Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study.

BACKGROUND: Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported. MATERIALS AND METHODS: This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group. RESULTS: The propensity score matching extracted 112 pairs. At 12 months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference (P = .004). However, at 36 months, the rate was 43.3% vs 39.2%, with no significant difference (P = .090). No baseline characteristics had any significant interaction effect (all P > .05). CONCLUSIONS: The New devices were more effective than the control group for ISR/O at 1 year, but caught up at 3 years.

Prognostic impact of Achilles tendon thickness in elderly patients after percutaneous coronary intervention: A 5-year follow-up.

BACKGROUND: Evaluating the Achilles tendon thickness (ATT) may be beneficial for risk stratification of long-term secondary cardiovascular events among patients who underwent percutaneous coronary intervention (PCI). METHODS: This observational study evaluated major adverse cardiac and cerebrovascular events (MACCEs), including cardiovascular death/death from unknown causes, at 5 years after PCI according to the baseline ATT (≥9 mm vs. <9 mm). RESULTS: Overall, 355 patients aged ≥75 years were enrolled; 47 (13.2 %) and 308 patients (86.8 %) had an ATT ≥9 mm and <9 mm, respectively. The incidence of MACCEs at 5 years was numerically higher but not significantly different for the ATT ≥9 mm group compared with the ATT <9 mm group (Gray's p-value = 0.10). However, the incidence of cardiovascular death/death from unknown causes at 5 years was significantly higher in the ATT ≥9 mm group than in the ATT <9 mm group (Gray's p-value = 0.034). Multivariable Fine and Gray competing risk analysis showed that an ATT ≥9 mm was associated with both MACCEs [hazard ratio (HR), 1.95; 95 % confidence interval (CI), 1.12-3.41; p-value = 0.019] and cardiovascular death/death from unknown causes (HR, 2.81; 95 % CI, 1.31-6.03; p-value = 0.008) at 5 years in patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2. CONCLUSIONS: A significantly thick Achilles tendon could be a marker for MACCEs, including cardiovascular death/death from unknown causes, at 5 years among elderly patients with an eGFR ≥30 mL/min/1.73 m2 after PCI.

Association between cancer history and second-generation drug-eluting stent thrombosis: insights from the REAL-ST registry.

BACKGROUND: Cancer-associated thrombosis is a frequent complication of cancer; however, little evidence is available regarding the association between cancer history and coronary artery stent thrombosis (ST). We aimed to investigate the relationship between cancer history and second-generation drug-eluting stent thrombosis (G2-ST). METHODS: From the REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation Drug-Eluting Stent Implantation) registry, this study evaluated 1265 patients (G2- ST cases, n = 253; controls, n = 1012) with cancer-related information available. RESULTS: The prevalence of patients with cancer history was higher (12.3% vs. 8.5%, p = 0.065), and that of currently diagnosed and currently treated cancer was significantly higher in ST cases than controls (3.6% vs. 1.4%, p = 0.021; 3.2% vs. 1.3%, p = 0.037, respectively). Multivariable logistic regression analysis revealed that cancer history was associated with late ST (odds ratio [OR]: 2.80, 95% confidence intervals [CI]: 0.92-8.55, p = 0.071) and very late ST (OR: 2.40, 95% CI: 1.02-5.65, p = 0.046), but not with early ST (OR: 1.01, 95% CI: 0.51-2.00, p = 0.97). During the median follow-up period of 872 days after the index ST events, patients with cancer history showed a higher mortality than those without, among both ST cases (hazard ratio [HR]: 1.93, 95% CI: 1.06-3.51, p = 0.031) and controls (HR: 1.93, 95% CI: 1.09-3.40, p = 0.023). CONCLUSION: A post hoc analysis of REAL-ST registry revealed that patients with G2-ST had a higher prevalence of currently diagnosed and currently treated cancer. Notably, cancer history was associated with the occurrence of late and very late ST, but not with early ST.

Multicenter, retrospective registry of isolated atherosclerotic popliteal arteries treated with endovascular revascularization.

Isolated atherosclerotic popliteal lesions (IAPLs) have been considered challenging. This study aimed to investigate the efficacy of endovascular therapy (EVT) using the newer devices for IAPLs. This retrospective multicenter registry analyzed patients with lower extremity artery disease having IAPLs who underwent EVT using the newer devices between 2018 and 2021. The primary outcome was primary patency 1 year after EVT. A total of 392 consecutive patients undergoing EVT for IAPLs were enrolled. The Kaplan-Meier analysis showed that the primary patency and the freedom from target lesion revascularization were 80.9% and 87.8% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that the clinical features that were independently associated with restenosis risk were drug-coated balloon (DCB) use for younger age (< 75 years old; adjusted hazard ratio, 3.08 [95% confidence interval 1.08-8.74]; P = 0.035), non-ambulatory status (2.74 [95% confidence interval 1.56-4.81]; P < 0.001), cilostazol use (0.51 [95% confidence interval 0.29-0.88]; P = 0.015), severe calcification (1.86 [95% confidence interval 1.18-2.94]; P = 0.007), and small external elastic membrane (EEM) area measured by intravascular ultrasound (IVUS) (< 30 mm2) (2.07 [95% confidence interval 1.19-3.60]; P = 0.010). From the univariate analysis, among patients treated with DCB, younger patients (n = 141) were associated with more comorbidities including smoking (P < 0.001), diabetes mellitus (P < 0.001), end-stage renal disease (P < 0.001), history of revascularization (P = 0.046) and small EEM area (P = 0.036), compared to older patients (n = 140). Moreover, smaller post-procedural minimum lumen area measured by IVUS after DCB dilatation was observed in younger patients (12 ± 4 vs. 14 ± 4 mm2, P = 0.033). This retrospective study demonstrated that the current EVT provided an acceptable 1-year primary patency rate in patients with IAPLs. The primary patency was lower following DCB in younger patients, likely due to the higher rates of comorbidities in this patient population.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns).

PURPOSE: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. MATERIALS AND METHODS: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. RESULTS: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). CONCLUSIONS: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. CLINICAL IMPACT: Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

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.

Limb-Based Patency After Surgical vs Endovascular Revascularization in Patients with Chronic Limb-Threatening Ischemia.

PURPOSE: To determine whether limb-based patency (LBP) after infrainguinal revascularization for chronic limb-threatening ischemia (CLTI) is similar between bypass surgery and endovascular therapy (EVT). MATERIALS AND METHODS: The database for the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study was interrogated to identify 130 patients (mean age 73±8 years; 94 men) who underwent bypass surgery and 271 patients (mean age 74±10 years; 178 men) who underwent EVT alone. Skin perfusion pressure (SPP) and the ankle-brachial index (ABI) were measured before the procedure and at 0, 1, and 3 months after revascularization. The outcome measure was hemodynamically evaluated LBP (SPP ≥10 mm Hg or ABI ≥0.1) maintained over the first 3 months after treatment. Any reintervention or major amputation was regarded as loss of LBP. The associations between the revascularization strategy (bypass vs EVT) and between the preoperative characteristics and the study outcome (ie, SPP- or ABI-based LBP), were determined using generalized linear mixed models with a logit link function. Patency rates are presented with the 95% confidence interval (CI). RESULTS: The bypass surgery group had a higher stage of limb severity (WIfI) and anatomic complexity (GLASS) than the EVT group, whereas the EVT group had a higher prevalence of heart failure. Both SPP- and ABI-based LBP rates were higher in the bypass group than in the EVT group. SPP-based LBP rates at 3 months were 73.8% (95% CI 63.4% to 84.2%) in the bypass group and 46.2% (95% CI 38.5% to 53.8%) in the EVT group; the corresponding ABI-based LBP rates were 71.5% (95% CI 61.8% to 81.2%) and 44.0% (95% CI 37.3% to 50.7%). CONCLUSION: LBP is an important concept in the new global vascular guidelines for assessing the anatomic and hemodynamic status of CLTI patients. The present study found that LBP was significantly lower in the EVT group vs the bypass surgery group.

Risk Factors and Long-Term Clinical Outcomes of Second-Generation Drug-Eluting Stent Thrombosis.

Background The risk factors and long-term clinical outcomes of patients with definite stent thrombosis (ST) after second-generation drug-eluting stent (DES) implantation have not yet been adequately assessed. Methods and Results The REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation DES Implantation) included 313 definite ST of second-generation DES (early ST, n=179; late ST, n=66; very late ST, n=68). Four patients without definite ST of second-generation DES were identified as control patients for each ST case. Risk factors of definite ST were mostly different according to the timing of ST: ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina at presentation, current smoking, left ventricular ejection fraction <40%, prior percutaneous coronary intervention, stent overlap, severely calcified lesion, left main coronary artery lesion, proximal left anterior descending lesion, postdiameter stenosis ≥20%, for early ST; age <70 years, ST-segment-elevation myocardial infarction at presentation, hemodialysis, left ventricular ejection fraction <40%, in-stent restenosis, and severely calcified lesion for late ST; and proximal left anterior descending lesion and in-stent restenosis for very late ST. Cumulative 4-year incidence of death after the index ST events was significantly higher in the ST patients than control patients (33.0% versus 12.3%, P<0.001 for early ST versus control; 30.6% versus 14.2%, P<0.001 for late ST versus control; and 28.0% versus 13.0%, P<0.001 for very late ST versus control, respectively). Conclusions Risk factors of definite ST after second-generation DES implantation were mostly different according to the timing of ST. Definite ST patients showed unfavorable long-term clinical outcomes compared with those without definite ST. Clinical Trial Registration URL: https://www.umin.ac.jp . Unique identifier: UMIN000025181.

Immunoglobulin G4-related constrictive pericarditis identified by cytological examination of pericardial effusion: a case report.

BACKGROUND: Immunoglobulin G4-related disease is increasingly recognized as a systemic autoimmune disorder characterized by immunoglobulin G4-positive lymphocyte infiltration. Organ biopsy and histopathology are the most important diagnostic methods; however, the significance of a cytological examination in immunoglobulin G4-related disease cases is still unclear. CASE PRESENTATION: A 73-year-old Asian man who was a former tobacco smoker presented with progressive exertional dyspnea, systemic edema, and pericardial effusion. A cytological examination of his pericardial effusion detected three or four plasma cells per high-power field by Giemsa staining. Moreover, immunoglobulin G4-positive plasma cells were detected by immunostaining. Cardiac catheterization after pericardiocentesis revealed that both ventricular pressure traces showed an early diastolic dip and plateau. Positron-emission tomography with 18F-fluorodeoxyglucose imaging revealed inflammatory foci in his pericardium. A surgical pericardiectomy was performed and the resultant specimen showed significant immunoglobulin G4-positive plasma cell infiltration and marked fibrous thickening of his pericardium; therefore, a diagnosis of constrictive pericarditis due to immunoglobulin G4-related disease was made. Oral administration of 0.6-mg/kg/day prednisolone resolved his heart failure and he was discharged on foot 1 week later. CONCLUSION: Our experience with this case indicates that cytological examination of pericardial effusion was useful in the diagnosis of immunoglobulin G4-related disease.