Impact of Optimal Preparation Before Drug-Coated Balloon Dilatation for De Novo Lesion in Patients With Coronary Artery Disease.

BACKGROUND: Drug eluting stent (DES) remain several problems, including stent thrombosis, stent fracture and neoatherosclerosis. Stent-less Percutaneous coronary intervention (PCI) using a drug coated balloon (DCB) is a stent-less strategy, and several trials have supported the efficacy of DCB. However, the optimal preparation before using DCB was uncertain. The aim of this study was to investigate the optimal preparation for plaque oppression/debulking before DCB dilatation for de novo coronary artery lesion. METHODS: A total 936 patients were treated using DCB from 2014 to 2017 at our institution. Among them, we analyzed 247 patients who underwent PCI using DCB alone for de novo lesion. The primary end point of this study was target lesion failure (TLF). RESULTS: The area under the receiver operating characteristic (ROC) curve (AUC) was used to determine the optimal cutoff value of % plaque area to predict TLF. ROC curve analysis revealed plaque area ≥ 58.5% (AUC, 0.81) were associated with TLF. Eligible 188 patients were divided into 2 groups (plaque area ≥ 58.5% [n = 38] and <58.5% [n = 150]) according to IVUS data before using DCB. TLF was significantly higher in plaque area ≥ 58.5% group than in <58.5% group (P < 0.01). Multivariable analysis selected plaque area ≥ 58.5% as an independent predictor of TLF (hazard ratio 7.59, P < 0.01). CONCLUSIONS: Lesion preparation achieving plaque area < 58.5% was important in stent-less PCI using DCB.

The Effect of Aggressive Wire Recanalization in Calcified Atheroma and Dilatation (ARCADIA) Technique in Eccentric Calcified Lesion of No-stenting Zone.

PURPOSE: The endovascular approach for eccentric calcified lesions of the no-stenting zone is challenging. This study aimed to investigate the effect of a novel technique for these lesions. METHODS: We performed EVT for severe and eccentric calcified lesions using the technique, which is presented previously and named aggressive wire recanalization in calcified atheroma and dilatation (ARCADIA). In brief, a guidewire is passed to the residual lumen firstly. Next, another guidewire is advanced into and cross through the calcified plaque and returned to the distal original lumen with intravascular ultrasound (IVUS) guided. The calcified plaque is dilated by using a scoring-balloon or non-compliant balloon. RESULTS: Consecutive 14 peripheral artery disease patients with isolated and eccentric calcification in a no-stenting zone were treated using ARCADIA technique between January 2018 and March 2020. In IVUS data, lumen cross-section area was significantly increased from 5.2 ± 2.0 mm2 to 18.1 ± 6.9 mm2 (p < 0.01), lumen area was expanded roundly evaluating as symmetry index from 0.45 ± 0.09 to 0.81 ± 0.12 (p < 0.01). There were no distal embolization and perforation after ARCADIA technique. One-year target lesion revascularization occurred in only 2 cases. The primary patency of 1 year was 85.7%. CONCLUSION: ARCADIA technique is safe and appropriate, and can be 1 option to treat for eccentric calcified lesions of the no-stenting zone as an optimal wire crossing method.

Validation of Global Limb Anatomical Staging System (GLASS) in patients with hemodialysis and Chronic Limb-Threatening Ischemia after endovascular treatment.

Recently, Society for Vascular Surgery guideline recommends evaluating anatomic pattern with use of Global Limb Anatomic Staging System (GLASS) in Chronic Limb-Threatening Ischemia (CLTI) patients. The aim of this study is to validate GLASS stage into CLTI patients on hemodialysis (HD) and investigate the impact of GLASS stage to wound healing and amputation-free survival (AFS). Between April 2009 and March 2018, we performed EVT for 154 limbs in CLTI patients on HD. GLASS was defined as femoropopliteal (FP) and infrapopliteal (IP) segments separately graded (0-4), then combined into three GLASS stages for the limb (I-III). We divided them into three GLASS stages with using this system. We compared the clinical outcomes between three groups (GLASS I, GLASS II, and GLASS III). Patient characteristics were almost similar between the three groups. Lesion characteristics was more complex and the rate of success was lower in GLASS III. Cox regression multivariate analysis revealed that diabetes mellitus (HR 2.4, 95% CI 1.37-4.01, p < 0.01) and WIfI high (HR 2.3, 95% CI 1.04-6.01, p = 0.04) were the predictors of non-wound healing, whereas age (HR 1.6, 95% CI 1.09-2.29, p = 0.01), WIfI clinical stage 4 (HR 2.4, 95% CI 1.30-4.36, p < 0.01), and non-ambulatory status (HR 2.0, 95% CI 1.17-3.29, p = 0.01) were the predictors of AFS. GLASS stage in CLTI patient on HD could not predict wound healing, and AFS in this study.

An External Iliac Artery Pseudoaneurysm Resulting From Stent Graft Migration.

The case of an 80-year-old male with claudication of his left foot who was referred to our hospital for evaluation and treatment. Computed tomography (CT) angiography revealed occlusion of left common and external iliac (EIA) arteries. Recanalization of the EIA lesion under intravascular ultrasound (IVUS) guidance and placement of 2 stent grafts was completed successfully. Nine months later, 27 × 29 mm pseudoaneurysm of the left EIA was identified that appeared to have developed secondary to migration of the original stent graft. A new stent graft was placed.

Incidence and Predictive Factors of Chronic Vessel Enlargement After Percutaneous Coronary Intervention for Severely Stenotic and Occluded Lesions.

BACKGROUND: Chronic vessel enlargement (CVE) of the coronary artery is observed in patients who undergo percutaneous coronary intervention (PCI) for severely stenotic or occluded lesions. Recently, the presence of a peri-medial high-echoic band (PHB) identified by intravascular ultrasound (IVUS) has been reported to correlate with this phenomenon. We sought to assess the incidence, predictive factors of CVE, and association between CVE and PHB. METHODS: From January 2017 to December 2018, 97 patients, with 101 severely stenotic and occluded lesions, who underwent IVUS-guided PCI and a 9-month follow-up angiography were enrolled. CVE was defined as more than a 10% increase of distal lumen gain at follow-up angiography. All lesions were stratified into 2 groups: CVE group and non-CVE group. Clinical outcomes were compared and predictive factors for CVE were assessed. Relationships between PHB angle and CVE were also assessed. RESULTS: At follow-up angiography, CVE was observed in 27 lesions (26.7%, 27/101). PHBs were frequently observed in the CVE group (88.9%), which was significantly higher than that in the non-CVE group (40.5%). The multivariate logistic regression analysis revealed that the presence of PHB was the only predictive factor for CVE (odds ratio, 11.3; 95% confidence interval, 2.95-43.0; p < 0.001). In addition, a linear relationship was observed between the incidence of CVE and PHB angle. The number of patients with CVE significantly increased in cases with a PHB angle more than 180 degrees. CONCLUSIONS: The presence of PHB strongly predicts CVE after PCI for severely stenotic or occluded lesions.

Comparison of ultrasound-guided versus angiography-guided endovascular treatment for femoropopliteal artery occlusive disease.

PURPOSE: This study aimed to compare the efficacy of ultrasound-guided and angiography-guided intraluminal approach for femoropopliteal (FP) artery occlusive disease. METHODS: A retrospective analysis was performed using the data collected regarding patients that underwent endovascular treatment (EVT) for FP artery occlusive disease between January 2010 and April 2018 at two centers. A total of 221 consecutive de novo lesions were analyzed according to the method of recanalization. Propensity score-matched analysis was performed to compare the clinical outcomes of recanalization methods for FP occlusive lesions. The prognostic value was analyzed based on the number of guidewires, wire cross time, distal puncture rate, radiation exposure, the amount of contrast media, primary patency, and clinically driven-target lesion revascularization (CD-TLR) at 1 year. RESULTS: A total of 44 matched pairs of patients were analyzed after propensity score-matched analysis. The number of guidewires, distal puncture rate, wire passage time, radiation exposure, and the amount of contrast media were significantly lower in the ultrasound-guide group, with 3.4 vs. 4.7, 9.1% vs. 54.5%, 47 min vs. 83 min, 207 mGy vs. 821 mGy, 66 ml vs. 109 ml, respectively (p < .01), but there were no significant differences between the two groups in terms of primary patency and CD-TLR. CONCLUSIONS: The ultrasound-guided EVT for FP occlusive disease significantly reduced the number of guidewires, wire cross time, the rate of distal puncture, radiation exposure, and the amount of contrast media used.

Long-Term Clinical Outcomes After Filter Protection During Percutaneous Coronary Intervention in Patients With Attenuated Plaque　- 1-Year Follow up of the VAMPIRE 3 (Vacuum Aspiration Thrombus Reemoval 3) Trial.

BACKGROUND: Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 [11.2%] vs. 2 [2.1%], P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32). CONCLUSIONS: In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.

Prediction of the Technical Success of Endovascular Therapy in Patients with Critical Limb Threatening Ischaemia Using the Global Limb Anatomical Staging System.

OBJECTIVE: This study aimed to determine the clinical impact of the Global Limb Anatomical Staging System (GLASS) and develop a model to determine the grade of difficulty for target artery path (TAP) using GLASS stage. METHODS: This was a single centre retrospective study. Endovascular treatment (EVT) was performed for 400 lesions in 257 patients with critical limb threatening ischaemia (CLTI) between April 2009 and March 2018. All lesions were divided into three groups (GLASS Ⅰ, Ⅱ, and Ⅲ), which were compared in terms of patient characteristics, lesion characteristics, technical success, and procedural complications. All observations were then randomly assigned to the derivation set or validation set at a ratio of 2:1 (derivation set: 166 patients; validation set: 91 patients). Predictors of technical success for TAP were identified by multivariable analysis. Each predictor was assigned a score based on its regression coefficient, and the total score was calculated. This value was used to categorise all lesions into the following four groups: low (score 0), intermediate (score 1), difficult (score 2), and very difficult (score ≥ 3). RESULTS: No significant differences in patient characteristics were observed between the three GLASS groups. In GLASS Ⅲ group, anatomic/limb severity and procedural complications were observed frequently, and the technical success rate was lower than that in the other groups. Through multivariable analysis, absence of pedal modifier (P)0 or P1, GLASS Ⅲ, total occlusion, and severe calcification predicted technical failure. The four groups stratified according to GLASS score demonstrated stepwise and highly reproducible difference in the probability of technical success for TAP. The area under the receiver operating characteristic (ROC) curve was 0.95 in the development group and 0.93 in the validation sample. CONCLUSION: In GLASS Ⅲ, anatomic/limb severity was more complex and procedural complications were more frequent. The GLASS scoring system reliably predicts the technical success of de novo TAP in patients with CLTI.

The Impact of Femoropopliteal Artery Calcium Score after Endovascular Treatment.

BACKGROUND: The coronary artery calcium score is a widely known independent predictor of cardiac events. Tibial artery calcification had been reported as an amputation risk, but the femoropopliteal artery calcium score is rarely known. METHODS: A retrospective analysis was performed using the data collected from the patients who underwent endovascular treatment for the femoropopliteal artery between January 2010 and December 2017. The femoropopliteal artery calcium scores on preprocedural computed tomography were calculated according to the Agatston definition. The mean value of total of femoropopliteal artery calcium scores was used to divide the scores into two groups. The prognostic value of the calcium score was analyzed based on primary patency, clinically driven target lesion revascularization, major amputation, and all-cause death. RESULTS: In total, 132 consecutive limbs that underwent successful endovascular intervention were analyzed in this study; 44 and 88 limbs were assigned to the high and low calcium score groups, respectively. There were no significant differences between the two groups in terms of patient and lesion characteristics, except for chronic kidney disease (7% vs. 25%, P < 0.01), hemodialysis (80% vs. 25%, P < 0.01), and coronary artery disease (73% vs. 53%, P = 0.03). Compared with the low calcium score group, the high calcium score group had a significantly higher rate of loss of primary patency and clinically driven target lesion revascularization at one year, based on the Kaplan-Meier curve (55% vs. 81%, 44% vs. 8%, both P < 0.01). There were no significant differences between the two groups in terms of major amputation and death. Multivariate analysis revealed that hemodialysis [hazard ratio (HR): 1.9; 95% confidence interval (CI): 1.01-5.28; P = 0.04] runoff grade 0 (HR: 2.9; 95% CI: 1.02-10.9; P = 0.04), lesion length > 200 mm (HR: 3.9; 95% CI: 1.1-13.7; P = 0.03), and calcium score per 100 increase (HR: 1.05; 95% CI: 1.02-1.08; P < 0.01) were predictors of clinically driven target lesion revascularization. As per receiver operating characteristic analysis, the best cutoff value of target lesion calcium score for target lesion revascularization was 206. CONCLUSIONS: A high femoropopliteal artery calcium score might increase loss of patency and the risk for clinically driven target lesion revascularization.

A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound.

OBJECTIVES: The aim of this study was to evaluate the utility of distal protection during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes at high risk for distal embolization. BACKGROUND: The results of previous clinical trials indicated that the routine use of distal protection in patients with ST-segment elevation myocardial infarction did not improve clinical outcomes. However, selective use of distal protection by means of a filter-based distal protection system has not been evaluated. METHODS: Two hundred patients with acute coronary syndromes who had native coronary artery lesions and attenuated plaque with longitudinal length ≥5 mm on pre-PCI intravascular ultrasound were randomly assigned to undergo PCI with distal protection or conventional treatment. RESULTS: The primary endpoint (no-reflow phenomenon) occurred in 26 patients (26.5%) in the distal protection group and 39 patients (41.7%) in the conventional treatment group (p = 0.026), and the corrected TIMI (Thrombolysis In Myocardial Infarction) frame count after revascularization was significantly lower in the distal protection group (23 vs. 30.5; p = 0.0003). The incidence of cardiac death, cardiac arrest, cardiogenic shock after revascularization requiring defibrillation, cardiopulmonary resuscitation, or extracorporeal membrane oxygenation was significantly lower in the distal protection group than in the conventional treatment group (0% vs. 5.2%; p = 0.028). CONCLUSIONS: The use of distal embolic protection applied with a filter device decreased the incidence of the no-reflow phenomenon and was associated with fewer serious adverse cardiac events after revascularization than conventional PCI in patients with acute coronary syndromes with attenuated plaque ≥5 mm in length. (Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome [ACS] [VAMPIRE3]; NCT01460966).

Thrombectomy Using Myocardial Biopsy Forceps in Acute Limb Ischemia Patients.

PURPOSE: To evaluate the efficacy and safety of thrombectomy using myocardial biopsy forceps for the treatment of acute limb ischemia (ALI). MATERIALS AND METHODS: A retrospective review of 11 ALI patients (12 affected limbs, 18 affected vessels) who underwent thrombectomy using biopsy forceps between November 2011 and April 2016 was performed. Of the 12 affected limbs, 2 limbs had stent thrombosis, 1 limb had thrombotic occlusion at a de novo stenosis site, and 9 limbs had embolic ALI. Biopsy forceps were used for angiographically limited arterial flow that persisted after the use of an aspiration catheter and conventional balloon angioplasty. The general technique for use of the biopsy forceps included advancement in parallel to a guidewire to the thrombus site, grasping of the thrombus with the forceps, and confirmation of grasping the thrombus with injection of a contrast medium prior to thrombus extraction. RESULTS: Partial or total retrieval of the thrombus was angiographically confirmed in 12 of the 18 affected vessels, with restoration of normal blood flow in 11 vessels. Unsuccessful results in the remaining 6 affected vessels appeared to be due to friction at the aortoiliac bifurcation caused by the contralateral approach, small vessel size, or curvature of the anterior tibial artery. None of the 18 treated vessels had any complications such as dissection or perforation of the target vessel wall and distal emboli. None of the surviving patients required major or minor amputation. CONCLUSIONS: Thrombectomy using biopsy forceps is a feasible technique for removal of an arterial thrombus in patients with ALI.

Comparison of Angiographic Dissection Patterns Caused by Long vs Short Balloons During Balloon Angioplasty of Chronic Femoropopliteal Occlusions.

PURPOSE: To describe the feasibility of balloon angioplasty using a long balloon for chronic femoropopliteal occlusions by evaluating angiographic dissection patterns for optimization of outcomes in balloon angioplasty. METHODS: A retrospective, single-center analysis examined 101 symptomatic patients (mean age 75.6±9.9 years; 65 men) with single de novo femoropopliteal occlusive lesions treated with balloon angioplasty between August 2012 and October 2016. The patients were classified into 2 groups for comparison of angiographic dissection patterns: 51 patients were treated with balloon angioplasty using long balloons (L-BA; defined as ≥220 mm in length) and 50 patients were treated with short balloon angioplasty (S-BA; defined as <150-mm-long balloons). RESULTS: Severe vessel dissection patterns, defined as type C or higher, were fewer in the L-BA group (47.1% vs 70.0% in the S-BA group, p=0.019) and the total dissection length was shorter (92.7±72.6 vs 160.4±84.6 mm in the S-BA group, p<0.001). Although the results showed no significant differences between the two groups regarding the length of chronic total occlusions (L-BA: 228.6±73.2 vs S-BA: 226.0±53.8 mm, p=0.83), inflation pressure (L-BA; 8.2±2.6 vs S-BA: 8.1±2.9 atm, p=0.86), and the other lesion characteristics, inflation time was significantly longer in the L-BA group (161.2±68.7 seconds vs 51.1±54.0 seconds in the S-BA group, p<0.001). Multivariate analysis identified a balloon length ≥220 mm as an independent negative predictor of severe vessel dissection (odds ratio 0.29, 95% confidence interval 0.11 to 0.83, p=0.02). CONCLUSION: Using long balloons for balloon angioplasty may help prevent severe vessel dissection in chronic femoropopliteal occlusions.

Evaluation for the efficacy and safety of the crosser catheter as a CTO crossing device and a flossing device.

The Crosser catheter is a unique device that facilitates antegrade intraluminal recanalization by high-frequency vibration energy and cavitation. We used this device not only as a chronic total occlusion (CTO) crossing device, but also as a flossing device in stenotic lesions and we also evaluated the efficacy of this device when used with both the "Crosser preceding" and the "Guidewire preceding" in CTOs. Complications related to this device were investigated, too. We retrospectively analyzed a total of 90 consecutive patients with peripheral artery disease in the femoropopliteal artery and below-the-knee artery (BTA). Primary technical success was defined as the successful delivery of this device into the distal true lumen. Secondary technical success was defined as successful revascularization. The safety endpoints were events of angiographic complications, including the occurrence of detachment of the metal tip from the shaft, slow flow, dissections, and perforations. Overall primary technical success rate was 93.3% and the secondary technical success rate was 96.7%. Detachment and slow flow occurred 14.4 and 4.4%, respectively, with no occurrences of either dissection or perforation. A predictor of detachment was Proposed Peripheral Arterial Calcium Scoring System (PACSS) grade 4 (OR 14.6; CI 1.26-168.5; P = 0.032). The Crosser catheter is useful not only as a CTO crossing device used with both the "Crosser preceding" and the "Guidewire preceding", but also as a flossing device in stenotic lesions. But we have to pay attention to complications related to the Crosser.

Effects of Ezetimibe-Statin Combination Therapy on Coronary Atherosclerosis in Acute Coronary Syndrome.

BACKGROUND: The results of previous clinical trials on the effects of ezetimibe-statin combination therapy on atherosclerosis are inconsistent, and the anti-atherosclerotic effect of ezetimibe remains controversial.Methods and Results:We conducted a prospective, randomized open-label study at 10 centers. One hundred and twenty-eight statin-naïve patients with acute coronary syndrome (ACS) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention were randomized to receive either 2 mg/day pitavastatin plus 10 mg/day ezetimibe, or 2 mg/day pitavastatin. One hundred and 3 patients had evaluable IVUS of non-culprit coronary lesions at baseline and at follow-up. The primary endpoint was the percentage change in non-culprit coronary plaque volume (PV) and lipid PV on integrated backscatter IVUS. Mean low-density lipoprotein cholesterol was reduced from 123 mg/dL to 64 mg/dL in the combination therapy group (n=50) and 126 mg/dL to 87 mg/dL in the statin alone group (n=53; between-group difference, 16.9%, P<0.0001). The percent change in PV was -5.1% in the combination therapy group and -6.2% in the statin alone group (P=0.66), although both groups had reduction of PV compared with baseline (both P<0.01). The percent change in lipid PV did not differ between the groups (4.3 vs. -3.0%, P=0.37). CONCLUSIONS: In statin-naïve patients with ACS, combined therapy with ezetimibe and statin did not result in a significant change in coronary plaque regression or tissue component compared with statin alone. [Clinical Trial Registration: www.clinicaltrials.gov (NCT00549926)].

Anterolateral Popliteal Puncture Technique: A Novel Retrograde Approach for Chronic Femoropopliteal Occlusions.

PURPOSE: To describe the feasibility and safety of an anterolateral popliteal puncture technique as a retrograde access to chronic total occlusions (CTOs) in the femoropopliteal segment. METHODS: Twenty consecutive patients (mean age 75.1±10.9 years; 13 women) with symptomatic femoropopliteal occlusive disease underwent endovascular therapy via a retrograde access using the anterolateral popliteal puncture technique. With the patient supine, the P3 segment of the popliteal artery was accessed with a sheathless technique intended to provide minimally invasive access. Subsequent to a wire rendezvous technique in the CTO, the antegrade guidewire was advanced to the below-the-knee artery. Hemostasis across the P3 segment was secured with balloon inflation alone or combined with thrombin-blood patch (TBP) injection. RESULTS: Both the anterolateral popliteal puncture technique and subsequent revascularization were successful in all patients. Mean hemostasis time for balloon inflation only was 7.73±4.03 vs 4.78±0.78 minutes for balloon inflation with TBP injection. There were no in-hospital deaths or complications, including pseudoaneurysms, arteriovenous fistulas, hematomas, embolic complications, or nerve damage. CONCLUSION: The anterolateral popliteal puncture technique is useful as an alternative retrograde access vs a conventional transpopliteal approach for CTOs in the femoropopliteal segment if antegrade recanalization has failed. This technique may become one option for retrograde access in patients with severe below-the-knee lesions or with CTOs that extend to the P2 segment of the popliteal artery. Furthermore, this technique has the added benefit of allowing patients to remain in the supine position throughout treatment.

Sheath rendezvous method: a novel distal protection technique during endovascular treatment of subclavian artery occlusions.

To describe an innovative distal protection technique, "sheath rendezvous method", during endovascular treatment for subclavian arterial occlusions. 4.5F and 6F guiding sheath were inserted from left brachial and common femoral artery, respectively. 0.014″ guidewire retrogradely passed through occlusion and into antegrade sheath to establish a pull-through system. 3.0 mm balloon was used to expand occlusion and anchor to deliver retrograde sheath into antegrade one. Both sheaths locked by balloon dilatation crossed occlusion until antegrade sheath passed over lesion. Balloon expandable stent was delivered within antegrade sheath. Sheath was removed, and stent was implanted. We obtained an excellent outcome without complications.

Contemporary outcomes after endovascular treatment for aorto-iliac artery disease.

BACKGROUND: The patency and complications in aorto-iliac (AI) stenting remain poorly understood. The aim of this paper was to investigate the safety and efficacy after AI stenting. METHODS AND RESULTS: This study was performed as a large-scale multicenter, retrospective registry. A total of 2,147 consecutive patients with AI disease were enrolled. The safety endpoints were procedure success, complications and 30-day mortality. The efficacy endpoints were primary, assisted primary and secondary patency, overall survival, freedom from major adverse cardiovascular events (MACE; all-cause death, myocardial infarction and stroke), and major adverse cardiovascular and limb events (MACLE; any repeat revascularization for limb and leg amputation in addition to MACE). Procedure success, complication rate and 30-day mortality were 97.6%, 6.4% and 0.7%. Primary patency was 92.5%, 82.6% and 77.5% at 1, 3 and 5 years, assisted primary patency was 97.0%, 92.7% and 91.9% at 1, 3 and 5 years and secondary patency was 99.0%, 98.7% and 98.5% at 1, 3 and 5 years. The overall survival rate was 95.0%, 87.6%, and 79.3% at 1, 3 and 5 years. The cause of death was cardiovascular in 44.1%. Freedom from MACE (MACLE) was 93.3% (89.9%), 84.4% (76.7%), and 74.9% (66.8%) at 1, 3 and 5 years. Female gender, diabetes, renal failure, absence of aspirin, reference vessel diameter <8.0mm and outflow lesion were found to be independent predictors of primary patency. CONCLUSIONS: The safety and efficacy after AI stenting are feasible compared to surgical reconstruction.

[Endovascular therapy for peripheral arterial disease].

Peripheral arterial disease (PAD) becomes a significant health problem in Japan, mostly because the rapid increase of aging and diabetic population. Intermittent claudication, rest pain, intractable foot ulcer and gangrene are the manifestations of PAD patients. Diagnosis of PAD is obtained by ankle brachial index. Several imaging modalities, such as duplex echo, multi-detector CT, are quite useful tools not only for the diagnosis but also for the planning of endovascular therapy. In this chapter, basic diagnosis, different treatment modalities in patients with PAD are described.

A new device for percutaneous mechanical thrombectomy in acute limb ischemia.

Acute limb ischemia caused by thromboembolism is an emergent and life-threatening disease. Rapid revascularization is inevitable to prevent major amputation. So far, thrombectomy by Fogarty balloon catheter has been a standard procedure for this emergent setting, though it is sometimes difficult to accomplish complete removal of thrombus within peripheral arteries. Herein, we report a case with acute limb ischemia which was successfully treated by a new mechanical thrombectomy device. This home-made device split thrombus into small pieces within arteries, and accelerated the efficiency of thrombus removal by an aspiration catheter thereafter.

Hydrogen peroxide derived from beating heart mediates coronary microvascular dilation during tachycardia.

OBJECTIVE: Coronary flow is closely correlated to the myocardial metabolic demand. We tested the hypothesis that hydrogen peroxide (H2O2) derived from beating hearts mediates metabolic coronary microvascular dilation. METHODS AND RESULTS: We used a bioassay method in which an isolated microvessel is placed on a beating heart to detect myocardium-derived vasoactive mediators. A rabbit coronary arterial microvessel (detector vessel [DV], n=25) was pressurized and placed on a canine beating heart. After intrinsic tone of DV had developed, we observed DV at rest (heart rate, 120 bpm) and during tachypacing (heart rate, 240 bpm) using an intravital microscope equipped with a floating objective. The tachypacing produced DV dilation by 8.2% (P<0.01 versus baseline), and the dilation was abolished by cell-impermeable catalase (a H2O2 scavenger, 500 U/mL). We performed myocardial biopsy at rest and tachypacing. The biopsy specimens were loaded with 2',7'-dichlorodihydrofluorescein diacetate (10 micromol/L) to visualize H2O2, and observed with confocal microscopy. Dichlorofluorescein fluorescence was diffusely identified in the myocardium and the tachypacing increased the fluorescence intensity (P<0.01). Exogenous H2O2 caused vasodilation of arterial microvessels in vitro in a concentration-dependent manner that was abolished by catalase. CONCLUSIONS: H2O2 derived from the beating heart mediates tachypacing-induced metabolic coronary vasodilation in vivo.