Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis.

The effect of drug-coated balloons (DCB) on hemodialysis (HD) in patients with femoropopliteal (FP) disease remains uncertain. This study aimed to investigate the outcomes of DCB therapy in patients with FP artery disease on HD. A total of 185 patients with FP lesions (140 HD patients) who underwent DCB treatment were included in the study. The incidence of restenosis and target lesion revascularization (TLR) at 12 months were measured. Risk factors for TLR were also investigated. The mean age was 71.7 years, and diabetes was observed in 82.3% of patients. The mean duration of receiving dialysis was 8.8 years. The mean lesion length was 11.0 cm, and approximately half of the lesions were severely calcified. Severe dissection after DCB therapy was observed in 19.5% of patients. During the follow-up period, 74 restenosis, 68 TLRs, 8 major amputations, and 28 deaths were observed. The freedom rates from restenosis and TLR at 12 months were 63.8% and 71.3%, respectively. The freedom rates after low- and high-dose DCB at 12 months were 61.9% and 70.6% for restenosis (P = 0.49) and 66.4% and 79.4% for TLR (P = 0.095), respectively. Independent risk factors for TLR at 12 months of age were diabetes, chronic limb-threatening ischemia, and severe calcification. When patients were divided into four groups according to the number of these three risk factors, the rates of freedom from TLR at 12 months were 100%, 94.8%, 76.7%, and 30.3% in the groups with no risk factors, any one risk factor, any two risk factors, and all risk factors, respectively (P < 0.0001). Clinical outcomes after endovascular therapy in HD patients with FP disease remain unsatisfactory, even if they are treated with DCB. In particular, patients on HD with diabetes, chronic limb-threatening ischemia, and severe calcification have poor outcomes.

Long-term clinical outcomes after self-expandable bare nitinol stent implantation for femoropopliteal occlusive disease in hemodialysis patients.

OBJECTIVES: To compare the long-term clinical outcomes after self-expandable bare nitinol stent (BNS) implantation between hemodialysis (HD) and non-HD patients with femoropopliteal (FP) disease. BACKGROUND: Although a BNS has been commonly used in patients with FP disease, the long-term efficacy of BNSs in HD patients remains unknown. METHODS: In total, 427 HD patients treated with a BNS for FP disease were enrolled, along with 157 non-HD patients as a control group. Over the following 5 years, the incidence of target lesion revascularization (TLR), major amputation and mortality was investigated. We also performed propensity-score matching analysis. RESULTS: The 5-year TLR rate (45.2 vs. 32.5%, p = .013) and mortality rate (39.3 vs. 14.0%, p = .0002) were significantly higher in the HD group than in the non-HD group. The major amputation rate was comparable between the groups (7.2% in the HD group vs. 2.8% in the non-HD group, p = .16). In the propensity-score-matched cohort, the TLR rate, and mortality rate were remained higher in the HD group than in the non-HD group (48.9 vs. 34.1%, hazard ratio [HR] 2.11, 95% confidence interval [CI] 1.30-3.49, p = .0024, and 47.9 vs. 12.0%, HR 3.38, 95% CI 1.86-6.56, p < .0001, respectively). The adjusted amputation rate was consistently similar between the groups (1.7% in the HD group vs. 2.7% in the non-HD group, HR 0.90, 95% CI 0.26-2.99, p = .86). CONCLUSIONS: The TLR rate and mortality at 5 years post BNS implantation for FP disease were significantly higher in HD patients than in non-HD patients, though the limb salvage rate was similar.

Outcomes after drug-coated balloon interventions for de novo coronary lesions in the patients on chronic hemodialysis.

The impact of drug-coated balloon (DCB) on hemodialysis (HD) patients with coronary lesions remains unclear. This study aimed to compare outcomes after DCB treatment between HD and non-HD patients with de novo coronary lesions. A total of 235 consecutive patients who electively underwent DCB treatment for de novo coronary lesions were included (HD group: n = 100; non-HD group: n = 135). Angiographic follow-up was performed 6 months after the procedure. Patients were clinically followed up for 2 years. The incidence rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) were investigated. Diabetes and a history of coronary bypass grafting were more frequent in the HD group than in the non-HD group (69.0% vs. 50.7%, p = 0.007, and 24.0% vs 9.1%, p = 0.013, respectively). The reference diameter and pre-procedural diameter stenosis were greater in the HD group than in the non-HD group (2.49 mm vs. 2.24 mm, p = 0.007, and 65.9% vs. 59.6%, p = 0.015, respectively). Calcification was observed in 65.5% of all lesions, and rotational atherectomy was performed in 30.2% patients. The average diameter of the DCB was 2.51 mm (2.57 mm, HD group vs. 2.47 mm, non-HD group, p = 0.14). Although post-procedural diameter stenosis was similar between the groups, late lumen loss on follow-up angiography was larger in HD patients than in non-HD patients (0.27 mm vs. - 0.03 mm, p = 0.0009). The 2-year rates of freedom from TLR and MACE were lower in HD patients than in non-HD patients [79.3% vs. 91.7%, hazard ratio (HR) 2.76, 95% confidence interval (CI) 1.23-6.77, p = 0.014; and 61.6% vs. 89.4%, HR 4.60, 95% CI 2.30-10.2, p < 0.001, respectively]. In conclusion, the rates of TLR and MACE after DCB treatment were higher in HD patients than in non-HD patients.

Comparison between biodegradable- and durable-polymer everolimus-eluting stents in hemodialysis patients with coronary artery disease.

To investigate the clinical outcomes after biodegradable-polymer (BP) and durable-polymer (DP) everolimus-eluting stent (EES) implantation in hemodialysis (HD) patients with coronary artery disease. We enrolled 221 consecutive HD patients successfully treated with EES implantation for coronary lesions. Over the following 2 years, we assessed the incidence of target lesion revascularization (TLR) and major adverse cardiac event (MACE), defined as the composite endpoint of TLR, all-cause mortality, or myocardial infarction. We performed a propensity-score matching analysis and collected follow-up coronary angiography data. There were 91 patients in the BP-EES group and 130 in the DP-EES group. Male sex and diabetes rates were significantly lower in the BP-EES group than in the DP-EES group. A debulking device was less frequently used in the BP-EES group than in the DP-EES group (7.6% vs. 21.5%, p = 0.006). TLR occurred in 38 patients, while stent thrombosis was observed in 3 patients; 19 patients died. TLR and MACE rates at 2 years were comparable between the two groups (19.2% in the BP-EES group vs. 20.4% in the DP-EES group, p = 0.73 and 26.9% vs. 34.2%, p = 0.93, respectively). In the propensity-score-matched cohort, TLR and MACE rates were similar between the two groups (19.2% in the BP-EES group vs. 18.1% in the DP-EES group, p = 0.69, and 26.9% vs. 30.2%, p = 0.66, respectively). Restenosis rates at follow-up angiography were similar between the two groups (p = 0.79). In hemodialysis patients, BP-EES and DP-EES showed similar 2-year clinical outcomes.

Association of protein-energy wasting and inflammation status with mortality after coronary revascularisation in patients on haemodialysis.

OBJECTIVE: Protein-energy wasting is associated with chronic inflammation and advanced atherosclerosis in haemodialysis (HD) patients. We investigated association of geriatric nutritional risk index (GNRI), C reactive protein (CRP) with prediction of mortality after coronary revascularisation in chronic HD patients. METHODS: We enrolled 721 HD patients electively undergoing coronary revascularisation. They were divided into tertiles according to preprocedural GNRI levels (tertile 1 (T1):<91.5, T2: 91.5-98.1 and T3:>98.1) and CRP levels (T1:≤1.4 mg/L, T2: 1.5-7.0 mg/L and T3:≥7.1 mg/L). RESULTS: Kaplan-Meier 10 years survival rates were 32.3%, 44.8% and 72.5% in T1, T2 and T3 of GNRI and 60.9%, 49.2% and 23.5% in T1, T2 and T3 of CRP, respectively (p<0.0001 in both). Declined GNRI (HR 2.40, 95% CI 1.58 to 3.74, p<0.0001 for T1 vs T3) and elevated CRP (HR 2.31, 95% CI 1.58 to 3.43, p<0.0001 for T3 vs T1) were identified as independent predictors of mortality. In combined setting of both variables, risk of mortality was 5.55 times higher (95% CI 2.64 to 13.6, p<0.0001) in T1 of GNRI with T3 of CRP than in T3 of GNRI with T1 of CRP. Addition of GNRI and CRP in a model with established risk factors improved C-statistics (0.648 to 0.724, p<0.0001) greater than that of each alone. CONCLUSION: Preprocedural declined GNRI and elevated CRP were closely associated with mortality after coronary revascularisation in chronic HD patients. Furthermore, combination of both variables not only stratified risk of mortality but also improved the predictability.

Efficacy of organic acids, bacteriocins, and the lactoperoxidase system in inhibiting the growth of Cronobacter spp. in rehydrated infant formula.

Thirty-three antimicrobial agents, including antimicrobial peptides (nisin, lacticin 3147, isracidin), organic acids, emulsifiers (organic acid esters), glycine, lysozyme, tocopherol, EDTA, milk fat globule membrane, and the lactoperoxidase system (LPOS) were screened for anti-Cronobacter sakazakii activity. The compounds were initially screened individually in parallel in synthetic media. Those showing antimicrobial activity were then tested in reconstituted whole milk and finally in reconstituted powdered infant formula (PIF), using mild temperatures of reconstitution and prolonged storage at room temperature. Propionic acid and monocaprylin (as POEM M-100) in combination showed inhibitory activity at sufficiently low concentrations (0.1 to 0.2%) in milk to be considered as potential antimicrobial additives for the inhibition of C. sakazakii in reconstituted PIF. More interestingly, LPOS, when combined with the broad-spectrum bacteriocins nisin or lacticin 3147, inhibited outgrowth of C. sakazakii at 37°C for 8 h. The combined effects of POEM M-100 and either acetate or propionate and LPOS with lacticin 3147 or nisin were evaluated under the Food and Agriculture Organization of the United Nations-World Health Organization high-risk scenario for PIF, i.e., low temperature of reconstitution and long storage or feeding times at ambient temperature. In the presence of LPOS and lacticin 3147, growth of Cronobacter spp. was inhibited for up to 12 h when the PIF was rehydrated at 40 or 50°C. These results highlight the potential of combinatory approaches to improving the safety of infant milk formula.

Real-time monitoring of luciferase-tagged Cronobacter sakazakii in reconstituted infant milk formula.

The aim of this study was to examine the potential of using a lux-tagged Cronobacter sakazakii strain to monitor growth of the bacterium in various liquids. C. sakazakii was transformed with plasmid p16S lux, and integration of the plasmid at the desired site on the chromosome was confirmed by PCR. The growth of the lux-tagged strain was similar to that of the non-lux-tagged strain, and the integrated plasmid was stable when cells were cultured in the absence of antibiotic. Growth of the lux-tagged strain was monitored in real time in Luria-Bertani broth, skim milk, and infant milk formula by using both the Luminoskan luminometer and the Xenogen IVIS imager. Bioluminescence could be detected when the lux-tagged strain was cocultured with other bacteria. The effect of monocaprylin and nisin on the growth of C. sakazakii in milk was monitored by measuring bioluminescence. In conclusion, growth of a lux-tagged C. sakazakii can be monitored in real time in both clear and opaque liquids by measuring bioluminescence. lux-tagged C. sakazakii strains could be potentially used in high-throughput assays to monitor the effects of various infant milk formula compositions on growth of the bacterium.

Accuracy of 64-slice multidetector computed tomography for classification and quantitation of coronary plaque: comparison with integrated backscatter intravascular ultrasound.

BACKGROUND: Noninvasive assessment of coronary plaque is important for coronary risk stratification. Whereas integrated backscatter intravascular ultrasound (IB-IVUS) has proven effective for analysis of the tissue components of coronary plaque, plaque assessment by 64-slice multidetector computed tomography (MDCT) has not been established. We therefore evaluated the accuracy of MDCT compared with IB-IVUS for identification of coronary plaque components and determination of plaque volume. METHODS: Thirty-one sites in 17 coronary vessels (7 left anterior descending, 5 left circumflex, and 5 right coronary arteries) with substantial stenosis were visualized by both 64-slice MDCT and IB-IVUS. Coronary plaque was evaluated by MDCT and the findings were compared with those of IB-IVUS at the same sites and for the same vessel lengths. Plaque was classified as low-attenuated, fibrous, or calcified, and the volume of each plaque component and total plaque volume were calculated. RESULTS: Total plaque volume per vessel determined by MDCT was significantly correlated with that determined by IB-IVUS (r=0.704, P<0.05, n=17). However, the volumes of individual plaque components determined by the two approaches were not correlated. The predominant plaque morphology as determined by the two approaches was consistent in 12 of the 17 vessels (70.6%), whereas calcified and low-attenuated plaques were overestimated by MDCT in the remaining vessels. CONCLUSIONS: MDCT is a promising approach for noninvasive detection of different types of coronary plaque and may therefore contribute to coronary risk stratification. The ability of MDCT to determine the volume of individual plaque components, however, is limited.