Impact of the time-to-target rate of urine volume concept on the outcome of acute decompensated heart failure.

BACKGROUND: Early decongestion with diuretics could improve clinical outcomes. This study aimed to examine the impact of the time-to-target rate of urine volume (T2TUV) concept on the outcome of acute decompensated heart failure (ADHF). METHODS: This multicenter retrospective study included 1670 patients with ADHF who received diuretics within 24 h of admission. T2TUV was defined as the time from admission to the rate of urine volume of 100 ml/h. The primary outcomes were in-hospital death, mortality, and re-hospitalization for 1 year. RESULTS: A total of 789 patients met the inclusion criteria (T2TUV on day 1, n = 248; day 2-3, n = 172; no target rate UV, n = 369). In-hospital mortality in the day 1 group was significantly lower (2.7% vs. 5.9% vs. 11.1%; p < 0.001) than that of other groups. The mortality and re-hospitalization for 1 year in the day 1 group was significantly lower (event-free rate: 67.7% vs. 54.1% vs. 56.9%; log-lank p = 0.004) than that of other groups. In multivariate analysis, predictors of T2TUV at day 1 were age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p = 0.007), previous hospitalized heart failure (OR: 1.47, 95% CI: [1.03-2.12], p = 0.03), N-terminal-pro B type natriuretic peptide per 1000 pg/ml (OR: 1.02, 95% CI: 1.01-1.04, p = 0.007), carperitide (OR: 0.69, 95% CI: 0.48-0.99, p = 0.05), and early administration of tolvaptan (OR: 0.6, 95% CI: 0.42-0.85, p = 0.004). CONCLUSIONS: T2TUV of less than day 1 was associated with lower in-hospital mortality and decreased mortality and re-hospitalization at 1 year.

Predictors of Poor Very Early Diuretic Response and Effectiveness of Early Tolvaptan in Symptomatic Acute Heart Failure.

BACKGROUND: Diuretic response (DR) in patients with symptomatic acute decompensated heart failure (ADHF) has an impact on prognosis. This study aimed to identify predictive factors influencing acute 6 h poor DR and to assess DR after early administration of tolvaptan (TLV). METHODS: This multicenter retrospective study included 1670 patients who were admitted for ADHF and received intravenous furosemide within 1 h of presentation in clinical scenario 1 or 2 defined based on initial systolic blood pressure ≥100 mmHg with severe symptoms (New York Heart Association class III or IV (n = 830). The score for the poor DR factors in the very acute phase was calculated in patients treated with furosemide-only diuretics (n = 439). The DR to TLV administration was also assessed in patients who received an additional dose of TLV within 6 h (n = 391). RESULTS: The time since discharge from the hospital for a previous heart failure < 3 months (odds ratio [OR] 2.78, 95% confidence interval [CI] 1.34-5.83; p = 0.006), loop diuretics at admission (OR 3.05, 95% CI 1.74-5.36; p < 0.0001), and estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 (OR 2.99, 95% CI 1.58-5.74; p = 0.0007) were independent determinants of poor DR. The frequency of poor DR according to the risk stratification group was low risk (no risk factor), 18.9%; middle risk (one risk factor), 33.1%; and high risk (two to three risk factors), 58.0% (p < 0.0001). All risk groups demonstrated a significantly lower incidence of poor DR with early TLV administration: 10.7% in the early TLV group versus 18.9% in the loop diuretics group (p = 0.09) of the low-risk group; 18.4% versus 33.1% (p = 0.01) in the middle-risk group, and 20.2% versus 58.0% (p < 0.0001) in the high-risk group. CONCLUSION: Early administration of TLV in patients with predicted poor DR contributed to a significant diuretic effect and suppression of worsening renal function.

Adult-onset Leigh Syndrome with a m.9176T>C Mutation Manifested As Reversible Cerebral Vasoconstriction Syndrome.

A 26-year-old woman developed a sudden headache, ptosis, and diplopia. Magnetic resonance imaging and angiography demonstrated a symmetrical lesion from the midbrain to the brainstem, involving the solitary nucleus and multifocal cerebral artery narrowing. Reversible cerebral vasoconstriction syndrome (RCVS) was suspected, and the patient improved after vasodilatation. Leigh syndrome was suspected due to the elevated serum pyruvate level, so mitochondrial DNA was analyzed, and an m.9176T>C mutation was detected. The final diagnosis was adult-onset Leigh syndrome manifesting as RCVS. An uncontrolled baroreflex due to a solitary nuclear lesion or endothelial dysfunction may have contributed to her unique presentation.

Cilostazol effectiveness in reducing drug-coated stent restenosis in the superficial femoral artery: The ZERO study.

PURPOSE: Drug-eluting stents (DESs) play an important role in endovascular therapy (EVT) for femoropopliteal (FP) lesions. Cilostazol improves patency after bare-metal nitinol stent (BNS) implantation for femoropopliteal lesions. This study aimed to establish whether cilostazol is effective in improving the patency of DESs and determine whether BNS or DESs with or without cilostazol are more effective in improving the 12-month patency after EVT for FP lesions. MATERIALS AND METHODS: In this prospective, open-label, multicenter study, 85 patients with symptomatic peripheral artery disease due to de novo FP lesions were enrolled and treated with DESs with cilostazol from eight cardiovascular centers between April 2018 and May 2019. They were compared with 255 patients from the DEBATE SFA study, in which patients were randomly assigned to the BNS, BNS with cilostazol, or DES groups. The primary endpoint was the 12-month patency rate using duplex ultrasound (peak systolic velocity ratio < 2.5). This study was approved by the ethics committee of each hospital. RESULTS: The 12-month patency rates for the BNS, BNS with cilostazol, DES, and DES with cilostazol groups were 77.6%, 93.1%, 82.8%, and 94.2%, respectively (p = 0.007). The 12-month patency rate was higher in the DES with cilostazol group than in the DES group (p = 0.044). In small vessels, the DES with cilostazol group had a higher patency rate than the DES group (100.0% vs. 83.4%, p = 0.023). CONCLUSIONS: DES with cilostazol showed better patency than DES alone. Cilostazol improved patency after EVT with DES in FP lesions and small vessels. CLINICAL TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (no. UMIN 000032473).

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.

Impact of Diabetes Mellitus on Critical Limb Ischemia With Below the Knee Disease: Japan Below-the-Knee Artery Treatment Subanalysis.

BACKGROUND: A strong association exists between diabetes mellitus and critical limb ischemia. METHODS AND RESULTS: We performed endovascular therapy on 1060 limbs in 884 patients with below knee lesions only. The patients were divided into diabetes (DG) and nondiabetes groups (NDG). Limb salvage was poorer in the DG (79% vs 89%, P = .0061). No significant difference was observed in mortality, amputation-free survival (AFS), and target vessel revascularization (TVR). Multivariate analysis revealed diabetes status, infection, poor activity of daily living (ADL), younger age, and procedure failure as independent predictors of major amputation in DG. In the NDG, procedure failure was the predictor, and younger age and poor ADL showed tendency of major amputation. CONCLUSIONS: Mortality, AFS, and TVR showed no significant difference between the 2 groups, but major amputation was more frequent in DG. Not only revascularization but also infection and diabetes control were very important for limb salvage in DG.

A novel validated method for predicting the risk of re-hospitalization for worsening heart failure and the effectiveness of the diuretic upgrading therapy with tolvaptan.

Increased re-hospitalization due to acute decompensated heart failure (ADHF) is a modern issue in cardiology. The aim of this study was to investigate risk factors for re-hospitalization due to worsening heart failure, and the effect of tolvaptan (TLV) on decreasing the number of re-hospitalizations. This was a multicenter, retrospective study. The re-hospitalization factors for 1191 patients with ADHF were investigated; patients receiving continuous administration of TLV when they were discharged from the hospital (n = 194) were analyzed separately. Patients were classified into 5 risk groups based on their calculated Preventing Re-hospitalization with TOLvaptan (Pretol) score. The total number of patients re-hospitalized due to worsening heart failure up to one year after discharge from the hospital was 285 (23.9%). Age ≥80 years, duration since discharge from the hospital after previous heart failure <6 months, diabetes mellitus, hemoglobin <10 g/dl, uric acid >7.2 mg/dl, left ventricular ejection fraction (LVEF) <40%, left atrial volume index (LAVI) >44.7 ml/m2, loop diuretic dose ≥20 mg/day, hematocrit <31.6%, and estimated glomerular filtration rate (eGFR) <50 ml/min/1.73m2 were independent risk factors for re-hospitalization for worsening heart failure. There was a significant reduction in the re-hospitalization rate among TLV treated patients in the Risk 3 group and above. In conclusions, age, duration since previous heart failure, diabetes mellitus, hemoglobin, uric acid, LVEF, LAVI, loop diuretic dose, hematocrit, and eGFR were all independent risk factors for re-hospitalization for worsening heart failure. Long-term administration of TLV significantly decreases the rate of re-hospitalization for worsening heart failure in patients with a Pretol score of 7.

Improved Diastolic Function Is Associated With Higher Cardiac Output in Patients With Heart Failure Irrespective of Left Ventricular Ejection Fraction.

BACKGROUND: Little is known regarding the impact of diastolic function on cardiac output (CO) in patients with heart failure, particularly in patients with lower ejection fraction. This study aimed to evaluate the impact of end-diastolic pressure-volume relationship (EDPVR) on CO and end-diastolic pressure (EDP). METHODS AND RESULTS: We retrospectively analyzed 1840 consecutive patients who underwent heart catheterization. We divided patients into 8 groups according to ejection fraction (EF) (35-45%, 46-55%, 56-65%, and 66-75%) and EDP (>16 or ≤16 mm Hg). We estimated EDPVR from single measurements in the catheterization data set. Then, we replaced EDPVRs of high-EDP groups with those of normal-EDP groups and compared CO before and after EDPVR replacement. Normalized EDPVR significantly increased CO at EDP=10 mm Hg regardless of EF (EF 35-45%, from 4.5±1.6 to 4.9±1.0; EF 46-55%, 4.6±1.3 to 5.1±1.1; EF 56-65%, 4.9±1.5 to 5.2±1.0; EF 66-75%, 4.9±1.5 to 5.2±1.1). Changes in CO were similar across EF groups. CONCLUSIONS: Diastolic function normalization was associated with higher CO irrespective of EF. Diastolic dysfunction plays an important role in determining CO irrespective of EF in heart failure patients.

A new scoring system (DAIGA) for predicting bleeding complications in atrial fibrillation patients after drug-eluting stent implantation with triple antithrombotic therapy.

BACKGROUND: No scoring system for evaluating the bleeding risk of atrial fibrillation (AF) patients after drug-eluting stent (DES) implantation with triple antithrombotic therapy (TAT) is available. We aimed to develop a new scoring system for predicting bleeding complications in AF patients after DES implantation with TAT. METHODS AND RESULTS: Between April 2007 and April 2014, 227 AF patients undergoing DES implantation with TAT were enrolled. Bleeding incidence defined as Bleeding Academic Research Consortium criteria≥2 was investigated and predictors of bleeding complications were evaluated using multivariate analysis. Bleeding complications occurred in 58 patients (25.6%) during follow-up. Multivariate analysis revealed dual antiplatelet therapy (DAPT) continuation (OR 3.33, P=0.01), age>75 (OR 2.14, P=0.037), international normalized ratio>2.2 (OR 5.82, P<0.001), gastrointestinal ulcer history (OR 3.06, P=0.037), and anemia (OR 2.15, P=0.042) as predictors of major bleeding complications. A score was created using the weighted points proportional to the beta regression coefficient of each variable. The DAIGA score showed better predictive ability for bleeding complications than the HAS-BLED score (AUC: 0.79 vs. 0.62, P=0.0003). Bleeding incidence was well stratified: 17.8% in low-risk (scores 0-1), 55.5% in moderate-risk (2-3), and 83.0% in high-risk (4-7) patients (P<0.001). CONCLUSIONS: This scoring system is useful for predicting bleeding complications and risk stratification of AF patients after DES implantation with TAT.

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.

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.

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.

Measuring Procedure and Maximal Hyperemia in the Assessment of Fractional Flow Reserve for Superficial Femoral Artery Disease.

AIM: The optimal fractional flow reserve (FFR) measurement method for superficial femoral artery (SFA) lesions remains to be established. We clarified the optimal measuring procedure for FFR for SFA lesions and investigated the necessary dose of papaverine for inducing maximal hyperemia in SFA lesions. METHODS: Forty-eight patients with SFA lesions who underwent measurement of peripheral FFR (pFFR: distal mean pressure divided by proximal mean pressure) after endovascular treatment by the contralateral femoral crossover approach were prospectively enrolled. In the pFFR measurement, a guide sheath was placed on top of the common iliac bifurcation and pressure equalization was performed. After advancing the pressure wire distal to the SFA lesion, sequential papaverine administration selectively to the affected common iliac artery was performed. RESULTS: There were no symptoms, electrocardiogram changes, and significant pressure drops at the guide sheath tip with increasing papaverine dose. pFFR changes following 20, 30, and 40 mg of papaverine were 0.87±0.10, 0.84±0.10, and 0.84±0.10, respectively (P＜0.001). Although not significantly different, pFFR decreased more in several patients at 30 mg of papaverine than at 20 mg. The pFFR at 40 mg of papaverine was almost similar to that at 30 mg of papaverine. The necessary papaverine dose was not changed according to sex and number of run-off vessels. CONCLUSIONS: The contralateral femoral crossover approach is useful in FFR measurement for SFA lesions, and maximal hyperemia is induced by 30 mg of papaverine.

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.