Angiography is not always an accurate indicator of physiologically significant stenosis. We examined the usefulness of functional evaluation of coronary stenosis severity by determining the ...fractional flow reserve (FFR) using a pressure wire in patients who received hemodialysis with angiographically intermediate lesions. We recruited 44 patients with intermediate lesions; of these, 22 were undergoing hemodialysis while 22 were not. Quantitative coronary angiography (QCA) was performed to measure the minimal lumen diameter (MLD) and calculate the percent diameter stenosis (%DS). The FFR was calculated as the ratio of the coronary pressure at the distal stenotic site to the mean aortic pressure during maximum hyperemia. In each group, we investigated the relationship between the FFR and %DS and FFR and MLD. The patients in the hemodialysis group were significantly younger and had more calcified and type B2/C lesions than those in the non-dialysis group. Although the FFR was correlated with both %DS (
r
= 0.71,
p
< 0.01) and MLD (
r
= 0.58,
p
< 0.01) in the non-dialysis group, the FFR was not correlated with either MLD or %DS in the hemodialysis group. In the hemodialysis group, there was a discordance between the QCA- and FFR-based assessments of the severity of coronary stenosis. In patients receiving hemodialysis, both anatomical and functional assessments should be conducted to determine the physiological significance of the stenosis accurately.
Background: Recently, coronary computed tomography angiography (CTA) findings of positive vessel remodeling (PR) and low-attenuation plaque (LAP) have been reported to be associated with the ...development of acute coronary syndromes (ACS). The aim of this study was to examine the CTA detected vulnerable plaque characteristics by using intracoronary optical coherence tomography (OCT). Method and Result: A total of 16 patients with 16 lesions underwent PCI by using intracoronary OCT, after coronary CTA examination, were enrolled in this study. The CTA detected vulnerable plaque (CT-VP) was defined as LAP (<30 hounsfield unit (HU)) with PR of at least 110%. The lesions were divided into a CT-VP and a non CT-VP group. The CT-VP was observed in 7 lesions (43.7%) of all 16 lesions. Acute coronary syndrome (ACS) was more frequent in the CT-VP group than in the non CT-VP group (71.4% vs 11.1%, p<0.001). OCT examination revealed that the frequency of lipid-rich plaque (100% vs 33.3%, p<0.001), thin-cap fibroatheroma (TCFA) (71.4% vs 22.2%, p<0.01), plaque rupture (42.8% vs 11.1%, p<0.05), thrombus (57.1% vs 11.1%, p<0.01) and macrophage accumulation (100% vs 44.4%, p<0.01) were significantly higher in the CT-VP compared with the non CT-VP group. Conclusion: Our OCT study revealed that the CT-VP was correlated with OCT detected lipid-rich plaque, TCFA and macrophage accumulation leading plaque rupture and thrombus formation, which might contribute to the development of ACS.
The aim of this study was to investigate the clinical outcomes of pedal artery angioplasty (PAA) for patients with critical limb ischemia.
Pedal artery disease is considered a predictor of delayed ...wound healing (DH) after endovascular therapy. Adjunctive PAA might improve the speed and extent of wound healing.
Consecutive patients with critical limb ischemia (n = 257) presenting with de novo infrapopliteal and pedal artery disease were retrospectively reviewed from a multicenter registry. Patients were divided into 2 groups according to whether PAA was performed (n = 140) or not (n = 117). The rate of wound healing and time to wound healing were compared between these groups. DH score was calculated using the number of independent predictors of DH. Patients were stratified into 3 groups according to DH score: low risk (DH score = 0), moderate risk (DH score = 1 or 2), and high risk (DH score = 3). Estimated efficacy was analyzed for each risk-stratified population.
The rate of wound healing was significantly higher (57.5% vs. 37.3%, p = 0.003) and time to wound healing significantly shorter (211 days vs. 365 days; p = 0.008) in the PAA group. In a multivariate analysis, nonambulatory status, target wound depth (UT grade ≥2), and daily hemodialysis were revealed as predictors of DH. In the moderate-risk population, adjunctive PAA significantly improved the rate of wound healing (59.3% vs. 33.9%; p = 0.001). In the high-risk population, however, PAA did not affect wound healing.
Patients who underwent PAA showed a higher rate of wound healing and shorter time to wound healing, especially in the moderate-risk population. With regard to wound healing, this aggressive strategy might become a salvage procedure for patients with critical limb ischemia presenting with pedal artery disease.
Surgical thromboendarterectomy has been the gold standard treatment for common femoral artery (CFA) disease. However, endovascular therapy (EVT) is conducted in certain patients with CFA lesions ...because of multiple comorbidities. The interwoven nitinol stent (IWS) has been developed to prevent stent fracture. Thus, this study aimed to evaluate the feasibility of EVT using IWS for CFA lesions in clinical practice.
This retrospective multicenter registry analyzed patients who had symptomatic lower-extremity artery disease due to CFA lesions and underwent EVT using IWS between 2019 and 2021. The primary endpoint was restenosis 2 years after EVT.
This study enrolled a total of 177 patients with 196 CFA lesions. The 2-year estimate of freedom from restenosis was 88.0%. The 2-year freedom rates from the target-lesion revascularization, major amputation, and all-cause death were 92.9%, 99.0%, and 75.2%, respectively. The clinical features significantly associated with restenosis risk were the reference vessel diameter (RVD, per 1.0 mm, hazard ratio HR, 0.24 0.08-0.70; p=0.009), external iliac artery (EIA) involvement (HR=4.03 1.56-10.4; p=0.004), superficial femoral artery (SFA) involvement (HR=3.05 1.00-9.25; p=0.049), body mass index (BMI; per 1.0, HR=0.85 0.73-0.99; p=0.032), occlusion of deep femoral arteries (DFAs) at baseline (HR=7.89 2.04-30.5; p=0.003), and chronic limb-threatening ischemia (CLTI, HR=2.63 1.02-6.78; p=0.045). Their significant association was also confirmed by the random survival forest analysis. During a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases (37.2%), and no patients had cannulation-related complications, such as failed hemostasis, fracture of IWS, and stent occlusion.
Endovascular therapy using IWS in CFA lesions showed acceptable 2-year patency rates at 88.0% and might preserve the arterial access via the ipsilateral CFAs. Small RVD, involving EIA and SFA lesions, emaciation, occluded DFA, and CLTI are associated with poor 2-year patency rates following EVT, thus, IWS implantation in CFA lesions may be an option for patients unsuitable for surgical revascularization.
This retrospective multicenter registry enrolled 177 patients with 199 CFA lesions treated with EVT using interwoven nitinol stents, because surgical thromboendarterectomy was difficult due to their multiple comorbidities. The 2-year estimate of freedom from restenosis was acceptable at 88.0%. The 2-year freedom rate from major amputation was also high at 99.0%. Moreover, during a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases, and no patients had cannulation-related complications such as failed hemostasis, fracture of IWS, and stent occlusion.
Purpose:
This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year ...outcomes of these stents have not been elucidated.
Materials and Methods:
Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings.
Results:
The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan–Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812).
Conclusions:
The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings.
Clinical Impact
This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.
In the multivariate analysis, non-ambulatory status, target wound depth (University of Texas grade >=2), and daily hemodialysis were revealed as predictors of delayed wound healing. Conclusion ...Patients who received PAA showed higher wound-healing rate and earlier time to wound healing, especially in the moderate-risk population.
Purpose: To assess calcium patterns in superficial femoral artery (SFA) disease before and after balloon angioplasty ± stent implantation using fluoroscopy, angiography, and intravascular ultrasound ...(IVUS) imaging and then correlate calcification severity and midterm clinical outcomes. Materials and Methods: A multicenter investigation was carried out to retrospectively review 130 symptomatic patients (mean age 73.2±8.4 years; 86 men) with de novo SFA lesions who had successfully undergone endovascular therapy (EVT) at 7 centers between January and October 2015. The primary outcome was lumen gain measured as minimum lumen area (MLA) in post-EVT IVUS images according to calcification severity. The secondary outcomes included rates of stent malapposition, restenosis, and clinically-driven target lesion revascularization (TLR). Results: A total of 102 (78.5%) cases had calcification in the lesions over a mean length of 64.3±72.8 mm. Of these, 70 cases were classified as having bilateral calcification according to fluoroscopy and angiography; 50 (49%) lesions had ≥180° calcification according to IVUS. The lumen gain in calcified lesions was significantly smaller than in the 28 noncalcified lesions (14.1±4.4 vs 17.8±5.2 mm
2
, p<0.001). IVUS-evaluated circumferential distribution of calcium (<180° or ≥180°) was independently associated with lumen gain after EVT (p<0.001). Among the calcification characteristics, a calcification angle ≥180° showed the strongest correlation to postprocedure MLA. Moreover, the restenosis rate was significantly higher in the severe (≥180°) calcification group (p<0.018). The severity of calcification was also associated with the risk of stent malapposition (p=0.022 for trend) but not TLR (p=0.57). Conclusion: IVUS evaluation of calcification in SFA lesions predicted lumen gain after EVT. Severe calcification in a ≥180° arc prevented successful dilation of the lesion with either plain balloon angioplasty or a nitinol stent. Accurate assessment of calcification patterns by IVUS is useful in maximizing the efficacy of endovascular therapy.
Objectives
To assess the efficacy of indigo carmine angiography for wound healing after successful below‐the‐knee intervention in patients with critical limb ischemia (CLI).
Methods
A multi‐center ...prospective intervention study was conducted. Fifty‐four limbs of 53 patients in Rutherford categories 5 and 6 underwent endovascular therapy (EVT). After successful EVT, 5 mL of indigo carmine was injected through a catheter at the distal popliteal artery and color changes in the foot were evaluated. The results of indigo carmine angiography were divided into three groups: In type I, the color change of the wound was deeper than the surrounding tissue; in type II, the change in wound color was similar to the surrounding tissue; and in type III, no discoloration of the wound was observed by the indigo carmine.
Results
The wound healing rates at 3 months were 78% (25/32) for type I, 70% (7/10) for type II, and 42% (5/12) for type III (P for trend = 0.025). Indigo carmine angiography‐related complications were not seen.
Conclusion
Indigo carmine angiography was found to be a safe and useful procedure to provide visual information on foot perfusion. This dye coloring method demonstrated that after successful angioplasty, the perfused area was made visible at the microcirculation level. Indigo carmine angiography can thus be considered an important predictor for wound healing by EVT in patients with CLI.
This study investigated the correlation between vascular flow reserve (VFR) values and wound healing rate in patients with critical limb ischemia.
Peripheral VFR may be useful for predicting complete ...wound healing after endovascular therapy (EVT). However, published reports included small numbers of patients from single centers and long-term outcomes remain unknown.
This was a prospective multicenter study that consecutively enrolled 104 patients (115 limbs) who received EVT for ischemic ulcerations. All lesions were treated with conventional balloon angioplasty. After EVT, VFR was measured using a pressure/temperature guidewire. The study endpoints were correlation between VFR values and wound healing rate at 3 months and 1 year.
The median VFR was 2.9. A total of 110 and 104 limbs completed the 3-month and 1-year follow-up, respectively. The 3-month and 1-year wound healing rates were 49% and 76%, respectively. VFR was significantly associated with the 3-month and 1-year wound healing (p < 0.001 for both). The crude hazard ratios of VFR (per 2-fold increase) for the 3-month and 1-year wound healing were 2.6 (1.7 to 3.9) and 2.9 (2.0 to 4.2), respectively. The estimated median time to wound healing was 5.0 (3.2 to 7.2) months, 3.3 (2.8 to 4.9) months, and 2.5 (2.0 to 3.0) months, when the VFR value was 2.4, 2.9, and 3.9, respectively.
Post-procedure VFR is significantly associated with wound healing. VFR, measured in the catheterization laboratory, is useful in clinical risk stratification for patients with critical limb ischemia after EVT. (Predictor of Wound Healing in Patients with Critical Limb Ischemia-Multicenter Prospective Study; UMIN000012746)
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