A novel bailout technique using myocardial biopsy forceps to grasp a dislodged angio-seal collagen with footplate.

BACKGROUND: Hemostatic devices are now frequently used in femoral artery punctures, and the Angio-Seal (Terumo, Tokyo, Japan) is one of the most commonly used devices for closure of the femoral artery because it provides rapid hemostasis. Although device failure rarely occurs, if the collagen falls into the femoral artery, it may lead to severe limb ischemia. Herein, we describe a case of a novel endovascular technique for the treatment of Angio-Seal arterial closure device failure. CASE PRESENTATION: The patient in Case 1 was a 75-year-old man with severe left limb claudication. We used a contralateral antegrade approach and used the Angio-Seal for hemostasis. However, the Angio-Seal collagen and footplate dropped and stopped at the bifurcation of the superficial femoral artery and deep femoral artery. The collagen with the footplate was caught with myocardial biotome forceps (MBF) and pulled into the external iliac artery (EIA). The distal common femoral artery (CFA) was punctured, and we delivered a 10.0- × 80-mm stent (SMART®; Cordis, USA) to the EIA from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen. The patient in Case 2 was an 88-year-old man with rest pain in the right limb. The right CFA was punctured using an ipsilateral approach and the Angio-Seal was used for hemostasis. The Angio-Seal collagen with the footplate dropped into the bifurcation of the deep femoral artery. The collagen and footplate were caught with MBF and pulled up to the EIA. The right CFA was punctured and a 10.0- × 60-mm stent (SMART®; Cordis) was delivered from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen with the footplate. CONCLUSIONS: MBF were used to grasp the dislodged collagen with the anchor and cover it with a stent at the iliac artery. This may be a useful bailout technique for Angio-Seal dislodgement.

Clinical validity of the Japanese below-the-knee chronic total occlusion scoring system for the prediction of successful guidewire crossing.

OBJECTIVE: To validate the Japanese below-the-knee (J-BTK) chronic total occlusion (CTO) score for the prediction of successful guidewire crossing (S-GC) in angiographic evaluation. METHODS: A prospective, multicenter, nonrandomized study examined 751 consecutive BTK CTOs in 497 patients treated with endovascular therapy in 16 Japanese medical centers from April 2021 to March 2022. The cohort was classified into 2 groups: an S-GC group and a failed guidewire crossing group. RESULTS: The J-BTK CTO score, which assigned one point to "Blunt type at the proximal entry point," one point to "Calcification at the proximal entry point," one point to "Reference vessel diameter <2.0 mm," one point to "CTO length ≥200 mm," and two points to "No outflow of the target vessel," was used to categorize BTK CTOs into 4 grades with varying probabilities of S-GC: grade A (J-BTK CTO score of 0 and 1), grade B (score of 2 and 3), grade C (score of 4 and 5), and grade D (score of 6). Rates of S-GC in each grade (grades A, B, C, and D) were 97.5%, 89.1%, 62.5%, and 27.3%, respectively. The area under the receiver-operating characteristic curve for S-GC was 0.8304. Although the previous J-BTK CTO study enrolled only de novo lesions, both de novo and restenotic lesions were evaluated in this study. De novo lesions have a lower chance of S-GC (odds ratio: 0.24, 95% confidence interval: 0.09-0.67) in the multivariate analysis, and the area under the receiver-operating characteristic curve of the modified J-BTK CTO score, which additionally assigned two points to "De novo lesion," was 0.846. The modified J-BTK CTO score showed an appropriate calibration (Hosmer-Lemeshow P = .957). CONCLUSIONS: The J-BTK CTO score and the modified J-BTK CTO score predict the probability of an S-GC of BTK CTOs and stratify the difficulty of endovascular therapy for BTK CTOs in angiographic evaluation.

Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study.

BACKGROUND: Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported. MATERIALS AND METHODS: This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group. RESULTS: The propensity score matching extracted 112 pairs. At 12 months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference (P = .004). However, at 36 months, the rate was 43.3% vs 39.2%, with no significant difference (P = .090). No baseline characteristics had any significant interaction effect (all P > .05). CONCLUSIONS: The New devices were more effective than the control group for ISR/O at 1 year, but caught up at 3 years.

Multicenter, retrospective registry of isolated atherosclerotic popliteal arteries treated with endovascular revascularization.

Isolated atherosclerotic popliteal lesions (IAPLs) have been considered challenging. This study aimed to investigate the efficacy of endovascular therapy (EVT) using the newer devices for IAPLs. This retrospective multicenter registry analyzed patients with lower extremity artery disease having IAPLs who underwent EVT using the newer devices between 2018 and 2021. The primary outcome was primary patency 1 year after EVT. A total of 392 consecutive patients undergoing EVT for IAPLs were enrolled. The Kaplan-Meier analysis showed that the primary patency and the freedom from target lesion revascularization were 80.9% and 87.8% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that the clinical features that were independently associated with restenosis risk were drug-coated balloon (DCB) use for younger age (< 75 years old; adjusted hazard ratio, 3.08 [95% confidence interval 1.08-8.74]; P = 0.035), non-ambulatory status (2.74 [95% confidence interval 1.56-4.81]; P < 0.001), cilostazol use (0.51 [95% confidence interval 0.29-0.88]; P = 0.015), severe calcification (1.86 [95% confidence interval 1.18-2.94]; P = 0.007), and small external elastic membrane (EEM) area measured by intravascular ultrasound (IVUS) (< 30 mm2) (2.07 [95% confidence interval 1.19-3.60]; P = 0.010). From the univariate analysis, among patients treated with DCB, younger patients (n = 141) were associated with more comorbidities including smoking (P < 0.001), diabetes mellitus (P < 0.001), end-stage renal disease (P < 0.001), history of revascularization (P = 0.046) and small EEM area (P = 0.036), compared to older patients (n = 140). Moreover, smaller post-procedural minimum lumen area measured by IVUS after DCB dilatation was observed in younger patients (12 ± 4 vs. 14 ± 4 mm2, P = 0.033). This retrospective study demonstrated that the current EVT provided an acceptable 1-year primary patency rate in patients with IAPLs. The primary patency was lower following DCB in younger patients, likely due to the higher rates of comorbidities in this patient population.

Efficacy and Safety of Percutaneous Venoarterial Extracorporeal Membrane Oxygenation Decannulation Using Endovascular Balloon Dilation and Perclose ProGlide Closure Device: Results from the Multicenter SKYLINE Study.

BACKGROUND: The venoarterial extracorporeal membrane oxygenation (VA-ECMO) cannula can be surgically removed, but postoperative complications and surgical staffing issues can be problematic. We previously reported a method of percutaneously removing the arterial cannula of VA-ECMO by combining intravascular balloon dilation and the Perclose ProGlide (PP) closure device. In this study, we investigated the efficacy and safety of this percutaneous decannulation of the VA-ECMO. METHODS: This multicenter, retrospective study involved consecutive patients who underwent percutaneous VA-ECMO decannulation at 2 cardiovascular centers from September 2019 to December 2021. We analyzed 37 patients in whom the VA-ECMO cannula was removed by the percutaneous procedure with balloon dilation and the PP. The primary end point was procedural success of hemostasis. The secondary end points were the procedural time, procedure-related complications, and rate of surgical conversion. RESULTS: The patients' mean age was 65.4 years. The approach site of the endovascular therapy (EVT) procedures were the transradial approach (56.8%), transfemoral approach (27.8%), and transbrachial approach (18.9%). The mean balloon diameter was 7.3 ± 0.68 mm, and the mean balloon inflation time was 14.8 ± 7.3 min. The mean procedure time was 58.5 ± 27.0 min. The procedure success rate was 94.6%, procedure-related complication rate was 10.8%, procedure-related death and postprocedural infection rate was 0.0%, surgical conversion rate was 0.0%, and EVT access site complication rate was 2.7%. CONCLUSIONS: We concluded that percutaneous VA-ECMO decannulation using a combination of intravascular balloon dilation in EVT and the PP appears to be a safe, minimally invasive, and effective procedure.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns).

PURPOSE: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. MATERIALS AND METHODS: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. RESULTS: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). CONCLUSIONS: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. CLINICAL IMPACT: Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

What should we expect from intravascular ultrasound use for complex femoropopliteal lesions?

In this review article, we summarize the clinical benefit of intravascular ultrasounds (IVUS) in the endovascular therapy (EVT) of complex femoropopliteal (FP) lesions. Due to the development of novel FP-dedicated devices, outcomes of FP-EVT have been improved. As a result, revascularization methods for the FP lesions have shifted to EVT. However, the long-term durability in complex FP lesions has not yet reached that of bypass surgery using autogenous vein. Strategies for EVT of complex FP lesions are still inconsistent and have room for improvement. Long-term results generally depend on the patient and lesion backgrounds but are also affected by the quality of the procedure. Previous reports have shown IVUS evaluation can better assess vessel size compared to conventional angiographic evaluation. In contrast to angio-guided EVT, which evaluates vessel size by inner diameter, IVUS can be evaluated it with an external elastic membrane, which leads to the selection of a more appropriate (basically, larger) size device. Conversely, angiographic evaluation underestimates the vessel size, suggesting that it may lead to insufficient result. Furthermore, IVUS can also assess the adequate guidewire route, presence of severe dissection etc. As the evidence so far shows, the use of IVUS may improve the quality of EVT procedure, resulting in improved long-term outcomes. In conclusion, despite the widespread use of IVUS in FP-EVT practice, it still conditionally applied. The purpose of IVUS in the EVT of complex FP lesions should be clarified. More evidence regarding the IVUS in complex FP lesions is needed.

Prediction of successful guidewire crossing of below-the-knee chronic total occlusions using a Japanese scoring system.

OBJECTIVE: To develop a scoring system that can adequately predict a successful guidewire crossing (S-GC) of below-the-knee (BTK) chronic total occlusions (CTOs) in angiographic evaluation. METHODS: A retrospective, multicenter, nonrandomized study examined 448 consecutive BTK CTOs in 299 patients treated with endovascular therapy in seven Japanese medical centers from April 2012 to April 2020. The cohort was classified into two groups: an S-GC group and a failed guidewire crossing group. RESULTS: The final logistic regression model created by a backward stepwise multivariate logistic regression model included five variables: "No outflow of the target vessel," "CTO length ≥200 mm," "Reference vessel diameter <2.0 mm," "Calcification at the proximal entry point," and "Blunt type at entry point." Optimisms were adjusted using 1000 bootstrap samples with replacement and candidate's risk score models developed according to optimism-adjusted correlation coefficients of risk factors. Choosing the best model as the Japanese-BTK (J-BTK) CTO score by comparing the optimism-adjusted area under receiver-operating characteristic curves it was decided to assign one point to "Blunt type at the proximal entry point," one point to "Calcification at the proximal entry point," one point to "Reference vessel diameter <2.0 mm," one point to "CTO length ≥200 mm," and two points to "No outflow of the target vessel." This rule was then used to categorize BTK CTOs into four grades with varying probabilities of S-GC: grade A (J-BTK CTO score of 0 and 1), grade B (score of 2 and 3), grade C (score of 4 and 5), and grade D (score of 6). Rates of S-GC in each grade (grades A, B, C, and D) were 97.3%, 76.8%, 19.3%, and 0%, respectively. Lesions categorized as grade C or D have a lower chance of S-GC. Internal validation was performed using the Hosmer-Lemeshow test (P = .99). CONCLUSIONS: The J-BTK CTO score predicts the probability of an S-GC of BTK CTOs and stratifies the difficulty of endovascular therapy for BTK CTOs in angiographic evaluation.

An Effective Method for Percutaneous Removal of Venoarterial Extracorporeal Membrane Oxygenation by a Combination of Balloon Dilatation in Endovascular Therapy and the Perclose Proglide™ Closure Device.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) can be undertaken surgically, but there are various problems with this method. METHODS AND CASE REPORT: We removed the arterial cannula of VA-ECMO percutaneously by combining intravascular balloon dilatation and the Perclose ProGlide™ (PP) closure device in a short amount of time and the extent of bleeding was extremely small. Simultaneously, the venous cannula was removed by suturing and manual compression. We report a series of cases of percutaneous removal of VA-ECMO using intravascular balloon dilatation and PP. CONCLUSIONS: By using this method, VA-ECMO removal was possible in a very short amount of time with minimal invasiveness.

Efficacy of three-dimensional road mapping by fusion of computed tomography angiography and fluoroscopy in endovascular treatment of aorto-iliac chronic total occlusion.

The efficacy of multimodality image fusion road-mapping technique for endovascular therapy has been reported recently. Our aim was to evaluate the efficacy of endovascular therapy (EVT) with three-dimensional (3D) road mapping by fusing computed tomography (CT) and angiographical volumetric data for aorto-iliac chronic total occlusion (CTO). We retrospectively analyzed 36 patients with aorto-iliac CTO from June 2017 to November 2019 and classified them into two groups: EVT using a CT fused 3D roadmap (CTf3D-RM; 3D group, n = 14) and standard EVT (standard group, n = 22). Primary endpoint was wiring time and secondary endpoints were procedural success rate, number of guidewires, procedure time, radiation dose, contrast medium dose, and complications. Wiring time was significantly shorter in the 3D group than the standard group (3D, 15.6 ± 10.23 min vs. standard, 44.6 ± 35.3 min; p = 0.0052). Both groups had high procedural success rates (3D, 100% vs. standard, 100%) and low complication rates (3D, 0.0% vs. standard, 9.1%; p = 0.51). There were significantly fewer guidewires in the 3D group than the standard group (3D, 2.78 ± 1.31 vs. standard, 4.36 ± 2.01; p = 0.0138). The 3D group trended towards shorter procedural time (3D, 78.8 ± 32.5 min vs. standard, 107.5 ± 52.5 min; p = 0.076), lower radiation dose (3D, 28.6 ± 18.9 Gycm2 vs. standard, 48.9 ± 49.2 Gycm2; p = 0.15), and lower contrast medium dose (3D, 102.2 ± 30.6 vs. standard, 127.5 ± 51.3; p = 0.11) than the standard group. Therefore, we concluded that EVT with CTf3D-RM is effective for aorto-iliac CTO. This method may improve the quality of aorto-iliac CTO interventions.

Efficacy and Safety of Angiography-Guided Retrograde Posterior Popliteal Puncture Technique in the Supine Position.

BACKGROUND: Various techniques are needed for successful treatment of femoropopliteal long chronic total occlusion (CTO). Previous reports have described popliteal puncture by duplex echo guidance, but the safety of angiography-guided popliteal puncture remains unclear. This study was performed to examine the efficacy and safety of angiography-guided retrograde posterior popliteal puncture in the supine position. METHODS: We analyzed 44 consecutive patients treated with retrograde femoropopliteal puncture for femoropopliteal CTO from October 2013 to February 2019. We compared 24 patients who underwent angiography-guided posterior popliteal puncture (posterior group) and 20 patients who underwent frontal superficial femoral artery/popliteal artery puncture (frontal group). The primary end point was successful revascularization. The secondary end points were the puncture time, hemostasis time, and procedure-related complications. RESULTS: The posterior group tended to have a higher procedural success rate than the frontal group (100% vs. 90.0%, respectively; P = 0.20). The hemostasis time was significantly shorter in the posterior than frontal group (527.1 ± 146.5 vs. 710.0 ± 337.8 sec, respectively; P = 0.021). There was no significant difference in the puncture time between the posterior and frontal groups (8.19 ± 9.22 vs. 7.50 ± 9.68 min, respectively; P = 0.81). Both groups had a low complication rate (posterior, 0.0% vs. frontal, 5.0%; P = 0.4). CONCLUSIONS: Angiography-guided posterior popliteal puncture in the supine position can facilitate hemostasis and may improve the success rate of the procedure. This technique may contribute to the treatment of complex femoropopliteal CTO as one option for a retrograde approach.

Efficacy and safety of endovascular therapy by diluted contrast digital subtraction angiography in patients with chronic kidney disease.

This study was performed to evaluate the efficacy and safety of endovascular therapy (EVT) by diluted contrast digital subtraction angiography (DSA) in patients with chronic kidney disease (CKD). Patients with peripheral artery disease (PAD) often have CKD; thus, EVT carries a risk of contrast-induced nephropathy (CIN). Reducing the amount of contrast medium is, therefore, important in these patients. We developed a novel EVT method using DSA with diluted contrast medium. DSA parameters were adjusted for diluted contrast angiography (1:10 dilution), and we defined this technique as low-concentration DSA (LC-DSA). We retrospectively analyzed 122 patients with CKD [estimated glomerular filtration rate (eGFR), < 45 mL/min/1.73 m2] from June 2012 to November 2017 and classified them into two groups: EVT with diluted contrast (LC-DSA group, n = 63) and conventional EVT (control group, n = 59). Patients with aortoiliac lesions and those undergoing hemodialysis were excluded. The primary endpoint was the incidence of CIN as defined by an absolute increase in serum creatinine of ≥ 0.5 mg/dL or relative increase of ≥ 25% 2-5 days after the procedure. The secondary endpoints were worsening renal function (defined as an eGFR reduction of ≥ 25% compared with that before the procedure), the amount of contrast medium used for EVT, freedom from complications related to LC-DSA, and procedural success. The incidence of CIN was significantly lower in the LC-DSA group than control group (0.0% vs. 11.9%, respectively; P = 0.001). The absolute eGFR increase (4.25 ± 4.7 vs. 1.24 ± 6.9, respectively; P = 0.005) and creatinine decrease ( - 0.16 ± 0.2 vs. 0.007 ± 0.34, respectively; P = 0.0078) were greater in the LC-DSA group than control group. Less contrast medium was used in the LC-DSA group than control group (30.0 ± 14.6 vs. 117.9 ± 52.8 mL, respectively; P < 0.0001). There were no differences in the procedural success rate (100% vs. 96.6%, P = 0.23) or complications related to LC-DSA (0.0% vs. 1.7%, P = 0.48). Therefore, we concluded that EVT with diluted contrast DSA reduced the amount of contrast medium and incidence of CIN. This method is effective and safe for treating patients with CKD who have infrainguinal lesions.