Improvement In Ankle-brachial Index Research Articles

Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities

Previous studies have shown that Jinlida (JLD) granules, an approved treatment for type 2 diabetes in China, can reduce blood glucose level, reduce glycated hemoglobin (HbA1c), and improve insulin resistance in people with type 2 diabetes. To evaluate the effect of long-term administration of JLD vs placebo on the incidence of diabetes in participants with impaired glucose tolerance (IGT) and multiple metabolic abnormalities. This multicenter, double-blind, placebo-controlled randomized clinical trial (FOCUS) was conducted across 35 centers in 21 cities in China from June 2019 to February 2023. Individuals aged 18 to 70 years with IGT and multiple metabolic abnormalities were enrolled. Participants were randomly allocated 1:1 to receive JLD or placebo (9 g, 3 times per day, orally). They continued this regimen until they developed diabetes, withdrew from the study, were lost to follow-up, or died. The primary outcome was the occurrence of diabetes, which was determined by 2 consecutive oral glucose tolerance tests. Secondary outcomes included waist circumference; fasting and 2-hour postprandial plasma glucose levels; HbA1c; fasting insulin level; homeostatic model assessment for insulin resistance (HOMA-IR); total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels; ankle-brachial index; and carotid intima-media thickness. A total of 889 participants were randomized, of whom 885 were in the full analysis set (442 in the JLD group; 443 in the placebo group; mean [SD] age, 52.57 [10.33] years; 463 [52.32%] female). Following a median observation period of 2.20 years (IQR, 1.27-2.64 years), participants in the JLD group had a lower risk of developing diabetes compared with those in the placebo group (hazard ratio, 0.59; 95% CI, 0.46-0.74; P < .001). During the follow-up period, the JLD group had a between-group difference of 0.95 cm (95% CI, 0.36-1.55 cm) in waist circumference, 9.2 mg/dL (95% CI, 5.4-13.0 mg/dL) in 2-hour postprandial blood glucose level, 3.8 mg/dL (95% CI, 2.2-5.6 mg/dL) in fasting blood glucose level, 0.20% (95% CI, 0.13%-0.27%) in HbA1c, 6.6 mg/dL (95% CI, 1.9-11.2) in total cholesterol level, 4.3 mg/dL (95% CI, 0.8-7.7 mg/dL) in low-density lipoprotein cholesterol level, 25.7 mg/dL (95% CI, 15.9-35.4 mg/dL) in triglyceride levels, and 0.47 (95% CI, 0.12-0.83) in HOMA-IR compared with the placebo group. After 24 months of follow-up, the JLD group had a significant improvement in ankle-brachial index and waist circumference compared with the placebo group. The findings suggest that JLD can reduce the risk of diabetes in participants with IGT and multiple metabolic abnormalities. Chinese Clinical Trial Register: ChiCTR1900023241.

Outcomes of Excimer Laser Ablation Combined with Drug-coated Balloon in Atherosclerotic Lesions of the Popliteal Artery

BackgroundThe treatment of atherosclerotic lesions in the popliteal artery is challenging. This study aims to investigate the efficacy and safety of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for these lesions. MethodsFrom June 2019 to December 2021, data of patients who underwent ELA combined with DCB in the popliteal artery were retrospectively reviewed. Demographics, lesion characteristics, periprocedural complications and follow-up information were analyzed. The primary endpoint was primary patency. Secondary endpoints included major amputation-free survival (MAFS) rate, technical success, bailout stenting, clinically-driven target lesion reintervention (CD-TLR), improvement of ankle-brachial index (ABI) and Rutherford class. ResultsA total of 61 patients were enrolled. The mean age was 73.4 ± 11.7 years. 20 (32.8%) patients had stenotic lesions while 41 (67.2%) patients had chronic total occlusions (CTOs). The mean length of these lesion was 7.3 ± 2.8 cm. Procedure technical success rate was 95.1%. Bailout stent was performed in 3 (4.9%) patients. Intraprocedural distal embolization occurred in 3 (4.9%) patients, while flow limiting dissections occurred in 3 (4.9%) patients. The mean ABI was significantly improved from 0.45 ± 0.13 at baseline to 0.90 ± 0.12 after ELA, 0.88 ± 0.11 at 6 months and 0.85 ± 0.12 at 12 months. during the follow-up period. The median follow-up time was 28.2 ± 6.1 months. Reintervention was performed in 5 (8.2%) patients. The 2-year primary patency was 83.5%. ConclusionELA combined with DCB is a safe and effective strategy in the treatment of popliteal artery atherosclerotic lesions with low rates of bail-out stenting and high primary patency.

Modified tibial cortex transverse transport for diabetic foot ulcers with Wagner grade ≥ II: a study of 98 patients.

Diabetic foot ulcers constitute a substantial healthcare burden on a global scale and present challenges in achieving healing. Our objective was to assess the efficacy of modified tibial cortex transverse transport surgery in managing refractory diabetic foot ulcers. We retrospectively analyzed clinical data from 98 patients suffering from diabetic foot ulcers classified as Wagner grade ≥II who were admitted to our medical facility between January 2020 and June 2022. All the patients were treated by modified tibial cortex transverse transport surgery, wherein the osteotomy scope was reduced to two rectangular bone windows measuring 1.5cm × 1.5cm each. Record the patient's general information and ulcer healing time; ulcer area, ankle-brachial index, WIFi classification, and visual analogue scale before and 3 months following the surgical intervention. The average duration of diabetes of 98 patients with diabetic foot ulcer was 20.22 ± 8.02 years, 52 patients had more than one toe gangrene on admission. The postoperative wound healing rate was 95.83% and the average healing time was 53.18 ± 20.18 days. The patients showed significant improvement in ankle-brachial index, WIFi classification, and visual analogue scale at 3 months postoperatively compared to preoperatively, with statistically significant differences (P< 0.05). Eight patients experienced complications, and the incidence of complications was 8.16%. Throughout the follow-up period, there were no instances of ulcer recurrence noted. Modified tibial cortex transverse transport surgery demonstrates effectiveness in the management of diabetic foot ulcers by enhancing lower limb microcirculation and facilitating the process of wound healing.

Factors Affecting the Success Rate of Percutaneous Transluminal Angioplasty in Patients with Peripheral Arterial Disease Rutherford Degrees 2-6 At Prof. Dr. I G. N. G. Ngoerah Hospital Denpasar

Background: Peripheral arterial disease (PAD) is a growing arterial disease that becomes a problem at the age of &gt;50 years. About 12% of the adult population worldwide is reported to be affected by PAD with equal prevalence between men and women and 50% of them are asymptomatic. Percutaneous Transluminal Angioplasty (PTA) has developed rapidly and from several sources, it is found that the success rate is quite high in handling complaints that can be monitored through the Ankle Brachial Index. Several factors that can affect the incidence of restenosis in PTA according to some literature include the levels of albumin, uric acid, potassium, ferritin, phosphorus, LDL, total bilirubin, and the length of atherosclerotic lesions. Method: This study used a retrospective cohort using secondary data in the form of medical records from January 2020 to June 2022. This study involved 46 samples of PAD patients who performed PTA. Data analysis in this study consisted of bivariate analysis and multivariate analysis using SPSS Windows version 24. Results: 32 (69.2%) PAD patients with Rutherford 2-6 had successful PTA outcomes based on improvement in ankle-brachial index (ABI) values before and after treatment. Multivariate analysis performed with a logistic regression test showed that lipid levels &lt;160 independently increased the risk of successful PTA outcomes by 6.318 times higher than patients with a history of hyperlipidemia (adjusted p=0.047; CI95%=1.026-38.992). The number of single lesions also independently increased the risk of successful PTA outcomes by 8.941 times higher than patients with multiple lesions (adjusted p=0.033; CI95%=1.195-66.026). Conclusion: Patients with LDL levels &lt;160 mg/dl and a single atherosclerotic lesion type are contributing factors to the success of PTA based on ABI in patients with Rutherford grade 2-6 PAD.

Fetal progenitor cells for treatment of chronic limb ischemia.

This study investigated the therapeutic potential of fetal progenitor cells (FPCs) in the treatment of chronic non-healing wounds and ulcers associated with chronic limb ischemia (CLI). The research aimed to elucidate the mechanism of action of FPCs and evaluate their efficacy and safety in CLI patients. The researchers isolated FPCs from aborted human fetal liver, brain, and skin tissues and thoroughly characterized them. The preclinical phase of the study involved assessing the effects of FPCs in a rat model of CLI. Subsequently, a randomized controlled clinical trial was conducted to compare the efficacy of FPCs with standard treatment and autologous bone marrow mononuclear cells in CLI patients. The clinical trial lasted 12 months, with a follow-up period of 24-36 months. The primary outcomes included wound healing, frequency of major and minor amputations, pain reduction, and the incidence of complications. Secondary outcomes involved changes in local hemodynamics and histological, ultrastructural, and immunohistochemical assessments of angiogenesis. In the animal model, FPC treatment significantly enhanced angiogenesis and accelerated healing of ischemic wounds compared to controls. The clinical trial in CLI patients demonstrated that the FPC therapy achieved substantially higher rates of complete wound closure, prevention of major amputation, pain reduction, and improvement in ankle-brachial index compared to control groups. Notably, the study reported no serious adverse events. FPC therapy exhibited remarkable efficacy in promoting the healing of ischemic wounds, preventing amputation, and improving symptoms and quality of life in patients with CLI. The proangiogenic and provasculogenic effects of FPCs may be attributed to their ability to secrete specific growth factors. These findings provide new insights into the development of cellular therapeutic angiogenesis as a promising approach for the treatment of peripheral arterial diseases.

Performance of BeBack Crossing Catheter in Chronic Total Occlusion in Patients With Chronic Limb-Threatening Ischemia: A Single-Center Experience.

To describe a single-center experience in the treatment of chronic limb-threatening ischemia (CLTI) with the application of BeBack catheter (Bentley InnoMed, Germany) in patients with arterial chronic total occlusion (CTO). A retrospective review of patients who underwent limb revascularizations using the BeBack catheter between 2015 and 2022. All patients had an initial failed attempt using a traditional guidewire and catheter technique. Technical success was considered whenever a successful re-entry or lesion crossing using the study device was achieved. Procedural success was defined as recanalization of the occluded artery with residual stenosis of less than 30%, and improvement in ankle-brachial index (ABI) after 24 hours. A Rutherford score was assigned to each limb and affected anatomical segments and lesion length were documented. Procedural access sites and complications were noted. The study included 72 patients who underwent 78 procedures using the BeBack crossing catheter. Procedural success was achieved in 91% of cases, with a technical success rate of 92.3%. The most frequently involved occluded segments were the femoral and popliteal arteries. The average ABI improved from 0.59 to 0.95 after the procedure. The most used access site was the contralateral femoral, and the BeBack catheter was employed on 85 occasions. Only 1 patient suffered a severe immediate adverse effect, and during the 30-day follow-up period, 2 patients needed reintervention. Unfortunately, 3 patients died during the follow-up period. The BeBack catheter offers a viable option for the treatment of patients with chronic total occlusion, with high procedural success and a low complication rate. The BeBack catheter presents a notable advancement for clinicians managing chronic limb-threatening ischemia (CLTI) and arterial chronic total occlusion (CTO), showcasing over 90% procedural and technical success rates in this study. Its adept ability to navigate and recanalize occluded segments provides a robust alternative, especially when traditional techniques falter. This innovation may chane clinical strategies in vascular interventions, offering an efficient and reliable option, thereby potentially enhancing patient outcomes in limb revascularizations.

Directional Atherectomy With Antirestenotic Therapy Versus PTA/Supera Stenting for Popliteal Artery Lesions: A Propensity-Matched Analysis.

This study examines the use and impact of directional atherectomy with antirestenotic therapy (DAART) versus angioplasty plus Supera stent implantation on the outcomes during endovascular treatment of popliteal lesions in clinical practice. Overall 143 consecutive patients (mean age 75.0±12.2 years, 72% male), with isolated atherosclerotic disease of the popliteal artery who underwent endovascular treatment using DAART therapy or percutaneous transluminal angioplasty (PTA)/Supera stenting of the popliteal artery between January 2016 and December 2021 were identified from a retrospectively database. Patient and plaque characteristics were collected. A propensity-score matched, case-control analysis was conducted to balance covariates between the group of patients who underwent DAART and the one treated by PTA/Supera stenting. A total of 51 patients (35.7%) showed severe claudication and 92 (64.3%) critical limb ischemia. There was a trend toward longer treated lesions (90.4±81 vs 72.5±5.3 mm, p=0.089) and more chronic total occlusions (60.5% vs 46.8%, p=0.058) in the PTA/Supera stenting group, although not reaching statistically significance. Moderate-to-severe calcification was present in most lesions treated (75.8% of DAART group, 80.2% of PTA/Supera stenting group, and 78.3% of total cohort). Among the 53 case-matched pairs of patients treated with DAART or PTA/Supera stenting, there were no significant differences in short-term outcomes, including rate of technical success (96.2% vs 98.1%, p=0.232), procedural success (88.7% vs 90.1%, p=0.251), distal embolization (1.9% vs 1.9%, p=0.178), dissection (5.7% vs 1.9%, p=0.268), perforation (3.8% vs 5.6%, p=0.163), hospital discharge (1.2±0.1 vs 1.0±0.1, p=0.325), 30 day minor (28.3% vs 32.1%, p=0.264) or major amputation rates (7.5% vs 3.8%, p=0.107), and 30 day mortality (1.9% vs 1.9%, p=0.173). At 1 year, there was no difference in primary patency (73.6% vs 77.4%, p=0.233), primary assisted patency (81.3% vs 84.9%, p=0.167), secondary patency (86.8% vs 92.5%, p=0.094), ipsilateral minor (35.8% vs 39.6%, p=0.472) or major amputation (9.4% vs 7.5%, p=0.186), ankle brachial index improvement (0.32±0.12 vs 0.37±0.37, p=0.401), or mortality (5.7% vs 5.7%, p=0.121) rate between patients who underwent DAART or PTA/Supera stenting for popliteal lesions. Twelve-month results following DAART technique or PTA/Supera stenting of atherosclerotic lesions of the popliteal artery are not different, regardless of patient and plaque characteristics. The DAART technique for the treatment of popliteal artery atherosclerotic disease is presented as a "leave nothing behind" strategy with on-year clinical outcomes similar to ATP/Supera stenting.

Pounce Thrombectomy System to Treat Acute and Chronic Peripheral Arterial Occlusions

Peripheral arterial occlusions are composed of variable amounts of thrombus. Endovascular techniques should initially address the variably aged thrombus prior to treating plaque (balloon angioplasty (PTA) +/- stenting). This should ideally be accomplished in a single procedural session. Forty-four consecutive patients treated with the Pounce thrombectomy system (PTS) as captured in a retrospective database who presented with acute (n=18), subacute (n=7), or chronic (n=19) lower extremity ischemia were treated and followed for a mean of 7 months. The peripheral occlusions were considered thrombus-dominant by the feel and ease of wire traversal. They were treated with PTS along with complimentary PTA/stenting when appropriate. The mean number of passes with PTS was 4.0 +/- 2.7. Sixty-five percent (29/44) were successfully revascularized in a single setting with only 2 requiring concomitant thrombolysis for incomplete thrombus removal from the PTS target artery. An additional fifteen patients (34%) had thrombolysis for tibial thrombus that was not attempted with PTS. PTA +/- stenting after PTS occurred in 57% of limbs. Technical success was 83% and procedural success was 95%. Reintervention rate throughout follow-up was 22.7%. Major amputation occurred in 4.5%. Complications were limited to minor groin hematomas (n=3). Outcomes were equally effective in patients with pre-existing stents or de-novo arterial occlusions as evidenced with ankle brachial index improvement from 0.48 pre- to 0.93 post-intervention and 0.95 at latest follow-up (p<0.001). PTS coupled with PTA/stenting is expeditiously safe and effective in patients with thrombus-associated lower limb occlusion.

Abstract No. 206 Intravascular Lithotripsy in the Treatment of Critical Limb Ischemia: A Single-Center Retrospective Study

Critical limb ischemia (CLI) represents a severe form of lower extremity peripheral artery disease (PAD) and is associated with significant risk of limb loss and mortality. The purpose of this study is to evaluate the efficacy and safety of intravascular lithotripsy in the treatment of CLI. The primary endpoints are acute reduction in luminal stenosis (i.e., luminal gain) and improvement in ankle-brachial index (ABI) following treatment. Philips’ IntelliSpace PACS Radiology was used to identify patients from 2018-2022 who underwent intravascular lithotripsy for treatment of lower extremity calcified lesions. Chart review using Cerner EHR was used to identify those patients with CLI, defined as Rutherford classification 4 to 6. Data was collected including pre- and post-IVL luminal stenosis, lesion location, adjunctive therapies used at the target lesion, pre- and post-IVL ABI in the treated limb, and intra-procedural complications. A total of 57 target lesions treated with intravascular lithotripsy were identified in 36 CLI patients. Of these, luminal stenosis data was available in 41 target lesions treated in 28 patients. ABI data was available in 20 treated lower extremities in 19 patients, with one patient receiving bilateral intervention. ABI measurements were analyzed using a paired sample t-test. In all 41 target lesions, treatment with intravascular lithotripsy yielded a mean luminal gain of 75.49%. Mean luminal gain by vessel location was measured at 87.25%, 57%, 78.5% for target lesions in the aortoiliac (n = 8), common femoral (n = 9), and femoropopliteal (n = 24) regions, respectively. The percentage of target lesions receiving any adjunctive therapy was 76%. Treatment with intravascular lithotripsy as the sole intervention (n = 10) yielded a mean luminal gain of 71.40%, while treatment alongside adjunctive therapy (n = 31) yielded a 76.81% gain. In 20 treated lower extremities for which ABI data was recorded, intravascular lithotripsy produced a mean improvement in ABI of 0.20 (P = 0.002) following treatment. Intra-procedural complications were present in only 1 of 36 patients (3%), which was one instance of distal embolization. Intravascular lithotripsy is an effective and safe option for lower extremity revascularization in patients with CLI, given the marked reduction in luminal stenosis, improvement in ABI, and low rate of intra-procedural complications.

Outcomes of open and endovascular infra-inguinal revascularization are poor in young patients with atherosclerotic peripheral artery disease but do not differ between genders.

The effect of gender on the outcomes of revascularization procedures in young patients with premature atherosclerotic peripheral arterial disease (PAD) is not known. The objective of this study was to compare short-term and long-term outcomes between young males and females undergoing infra-inguinal revascularization procedures. We examined postoperative outcomes of male and female PAD patients under the age of 55 who underwent infra-inguinal revascularization procedures at a single tertiary institution from 2011 to 2019. Primary outcomes included 30-day morbidity, patency of the revascularization procedures, and major adverse limb events (MALE). Secondary outcomes included survival, amputation rate, reintervention rate, improvement of ankle-brachial index (ABI), and number of reinterventions. Eighty-one infra-inguinal revascularization procedures (46 endovascular and 35 open procedures) were reviewed including 45 procedures in 37 males and 36 procedures in 31 females. Fifty-three (65.4%) of the procedures were performed in patients with chronic limb-threatening ischemia symptoms. The rest were treated for life-disabling claudication. The female patients were younger, had higher body mass index, and were more likely to have diabetes, hyperlipidemia, or chronic obstructive pulmonary disease in comparison to males. Thirty-day major adverse cardiovascular event was 0.0% and MALE was 16.0%. Mean follow-up was 806.2days. At 1 year, primary patency was 34.4 ± 6.2%, primary assisted patency was 52.7 ± 6.5%, secondary patency was 61.8 ± 6.3%, and MALE-free rate was 47.0 ± 6.4%. For secondary outcomes at 1 year, amputation-free rate was 92.5 ± 3.2%, reintervention-free rate was 50.2 ± 6.4%, and survival was 96.2 ± 2.6%. By the end of the study, overall mortality rate was 14.8% and major amputation rate was 13.6%. No major differences were observed between males and females among these outcomes. A smaller improvement in ABI after revascularization was noted in females compared to males (female 0.2 ± 0.2 vs male 0.4 ± 0.2, p = .04). Among patients who required reintervention, females required a higher number of reinterventions than males (female 1.7 ± 2.5 vs male 0.8 ± 1.1, p = .03). There were no significant differences in short-term and long-term outcomes between males and females under the age of 55 after infra-inguinal revascularization. Poor patency, high MALE rate, and high mid-term mortality, and amputation rates after revascularization in young PAD patients highlight the need for improved strategies to treat premature PAD.

Embolic Protection Devices are Not Associated with Improved Outcomes of Atherectomy for Lower Extremity Revascularization

Atherectomy is associated with a risk of distal embolization, but the role of embolic protection devices (EPDs) during atherectomy is not well-defined. This study examines the utilization and impact of EPD on the outcomes of atherectomy during peripheral vascular interventions (PVIs). The annual trend in utilization of EPD during atherectomy in the Vascular Quality Initiative PVI files (2010-2018) was derived. Patients with concomitant open surgery, acute limb ischemia, emergent-status, concomitant thrombolysis, missing indication, missing EPD use, and missing long-term follow-up data were excluded. The characteristics of patients undergoing atherectomy with and without EPD were compared. Propensity matching based on age, gender, race, chronic obstructive pulmonary disease, coronary artery disease, end-stage renal disease, prior PVI, indication, urgent-status, TransAtlantic interSociety Consensus classification, and anatomical location of lesion was performed. The perioperative and 1-year outcomes of the matched groups were compared. EPD was used in 23.3% of atherectomy procedures (n=5,013/21,500). The utilization of EPD with atherectomy increased from 8.8% to 22.7% (P=0.003) during the study period. Patients undergoing atherectomy without EPD were more likely to have ESRD (7.8% vs. 5.2%; P<0.001), tissue loss (31% vs. 23.1; P<0.001), tibial intervention (39.6% vs. 23.3%; P<0.001), higher number of arteries treated (1.78±0.92 vs. 1.68±0.93; P=0.001), and longer length of lesion (21.15±21.14 vs. 19±20.27cm; P=0.004). Conversely, patients undergoing atherectomy with EPD were more likely to be White (81.1% vs. 74%; P<0.001), have a history of smoking (80.6% vs. 74.5%; P<0.001), chronic obstructive pulmonary disease (24.8% vs. 21.6%; P<0.037), coronary artery disease (38.5% vs. 33.2%; P=0.002), prior percutaneous coronary intervention (24.3% vs. 19.9%, P=0.005), prior coronary artery bypass grafting (32.3% vs. 24.9%; P<0.001), and prior PVI (49.2% vs. 45.1%; P=0.023). After propensity matching, there were 1,007 patients in each group with no significant difference in baseline characteristics. There was no significant difference in short-term outcomes including the rate of distal embolization, technical success, dissection, perforation, discharge to home, and 30-day mortality. The use of EPD was, however, associated with longer fluoroscopy time. At 1-year, there was also no difference in primary patency, ipsilateral minor or major amputation, ankle brachial index improvement, reintervention, or mortality rate between patients who underwent atherectomy with and without EPD. EPD has been increasingly used in conjunction with atherectomy especially in patients with claudication and femoropopliteal disease. However, the use of EPD during atherectomy does not seem to impact the outcomes. Further research is needed to justify the additional cost and fluoroscopy time associated with the use of EPD during atherectomy.

A Multinational, Single-Arm Pivotal Study Assessing the Performance of the SoundBite Crossing System for Peripheral Chronic Total Occlusions (The PROSPECTOR Study)

PurposeThis study aimed to demonstrate the efficacy and safety of the SoundBite Crossing System‒Peripheral (SCS-P) to facilitate crossing chronic total occlusions (CTOs) of infrainguinal arteries. Materials and MethodsThis clinical trial was approved by the Ethics Committees of all 4 participating centers and enrolled 52 patients with symptomatic de novo infrainguinal CTOs. Technical device success, the primary efficacy endpoint, was defined as the ability to facilitate the treatment of the target lesion by crossing a portion or the whole length of the CTO. Freedom from SCS-P–related major adverse events (MAEs) at 30 days after the procedure was the primary safety endpoint. ResultsThe SCS-P met the primary efficacy and safety endpoints in 92.3% (48/52) and 100% (52/52) of subjects, respectively. Technical device success with postprocedural patency and freedom from SCS-P–related MAEs was achieved in 88.5% (46/52) of subjects. The mean CTO crossing time was 20.0 minutes ± 30.8, and the SCS-P was able to traverse the whole CTO and enter the distal true lumen without the need of any other device in 59.6% (31/52) of subjects. The mean Rutherford category and ankle-brachial index improvement at the 30-day follow-up was 2.4 ± 1.17 and 0.23 ± 0.22, respectively. ConclusionsThe SCS-P demonstrated a satisfactory safety and performance profile to cross peripheral CTOs and enter the distal true lumen of infrainguinal CTOs.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC).

Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

Association of the Prognosis of Ankle-brachial Index Improvement One Year Following Endovascular Therapy in Patients with Peripheral Artery Disease: Data from the I-PAD NAGANO Registry.

Objective Despite reports on the effects of ankle-brachial index (ABI) improvement following endovascular therapy (EVT) on the limb prognosis, studies evaluating cardiovascular events are limited. We investigated whether or not ABI improvement 1 year following EVT was associated with cardiovascular events. Methods The I-PAD NAGANO registry is an observational multicenter cohort study that enrolled 337 patients with peripheral artery disease (PAD) who underwent EVT between August 2015 and July 2016. From this cohort, we identified 232 patients whose ABI data 1 year following EVT were available, after excluding patients with critical limb ischemia. We divided the patients into two groups according to the degree of ABI improvement 1 year following EVT (ΔABI) - the ΔABI <0.15 group and the ΔABI ≥0.15 group - and compared the outcomes. The primary endpoint was major adverse cardiovascular events (MACEs), including all - cause death, myocardial infarction (MI), and stroke. The secondary endpoints were major adverse limb events (MALEs), defined as a composite of target lesion revascularization and major amputation, all - cause death, MI, and stroke. The median follow-up period was 3.3 years. Results The incidence of MACEs was significantly higher in the ΔABI <0.15 group than in the ΔABI ≥0.15 group (ΔABI <0.15 vs. ΔABI ≥0.15, 25.8% vs. 11.9%, log-rank p=0.036), as was the incidence of stroke (14.1% vs. 2.2%, log-rank p=0.016). A Cox regression analysis revealed that ΔABI ≥0.15 was significantly associated with fewer MACEs (hazard ratio 0.38, 95% confidence interval 0.17-0.83, p=0.016). Conclusion An increase in ABI ≥0.15 at 1 year following EVT was a predictor of reduced MACEs.

Covered versus bare metal kissing stents for reconstruction of the aortic bifurcation in the ILIACS registry

ObjectiveWe compared the early and midterm outcomes of polytetrafluoroethylene covered stents (CSs) vs bare metal stents (BMSs) used in the kissing conformation for the reconstruction of the aortic bifurcation in aortoiliac obstructive disease. MethodsA multicenter cohort registry (2015-2019) collected data from 1306 patients who had undergone endovascular treatment of aortoiliac arterial obstructive disease. Only patients who had received bilateral iliac kissing stents for TransAtlantic Inter-Society Consensus (TASC) class C and D lesions were included in the present analysis. The 30-day outcomes, midterm primary patency, and limb salvage rates were compared between the CSs and BMSs in matched patient cohorts after propensity score matching. The follow-up results were analyzed using Kaplan-Meier curves. Cox proportional hazards models were used to identify the predictors of primary patency. ResultsA total of 336 patients were treated with kissing stents, 201 with CSs (60%) and 135 with BMSs (40%). In the unmatched cohort, patients receiving CSs were more likely to have critical limb ischemia (41% vs 30%; P = .038), complex iliac lesions, such as TASC D (90% vs 56%; P < .01), and iliac occlusions (59% vs 44%; P < .01). After propensity score matching, 220 patients were selected (110 with CSs and 110 with BMSs), without differences in the clinical presentation (critical limb ischemia, 41% vs 33%; P = .167), or anatomic complexity (TASC D, 66% vs 60%, P = .21; iliac occlusion, 48% vs 49%, P = .89). The 30-day mortality was 0%. The early medical (unmatched, 5% vs 4%, P = 1.00; matched, 5% vs 4%, P = .75) and surgical (unmatched, 5% vs 5%, P = 1.00; matched, 5% vs 3%, P = .72) complication rates were similar between the CSs and BMSs. However, the CSs resulted in a lower risk of intraoperative iliac rupture (0% vs 3.5%; P = .013) and greater ankle-brachial index improvement (0.43 ± 0.22 vs 0.36 ± 0.24; P = .02). At 36 months, the overall primary patency (92% ± 7% vs 92% ± 8%; P = .38), secondary patency (98% ± 3% vs 98% ± 4%; P = .50), and limb salvage (93% ± 9% vs 97% ± 5%; P = .20) rates were similar. In cases of moderate to severe iliac calcification, the CSs showed better results in the matched cohort (100% vs 89% ± 9%; P = .048). On multivariate analysis, CS use (hazard ratio [HR], 1.67; P = .45) did not significantly affect primary patency, but older age (HR, 0.93; P = .03) and kissing stent diameter ≥8 mm (HR, 0.25; P = .03) were significantly associated. ConclusionsIn the present multicenter study, the use of kissing stents for the treatment of the aortic bifurcation provided good early and midterm results. CSs were preferred for more complex lesions, were protective from iliac rupture, and allowed for greater ankle-brachial index improvement. The 3-year patency rates were similar between the CSs and BMSs. However, CSs showed improved results in the case of moderate to severe calcification.

Facilitated Intravascular Ultrasound-Guided Balloon-Assisted Re-Entry Technique for Complex Lower-Extremity Chronic Total Occlusions: The FIBRE Technique

PurposeTo examine the efficacy and safety of the facilitated intravascular ultrasound (IVUS)-guided balloon assisted-re-entry (FIBRE) technique in the treatment of complex, chronic total occlusion (CTO) peripheral arterial lesions. MethodsA retrospective analysis of 150 patients undergoing peripheral intervention for lower extremity CTO was performed from 2014 to 2017 at two institutions. From the selected population, 10 patients with complex CTOs were identified using the FIBRE technique. Procedural success, 30 day and 6 month patency rates, ankle brachial index improvement, and complications were analyzed. ResultsTen out of 150 patients had the FIBRE technique utilized to attempt revascularization of a complex CTO of a femoropopliteal artery. Technical success was achieved in all 10 patients (100%). There were no intra-operative or peri-procedural complications reported including vessel perforation, bleeding, distal embolization, infrapopliteal vessel compromise, or infection. Arterial studies were obtained at 30 days and 6 months to assess patency in 9/10 patients (90%), with 1 patient being lost to follow up. Of the 9 patients, all 9 (100%) had documented arterial patency at both 30 days and 6 months. All patients reported improvement in symptoms. There were also no reports of re-intervention, amputation, or death at 6-month follow up. ConclusionsThe FIBRE technique is a safe and feasible strategy with excellent technical success in experienced hands for revascularization of complex lower extremity CTO when conventional modalities fail.

Impact of number of run-off vessels on interwoven nitinol mesh stents patency in the femoropopliteal segment.

ObjectiveTo evaluate the impact of run-off vessels number on the outcomes of Supera stent (Abbott Vascular, Santa Clara, Calif, USA) for treatment of femoropopliteal occlusive disease.MethodsWe retrospectively evaluated the medical records of 188 consecutive patients (mean age 68.2 ± 9.6 years, 100 males) undergone angiography and woven mesh stent implantation in femoral or popliteal arteries or both arterial segments, in our institution between January 1 2014 and January 1 2018. Target lesion revascularization and major adverse limb events at 12-month were evaluated comparing patients with 1-, 2- or 3-run-off vessels in the foot.ResultsInterventional success was achieved in 100%. Stent implantation involved in the femoral site in 56 patients (30.3%), the femoropopliteal in 92 patients (48.9%) and the popliteal site in 40 patients (21.3%). A significant improvement of ankle-brachial index (0.29 ± 0.6 vs. 0.88 ± 0.3, P < 0.001) and Rutherford class (5.3 ± 0.8 vs. 0.7 ± 1.9, P < 0.01) were observed before discharge. The median follow-up duration was 12.3 months (inter quartile range: 11.0 to 13.9). During the follow-up period, 52 patients (27.6%) had clinical events. Primary patency at 12 months was 72.4%. The primary patency significantly increased when the runoff status. Comparing the number of events among patients with different number of run-off vessels, a significant difference (P < 0.001) was observed for patients having one (24.0%) and two run-off vessels (15.0%).ConclusionsThe outcomes of Supera stent in femoropopliteal occlusive disease depend strictly on the number of run-off vessels.

Inguinal lymphadenopathy as a predicting factor for ipsilateral primary limb amputation after a successful endovascular treatment

PurposeTo assess the correlation between inguinal lymph node characteristics and ipsilateral limb amputation rates in patients with ischemic foot ulcers after a successful endovascular treatment. MethodA retrospective review of patients who were endovascularly treated for ischemic foot ulcers between January 2015 and May 2017. Technical success was defined as arterial recanalization with stenosis less than 30 % and ankle brachial index improvement by > 0.2 after 24 h. Unilateral lymph node size, contrast enhancement, necrosis, and perinodular fat stranding were assessed on pre-procedural CTA. Primary endpoints were amputation and sepsis within 12 months following treatment. The relationship between lymph node characteristics and limb amputation and septic shock were examined. ResultsEndovascular treatment of 202 limbs in 202 patients (135 males; median age 72.8 years [42.2–93.7]) was technically successful. Forty-two (20.8 %) patients underwent amputation, six (3 %) patients had septic shock. There was a significant difference in lymph node sizes between the amputated and the non-amputated limbs (P = 0.000). Lymph node characteristics (size, enhancement, necrosis, and perinodular fat stranding) were significantly related to amputation (P < 0.001). Patients with perinodular fat stranding or increased node size were 5.940 and 1.109 times more likely to undergo limb amputation, respectively. Lymph node characteristics were also significantly related to septic shock (P < 0.05). ConclusionsCertain lymph node characteristics are associated with amputation in patients with ischemic foot ulcers, after a technically successful endovascular treatment of the limb. Large lymph node size and perinodular fat stranding are predictive of limb amputation.

Outcomes of rotational atherectomy in complex lesions of the superficial femoral artery

BackgroundThe effectiveness of rotational atherectomy in the treatment of complex superficial femoral artery (SFA) lesions remains poorly defined. Outcomes of SFA lesions treated with rotational atherectomy were analyzed. MethodsThis retrospective review assessed all patients who underwent rotational atherectomy of the SFA at a single institution between 2015 and 2018. The data of all patients were deidentified, and the study was approved by the Institutional Review Board. Informed consent was not obtained for this retrospective analysis. Main outcomes were Kaplan-Meier primary patency rate, freedom from major amputation, and 2-year survival rate. The effect of drug-coated balloon angioplasty (DCBA) on patency and time to death was investigated with univariate regression. The safety profile for atherectomy and DCBA was assessed by the 30-day incidence of major amputation and all-cause mortality. ResultsFifty-three patients (mean age, 70.2 ± 9.8 years; 73% male; 65% critical limb-threatening ischemia; 47 [90%] current or former smokers; seven [13%] with prior failed ipsilateral endovascular intervention) underwent rotational atherectomy (Jetstream; Boston Scientific, Marlborough, Mass) with mean follow-up of 543 days. Forty-six (87%) patients underwent DCBA (Lutonix; BD Bard, Covington, Ga) after atherectomy. Mean lesion length was 13.2 ± 9.0 cm. Thirty-one (58%) lesions were TransAtlantic Inter-Society Consensus C or D class. At 1-month follow-up, 39 of 45 (87%) patients experienced improvement in symptoms and Rutherford class. An improvement in ankle-brachial index was also noted in 13% of patients without improvement of symptoms, with no patients progressing to surgical bypass or major amputation. Mean ankle-brachial index increased from 0.54 ± 0.035 to 0.90 ± 0.031 at 1 month after intervention (P < .001) and remained constant out to 18 months. Mean toe pressure increased from 36 ± 3.8 mm Hg to 67 ± 4.5 mm Hg at 1 month after intervention (P < .001) and remained constant out to 18 months. Kaplan-Meier primary patency rate was 75% (95% confidence interval, 61%-85%) at 12 months and 65% (51%-77%) at 24 months. There was a trend toward improved primary patency after adjunctive DCBA compared with plain balloon angioplasty at 1 year (75% vs 43%; P = .1082). There was no significant difference in mortality between adjunctive DCBA and plain balloon angioplasty at 2 years (11% vs 0%). The 2-year incidence of major amputation in critical limb-threatening ischemia patients was 3.9% (1.2%-6.5%). One patient died and none underwent amputation within 30 days. ConclusionsRotational atherectomy with adjunctive DCBA of long SFA lesions has excellent long-term patency. Two-year major amputation and mortality rates are low, and the technique has an exceptional safety profile.

Safety and feasibility of transradial infrainguinal peripheral arterial disease interventions

ObjectiveTransradial access (TRA) has traditionally been favored for coronary interventions. Tools with up to 200 cm length now allow operators to treat infrainguinal peripheral arterial disease (PAD) using TRA. This study aims to assess the safety and feasibility of TRA infrainguinal interventions. MethodsPatients with infrainguinal PAD who underwent intervention via TRA from July 2013 through June 2019 were retrospectively reviewed. Exclusion criteria included Barbeau D waveform, a radial artery diameter of greater than 2 mm, radial artery occlusion, Raynaud syndrome, or peripheral vasculitis. Procedural success (adequate inline flow to the foot), TRA alone failure (crossover or use of an additional access site), clinical success (defined as improvement in ankle brachial index, clinical symptoms, or wound healing) and adverse events were recorded from procedure notes and follow-up visits. ResultsThirty-six procedures were attempted using TRA in 32 patients (mean age, 65.8 years; range, 29-86; 22 male, 14 female) with mean height of 65.8 inches (range, 59.0-72.0 inches) and a body mass index of 28.7 (range, 19.1-43.9). Preprocedure Rutherford classification (II/III/IV/V/VI) was 8/15/2/7/4, respectively. The left radial artery was used for 35 of 36 procedures (97.2%). Treated vessels included the common femoral (n = 4), superficial femoral (n = 25), deep femoral (n = 1), popliteal (n = 10), tibioperoneal trunk (n = 2), tibial (n = 4), and plantar (n = 1) arteries. Interventions included angioplasty (n = 32, 100%), atherectomy (n = 8, 25%), and stenting (n = 13, 41%). Procedural success was 100%, the TRA alone failure rate was 11.1%, and clinical success was 89.3%. The median follow-up was 286.5 days (range, 0-919 days). Adverse events included radial artery pseudoaneurysm (n = 1), access site hematoma/bleeding (n = 3), radial artery occlusion (n = 1), groin hematoma (n = 1), popliteal artery dissection treated with stenting (n = 2), and a small superficial femoral artery perforation (n = 1) treated with prolonged balloon tamponade. No patients experienced signs of cerebrovascular events or distal embolism. ConclusionsTRA is a useful option for treating patients with PAD; however, several limitations still exist.