Prognostic Impact of Reduced Left Ventricular Ejection Fraction After Endovascular Therapy for Lower Extremities.

BACKGROUND: The mechanism underlying a poor prognosis in patients with lower-extremity artery disease (LEAD) with heart failure is unknown. We examined the prognostic impact of the left ventricular ejection fraction (LVEF) in patients with LEAD who underwent endovascular therapy (EVT).Methods and Results: From August 2014 to August 2016, 2,180 patients with LEAD (mean age, 73.2 years; male, 71.9%) underwent EVT and were stratified into low-LVEF (LVEF <40%; n=234, 10.7%) and not-low LVEF groups. In the low- vs. not-low LVEF groups, there was a higher prevalence of heart failure (i.e., history of heart failure hospitalization or New York Heart Association functional class III or IV symptoms) (44.0% vs. 8.3%, respectively), diabetes mellitus, chronic kidney disease, below-the-knee lesion, critical limb ischemia, and incidence of major cardiovascular and cerebrovascular events (MACCEs) and major adverse limb events (MALEs) (P<0.001, all). Low LVEF independently predicted MACCEs (hazard ratio: 2.23, 95% confidence interval: 1.63-3.03; P<0.001) and MALEs (hazard ratio: 1.85, 95% confidence interval: 1.15-2.96; P=0.011), regardless of heart failure (P value for interaction: MACCEs: 0.27; MALEs: 0.52). CONCLUSIONS: Low LVEF, but not symptomatic heart failure, increased the incidence of MACCEs and MALEs. Intensive cardiac dysfunction management may improve LEAD prognosis after EVT.

Prognostic Values of Fractional Flow Reserve Based on Clinical Outcomes in Patients on Chronic Hemodialysis.

The fractional flow reserve (FFR) cut-off values of 0.75 or 0.8 have been widely used; however, whether they apply to patients on hemodialysis remains unknown. We aimed to investigate the cut-off value of FFR associated with clinical outcomes in patients on hemodialysis. Using the Japanese multicenter registry, we analyzed data of patients on hemodialysis with measured FFR between January 2010 and December 2016. Survival classification and regression tree analysis for the composite primary outcome of cardiovascular mortality, myocardial infarction, and target vessel revascularization revealed a threshold FFR of 0.83. Multivariate Cox regression analyses were performed for the clinical outcomes. Additionally, the primary outcome was analyzed using propensity score matching by dividing the patients into complete and incomplete revascularization groups according to the presence of residual lesions with an FFR of ≤0.83 after the intervention. Of the 212 included patients, 112 (52.8%) had lesions with an FFR of ≤0.83. After adjusting for confounders, an FFR of ≤0.83 was associated with a higher risk for the primary outcome (adjusted hazard ratio 2.01, 95% confidence interval 1.11 to 3.66, p = 0.021). Propensity score matching showed that complete revascularization for lesions with an FFR of ≤0.83 was associated with a reduced risk for the primary outcome compared with incomplete revascularization (hazard ratio 0.38, 95% confidence interval 0.20 to 0.71, log-rank p = 0.0016). In conclusion, an FFR of ≤0.83 was an independent predictor of clinical events in patients on hemodialysis. Furthermore, complete revascularization was associated with better clinical outcomes. Thus, this population may require a distinct FFR cut-off value.

Predictors of procedural complications in balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

BACKGROUND: Balloon pulmonary angioplasty (BPA) is an effective treatment for inoperable chronic thromboembolic pulmonary hypertension, with good results reported for residual pulmonary hypertension (PH) after pulmonary endarterectomy (PEA). However, BPA is associated with complications, such as pulmonary artery perforation and vascular injury, which can lead to critical pulmonary hemorrhage requiring embolization and mechanical ventilation. Furthermore, the risk factors for occurrence of complications in BPA are unclear; therefore, this study aimed to evaluate predictors of procedural complications in BPA. METHODS: In this retrospective study, we collected clinical data (patient characteristics, details of medical therapy, hemodynamic parameters, and details of the BPA procedure) from 321 consecutive sessions involving 81 patients who underwent BPA. Procedural complications were evaluated as endpoints. RESULTS: BPA for residual PH after PEA was performed in 141 sessions (43.9 %), which involved 37 patients. Procedural complications were observed in 79 sessions (24.6 %), including severe pulmonary hemorrhage requiring embolization in 29 sessions (9.0 % of all sessions). No patients experienced severe complications requiring intubation with mechanical ventilation or extracorporeal membrane oxygenation. Age ≥ 75 years and mean pulmonary artery pressure ≥ 30 mmHg were independent predictors of procedural complications. Residual PH after PEA was a significant predictor of severe pulmonary hemorrhage requiring embolization (adjusted odds ratio, 3.048; 95 % confidence interval, 1.042-8.914, p = 0.042). CONCLUSIONS: Older age, high pulmonary artery pressure, and residual PH after PEA increase the risk of severe pulmonary hemorrhage requiring embolization in BPA.

The association of calcium channel blocker with risk of adverse limb events in patients with chronic limb-threatening ischemia after endovascular treatment.

Symptoms of lower-extremity artery disease (LEAD) emerge from impaired vascularization in distal circulation of the extremities. Calcium channel blockers (CCB) can improve distal circulation when used as adjunctive therapy with endovascular treatment (EVT), but few studies have evaluated that. We investigated the relationship between CCB therapy and post-EVT outcomes. Through a consecutive EVT registry, we evaluated those relationships in whole cohort and the following 2 subgroups; the patients suffered from intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI), with adjusting baseline characteristics by propensity score matchings. The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE, a composite endpoint of all death, nonfatal myocardial infarction, and nonfatal stroke), and major adverse limb event (MALE, a composite of major amputation, acute limb ischemia, and surgical reintervention). The group that received CCB had less MALE in whole cohort (HR 0.31; 95% confidence interval (CI) 0.20-0.47), and less MACCE and MALE in CLTI cohort (HR 0.67; 0.50-0.89 and 0.32; 0.20-0.52 respectively) compared to the group that did not receive CCB. The relationships were common in the cohorts with baseline adjustment. MACCE and MALE in IC (HR 1.01; 0.57-1.80 and 0.60; 0.25-1.45, respectively) showed no significant differences both with and without baseline adjustment. CCB use was related to fewer MACCE and MALE events in adjusted patients who underwent EVT, and the trend was more evident, especially in the adjusted CLTI cohort. This study highlights the necessity of future studies regarding CCB. Clinical Trial Registration: URL: https://www.umin.ac.jp ; Unique identifiers: UMIN000015100.

Association of the severity of vascular damage with discordance between the fractional flow reserve and non-hyperemic pressure ratios.

BACKGROUND: While there is a discordance between fractional flow reserve (FFR) and non-hyperemic pressure ratios (NHPRs) in some cases, the mechanisms underlying these discordances have not yet been fully clarified. We examined whether vascular damage as assessed by measurement of the brachial-ankle pulse wave velocity (baPWV), a marker of arterial stiffness, or ankle brachial pressure index (ABI), a marker of atherosclerotic arterial stenosis, might be associated with their discordances. METHODS: FFR and NHPRs were measured in 283 consecutive patients (69 ±â€¯10 years old). Based on previously established cut-off values of the two markers (i.e. +/- = FFR ≤/> 0.80 or =NHPRs ≤/> 0.89), the study participants were divided into four groups (the + and - signs denoting "predictive of significant stenosis" and "not predictive of significant stenosis," respectively): the FFR+/NHPRs+ group (n = 124), FFR-/NHPRs+ group (n = 16), FFR+/NHPRs- group(n = 65), and FFR-/NHPRs- group (n = 78). The baPWV and ABI were also measured in all the participants, and values of <2000 cm/s and ≥1.00 of the baPWV and ABI, respectively, were considered as representing relatively less advanced atherosclerotic systemic vascular damage. RESULTS: The prevalence of subjects with ABI ≥1.00 was higher in the FFR+/NHPRs- group than in the FFR-/NHPRs- group (p < 0.05). When the study subjects were divided into 2 groups, namely, the FFR+/NHPRs- group and the combined group, the prevalence of ABI ≥1.00 and that of baPWV <2000 cm/s were higher in the FFR+/NHPRs- group as compared with those in the combined group (p < 0.05). The results of binary logistic regression analysis demonstrated that ABI ≥1.00 was associated with a significant odds ratio (2.34, p < 0.05) for the FFR+/NHPRs- discordance. CONCLUSION: The FFR+/NHPRs- discordance appears to be observed in patients with relatively less advanced atherosclerotic systemic vascular damage. Thus, ABI ≥1.00 may be a marker of the presence of the FFR+/NHPRs- discordance.

Differences in major limb outcomes by indication for lower extremity endovascular revascularization in patients receiving hemodialysis.

The incidence of lower extremity artery disease (LEAD) in patient receiving hemodialysis is remarkably higher than the general population. The treatment strategy and prognosis for LEAD patients differs depending on whether a patient has intermittent claudication (IC) or critical limb-threatening ischemia (CLTI). However, the distinction between the prognosis in HD-dependent patients with IC and CLTI has not been fully elucidated. This study is to determine whether indication of PAD has a distinct impact on major adverse cardiovascular and cerebrovascular events (MACCE) and limb events in patients receiving hemodialysis. The current study included 2321 prospectively enrolled patients from the Tokyo taMA peripheral vascular intervention research ComraDE registry (UMIN-CTR no. UMIN000015100) between September 2014 and December 2016. Out of the enrolled patients, 1644 were not receiving hemodialysis (non-HD patients) and 603 were receiving hemodialysis (HD patients). A composite of all-cause death, myocardial infarction, and stroke events defined as MACCE; while limb events were defined as a composite of unscheduled major amputation, unscheduled major lower limb surgery, acute limb ischemia, unscheduled endovascular treatment, and target lesion revascularization. Propensity score matching was applied among the non-HD and HD patients, in whole group, IC subgroup, and CLTI subgroup. Kaplan-Meier analysis was used for the analysis of outcomes for the whole group, IC subgroup, and the CLTI subgroup. CLTI accounted for 75.5% of the HD patients, whereas IC was 63.4% in the non-HD patients. The HD patients exhibited more frequent below-the-knee lesions than those in the non-HD patients in both IC (p = 0.01) and CLTI (p < 0.001) subgroups. Overall, HD patients exhibited a significantly higher rate of MACCE at 24 months. This trend was similar for limb events in whole group and CLTI subgroup. In contrast, no significant differences in outcomes for limb events were found in IC subgroup. Although, prognosis after EVT in HD patients were significantly worse than non-HD patients, comparable outcome with non-HD patients was observed in the patients treated for IC. Clinical trial registration: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR No. UMIN000015100).

Comparison of the incidence of depression before and after endovascular treatment in patients with lower limb peripheral artery disease.

Depression is a chronic illness that affects mood, physical health, and overall vitality and quality of life. Depression has been associated with an increased risk of all-cause and cardiovascular mortality among patients with peripheral arterial disease (PAD). Therefore, this study aimed to compare the incidence of depression before and after endovascular treatment in patients with lower limb PAD. This is an important clinical issue considering the worldwide increase in PAD with the aging population and the known negative impact of depression on recovery. This was a retrospective sub-analysis of data from the Tokyo Peripheral Vascular Intervention Study using the TOMA-CODE registry. The presence and extent of depressive symptoms were evaluated using the patient health questionnaire (PHQ-9), with a depressive tendency score of ≥ 5. The PHQ-9 score was evaluated before endovascular treatment (EVT) and at 4 (± 1) weeks after EVT. The study population consisted of 87 patients who completed the PHQ-9 before EVT, with 76 completing the post-EVT PHQ-9. Of these 76, 19 had a pre-EVT score ≥ 5. Overall, there was no difference in the pre- and post-EVT scores (P = 0.091). There was no significant change in the 19 patients with a pre-EVT score ≥ 5 (mean 9.2 ± 4.4); however, there was a tendency to improve in the pre- to post-EVT score (mean, 6.9 ± 5.2; P = 0.059). Diabetes was a significant negative factor for pre- to post-EVT score improvement (P = 0.023). Overall, symptoms of depression showed the tendency to improve at 30 days post-EVT. However, diabetes was associated with lower improvement in symptoms.

Three-Year Clinical Outcomes of the Innova™ Self-Expanding Nitinol Stent for the Treatment of Femoropopliteal Lesions.

PURPOSE: To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting. METHODS: This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1-6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events. RESULTS: Restenosis following Innova™ implantation was found in 61% of the cases at 3 years. At the end of 3 years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1 year, no predictive factors for restenosis at 3 years could be determined. CONCLUSION: The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting.

Efficacy and safety of balloon pulmonary angioplasty for residual pulmonary hypertension after pulmonary endarterectomy.

BACKGROUND: Pulmonary endarterectomy (PEA) is the standard treatment for chronic thromboembolic pulmonary hypertension (CTEPH), although some patients may experience residual pulmonary hypertension (PH). It is unclear whether balloon pulmonary angioplasty (BPA) is effective for residual PH after PEA. This study aimed to compare the BPA outcomes between patients with residual PH after PEA and those with inoperable CTEPH. METHODS: This retrospective study compared BPA for residual PH after PEA (25 patients, 101 BPA sessions) and BPA alone for inoperable CTEPH (21 patients, 89 BPA sessions). All patients underwent right heart catheterisation and functional and laboratory tests before PEA or before and after BPA. RESULTS: There was no difference in the number of BPA sessions per patient (4.0 ± 1.9 vs. 4.2 ± 1.9, p = 0.671). No significant differences were observed with respect to the mean pulmonary artery pressure (23.6 ± 9.1 vs. 21.9 ± 5.7 mmHg, p = 0.44), pulmonary vascular resistance (3.7 ± 0.5 vs. 2.8 ± 1.2 Wood units, p = 0.14), 6-min walking distance (392.1 ± 117.7 vs. 452.4 ± 90.1 m, p = 0.096), and World Health Organization functional class (I/II/III/IV: 14/11/0/0 vs. 9/12/0/0, p = 0.375). Severe haemoptysis requiring embolisation was more common in the PH after PEA group (16.0% vs. 5.4%, p = 0.018). However, no patients required mechanical ventilation or extracorporeal membrane oxygenation, and there were no procedural deaths. CONCLUSION: Although BPA might be effective for residual PH after PEA, it was associated with a high rate of haemoptysis.

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

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

Differences in Intravascular Ultrasound Measurement Values Between Treatment Modalities for Restenosis in Femoropopliteal Lesions.

BACKGROUND: The risk of restenosis after intervention is higher in femoropopliteal than in aortoiliac lesions. However, the appropriate endovascular therapy (EVT) for preventing restenosis after intervention for femoropopliteal lesions remains unknown. This study aimed to elucidate the relationship between lesion characteristics and patency after EVT using intravascular ultrasound (IVUS) measurement and to determine the predictors of restenosis on IVUS.Methods and Results:This prospective observational study was performed at 18 Japanese centers. We evaluated the lesion characteristics before and after EVT for femoropopliteal lesion using IVUS. Angiographic or duplex ultrasound follow-up was performed at 1 year after EVT. A total of 263 lesions underwent EVT between December 2016 and December 2017. In total, 20 lesions (8 cases of isolated common femoral artery lesion and 12 cases of restenosis lesion) were excluded, and 243 lesions were enrolled in this study. A total of 181 lesions were treated with stent placement, and 62 lesions were treated only with balloon angioplasty. In the case of stent use, a larger distal plaque burden was associated with restenosis, while a lower calcification angle was associated with higher patency in the case of balloon angioplasty alone. CONCLUSIONS: The factors related to patency differed depending on the treating modality. The findings suggest that IVUS is a useful tool for predicting patency because it can provide a more accurate evaluation after EVT for femoropopliteal lesions.

Increase in the Arterial Velocity Pulse Index of Patients with Peripheral Artery Disease.

BACKGROUND: Recently, a simple parameter calculated from the brachial pressure waveform recorded using an oscillometric device (arterial velocity pulse index [AVI]: ratio of the forward/reflected pressure wave amplitudes) has become available to assess the pathophysiological abnormalities associated with vascular damage. Peripheral artery disease (PAD) represents one of the disease entities associated with the advanced stages of atherosclerotic vascular damage. The present study was conducted to examine whether an increase in the AVI might be influenced by the presence of PAD. METHODS AND RESULTS: The AVI was measured from oscillometric recordings of the brachial pressure waveform, and the ankle-brachial pressure index (ABPI) was determined by an oscillometric method. Study 1: In 341 consecutive patients admitted for the management of cardiovascular disease and/or cardiovascular risk factors, the ABPI and the AVI were measured simultaneously. An ABPI ≤0.90 was observed in 19 subjects, and logistic regression analysis revealed a significant association between AVI and ABPI ≤0.90 (odds ratio = 1.81; 95% confidence interval = 1.15-2.84; p = 0.01). Study 2: In another 19 patients with PAD, percutaneous transluminal angioplasty resulted in a decrease in the AVI from 31 ± 8 to 27 ± 8 (p < 0.01). CONCLUSION: Possible presence of PAD must be taken into account while applying the AVI for the assessment of vascular damage.

New Endovascular Technique to Prevent Distal Embolism for Iliofemoral Occlusive Disease: Reverse Flow Aspiration With Proximal Sheath Blockage.

PURPOSE: To report the safety and efficacy of a new technique to prevent distal embolism during treatment of iliofemoral occlusions: reverse flow aspiration with proximal sheath blockage (ReFLAP). METHOD: Between October 2013 and December 2014, 90 patients (mean age 74 years; 66 men) were prospectively enrolled in a study to evaluate the ReFLAP technique during treatment of 110 occlusions in the iliac artery (72, 65%) or superficial femoral artery (SFA; 38, 35%). The mean occlusion lengths of iliac and SFA lesions were 79 and 179 mm, respectively. The concept of ReFLAP is to aspirate debris after balloon dilation using reverse flow through collaterals without antegrade flow. The main endpoints were the incidence of distal embolization, amputation, complications, and the ReFLAP capture rate, which was visually estimated during aspiration using 4 prespecified grades (0, none; 1, foamy debris; 2, small particles; 3, massive particles). RESULTS: ReFLAP was successful in 105 (95.4%) of the 110 lesions attempted; the 5 failures were due to severe vessel tortuosity or calcification. The incidences of distal embolization and amputation were both 0. Minor complications unrelated to ReFLAP were observed in 8 patients. The ReFLAP procedure aspirated debris in 57 (54%) of the 105 lesions. Aspirated material, including marked clots (grades 2 and 3), was confirmed in 40 (38%) of the lesions. The distribution of aspiration grades was significantly different between iliac and SFA lesions (p=0.02). CONCLUSION: Our results suggest that the ReFLAP endovascular technique to prevent distal embolization during iliofemoral occlusive disease treatment is simple, safe, and effective.

Analysis of suboptimal stent deployment using intravascular ultrasound and coronary pressure pullback measurement.

BACKGROUND: There are some cases in whom a sufficient improvement in fractional flow reserve (FFR) could not be achieved even if anatomical results indicated satisfactory stent deployment. We investigated the relation of abnormal findings between intravascular ultrasound (IVUS) and coronary pressure pullback measurement (CP-PB). METHODS: IVUS and CP-PB were investigated after stent deployment in 60 vessels in 53 patients. CP-PB criterion for adequate stent deployment was defined as a ratio of coronary pressure at the stent distal edge to the proximal edge (Psd/Psp) that is greater than 0.95. RESULTS: Residual pressure gradient across the stent which was indicated by Psd/Psp≤0.95 was present in 11 (18%), and four of them were caused by insufficient stent expansion (incomplete apposition and asymmetric dilation), and five of them were caused by issues with stent edge (edge dissection and incomplete coverage of the plaques). Insufficient FFR recovery which was recorded at distal part of target vessel was present in 10 (17%), and the main causes corresponded to inadequate stent deployment in half of the lesions, and presence of residual lesion at a non-stent segment in the other half. There were six lesions in whom Psd/Psp was ≤0.95 but FFR was ≥0.80. Disagreement between IVUS and CP-PB findings was seen in 12 (20%). CONCLUSIONS: Residual pressure gradient across the stent can reflect not only an insufficient stent expansion but also issues with stent edges. The decision of optimum stent deployment as assessed by IVUS and CP-PB was mismatched in 20% of cases, therefore careful attention should be paid to decoding the CP-PB findings.

Diagnostic Performance of a Cadmium-Zinc-Telluride Single-Photon Emission Computed Tomography System With Low-Dose Technetium-99m as Assessed by Fractional Flow Reserve.

BACKGROUND: Although stress single-photon emission computed tomography (SPECT) using a cadmium-zinc-telluride (CZT) camera facilitates radiation dose reduction, only a few studies have evaluated its diagnostic accuracy in Japanese patients by applying fractional flow reserve (FFR) measurements. METHODS AND RESULTS: We prospectively evaluated 102 consecutive patients with suspected or known coronary artery disease with a low-dose stress/rest protocol ((99m)Tc radiotracer 185/370 MBq) using CZT SPECT. Within 3 months, coronary angiography was performed and a significant stenosis was defined as ≥90% diameter narrowing on visual estimation, or as a lesion of <90% and ≥ 50% stenosis with FFR ≤0.80. To detect individual coronary stenosis, the respective sensitivity, specificity, and accuracy were 86%, 75%, and 82% for left anterior descending artery stenosis, 76%, 81%, and 79% for left circumflex artery stenosis, and 87%, 92%, and 90% for right coronary artery stenosis. When limited to 92 intermediate stenotic lesions in which FFR was measured, stress SPECT showed 77% sensitivity, 91% specificity, and 84% accuracy, whereas the diagnostic value decreased to 52% sensitivity, 68% specificity, and 58% accuracy based only on visual estimation of ≥75% diameter narrowing. CONCLUSIONS: CZT SPECT demonstrated a good diagnostic yield in detecting hemodynamically significant coronary stenoses as assessed by FFR, even when using a low-dose (99m)Tc protocol with an effective dose ≤5 mSv. (Circ J 2016; 80: 1217-1224).

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.

Association of moderate chronic kidney disease with insufficient improvement of fractional flow reserve after stent implantation.

OBJECTIVES: This study aims to investigate the association of moderate chronic kidney disease (CKD) with fractional flow reserve (FFR) after stent implantation. BACKGROUND: Patients with moderate CKD have a higher prevalence of severe and diffuse coronary artery disease, and have increased risk of cardiovascular events even after stent implantation. On the other hand, in some patients, FFR could not be sufficiently improved even after stent implantation. However, the association between these pathophysiological processes is unclear. METHODS AND RESULTS: A total of 102 patients with stable angina, in whom a stent was implanted for the left anterior descending coronary artery (LAD) lesion, were included. Patients with a severely decreased glomerular filtration rate (GFR; > CKD stage 4) were excluded. Patients were stratified into 3 groups: those with an estimated GFR (eGFR) ≥ 60 mL per min per 1.73 m(2) (stage 0-2), 45 to 59 mL per min per 1.73 m(2) (stage 3a), and 30 to 44 mL per min per 1.73 m(2) (stage 3b). FFR after stent implantation (post-stent FFR) was significantly lower in the stage 3b group than in both the stage 0-2 group and the stage 3a group (P < 0.01). Post-stent FFR had a significant positive correlation with eGFR (r = 0.223, P = 0.024). Multivariate analysis demonstrated that eGFR was an independent predictor of post-stent FFR. CONCLUSIONS: Moderate CKD was independently associated with insufficient improvement of FFR after stent implantation. This can partly explain the poor prognosis of patients with CKD. © 2015 Wiley Periodicals, Inc.

Validation of pressure gradient and peripheral fractional flow reserve measured by a pressure wire for diagnosis of iliofemoral artery disease with intermediate stenosis.

OBJECTIVE: To examine the pressure gradient and peripheral fractional flow reserve (pFFR) measured by a pressure wire as indicators of hemodynamic significance in iliofemoral angiographic intermediate stenosis. BACKGROUND: The utility of pressure measurements using a pressure wire with vasodilators is unclear in cases with intermediate iliofemoral stenosis. METHODS: The mean pressure gradient (MPG) and mean pressure ratio (MPR) were measured at baseline and after injection of isosorbide dinitrate in 23 lesions with angiographically intermediate iliofemoral stenosis. Patients with complex lesions, infrapopliteal artery lesions, chronic total occlusion, and surgical bypass grafts were excluded. Hyperemic MPR was considered equivalent to pFFR. Changes in parameters in response to vasodilators were assessed and correlations of peak systolic velocity ratio (PSVR) with hyperemic MPG and pFFR were examined using duplex ultrasound. RESULTS: After injection of isosorbide dinitrate, hyperemic MPG increased significantly (from 9.0±5.7 to 16.3±6.2 mmHg; P<0.05) and hyperemic MPR (pFFR) decreased significantly (from 0.92±0.06 to 0.81±0.07; P<0.05). PSVR was significantly correlated with hyperemic MPG (R=0.52; P<0.05) and pFFR (R=-0.50; P<0.05). The optimal cut-off value of pFFR as an indicator of significant hemodynamic stenosis (PSVR >2.5) was 0.85 (area under the curve 0.72; sensitivity 94%; specificity 50%, P<0.05). CONCLUSION: pFFR measured using a pressure wire is reliable for prediction of hemodynamic significance in iliofemoral intermediate stenosis.

Usefulness of combined intravascular ultrasound parameters to predict functional significance of coronary artery stenosis and determinants of mismatch.

AIMS: Efficacy of combined intravascular ultrasound (IVUS) parameters in functional significance prediction and discrepancy between IVUS and fractional flow reserve (FFR) have not been well defined. This study therefore aimed to: 1) evaluate the diagnostic accuracy of combined IVUS parameters, namely minimal lumen area (MLA) and percent plaque burden (%PB), in functional significance prediction of coronary artery stenosis; and 2) define factors that affect the relation between FFR value and IVUS parameters. METHODS AND RESULTS: At 11 international centres, IVUS and FFR measurements were concurrently performed in 945 major epicardial coronary artery lesions (886 patients). Functional significance was defined as FFR ≤0.8. MLA and FFR correlated weakly (r=0.289, p<0.001). Diagnostic accuracy of MLA ≤4.0 mm2, %PB >70% and their combination were 50%, 47% and 51%, respectively, with similar area under the curve (AUC) of 0.561, 0.511 and 0.516, respectively. The best cut-off values (BCV) were MLA ≤3.0 mm2 and %PB >75%, with accuracy of 60% for MLA, 50% for %PB and 56% for their combination, and AUC of 0.618, 0.511 and 0.533, respectively. MLA BCV ≤3.0 mm2 had higher predictive power than %PB BCV >75% or their combination. Independent predictors of functional significance were male gender (odds ratio 1.76 [95% confidence interval: 1.19-2.62]), left ventricular ejection fraction (LVEF, 0.98 [0.96-0.99]), LAD lesion (2.52 [1.73-3.67]), reference vessel diameter (0.60 [0.41-0.86]), lesion length (1.04 [1.02-1.06]) and MLA (0.79 [0.69-0.92]). False negative lesion incidence was 24.4% in association with race (for Asians, 0.391 [0.219-0.698]), LAD lesion (2.677 [1.709-4.191]) and LVEF (0.977 [0.957-0.997]). False positive lesion incidence was 17.0% in association with non-LAD lesion (2.444 [1.620-3.686]). CONCLUSIONS: Combined IVUS parameters did not improve the accuracy of functional significance prediction. Discrepancy between IVUS and FFR, which was not rare, should be taken into account in clinical decision making.