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.

Utility of indigo carmine angiography in patients with critical limb ischemia: Prospective multi-center intervention study (DIESEL-study).

OBJECTIVES: To assess the efficacy of indigo carmine angiography for wound healing after successful below-the-knee intervention in patients with critical limb ischemia (CLI). METHODS: A multi-center prospective intervention study was conducted. Fifty-four limbs of 53 patients in Rutherford categories 5 and 6 underwent endovascular therapy (EVT). After successful EVT, 5 mL of indigo carmine was injected through a catheter at the distal popliteal artery and color changes in the foot were evaluated. The results of indigo carmine angiography were divided into three groups: In type I, the color change of the wound was deeper than the surrounding tissue; in type II, the change in wound color was similar to the surrounding tissue; and in type III, no discoloration of the wound was observed by the indigo carmine. RESULTS: The wound healing rates at 3 months were 78% (25/32) for type I, 70% (7/10) for type II, and 42% (5/12) for type III (P for trend = 0.025). Indigo carmine angiography-related complications were not seen. CONCLUSION: Indigo carmine angiography was found to be a safe and useful procedure to provide visual information on foot perfusion. This dye coloring method demonstrated that after successful angioplasty, the perfused area was made visible at the microcirculation level. Indigo carmine angiography can thus be considered an important predictor for wound healing by EVT in patients with CLI.

Cardiovascular Outcome and Mortality in Patients Undergoing Endovascular Treatment for Symptomatic Peripheral Artery Disease　- Short-Term Results of the Toma-Code Registry.

BACKGROUND: The present study was performed to clarify whether the preoperative clinical symptoms for endovascular therapy (EVT) can predict post-EVT death and cardiovascular prognosis in Japanese patients with peripheral artery disease (PAD), including acute disease.Methods and Results:The TOkyo taMA peripheral vascular intervention research COmraDE (Toma-Code) Registry is a Japanese prospective cohort of 2,321 consecutive patients with PAD treated with EVT, in 34 hospitals in the Kanto and Koshin'etsu regions, from August 2014 to August 2016. In total, 2,173 symptomatic patients were followed up for a median of 10.4 months, including 1,370 with claudication, 719 with critical limb ischemia (CLI), and 84 with acute limb ischemia (ALI) for EVT. The all-cause death rates per 100 person-years for claudication, CLI and ALI were 3.5, 26.2, and 24.5, respectively. Similarly, major adverse cardiac and cerebrovascular events (MACCE) rates per 100 person-years for claudication, CLI, ALI, and others were 5.2, 31.2, and 29.7, respectively. After adjusting for the predictors of all-cause death and MACCE, namely, age, body mass index <18, diabetes mellitus, dialysis, cerebrovascular disease, and low left ventricular ejection fraction, it was determined that the preoperative indication for EVT was strongly associated with all-cause death and MACCE. CONCLUSIONS: The preoperative clinical symptoms for EVT can predict the prognosis in patients with PAD undergoing EVT.

Angiographic Dissection Patterns and Patency Outcomes After Balloon Angioplasty for Superficial Femoral Artery Disease.

PURPOSE: To investigate the angiographic dissection patterns after balloon angioplasty for superficial femoral artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and the predictive factors for severe dissection. METHODS: A retrospective, multicenter analysis examined 621 patients (mean age 72.8±9.5 years; 414 men) with 748 symptomatic de novo SFA lesions treated with endovascular therapy. Vessel dissection after the initial balloon angioplasty procedure was graded into 7 types according to a modified version of the coronary artery classification types A to F. Severe vessel dissection patterns were defined as type C or higher. Nitinol stent implantation was performed in 555 (74.2%) lesions for residual stenosis >30% or flow-limiting dissection; 193 lesions (25.8%) were treated with balloon angioplasty only. To determine the clinical outcomes associated with each dissection pattern and identify predictive factors for severe dissection, 2-year follow-up data for the 193 lesions treated with balloon angioplasty only were analyzed for primary patency and clinically driven target lesion revascularization (TLR). RESULTS: No dissection was found in 16% (120/748) of lesions, and types A and B dissections were seen in 19% (142/748) and 23% (172/748), respectively. Dissection grades above type C were observed in 42% of cases, most frequently type D (180/748, 24%) and less often type C (37/748, 5%), type E (67/748, 9%), and type F (30/748, 4%). The bailout stent implantation rate increased according to dissection severity. At up to 2 years, the severe dissection group (types C-F) showed a significantly lower patency rate (p<0.001) and higher clinically driven TLR (p<0.001) compared to the nonsevere group (no dissection and types A and B dissections). Severe dissection was a significant risk factor for restenosis, which rose progressively from types C to F. Multivariate analysis identified a small reference vessel diameter <5 mm (p=0.001), lesion length >15 cm (p=0.001), and chronic total occlusion (p<0.001) as independent predictors of severe dissection. In subgroup analysis, vessels with a small reference diameter and TASC II C and D lesions had a higher prevalence of severe dissection. CONCLUSION: Severe dissection was found in 42% of cases after PTA. A small vessel diameter and/or TASC II C/D lesions were related to a high incidence of dissection. Severe dissection during procedures employing balloon angioplasty only could affect long-term patency.

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.

Outcomes of Zilver PTX stent implantation for the treatment of complex femoropopliteal artery disease.

The purpose of this study was to evaluate the efficacy of Zilver PTX, the first drug-eluting stent, in patients with complex femoropopliteal (FP) artery disease. Between July 2012 and March 2013, 60 consecutive patients (39 males; mean age: 72.5 ± 8.6 years) with complex risk factors including TASC II C/D lesions, in-stent restenosis (ISR) and/or on haemodialysis underwent successful Zilver PTX implantation for symptomatic FP artery disease. The primary outcome was primary patency, which was defined as freedom from restenosis at 12 months, as verified by duplex ultrasound. Secondary outcomes included the technical success rate, the freedom from target lesion revascularisation (TLR) rate and the amputation-free survival (AFS) rate. The average follow-up period was 13.2 ± 5.3 months. 62 % of the patients had TASC II C/D lesions, 35.0 % experienced ISR, and 41.6 % were on haemodialysis. The mean lesion length was 188 ± 96 mm. The technical success rate was 98.3 %. The primary patency rate was 50.2 %, the freedom from clinically driven TLR rate was 68.6 %, and the AFS rate was 83.2 % at 12 months. In conclusion, Zilver PTX stent implantation for complex FP artery disease did not affect long-term durability.

Predictive value of skin perfusion pressure after endovascular therapy for wound healing in critical limb ischemia.

PURPOSE: To determine the predictive value of skin perfusion pressure (SPP) for wound healing after endovascular therapy (EVT). METHODS: Between May 2004 and March 2011, 113 consecutive patients (84 men; mean age 71.5±12.5 years) with CLI (123 limbs) underwent successful balloon angioplasty ± stenting (flow from >1 vessel to the foot without bypass) and were physically able to undergo SPP measurement before and within 48 hours after EVT. The status of wound healing was recorded over a mean follow-up of 17.4±12.4 months. RESULTS: The wound healing rate was 78.9% (97 limbs of 89 patients). SPP values after EVT were significantly higher in these patients than in the 24 patients (26 limbs) without wound healing (44.2±15.6 mmHg vs. 27.5±10.4 mmHg, p<0.001). Receiver operating characteristics analysis of SPP after EVT to predict wound healing had an area under the curve of 0.81 (95% CI 0.723 to 0.899, p<0.001). The optimal cutoff for predicting wound healing was 30 mmHg, with a sensitivity of 81.4% and a specificity of 69.2%. Binary logistic regression analysis demonstrated SPP after EVT to be an independent predictor of wound healing (p<0.001). The probability of wound healing with SPP values >30 mmHg, 40 mmHg, and 50 mmHg were 69.8%, 86.3%, and 94.5%, respectively. CONCLUSION: SPP after EVT is an independent predictor of wound healing in patients with CLI. In our study, an SPP value of 30 mmHg was shown to be the best cutoff for prediction of wound healing after EVT.

Visualization of coronary plaque in arterial remodeling using a new 40-MHz intravascular ultrasound imaging system.

OBJECTIVES: The aim of this study was to characterize coronary plaque in target lesions with vessel remodeling using iMap-intravascular ultrasound (IVUS). BACKGROUND: The relationship between the plaque component and vessel remodeling remains to be elucidated. iMAP-IVUS is an imaging system that can be used to assess the plaque composition by radiofrequency signals from 40 MHz IVUS. METHODS: IVUS examinations were performed for the de novo target vessels of 146 stable angina pectoris patients (174 vessels). The patients were divided into two groups: including a nonpositive remodeling group (non-PR, remodeling index ≤ 1.0, 125 vessels) and a positive remodeling group (PR, remodeling index > 1.0, 49 vessels). RESULTS: The percent plaque burden in the PR group were lager than those in the non-PR group (79.05% vs. 74.36%, P < 0.01). Attenuation plaques were more frequently observed in PR group (40.8% vs. 12.1%, P < 0.0001). The percentages of lipidic and necrotic relative areas at the minimum lumen sites were greater in the PR group than in the non-PR group (7.22% vs. 6.03%, P <0.05 and 22.08% vs. 14.71%, P < 0.001, respectively), and the percentage of the fibrotic area was smaller (54.82% vs. 61.42%, P < 0.05). In addition, a positive linear correlation was observed between the remodeling index and either the lipidic or necrotic area (r = 0.37, P <0.0001 and r = 0.35, P < 0.0001, respectively). CONCLUSIONS: The coronary plaque characteristics in PR patients showed increased lipidic and necrotic areas and the degree of coronary remodeling correlated with the lipidic and necrotic plaque area. © 2012 Wiley Periodicals, Inc.

Impact of wound blush as an angiographic end point of endovascular therapy for patients with critical limb ischemia.

OBJECTIVES: Several reports have been published of the acceptable patency and limb salvage rates after infrapopliteal interventions for the treatment of critical limb ischemia (CLI). However, the optimal angiographic end point of endovascular therapy (EVT) remains unclear. This study assessed the relationship between the appearance of wound blush as an angiographic end point and the limb salvage rate in patients with CLI. METHODS: "Wound blush" was defined as contrast opacification of the vessels around the wound in digital subtraction angiograms obtained immediately after EVT through the catheter introduced into the popliteal artery. We analyzed the data of 77 consecutive patients (93 limbs) with ischemic ulcerations, classified as Rutherford category 5 or 6, who underwent EVT without bypass surgery. Patients were divided into two groups depending on whether wound blush was seen in the angiogram obtained immediately after the procedure. The freedom from amputation rate was compared between the two groups. RESULTS: The overall limb salvage rate was 81.7%. The limb salvage rate was significantly higher in the wound blush-positive group than in the wound blush-negative group and remained so for at least 3 years after the EVT (96.4% vs 56.8%, P < .001). CONCLUSIONS: Presence of wound blush after EVT is associated with higher skin perfusion pressure, both of which are associated with higher rates of limb salvage. Wound blush as an angiographic end point in EVT may be a novel predictor of limb salvage in patients with CLI.

Hemodynamic evaluation of lower limbs in patients with chronic limb-threatening ischemia.

Revascularization plays an important role in the treatment of chronic limb-threatening ischemia. Evaluation of hemodynamic compromise in the lower extremity is required to optimize the treatment strategy for each patient. A variety of methods have been reported to detect arterial obstruction or impaired foot perfusion. This article reviews each method, clarifying features and limitations.

Higher body mass index at the time of acute myocardial infarction is associated with a favorable long-term prognosis (8-year follow-up).

Obesity is an important public health problem, especially among patients with cardiovascular disease. However, little is known about the impact of obesity on the long-term prognoses of patients with acute myocardial infarction (AMI). Major adverse cardiac and cerebrovascular events (MACCE) consist of all causes of death, stroke, target lesion revascularization, target vessel revascularization, non-fatal myocardial infarction, and hospitalization. From January 2001 to March 2005, we analyzed 121 patients who survived >30 days after suffering their first AMI of the left anterior descending artery for MACCE. The mean follow-up period for this study was 59 ± 26 months. Seventy-five patients presented with normal weight (BMI <25 kg/m(2)) and 46 were obese (BMI >25 kg/m(2)). During the follow-up period, 56 patients presented MACCE, including 18 deaths, 11 strokes, and seven non-fatal myocardial infarctions. Normal weight was significantly associated with the occurrence of MACCE (p = 0.012). Grouping of the patients by BMI and homeostasis model assessment ratio (HOMA-R) indicated that the combination of a higher BMI (>25) and lower insulin resistance (HOMA-R < 2.0) provided the best prognosis (p = 0.0006). Kaplan-Meier curves stratified to the four groups, sorted by diabetes mellitus and BMI at admission, showed that the normal weight patients with diabetes mellitus presented the highest risk of MACCE (p < 0.0001). Patients with higher BMI and no insulin resistance or diabetes mellitus present better long-term outcomes following anterior AMI.

One-year limb outcome and mortality in patients undergoing revascularization therapy for acute limb ischemia: short-term results of the Edo registry.

The present study aimed to clarify the current status, therapeutic strategy, and 1-year outcome in acute limb ischemia (ALI) patients in Japan. The EnDOvascular treatment (Edo) registry database includes 324 patients from 10 institutes who were registered between November 2011 and October 2013. A total of 70 ALI patients (mean age 74.0 years) from the Edo registry database were enrolled in this study. Of the 70 included patients, 72.9% were male and 35.7% had embolism. Of patients, 38.6%, 42.9%, and 18.6% underwent EVT, surgery, and hybrid thrombectomy, respectively, in primary revascularization strategy. Limb ischemia was categorized into four classes at initial evaluation: SVS/ISCVS class I (n = 13, 18.6%), SVS/ISCVS class IIa (n = 36, 51.4%), SVS/ISCVS class IIb (n = 21, 30%), and SVS/ISCVS class III (n = 0, 0%). Three patients with SVS/ISCVS class IIb limb ischemia developed myonephropathic metabolic syndrome. No catheter-directed thrombolysis was employed as a primary revascularization strategy. The 1-year rates of all-cause death, major amputation, and a composite of perioperative death or major adverse limb event were 28.6%, 5.7%, and 40.0%, respectively. Lower age, male sex, dyslipidemia, high estimated glomerular filtration rate, high albumin level, and low C-reactive protein level were independent positive predictors of all-cause death. In this registry, SVS/ISCVS class IIa ALI was predominant. Approximately 40% of primary revascularization strategy was surgery and EVT, followed by hybrid therapy. All-cause death and major amputation rates at 1 year were less than 30% and 6%, respectively.

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.

Optimal cut-off value of preprocedural geriatric nutritional risk index for predicting the clinical outcomes of patients undergoing endovascular revascularization for peripheral artery disease.

BACKGROUND: Malnutrition measured by the geriatric nutritional risk index (GNRI) was reported to be associated with poor prognosis for patients with peripheral artery disease (PAD). However, the optimal cut-off value of preprocedural GNRI for critical limb ischemia (CLI) and intermittent claudication (IC) is unknown. We aimed to determine its optimal cut-off value for CLI or IC patients requiring endovascular revascularization. METHODS: We explored data of 2246 patients (CLI: n = 1061, IC: n = 1185) registered in the Tokyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry, which prospectively enrolled consecutive PAD patients who underwent endovascular revascularization in 34 hospitals in Japan from August 2014 to August 2016. The optimal cut-off values of GNRI were assessed by the survival classification and regression tree (CART) analyses, and the survival curve analyses for major adverse cardiovascular and limb events (MACLEs) were performed for these cut-off values. RESULTS: In addition to the first cut-off value of 96.2 in CLI and 85.6 in IC, the survival CART provided an additional cut-off value of 78.2 in CLI and 106.0 in IC for further risk stratification. The survival curve was significantly stratified by the GNRI-based malnutrition status in both CLI [high risk: 47.7% (51/107), moderate: 30.1% (118/392), and low: 10.2% (53/520), log-rank p < 0.001] and IC [high risk: 14.3% (7/49), moderate: 4.5% (29/646), and low: 0.5% (2/407), log-rank p < 0.001]. The multivariate Cox-proportional hazard analysis showed that a higher GNRI was significantly associated with a better outcome in both CLI [hazard ratio (HR) per 1-point increase: 0.97, 95% CI: 0.96-0.98, p < 0.001] and IC (HR: 0.94, 95% CI: 0.91-0.97, p < 0.001). CONCLUSIONS: Preprocedural nutritional status significantly stratified future events in patients with PAD. Given that the optimal cut-off value of GNRI in CLI was almost 10-points lower than that of IC, using a disease-specific cut-off value is important for risk stratification.

An unmappable ventricular tachycardia in the arrhythmogenic right ventricular cardiomyopathy: elucidation of critical isolated delayed components with high-resolution electroanatomical mapping.

Unmappable ventricular tachycardia (VT) is a challenge in the management of arrhythmogenic right ventricular cardiomyopathy (ARVC). We report a feasible strategy for a curative ablation. In the present case with ARVC, the clinical VT showed a single morphology of left bundle branch block with inferior axis. Neither activation mapping nor entrainment mapping could be done because of instability of the haemodynamics. Furthermore, pace mapping could not be obtained due to electrically unexcitable scars covering with the RV. We found isolated delayed components (IDCs) in the diastolic phase recorded within the scar areas. Electroanatomical mapping (CARTO) with tiered decreasing voltage definition revealed that IDCs were delineated on the narrow conducting channels along or between the complete scars (amplitude < or =0.1 mV). Isolated delayed components on the narrow channels were targeted under the guidance with CARTO. After 11 radiofrequency applications, the clinical VT was eliminated. Moreover, epsilon waves recorded on the 12-lead electrocardiogram disappeared. No ventricular tachyarrhythmia was recognized at 6-month follow-up. Isolated delayed component ablation with high-resolution CARTO map was feasible and provided a curative approach in the treatment of an unmappable VT in ARVC.

Ventricular late potential in patients with apparently normal electrocardiogram; predictor of Brugada syndrome.

BACKGROUND: Brugada syndrome can be overlooked due to its dynamic change in its electrocardiogram (ECG) manifestation. We hypothesized that positive ventricular late potential (VLP) in patients with nonspecific ECG would predict the inducible coved ST elevation (type-1 Brugada ECG) and the patients at high risk. METHODS: Thirty-four patients of nonspecific ECG without structural heart disease were eligible for this study. All patients were referred for evaluation of syncopal episodes and/or cardiac arrest and/or frequent episodes of ventricular premature contractions. We assessed the correlation between baseline VLP and the alteration to a drug-induced type-1 Brugada ECG, and also evaluated the diagnostic accuracy of positive VLP in normal ECG subjects for the appearance of a drug-induced type-1 Brugada ECG. RESULTS: Twenty-one patients presented positive VLP and 13 patients showed negative VLP. Parameters of VLP (fQRSd, RMS(40), LAS(40)) presented significant correlation with the alteration to a type-1 ECG by pilsicainide. VLP demonstrated high sensitivity and negative predictive value for the prediction of type-1 Brugada ECG. Furthermore, in their follow-up, at least two cases of ventricular fibrillation were recognized in 21 of positive VLP patients with apparently normal ECGs. CONCLUSIONS: VLP in apparently normal ECG can predict the alteration to a drug-induced type-1 Brugada ECG and unmask the patients at risk.

Duration from Wound Occurrence to Referral to a Vascular Center in Japanese Patients with Critical Limb Ischemia.

Objective: Clinical guidelines have long recommended referring patients with clerical limb ischemia (CLI) to a vascular specialist early in the course of their disease to plan for revascularization options. However, no data were so far available on how promptly CLI patients were referred to a vascular center in the real-world settings in Japan. This study aimed to survey the duration from wound occurrence to referral to a vascular center in CLI patients in Japan. Materials and Methods: We analyzed a database of a prospective, multicenter registry in Japan, including 428 CLI patients presenting ischemic wounds and referred to vascular centers. The duration of the wound occurrence was surveyed at registration. Results: The wound duration exceeded 1 month in 58.2% [95% confidence interval: 53.2% to 63.1%] of the patients, and 3 months (i.e., one season) in 15.9% [12.4% to 19.4%]. No clinical features were significantly associated with the wound duration. The wound duration was independently associated with the wound severity evaluated using the Wound, Ischemia, and foot Infection classification system (P=0.030). Conclusion: A substantial number of CLI patients referred to vascular centers had a long duration of wounds, i.e., time from wound occurrence to the referral.

Clinical Outcome and Diverse Risk Factors for Different Therapeutic Target Locations of Peripheral Artery Disease.

AIM: Previous studies on peripheral artery disease (PAD) only enrolled patients with atherosclerotic lesion limited to any one of isolated locations (aortoiliac [AI], femoropopliteal [FP], and below the knee [BTK]). However, the interventions for PAD in a real-world clinical setting are often simultaneously performed for several different locations. METHODS: We conducted a prospective multicenter study that included 2,230 patients with PAD who received intervention for lower extremity lesions in each area and across different areas. Patients were divided into 7 groups according to the combination of treatment locations. Overall survival (OS), major adverse limb events (MALEs), and risk factors for OS and MALEs were statistically analyzed. RESULTS: After adjustment for confounding factors, the attributable risk for OS was similar among isolated AI, FP, and BTK treatments. MALEs increased in correlation with the number of treatment locations. Dialysis and critical limb ischemia were the common risk factors for OS and MALEs. However, the contribution of other factors such as type of drug usage was different according to treatment locations. CONCLUSIONS: In patients with PAD, OS was largely defined by comorbidities but not by lesion location. The background risk factors, underlying comorbidities, and event rates were different according to PAD location, suggesting that stratified treatment should be established for different patient populations.

Assessment of Microvasculature After Intervention as a Predictor of Wound Healing in Patients With Tissue Loss.

OBJECTIVES: This study investigated the correlation between vascular flow reserve (VFR) values and wound healing rate in patients with critical limb ischemia. BACKGROUND: Peripheral VFR may be useful for predicting complete wound healing after endovascular therapy (EVT). However, published reports included small numbers of patients from single centers and long-term outcomes remain unknown. METHODS: This was a prospective multicenter study that consecutively enrolled 104 patients (115 limbs) who received EVT for ischemic ulcerations. All lesions were treated with conventional balloon angioplasty. After EVT, VFR was measured using a pressure/temperature guidewire. The study endpoints were correlation between VFR values and wound healing rate at 3 months and 1 year. RESULTS: The median VFR was 2.9. A total of 110 and 104 limbs completed the 3-month and 1-year follow-up, respectively. The 3-month and 1-year wound healing rates were 49% and 76%, respectively. VFR was significantly associated with the 3-month and 1-year wound healing (p < 0.001 for both). The crude hazard ratios of VFR (per 2-fold increase) for the 3-month and 1-year wound healing were 2.6 (1.7 to 3.9) and 2.9 (2.0 to 4.2), respectively. The estimated median time to wound healing was 5.0 (3.2 to 7.2) months, 3.3 (2.8 to 4.9) months, and 2.5 (2.0 to 3.0) months, when the VFR value was 2.4, 2.9, and 3.9, respectively. CONCLUSIONS: Post-procedure VFR is significantly associated with wound healing. VFR, measured in the catheterization laboratory, is useful in clinical risk stratification for patients with critical limb ischemia after EVT. (Predictor of Wound Healing in Patients with Critical Limb Ischemia-Multicenter Prospective Study; UMIN000012746).