Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study.

OBJECTIVES: To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. BACKGROUND: Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. METHODS: In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). RESULTS: At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001). CONCLUSIONS: In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.

S.M.A.R.T. self-expanding nitinol stent for the treatment of atherosclerotic lesions in the superficial femoral artery (STROLL): 1-year outcomes.

PURPOSE: To assess safety and efficacy of the S.M.A.R.T. Vascular Stent System (Cordis Corp, Fremont, California) in obstructive superficial femoral artery (SFA) disease. MATERIALS AND METHODS: The single-arm, multicenter STROLL study (S.M.A.R.T. Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) included 250 patients (250 lesions in SFA or proximal popliteal artery). The efficacy endpoint was primary patency defined by freedom from binary restenosis (peak systolic velocity ratio > 2.5) as derived by duplex ultrasound plus clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: Mean age of patients was 67.7 years ± 10.3; 47.2% of patients had diabetes; distribution of Rutherford/Becker classes 2, 3, and 4 was 45.8%, 51.4%, and 2.8%. Mean lesion length and reference vessel diameter were 77.3 mm ± 35.3 and 4.9 mm ± 0.7, respectively (23.6% cases with total occlusions). The 30-day freedom from major adverse events (death, index limb amputation, clinically driven TLR) was 100%. The 1-year primary patency was 81.7% by Kaplan-Meier estimate. The presence of diabetes or total occlusion had no effect on primary patency. Ankle-brachial index was 0.4-0.8 in 84.6% of patients at baseline and improved to > 0.8 in 81.0% of patients at 12 months. The proportion of patients in Rutherford/Becker class 3-4 was reduced from 54.2% at baseline to 8.0% at 12 months. Four patients (2.0%) experienced single-stent strut fracture (type I) at 1 year, without associated loss of stent patency. CONCLUSIONS: The S.M.A.R.T. Vascular Stent System proved to be safe and effective for endovascular treatment of obstructive SFA and proximal popliteal artery disease, based on 1-year vessel patency and associated hemodynamic and clinical improvements.

One-year water sorption and solubility of "all-in-one" adhesives.

The aim of this study was to evaluate the water sorption and solubility of different adhesives. Adper Easy Bond, Adper Single Bond Plus, Bond Force, Clearfil SE Bond (bonding resin only), and Xeno IV were the materials evaluated. Ten disks of each adhesive were made in Teflon molds and evaporation of any volatile components was allowed. The disks were weighed daily in an analytical balance until a constant mass was obtained (m1). Disks were then immersed in water for 12 months when their wet weight was recorded (m2). The disks were again weighed daily until a constant mass was obtained and the final weight recorded (m3). Water sorption and solubility (percentages) were calculated using the recorded mass values. Kruskal-Wallis tests were used to compare the average water sorption and solubility among the different adhesives. Mann-Whitney tests with a Bonferroni correction were used to determine the pairwise differences between adhesives in water sorption and solubility. The level of significance was set at 0.05. Water sorption and solubility were significantly different among the groups (p<0.05). Pairwise comparisons showed no significant differences (p>0.05) between Adper Single Bond Plus and Bond Force, or between Clearfil SE Bond and Xeno IV in either water sorption or solubility. Xeno IV did not differ from Adper Easy Bond in water sorption (p>0.05). Water sorption and solubility of all-in-one adhesives increased with time, and the rates of increase were composition-dependent. The results suggest that monomers other than HEMA contribute to water sorption and solubility of adhesive systems from different categories.

One-Year Water Sorption and Solubility of All-in-One Adhesives

The aim of this study was to evaluate the water sorption and solubility of different adhesives. Adper Easy Bond, Adper Single Bond Plus, Bond Force, Clearfil SE Bond (bonding resin only), and Xeno IV were the materials evaluated. Ten disks of each adhesive were made in Teflon molds and evaporation of any volatile components was allowed. The disks were weighed daily in an analytical balance until a constant mass was obtained (m1). Disks were then immersed in water for 12 months when their wet weight was recorded (m2). The disks were again weighed daily until a constant mass was obtained and the final weight recorded (m3). Water sorption and solubility (percentages) were calculated using the recorded mass values. Kruskal-Wallis tests were used to compare the average water sorption and solubility among the different adhesives. Mann-Whitney tests with a Bonferroni correction were used to determine the pairwise differences between adhesives in water sorption and solubility. The level of significance was set at 0.05. Water sorption and solubility were significantly different among the groups (p<0.05). Pairwise comparisons showed no significant differences (p>0.05) between Adper Single Bond Plus and Bond Force, or between Clearfil SE Bond and Xeno IV in either water sorption or solubility. Xeno IV did not differ from Adper Easy Bond in water sorption (p>0.05). Water sorption and solubility of all-in-one adhesives increased with time, and the rates of increase were composition-dependent. The results suggest that monomers other than HEMA contribute to water sorption and solubility of adhesive systems from different categories.

O objetivo deste estudo foi avaliar a absorção de água e a solubilidade de diferentes sistemas adesivos: Adper Easy Bond, Adper Single Bond Plus, Bond Force, Clearfil SE Bond (apenas a resina adesiva) e Xeno IV. Foram fabricados 10 discos de cada material em moldes de Teflon e foi permitida a evaporação de todos os componentes voláteis. Os discos foram pesados diariamente em balança analítica até atingir massa seca constante (m1). Após esta mensuração, os discos foram imersos em água por 12 meses e seu peso úmido foi anotado (m2). Os discos foram novamente pesados diariamente até obter-se massa constante (m3). As percentagens de absorção de água e solubilidade foram calculadas utilizando os valores de massa registrados. A comparação das médias de absorção de água e solubilidade entre os diversos adesivos foi feita com o teste Kruskal-Wallis. As diferenças de absorção de água e solubilidade entre os pares de adesivos foram determinadas pelo testes Mann-Whitney com correção de Bonferroni. O nível de significância adotado foi de 0,05. Absorção de água e solubilidade apresentaram diferenças estatisticamente significantes entre os grupos (p<0,05). As comparações pareadas dos adesivos não mostraram diferenças significantes (p>0,05) entre Adper Single Bond Plus e Bond Force nem entre Clearfil SE Bond e Xeno IV para absorção de água e solubilidade. Xeno IV apresentou diferença significante do Adper Easy Bond quanto à absorção de água (p>0,05). A absorção de água e solubilidade dos adesivos “all-in-one” aumentaram com o tempo e as taxas de aumento mostraram-se dependentes da composição do material. Os resultados sugerem que outros monômeros além do HEMA contribuem para a absorção de água e solubilidade dos diversos sistemas de adesivos.

Antegrade popliteal artery approach for the treatment of critical limb ischemia in patients with occluded superficial femoral arteries.

Treating patients with critical limb ischemia (CLI) secondary to superficial femoral artery (SFA) occlusions and jeopardized tibial-peroneal run-off is challenging, especially when the SFA cannot be recanalized. These patients are frequently poor candidates for surgical revascularization and thus amputation is the therapy most often recommended. In this article, we describe a new technique for treating these patients, which combines antegrade popliteal arterial access with tibial arterial revascularization using drug eluting stents (DES). Five patients scheduled for below-knee amputations were successfully treated using this endovascular approach. For the duration of follow-up (29 +/- 8 months), all patients remained free of death, amputation, or target lesion revascularization. ABI's post intervention demonstrated a modest improvement (ABI = 0.32 +/- 0.09 vs. 0.58 +/- 0.09 pre vs. post, P