Prognostic Impact of Hyperpolypharmacy Due to Noncardiovascular Medications in Patients After Acute Decompensated Heart Failure　- Insights From the Clue of Risk Stratification in the Elderly Patients With Heart Failure (CURE-HF) Registry.

BACKGROUND: Hyperpolypharmacy is associated with adverse outcomes in older adults, but because literature on its association with cardiovascular (CV) outcomes after acute decompensated heart failure (ADHF) is sparse, we investigated the relationships among hyperpolypharmacy, medication class, and death in patients with HF.Methods and Results: We evaluated the total number of medications prescribed to 884 patients at discharge following ADHF. Patients were categorized into nonpolypharmacy (<5 medications), polypharmacy (5-9 medications), and hyperpolypharmacy (≥10 medications) groups. We examined the relationship of polypharmacy status with the 2-year mortality rate. The proportion of patients taking ≥5 medications was 91.3% (polypharmacy, 55.3%; hyperpolypharmacy, 36.0%). Patients in the hyperpolypharmacy group showed worse outcomes than patients in the other 2 groups (P=0.002). After multivariable adjustment, the total number of medications was significantly associated with an increased risk of death (hazard ratio [HR] per additional increase in the number of medications, 1.05; 95% confidence interval [CI], 1.01-1.10; P=0.027). Although the number of non-CV medications was significantly associated with death (HR, 1.07; 95% CI, 1.02-1.13; P=0.01), the number of CV medications was not (HR, 1.01; 95% CI, 0.92-1.10; P=0.95). CONCLUSIONS: Hyperpolypharmacy due to non-CV medications was associated with an elevated risk of death in patients after ADHF, suggesting the importance of a regular review of the prescribed drugs including non-CV medications.

Clinical Profile and Prognosis of Dementia in Patients With Acute Decompensated Heart Failure　- From the CURE-HF Registry.

BACKGROUND: Acute decompensated heart failure (ADHF) has a poor prognosis and common comorbidities may be contributory. However, evidence for the association between dementia and clinical outcomes in patients with is sparse and it requires further investigation into risk reduction.Methods and Results: We assessed the clinical profiles and outcomes of 1,026 patients (mean age 77.8 years, 43.2% female) with ADHF enrolled in the CURE-HF registry to evaluate the relationship between investigator-reported dementia status and clinical outcomes (all-cause death, cardiovascular (CV) death, non-CV death, and HF hospitalization) over a median follow-up of 2.7 years. In total, dementia was present in 118 (11.5%) patients, who experienced more drug interruptions and HF admissions due to infection than those without dementia (23.8% vs. 13.1%, P<0.01; 11.0% vs. 6.0%, P<0.01, respectively). Kaplan-Meier analysis revealed that dementia patients had higher mortality rates than those without dementia (log-rank P<0.001). After multivariable adjustment for demographics and comorbidities, dementia was significantly associated with an increased risk of death (adjusted hazard ratio, 1.43; 95% confidence interval, 1.06-1.93, P=0.02) and non-CV death (adjusted hazard ratio, 1.65; 95% confidence interval, 1.04-2.62, P=0.03), but no significant associations between dementia and CV death or HF hospitalization were observed (both, P>0.1). CONCLUSIONS: In ADHF patients dementia was associated with aggravating factors for HF admission and elevated risk of death, primarily non-CV death.

Association between complete revascularization of the coronary artery and clinical outcomes in peripheral artery disease: a sub-analysis of the I-PAD Nagano registry.

Peripheral artery disease (PAD) is commonly caused by atherosclerosis and has an unfavorable prognosis. Complete revascularization (CR) of the coronary artery reduces the risk of major adverse cardiovascular event (MACE) in patients with coronary artery disease (CAD). However, the impact of CR in patients with PAD has not been established to date. Therefore, we evaluated the impact of CR of CAD on the five-year clinical outcomes in patients with PAD. This study was based on a prospective, multicenter, observational registry in Japan. We enrolled 366 patients with PAD undergoing endovascular treatment. The primary endpoint was MACE, defined as a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke. After excluding ineligible patients, 96 and 68 patients received complete revascularization of the coronary artery (CR group) and incomplete revascularization of the coronary artery (ICR group), respectively. Freedom from MACE in the CR group was significantly higher than in the ICR group at 5 years (66.7% vs 46.0%, p < 0.01). Multivariate analysis revealed that CR emerged as an independent predictor of MACE (Hazard ratio: 0.56, 95% confidential interval: 0.34-0.94, p = 0.03). CR of CAD was significantly associated with improved clinical outcomes in patients with PAD undergoing endovascular treatment.

Validation and Comparison of the Prognosis Predicting Ability of Inflammation-Based Scores Following Endovascular Treatment for Peripheral Artery Disease.

We assessed the prognostic ability of several inflammation-based scores and compared their long-term outcomes in patients with peripheral artery disease (PAD) following endovascular treatment (EVT). We included 278 patients with PAD who underwent EVT and classified them according to their inflammation-based scores (Glasgow prognostic score [GPS], modified GPS [mGPS], platelet to lymphocyte ratio [PLR], prognostic index [PI], and prognostic nutritional index [PNI]). Major adverse cardiovascular events (MACE) at 5 years were examined, and C-statistics in each measure were calculated to compare their MACE predictive ability. During the follow-up period, 96 patients experienced MACE. Kaplan-Meier analysis showed that higher scores of all measures were associated with a higher MACE incidence. Multivariate Cox proportional hazard analysis showed that GPS 2, mGPS 2, PLR 1, and PNI 1, compared with GPS 0, mGPS 0, PLR 0, and PNI 0, were associated with an increased risk of MACE. C-statistics for MACE for PNI (.683) were greater than those for GPS (.635, P = .021), mGPS (.580, P = .019), PLR (.604, P = .024), and PI (.553, P < .001). PNI is associated with MACE risk and has a better prognosis-predicting ability than other inflammation-scoring models for patients with PAD following EVT.

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).

Therapeutic angiogenesis for patients with no-option critical limb ischemia by adipose-derived regenerative cells: TACT-ADRC multicenter trial.

BACKGROUND: Patients with critical limb ischemia (CLI) still have a high rate of lower limb amputation, which is associated with not only a decrease in quality of life but also poor life prognosis. Implantation of adipose-derived regenerative cells (ADRCs) has an angiogenic potential for patients with limb ischemia. OBJECTIVES: We investigated safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs for those patients in multicenter clinical trial in Japan. METHODS: The TACT-ADRC multicenter trial is a prospective, interventional, open-labeled study. Patients with CLI (Fontaine class III-IV) who have no other option for standard revascularization therapy were enrolled in this study. Thirty-four target ischemic limbs of 29 patients were received freshly isolated autologous ADRCs implantation. RESULTS: The overall survival rate at a post-operative period and at 6 months follow-up was 100% at any time points. As a primary endpoint for efficacy evaluation, 32 limbs out of 34 (94.1%) were free from major amputation for 6 months. Numerical rating scale (from 6 to 1) as QOL score, ulcer size (from 317 mm2 at to 109 mm2), and 6-min walking distance (from 255 to 369 m) improved in 90.6%, 83.3%, and 72.2% patients, respectively. CONCLUSIONS: Implantation of autologous ADRCs could be safe and effective for the achievement of therapeutic angiogenesis in the multicenter settings, as a result in no major adverse event, optimal survival rate, and limb salvage for patients with no-conventional option against critical limb ischemia. TRN: jRCTb040190118; Date: Nov. 24th, 2015.

Successful endovascular treatment with a stent graft for chronic deep vein thrombosis with multiple arteriovenous fistulas: a case report.

BACKGROUND: Deep vein thrombosis with arteriovenous fistulas is rare, with few therapeutic options available for chronic-phase deep vein thrombosis. Moreover, the effectiveness of endovascular treatment for chronic-phase deep vein thrombosis with arteriovenous fistulas has not been established. We describe herein a case of successful endovascular treatment for chronic deep vein thrombosis with multiple arteriovenous fistulas. CASE PRESENTATION: We describe the case of a 72-year-old Asian woman who had begun experiencing left leg swelling and intermittent claudication 2 years prior. Enhanced computed tomography revealed left common iliac vein occlusion with vein-to-vein collateral formation and several arteriovenous fistulas. Angiography and ultrasound showed the arteriovenous fistulas to run from the common and internal iliac arteries to the external iliac and superficial femoral veins. We opted against surgical repair for the arteriovenous fistulas due to their complex nature and complicated morphology. Since her condition was progressive, endovascular treatment with a stent graft was performed for the deep vein thrombosis, after which her symptoms gradually improved. Four months following the procedure, enhanced computed tomography confirmed remarkable reduction of the vein-to-vein collaterals and arteriovenous fistulas. CONCLUSIONS: In the present case, enhanced computed tomography with a stent graft was effective in improving symptoms. This strategy may therefore be a treatment option for intractable chronic deep vein thrombosis with arteriovenous fistulas.

Intensive exercise therapy for restenosis after superficial femoral artery stenting: the REASON randomized clinical trial.

Endovascular treatment (EVT) is the main treatment for peripheral artery disease (PAD). Despite advances in device development, the restenosis rate remains high in patients with femoropopliteal lesions (FP). This study aimed to evaluate the effectiveness of exercise training in reducing the 1-year in-stent restenosis rate of bare metal nitinol stents for FPs. This prospective, randomized, open-label, multicenter study was conducted from January 2017 to March 2019. We randomized 44 patients who had claudication with de novo stenosis or occlusion of the FP into an intensive exercise group (n = 22) and non-intensive exercise group (n = 22). Non-intensive exercise was defined as walking for less than 30 min per session, fewer than three times a week. We assessed exercise tolerance using an activity meter at 1, 3, 6, and 12 months, and physiotherapists ensured maintenance of exercise quality every month. The primary endpoint was instant restenosis defined as a peak systolic velocity ratio > 2.5 on duplex ultrasound imaging. Kaplan-Meier analysis was used to evaluate the data. There were no significant differences in background characteristics between the groups. Six patients dropped out of the study within 1 year. In terms of the primary endpoint, intensive exercise significantly improved the patency rate of bare nitinol stents at 12 months. The 1-year freedom from in-stent restenosis rates were 81.3% in the intensive exercise group and 47.6% in the non-intensive exercise group (p = 0.043). No cases of stent fracture were observed in the intensive exercise group. Intensive exercise is safe and reduces in-stent restenosis in FP lesions after endovascular therapy for PAD. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (No. UMIN 000025259).

Effects of cardiac surgical support on long-term outcomes of emergent or complex percutaneous coronary intervention cases: a sub-analysis of the SHINANO 5-year registry.

Significant improvements in percutaneous coronary intervention (PCI) technology have enabled cardiovascular procedures to be performed without onsite cardiac surgery facilities. However, little is known about the association between onsite cardiac surgical support and long-term outcomes of PCI, particularly among emergent and complex cases. We investigated whether the presence or absence of cardiovascular surgery affects the long-term prognosis after PCI, emergent and complex elective cases. The SHINANO 5-year registry, a prospective, observational, and multicenter cohort study registry in Nagano, Japan, consecutively included 1665 patients who underwent PCI between August 2012 and July 2013. The procedures were performed at 11 hospitals with onsite cardiac surgery facilities [onsite surgery (+) group; n = 1257] and 8 hospitals without onsite cardiac surgery facilities [onsite surgery (-) group; n = 408]. The primary endpoint was all-cause mortality and the secondary endpoint was major adverse cardiac and cerebrovascular events [MACCE: all-cause death, Q-wave myocardial infarction, non-fatal stroke, and target lesion revascularization]. The onsite surgery group (+) had a lower rate of emergent PCI and ST-segment elevation myocardial infarction (40.8% vs. 51.7%, p < 0.01 and 24.9% vs. 39.2%, p < 0.01, respectively), and a higher prevalence of hemodialysis and history of peripheral artery disease (7.6% vs. 2.45%, p < 0.01 and 12.1% vs. 6.9%, p < 0.01, respectively). However, the Kaplan-Meier analysis showed no difference in the 5-year mortality rate (16.4% vs. 15.2%, p = 0.421) and MACCE incidence (31.6% vs. 28.9%, p = 0.354) between the groups. Also, there were no differences in the mortality rate and incidence of MACCE among emergent cases of ST-segment elevation myocardial infarction and complex elective cases who underwent PCI. Long-term outcomes of PCI appear to be comparable between institutions with and without onsite cardiac surgical facilities.

The Impact of Hyperuricemia on Patients With Low Body Mass Index After Endovascular Treatments: Data From the I-PAD Registry.

We investigated the prognostic effects of hyperuricemia and high or low body mass index (BMI) in peripheral artery disease (PAD) after endovascular therapy (EVT). Between July 2015-2016, 357 consecutive patients with PAD who underwent EVT were enrolled. Patients were divided into 2 groups: BMI < 25 kg/m2 (low BMI) and ≥ 25 kg/m2 (high BMI); they were also divided into 2 more groups based on the presence/absence of hyperuricemia. The primary and secondary endpoints were major adverse cardiovascular and limb events (MACLE), and all-cause death at 3 years post-EVT. Patients with hyperuricemia had significantly lower freedom from MACLE than patients without hyperuricemia at 3 years (57.0 vs 71.9%, p = .0068). The overall survival of patients with hyperuricemia was significantly lower than that of patients without hyperuricemia (63.9 vs 81.7%, p = .0012). Patients with hyperuricemia who had low BMI experienced significantly lower freedom from MACLE than those without hyperuricemia who had low BMI (48.2 vs 69.9%, p = .002). The overall survival of patients with hyperuricemia who had low BMI was significantly lower than that of patients without hyperuricemia who had low BMI (55.2 vs 77.1%, p = .003). Patients with hyperuricemia had significantly more MACLE and a lower survival at 3 years than patients without hyperuricemia, even if they had a low BMI.

Impact of Frailty and Age on Clinical Outcomes in Patients Who Underwent Endovascular Therapy.

PURPOSE: Information on the relationship between frailty and the outcome of endovascular therapy (EVT) in elderly patients with lower extremity peripheral artery disease (PAD) is scarce. This study aimed to reveal the impact of frailty on the prognosis of super-elderly patients who underwent EVT. MATERIALS AND METHODS: From August 2015 to August 2016, 335 consecutive patients who underwent EVT were enrolled in the I-PAD registry from 7 institutes in Nagano prefecture. Among them, we categorized 323 patients into 4 groups according to age and the presence or absence of frailty as follows: elderly with frailty (age ≥ 75, Clinical Frailty Scale [CFS] ≥ 5), elderly without frailty (age ≥ 75, CFS ≤ 4), young with frailty (age < 75, CFS ≥ 5), and young without frailty (age < 75, CFS ≤ 4); we analyzed them accordingly. The primary endpoints were major adverse cardiovascular and limb events (MACLE), defined as a composite of cardiovascular death, myocardial infarction, stroke, admission for heart failure, major amputation, and revascularization. The secondary endpoint was cardiovascular death. RESULTS: The median follow-up period was 2.7 years. In the elderly with frailty, elderly without frailty, young with frailty, and young without frailty groups, the freedom rates from MACLE were 34.9%, 55.7%, 35.4%, and 63.0%, respectively (p<0.001) and from all-cause death were 43.5%, 73.4%, 50.7%, and 90.9%, respectively (p<0.001). The freedom rates from MACLE were significantly higher among elderly patients with frailty than among young patients without frailty (55.7% vs 35.4%, p=0.01). In multivariate analysis, frailty was independently associated with MACLE incidence. CONCLUSION: Frailty as defined by CFS might be a predictor of MACLE incidence in patients with PAD who underwent EVT. By considering treatment indications for patients with PAD by focusing on frailty rather than age, we may examine whether EVT policies are appropriate and manage patient and caregiver expectations for potential improvement in functional outcomes. Further studies are expected to investigate whether changes in frailty after EVT change prognosis.

Which plantar region can predict peripheral arterial disease by using laser speckleflowgraphy?

Laser speckle flowgraphy (LSFG) is a new device that can measure skin blood flow and capture the movement of erythrocytes. However, there are a few reports on the use of LSFG to estimate skin blood flow, especially in the lower extremities. We aimed to compare plantar skin blood flow between patients with and without peripheral arterial disease (PAD) to discern the extent to which LSFG could accurately predict PAD. We prospectively measured the plantar skin blood flow in 28 patients with PAD and 37 participants without PAD at two hospitals from 2017 to 2021, using the ankle-brachial index (ABI) and LSFG. We partitioned the plantar into 12 parts: digits 1-5, medial metatarsal, middle metatarsal, lateral metatarsal, medial arch, middle arch, lateral arch, and heel, and compared the difference between the two groups and the area under the curve (AUC) of each point. Statistical analyses were performed to determine the sensitivity, specificity, false-positive rate, and false-negative rate at high accuracy points of AUC and ABI. There was a significant difference among the 12 points between the two groups, and the ratio using toe 1 and toe 5 was highly accurate. The ratio using toe 1 indicated higher sensitivity (89 vs. 82%), higher false-positive rate (22 vs. 4%), lower specificity (81 vs. 97%), and an equivalent false-negative rate (9 vs. 12%) to that of the ABI. These findings could facilitate the use of LSFG to estimate the skin blood flow condition in the plantar skin. Our results indicate that measuring toe 1 using LSFG could be used to somewhat assess PAD.

Body composition and mortality in patients undergoing endovascular treatment for peripheral artery disease.

An inverse correlation between body mass index and mortality in patients with peripheral artery disease (PAD) has been reported. However, little information is available regarding the impact of body composition on the clinical outcomes in patients with PAD. This study evaluated the relationships between the lean body mass index (LBMI), body fat % (BF%), and mortality and major amputation rate in patients with PAD. We evaluated 320 patients with PAD after endovascular treatment (EVT) enrolled from August 2015 to July 2016 and divided them into low and high LBMI and BF% groups based on their median values (17.47 kg/m2 and 22.07%, respectively). We assessed 3-year mortality and major amputation for the following patient groups: Low LBMI/Low BF%, Low LBMI/High BF%, High LBMI/Low BF%, and High LBMI/High BF%. During the median 3.1-year follow-up period, 70 (21.9%) patients died and 9 (2.9%) patients experienced major amputation. The survival rate was lower in the Low LBMI than in the High LBMI group, and was not significantly different between the Low and High BF% groups. Survival rates were lowest in the Low LBMI/Low BF% group (57.5%) and highest in the High LBMI/High BF% group (94.4%). There were no significant differences in major amputation rate between the Low LBMI and High LBMI groups, and between the Low BF% and High BF% groups. The Low LBMI and Low BF% groups were associated with an increased risk of mortality after adjustment for age, sex, frailty and conventional risk factors [hazard ratio (HR): 4.02; 95% confidence interval (CI) 2.10-7.70; p < 0.001 and HR: 4.48; 95% CI 1.58-12.68, p = 0.005, respectively], for age, sex, hemodialysis, and prior cerebral cardiovascular disease (HR: 3.63; 95% CI 1.93-6.82; p < 0.001 and HR: 4.03; 95% CI 1.43-11.42, p = 0.009, respectively) and for age, sex, and laboratory date (HR: 3.97; 95% CI 1.88-8.37; p < 0.001 and HR: 3.31; 95% CI 1.15-9.53, p = 0.026, respectively). In conclusion, Low LBMI and Low BF% were associated with poor prognosis in patients undergoing EVT for PAD, and mortality was the lowest in the High LBMI/High BF% group compared with other body composition groups.

Predictive Value of Abdominal Fat Distribution on Coronary Artery Disease Severity Stratified by Computed Tomography-Derived SYNTAX Score.

This study aimed to evaluate the association between abdominal fat distribution (AFD) and coronary artery disease (CAD) complexities using the computed tomography (CT)-derived SYNTAX score (CT-SXscore). Coronary computed tomographic angiography (CCTA) was performed in patients with suspected CAD. Plain abdominal CT was performed to measure visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) areas. To assess AFD, VAT/SAT (V/S) ratios were calculated. The CT-SXscore was calculated in patients with significant stenoses assessed by CCTA. Of 942 enrolled patients, 310 (32.9%) had 1 or more significant stenoses. The CT-SXscore showed a positive correlation with the V/S ratio (r = 0.33, p < 0.001). In the multivariate regression analysis, the V/S ratio was the only independent predictor for CAD severity based on the CT-SXscore (ß = 0.25; t = 4.14; p < 0.001), even though the absolute SAT and VAT areas showed no relationship to the CT-SXscore. Regarding the 4 CAD-patient groups divided according to their median VAT and SAT areas, the CT-SXscore was significantly higher for the high VAT/low SAT group than for any other group (19.6 ± 11.5 vs 13.3 ± 9.6 in the low VAT/low SAT, 10.1 ± 8.5 in the low VAT/high SAT, and 12.2 ± 8.7 in the high VAT/high SAT groups; p < 0.001 for all). In conclusion, it was found that the V/S ratio is a useful index for predicting CAD severity and that AFD may be a more important risk factor for CAD than the absolute amount of each abdominal fat.

Association of the Prognosis of Ankle-brachial Index Improvement One Year Following Endovascular Therapy in Patients with Peripheral Artery Disease: Data from the I-PAD NAGANO Registry.

Objective Despite reports on the effects of ankle-brachial index (ABI) improvement following endovascular therapy (EVT) on the limb prognosis, studies evaluating cardiovascular events are limited. We investigated whether or not ABI improvement 1 year following EVT was associated with cardiovascular events. Methods The I-PAD NAGANO registry is an observational multicenter cohort study that enrolled 337 patients with peripheral artery disease (PAD) who underwent EVT between August 2015 and July 2016. From this cohort, we identified 232 patients whose ABI data 1 year following EVT were available, after excluding patients with critical limb ischemia. We divided the patients into two groups according to the degree of ABI improvement 1 year following EVT (ΔABI) - the ΔABI <0.15 group and the ΔABI ≥0.15 group - and compared the outcomes. The primary endpoint was major adverse cardiovascular events (MACEs), including all - cause death, myocardial infarction (MI), and stroke. The secondary endpoints were major adverse limb events (MALEs), defined as a composite of target lesion revascularization and major amputation, all - cause death, MI, and stroke. The median follow-up period was 3.3 years. Results The incidence of MACEs was significantly higher in the ΔABI <0.15 group than in the ΔABI ≥0.15 group (ΔABI <0.15 vs. ΔABI ≥0.15, 25.8% vs. 11.9%, log-rank p=0.036), as was the incidence of stroke (14.1% vs. 2.2%, log-rank p=0.016). A Cox regression analysis revealed that ΔABI ≥0.15 was significantly associated with fewer MACEs (hazard ratio 0.38, 95% confidence interval 0.17-0.83, p=0.016). Conclusion An increase in ABI ≥0.15 at 1 year following EVT was a predictor of reduced MACEs.

Hallucal thenar index: A new index to detect peripheral arterial disease using laser speckle flowgraphy.

OBJECTIVES: Laser speckle flowgraphy is a technology using reflected scattered light for visualization of blood distribution, which can be used to measure relative velocity of blood flow easily without contact with the skin within a short time. It was hypothesized that laser speckle flowgraphy may be able to identify foot ischemia. This study was performed to determine whether laser speckle flowgraphy could distinguish between subjects with and without peripheral arterial disease. MATERIALS AND METHODS: All subjects were classified based on clinical observations using the Rutherford classification: non-peripheral arterial disease, class 0; peripheral arterial disease group, class 2-5. Rutherford class 6 was one of the exclusion criteria. Laser speckle flowgraphy measured the beat strength of skin perfusion as an indicator of average dynamic cutaneous blood flow change synchronized with the heartbeat. The beat strength of skin perfusion indicates the strength of the heartbeat on the skin, and the heartbeat strength calculator in laser speckle flowgraphy uses the blood flow data to perform a Fourier transform to convert the temporal changes in blood flow to a power spectrum. A total of 33 subjects with peripheral arterial disease and 40 subjects without peripheral arterial disease at a single center were prospectively examined. Laser speckle flowgraphy was used to measure hallucal and thenar cutaneous blood flow, and the measurements were repeated three times. The hallucal and thenar index was defined as the ratio of beat strength of skin perfusion value on hallux/beat strength of skin perfusion value on ipsilateral thenar eminence. The Mann-Whitney U-test was used to compare the median values of hallucal and thenar index and ankle brachial index between the two groups. A receiver operating characteristic curve for hallucal and thenar index of beat strength of skin perfusion was plotted, and a cutoff point was set. The correlation between hallucal and thenar index of beat strength of skin perfusion and ankle brachial index was explored in all subjects, the hemodialysis group, and the non-hemodialysis (non-hemodialysis) group. RESULTS: The median value of the hallucal and thenar index of beat strength of skin perfusion was significantly different between subjects with and without peripheral arterial disease (0.27 vs. 0.87, respectively; P < 0.001). The median value of ankle brachial index was significantly different between subjects with and without peripheral arterial disease (0.8 vs. 1.1, respectively; P < 0.001). Based on the receiver operating characteristic of hallucal and thenar index, the cutoff was 0.4416 and the sensitivity, specificity, positive predictive value, and negative predictive value were 68.7%, 95%, 91.7%, and 77.6%, respectively. The correlation coefficients of all subjects, the hemodialysis group, and the non-hemodialysis group were 0.486, 0.102, and 0.743, respectively. CONCLUSIONS: Laser speckle flowgraphy is a noninvasive, rapid, and widely applicable method. Laser speckle flowgraphy using hallucal and thenar index would be helpful to determine the differences between subjects with and without peripheral arterial disease. The correlation between hallucal and thenar index of beat strength of skin perfusion and ankle brachial index indicated that this index was especially useful in the non-hemodialysis group.

Impact of nutritional index on long-term outcomes of elderly patients with coronary artery disease: sub-analysis of the SHINANO 5 year registry.

Nutritional status is a novel approach to prognostic assessment in patients with cardiovascular disease. However, assessment of nutritional status in elderly patients is challenging due to the significant differences between young patients. The TCBI (Triglycerides × Total cholesterol × Body Weight Index) is a novel and simple nutritional index for predicting long-term outcomes in patients with coronary artery disease. This retrospective study evaluated the efficacy of TCBI in 597 elderly (≥ 75 years) patients enrolled in the SHINANO 5 year registry. The SHINANO 5 year registry, a prospective observational multicenter cohort study, had enrolled 1501 consecutive patients who underwent elective/urgent percutaneous coronary intervention (PCI). In this study, patients were categorized into TCBI quartile groups. The primary endpoints were the occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, stroke, and myocardial infarction at 5 year. The mean duration of follow up was 4.3 ± 1.7 years. The average patient age was 80.9 ± 4.3 years. MACCE was observed in 61 (40.9%) patients in the lowest TCBI quartile group. Kaplan-Meier analysis demonstrated an inverse relationship between MACCE and TCBI (log-lank P < 0.001). Multivariate analysis demonstrated that low TCBI significantly predicted the incidence of MACCE (hazard ratio: 1.44, 95% confidence interval: 1.03-2.00; P = 0.031). The TCBI is useful in predicting long-term outcomes in elderly patients undergoing PCI.

Prognostic usefulness of residual SYNTAX score combined with clinical factors for patients with acute coronary syndrome who underwent percutaneous coronary intervention from the SHINANO Registry.

The optimal strategy for percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) with multi-vessel disease (MVD) is still controversial. Residual anatomical features alone are not sufficient to appropriately stratify patient risk. Our aim was to assess the effectiveness of the residual Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score (rSS) combined with clinical factors to predict long-term clinical outcomes in ACS patients. A total of 120 patients with ACS and MVD undergoing PCI were recruited from the SHINANO 5-year registry: a prospective, multi-center, cohort study. The rSS combined with clinical factors (Combined Score) were calculated based on the residual coronary angiogram and each clinical feature after primary PCI. The Combined Score was calculated by replacing SS with rSS using the SYNTAX score II (SSII) calculator. We grouped the Combined Score in two groups according to the cut-off value calculated by the ROC curve (the C-statistic was 0.82 [95% CI 0.74-0.91]) for all-cause mortality. The primary endpoint was all-cause mortality during the 5-year follow-up. The Combined Score was associated with long-term mortality in Cox-regression analysis (HR 1.08, 95% CI 1.05-1.11, P < 0.001). The mortality rate was significantly higher in the high-score group compared with the low-score group (5.7% vs 38.0%; P < 0.001). In ACS with MVD, the Combined Score might be considered an important tool to predict long-term mortality following PCI.

Impact of changes in body mass index after percutaneous coronary intervention on long-term outcomes in patients with coronary artery disease.

Little is known about the impact of changes in body mass index (BMI) after the percutaneous coronary intervention (PCI) on long-term outcomes in patients with coronary artery disease (CAD). Therefore, this study aimed to clarify this issue. We investigated data on CAD obtained from the SHINANO Registry, a prospective, observational, multicenter cohort study, from 2012 to 2013 in Nagano, Japan. One year after PCI, the enrolled patients were divided into the following three groups based on changes in BMI by tertiles: reduced, maintained, and elevated BMI. The associations among the groups and the 4-year outcomes [major adverse cardiac events (MACEs), all-cause death, Q-wave myocardial infarction, and stroke] were examined. Five hundred seventy-two patients were divided into the reduced, maintained, and elevated BMI groups. Over the 4-year follow-up period, the cumulative incidence of MACEs was 10.5% (60 cases). In the Kaplan-Meier analysis, the incidence rates of MACE were significantly higher in the reduced BMI group than in the maintained and elevated BMI groups [17.7% versus (vs.) 7.3% vs. 9.0%, p = 0.004]. Multivariable cox regression analysis showed that the reduced group showed increased risks of MACEs (hazard ratio 2.15; 95% confidence interval 1.29-3.57; p = 0.003). The long-term clinical outcomes of patients with CAD who underwent PCI were affected by the reduction in BMI after PCI. Furthermore, the elevation of BMI after PCI was not a poor prognostic factor.