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

OBJECTIVE: To validate Japanese below-the-knee (J-BTK) chronic total occlusion (CTO) score for the prediction of successful guidewire crossing in angiographic evaluation. METHODS: A prospective, multicenter, non-randomized study examined 751 consecutive BTK CTOs in 497 patients treated with endovascular therapy (EVT) in 16 Japanese medical centers from April 2021 to March 2022. The cohort was classified into 2 groups: a successful guidewire crossing (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 < 2.0mm", one point to "CTO length ≥ 200mm", and two points to "No outflow of the target vessel" was utilized to categorize BTK CTOs into 4 grades with varying probabilities of successful guidewire crossing: 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 successful guidewire crossing in each grade (grade A, B, C, and D) were 97.5%, 89.1%, 62.5%, and 27.3%, respectively. The area under the receiver-operating characteristic (ROC) curve for successful guidewire crossing 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 ROC 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=0.957). CONCLUSION: The J-BTK CTO score and the modified J-BTK CTO score predict the probability of a S-GC of BTK CTOs and stratify the difficulty of EVT for BTK CTOs in angiographic evaluation.

Negative Pressure Wound Therapy with Instillation and Dwell Time Using Antiseptic Solution in Chronic Limb-threatening Ischemia.

Background: Chronic limb-threatening ischemia (CLTI) is a severe peripheral artery disease with rest pain and lower limb ulceration. After revascularization, limb ulceration treatment should be completed quickly before restenosis. We aimed to investigate the effect of negative pressure wound therapy with instillation and dwell (NPWTi-d) using an antiseptic solution (AS) versus a saline solution (SS) in CLTI. There is no research limited to CLTI on this topic. Methods: All patients underwent revascularization and surgical debridement. NPWTi-d was applied after surgical debridement. We evaluated wound tissue cultivation from pre- and post-NPWTi-d, length of NPWTi-d, and laboratory data pre- and post-NPWTi-d. All data are presented as the median, interquartile range. For univariate analysis, nonnormally distributed data were examined using the Wilcoxon rank sum test between the two groups of NPWTi-d (AS and SS group). A P value of less than 0.05 was considered statistically significant. Results: Forty-eight CLTI patients participated. The SS group included 24 patients (19 men, five women, average age 68.8 years) and the AS group included 24 patients (16 men, eight women, average age 67.4 years). The comorbidities included 23 and 19 patients with diabetes mellitus and hemodialysis in the SS group, and 22 and 16 patients in the AS group, respectively. There were no adverse events in either group. Both groups reduced the number of bacteria. The AS group required shorter NPWTi-d time (P = 0.02). Conclusion: The AS group was able to shorten the treatment duration in CLTI.

Application of first-generation high- and low-dose drug-coated balloons to the femoropopliteal artery disease: a sub-analysis of the POPCORN registry.

BACKGROUND: Drug-coated balloons (DCBs) have significantly changed endovascular therapy (EVT) for femoropopliteal artery (FPA) disease, in terms of the expansion of indications for EVT for symptomatic lower extremity arterial disease (LEAD). However, whether there is a difference in the performance among individual DCBs has not yet been fully discussed. The present sub-analysis of real-world data from a prospective trial of first-generation DCBs compared the clinical outcomes between high- and low-dose DCBs using propensity score matching methods. The primary endpoint was the restenosis-free and revascularization-free rates at 1 year. RESULTS: We compared 592 pairs matched for patient and lesion characteristics using propensity score matching among a total of 2,507 cases with first-generation DCBs (592 and 1,808 cases in the Lutonix low-dose and In.PACT Admiral high-dose DCB groups, respectively). There were no differences in patient/lesion characteristics, procedural success rates, or complications between the two groups. First-generation low-dose DCB had significantly lower patency (73.3% [95% confidence interval, 69.6%-77.3%] in the low-dose DCB group versus 86.2% [84.1%-88.3%] in the high-dose DCB group; P < 0.001) and revascularization-free (84.9% [81.9%-88.1%] versus 92.5% [90.8%-94.1%]; P < 0.001) rates. Chronic kidney disease on dialysis, cilostazol use, anticoagulant use, and severe calcification had a significant interaction effect in the association (all P < 0.05). CONCLUSIONS: EVT to FPA with first-generation DCBs had inferior low-dose patency outcomes as compared with high-dose outcomes in the present cohort. LEVEL OF EVIDENCE: Sub analysis of a prospective multicenter study.

Prognostic impact of atrial fibrillation on the outcomes of peripheral artery disease according to preoperative symptoms for endovascular revascularization.

Peripheral artery disease (PAD) and atrial fibrillation (AF) are associated with major cardiovascular and cerebrovascular events (MACCE). However, outcomes stratified according to the preoperative symptoms of PAD in patients with AF have not been sufficiently investigated. This was a retrospective study of prospectively collected data pertaining to 2237 patients (1179 patients with intermittent claudication [IC] and 1058 patients with critical limb-threatening ischemia [CLTI]) who underwent endovascular therapy at 34 hospitals between August 2014 and August 2016. AF was present in 91 (7.7%) patients with IC and 150 (14.2%) patients with CLTI. In the CLTI group, patients with AF had a higher event rate of MACCE and all-cause death than those without AF (1-year rates of freedom from MACCE: 0.66 and 0.81 in patients with and without AF, respectively, p < 0.001). In contrast, in the IC group, there was no statistically significant difference in the rates of MACCE between patients with and without AF. In the Cox multivariate analysis, AF was a significant predictor of MACCE in patients with CLTI but not in patients with IC, even after adjusting for covariates. The impact of AF on the outcome of patients with PAD was greater in those with CLTI. Further studies are needed to clarify the possible mechanisms underlying these differences.

Three years progress chronic limb-threatening ischemia case with simultaneous surgery.

INTRODUCTION AND IMPORTANCE: Chronic limb-threatening ischemia (CLTI) is a severe limb problem. The causes of foot ulcer are influenced by several factors, which lead to ischemia and foot deformity causing recurrence after wound healing. This report focuses on the long-term course. CASE PRESENTATION: An 80-year-old male with CLTI was treated. The patient had an ulcer in the second toe of his left foot and stenosis of above the knee vessels. He performed his daily activities independently and his left foot was hallux valgus. After improving blood flow, foot deformity was corrected with ulcer treatment. The patient's second toe was amputated after the endovascular treatment. Finally, the toe was closed and hallux abductive valgus was corrected at the same time. After three years, he had no recurrence of foot ulcer. The patient uses a foot orthosis and his life is independent with no recurrence. CLINICAL DISCUSSION: Surgical offloading is an effective method to prevent recurrence. Surgical offloading is sometimes performed in patients with CLTI, but there is few occasion to undergo. This is because, there are problems of re-ischemia and an advanced age. Therefore, simultaneous surgery, as in this case, could be useful and help reduce the ulcer recurrence rate. CONCLUSION: Simultaneous surgery for CLTI was useful in leading to a reduction in recurrence rate.

The Efficacy of the Transdermal Isosorbide Dinitrate Patch in Patients With Chronic Limb-Threatening Ischemia.

Recently, the number of patients with peripheral artery disease (PAD), including those with chronic limb-threatening ischemia (CLTI), has increased because of the increasing number of diabetic or dialysis patients worldwide. Revascularization is an important therapy for patients with CLTI. However, we sometimes experience refractory cases with insufficient peripheral circulation or microcirculation after revascularization. In this situation, additional therapy can be administered, such as low-density lipoprotein apheresis, high-pressure oxygen therapy, and spinal cord stimulation. However, they are not effective in some cases. Some reports have also indicated that transdermal isosorbide dinitrate patch (ISDN-P) is a useful therapy for PAD. As the efficacy of ISDN-P for patients with CLTI is not well-known, we examined it in this study. We assessed the skin perfusion pressure (SPP) after affixing an ISDN-P on the foot, because SPP measurement has proved useful in the assessment of PAD and is a good indicator of wound healing potential. The SPP (dorsal and plantar aspects) after ISDN-P application on the foot of healthy volunteers increased (n = 8; mean ± SD, 12.6 ± 7.9 [P = .12], and 21.2 ± 7.7 mm Hg [P < .05], respectively), as did SPP of patients with CLTI (n = 10; mean ± SD, 19.8 ± 2.5 [P < .01], and 14.1 ± 5.9 mm Hg [P < .05], respectively). All the patients who received an ISDN-P on the foot had no major complication, and no significant change in blood pressure. In conclusion, the ISDN-P is one of the effective and safe therapies for patients with CLTI.

Long-term efficient management of diabetic foot ulcer using simultaneous foot ulcer closure and surgical off-loading.

Foot deformity is one of the causes of foot ulcers. Foot ulcers often recur due to foot deformity. Foot ulcer healing alone does not reduce the risk factor of foot ulcer recurrence. The majority of foot ulcer patients, most of whom are elderly, have foot deformities. This limits the chances of undergoing surgical off-loading following surgery. We present a case of diabetic foot ulcer (DFU) in which surgical off-loading was performed simultaneously with foot ulcer closure that did not recur for a period of 2 years following surgery. A 70-year-old diabetic male with a DFU presented to our hospital. He underwent surgical debridement followed by reconstruction surgery (stump plasty) simultaneous with surgical off-loading (metatarsal head resection). The immediate postoperative period during which he used the off-loading device was uneventful. Following this, he used orthosis. After 2 years, the foot ulcer had not recurred, and he was able to independently perform his daily activities. Simultaneous surgery (reconstructive surgery and surgical off-loading) is less likely to limit daily activities and can reduce the ulcer recurrence rate.

Giant Hepatic Cyst: A Possible Cause of Inferior Vena Cava Syndrome.

An 80-year-old man was transferred to our institution with lower limb edema and worsening dyspnea following the administration of diuretic medication. Transthoracic echocardiography and computed tomography revealed a giant hepatic cyst (176×190 mm) compressing his right atrium and inferior vena cava (IVC). Laparoscopic cyst deroofing combined with omental packing and subsequent tube drainage immediately alleviated all his symptoms. The procedure was uneventful, and he was discharged without any complications on postoperative day 9; he had no recurrent symptoms or hepatic cysts at the postoperative 2-month follow-up. Therefore, a giant hepatic cyst can cause IVC syndrome, and laparoscopic deroofing is a beneficial approach for the treatment of accessible cysts.

Pseudo-aneurysm caused by stent fracture in the "sub-acute" phase after endovascular therapy for in-stent restenosis lesions.

Despite the reported favorable patency of stents in the treatment of femoropopliteal lesions, concern regarding stent fracture is increasing. Development of pseudo-aneurysm by stent fracture is rare and has been reported to occur in the chronic phase owing to mechanical fatigue. Here, we present the first report of a pseudo-aneurysm caused by stent fracture in the "sub-acute" phase after endovascular therapy for in-stent restenosis lesion. A 79-year-old man underwent endovascular therapy for an in-stent restenosis lesion of the right superficial femoral artery. Echography 48 days after the treatment showed a saccular pseudo-aneurysm at the proximal stent site, suggestive of stent fracture. Angiography confirmed the pseudo-aneurysm caused by stent fracture. A self-expandable endoluminal stent graft was deployed, which showed complete resolution of the pseudo-aneurysm. A pseudo-aneurysm caused by stent fracture can occur in the "sub-acute" phase after endovascular therapy for in-stent restenosis lesions. .

Combined Use of Excimer Laser and High-Speed Rotational Atherectomy to Overcome a Severely Calcified Lesion in Endovascular Therapy.

Although endovascular therapy (EVT) is commonly used in treatment of peripheral artery disease (PAD), severely calcified lesions pose a challenge, in spite of the technical advancement. In this report, we discuss the case of a 74-year-old male with coronary artery disease and end-stage renal disease who presented at our institution with bilateral intermittent claudication. Angiography showed chronic total occlusion (CTO) of the right superficial femoral arteries (SFA). Because the bilateral external iliac arteries demonstrated moderate stenosis, we performed endovascular therapy on the right SFA-CTO using a contralateral approach. With the antegrade wire progressing into the subintimal space, direct distal-SFA puncture was performed and wire externalization was established. However, no devices (minimal balloon, microcatheter, or Crosser system) were able to pass the lesion in antegrade or retrograde manner, even though the child catheter support or needle cracking technique from outside/inside was applied. Therefore, we used a combination of an excimer laser and high-speed rotational atherectomy to overcome the severely calcified lesion. First, the excimer laser catheter (Turbo Elite 0.9 mm) ablated the entry to the CTO; however, it did not pass through completely. Thereafter, the thin microcatheter (Caravel) succeeded in crossing the CTO in an antegrade manner using the BAlloon Deployment using FORcible Manner (BADFORM) technique. After wire-exchange to the Rota-wire, rotational atherectomy (RotaLink Plus 1.5 mm) passed through the CTO. Subsequently, we could dilate the CTO lesion with a conventional balloon followed by bare metal stent deployment. The right ankle-brachial index of the patient improved from being unmeasurable to 0.79, and the intermittent claudication disappeared. This combination therapy, described as the "RASER" technique in coronary section, is accepted for reimbursement. However, these devices in EVT section are considered off-label use in Japan. Therefore, we have to refrain from frequent use of this strategy; however, this method provides an option for severely calcified lesions.

Simple percutaneous coronary interventions using the modification of complex coronary lesion with excimer laser.

Excimer laser coronary atherectomy (ELCA), a unique percutaneous coronary intervention (PCI) device, comprises a monorail-type system and is compatible with any standard 0.014-inch guidewire. ELCA is the only device that vaporizes the atherosclerotic plaques or modifies underlying plaque located underneath to a hard tissue, such as severe calcification or a stent. Therefore, ELCA differs from other coronary atherectomy devices and is useful for patients with acute coronary syndrome, chronic total occlusion or under-expanded stents. This case series reports on patients treated using ELCA to simplify complex PCI procedures. Furthermore, we review and discuss ELCA in several situations.

The Wire Rendezvous and Chasing Wire Technique in the Bidirectional Approach for the Percutaneous Coronary Intervention for Chronic Total Occlusion with a Single Guiding Catheter.

A bidirectional approach for percutaneous coronary intervention for chronic total occlusion (CTO-PCI) using ipsilateral collaterals with a single guiding catheter limits procedural choices. The CTO of the left circumflex artery with ipsilateral collateral artery was treated by the bidirectional approach using a single guiding catheter. While the retrograde wire directly crossed the CTO lesion, the microcatheter could not pass the CTO lesion despite the conventional strategies. Therefore, we performed the wire rendezvous and chasing wire techniques. The wire rendezvous technique enables deeper retrograde guidewire progression, and the antegrade microcatheter can reach the CTO entry. The chasing wire technique enables the antegrade guidewire to pass the route made by the retrograde guidewire. These techniques might offer a possible solution for bidirectional CTO-PCI using a single guiding catheter. However, this technique should be considered as a last resort because of the risk of rapid reocclusion.

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.

Crossover stenting across the deep femoral artery entry: a multicenter retrospective study.

Crossover stenting of femoral bifurcation raises the concern of jeopardizing the deep femoral artery (DFA) entry, thereby increasing future risk of limb-threatening ischemia and amputation. This retrospective multicenter study compared clinical outcomes of crossover stenting and non-crossover stenting for ostial superficial femoral artery (SFA) lesions. We reviewed 125 limbs in 103 patients with successful stent implantation for ostial SFA lesions and allocated them to two groups, based on whether the stent crossed over the DFA orifice (CO, n = 54) or not (NC, n = 71). The decision of applying whether CO or NC was at the operators' discretion. Primary endpoints were incidences of major amputation and acute limb ischemia (ALI) at 24 months, and secondary endpoints were incidences of death, target lesion revascularization (TLR), composite of amputation or death, and major adverse limb events which was a composite of major amputation, ALI, TLR, or death at 24 months. Baseline characteristics were similar between the groups. Major amputation occurred only in the NC group, while ALI occurred only in the CO group. Kaplan-Meier estimation showed no significant differences in incidences of major amputation (NC: 3.0% vs. CO: 0.0%, p = 0.21), ALI, or any of the secondary endpoints. However, there was a trend towards higher incidence of ALI in the CO group (NC 0.0% vs. CO 3.9%, p = 0.11). Crossover stenting did not result in a significant difference in major amputation compared to non-crossover stenting within 24 months. However, it showed a trend towards higher incidence of ALI.

Utility of a 0.035″ compatible rapid-exchange balloon (Metacross RX™) as a perfusion balloon in endovascular therapy compared with conventional percutaneous coronary intervention: A mini-review.

Since endovascular treatment for peripheral artery disease has been rapidly and widely adopted as the preferred strategy, interventionists sometimes experience complications such as vessel perforation and severe dissections. We have a long-time inflation strategy for perfusion balloon catheters, which could be a solution for vessel complications in coronary sections, but not in peripheral sections. We invented a simple device for application as a perfusion balloon in peripheral sections, using a 0.035″ wire compatible rapid-exchange balloon Metacross RX™ (TERUMO, Tokyo, Japan) and reviewed this strategy using three cases as examples and compared them with the coronary perfusion balloon. TABLE OF CONTENTS SUMMARY: Metacross RX (TERUMO, Tokyo, Japan) is being used as a rapid exchange balloon and can be potentially used as a perfusion balloon. We report a series of cases in which patients were treated using the Metacross RX at a single-center for endovascular treatment of peripheral artery disease. We review and discuss the use of this device in comparison with the conventional coronary perfusion balloon catheter.

A novel lesion crossing technique: Balloon deployment using FORcible Manner (BADFORM) technique.

OBJECTIVES: We evaluated the efficacy and safety of a novel endovascular technique for crossing arterial lesions: The BAlloon Deployment using FORcible Manner (BADFORM) technique. BACKGROUND: Endovascular treatment (EVT) for peripheral artery disease has been widely adopted, and developments in device technology and techniques have resulted in acceptable success rates. However, it may be difficult to deliver devices even after wire externalization, especially in the presence of an extremely long chronic total occlusion or severely calcified lesion. The BADFORM technique might be useful in these cases. METHODS: We retrospectively reviewed ten consecutive EVT cases using the BADFORM technique performed at our institution between April 2015 and September 2016. In all cases, wire externalization was established with the rendezvous technique. The BADFORM technique was performed when antegrade passage of any device was impossible after wire externalization. Physicians positioned a low-profile balloon or microcatheter just proximal to the calcified lesion and attached the device to the externalized wire using a torque device at the proximal catheter exit port. The externalized wire was then pulled retrogradely. RESULTS: All patients were receiving hemodialysis and had critical limb ischemia. All lesions were severely calcified, and 90% were chronic total occlusions. The technical success and procedure success rates were 90% and 70%, respectively. Delivered devices included five balloon catheters and four microcatheters. One procedure-related vessel injury occurred at the distal puncture site (digital artery), however, this was controlled by external manual compression. CONCLUSIONS: The efficacy and safety of the BADFORM technique might be acceptable. © 2017 Wiley Periodicals, Inc.