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.

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Impact of Advanced Technique on Improvement in the Retrievable Inferior Vena Cava Filter Retrieval Rate.

BACKGROUND: It is recommended to remove retrievable inferior vena cava filters (r-IVCFs) when they are no longer needed because their presence may give rise to serious complications related to prolonged placement of the filter. An advanced filter retrieval technique may help improve the retrieval rate.Methods and Results:107 consecutive patients (mean age; 61±18 years, male 53%) in whom r-IVCF retrieval was attempted were prospectively enrolled between April 2012 and December 2018. The frequently used advanced techniques were sling technique and biopsy forceps dissection technique. Retrieval success was 75% with standard retrieval technique alone; however, the overall retrieval success rate improved to 98% with advanced techniques. We observed few serious complications related to the retrieval procedure. Logistic multivariate analysis identified prolonged indwelling time (P=0.0011) and embedded hook in the caval wall (P=0.0114) as independent predictors, and the cutoff value for the indwelling time for requirement of advanced technique was 80 days. CONCLUSIONS: Advanced retrieval techniques helped improve the retrieval rate without serious complications. We may need to consider the referral of patients to centers with expertise in advanced retrieval techniques when the indwelling time is >80 days, and pre-retrieval CT image shows a hook embedded in the vessel wall.

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta-analysis of randomized trials.

OBJECTIVES: We aimed to evaluate whether paclitaxel eluting devices increased the risk of death in patients undergoing revascularization for infrainguinal peripheral artery disease using network meta-analyses. METHODS: PUBMED and EMBASE were searched through April 2020 for randomized trials in patients with infrainguinal peripheral artery disease who underwent revascularization with or without a paclitaxel eluting device (balloon/stent). Short-term mortality defined as death at 6-12 months, and long-term mortality defined as death at >12 months after revascularization. RESULTS: Our search identified 57 eligible randomized controlled studies enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel-coated balloon vs. bypass surgery). Overall, paclitaxel eluting stent and paclitaxel-coated balloons did not increase short-term mortality (eg, vs. balloon angioplasty: paclitaxel-coated balloon OR [95% CI] 1.21 [0.88-1.66], p = .24; paclitaxel eluting stent OR [95%CI] 1.01 [0.63-1.63], p = .97, respectively). In addition, paclitaxel eluting stent did not show significant increase in long-term mortality (eg, vs. balloon angioplasty: OR [95%CI] 1.06 [0.70-1.59], p = .79). However, paclitaxel-coated balloon showed significant increase in long-term mortality compared to balloon angioplasty and bypass (vs. balloon angioplasty: OR [95% CI] 1.48 [1.06-2.07], p = .021; vs. bypass: OR [95%CI] 1.73 [1.05-2.84], p = .031, respectively). CONCLUSIONS: In this meta-analysis of randomized trials, there was no significant increase in mortality with paclitaxel eluting stent, but there was increased risk of long-term mortality in paclitaxel-coated balloon for the treatment of infrainguinal peripheral artery disease.

Monotherapy With Prasugrel After Dual-Antiplatelet Therapy for Japanese Percutaneous Coronary Intervention Patients With High Bleeding Risk　- A Prospective Cohort Study (PENDULUM mono Study).

BACKGROUND: The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI.Methods and Results:The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. CONCLUSIONS: Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.

Risk of undiagnosed coronary artery disease associated with infrapopliteal artery occlusion from a multicenter study.

Peripheral artery disease (PAD) is associated with high cardiovascular mortality. Which part of PAD with lower extremities is related to coronary artery disease (CAD) remains unknown. We hypothesized that PAD including infrapopliteal artery (IPA) occlusion was associated with CAD. A total of 260 patients who have no history of CAD or the anginal symptom, complain of the claudication or critical limb ischemia and underwent peripheral angiography were retrospectively analyzed. IPA occlusion was diagnosed with peripheral angiography, and CAD was diagnosed with the coronary angiography. A multivariate logistic regression analysis was performed to determine the predictors of silent CAD. Among them, a total of 146 patients (56.2%) had IPA occlusion. Baseline characteristics were significantly different between two groups as to the proportions of age, male, dyslipidemia (with vs. without IPA occlusion; 72.4 ± 10.8 vs. 69.1 ± 10.2; 62.3% vs. 75.4%; 38.6% vs. 52.6%, respectively, all comparisons P < 0.05). Notably, the prevalence of CAD was significantly higher in patients with IPA occlusion (50.7% vs. 34.2%, P = 0.008). On a multivariate analysis, IPA occlusion was an independent predictor for the presence of silent CAD (OR, 1.94; CI, 1.09-3.44, P = 0.024), but aortoiliac artery occlusion (OR, 1.16; CI, 0.53-2.56, P = 0.71) and femoropopliteal artery occlusion (OR, 1.02; CI, 0.57-1.83, P = 0.96) were not. IPA occlusion was associated with silent CAD. Vascular surgeons, interventional radiologists, as well as interventional cardiologists should recognize IPA occlusion as a risk factor of silent CAD.

[Surgical Treatment of Aortic Stenosis Combined with Bilateral Pheochromocytomas in a Dialysis Patient].

We report a case of a dialysis patient with severe aortic stenosis(AS) along with bilateral pheochromocytomas. A 52-year-old man presented with syncope and was diagnosed with severe AS. Although aortic valve replacement(AVR) was scheduled, bilateral pheochromocytomas were found during preoperative examination. There was a high possibility of developing hemodynamical crisis during AVR, and we planned to perform adrenalectomy prior to AVR. To avoid circulatory collapse just after adrenalectomy, balloon aortic valvuloplasty (BAV) was performed beforehand. Two weeks after the adrenalectomy, AVR was performed in a stable condition.

[Euglycemic Diabetic Ketoacidosis Caused by a Sodium-glucose Co-transporter (SGLT) 2 Inhibitor after Coronary Artery Bypass Grafting].

A 65-year-old woman with type Ⅱ diabetes and unstable angina presented with chest pain due to in-stent restenosis. Her regular medication comprised an sodium-glucose co-transporter( SGLT) 2 inhibitor. Because of unstable hemodynamic status, semi-emergency coronary artery bypass grafting (CABG) was performed. Postoperatively, the cardiac and hemodynamic status stabilized, but there was progression of metabolic acidosis. Based on the presence of massive urinary ketone bodies without hyper glycosuria, the patient was diagnosed with euglycemic diabetic ketoacidosis( DKA) caused by an SGLT2 inhibitor. Ketoacidosis without elevated blood glucose( i.e., euglycemic DKA) has been reported to be associated with intake of an SGLT2 inhibitor, which promoted glucose excretion in the urine. Our patient developed euglycemic DKA due to the progression of myocardial ischemia and surgical stress. Guidelines in other countries have stipulated that SGLT2 inhibitor should be stopped 24 hours preoperatively. In our case, euglycemic DKA occurred even when the SGLT2 inhibitor was stopped for more than 24 hours preoperatively. Further studies on the withdrawal of an SGLT2 inhibitor in the appropriate perioperative period are required.

Cardiovascular Outcome and Mortality in Patients Undergoing Endovascular Treatment for Symptomatic Peripheral Artery Disease　- Short-Term Results of the Toma-Code Registry.

BACKGROUND: The present study was performed to clarify whether the preoperative clinical symptoms for endovascular therapy (EVT) can predict post-EVT death and cardiovascular prognosis in Japanese patients with peripheral artery disease (PAD), including acute disease.Methods and Results:The TOkyo taMA peripheral vascular intervention research COmraDE (Toma-Code) Registry is a Japanese prospective cohort of 2,321 consecutive patients with PAD treated with EVT, in 34 hospitals in the Kanto and Koshin'etsu regions, from August 2014 to August 2016. In total, 2,173 symptomatic patients were followed up for a median of 10.4 months, including 1,370 with claudication, 719 with critical limb ischemia (CLI), and 84 with acute limb ischemia (ALI) for EVT. The all-cause death rates per 100 person-years for claudication, CLI and ALI were 3.5, 26.2, and 24.5, respectively. Similarly, major adverse cardiac and cerebrovascular events (MACCE) rates per 100 person-years for claudication, CLI, ALI, and others were 5.2, 31.2, and 29.7, respectively. After adjusting for the predictors of all-cause death and MACCE, namely, age, body mass index <18, diabetes mellitus, dialysis, cerebrovascular disease, and low left ventricular ejection fraction, it was determined that the preoperative indication for EVT was strongly associated with all-cause death and MACCE. CONCLUSIONS: The preoperative clinical symptoms for EVT can predict the prognosis in patients with PAD undergoing EVT.

Vascular response to biolimus A-9 eluting stent in patients with shorter and prolonged dual antiplatelet therapy: optical coherence tomography sub-study of the NIPPON trial.

Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.

Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.

PURPOSE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients. METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate. RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD. CONCLUSION: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL TRIAL REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

Acute limb ischemia due to severe heparin-included thrombocytopenia with thrombosis during puerperium.

We present the case of a 39-year-old pregnant woman who had intrauterine fetal death and imminent uterine rupture and underwent cesarean section. She also underwent catheter embolization for hemorrhagic shock due to bleeding from the uterine artery, and heparin-containing saline was used. On day 7 of hospitalization, she felt severe pain in her right lower leg, and computed tomography (CT) revealed focal nonocclusive thrombus formations in the right common and external iliac artery. After intravenous heparin administration, she suddenly developed dyspnea, her blood pressure dropped, and her platelet count decreased. We diagnosed her with heparin-induced thrombocytopenia (HIT). Although we discontinued heparin and switched to argatroban, CT after 5 days revealed subtotal occlusion of the right iliac artery by a massive thrombus. We performed surgical thrombectomy using a Fogarty catheter, but blood flow was not restored. Therefore, we administered urokinase continuously with catheter-directed thrombolysis (CDT). The thrombus in the iliac artery gradually cleared and was successfully eliminated. However, the patient developed gangrene in her right lower leg, and we decided to perform an above-knee amputation of the right leg. She was discharged with a prosthetic leg and prescribed 15 mg of rivaroxaban per day. Learning objective: HIT is a known serious side effect of heparin administration, and it can sometimes be fatal. HIT treatment using aggressive thrombectomy procedures may be ineffective since such procedures may accelerate thrombus formation when the coagulation cascade is highly activated. In this case, CDT may have to be considered as the first-line treatment before Fogarty thrombectomy when argatroban therapy fails.

Slowly Progressive ANCA-associated Glomerulonephritis with Strong Mesangial MPO Deposits Following a Diagnosis of Interstitial Lung Disease: A Case Report.

An elderly woman showed positive conversion of myeloperoxidase (MPO)-antineutrophil cytoplasmic antibodies (ANCAs) following the diagnosis of interstitial lung disease (ILD) and glomerular hematuria and subsequently experienced slowly progressive glomerulonephritis. A kidney biopsy revealed chronic damage and necrotizing crescentic glomerulonephritis with mesangial MPO deposits. After corticosteroid treatment, the patient's urinalysis results and MPO-ANCA titers almost normalized and her renal function stabilized. This case is similar to recently reported cases of slowly progressive ANCA-associated glomerulonephritis. ILD likely triggered the production of MPO-ANCAs, and the accumulation of MPO deposits in the glomeruli may have contributed to the progression of her renal disease.

Less frequent post-thrombotic syndrome after successful catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis.

Post-thrombotic syndrome (PTS) occurs in 20-50% of patients with proximal deep vein thrombosis (DVT). In this study, we aimed to identify potential markers of thrombolysis success at the early stage and to clarify the relationship between early thrombolysis success and subsequent PTS development in patients with acute DVT in the iliac vein. Fifty-two consecutive patients with acute iliofemoral DVT who were treated with catheter-directed thrombolysis (CDT) within 21 days of onset were enrolled. An infusion catheter with multiple side holes was placed to cover the thrombosed vessel entirely. Urokinase solution was administered either continuously or with the pulse-spray method at a dose of 480,000-720,000 IU/day over the course of 2-7 days. During CDT, unfractionated heparin (UFH) was infused simultaneously via the access sheath to prevent thrombus formation. Early success was defined as lysis grade ≥ 50% and restoration of forward flow. PTS was diagnosed based on the Villalta scale. Based on the lysis grading method, complete lysis (grade III) was achieved in 8 of 52 (16%) limbs. Lysis grade II (50-99%) was achieved in 35 of 52 (67%) limbs. Lysis grade I (< 50%) was achieved in 9 of 52 (17%) limbs. Therefore, grade II and grade III lytic outcomes (early success) were observed in 43 patients (83%). One-year clinical follow-up was performed for 43 patients (83%). PTS occurred in seven (16%) patients. Early success was more frequently observed in patients without PTS than in those with PTS (92% vs. 43%; P < 0.01). Early success was only significantly associated with PTS in the multivariate analysis. Patients with acute symptomatic iliofemoral DVT who had early success from CDT treatment during the acute phase less frequently progressed to PTS. Patients with early success tended to undergo the pulse-spray method and had a shorter interval from symptom onset to CDT. The use of pulse-spray method and early initiation of CDT since DVT onset were potential markers of thrombolysis success.

Bidirectional Sling Technique with Biopsy Forceps for Inferior Vena Cava Filter Retrieval.

Although the importance of the retrieval of an optional inferior vena cava filter (o-IVCF) has gained attention because of the awareness of a high complication rate with long indwelling time, the o-IVCF retrieval rate remains low. The advanced retrieval technique of o-IVCF may increase the retrieval rate, which in turn diminishes future adverse events. Through two cases, we describe how to perform the novel approach "bidirectional sling technique with biopsy forceps." This technique will improve the retrieval rate in patients following the failure by conventional retrieval technique.

Successful stent implantation in the internal jugular vein occlusion using Brockenbrough needle under intravascular ultrasound guidance leading to prevention of vision loss in a hemodialysis patient with neovascular glaucoma.

Central venous occlusion (CVO) remains an unresolved issue in hemodialysis patients. We herein present an interesting case of a 42-year-old hemodialysis female patient with complete vision loss in the left eye, who was at high risk of losing vision in her right eye because of neovascular glaucoma (NVG). Computed tomography (CT) showed occlusion of the right internal jugular vein (IJV) just above the junction with the right innominate vein. From the configuration and location of the lesion, it was concluded the occlusion had been caused by venous valvular degeneration. Her NVG with progressive intraocular pressure (IOP) elevation was presumably attributed to the right IJV occlusion. The extra-rigid occlusive lesion was successfully penetrated by means of a Brockenbrough needle and subsequently implanted with a balloon-expandable stent. Intravascular ultrasound (IVUS) guidance allowed us to manipulate the Brockenbrough needle safely. After stent implantation, the right IOP declined dramatically, resulting in the preservation of her eyesight. .

One-year limb outcome and mortality in patients undergoing revascularization therapy for acute limb ischemia: short-term results of the Edo registry.

The present study aimed to clarify the current status, therapeutic strategy, and 1-year outcome in acute limb ischemia (ALI) patients in Japan. The EnDOvascular treatment (Edo) registry database includes 324 patients from 10 institutes who were registered between November 2011 and October 2013. A total of 70 ALI patients (mean age 74.0 years) from the Edo registry database were enrolled in this study. Of the 70 included patients, 72.9% were male and 35.7% had embolism. Of patients, 38.6%, 42.9%, and 18.6% underwent EVT, surgery, and hybrid thrombectomy, respectively, in primary revascularization strategy. Limb ischemia was categorized into four classes at initial evaluation: SVS/ISCVS class I (n = 13, 18.6%), SVS/ISCVS class IIa (n = 36, 51.4%), SVS/ISCVS class IIb (n = 21, 30%), and SVS/ISCVS class III (n = 0, 0%). Three patients with SVS/ISCVS class IIb limb ischemia developed myonephropathic metabolic syndrome. No catheter-directed thrombolysis was employed as a primary revascularization strategy. The 1-year rates of all-cause death, major amputation, and a composite of perioperative death or major adverse limb event were 28.6%, 5.7%, and 40.0%, respectively. Lower age, male sex, dyslipidemia, high estimated glomerular filtration rate, high albumin level, and low C-reactive protein level were independent positive predictors of all-cause death. In this registry, SVS/ISCVS class IIa ALI was predominant. Approximately 40% of primary revascularization strategy was surgery and EVT, followed by hybrid therapy. All-cause death and major amputation rates at 1 year were less than 30% and 6%, respectively.

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.