Gender Disparities in Japanese Interventional Cardiology: Outcomes of Female Operators in Percutaneous Coronary Interventions.

Background: Gender disparity remains a significant global concern in interventional cardiology, and there is a lack of extensive research examining the outcomes of percutaneous coronary interventions (PCIs) performed by female interventionalists. Objectives: The aim of this study was to examine the practice patterns and outcomes of PCIs conducted by female interventionalists in Japan. Methods: This retrospective observational study analyzed data from the Japanese Percutaneous Coronary Intervention registry between January 2019 and December 2021. The primary endpoint was in-hospital mortality and the secondary endpoint was the success rate of PCIs. Results: A total of 447 female operators (7.3% of all operators) performed 35,211 PCIs (5.3%) during the study period. Female doctors treated a higher percentage of patients with ST-segment elevation myocardial infarction compared with their male counterparts (20.2% vs 17.7%; P = 0.001), whereas male doctors were more likely to perform PCIs for left main disease (4.9% vs 5.9%; P < 0.001) and lesions treated with rotational atherectomy (3.5% vs 4.9%; P < 0.001). The success rate of PCIs was higher for female interventionalists (97.8% vs 97.2%; P < 0.001). After conducting a risk-adjusted analysis, we found no significant difference in in-hospital mortality (adjusted OR: 0.896; 95% CI: 0.78-1.03; P = 0.12), or procedural complications associated with the operator's gender. Conclusions: Overall, female operators exhibited outcomes similar to their male counterparts in terms of adjusted procedural outcomes, and higher crude success rate in certain subgroups. These findings emphasize gender disparities and stress the need to increase gender diversity in interventional cardiology.

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.

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.

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.

Randomized comparison between provisional and routine kissing-balloon technique after main vessel crossover stenting for coronary bifurcation lesions.

We compared the myocardial ischemic burden of provisional and routine final kissing-balloon inflation (FKI) with the 1-stent strategy using a second-generation drug-eluting stent for coronary bifurcation lesions (CBL). There are no established guidelines for side branch (SB) intervention after main vessel stenting. In total, 113 CBL patients were randomized to receive different SB intervention strategies: provisional-FKI group (n = 57; FKI only when SB flow was TIMI <3) and routine-FKI group (n = 56; mandatory FKI with aggressive treatment until SB-residual stenosis <50%). Dipyridamole-stress myocardial perfusion scintigraphy with 99mTc was performed after 8 months. The regional summed-difference score (r-SDS) was calculated according to the coronary territory. The primary endpoint included target vessel ischemia (TVI; r-SDS ≥ 2) at 8 months, whereas the clinical primary endpoint was major adverse cardiovascular events (MACE) at 3 years. The percent (%) myocardial ischemia (100 × SDS/68) was also calculated. At 8 months, TVI was identified in 11 and 4% in the provisional-FKI and routine-FKI groups, respectively (p = 0.226). SB-binary restenosis (48 vs. 4%, p < 0.001) and myocardial ischemia at the SB territory (11 vs. 0%, p = 0.030) were more common in the provisional-FKI group; however, in TVI patients, % myocardial ischemia (4.12 ± 1.23% vs. 3.68 ± 1.04%; p = 0.677) did not significantly differ. Moderate/severe ischemia (>10% myocardial ischemia) was not observed in the target vessel in either group. Long-term cumulative MACE were similar between the groups (9 vs. 14%; p = 0.358). Provisional-FKI according to TIMI-SB flow grade led to similar and acceptable myocardial ischemia, in comparison with routine-FKI, which may contribute to the identical long-term follow-up.

Mechanism of Residual Lumen Stenosis at the Side Branch Ostium After Final Kissing Balloon Inflation: A Volumetric Intracoronary Ultrasound Study of Coronary Bifurcation Lesions.

OBJECTIVES: To investigate the mechanisms of residual stenosis (RS) at side branch ostium (SBO) after final kissing balloon inflation (FKI) and clarify the impact of carina- and plaque-shifts on RS. BACKGROUND: Carina- and plaque-shift induce SBO compromise. FKI is an effective technique to treat this complication; however, RS often persist, and are associated with restenosis at SBO. METHODS: We performed serial volumetric analysis of 91 bifurcations in which crossover-stenting with FKI and pre-/post-intravascular ultrasounds (IVUS) were completed in both branches. The plaque- and carina-shifts were defined as an increase in the plaque-volume and a decrease in the vessel-volume at the SBO, respectively. RS at the SBO, defined as area stenosis >50% on IVUS, was identified in 19 lesions. RESULTS: After FKI, the plaque volume- significantly increased at the SBO, with its reduction in the proximal main vessel (MV). However, at the SBO, the volumetric lumen change correlated with vessel change (ρ = 0.690, P < 0.001), but not plaque change (P = 0.390), suggesting that RS at SBO was more likely associated with inadequate vessel stretch, not plaque increase after FKI. Carina-shift was more frequently found in cases with RS, compared to those without RS (37% vs. 11%, P = 0.013). Pre-procedure IVUS findings to predict RS at SBO after FKI were negative-remodeling at distal MV, plaque -burden at distal MV, and plaque-burden at the SBO. CONCLUSIONS: Carina-shift has a greater contribution to the formation of RS at SBO after FKI. The pre-procedure IVUS provides helpful information for predicting the RS after FKI.

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.

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.

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.

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.

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.

Failure of a balloon to deflate during post dilatation in a coronary artery.

Entrapment of nondeflated balloon is a rare complication of percutaneous coronary intervention. Sometimes it has hazardous potentials for the patient. We experienced a rare complication of percutaneous coronary intervention (PCI) caused by a defective balloon. We reported this experience and simple bailout technique.

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.

Arousal electrical stimuli evoke sudomotor activity related to P300, and skin vasoconstrictor activity related to N140 in humans.

OBJECTIVE: Arousal stimuli evoke bursts of skin sympathetic nerve activity (SSNA). SSNA usually contains sudomotor and vasoconstrictor neural spikes. The aim of this study was to elucidate which components of event-related potentials (ERPs) are related to sudomotor and vasoconstrictor responses comprising arousal SSNA bursts. METHODS: We recorded SSNA from the tibial nerve by microneurography, with corresponding sympathetic skin response (SSR), sympathetic flow response (SFR), and ERPs in 10 healthy subjects. Electrical stimulation of the median nerve was used to induce arousal responses. ERPs were classified by the occurrence of SSR and SFR. RESULTS: SSNA bursts followed by SSR were associated with larger P300 than SSNA bursts followed by no SSR. For N140, no difference in the amplitude was found between SSNA bursts with and without SSR. SSNA bursts followed by SFR were associated with larger N140 than SSNA bursts followed by no SFR. However, there were no differences in the amplitude of P300 between SSNA bursts with and without SFR. CONCLUSIONS: Sudomotor and skin vasoconstrictor responses to arousal stimuli were differently associated with distinct ERP components. SIGNIFICANCE: The possibility that sudomotor and skin vasoconstrictor activities comprising arousal SSNA reflect different stages of the cognitive process is suggested.