Clinical feasibility of endovascular recanalization with intravascular ultrasound-guided wiring for chronic total occlusion of below-the-knee arteries.

BACKGROUND: Revascularization with endovascular therapy (EVT) for complex below-the-knee (BTK) chronic total occlusion (CTO) remains a challenging problem. The Japanese-BTK (J-BTK) CTO score is reported as an indicator of the difficulty of BTK CTO, with the guidewire (GW) passage success rate decreasing as the grade increases. We previously reported an effective GW crossing method for the intravascular ultrasound (IVUS)-guided parallel wiring of complex BTK CTO. In this study, we investigated the feasibility of EVT using IVUS-guided wiring for BTK CTO. MATERIALS AND METHODS: This single center, retrospective study analyzed 65 consecutive BTK CTO vessels in which IVUS-guided wiring was attempted after the failure of a conventional antegrade wiring approach from November 2020 to November 2022. The primary endpoint was the clinical success of the target CTO vessel. The secondary endpoints were the GW success rate per grade based on the J-BTK CTO score, number of GW used for CTO crossing, fluoroscopy time, and complications. RESULTS: Target vessels were the anterior tibial artery (66.2% of cases), peroneal artery (9.2%), and posterior tibial artery (24.6%). Blunt type CTO entry was performed in 55.4% of cases, calcification of entry was observed in 24.6% of cases, the mean occlusion length was 228.2 ± 93.7 mm, mean reference vessel diameter was 2.1 ± 0.71 mm, and outflow was absent in 38.5% of cases. J-BTK CTO scores of 0/1 (grade A), 2/3 (grade B), 4/5 (grade C), and 6 (grade D) were seen in 18.5%, 43.1%, 36.3%, and 1.5% of cases, respectively. The clinical success rate was 95.4%. The GW success rate by J-BTK CTO grade was as follows: grade A (100%), B (100%), C (91.7%), and D (0%). The mean number of GW used was 3.4 ± 1.4, the mean fluoroscopy time was 72.3 ± 32.5 min, and complications occurred in 7.7% of cases. CONCLUSION: This study showed a very high clinical success rate despite the difficulty of BTK CTO. IVUS-guided EVT might be a feasible strategy for complex BTK CTO.

Body Surface Radiation Exposure in Interventional Echocardiographers During Structural Heart Disease Procedures.

Background: The distribution of radiation exposure on the body surface of interventional echocardiographers during structural heart disease (SHD) procedures is unclear. Objectives: This study estimated and visualized radiation exposure on the body surface of interventional echocardiographers performing transesophageal echocardiography by computer simulations and real-life measurements of radiation exposure during SHD procedures. Methods: A Monte Carlo simulation was performed to clarify the absorbed dose distribution of radiation on the body surface of interventional echocardiographers. The real-life radiation exposure was measured during 79 consecutive procedures (44 transcatheter edge-to-edge repairs of the mitral valve and 35 transcatheter aortic valve replacements [TAVRs]). Results: The simulation demonstrated high-dose exposure areas (>20 µGy/h) in the right half of the body, especially the waist and lower body, in all fluoroscopic directions caused by scattered radiation from the bottom edge of the patient bed. High-dose exposure occurred when obtaining posterior-anterior and cusp-overlap views. The real-life exposure measurements were consistent with the simulation estimates: interventional echocardiographers were more exposed to radiation at their waist in transcatheter edge-to-edge repair than in TAVR procedures (median 0.334 µSv/mGy vs 0.053 µSv/mGy; P < 0.001) and in TAVR with self-expanding valves than in those with balloon-expandable valves (median 0.067 µSv/mGy vs 0.039 µSv/mGy; P < 0.01) when the posterior-anterior or the right anterior oblique angle fluoroscopic directions were used. Conclusions: During SHD procedures, the right waist and lower body of interventional echocardiographers were exposed to high radiation doses. Exposure dose varied between different C-arm projections. Interventional echocardiographers, especially young women, should be educated regarding radiation exposure during these procedures. (The development of radiation protection shield for catheter-based treatment of structural heart disease [for echocardiologists and anesthesiologists]; UMIN000046478).

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.

Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study.

BACKGROUND: Several studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO. MATERIALS AND METHODS: We retrospectively analyzed 359 limbs of 318 patients who underwent endovascular therapy with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model. RESULTS: The 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P = 0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P = 0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P = 0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P = 0.003). CONCLUSIONS: Despite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis.

Combining transradial access and sheathless femoral access for complex iliac artery chronic total occlusions.

BACKGROUND: The transradial approach (TRA) is associated with fewer serious access site-related complications compared with the transfemoral or transbrachial approach. However, TRA has associated problems in complex aortoiliac (AI) lesions, including the procedural difficulty. A bidirectional approach was used combining TRA with a sheathless technique for femoral artery (FA) puncture to treat complex AI lesions, as a minimally-invasive approach. This report describes a representative cases with AI chronic total occlusion in which the combination of TRA and a sheathless technique for FA puncture was useful for guidewire crossing. CASE PRESENTATION: Case 1 was a 71-year-old man with intermittent claudication (IC). Control angiography showed total occlusion of the left common iliac artery (CIA) ostium to the distal external iliac artery (EIA). Guidewire externalization was achieved by combining TRA using a 6Fr guiding sheath and a sheathless technique for the left FA. Two nitinol stents were deployed in the CIA to EIA. Case 2 was a 63-year-old man with IC. Control angiography revealed total occlusion of the right CIA ostium to the common femoral artery (CFA) with severe calcification. The antegrade wire could not pass through the CTO lesion because of the calcified CFA occlusion. A 21-G metal needle was used to penetrate the CFA calcification through the distal true lumen of the CFA, and the wire was inserted into the EIA for wire externalization. Three nitinol stents were deployed in the CIA to EIA, and a drug-coated balloon was dilated in the CFA with hemostasis of the distal puncture site. In both cases, the retrograde puncture site was hemostatic during the procedure and postoperative bed rest was not required. CONCLUSIONS: TRA combined with a sheathless technique from the FA has the potential to treat AI complex lesions in a less invasive manner.

Optimal Intraluminal Drug-Coated Balloon Versus Drug-Eluting Stent in Patients With Chronic Total Occlusion of the Superficial Femoral Artery: A Retrospective Analysis.

BACKGROUND: Paclitaxel-eluting technologies improve the clinical outcome of femoropopliteal (FP) occlusive disease. Several studies reported efficacy of the high-dose (nominal paclitaxel density of 3.5 µg/mm2) drug-coated balloon (DCB) for complex FP lesions. However, previous studies of DCB have shown a high rate of bailout stents, and few studies have compared the high-dose DCB with successful lesion pre-dilation without bailout stent and drug-eluting stent (DES) in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare the clinical outcome of high-dose DCB with successful lesion preparation and DES in CTO of the SFA. METHODS: This was a single-center, retrospective study. From June 2018 to November 2020, we compared 41 patients (43 lesions) treated with high-dose DCB and 36 patients (37 lesions) treated with DES. The study period was defined as the period after DCB and DES became available simultaneously at our hospital, when all surviving patients had at least 1 year of follow-up. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from: (1) clinically driven target lesion revascularization (CD-TLR), and (2) re-occlusion. RESULTS: Baseline clinical data were comparable between the two groups. Reference vessel diameter was smaller in the DCB group. The mean lesion and occlusion lengths were about the same in both groups. The subintimal angioplasty and bailout stent rate was 0% in the DCB group. The Kaplan-Meier estimate for 12-month primary patency was 92.0% in the DCB group and 87.2% in the DES group (p = 0.47). Freedom from CD-TLR also did not differ significantly between the two groups. The 12-month freedom from re-occlusion rate tended to be higher in the DCB group than in the DES group. CONCLUSIONS: High-dose DCB with successful lesion preparation showed 12-month clinical outcomes comparable with DES for CTO of the SFA, even without bailout stents.

Dermoscopic furrow ink test of the palmar lesion in loricrin keratoderma.

Palmoplantar keratodermas (PPK) comprise a heterogeneous group of keratinization disorders that gradually progress during childhood, resulting in difficulties to establish a diagnosis and to identify a candidate gene for sequencing. Dermoscopic examination with staining of palmoplantar skin using a whiteboard marker, so-called "furrow ink test", could be a useful tool for differentiation between furrow and ridge in understanding the morphological characteristics of PPK. One of the striking features in autosomal dominant loricrin keratoderma (LK) is diffuse PPK with honeycomb pattern. In this study, we performed dermoscopic furrow ink test in a Japanese family of LK with the most frequent mutation c.684dup, p.Ser229Valfs*107 in the loricrin gene. The severe lesion revealed that irregular circular hyperkeratoses were aggregated and normal structures of furrows and ridges were disrupted. To accurately describe the nature of this dermoscopic patterned skin surface, we suggest that the condition could be termed as "irregular cobblestone appearance" rather than "honeycomb pattern". Regular cobblestone appearance to maintain parallel furrow structure was observed in early or mild hyperkeratotic lesions. Eccrine sweat glands that open on the surface of ridges nearly disappeared, resulting in hypohidrosis.

An AnteOwl WR intravascular ultrasound-guided parallel wiring technique for chronic total occlusion of below-the-knee arteries.

BACKGROUND: Although endovascular therapy is used to treat chronic limb-threatening ischemia, long chronic total occlusion (CTO) is still challenging to treat. Especially in patients with poor run-off below-the-knee (BTK) arteries, it is difficult to perform a retrograde approach, and even guidewire passage may be difficult. CASE PRESENTATION: We treated two cases of chronic limb-threatening ischemia using our novel extreme antegrade guidewire crossing technique by AnteOwl WR intravascular ultrasound (IVUS)-guided parallel wiring to a BTK artery (EXCAVATOR technique). Case 1 was a 70-year-old man with ulceration of the right toe. The AnteOwl WR IVUS was intentionally advanced into the subintimal space of the posterior tibial artery, and the totally intraplaque route was advanced by IVUS-guided parallel wiring that was successfully passed from the lateral plantar aspect to the true lumen of the digital artery. Case 2 was a 76-year-old woman with rest pain and cyanosis of the right lower limb. Angiography showed total occlusion from the superficial femoral artery to BTK arteries. AnteOwl WR IVUS-guided parallel wiring was repeatedly performed until the distal true lumen of the peroneal artery was reached, and revascularization was successfully achieved via the antegrade approach alone. CONCLUSIONS: With its excellent crossable performance, good image quality, and high navigational ability within the CTO, the AnteOwl WR can be used to pass parallel wiring into the distal true lumen for BTK CTO.

Effective treatment of iatrogenic femoral pseudoaneurysms by combined endovascular balloon inflation and percutaneous thrombin injection.

The increasing number of percutaneous endovascular procedures in highly anticoagulated patients has increased the possibility of iatrogenic femoral artery pseudoaneurysm (IFAP). Ultrasound (US)-guided percutaneous thrombin injection is one of the feasible treatments; however, there are concerns about complications such as peripheral embolization. This study was performed to examine the efficacy and safety of treatment of IFAPs using a combination of percutaneous thrombin injection and intravascular balloon inflation. In this retrospective, single-center study, we analyzed 11 patients who developed and were treated for IFAPs from January 2017 through April 2020. The patients were treated with endovascular therapy (EVT) with percutaneous thrombin injection. The technique utilized fluoroscopic guidance to place a balloon at the neck of the IFAP, and the balloon was then inflated to prevent the inflow of blood to the aneurysm. We then performed US-guided thrombin injection. The mean age was 72.36 ± 10.43 years; mean body mass index (BMI) was 25.25 ± 3.18. All patients had hypertension, 72.7% were undergoing hemodialysis, and 54.5% used oral anticoagulant drugs. The mean aneurysm size was 24.34 ± 13.54 mm. The approach was transfemoral in ten patients and transradial in one patient. All procedures were successful, and there were no complications. The mean thrombin dose was 677.3 ± 410.7 IU; the total hemostatic time was 45.4 ± 24.9 min. In conclusion, the combination of percutaneous thrombin injection and endovascular balloon inflation was feasible and safe for the treatment of IFAPs. This technique may contribute to the treatment of IFAPs.

Clinical outcome of drug-coated balloon versus scaffold device in patients with superficial femoral artery chronic total occlusion.

The demand for endovascular therapy is increasing in an aging society, but the problem of restenosis in the chronic phase has not been resolved in femoropopliteal occlusive disease. Few studies have compared drug-coated balloon (DCB) and scaffold devices in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare DCBs with scaffold in patients with CTO of the SFA. This was a single-center, retrospective study. From June 2018 to December 2019, we compared 31 patients and 33 limbs treated with DCBs and 44 patients and 45 limbs treated with a stent or stent-graft (scaffold) for SFA CTO. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR) and 12-month freedom from re-occlusion. The DCBs were performed using an intravascular ultrasound (IVUS)-guided approach or a non-loop wire technique. Baseline characteristics were similar between the groups. An intraluminal approach was performed to use all DCBs. The bailout stent rate was 0% in the DCB group. Kaplan-Meier analysis showed that rates of 12-month primary patency tended to be higher in the DCB than in the scaffold group (92.7 vs. 76.6%, p = 0.073) and that freedom from CD-TLR also did not differ significantly between the two groups (96.8 vs. 86.3%, p = 0.17). Kaplan-Meier analysis also showed that the 12-month freedom from re-occlusion rate was significantly less in the Scaffold than in the DCB group (96.8 vs. 79.3%, p = 0.045). Therefore, we concluded that in treatment for CTO of the SFA, a DCB with intraluminal angioplasty without bailout stenting was less re-occlusion compared with scaffold.

Direct bare metal needle puncture and balloon angioplasty in calcified plaques of the common femoral artery guided by angiography ("BAMBOO SPEAR").

BACKGROUND: Surgical endarterectomy for common femoral artery (CFA) disease is still considered the gold standard for treatment. Development of various techniques and devices has improved the clinical results of endovascular therapy (EVT) for CFA. However, severe conditions remain, especially for occlusive lesions owing to calcified plaque. We developed a useful technique for passing a lesion by directly penetrating the calcified plaque of the CFA using a bare metal needle and then passing through a balloon or dilating it. We named this technique "direct bare metal needle puncture and balloon angioplasty in calcified plaques of the common femoral artery guided by angiography" or "BAMBOO SPEAR." MAIN TEXT: This report describes our technique for crossing a lesion by directly penetrating the calcified plaque of the CFA using a needle. We report a case of a 73-year-old male with hemodialysis who presented with cyanosis and ischemic rest pain of both lower limbs. Control angiography showed total occlusion of the left CFA with a calcified plaque. We advanced a 21-G metal needle that was slightly curved into the blood vessel from where the lumen of the distal CFA was located. The needle was advanced into the center of the calcified plaque, while observing from multiple directions with a fluoroscopic guide. We succeeded in advancing the needle into the lumen of the distal external iliac artery. After guidewire crossing, intravascular ultrasound (IVUS) showed that guidewire was able to completely pass through the center of the calcified plaque. We could dilate the lesion by scoring balloon and drug-coated balloon. The final angiography showed sufficient results. We named this technique "direct BAre Metal needle puncture and BallOOn angioplaSty in calcified PlaquEs of the common femoral ARtery guided by angiography" (BAMBOO SPEAR). CONCLUSIONS: The BAMBOO SPEAR technique may be considered a useful option in EVT for occlusive CFA with calcified plaques.

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.

Successful re-entry using the outback® elite catheter via retrograde popliteal access with IVUS guidance for femoropopliteal occlusion: a case report.

BACKGROUND: There are still cases that are difficult to treat for femoropopliteal chronic total occlusion (CTO). The Outback® Elite catheter is effective re-entry device to treat such kind of difficult cases, however, it might be difficult to use the Outback® Elite catheter antegradely in cases with severely calcified lesions. In this case, we performed EVT using the Outback Elite® catheter via the retrograde popliteal approach. CASE PRESENTATION: We report a case of a 77-year-old male with end-stage renal disease who presented with pain and cyanosis of his left foot. Control angiography showed total occlusion from the middle of the left superficial femoral artery to the proximal portion of the popliteal artery. The CTO lesion was severely calcified, which prevented the antegrade advancement of any guidewire. Retrograde popliteal puncture was performed with the patient in the supine position. After intentional retrograde subintimal wiring, the Outback® Elite catheter was advanced via the retrograde approach after the identification of a suitable re-entry site using intravascular ultrasound. After wire crossing, one nitinol stent was deployed and sufficient antegrade flow was achieved without any complications. CONCLUSIONS: Using Outback® Elite from retrograde should be considered in cases where antegrade advancement fails and bidirectional wiring cannot pass through the CTO lesion.

Lesional Th17 cells and regulatory T cells in bullous pemphigoid.

Th17 cells play crucial roles in the pathogenesis of autoimmune diseases. We previously reported that Th17 cells are recruited to the lesional skin in pemphigus vulgaris (PV) and pemphigus foliaceus (PF). The aim of this study was to evaluate lesional Th17 cells and Treg cells in bullous pemphigoid (BP). Correlations between these cells and disease severity of BP were also evaluated. Immunohistochemical studies showed that both IL-17+ and Foxp3+ cells were present in higher numbers in BP lesions, compared with control skin. IL-17/CD4 ratio in BP was significantly higher than that in PF. Foxp3/CD4 ratio in BP was significantly less than that in either PV or PF. There were no obvious correlations between these cells and disease severity of BP. This study suggests that, compared with pemphigus, BP shows more Th17 cell-related inflammation and less Treg-related regulation.