Pathological evaluation of a fluoropolymer-based drug-eluting stent in an arteriovenous graft outflow venous stenosis.

A fluoropolymer-based drug-eluting stent was implanted in an arteriovenous graft outflow venous stenosis. Two and a half years later, due to a local infection, the stent was removed surgically, and a pathological evaluation was conducted. The stent struts exhibited partial endothelial cell coverage, with the remaining surface predominantly covered by fibrin. Notably, there was no evidence of restenosis or aneurysmal change.

Intraluminal vs Subintimal Drug-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Chronic Total Occlusions.

BACKGROUND: Whether intraluminal drug-coated balloon (DCB) angioplasty is superior to subintimal DCB angioplasty regarding femoropopliteal (FP) chronic total occlusion (CTO) outcomes has not been systematically determined. OBJECTIVES: The aim of this study was to compare the 1-year clinical outcomes of intraluminal and subintimal DCB angioplasty for the treatment of patients with symptomatic FP CTO. METHODS: This subanalysis of POPCORN (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease) evaluated 469 lesions in 469 symptomatic patients with lower extremity artery disease who presented with FP CTO and underwent DCB treatment. Wire passage (intraluminal vs subintimal) was evaluated using intravascular ultrasound. The outcome measure, 1-year freedom from restenosis, was compared between subintimal and intraluminal DCB angioplasty groups after propensity score matching analysis. The Institutional Review Boards of participating centers approved this study. Informed consent was obtained from the participants or their families. RESULTS: During the median follow-up period of 14.2 months, restenosis occurred in 140 patients. After propensity score matching, the subintimal group had a significantly lower 1-year rate of freedom from restenosis than the intraluminal group (77.0% vs 84.2%, respectively; P = 0.024). Interaction analysis revealed a more marked increased risk for restenosis in the subintimal DCB angioplasty group in patients with severe calcification, low-dose DCB use, or smoking. CONCLUSIONS: The present study revealed that intraluminal DCB angioplasty was superior to subintimal DCB angioplasty for FP CTO treatment, with a significantly better 1-year rate of freedom from restenosis.

Association of Smoking, Diabetes, and Dialysis with the Presence of Popliteal Lesions in Femoropopliteal Artery Disease.

AIM: Although recent advances in endovascular devices have markedly improved clinical outcomes of femoropopliteal endovascular therapy, lesions located in the popliteal artery are still a major challenge. This study aimed to determine the association of cardiovascular risk factors, including smoking, diabetes mellitus, and dialysis-dependent renal failure, with the location of atherosclerotic lesions in femoropopliteal artery disease. METHODS: We used a multicenter prospective study database registering patients with symptomatic femoropopliteal artery disease undergoing drug-coated balloon treatment. The analysis included 1912 patients with de novo femoropopliteal lesions. The association of clinical characteristics with popliteal lesions was investigated using the logistic regression model. In addition, the femoropopliteal artery was divided into six segments (the proximal, middle, and distal portions of the superficial femoral artery and P1, P2, and P3 segments of the popliteal artery), and the association of clinical characteristics with the presence of atherosclerotic lesions in the respective arterial segments was investigated. RESULTS: Smoking and dialysis-dependent renal failure showed a statistically significant inverse and positive association with the presence of popliteal lesions, respectively (adjusted odds ratio, 0.66 [95% confidence interval, 0.51-0.85] and 2.01 [1.62-2.49]; P=0.001 and P＜0.001), whereas diabetes mellitus did not (P=0.17). The subsequent per-segment analysis presented similar results. CONCLUSIONS: Smoking was inversely associated with popliteal lesions, whereas renal failure on dialysis was positively associated in patients with symptomatic femoropopliteal artery disease who underwent drug-coated balloon treatment. Diabetes mellitus was not significantly associated.

Angioscopic Evaluation of Vascular Response After Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Artery Lesions.

BACKGROUND: Although favorable clinical outcomes have been demonstrated for fluoropolymer-based paclitaxel-eluting stents (FP-DES) in the treatment of femoropopliteal lesions, the vascular response after implantation has not been systematically studied through intravascular imaging.Methods and Results: We angioscopically compared FP-DES: 24 in the early phase (mean [±SD] 3±1 months), 26 in the middle phase (12±3 months), and 20 in the late phase (≥18 months) after implantation. The dominant neointimal coverage grade, heterogeneity of neointimal coverage grade, and thrombus adhesion in the stent segment were evaluated. Neointimal coverage was graded as follows: Grade 0, stent struts exposed; Grade 1, struts bulging into the lumen, although covered; Grade 2, struts embedded in the neointima, but visible; Grade 3, struts fully embedded and invisible. Dominant neointimal coverage and heterogeneity grades were significantly higher in the middle and late phases than in the early phase (all P<0.05), but did not differ significantly between the middle and late phases. The incidence of thrombus adhesion was recorded for all stents in each of the 3 different phases. CONCLUSIONS: The middle and late phases after FP-DES implantation were associated with significantly higher dominant neointimal coverage and heterogeneity grades than the early phase. However, thrombus adhesion was observed in all phases after FP-DES implantation. Arterial healing may not be completed even in the late phase after FP-DES implantation.

Identification of post-procedural optical coherence tomography findings associated with the 1-year vascular response evaluated by coronary angioscopy.

Optical coherence tomography (OCT) provides higher resolution intravascular imaging and allows detailed evaluations of stent implantation sites post-percutaneous coronary intervention (PCI). Coronary angioscopy (CAS) can evaluate the vascular response after drug-eluting stent (DES) implantation. The post-PCI OCT findings that are associated with the CAS 1-year vascular response have not been known. We enrolled 168 lesions from 119 patients who underwent OCT-guided PCI using DES and follow-up CAS observation at 1 ± 0.5 year from August 2012 to December 2019. Outcome measures were sufficient neointimal coverage (NIC) defined as stent struts embedded in the neointima, subclinical intrastent thrombus, and vulnerable stented segments defined as those with angioscopic yellow or intensive yellow color 1 year after PCI. We identified the post-PCI OCT findings associated with these CAS findings. Sufficient NIC, subclinical intrastent thrombus, and vulnerable stented segment were detected in 85 lesions (51%), 47 lesions (28%), and 54 lesions (32%), respectively. A multivariate analysis demonstrated that malapposed struts were negatively associated with sufficient NIC (odds ratio 0.87; 95% CI 0.76-0.99; p = 0.029). However, no specific OCT findings immediately after PCI were associated with subclinical intrastent thrombus or vulnerable stented segment. Malapposition immediately after PCI was negatively associated with sufficient NIC at 1 year even without associations between post-PCI OCT findings and subclinical intrastent thrombus or vulnerable stented segment.

Impact of Guideline-Directed Medical Therapy on 10-Year Mortality after Revascularization for Patients with Chronic Limb-Threatening Ischemia.

AIMS: This study aimed to investigate the long-term impact of guideline-directed medical therapy (GDMT) on 10-year mortality in patients with chronic limb-threatening ischaemia (CLTI) after revascularization. METHODS: We performed a retrospective multicentre study enrolle 459 patients with CLTI who underwent revascularization (396 endovascular therapy [EVT] and 63 bypass surgery [BSX] cases) between January 2007 and December 2011. The primary outcome measure was all-cause mortality. We additionally explored the predictors for all-cause mortality using Cox regression hazard models; the influence of GDMT, defined as prescription of antiplatelet agents, statins, and angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in aggregate, on all-cause mortality, and the association between baseline characteristics using interaction effects. RESULTS: During the 10-year follow-up after revascularization, 234 patients died. In Kaplan-Meier analysis, 10-year mortality was significantly lower in patients who received statins (p＜.001) and ACE inhibitors or ARBs (p=.010) than those who did not. However, there were no differences in 10-year mortality between patients who received anti-platelet agents and those who did not (p=.62). Interaction analysis revealed that GDMT had a significantly different hazard ratio in patients who were and were not on hemodialysis and in those treated with EVT or BSX (p for interaction =.002 and .044, respectively). In the multivariate analysis, age ＞75 years, non-ambulatory status, hemodialysis, congestive heart failure, left ventricular ejection fraction ＜50%, and GDMT were significantly associated with all-cause mortality. CONCLUSIONS: Appropriate GDMT use was independently associated with 10-year mortality in patients with CLTI after revascularization.

Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention.

BACKGROUND: Drug-coated balloons (DCB) are frequently used to treat femoropopliteal artery disease. However, patency loss occurs in ≥10% of patients within 12 months posttreatment with poor understanding of the underlying mechanisms. OBJECTIVES: The authors sought to investigate the determinants of DCB failure in femoropopliteal disease. METHODS: Data from randomized clinical trials (IN.PACT SFA, MDT-2113 SFA Japan) and 2 prespecified imaging cohorts of the IN.PACT Global Clinical Study were included. Influential procedural characteristics were evaluated by an independent angiographic core laboratory. The primary endpoint was DCB failure (patency loss during follow-up). Additional endpoints were binary restenosis and clinically driven target lesion revascularization. Multivariable analyses evaluated the clinical, anatomical, and procedural predictors of DCB failure. RESULTS: Included were 557 participants with single lesions and 12-month core laboratory-adjudicated duplex ultrasonography. Key clinical characteristics were as follows: mean age 68.8 years, 67.5% male, 87.6% with hypertension, 76.9% with hyperlipidemia, 40.5% with diabetes mellitus, 90.5% in Rutherford Classification Category (RCC) 2 to 3, and 9.5% in RCC 4 to 5. Average length and reference vessel diameter (RVD) were 16.37 cm and 4.66 mm, respectively; 49.7% of lesions were totally occluded. In multivariable analysis, only residual stenosis >30% was associated with patency loss, whereas residual stenosis >30% and smaller preprocedure RVD were associated with increased binary restenosis risk. RCC >3 and residual stenosis >30% were associated with increased 12-month clinically driven target lesion revascularization risk. CONCLUSIONS: Patency loss after DCB treatment was influenced by procedural and clinical factors. Residual stenosis >30%, smaller preprocedure RVD, and higher RCC may be considered predictors of increased risk of DCB failure and its components in femoropopliteal artery disease. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA]; NCT01947478; IN.PACT Global Clinical Study; NCT01609296).

What should we expect from intravascular ultrasound use for complex femoropopliteal lesions?

In this review article, we summarize the clinical benefit of intravascular ultrasounds (IVUS) in the endovascular therapy (EVT) of complex femoropopliteal (FP) lesions. Due to the development of novel FP-dedicated devices, outcomes of FP-EVT have been improved. As a result, revascularization methods for the FP lesions have shifted to EVT. However, the long-term durability in complex FP lesions has not yet reached that of bypass surgery using autogenous vein. Strategies for EVT of complex FP lesions are still inconsistent and have room for improvement. Long-term results generally depend on the patient and lesion backgrounds but are also affected by the quality of the procedure. Previous reports have shown IVUS evaluation can better assess vessel size compared to conventional angiographic evaluation. In contrast to angio-guided EVT, which evaluates vessel size by inner diameter, IVUS can be evaluated it with an external elastic membrane, which leads to the selection of a more appropriate (basically, larger) size device. Conversely, angiographic evaluation underestimates the vessel size, suggesting that it may lead to insufficient result. Furthermore, IVUS can also assess the adequate guidewire route, presence of severe dissection etc. As the evidence so far shows, the use of IVUS may improve the quality of EVT procedure, resulting in improved long-term outcomes. In conclusion, despite the widespread use of IVUS in FP-EVT practice, it still conditionally applied. The purpose of IVUS in the EVT of complex FP lesions should be clarified. More evidence regarding the IVUS in complex FP lesions is needed.

Clinical features and prognosis of patients with and without diabetes mellitus undergoing endovascular aortic aneurysm repair.

BACKGROUND: This study aimed to compare the clinical features and prognoses of patients with and without diabetes mellitus (DM) who underwent endovascular repair for aortic aneurysm (AA). METHODS: We analyzed the clinical database of a prospective multicenter study, registering 929 patients who underwent their first endovascular AA repair in Japan between January 2016 and June 2018. The baseline characteristics and prognoses (including all-cause mortality and cardiovascular events) after repair were compared between the DM and non-DM groups. Prognoses were also compared between the groups after propensity score matching. RESULTS: In total, 226 patients (24.3%) had DM. Compared with non-DM patients, DM patients had higher pack-years of smoking (P = 0.011), higher body mass index (P = 0.009), lower high-density lipoprotein cholesterol levels (P = 0.038), higher triglyceride levels (P = 0.025), and lower left ventricular ejection fraction (P = 0.005). Meanwhile, the low-density lipoprotein cholesterol and blood pressure levels showed no significant intergroup difference (all P > 0.05). DM patients had a higher prevalence of myocardial infarction (P = 0.016), history of coronary revascularization (P = 0.015), and lower extremity artery disease (P = 0.019). Lesion characteristics and procedures were similar between the groups (all P > 0.05). DM patients had a higher risk of all-cause mortality and cardiovascular events than non-DM patients (both P < 0.001). Subsequent propensity score matching also demonstrated that DM patients had a significantly lower rate of overall survival (P = 0.001) and freedom from cardiovascular events (P = 0.010). The Kaplan-Meier estimates at 1 year for the overall survival were 85.6% (95% confidence interval [CI], 80.9% to 90.5%) and 94.3% (95% CI, 91.7% to 97.0%) for patients with and without DM, respectively. The corresponding estimates for freedom from cardiovascular events were 79.8% (95% CI, 74.5% to 85.5%) and 87.7% (95% CI, 84.2% to 91.3%), respectively. CONCLUSIONS: Among patients undergoing endovascular AA repair, those with DM had more cardiovascular risk factors. DM patients had a higher incidence rate of all-cause mortality and cardiovascular events. Matching analysis indicated that DM per se would be a risk factor for poor prognoses after AA repair.

Independent Predictors of Major Adverse Cardiovascular Events at 3 Years after Aortoiliac Stent Implantation.

PURPOSE: To identify the risk factors for major adverse cardiovascular events (MACEs) in real-world practice for symptomatic peripheral artery disease in Japan. MATERIALS AND METHODS: Data on Japanese patients (N = 880) from the Observational Prospective Multicenter Registry Study on Outcomes of Peripheral Arterial Disease Patients Treated by Angioplasty Therapy for Aortoiliac Artery who underwent de novo aortoiliac stent placement. The 3-year risk of incident MACEs was investigated. RESULTS: The median age of the patients was 72.6 years (range, 34-97 years), and 83.1% of the patients were men. The patients had the following conditions: smoking (35.6%), hypertension (94.1%), dyslipidemia (81.7%), diabetes (48.0%), renal failure on dialysis (12.6%), myocardial infarction (12.7%), stroke (15.8%), and chronic limb-threatening ischemia (7.1%). Femoropopliteal lesions were present in 38.8% of the limbs with aortoiliac lesions. The 3-year rate of freedom from MACEs was 89.1%. Baseline characteristics, such as age, renal failure on dialysis, myocardial infarction, stroke, and femoropopliteal lesions, were independently associated with the risk of incident MACEs. When the study population was stratified according to these risk factors, the rate of MACEs was highest in patients with at least 3 risk factors (32.9% at 3 years). CONCLUSIONS: The 3-year rate of freedom from MACEs was reported. Baseline characteristics, such as age, renal failure on dialysis, myocardial infarction, stroke, and femoropopliteal lesions, are independent risk factors for MACEs after aortoiliac stent placement.

Influence of catheter ablation for atrial fibrillation on atrial and ventricular functional mitral regurgitation.

AIMS: The purpose of this study was to compare the impact of catheter ablation on cardiac structural reverse remodelling and atrial (AFMR) and ventricular (VFMR) functional mitral regurgitation (MR), and the long-term prognosis of patients with AFMR and VFMR. METHODS AND RESULTS: The retrospective study included persistent AF patients who had AFMR (n = 136, left atrial (LA) volume index >30 mL/m2 and left ventricular (LV) ejection fraction ≥40%) or VFMR (n = 31, LV ejection fraction <40% or LV regional asynergy) and had undergone the initial AF ablation from April 2015 to December 2019. Baseline and 6 month follow-up echocardiography were performed to assess MR, LA, and LV sizes. MR improvement after ablation was comparable in the AFMR (64%) and VFMR groups (52%, P = 0.20). Patients with AFMR improvement showed a greater decrease in left atrial volume after ablation than those without (amount of change: -11.4 ± 15.1 vs. -2.3 ± 21.1 mL/m2 , P = 0.01). Patients with VFMR improvement showed a greater increase in LV ejection fraction than those without (amount of change: 28.5 ± 13.6% vs. 9.0 ± 14.8%, P = 0.001). The composite endpoint of all-cause death and heart failure hospitalization during the 2 year follow-up period was more frequently observed in the VFMR than in the AFMR group (22.6% vs. 3.7%, P < 0.0001). Patients with MR improvement after catheter ablation less frequently demonstrated the composite endpoint than those without (1.9% vs. 15.6%, P < 0.0001). CONCLUSIONS: Atrial functional mitral regurgitation and VFMR improvement after ablation were associated with atrial and ventricular reverse remodelling, respectively. It is possible that long-term prognosis is better in patients with AFMR than with VFMR, and in those with MR improvement than in those without.

Safety, efficacy, and cost-performance of a simplified cryoballoon ablation procedure for paroxysmal atrial fibrillation.

BACKGROUND: The search for a less invasive and lower cost cryoballoon-based strategy for atrial fibrillation (AF) ablation has resulted in a simplified procedure that may be suitable for cryoballoon ablation (CBA). Here, we compared procedural characteristics and outcomes between conventional CBA and simple CBA. METHODS: We enrolled 628 consecutive patients who underwent initial CBA for AF (age, 69 ± 12 years; female, 263 (42%); paroxysmal AF, 576 (92%); CHA2DS2-VASc score, 2.7 ± 1.6 points). Simple CBA was characterized by the minimal procedure required to isolate pulmonary veins, including the following: (1) CBA was performed without guidance from a 3-D mapping system; (2) a coronary sinus electrode and esophageal temperature probe were not used; (3) a waiting period after pulmonary vein isolation was not set; and AF induction by isoproterenol and atrial burst stimuli were not performed. RESULTS: Simple CBA was performed in 240 (38%) patients. Procedural time (49 ± 18 versus 85 ± 27 min, p < 0.01) was shorter, and total procedural costs (20,699 ± 8,091 versus 30,350 ± 11,647 US dollars, p < 0.01) were lower with simple CBA than conventional CBA. Freedom from AF recurrence during the 12-month study period (79.8% versus 78.4%, p = 0.52) and complication rate (8.8% versus 13.1%, p = 0.09) were similar between the two groups. CONCLUSION: Compared with conventional CBA, simple CBA reduced procedural time and procedural costs while providing comparable outcomes.

Association of Age with Mortality Rate after Femoropopliteal Endovascular Therapy for Intermittent Claudication.

AIM: This study aimed to reveal the mortality risk by age in patients undergoing femoropopliteal endovascular therapy for intermittent claudication, in comparison to the national age-specific standard value. METHODS: We analyzed 2056 patients undergoing endovascular therapy for moderate to severe intermittent claudication between 2010 and 2018, performed at five cardiovascular centers in Japan. The 3-year mortality risk by age was compared with the data from year- and sex-matched Japanese citizens, which were obtained from Japan's national life table data. Clinical characteristics associated with age in the study patients were also explored. RESULTS: The mean age was 73±9 years. The 3-year mortality risk was increased with age in the patient population, from 6.4% for patients aged ＜65 years to 21.2% for those aged ≥ 85 years. On the contrary, its risk ratio relative to the matched citizens of the same age was decreased with age; the relative risk ratio was 3.08 for patients aged ＜65 years (P=0.001) and 0.60 for those aged ≥ 85 years (P=0.016). Current smoking, body mass index ≥ 25 kg/m2, hyperlipidemia, diabetes mellitus, and dialysis dependence were inversely associated with age (all P＜0.05). CONCLUSION: Mortality risk increased with age, but the risk ratio relative to the matched citizens decreased with age. Younger patients had a higher mortality risk relative to the matched citizens, whereas patients aged ≥ 85 years had a lower mortality risk relative to the matched citizens. Younger patients were more likely to accumulate cardiovascular risk factors.

Health Related Quality of Life Over Time After Revascularisation in Patients With Chronic Limb Threatening Ischaemia.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) decreases life expectancy and impairs health related quality of life (HR-QOL). Revascularisation is needed to relieve ischaemia and salvage limbs. Although a major goal of CLTI treatment is maintaining QOL, little information is available about changes of HR-QOL over time after revascularisation. HR-QOL with survival after revascularisation for CLTI was assessed. METHODS: The clinical database of the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH), a prospective multicentre observational study, was analysed. Outcome measures were disease specific QOL per the Vascular Quality of Life (VascuQOL) questionnaire and the Short Form (SF) 36 evaluated generic QOL, which were assessed at baseline and three, 12, 24, and 36 months. The outcome measure was change of QOL from baseline. The minimally important difference (half a standard deviation from baseline) was used as the cut off point for improved, worsened, and unchanged QOL. RESULTS: Overall QOL was improved in 61% of patients for the VascuQOL and approximately 40% for the SF-36 component summaries at three months. However, these proportion gradually decreased to 21% - 31% at three years. In contrast, the proportion of deceased patients gradually increased over the three year follow up. Multivariable analysis revealed that pre-operative non-ambulatory status was inversely associated with improved QOL for the three month VascuQOL and SF-36 mental component summary, and surgical reconstruction was positively associated with these measurements. Advanced age and renal failure were inversely associated with improved QOL for the SF-36 mental component summary and VascuQOL at one to three years. CONCLUSION: Revascularisation improved QOL. However, patients with non-ambulatory status exhibited a negative association with improved QOL at three months, and advanced age and renal failure limited benefits one to three years after revascularisation. Accumulating QOL data will be essential for post-revascularisation QOL estimation. Pre-operative assessment, including estimated QOL, is important in shared decision making for patient oriented outcomes in the treatment of CLTI patients.

Impact of homocysteine levels on mortality risk in patients with chronic limb-threatening ischemia undergoing revascularization.

The current study aimed to reveal the clinical impact of plasma homocysteine levels in chronic limb-threatening ischemia (CLTI) patients undergoing revascularization. This was a sub-analysis of a prospective multicenter registry of CLTI patients, named the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH) study. The current analysis included 192 non-dialysis-dependent CLTI patients who underwent revascularization for CLTI, and whose plasma homocysteine levels at baseline were available. The association of clinical characteristics with homocysteine levels was evaluated with the linear regression model. The association of homocysteine levels with the mortality risk was investigated using the Cox proportional hazards regression model. Cystatin C-based estimated glomerular filtration rate (eGFR) was independently associated with log-transformed homocysteine levels; the adjusted standardized regression coefficient (95% confidence interval) was - 0.432 (- 0.657 to - 0.253; P < 0.001). Homocysteine levels were significantly associated with the mortality risk in the univariate model (P = 0.017); the unadjusted hazard ratio was 1.71 (1.13-2.50) per twofold increase. The association was significantly attenuated when adjusted for cystatin C-based eGFR (P < 0.001); the hazard ratio adjusted for cystatin C-based eGFR was 1.28 (0.80-1.90; P = 0.29). An apparent association of homocysteine levels with an increased risk of mortality could be explained by renal dysfunction. Future studies will be needed to validate the current findings.

Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery.

OBJECTIVE: We assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). METHODS: The present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. RESULTS: Of the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier-estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. CONCLUSIONS: Stent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

Saphenous vein size as a surrogate marker for mortality of patients with chronic limb-threatening ischemia undergoing endovascular therapy.

BACKGROUND: The size of the autologous vein graft is an important determinant of prognosis in patients with chronic limb-threatening ischemia (CLTI) undergoing bypass surgery. However, it is unclear whether reconstruction using a small vein graft would directly affect prognosis, or a subgroup having small veins would be subject to a poor prognosis. If the latter is true, having small veins would work as a marker for a poor prognosis even in patients with CLTI undergoing endovascular therapy (EVT). Therefore, we investigated the association between the size of saphenous veins and prognosis in patients with CLTI undergoing EVT. METHODS: This study included 209 consecutive patients with CLTI who primarily underwent EVT between January 2017 and December 2018. The diameter of the saphenous vein was measured at three locations (saphenous-femoral junction, knee, and ankle joint) per limb before EVT by ultrasonography. A small saphenous vein was defined as the mean diameter <3.0 mm. RESULTS: All-cause mortality rate was significantly higher in patients with a small saphenous vein than in those with non-small one (46.3% versus 10.7% at 2 years, p<0.001). The multivariate Cox regression analysis revealed that a small saphenous vein was independently associated with an increased risk of all-cause mortality. CONCLUSIONS: Having a small saphenous vein was an independent marker for all-cause mortality in patients with CLTI undergoing EVT.

Use of a fluoropolymer-based paclitaxel-eluting stent for arteriovenous graft outflow vein stenosis in hemodialysis patients.

We implanted a fluoropolymer-based paclitaxel-eluting stent (FP-PES) in four hemodialysis patients with refractory outflow venous stenosis of their arteriovenous graft. The mean observation period after FP-PES implantation was 11.5 ± 4.7 months (range, 7.0-18.0 months). After FP-PES implantation, the patients were evaluated by ultrasound every 3 months. No of the patients experienced neointimal hyperplasia in the stents during the observation period, and no reintervention was performed. FP-PESs could be an attractive alternative to percutaneous transluminal angioplasty for patients with refractory outflow venous stenosis of arteriovenous hemodialysis grafts.

A case of occluded femoropopliteal saphenous vein bypass with threatening limb ischemia treated with endovascular stent graft relining.

A 61-year-old man presented with chronic limb threatening ischemia due to reocclusion of a femoropopliteal (FP) bypass using a saphenous vein graft (SVG). After performing endovascular intervention using plain angioplasty and drug-coated balloon and drug-eluting stent implantation of the proximal anastomosis of FP bypass, refractory early reocclusion occurred during the perioperative period. Thus, we decided to alternatively place a stent-graft in the occluded FP bypass. After the SVG had been dilated using a high-pressure balloon, a stent-graft was successfully placed. This alternative therapy using a stent-graft prevented SVG FP bypass reocclusion, and the patient's ulcers had completely healed within 1 month.

Drug-coated stent implantation vs. bypass surgery for in-stent occlusion after femoropopliteal stenting.

The optimal revascularization for in-stent occlusion (ISO) lesions after femoropopliteal (FP) bare-nitinol stenting has not been established. We, therefore, investigated the comparison between drug-coated stent (DCS) implantation and bypass surgery (BSX) for ISO lesions after FP bare-nitinol stenting. This study was a dual-center, observational study from January 2004 to December 2015. A total of 172 ISO lesions were observed, and after excluding 120 ISO lesions, 52 ISO lesions (50 patients; mean age, 71.0 ± 9.2 years; male, 59.6%) after FP bare-nitinol stenting were enrolled. The included patients with clinical symptoms underwent either DCS implantation (n = 28) or BSX (n = 22). The primary endpoint was recurrent in-stent restenosis (ReISR); secondary endpoints were recurrent target lesion revascularization (ReTLR), recurrent occlusion (reocclusion) and major adverse limb events (MALE), and perioperative complications (POCs), respectively. ReISR or reocclusion was defined as ISR or occlusion after TLR. Stent restenosis was defined as a peak systolic velocity ratio (PSVR) > 2.4 on a duplex scan or ≥ 50% stenosis on angiography. Graft restenosis was defined as a PSV > 300 cm/s and velocity ratio 3.5 or uniformly low PSV < 45 cm/s throughout the entire graft based on graft surveillance. The mean follow-up period was 36.6 ± 25.5 months. At 2 years, the rates of freedom from ReISR, ReTLR, and MALE were not significantly different between the DCS implantation and BSX groups (68.9% vs. 73.7%, p = 0.81; 84.7% vs. 73.7%, p = 0.45; 84.7% vs. 78.6%, p = 0.60, respectively). However, the freedom from reocclusion rate was significantly lower in the DCS implantation group (81.6% vs. 100%, p = 0.04). The occurrence of POCs was not significantly different between the DCS implantation and BSX groups (7.1% vs 4.2%, p = 1.0). Although BSX was the gold-standard therapy for ISO lesions after FP bare-nitinol stenting, DCS implantation might be a good option because the rates of freedom from ReISR, ReTLR, and MALE were similar.