex x 15,5%+/- 5,39 CC Flex ProActive) e estatisticamente não significativo entre os grupos (p=0,785). Conclusão: Os achados deste estudo experimental sugerem que o uso de stents de cromo-cobalto revestidos com polímero Camouflage® em artérias carótidas de suínos parece estar associado, pelo menos no curto prazo, a uma resposta histológica semelhante àquela encontrada após o implante de stents de cromo-cobalto não revestidos. Neste período não se observou uma menor hiperplasia intimal em virtude do revestimento de polímero. / Introduction: Despite all the advances in the endovascular treatment of coronary and peripheral artery diseases, in-stent restenosis is still the main limiting factor of these procedures in the medium and long-term. The mechanism of in-stent restenosis is mainly the intimal hyperplasia, as the stent prevents acute elastic recoil and later negative geometric arterial remodeling. Intimal hyperplasia occurs basically in response to the formation of local thrombus, inflammation and intimal and medial dissections secondary to the injury caused by the stent, with the degree of intimal response being the cause of long-term effects. Coating drug-eluting stents with polymers and drugs with thinner struts have been considered a new alternative for in-stent restenosis prevention. Objective: Analyse the arterial response to the cobalt-chromium stent implant with and without polymer coating Camouflage® in carotid arteries of pigs, using the following histological parameters: degree of endothelialization, smooth muscle cells (SMC) content, degree of angiogenesis, intimal fibrin content, degree of inflammation and injury; plus histomorphometric analysis. Method: Cobaltchromium balloon-expandable stents (8 CC Flex stents and 5 CC Flex Proactive), 4 x 16 mm, were deployed in common carotid arteries of 8 young pigs, with one stent being deployed in each artery. After 30 days, the arteries containing the stents were removed and underwent fixation and staining using the hematoxilin/eosin and Verhoeff /Van Giesson methods. The arterial segment containing the stent was divided into 3 distinct portions: proximal, middle and distal. The histological sections were obtained using impact microtome (Polycut S, Leica, Germany), equipped with a 16 cm, type D, 5 ^m thick tungsten knife (Leica, Germany). The tungsten knife maintains the stent shaft intact in cross sections, minimizing the potential artifacts caused by stent removal. The evaluation was carried out using histological and histomorfometric criteria. Results: All the stents were deployed with success and with no technical difficulties. The histological analysis performed after 30 days showed a high level of endothelialization in all the evaluated portions and mild to moderate infiltration of the SMC in the intima layer. A low level of angiogenesis of about 50% of the evaluated portions was observed and a complete absence of fibrin deposition in at least 80% of the portions, with similar distribution among the groups. The inflammatory response and the level of injury caused by the struts of the stents were also minimum and this was similar among the groups. There was no correlation between inflammatory response and injury and between the two latter parameters and the neo-intima area. The level of neo-intimal obstruction identified in this period was small (15,1% +/- 8,38 CC Flex x 15,5%+/- 5,39 CC Flex ProActive ) and no statistical significance between the groups (p=0,785). Conclusion: The findings of this experimental study suggest the use of balloonexpandable cobalt-chromium stents coated with polymer Camouflage® in carotid arteries of pigs seems to be associated, at least in the short-term, with a similar histological response to that found in the implantation of non-coated cobalt-chromium stents. In this period, a lower intimal hyperplasia was not observed with polymer coating stents.
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Perivascular Drug Delivery Systems for the Inhibition of Intimal HyperplasiaKanjickal, Deenu George January 2005 (has links)
No description available.
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Κλινική μελέτη των καλυμμένων με φαρμακευτικές ουσίες ενδοπροθέσεων στα κνημιαία αγγείαΚρανιώτης, Παντελής 26 January 2009 (has links)
Σκοπός: Η μελέτη είχε ως σκοπό την διερεύνηση της ασφάλειας και της
αποτελεσματικότητας των sirolimus-eluting stent, σε σχέση με τα απλά
μεταλλικά stent, στα πλαίσια αγγειοπλαστικής των κνημιαίων αγγείων, σε
ασθενείς με χρόνια κρίσιμη ισχαιμία του κάτω άκρου. Πρόκειται για μια
προοπτική ελεγχόμενη, κλινική μελέτη με διπλό σκέλος. Τα stent
τοποθετήθηκαν σε περιπτώσεις μη ικανοποιητικής αγγειοπλαστικής (δηλ. σε
περιπτώσεις ελαστικής επαναφοράς-υπολειμματικής στένωσης >30% και σε
περιπτώσεις διαχωρισμού). Οι ασθενείς ελέγχθηκαν κλινικά και αγγειογραφικά
στο εξάμηνο και στο 1 έτος.
Ασθενείς και μέθοδοι: 29 ασθενείς, εκ των οποίων 8 γυναίκες και 21 άνδρες,
με μέση ηλικία τα 68,7 έτη υποβλήθηκαν σε αγγειοπλαστική στα κνημιαία
αγγεία, με απλά μεταλλικά stent, ομάδα Β. Σε αυτή την ομάδα τοποθετήθηκαν
απλά stent σε 65 αλλοιώσεις, εκ των οποίων 38 στενώσεις και 27 αποφράξεις
σε συνολικά 40 κνημιαία αγγεία. Άλλοι 29 ασθενείς, 8 γυναίκες και 21 άνδρες,
με μέση ηλικία τα 68,8 έτη αντιμετωπίστηκαν με sirolimus-eluting stent, ομάδα
S. Σε αυτή την ομάδα αντιμετωπίστηκαν 66 αλλοιώσεις εκ των οποίων 46
στενώσεις και 20 αποφράξεις, σε 41 συνολικά αγγεία. Οι ασθενείς
επανελέγχθηκαν κλινικά και με ενδαρτηριακή αγγειογραφία στους 6 μήνες και
στο 1 έτος, μετά την αρχική επέμβαση. Έγινε στατιστική ανάλυση των
αποτελεσμάτων.
Αποτελέσματα: Οι συνοδές νόσοι ήταν περισσότερες στην ομάδα S (όπως η
συμπτωματική νόσος από την καρδιά και τις καρωτίδες, καθώς και η
υπερλιπιδαιμία, p<0.05).
Η τεχνική επιτυχία ήταν 96,6% (28/29 άκρα) στην ομάδα Β έναντι 100%
(29/29 άκρα) στην ομάδα S (p=0.16)
Στον επανέλεγχο εξαμήνου:
Η βατότητα ήταν 68,1% στην ομάδα Β και 92,0% στην ομάδα S, (p<0.002).
Τα μεγαλύτερα ποσοστά βατότητας των sirolimus-eluting stent, μετά από
πολυπαραγοντική regression analysis είχαν OR 5.625, με 95% CI 1.711-
18.493, που ήταν στατιστικά σημαντικό (p=0.004).
Η δυαδική επαναστένωση εντός του stent ήταν 55,3% ενώ η επαναστένωση
στα άκρα του stent ήταν 66,0% στους ασθενείς με τα απλά μεταλλικά stent.
Αντιθέτως τα ποσοστά στους ασθενείς με sirolimus-eluting stent ήταν 4,0%
και 32,0% αντίστοιχα. Συγκεκριμένα η επαναστένωση εντός του stent είχε OR
0.067, με 95% CI 0.021-0.017, και η επαναστένωση στα άκρα του stent είχε
OR 0.229 με 95% CI 0.099-0.533. Και τα δύο ήταν ήταν στατιστικά σημαντικά
με p<0.001 και p=0.001, αντίστοιχα.
Τα συνολικά ποσοστά επανεπέμβασης (TLR) στο εξάμηνο ήταν 17,0% στην
ομάδα Β έναντι 4,0% στην ομάδα S, (OR 0.057, με 95% CI 0.008-0.426). Το
αποτέλεσμα ήταν επίσης στατιστικά σημαντικό υπέρ των sirolimus stent.
(p=0.02)
Η διάσωση του άκρου ήταν 100% και στις δύο ομάδες.
Η θνησιμότητα και ο ελάσσων ακρωτηριασμός στο εξάμηνο ήταν 6,9% και
17,2% στην ομάδα Β έναντι 10,3% και 3,4% στην ομάδα S (p=0.32 και
p=0.04, αντίστοιχα).
Στον επανέλεγχο έτους:
Τα sirolimus-eluting stent σχετίζoνταν και πάλι με καλύτερη πρωτογενή
βατότητα (OR 10.401, με 95% CI 3.425-31.589, p<0.001) και σημαντικά
μειωμένη δυαδική επαναστένωση εντός του stent (OR 0.156, με 95% CI
0.060-0.407, p<0.001), καθώς και στα άκρα του stent. (OR 0.089, με 95% CI
0.023-0.349, p=0.001)
Τα ποσοστά επανεπέμβασης στις βλάβες (TLR) ήταν πολύ μικρότερα στην
ομάδα του sirolimus (OR 0.238, με 95% CI 0.067-0.841, p=0.026) .
Δεν υπήρξαν στατιστικά σημαντικές διαφορές ανάμεσα στις δύο ομάδες Β και
S όσον αφορά στα ποσοστά θνησιμότητας 10,3% έναντι 13,8%, στη διάσωση
του άκρου 100% έναντι 96% και στους ελάσσονες ακρωτηριασμούς 17,2%
έναντι 10,3% αντίστοιχα.
Συμπεράσματα: Τα sirolimus-eluting stents περιορίζουν την ενδοθηλιακή
υπερπλασία στα κνημιαία αγγεία. Η εφαρμογή τους έχει ως αποτέλεσμα την
σημαντική μείωση των ποσοστών επαναστένωσης και μειώνει την ανάγκη για
επανεπεμβάσεις. / Aim : The purpose of our study was to investigate the 6-month and 1-year
angiographic and clinical outcome in the setting of a controlled clinical study.
The study examined the safety and relative effectiveness of sirolimus-eluting
stents opposed to conventional metal stents, in the infrapopliteal vessels, in
patients with critical limb ischemia (CLI). The stents were used in a bail-out
setting during infrapopliteal endovascular procedures, i. e. stenting was
carried out in cases of suboptimal angioplasty results (recoil - residual
stenosis >30%, or in cases of dissection, after angioplasty).
Patients and Methods: Twenty-nine patients comprising 8 women and 21
men with a mean age of 68.7 years were submitted to infrapopliteal
revascularization with conventional (bare) metal stents, called group B. In
these patients 65 lesions were treated with bare stents, of whom 38 stenoses
and 27 occlusions, in a total of 40 infrapopliteal vessels. Another 29 patients,
again 8 women and 21 men, with a mean age of 68.8 years were treated with
sirolimus-eluting stents, named group S. There were 66 lesions in this group
with 46 of them stenoses and 20 occlusions, in a total of 41 arteries. Patients
were followed-up with clinical examination and intrarterial angiography 6
months and 1 year after the procedure. Both results were subsequently
analyzed statistically.
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Results: Co morbidities like symptomatic cardiac and carotid disease, as well
as hyperlipidemia were more prominent in group S (p<0.05).
Technical success was 96.6% (28/29 limbs) in group B against 100.0% (29/29
limbs) in group S (p=0.16).
During 6-month patient follow-up:
Primary patency was 68.1% in group B opposed to 92.0% in group S
(p<0.002). Sirolimus-eluting stents exhibited higher primary patency with OR
5.625 and 95% CI 1.711-18.493, which was statistically significant (p=0.004).
Binary in-stent restenosis rate was 55.3% while in-segment restenosis
was 66.0%, in patients who had received bare metal stents. In opposition the
respective restenosis rates, in patients with sirolimus-eluting stents were 4.0%
and 32.0%. Diminished in-stent (OR 0.067 with 95% CI 0.021-0.017) and insegment
(OR 0.229 with 95% CI 0.099-0.533) binary restenosis were both
statistically significant with p values being p<0.001 and p=0.001 respectively.
Collective target lesion re-intervention (TLR) at 6 month follow-up was
17.0% in group B against 4.0% (OR 0.057 with 95% CI 0.008-0.426) in group
S, which proved again statistically significant for sirolimus stents (p=0.02).
Six-month limb salvage rate was 100% in both groups.
Six-month mortality and minor amputation rates were respectively 6.9%
and 17.2%, in group B versus 10.3% and 3.4%, in group S (p=0.32 and
p=0.04, respectively).
During 1-year patient follow-up:
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SES were still related with better primary patency rate (OR 10.401 with
95% CI 3.425-31.589, p<0.001) and considerably lesser events of in-stent
binary restenosis (OR 0.156, 95% CI 0.060-0.407, p<0.001) as well as insegment
(OR 0.089, 95% CI 0.023-0.349, p=0.001) binary restenosis.
Target lesion re-intervention (TLR), was much lower in the SES
patients group during 1-year follow-up (OR 0.238 with 95% CI 0.067-0.841,
p=0.026) .
At 1 year follow-up there were no statistically significant differences
among group B and group S regarding mortality (10.3% against 13.8%), limb
salvage rates (100% vs. 96%) and minor amputation (17.2% vs. 10.3%).
Conclusions: Sirolimus-eluting stents appear to limit intimal hyperplasia in
the infrapopliteal vessels. The use of sirolimus-eluting stents decreases
considerably restenosis rates in the infrapopliteal vessels and reduces the
need for repeat interventions
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Současné možnosti ovlivnění dlouhodobé průchodnosti koronárních bypassů / Current possibilities of influence long-term patency of coronary artery bypass graftsSkalský, Ivo January 2014 (has links)
The main complication of aortocoronary reconstruction with vein grafts is restenosis in the course of time. The aim was to assess the effect of a periadventitial polyester system releasing sirolimus on intimal hyperplasia of autologous grafts. The controlled-release system comprises a polyester mesh coated with a sirolimus-eluting copolymer of L lactic acid and ε-caprolactone system designed to be wrapped around an autologous venous graft during its implantation. In vitro sirolimus release and its effects on smooth muscle and endothelial cells were assessed. In vitro, the copolymer-coated polyester mesh released sirolimus over a period of 6 weeks. Mesh-eluted sirolimus inhibited the growth of smooth muscle and endothelial cells in seven-day in vitro experiments. After seven days of sirolimus release from the mesh, smooth muscle and endothelial cell counts decreased by 29% and 75%, respectively, with the cells maintaining high viability. We implanted v. jugularis ext. into a. carotis communis in rabbits. The vein graft was either intact, or was wrapped with a pure polyester mesh, or with a sirolimus-releasing mesh. Three and six weeks after surgery, the veins were subjected to standard histological staining and the thicknesses of the tunica intima, the media and the intima-media complex were...
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Současné možnosti ovlivnění dlouhodobé průchodnosti koronárních bypassů / Current possibilities of influence long-term patency of coronary artery bypass graftsSkalský, Ivo January 2014 (has links)
The main complication of aortocoronary reconstruction with vein grafts is restenosis in the course of time. The aim was to assess the effect of a periadventitial polyester system releasing sirolimus on intimal hyperplasia of autologous grafts. The controlled-release system comprises a polyester mesh coated with a sirolimus-eluting copolymer of L lactic acid and ε-caprolactone system designed to be wrapped around an autologous venous graft during its implantation. In vitro sirolimus release and its effects on smooth muscle and endothelial cells were assessed. In vitro, the copolymer-coated polyester mesh released sirolimus over a period of 6 weeks. Mesh-eluted sirolimus inhibited the growth of smooth muscle and endothelial cells in seven-day in vitro experiments. After seven days of sirolimus release from the mesh, smooth muscle and endothelial cell counts decreased by 29% and 75%, respectively, with the cells maintaining high viability. We implanted v. jugularis ext. into a. carotis communis in rabbits. The vein graft was either intact, or was wrapped with a pure polyester mesh, or with a sirolimus-releasing mesh. Three and six weeks after surgery, the veins were subjected to standard histological staining and the thicknesses of the tunica intima, the media and the intima-media complex were...
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Fluid dynamic assessments of spiral flow induced by vascular graftsKokkalis, Efstratios January 2014 (has links)
Peripheral vascular grafts are used for the treatment of peripheral arterial disease and arteriovenous grafts for vascular access in end stage renal disease. The development of neo-intimal hyperplasia and thrombosis in the distal anastomosis remains the main reason for occlusion in that region. The local haemodynamics produced by a graft in the host vessel is believed to significantly affect endothelial function. Single spiral flow is a normal feature in medium and large sized vessels and it is induced by the anatomical structure and physiological function of the cardiovascular system. Grafts designed to generate a single spiral flow in the distal anastomosis have been introduced in clinical practice and are known as spiral grafts. In this work, spiral peripheral vascular and arteriovenous grafts were compared with conventional grafts using ultrasound and computational methods to identify their haemodynamic differences. Vascular-graft flow phantoms were developed to house the grafts in different surgical configurations. Mimicking components, with appropriate acoustic properties, were chosen to minimise ultrasound beam refraction and distortion. A dual-beam two-dimensional vector Doppler technique was developed to visualise and quantify vortical structures downstream of each graft outflow in the cross-flow direction. Vorticity mapping and measurements of circulation were acquired based on the vector Doppler data. The flow within the vascular-graft models was simulated with computed tomography based image-guided modelling for further understanding of secondary flow motions and comparison with the experimental results. The computational assessments provided a three-dimensional velocity field in the lumen of the models allowing a range of fluid dynamic parameters to be predicted. Single- or double-spiral flow patterns consisting of a dominant and a smaller vortex were detected in the outflow of the spiral grafts. A double- triple- or tetra-spiral flow pattern was found in the outflow of the conventional graft, depending on model configuration and Reynolds number. These multiple-spiral patterns were associated with increased flow stagnation, separation and instability, which are known to be detrimental for endothelial behaviour. Increased in-plane mixing and wall shear stress, which are considered atheroprotective in normal vessels, were found in the outflow of the spiral devices. The results from the experimental approach were in agreement with those from the computational approach. This study applied ultrasound and computational methods to vascular-graft phantoms in order to characterise the flow field induced by spiral and conventional peripheral vascular and arteriovenous grafts. The results suggest that spiral grafts are associated with advanced local haemodynamics that may protect endothelial function and thereby may prevent their outflow anastomosis from neo-intimal hyperplasia and thrombosis. Consequently this work supports the hypothesis that spiral grafts may decrease outflow stenosis and hence improve patency rates in patients.
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