![]() At 4 weeks, catheter angiography and histopathologic evaluation was performed (Fig. Control pigs received an adequately sized SENS, whereas the COF group received an over-sized stent 1.5 to 1.8 times larger than the control size. The model was used to evaluate the impact of COF on angiographic outcomes and histopathologic outcomes at 1 month. Preclinical data were obtained from a porcine model following SENS (CV Bio, Seoul, Korea) implantation. We examined clinical and animal experiments data to determine the impact of COF on the arterial wall, and investigated the impact of SENS oversizing with respect to continued expansion following stenting and the mid-term histological impact of oversized stent on SFA. This study aimed to evaluate the impact of SENS oversizing on ISR of SFA. COF could produce continuous mechanical stimulation of the arterial wall, which can increase neointimal hyperplasia and lead to significant ISR. ![]() The chronic outward force (COF) exerted by a SENS is another important factor to cause restenosis, and several investigations evaluated the effect of SENS oversizing on the risk of in-stent restenosis (ISR). ![]() The mechanical stresses to the SFA are associated with an increased risk of stent fracture and subsequent significant restenosis. SFA stents are under dynamic stress to external forces including bending, twisting, torsion, elongation, foreshortening and external compression. Implanted SENS is commonly oversized in the SFA, especially at the distal portion due to tapered diameter of SFA for long SENS. However, stent size influences clinical outcomes. The self-expanding nitinol stent (SENS) for superficial femoral artery (SFA) lesions is morphologically and clinically superior to balloon angioplasty. Therefore, COF was an important factor of restenosis following distal SFA stenting.īalloon angioplasty and stent implantation are popular in patients with peripheral artery disease (PAD). Optimal sizing of the SFA stent is important to reduce the incidence of restenosis. ConclusionsĬOF is an important cause of restenosis in the distal portion of the SFA stent. The neointimal area was 5.37 ± 1.15 mm 2 vs. The vessel diameter was 4.04 ± 0.40 mm (control group) vs 4.45 ± 0.63 mm (oversized group), and the implanted stent diameter was 5.27 ± 0.46 mm vs. All 11 pigs survived for 4 weeks after SENS implantation. ISR incidence was higher at the distal stent (37.3% vs 52.6%, P = 0.029). In the long SFA stent, stent-to-vessel ratio was significantly higher in the distal stent than in the proximal stent (1.3 ± 0.2 vs. The ratio of the diameter of the stent to the reference vessel was 1.3 ± 0.24 at the proximal portion and 1.53 ± 0.27 at the distal portion ( P < 0.001). The baseline diameter was 6.8 ± 0.71 mm and length were 97.0 ± 33.8 mm for the SENS. We analyzed 65 SENS in 61 patients with follow-up angiography at 6 months to 1 year. Excised stented arteries were evaluated by histopathologic analysis. In addition, porcine model with implanted SENS was used to evaluate the impact of COF on angiographic and histopathologic outcomes at 1 month. In patients with implanted SENS in SFA, intimal hyperplasia especially between proximal segment and distal segment was evaluated by quantitative angiography, and the impact of COF on mid-term angiographic outcomes was investigated. This study aimed to investigate the impact of COF of oversizing SENS on ISR of SFA. Self-expanding nitinol stent (SENS) implantation is commonly oversized in the superficial femoral artery (SFA), and leads to chronic outward force (COF) and in-stent restenosis (ISR).
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