Femoropopliteal Balloon Angioplasty Research Articles

Predictive Factors of Severe Dissection after Balloon Angioplasty for Femoropopliteal Artery Disease

Arterial dissection is one of the mechanisms of balloon angioplasty. Although some degree of dissection is unavoidable, severe dissection that impedes blood flow decreases patency and increases the need for additional procedures. To improve the results of angioplasty, it is necessary to understand the factors related to severe dissection and make efforts to reduce its occurrence. This study aimed to elucidate the predictive and protective factors associated with severe dissection in femoropopliteal balloon angioplasty. This was a retrospective, single-center, nonrandomized study. A total of 409 limbs were studied in 334 patients with symptomatic femoropopliteal lesions treated between 2010 and 2019. Dissections after initial balloon angioplasty were classified according to the Kobayashi dissection classification (grade A: no dissection; B: mild dissection <1/3 of the lumen; C: severe dissection, ≥1/3 of the lumen) into the nonsevere dissection group (grades A and B), and severe dissection group (grade C). We compared clinical, procedural and lesion-related characteristics between the 2 groups. Factors with statistical significance in univariate analyses were entered into a multivariate logistic regression model to identify independent predictive factors of severe dissection. Severe dissection occurred in 237 limbs and nonsevere dissection in 172 limbs. In univariate analyses, the predictive factors of severe dissection were TransAtlantic Inter-Society Consensus II C/D grades (P < 0.001), lesion length ≥15cm (P < 0.001), chronic total occlusion (P=0.004), and degree of stenosis ≥70% (P < 0.001). Protective factors for severe dissection were end-stage renal disease (P=0.008), severe calcification >50% (P < 0.001), and the use of a scoring balloon (P=0.001). In multivariate analysis, factors associated with severe dissection were lesion length ≥15cm (OR, 2.259; 95% CI: 1.417-4-3.601), occlusion or degree of stenosis ≥70% (OR, 1.931; 95% CI: 1.255-2.971), severe calcification (OR, 0.520; 95% CI: 0.338-0.800), and the use of a scoring balloon (OR, 0.467; 95% CI: 0.263-0.830). Lesion length ≥15cm and occlusion or stenosis ≥70% were identified as independent predictive factors of severe dissection in femoropopliteal artery balloon angioplasty. Conversely, severe calcification and the use of a scoring balloon appeared to be protective factors against severe dissection.

Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry (ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

Predictive Factors of Femoropopliteal Patency after Suboptimal Duplex–Guided Balloon Angioplasty and Stenting: Is Recoil a Bad Sign?

Currently, the value of stenting during femoropopliteal balloon angioplasty (FPBA) remains unclear. Herein we evaluate the patency rates of successful duplex-guided balloon angioplasty (DAGBA) alone versus suboptimal DAGBA followed by stenting and the prestenting dissection versus recoil as potential indicators of stent success or failure. Over a period of 27 months, we performed 291 duplex-guided FPBAs (194 stenoses; 97 occlusions) on 244 limbs in 220 patients. Disabling claudication was the indication in 67%. Critical limb ischemia was the indication in the remaining 33%. Self-expanding nitinol stents were used when plaque dissection and/ or recoil caused diameter reduction > or = 40%. Serial follow-up duplex scans were obtained. Severe restenosis (> 70%) was measured by B-mode imaging and a peak systolic velocity ratio > 3. Follow-up ranged from 1 to 41 months (mean 10 +/- 8.3 months). The overall mean interval for restenosis and occlusion was 6.5 +/- 4.2 months and 5.6 +/- 6.1 months, respectively. Stents did affect overall patency results compared with not using stents. Reasons for stenting were plaque recoil, dissection, or both in 98 (53%), 44 (24%), and 42 (23%) cases, respectively. Six-month patency was 59%, 94%, and 69%, respectively. The difference between plaque recoil and dissection was significant (p<.04). The use of stents during FPBA may be associated with balloon angioplasty site failure in the femoropopliteal segment. To our knowledge, this is the first report ever to document plaque recoil as a predictor of balloon angioplasty site failure notwithstanding stent placement.

Interleukin-6 promoter genotype and restenosis after femoropopliteal balloon angioplasty: initial observations.

To investigate whether there is an association between a functional polymorphism in the interleukin (IL)-6 gene promoter (-174)G/C and restenosis after percutaneous transluminal angioplasty (PTA) of the femoropopliteal artery. A total of 281 patients underwent PTA of the femoropopliteal artery during the study period; 23 (8%) patients had to be excluded due to missing genetic data. We studied 258 patients with intermittent claudication (n = 174) or critical limb ischemia (n = 84). The IL-6 promoter genotype was determined from venous blood samples before intervention by using a mutagenically separated polymerase chain reaction, and patients were followed up for 6 months with duplex ultrasonography for the occurrence of restenosis (> or =50%) after angioplasty. Multivariate Cox proportional hazards analysis was performed to assess the association between the IL-6 promoter genotype and restenosis, with adjustment for possible confounders such as atherosclerotic risk factors and angiographic covariates. The 6-month restenosis rate was 26% (23 of 90) in patients with the (-174)GG genotype, 28% (33 of 117) with the (-174)GC genotype, and 43% (22 of 51) with the (-174)CC genotype (P =.044). Homozygous carriers of the (-174)C allele ([-174]CC) exhibited a 2.42-fold increased adjusted risk for restenosis (95% CI: 1.28, 4.58; P =.007) compared with homozygous (-174)G allele carriers ([-174]GG). Heterozygous carriers ([-174]GC) had no significantly increased restenosis risk (hazard ratio, 1.37; 95% CI: 0.84, 2.22; P =.21). The IL-6 promoter polymorphism (-174)G/C seems to influence the occurrence of restenosis after PTA. Homozygous carriers of the (-174)C allele have an increased rate of intermediate-term restenosis.

Heme oxygenase-1 genotype and restenosis after balloon angioplasty: a novel vascular protective factor

ObjectivesWe investigated the association of the heme oxygenase-1 (HO-1) promoter genotype with the inflammatory response and restenosis after balloon angioplasty. BackgroundHeme oxygenase-1, which is induced by balloon angioplasty, can inhibit neointima formation and vascular remodeling. A dinucleotide repeat in the HO-1 gene promoter shows a length polymorphism that modulates HO-1 gene transcription. Short (<25 guanosine thymidine [GT]) repeats are associated with a 10-fold greater up-regulation of HO-1 than are longer repeats. MethodsWe studied 381 consecutive patients who underwent femoropopliteal balloon angioplasty (n = 210) and comparison groups with femoropopliteal stenting (n = 68) and lower limb angiography (n = 103). C-reactive protein (CRP) was measured at baseline, 24, and 48 h. We evaluated patency at six months by duplex sonography and assessed the association of the length of GT repeats in the HO-1 gene promoter with postintervention CRP and restenosis. ResultsRestenosis within six months was found in 74 patients (35%) after balloon angioplasty and in 21 patients (31%) after stenting. After balloon angioplasty, carriers of the short length (<25 GT) dinucleotide repeats had a lower postintervention CRP at 24 h (p = 0.009) and 48 h (p < 0.001) and a reduced risk for restenosis (adjusted relative risk 0.43, 95% confidence interval: 0.24 to 0.71, p < 0.001) compared with patients with longer alleles. After stenting or angiography, we found no association between the HO-1 genotype with CRP or restenosis. ConclusionsThe HO-1 promoter genotype that controls the degree of HO-1 up-regulation in response to stress stimuli is associated with the postintervention inflammatory response and the restenosis risk after balloon angioplasty.

E-Selectin and restenosis after femoropopliteal angioplasty: prognostic impact of the Ser128Arg genotype and plasma levels.

Perivascular inflammation plays a key role in the development of restenosis after percutaneous transluminal angioplasty (PTA). The adherence of leucocytes to the activated endothelium, an essential feature in the restenotic process, is mediated by the cellular adhesion molecule E-Selectin. A DNA polymorphism in the regulator region of E-Selectin at codon 561 (Ser128Arg) is suggested to modulate the molecule's physiological effects. Therefore, we investigated the association between the E-Selectin Ser128Arg genotype, E-Selectin plasma levels and restenosis after femoropopliteal PTA. We prospectively studied 175 consecutive patients with peripheral artery disease and intermittent claudication (n=126) or critical limb ischemia (n=49) who underwent primary successful femoropopliteal balloon angioplasty. E-Selectin Ser128Arg genotype and base-line E-Selectin plasma levels were determined and patients were followed up for median 12 months (IQR 11 to 14, total range 6 to 24) for the occurrence of postangioplasty restenosis(>/=50%). E-Selectin plasma levels in homozygous Arg128Arg and heterozygous Ser128Arg patients were significantly higher compared to wildtype Ser128Ser patients (p=0.041). Patency rates for wildtype Ser128Ser, heterozygous Ser128Arg and homozygous Ser128Ser patients were 57%, 44% and 50% at 6 months, and 46%, 40% and 17%, at 12 months, respectively (Log Rank p=0.31). Patency rates for increasing tertiles of E-Selectin were 61%, 58% and 37% at 6 months, and 54%, 45% and 30% at 12 months, respectively (Log Rank p=0.020). Patients with an E-Selectin plasma level above 44.9 mg/dL (third tertile) had an 1.9-fold increased adjusted risk for restenosis (95% CI 1.09 to 3.30). E-Selectin plasma levels are modulated by the E-Selectin Ser128Arg genotype, and predict the risk for restenosis after PTA in patients with PAD. A direct association of the Ser128Arg polymorphism with late postangioplasty failure could not be demonstrated.

Angioplasty and Elective Stenting of De Novo versus Recurrent Femoropopliteal Lesions: 1-Year Follow-up

To investigate patency rates after percutaneous transluminal angioplasty (PTA) and PTA plus elective stenting in de novo versus recurrent femoropopliteal lesions. The data were collected from a prospective registry including 533 consecutive patients (284 men; median age 71 years, interquartile range [IQR] 72-78) with severe claudication (n=387) or critical limb ischemia (n=146) who underwent femoropopliteal percutaneous interventions during a 36-month period. PTA was used to treat 357 de novo and 99 recurrent lesions; PTA plus elective stent implantation was performed in 58 de novo and 19 recurrent lesions. Patients were followed for a median 12 months (IQR 7-14) using color duplex sonography. Rates of restenosis (>/=50%) were compared by multivariate analysis. Overall primary technical success was achieved in 517 (97%) patients; 31 (6%) periprocedural complications were encountered. Restenosis occurred in 213 (40%) patients after a median 6 months (IQR 4-7). Twelve-month patency after PTA was 61% in de novo and 33% in recurrent lesions (p<0.0001). Patients with recurrent lesions had a 2.3-fold increased adjusted risk for restenosis after PTA (95% confidence interval 1.7 to 3.2). Twelve-month patency after stenting was 58% in de novo and 52% in recurrent lesions (p=0.9). In patients with de novo lesions, patency rates after PTA and stent were similar (p=0.8); however, in patients with recurrent lesions, elective stenting performed better (p=0.05). Recurrent stenosis after prior femoropopliteal balloon angioplasty is an independent risk factor for restenosis; these lesions exhibit disappointing patency after repeated PTA. Stent implantation may improve intermediate-term results in these patients.

Heme oxygenase-1 genotype is a vascular anti-inflammatory factor following balloon angioplasty.

To investigate the association of the heme oxygenase-1 (HO-1) genotype, which has potent anti-inflammatory capability, and the inflammatory response induced by balloon angioplasty. Three hundred seventeen patients (188 men; median age 70 years, range 57-77) undergoing femoropopliteal balloon angioplasty (n=150) or stenting (n=61) were evaluated for upregulation of the HO-1 genotype; 106 patients undergoing lower limb angiography served as controls. The acute phase reactants C-reactive protein (CRP), serum amyloid A (SAA), and fibrinogen were measured 24 and 48 hours postintervention and compared to baseline values. An association of the relative increase (Delta, %) of these inflammatory markers with short (<25) (GT)(n) dinucleotide repeats in the HO-1 gene promoter was assessed. The HO-1 genotype was significantly associated with Delta CRP(24) (p<0.0001), Delta CRP(48) (p<0.0001), Delta SAA(24) (p=0.02), and Delta SAA(48) (p=0.006) after balloon angioplasty; Delta fibrinogen showed no association. Patients with a higher Delta CRP(48) after balloon angioplasty exhibited significantly reduced odds for the presence of short (<25) (GT)(n) repeats. The adjusted odds reduction in the multivariate model was 80% (p=0.002) in the third quartile of Delta CRP(48) values and 90% (p=0.001) in the fourth quartile. No association of HO-1 genotype and inflammatory response was found 24 and 48 hours after stenting (p=0.3, p=0.5) or angiography (p=0.2, p=0.6). The HO-1 promoter genotype is independently associated with the inflammatory response seen after balloon angioplasty. Short alleles (<25 GT repeats) seem to be an intrinsic vascular anti-inflammatory factor.

Prediction of outcome after femoropopliteal balloon angioplasty by intravascular ultrasound

To evaluate intravascular ultrasound (IVUS) as a control procedure after femoropopliteal percutaneous transluminal angioplasty (PTA), and compare it with arteriography. Descriptive study. Arteriographic and intravascular ultrasound data obtained from 18 patients (20 limbs) undergoing PTA of the superficial femoral or popliteal artery. The degree of stenosis, the diameter and area of the lumen and the morphological changes in the plaque were related to the short-term patency of the intervention, as evaluated by duplex scan and ankle branchial index. Fifteen arteries remained patent. Two occlusions and two stenoses developed during the first 3 months after the intervention and one occlusion occurred after 1 year. The following IVUS parameters were related to a favourable patency: presence of calcification; dissection or plaque rupture and residual stenosis of less than 70%. The arteriographically determined diameter reduction did not show predictive value. This study shows that in contrast to arteriography, IVUS revealed parameters predictive for patency following PTA.