Impact of Dialysis Vintage and Renal Biomarkers on Mortality in Dialysis-Dependent Patients With Critical Limb Ischemia Undergoing Revascularization.

PURPOSE: Revascularization of both endovascular therapy (EVT) and surgical reconstruction improve clinical outcomes of patients with critical limb ischemia (CLI); however, treatment of dialysis-dependent patients with CLI is still challenging. This study aimed to investigate the impact of dialysis-related parameters on the risk of mortality in dialysis-dependent patients undergoing revascularization for CLI. MATERIALS AND METHODS: We retrospectively identified 274 dialysis-dependent patients with CLI (196 males; mean age 71 years), who underwent revascularization, from the clinical database of the surgical reconstruction vs peripheral intervention in patients with critical limb ischemia (SPINACH) study, which was a prospective, multicenter, observational study. Of these patients, 175 patients underwent EVT and 99 patients received surgical reconstruction. The current study evaluated the impact of dialysis vintage and renal biomarkers on the mortality rate of dialysis-dependent patients with CLI undergoing revascularization. RESULTS: During a mean follow-up period of 1.7 ± 1.1 years, 147 deaths were observed. The 3-year overall survival rate and its standard error were estimated to be 40.5% ± 8.1% using the Kaplan-Meier method. A Cox proportional hazard analysis revealed that dialysis vintage ≥4 years, serum creatinine levels <4.7 mg/dL, serum urea nitrogen ≥88 mg/dL, and calcium-phosphate product ≥62.6 mg2/dL2 were independent risk factors for mortality after adjustment for the detailed mortality risk score developed in the SPINACH study. Adding these parameters to the original mortality risk score slightly, but not significantly, increased the area under the time-dependent receiver operating characteristics curve from 0.74 (95% CI, 0.67 to 0.81) to 0.77 (0.71 to 0.84) (p=0.084), whereas continuous net reclassification improvement reached 0.75 (0.12 to 0.90) (p=0.027). CONCLUSION: We found that long dialysis vintage, low serum creatinine, high serum urea nitrogen, and high calcium-phosphate product were independently associated with the increased risk of mortality in dialysis-dependent patients with CLI undergoing revascularization.

The impact of percutaneous coronary intervention using the novel dynamic coronary roadmap system.

The dynamic coronary roadmap (DCR) is a novel technology that creates a dynamic, motion-compensated, real-time overlay of the coronary arteries on a fluoroscopic image. Whether the DCR reduces contrast volume and enables safe and effective treatment was examined. A total of 146 patients undergoing percutaneous coronary intervention (PCI) from June 2017 to September 2017 in our hospital were retrospectively evaluated. Chronic total occlusion lesions, acute coronary syndrome, and hemodialysis patients were excluded. Patients were divided into the control group (PCI without DCR, 92 patients, 103 lesions) and the DCR group (38 patients, 43 lesions). The primary endpoint was contrast medium volume, and secondary endpoints were radiation dose, fluoroscopy time, and clinical success rate. There was no significant difference in the success rate (100% vs. 100%, P = 1.000) between the groups. Fluoroscopy time (16.3 ± 11.2 min. vs. 11.4 ± 5.5 min, P = 0.007) and contrast medium volume (152.1 ± 73.0 ml vs. 118.8 ± 49.7 ml, P = 0.006) were significantly lower in the DCR group than in the control group. DCR use during PCI was associated with a significant reduction in contrast volume and fluoroscopy time compared to a control group despite similar clinical, lesion, and procedural characteristics.

Influence of Repeat Intervention on the Risk of Major Amputation After Infrapopliteal Angioplasty for Critical Limb Ischemia.

PURPOSE: To assess the influence of repeat intervention on the risk of major amputation after infrapopliteal angioplasty for patients with critical limb ischemia (CLI). METHODS: A multicenter database of Japanese CLI patients was interrogated to identify patients who underwent balloon angioplasty for isolated infrapopliteal lesions from April 2004 to December 2012. In that time frame, 1298 limbs of 1065 patients (mean age 72±10 years; 739 men) were eligible for this analysis. The prevalence of tissue loss was 76%, with 33% accompanied by infection. The association between repeat intervention and future risk for major amputation was evaluated using a mixed effects logistic regression model. A stratification analysis was also performed with baseline variables. A supplementary analysis compared baseline characteristics between the cases with and without repeat intervention. Hazard ratios (HR) and their 95% confidence intervals (CI) are reported. RESULTS: Median follow-up was 1.2 years (interquartile range 0.4-2.5), during which time 143 (11.0%) limbs had major amputations and 499 (38.4%) underwent repeat intervention. The mixed effects modeling revealed that repeat intervention was significantly associated with future risk for major amputation (unadjusted HR 3.01, 95% CI 2.05 to 4.41, p=0.001). From the stratification analysis, repeat intervention significantly increased future risk of major amputation in cases with regular dialysis (HR 3.35, 95% CI 2.14 to 5.26, p<0.001), whereas it did not in those without dialysis. The supplemental analysis showed that patients with repeat intervention within 1 year had a higher prevalence of nonambulatory status, regular dialysis, tissue loss, and infection at baseline compared to those without repeat intervention for 1 year. CONCLUSION: In the patients with CLI due to infrapopliteal lesions, the need for repeat intervention increased the risk of future major amputation. However, this correlation was not applicable to nondialysis patients.

Propensity Score Analysis Comparing Clinical Outcomes of Drug-Eluting vs Bare Nitinol Stents in Femoropopliteal Lesions.

PURPOSE: To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS). METHODS: A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis. RESULTS: The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup. CONCLUSION: These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions.

Drug-Eluting Stent vs Percutaneous Transluminal Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis: Results From a Retrospective 1-Year Multicenter Study.

PURPOSE: To compare drug-eluting stent (DES) implantation with percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal in-stent restenosis (ISR). METHODS: A comparison was performed of data from 112 ZEPHYR registry patients (mean age 74±9 years; 60 men) with 119 femoropopliteal ISR lesions treated with a drug-eluting stent (Zilver PTX) with historical data from 116 patients (mean age 72±8 years; 83 men) with 133 lesions treated with PTA. The patients were stratified for analysis by lesions with (101/252, 40%) and without (n=151) in-stent occlusion. The primary outcome measure was the 1-year incidence of recurrent restenosis; the secondary outcome was major adverse limb events (MALE). Multivariate logistic regression analysis was performed to look for any independent association of DES implantation with 1-year recurrent restenosis in the respective subgroups; results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: In the subgroup without in-stent occlusion, there was no significant difference between DES and PTA in the 1-year incidence of recurrent restenosis (40.5% vs 45.7%, p=0.583, respectively) or MALE (27.8% vs 20.7%, p=0.322, respectively). However, in the subgroup with in-stent occlusion, DES implantation was associated with significantly lower incidences of recurrent restenosis (44.1% vs 90.3% for PTA, p<0.001) and MALE (25.5% vs 53.6% for PTA, p<0.001). Multivariate analysis confirmed that DES implantation had a significant independent negative association with the risk of recurrent restenosis in the subgroup with occlusion (OR 0.2, 95% CI 0.1 to 0.6, p=0.006). CONCLUSION: DES implantation may be more effective than PTA in the management of femoropopliteal ISR with occlusion, but equally effective to PTA in nonocclusive ISR lesions. These results require confirmation in prospective randomized studies.

Influence of hemodialysis duration on mid-term clinical outcomes in hemodialysis patients with coronary artery disease after drug-eluting stent implantation.

Accelerated atherosclerosis in prolonged maintenance hemodialysis (HD) has been recognized; however, whether HD duration is associated with poor clinical outcome in HD patients with coronary artery disease (CAD) after drug-eluting stent (DES) implantation is unknown. We evaluated the impact of HD duration on clinical outcomes in HD patients with CAD after DES implantation. Between April 2007 and December 2012, 168 angina pectoris patients (320 de novo lesions) on HD were treated with DES. Major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) were investigated at 3 years according to the HD duration (≤ 3 years, 83 patients; >3 years, 85 patients). The incidence of MACE was significantly higher in the long HD duration group (25.3 vs. 50.6 %; P = 0.001). Especially, sudden cardiac death (SCD) was significantly higher in the long HD duration group (3.6 vs. 16.5 %; P = 0.006). On the other hand, the rates of TLR were similar between the two groups (12.0 vs. 14.1 %; P = 0.69). Cox's proportional hazard analysis revealed that HD duration (HR 1.08 per year, 95 % CI 1.03-1.13, P = 0.002), ß-blocker use (0.28, 0.17-0.46, P < 0.001), and diabetes mellitus (2.10, 1.23-3.56, P = 0.007) were independent predictors of MACE. Longer HD duration did not affect TLR; however, SCD was significantly higher in the long HD duration group.

Clinical effect of wound depth in critical limb ischemia with tissue loss after endovascular treatment.

OBJECTIVE: Wound severity is assessed mainly by the Rutherford classification for critical limb ischemia (CLI) with tissue loss. The Rutherford classification is based on the extent of tissue loss; however, its classification criteria are ambiguous and do not include information regarding wound depth. We investigated the effects of wound depth on clinical outcomes in CLI with tissue loss after endovascular treatment (EVT). METHODS: Between April 2007 and August 2013, we enrolled 210 consecutive patients (247 limbs) who received EVT for CLI with tissue loss. In the limbs examined, 271 individual wounds existed. We evaluated wound depth using the University of Texas grade (grade 1: superficial wound not involving the tendon, capsule, or bone, n = 97; grade 2: wound penetrating the tendon or capsule, n = 124; and grade 3: wound penetrating the bone or joint, n = 50). We also investigated the wound healing rate at 12 months and limb salvage and major amputation-free survival rates 3 years after EVT. RESULTS: The wound healing rates at 12 months in Texas 1, 2, and 3 were 88%, 48%, and 24%, respectively (log-rank P < .001). The limb salvage and major amputation-free survival rates at 3 years were lower in deep wounds than in shallow wounds (limb salvage rates: 98%, 82%, and 67%, respectively; P < .001; major amputation-free survival rates: 78%, 52%, and 42%, respectively; P < .001). In only minor tissue loss, the wound healing rates at 12 months and the limb salvage and major amputation-free survival rates at 3 years were stratified according to wound depth (wound healing rates: 92% in Texas 1 and 51% in Texas 2 or 3; P < .001; limb salvage rates: 99% in Texas 1 and 86% in Texas 2 or 3; P = .001; major amputation-free survival rates: 79% in Texas 1 and 57% in Texas 2 or 3; P = .001). In only major tissue loss, deep wounds also caused poor outcomes compared with shallow wounds (wound healing rates: 70% in Texas 1 and 36% in Texas 2 or 3; P = .019; limb salvage rates: 94% in Texas 1 and 73% in Texas 2 or 3; P = .050; major amputation-free survival rates: 75% in Texas 1 and 45% in Texas 2 or 3; P = .039). CONCLUSIONS: Wound depth is an important indicator of wound status and affects the clinical outcomes of CLI with tissue loss.

Prognosis of critical limb ischemia patients with tissue loss after achievement of complete wound healing by endovascular therapy.

OBJECTIVE: Critical limb ischemia (CLI) patients with tissue loss have been recognized to have a poor survival rate. In this study, we aimed to determine whether the prognosis of CLI patients with tissue loss improves after complete wound healing is achieved by endovascular therapy. METHODS: We treated 187 CLI patients with tissue loss by endovascular therapy from April 2007 to December 2012. Among these patients, 113 patients who achieved complete wound healing were enrolled. The primary end point was survival rate at 3 years. The secondary end points were limb salvage rate and recurrence rate of CLI at 3 years. RESULTS: The mean follow-up period after achievement of complete wound healing was 32 ± 18 months. At 1 year, 2 years, and 3 years, the survival rates were 86%, 79%, and 74%; the limb salvage rates were 100%, 100%, and 100%; the recurrence rates of CLI were 2%, 6%, and 9%, respectively. On multivariate Cox proportional hazard analysis, age >75 years (hazard ratio, 3.18; 95% confidence interval, 1.23-8.24; P = .017) and nonambulatory status (hazard ratio, 2.46; 95% confidence interval, 1.08-5.65; P = .035) were identified as independent predictors of death for CLI patients with tissue loss even after complete wound healing was achieved. The Kaplan-Meier curve for the overall survival rate at 3 years showed that CLI patients of older age (>75 years) had a significantly decreased survival rate compared with CLI patients of younger age (≤75 years) (58% vs 87%; log-rank test, P < .001). In addition, nonambulatory CLI patients had a significantly poor survival rate relative to ambulatory CLI patients (40% vs 93%; log-rank test, P < .001). CONCLUSIONS: The overall survival rate of CLI patients was acceptable and the recurrence rate of CLI was extremely low once complete wound healing was achieved. Nonambulatory status and age >75 years can serve as predictors of death even after complete wound healing is achieved.

Three-year clinical outcome after infrapopliteal angioplasty for critical limb ischemia in hemodialysis patients with minor or major tissue loss.

OBJECTIVES AND BACKGROUND: Among hemodialysis (HD)-dependent patients with critical limb ischemia (CLI), Endovascular therapy (EVT) of isolated infrapopliteal lesions improves limb salvage. Accordingly, we sought to determine the outcomes of this group of patients based on the extent of tissue loss at baseline. METHODS: From 2004 to 2011, 449 consecutive HD patients with CLI had ischemic wounds and underwent EVT for isolated infrapopliteal lesions. The "minor tissue loss" (MI) group was confirmed by 340 HD patients with wounds located distal to the metatarsophalangeal joints, and the "major tissue loss" (MA) group included 109 HD patients with wounds that extended beyond this point. The two groups were compared for limb salvage and amputation free survival (AFS) rates by Kaplan-Meier analysis. RESULTS: There was no significant difference in the percentage of diabetic patients (MI: 76.5 vs. MA: 75.2%). The percentage with direct flow to the wound site was lower in the MA group than in the MI group (MI: 63.5 vs. MA: 45.9%, P < 0.01). After EVT the MI group had a significantly better limb salvage rate (MI: 83.7 vs. MA: 71.2% at 3 years, P < 0.01), and AFS rate (MI: 44.1 vs. MA: 29.1% at 3 years, P < 0.01) compared to the MA group. CONCLUSIONS: EVT is an efficient treatment for HD patients with minor tissue loss, achieving >80% limb salvage rates at 3 years. However, AFS rates in all HD patients with tissue loss are <50% at 3 years, making their prognosis poor.

Predictors of non-healing in patients with critical limb ischemia and tissue loss following successful endovascular therapy.

OBJECTIVES: To evaluate the predictors of non-healing in patients with critical limb ischemia (CLI) after successful endovascular therapy (EVT). BACKGROUND: Occasionally, wound healing in patients with CLI and tissue loss cannot be achieved even after successful EVT. Patient's co-morbidities, vascular anatomy, wound features, and interventional strategies/outcomes are associated with the probability of wound healing. METHODS: Between April 2007 and October 2012, 182 patients with CLI (220 limbs) with tissue loss were treated with EVT in our institute. Of these, 164 individual wounds (130 patients, 149 limbs) out of 243 individual wounds were successfully treated. Successful EVT was defined as revascularization by achieving visible blood flow to the wounds, as evaluated by digital subtraction angiography performed just after EVT. A Cox proportional hazards model was used to analyze predictors associated with wound healing. RESULTS: The mean follow-up period was 23±18 months. The wound healing rates were 40.2%, 57.3%, 62.2%, and 70.7% at 3, 6, 9, and 12 months, respectively. Multivariate Cox proportional hazards analysis revealed that insulin use [hazard ratio (HR), 0.541; 95% confidence interval (CI), 0.329-0.890; P=0.016], dependence on hemodialysis [HR, 0.429; 95% CI, 0.272-0.678; P<0.001], and major tissue loss [HR, 0.460; 95% CI, 0.294-0.720; P=0.001] were independent predictors of non-healing after successful EVT. CONCLUSIONS: Insulin use, dependence on hemodialysis, and major tissue loss were independent predictors of non-healing after successful EVT.

Incidence and Characteristics of Late Catch-Up Phenomenon Between Sirolimus-Eluting Stent and Everolimus-Eluting Stent: A Propensity Matched Study.

OBJECTIVES: We evaluated and compared the incidence and characteristics of late catch-up phenomenon (LCU) between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) implantations. BACKGROUND: Late catch-up phenomenon after everolimus-eluting stent (EES) implantation has not yet been evaluated sufficiently. METHODS: Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES-treated patients and 495 ESS-treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1-3 years]) were compared. RESULTS: The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different. CONCLUSIONS: EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation.

Intravascular ultrasound measurements after drug-eluting stent placement in femoropopliteal lesions: determining predictors of restenosis.

PURPOSE: To investigate the relationship between postprocedure intravascular ultrasound (IVUS) findings and restenosis after placement of drug-eluting stents (DES) for femoropopliteal lesions. METHODS: Between July 2012 and May 2013, DES were placed in 64 patients with 88 de novo femoropopliteal lesions. In 40 patients (mean age 74.2±9.4 years; 27 men), DES were placed in 50 lesions under IVUS guidance, and restenosis was monitored for 1 year. All patients were symptomatic (Rutherford 2-6), and 17 patients (43%) suffered from critical limb ischemia. IVUS findings after stenting were compared for patients with vs without restenosis, which was defined as a peak systolic velocity ratio >2.4 on duplex ultrasonography or >50% diameter stenosis on angiography. RESULTS: Ten patients (14 lesions) developed restenosis, while 30 patients (36 lesions) did not. There were no significant differences in the frequency of diabetes or dialysis between the 2 groups. Female patients were predominant in the restenosis group (p<0.003). There were no significant differences of the percentage of TransAtlantic Inter-Society Consensus C/D lesions or stent edge dissection. Multivariate analysis indicated that cilostazol use [odds ratio (OR) 0.13; p=0.046], distal lumen cross-sectional area (CSA) (OR 0.86; p=0.035), and axial symmetry index (OR 0.60; p=0.045) were independent predictors of restenosis. Using receiver operator characteristic analysis, the best cutoff values of the distal lumen CSA and axial symmetry index for predicting restenosis were 17.1 cm(2) and 0.6, respectively. CONCLUSION: IVUS guidance of DES placement in femoropopliteal lesions can offer useful predictors of restenosis at 1 year. The utility of distal lumen CSA and the axial symmetry index in the prediction of restenosis after femoropopliteal DES placement should be confirmed in a larger cohort.

Development and validation of a new scoring system to predict wound healing after endovascular therapy in critical limb ischemia with tissue loss.

PURPOSE: To develop a scoring system to predict wound healing in critical limb ischemia (CLI) patients treated with endovascular therapy (EVT). METHODS: Between July 2007 and January 2013, 184 patients (118 men; mean age 73.0 years) with CLI (217 limbs) and tissue loss underwent EVT. From this cohort 236 separate wounds were divided into development (n = 118) and validation (n = 118) groups. Predictors of wound healing were identified using multivariable analysis. Each predictor was assigned a score based on its regression coefficient, and total scores were calculated, ranging from 0 to 1 for low risk up to ≥ 4 for high risk of a nonhealing wound. The performance of the scoring system in the prediction of wound healing was evaluated by calculating the area under the receiver operating characteristics (ROC) curve. RESULTS: By multivariable analysis, a University of Texas grade ≥ 2 (HR 0.524, 95% CI 0.288-0.951, p = 0.034), an infected wound (HR 0.497, 95% CI 0.276-0.894, p = 0.020), dependence on hemodialysis (HR 0.459, 95% CI 0.259-0.814, p = 0.008), no visible blood flow to the wound (HR 0.343, 95% CI 0.146-0.802, p = 0.014), and major tissue loss (HR 0.322, 95% CI 0.165-0.630, p = 0.001) predicted a non-healing wound. The 1-year rates of wound healing in the low-, intermediate-, and high-risk groups were 94.6%, 67.6%, and 9.1%, respectively, in the development group (p < 0.001) and 92.3%, 70.5%, and 31.3%, respectively, in the validation sample (p < 0.001). The area under the ROC curve was 0.922 in the development group and 0.808 in the validation sample. CONCLUSION: This scoring system reliably predicts wound healing in CLI patients after endovascular revascularization and is potentially helpful in deciding if additional adjuncts or revascularization should be considered.

Bypass Surgery vs. Drug-Eluting Stent for Trans-Atlantic Inter-Society Consensus-II (TASCII) C or D Femoropopliteal Lesions.

BACKGROUND: Bypass surgery (BSX) as first-line therapy for Trans-Atlantic Inter-Society Consensus-II (TASCII) C/D femoropopliteal (FP) lesions is recommended. Recent reports have shown that a drug-eluting stent (DES) provides good durability up to the mid-term. We investigated clinical outcomes after BSX vs. DES for TASCII C/D FP lesions. METHODS AND RESULTS: As treatment of de novo TASCII C/D FP lesions, 274 patients who underwent DES implantation and 201 patients who had BSX were identified and analyzed. Each group had at least 1 year of follow-up data. The primary endpoint was binary restenosis. Secondary endpoints were major amputation, reintervention, reocclusion and major adverse limb event (MALE; including major amputation or any reintervention and restenosis). Before matching, the binary restenosis rate was significantly higher in the DES group than in the BSX group (42% vs. 18%, P<0.001). After propensity matching, the 1-year restenosis rate was still higher in the DES group (44% vs. 18%, P<0.001). The DES group also had a significantly higher incidence of reintervention and MALE. Major amputation and reocclusion showed no significant difference. The subsequent stratification analysis reconfirmed no significant interaction effect of any background characteristics on the association of DES implantation vs. BSX with the 1-year restenosis risk. CONCLUSIONS: BSX is still a feasible and recommended treatment for TASCII C/D FP lesions in Japanese patients, based on good durability up to 1 year.

Simultaneous occlusion of left anterior descending and left circumflex arteries by very late stent thrombosis: vascular response to drug-eluting stents assessed by intravascular ultrasound.

Very late stent thrombosis (VLST) is a catastrophic complication after implantation of a drug-eluting stent (DES). It has been reported that VLST is associated with pathological changes, which often include late acquired incomplete stent apposition (LAISA) with thrombus formation. In addition, the vascular response to the stent (evaginations, neointimal growth, and thrombosis) and the incidence of LAISA are reported to vary among the different types of DES. We experienced a patient with cardiogenic shock induced by simultaneous VLST of both the left anterior descending artery (LAD) and the left circumflex artery (LCX) at 3 years after implantation of two sirolimus-eluting stents. Intravascular ultrasound (IVUS) showed LAISA of both arteries. A paclitaxel-eluting stent, which had been implanted in the right coronary artery 3 years earlier, did not show such a finding. IVUS revealed "different vascular reactions" to "different types of DES" in this patient.

Clinical efficacy of infrapopliteal endovascular procedures for hemodialysis patients with critical limb ischemia.

PURPOSE: To investigate 5-year clinical outcomes after infrapopliteal endovascular therapy (EVT) for critical limb ischemia (CLI) patients on or not on hemodialysis (HD), and compare the clinical efficacy of EVT between the 2 groups. METHODS: The subjects were 1091 CLI patients (1310 limbs) who underwent EVT for isolated infrapopliteal lesions from 2004 to 2012, and were classified into 2 groups for comparative study: the patients on HD group (670 patients, 830 limbs) and not on HD group (421 patients, 480 limbs). RESULTS: The HD group had a significantly lower rate of freedom from major adverse limb events or perioperative death (HD 78.4% vs. non-HD 86.0% at 1 year, HD 70.3% vs. non-HD 82.4% at 5 years, P = 0.01), or amputation-free survival (AFS) rate (HD 65.7% vs. non-HD 78.7% at 1 year, HD 34.4% vs. non-HD 59.8% at 5 years, P < 0.01) after EVT compared with the non-HD group. Independent predictors of AFS in HD patients were nonambulatory, diabetes mellitus, albumin <3.0 g/dL, ejection fraction ≤0.48, and no patent pedal arch arteries before EVT. AFS at 1 year was 81% in patients with 0 or 1 predictor, surpassing the suggested AFS objective performance goal (OPG) end points of 68%, but AFS in patients with 2 or more predictors failed to reach the OPG. CONCLUSIONS: In comparison with non-HD patients, the clinical efficacy of infrapopliteal EVT for HD patients was poor. Preoperative risk stratification based on AFS predictors can be used as an index for predicting the prognosis.

A sheathless retrograde approach via the popliteal artery is useful and safe for treating chronic total occlusions in the superficial femoral artery.

PURPOSE: To compare the safety and success of a retrograde approach using a microcatheter vs. a sheath in the treatment of superficial femoral artery (SFA) chronic total occlusions (CTOs). METHODS: From April 2007 to December 2012, 188 consecutive patients underwent EVT for 229 de novo SFA CTOs using the retrograde approach in 68 patients (35 men; mean age 72 years). This cohort was divided into cases performed with a 4-F or 6-F sheath (n=28, 36 limbs) and those with a 2.1-F microcatheter (n=35, 49 limbs). The primary outcomes were mean time to hemostasis and number of intra- and postoperative puncture site complications, as well as the success of popliteal artery puncture, lesion crossing, and reperfusion. RESULTS: There were no significant differences between two groups in baseline characteristics. PA puncture was successful in all limbs, and the success in crossing the lesion with the wire was not significantly different (91.9% in the sheath group vs. 89.8% in the microcatheter group). Mean time to hemostasis was 8.9±8.8 minutes in the microcatheter group vs. 47.7±13 minutes in the sheath group (p<0.0001). There was a significant difference in intraoperative and postoperative complications (22.2% in the sheath group vs. 2.0% in the microcatheter group, p=0.002). CONCLUSION: Based on this retrospective analysis, the use of a microcatheter for SFA CTO retrograde access appears to be superior to 4-F or 6-F sheaths in terms of shorter time to hemostasis and fewer complications.

Vascular elastography: a novel method to characterize occluded lower limb arteries prior to endovascular therapy.

PURPOSE: To examine the effectiveness of vascular elastography (VE) for the assessment of totally occluded lower limb arteries prior to endovascular treatment (EVT). METHODS: Of 812 consecutive patients who underwent EVT between April 2010 and April 2012, VE was used to evaluate the hardness of chronic total occlusions of the femoropopliteal segment prior to EVT in 65 consecutive patients (48 men; mean 73.9 years, range 63-86). Elastograms of the CTOs proximally and distally were scored using a 5-point scale, and outcomes in limbs with hard lesions (VE score 0-2) were compared to those with soft lesions (VE score 3-4) according to lesion length. The interventionists who performed the endovascular procedures were not informed of the VE score results. RESULTS: CTO characteristics could be evaluated in all cases. A VE score ≤2 was found in 14 of the 23 lesions <150 mm in length. A flexible guidewire was sufficient for recanalization in more of the soft lesions than in the hard lesions [6/9 vs. 2/14, respectively]. In 39 lesions >150 mm, a VE score of 3 was recorded in most lesions proximally, while lesions distally were hard in many cases (VE score 1 or 2). A flexible guidewire alone was sufficient in many soft CTOs (8/13, p<0.01). In 16 cases, hard calcified plaque was indicated by difficulty in penetrating the lesion even with a stiff guidewire; all these cases had a VE score of 1 or 2. A retrograde approach was required only in hard CTOs (p<0.01). The procedure time was significantly longer for the hard lesion group (152.9±63.2 vs. 87.0±29.8 minutes, p=0.001). In 11 in-stent occlusions, only VE scores of 3 (n=4) or 4 (n=7) were recorded, indicating soft thrombus, which was aspirated under distal protection in 7 cases. CONCLUSION: VE may be a useful method for determining the hardness of CTO lesions noninvasively before endovascular therapy, providing information that can help plan the procedure.

Wound healing and wound location in critical limb ischemia following endovascular treatment.

BACKGROUND: The differences in wound healing according to wound location remain unclear. METHODS AND RESULTS: Between April 2007 and October 2011, 138 patients (166 limbs) with critical limb ischemia with tissue loss were treated with endovascular treatment. On these limbs, 177 individual wounds were identified on the foot and were evaluated for wound healing rates and time to healing according to their locations. Wound locations were divided into 3 groups: group T (Toe wounds, n=112), group H (Heel wounds, n=25), and group E (Extensive wounds extending onto the fore- or mid-foot along with dorsum or plantar surfaces, n=40). The mean follow-up period was 23±19 months. At 3, 6, 9, and 12 months, wound healing rates were 51%, 64%, 75%, and 75%, respectively, in group T; 12%, 36%, 36%, and 52%, respectively, in group H; and 0%, 5%, 8%, and 13%, respectively, in group E. The median time to healing was 64 days (interquartile range 25-156 days) in group T, 168 days (interquartile range 123-316 days) in group H, and 267 days (interquartile range 177-316 days) in group E (P=0.038). CONCLUSIONS: Extensive wounds extending onto the fore- or mid-foot along with dorsum or plantar surfaces were the most difficult type of wound to heal.

Hyper numerical aperture imaging lens using a thin multi reflection Catadioptric optical element.

Several state-of-the-art imaging applications require a large operational spectral band, a large field size, and a high numerical aperture (NA). The design of a lens that simultaneously meets these requirements is a challenging task. We present optical designs of hyper NA imaging systems that comprise a multi reflection optical element. Light entering this element reflects multiple times before exiting. The present lens designs are 1.65 NA imaging system that operate in the broad spectral band [486.1 ~656.3 nm], have field size of 1.75 mm, and 20X magnification.