Safety and efficacy of Symani robotic-assisted microsurgery: Assessment of vascular anastomosis patency, thrombus, and stenosis in a randomized preclinical study.

INTRODUCTION: The Symani surgical system undergoes scrutiny in this study as part of a series of preclinical investigations. Previous studies compared the precision of robotic-assisted anastomoses with manual techniques. This study aimed to evaluate the critical, histological, and gross parameters at the site of anastomosis and at distant sites in a rat model to provide insights into the safety and efficacy of robotic-assisted microsurgery to enhance its potential for clinical adoption. MATERIALS AND METHODS: Experienced microsurgeons performed arterial and venous anastomoses in 16 Wistar rats, randomized into four treatment groups: robotic artery, robotic vein, manual artery, and manual vein. Various parameters were evaluated at two time points (T0 and T30) on the day of the procedure and at Day 28 (T28d). In the second phase of the study, the animals underwent necropsy, histopathologic analysis, micro-CT scans, and angiography imaging of the anastomosis sites, major organs, and distant target organs by a blinded assessor. RESULTS: Patency rates were 100% at T0 and T30 for all anastomoses and stayed at 100% on T28d for the robotic subgroups; however, it decreased to 87.5% for manual arterial anastomoses owing to a case of obstructive thrombus. No evidence of clot migration was observed. Blood flow parameters and procedure times did not differ significantly. The blinded semiquantitative histological analysis revealed no significant disparities between the robotic and manual anastomoses across various pathological indicators. No gross abnormalities were detected in musculoskeletal examinations. CONCLUSION: This preclinical study demonstrated the safety of the Symani surgical system. Results suggest equivalence between robotic and manual techniques regarding thrombus formation at the anastomotic site and distal organs.

CD163+ Macrophages Induce Endothelial-to-Mesenchymal Transition in Atheroma.

BACKGROUND: Cell phenotype switching is increasingly being recognized in atherosclerosis. However, our understanding of the exact stimuli for such cellular transformations and their significance for human atherosclerosis is still evolving. Intraplaque hemorrhage is thought to be a major contributor to plaque progression in part by stimulating the influx of CD163+ macrophages. Here, we explored the hypothesis that CD163+ macrophages cause plaque progression through the induction of proapoptotic endothelial-to-mesenchymal transition (EndMT) within the fibrous cap. METHODS: Human coronary artery sections from CVPath's autopsy registry were selected for pathological analysis. Athero-prone ApoE-/- and ApoE-/-/CD163-/- mice were used for in vivo studies. Human peripheral blood mononuclear cell-induced macrophages and human aortic endothelial cells were used for in vitro experiments. RESULTS: In 107 lesions with acute coronary plaque rupture, 55% had pathological evidence of intraplaque hemorrhage in nonculprit vessels/lesions. Thinner fibrous cap, greater CD163+ macrophage accumulation, and a larger number of CD31/FSP-1 (fibroblast specific protein-1) double-positive cells and TUNEL (terminal deoxynucleotidyl transferase-dUTP nick end labeling) positive cells in the fibrous cap were observed in nonculprit intraplaque hemorrhage lesions, as well as in culprit rupture sections versus nonculprit fibroatheroma sections. Human aortic endothelial cells cultured with supernatants from hemoglobin/haptoglobin-exposed macrophages showed that increased mesenchymal marker proteins (transgelin and FSP-1) while endothelial markers (VE-cadherin and CD31) were reduced, suggesting EndMT induction. Activation of NF-κB (nuclear factor kappa ß) signaling by proinflammatory cytokines released from CD163+ macrophages directly regulated the expression of Snail, a critical transcription factor during EndMT induction. Western blot analysis for cleaved caspase-3 and microarray analysis of human aortic endothelial cells indicated that apoptosis was stimulated during CD163+ macrophage-induced EndMT. Additionally, CD163 deletion in athero-prone mice suggested that CD163 is required for EndMT and plaque progression. Using single-cell RNA sequencing from human carotid endarterectomy lesions, a population of EndMT was detected, which demonstrated significant upregulation of apoptosis-related genes. CONCLUSIONS: CD163+ macrophages provoke EndMT, which may promote plaque progression through fibrous cap thinning.

Impact of baseline yellow plaque assessed by coronary angioscopy on vascular response after stent implantation.

BACKGROUND: The relationship between baseline yellow plaque (YP) and vascular response after stent implantation has not been fully investigated. METHODS: This was a sub-analysis of the Collaboration-1 study (multicenter, retrospective, observational study). A total of 88 lesions from 80 patients with chronic coronary syndrome who underwent percutaneous coronary intervention were analyzed. Optical coherence tomography (OCT) and coronary angioscopy (CAS) were serially performed immediately and 11 months after stent implantation. YP was defined as the stented segment with yellow or intensive yellow color assessed by CAS. Neoatherosclerosis was defined as a lipid or calcified neointima assessed by OCT. OCT and CAS findings at 11 months were compared between lesions with baseline YP (YP group) and lesions without baseline YP (Non-YP group). RESULTS: Baseline YP was detected in 37 lesions (42 %). OCT findings at 11 months showed that the incidence of neoatherosclerosis was significantly higher in the YP group (11 % versus 0 %, p = 0.028) and mean neointimal thickness tended to be lower (104 ±â€¯43 µm versus 120 ±â€¯48 µm, p = 0.098). CAS findings at 11 months demonstrated that the dominant and minimum neointimal coverage grades were significantly lower (p = 0.049 and P = 0.026) and maximum yellow color grade was significantly higher (p < 0.001) in the YP group. CONCLUSIONS: Baseline YP affected the incidence of neoatherosclerosis as well as poor neointimal coverage at 11 months after stent implantation.

Cardiac sympathetic nerve activity trends after renal denervation in heart failure with preserved ejection fraction.

This case report describes the application of ultrasound renal denervation (uRDN) using the Paradise System in a patient with heart failure with preserved ejection fraction. Initially, the cardiac sympathetic nerve activity of the patient exhibited a late heart/mediastinum (H/M) ratio of 2.00 and a washout rate of 66.0% by cardiac iodine-123 metaiodobenzylguanidine (123I-MIBG) scintigraphy. Subsequently, the patient underwent transfemoral uRDN targeting the left, right upper, and right lower renal arteries. At the 6 month follow-up, no significant change was observed in 123I-MIBG findings; however, the estimated stressed blood volume (eSBV) decreased from 1722 to 1029 mL/70 kg. At 18 months, 123I-MIBG findings improved, with the late H/M ratio reaching 2.76 and the washout rate decreasing to 43.1%. This case report highlights the potential of uRDN in reducing eSBV within 6 months and subsequently improving cardiac sympathetic nerve activity at the 18 month follow-up.

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.

Effect of Target Lesion Revascularization on Restenosis Lesions of the Superficial Femoral Artery without Recurred Symptoms after Endovascular Therapy.

AIM: This study aims to elucidate the effects of early application of target lesion revascularization (TLR) to restenosis lesions of the superficial femoral artery (SFA) without recurrence of symptoms. Despite recent improvements in endovascular therapy (EVT) for the SFA, restenosis remains to be a problem. However, restenosis is not always associated with the recurrence of limb symptoms. Although early application of TLR is not generally approved for restenosis lesions of the SFA without recurred symptoms, it is expected to contribute to long-term patency and other favorable outcomes. Nonetheless, its effectiveness remains to be determined. METHODS: We retrospectively analyzed 616 patients who developed restenosis after undergoing femoro-popliteal EVT for claudication (Rutherford category 1 to 3) due to de novo femoro-popliteal lesions between January 2010 and December 2016 at 11 centers in Japan. Recurred symptoms were defined as symptoms of the same or higher Rutherford categories than those immediately before the initial EVT. RESULTS: Of the patients, 291 (47 %) lacked recurred symptoms; 69 (24 %) underwent TLR for restenosis. After propensity matching, the risk of occlusion was determined to be not significantly different between the TLR and observation groups; the 3-year occlusion-free rate was 68 % and 62 %, respectively (P=0.84). The risk of recurring symptoms, critical limb ischemia, and all-cause death was also found to be comparable between groups. The incidence of target vessel revascularization was significantly higher in the TLR than in the observation group (1.55 [95 % confidence interval: 1.25-1.93] vs. 0.59 [0.41-0.85] per 3 person-years). CONCLUSIONS: In patients with SFA restenosis without recurred symptoms, early application of TLR showed no advantages.

Baseline and Updated Information on Nutritional Status in Patients With Chronic Limb Threatening Ischaemia Undergoing Revascularisation.

OBJECTIVE: The aim of this study was to assess the impact of baseline and updated nutritional status on prognosis in patients with chronic limb threatening ischaemia (CLTI) undergoing revascularisation. METHODS: The clinical database of the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH) study, a prospective, multicentre, observational study, was used. The current analysis included 499 patients who underwent endovascular therapy or surgical reconstruction for CLTI. Nutritional status at baseline was evaluated using the Geriatric Nutritional Risk Index (GNRI; baseline GNRI). A GNRI <82 points indicates major nutrition related risk. GNRI was also calculated at 1, 3, 6, 12, 24, and 36 months after revascularisation (updated GNRI). The association between baseline and updated GNRIs and the mortality risk was analysed with the Cox regression model. RESULTS: Mean ± standard deviation (SD) GNRI at baseline was 89.9 ± 9.8 points. The proportion of patients alive with a GNRI ≥82 points was 78% (95% confidence interval [CI] 74-81) at baseline but gradually decreased during follow up, finally reaching 19% (95% CI 0-42) at 36 months. In patients with a GNRI <82 points at baseline, a GNRI of ≥82 points was increased to 37% (95% CI 6-68) 12 months after revascularisation. In the multivariable analysis, baseline and updated GNRIs were associated with a reduced mortality risk independently of each other; the adjusted hazard ratios per 1 SD were 0.80 (95% CI 0.65-0.98; p = .031) and 0.66 (95% CI 0.49-0.91; p = .015), respectively. Similar findings were observed when nutritional status was evaluated using the Controlling Nutritional Stats (CONUT) score, except for the association between its updated value and mortality risk, which marginally lost significance. CONCLUSION: There was still room for improvement in nutritional status after revascularisation for patients with CLTI. Updated GNRI was associated with death independently of baseline GNRI.

Diagnostic performance of coronary angiography utilizing intraprocedural 320-row computed tomography with minimal contrast medium.

Recently developed coronary angiography with intraprocedural 320-row computed tomography can be performed in a catheterization laboratory (XACT) by injecting contrast medium from a place close to the coronary arteries, thereby requiring a minimal amount of contrast medium. However, its clinical application has not yet been established. This study aimed to evaluate the diagnostic accuracy of XACT angiography with a minimal volume of contrast medium in patients with suspected coronary artery disease (CAD). A total of 167 coronary segments were analyzed in 14 patients (9 males, median age 70 years) with suspected CAD by XACT angiography with 7.5 ml of contrast medium and invasive coronary angiography (ICA) with standard techniques. The segmental-based diagnostic accuracy of XACT angiography in detecting stenosis of ≥ 50% and ≥ 75% and visualized by ICA was good (sensitivity: 74% and 62%, specificity: 99% and 99%, positive predictive value: 93% and 80%, and negative predictive value: 97% and 97%, respectively). These results suggest that XACT angiography with a very low amount of contrast medium may have strong clinical utility for screening coronary arteries in patients with renal dysfunction or undergoing clinical procedures such as pacemaker implantation.

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.

Potential mechanisms of in-stent occlusion in the femoropopliteal artery: an angioscopic assessment.

Although stent implantation has become widespread for the treatment of patients with peripheral artery disease with femoropopliteal (FP) lesions, in-stent restenosis, especially in-stent occlusion (ISO), remains as a major concern for refractory recurrence. Furthermore, the mechanisms of ISO in FP lesions have not been well elucidated. We performed angioscopy for 6 lesions (bare-metal stent: 3, drug-eluting stent: 3) from 5 patients (mean age 74 ± 10 years, male 40 %) with ISO in the FP artery immediately after wire-passing or thrombus aspiration. The presence of thrombus as well as the presence and location of organic stenosis were evaluated. Median duration from stent implantation to angioscopic evaluation was 1099.5 (514.5-2272.5) days, while the duration from recurrence of symptoms to angioscopic evaluation was 45 (5.75-60) days. Mixed thrombi were observed in all stents. Organic stenosis was detected at the proximal edge of the stents in 5 lesions. Organic stenosis was observed at the overlapping segment of the stent in one lesion. The distal edge of the stents could be evaluated in 3 lesions, and all of them showed organic stenosis at the site. Mixed thrombi and organic stenosis were observed in all stents. Partial development of organic stenosis in a stent followed by thrombus formation may be the potential mechanism of the development of ISO in the FP artery though the sample size of this study was small and it had no serial angioscopic data so that we should consider it as preliminary one at best.

Impact of infrapopliteal endovascular treatment on the outcome of subsequent ipsilateral distal bypass for critical limb ischemia.

BACKGROUND: We retrospectively reviewed the outcomes of distal bypass for critical limb ischemia and investigated the impact on outcomes of prior unsuccessful ipsilateral infrapopliteal endovascular treatment (EVT). METHODS: Between January 2005 and December 2014, we performed 142 infrainguinal bypasses for critical limb ischemia with ischemic gangrene (Rutherford classes V or VI), including 80 distal bypasses in 74 patients (male 54, female 20, median age 68.4 years, range 51-81 years). All distal bypasses used an autologous saphenous vein graft. Surgical outcomes were compared between 37 distal bypasses without prior infrapopliteal EVT (NEVT group) and 43 distal bypasses after unsuccessful infrapopliteal EVT (PEVT group). Infrapopliteal EVT was performed with balloon dilatation without stenting in all cases. RESULTS: There were no significant differences in preoperative conditions or risk factors between the NEVT and PEVT groups, except for the era of bypass surgery and dependence on hemodialysis. The 3-year primary and secondary patencies were 69% and 72% in the NEVT group and 78% and 80% in the PEVT group (P=0.86, P=0.79). The 3-year limb salvage rates were 81% in the NEVT group and 82% in the PEVT group (P=0.52), and the 3-year amputation-free survival rates were 56% and 57% in the respective groups (P=0.32). Standard errors of the mean for all Kaplan-Meier curves were <10% within 3 years follow-up. CONCLUSIONS: The clinical outcomes of distal bypass without prior infrapopliteal EVT were not superior to those of distal bypass after unsuccessful ipsilateral infrapopliteal EVT. Therefore, unsuccessful infrapopliteal EVT does not have a negative impact on the outcome of subsequent ipsilateral distal bypass in patients with critical limb ischemia.

Comparison of Clinical Outcomes after Surgical and Endovascular Revascularization in Hemodialysis Patients with Critical Limb Ischemia.

AIM: The treatment strategy for hemodialysis (HD) patients with critical limb ischemia (CLI) has been clinically debatable. Here we compared clinical outcomes after bypass surgery (BSX) and after endovascular therapy (EVT) using propensity score matching. METHODS: A retrospective multicenter database of 246 (68 BSX and 178 EVT) consecutive HD patients with CLI (79% with tissue loss) who underwent infrainguinal revascularization from 2007 to 2009 was used to compare clinical outcomes, including overall survival (OS), major amputation (MA), major adverse limb event (MALE: repeat EVT, surgical reconstruction, or MA), and MALE-free survival after BSX vs. EVT using propensity score matching. RESULTS: The median (interquartile range) follow-up duration after revascularization was 21 (8-33) months. The analysis of the 63 propensity score-matched pairs revealed no significant difference in OS (53% vs. 52%, P=0.96), MA (25% vs. 14%, P=0.71), MALE (42% vs. 58%, P=0.63), and MALE-free survival (33% vs. 11%, P=0.37) at 3 year after BSX vs. EVT. CONCLUSIONS: In HD patients with CLI who underwent infrainguinal revascularization, OS, MA, MALE, and MALE-free survival rates were not significantly different after EVT vs. BSX. The less invasive EVT should be considered as the first-choice therapeutic strategy for HD patients with CLI.

Retrograde Approach Using Surgical Cutdown Technique for Limb Salvage in a Case of Critical Limb Ischemia With Severely Calcified Tibial Occlusive Disease.

We here report a successful angioplasty for tibial artery occlusion using direct tibial puncture and subsequent retrograde approach under surgical cutdown technique. An 82-year-old man with ulcer/gangrene in first and second digits was referred to our hospital for endovascular therapy (EVT) of lower extremity ischemia. Diagnostic angiogram revealed anterior tibial artery (ATA) occlusion with severe calcification. Subintimal angioplasty was attempted using a 0.014-inch hydrophilic guidewire but was unsuccessful. A retrograde approach was subsequently attempted for ATA recanalization. However, because of severe calcification of dorsal pedis artery (DPA), percutaneous distal puncture was also unsuccessful. Direct puncture under surgical cutdown technique for DPA was subsequently performed and was successful. A 0.014-inch hydrophilic wire was advanced in retrograde fashion across the ATA occlusion and was used to access the microcatheter positioned at the proximal ATA via antegrade approach. Angioplasty of the ATA occlusion was performed using a 2.5-/3.0-mm tapered balloon. Completion angiogram revealed restoration of flow without dissection. Skin perfusion pressure was dramatically improved. Complete wound healing was achieved 5 months after EVT.

Predicting loss of patency after forearm loop arteriovenous graft.

OBJECTIVE: Although arteriovenous grafts (AVGs) for dialysis access have been applied to patients who were poor candidates for an arteriovenous fistula, durability after AVGs has been clinically suboptimal. This retrospective study investigated whether forearm AVGs based on radial artery inflow would have superior patency to those with brachial artery inflow and evaluated the operative predictors for loss of patency after AVG. METHODS: This multicenter retrospective study included 156 upper limbs in 150 consecutive patients (50% male; age, 70.5 ± 12.8 years) who underwent forearm loop AVG formation from January 2010 to October 2013. The outcome measures were the primary and secondary functional graft patency rates and factors related to primary patency. Primary and secondary patency of AVGs was evaluated by Kaplan-Meier analysis, and predictors for loss of primary patency of AVGs were determined using a Cox proportional hazards model. RESULTS: The median observation period was 10 months (interquartile range, 6-18 months). The 1-year primary patency rate was 32.4%, and the secondary patency rate was 83.4%. Use of the radial artery as the inflow arteriovenous anastomosis (hazard ratio, 0.56; 95% confidence interval, 0.30-0.99) was independently associated as an operative predictor for primary patency after AVG. The primary patency rate was significantly different between radial artery inflow and brachial artery inflow at 1 year (53.8% vs 24.4%; P = .032). CONCLUSIONS: Radial artery selection as inflow artery was independently associated with primary patency after AVG.

Predictors of 2-Year Mortality and Risk Stratification After Surgical or Endovascular Revascularization of Infrainguinal Artery Disease in Hemodialysis Patients With Critical Limb Ischemia.

PURPOSE: To examine the 2-year mortality in hemodialysis (HD) patients with critical limb ischemia (CLI) and determine predictors that may aid in the selection of a revascularization strategy [bypass surgery or endovascular therapy (EVT)] according to current guidelines. METHODS: From 2007 to 2009, 246 consecutive CLI patients (mean age 69±10 years; 170 men) on HD underwent revascularization for de novo infrainguinal lesions (178 EVT and 68 bypass grafting). The majority of the patients had diabetes (170, 69%) and tissue loss (194, 79%); nearly half (111, 45%) were nonambulatory. Overall survival after revascularization was estimated by Kaplan-Meier analysis. Predictors for 2-year mortality after revascularization were determined using a Cox proportional hazards model; results are given as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: Overall survival rate was 77% at 1 year and 66% at 2 years. Predictors of 2-year mortality after revascularization were age >75 years (HR 1.82, 95% CI 1.14 to 2.91, p=0.012), albumin <3 g/dL (HR 2.31, 95% CI 1.39 to 3.84, p=0.001), and ejection fraction <50% (HR 1.73, 95% CI 1.06 to 2.83, p=0.027). Patients with more predictors had a higher incidence of death within 2 years after revascularization. CONCLUSION: Advanced age, low albumin level, and low ejection fraction were independently associated with 2-year mortality after revascularization in HD patients with CLI. Risk stratification by these factors would be useful for deciding on a revascularization strategy.

Usefulness of Endovascular Therapy for Penile Gangrene Secondary to Calciphylaxis: A Case Report.

We here report a case of successful endovascular therapy for penile gangrene in a patient with calciphylaxis and a long history of diabetes mellitus and end-stage renal disease on dialysis. The internal iliac artery, with 75% stenosis, was treated with balloon-expandable bare metal stent implantation, whereas the inferior gluteal artery, 75% stenosis, was treated with balloon dilatation. After endovascular therapy, the intractable penile pain immediately resolved, and penile salvage with complete wound healing was achieved 6 months after the procedure.

Extensive arterial repair one year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery.

Arterial repair differences between paclitaxel-coated nitinol drug-eluting stent (DES) vs. bare-metal stent (BMS) up to 1 year after implantation in the superficial femoral artery (SFA) have not been well characterized. We compared angioscopic findings 1 year after implantation in the SFA of 22 DES in 18 patients and 12 BMS in 9 patients (follow-up period 354 ± 49 vs. 383 ± 81 days, P = 0.20). Neointimal coverage (NIC) was graded as: 0, stent struts exposed; 1, struts bulged into the lumen, although covered; 2, struts embedded by the neointima, but translucent; and 3, struts fully embedded and invisible. NIC was defined as heterogeneous when NIC grade variation was ≥1. Presence of thrombus and yellow plaques (YP) was assessed. Baseline patient and lesion characteristics were similar between the groups. In terms of procedural characteristics, stent diameter was smaller in DES than in BMS (6.5 ± 0.5 vs. 7.4 ± 0.8 mm, P = 0.0020). Both DES (grade 2 5 %, grade 3 95 %) and BMS (grade 3 100 %) revealed dominant NIC grades of 2 or 3 (P = 0.46), however, DES showed greater NIC heterogeneity than BMS (91 vs. 42 %, P = 0.004). Both thrombus and YP were more frequently observed in DES than in BMS (64 vs. 17 %, P = 0.001; 95 vs. 67 %, P = 0.042, respectively). In conclusion, although arterial repair was limited after DES implantation in the SFA, it was extensive at 1 year.

Predictive scoring model of mortality after surgical or endovascular revascularization in patients with critical limb ischemia.

OBJECTIVE: The latest guideline points to life expectancy of <2 years as the main determinant in revascularization modality selection (bypass surgery [BSX] or endovascular therapy [EVT]) in patients with critical limb ischemia (CLI). This study examined predictors and a predictive scoring model of 2-year mortality after revascularization. METHODS: We performed Cox proportional hazards regression analysis of data in a retrospective database, the Bypass and Endovascular therapy Against Critical limb ischemia from Hyogo (BEACH) registry, of 459 consecutive CLI patients who underwent revascularization (396 EVT and 63 BSX cases between January 2007 and December 2011) to determine predictors of 2-year mortality. The predictive performance of the score was assessed with the area under the time-dependent receiver operating characteristic curve. RESULTS: Of 459 CLI patients (mean age, 72 ± 10 years; 64% male; 49% nonambulatory status, 68% diabetes mellitus, 47% on regular dialysis, and 18% rest pain and 82% tissue loss as treatment indication), 84 died within 2 years after revascularization. In a multivariate model, age >75 years (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.10-2.85), nonambulatory status (HR, 5.32; 95% CI, 2.96-9.56), regular dialysis (HR, 1.90; 95% CI, 1.10-3.26), and ejection fraction <50% (HR, 2.49; 95% CI, 1.48-4.20) were independent predictors of 2-year mortality. The area under the time-dependent receiver operating characteristic curve for the developed predictive BEACH score was 0.81 (95% CI, 0.76-0.86). CONCLUSIONS: Predictors of 2-year mortality after EVT or BSX in CLI patients included age >75 years, nonambulatory status, regular dialysis, and ejection fraction <50%. The BEACH score derived from these predictors allows risk stratification of CLI patients undergoing revascularization.

Angioscopically apparent large thrombus and uncovered stent struts 6 months after late stent thrombosis of a paclitaxel-coated nitinol drug-eluting stent implanted in the superficial femoral artery.

A 74-year-old woman complained of claudication due to in-stent restenosis of bare-metal stents in the right superficial femoral artery, and two Zilver PTXs were deployed. However, hemarthrosis developed, and aspirin and clopidogrel were discontinued. Thirty-six days later, she suddenly felt rest pain in her right leg. Angiography revealed total occlusion at the Zilver PTX implantation site, demonstrating late stent thrombosis. Aspiration and thrombolysis yielded adequate flow and symptom resolution. Follow-up catheterization was scheduled 6 months later. While the Zilver PTX stents were angiographically patent, angioscopy demonstrated a large red thrombus and uncovered stent struts. Therefore, dual antiplatelet therapy was continued.