Below-the-knee Lesions Research Articles

Polymer Everolimus-Eluting Stent as Bailout Stenting for Below-the-Knee Artery Repair in Patients with Critical Limb-Threatening Ischemia: A Real-World National Registry.

Percutaneous old balloon angioplasty is still the preferred treatment for the treatment of below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). In the case of a suboptimal angioplasty result, a bailout stenting is required. So far, few data are available to assess the outcomes of bailout stenting after BTK angioplasty. This study aims to investigate the 1-year efficacy and safety after implantation of a polymer everolimus-eluting stent (PEES) as bailout stenting for BTK repair in patients with CLTI in a real-world setting. This was a national multicenter prospective observational study. Patients with CLTI (Rutherford 4 to 6) BTK lesions (including P3) and requiring a bailout PEES due to dissection, thrombosis, or residual stenosis ≥30% after angioplasty were included. The freedom of a major adverse limb event at 12 months of the target limb was the primary endpoint. XIENCE assessed 106 limbs (CLTI, 96.2%; chronic total occlusion, 2.8%) in 106 patients (mean age 77.1 years; males, 71.7%; diabetes mellitus, 66.9%; chronic kidney failure, 36.8%) with CLTI undergoing PEES stenting as a bailout for BTK lesions. Bailout stenting was required after 75.5% and 26.4% of residual stenosis and dissection, respectively. The mean diameter and length of the PEES were 3 mm and 3.4 ± 0.5 cm, respectively. At 1 year, the freedom of a major adverse limb event was 79.6% (95% CI, 71.5%-88.7%), the major amputation rate was 6.2% (95% CI, 1.3%-11%), and the target revascularization rate was 14.9% (95% CI, 6.5%-22.5%). In CLTI patients with BTK lesions, PEES stenting showed safety and efficacy as bailout stenting for BTK arterial lesions. This confirms the need for PEES stenting in a real-world practice. The XIENCE study introduces the PEES as an effective bailout stenting option for patients with CLTI undergoing BTK revascularization, particularly for lesions under 4 cm. The study focuses on real-world cases where POBA alone is insufficient, demonstrating that PEES significantly improves outcomes by enhancing limb salvage and reducing the need for major amputations. For clinicians, this innovation offers a precise, size-adaptable solution, especially in cases where bailout stenting is required for short, focal lesions, improving both clinical and procedural results.

Compensating for Angiographic Underestimation With Oversized Balloon Angioplasty in Patients With Chronic Limb-Threatening Ischemia and Occluded Below-the-Knee Vessels.

Our study aims to determine optimal sizing of below-the-knee (BTK) artery angioplasty without intravascular ultrasound (IVUS), compensating for conventional angiography underestimation by selecting a balloon size one size larger than the 1-to-1 angiographic sizing. Our study is a retrospective, single-center study. Patients were separated into 2 groups as over and angiographic reference group which the over group is larger balloon diameter selection (0.5-mm larger balloon diameter selection), and angiographic reference group is 1-to-1 balloon diameter selection by angiographic images. Primary end point was the target vessel reocclusion, whereas major and minor amputation was the secondary end point. Eighty-four patients with occluded BTK lesions treated with balloon angioplasty (Opt=43, Over=41). Primary patency was 62.8% at 12 months in angiographic reference group and 82.9% in over group (p=0.039). Amputation rate at 1-year follow-up was 9.8% in angiographic reference group and 16.3% in over group (p=0.382). TLR rate is 4.9% in over group versus 20.9% in angiographic reference group (20.9%) at 1-year follow-up (p=0.029). Our study demonstrates that oversizing the balloon diameter by one size larger in BTK artery angioplasty, guided by conventional angiography, results in a higher patency rate and a lower target lesion revascularization (TLR) rate, while amputation rate remains statistically similar between the 2 groups. Our study highlights the importance of compensating for conventional angiography's underestimation in BTK artery angioplasty by using a balloon size one size larger than the 1-to-1 angiographic sizing. Our findings demonstrate that oversizing the balloon leads to significantly higher patency rates and lower TLR rates, with no increase in amputation risk. This approach provides a practical, cost-effective solution for clinicians performing angioplasty without IVUS, allowing for better vessel treatment and outcomes in patients with chronic limb-threatening ischemia. Clinicians can implement this strategy to optimize long-term results in BTK interventions.

Prospective, Multi-center, Single-Arm Study of the Auryon Laser System for Treatment of Below-the-Knee Arteries in Patients With Chronic Limb-Threatening Ischemia: 30-Day Results of the Auryon BTK

The 355 nm Auryon laser has been shown to be effective and safe in treating various morphology lesions in the femoropopliteal arteries. There are limited data on the Auryon laser in treating below the knee (BTK) arteries in patients with chronic limb threatening ischemia (CLTI). We present the 30-day efficacy and safety findings from the ongoing Auryon BTK study.Patients with CLTI were prospectively enrolled in the Auryon BTK study between March 2022 and February 2023 in 4 US centers after obtaining informed consent. The primary safety endpoint included Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of all-cause death, major amputation and target vessel revascularization. Demographic, procedural, angiographic and outcome data were collected.A total of 60 patients (61 lesions) were treated. The mean age was 74.6 ± 10.3 years with 65.0 % males, 58.3% diabetics, 43.3% Rutherford Becker (RB) IV and 56.7% RB V. Of the 61 lesions, 59% had severe calcification, 31.1 % were chronic total occlusions and 90.2% were denovo disease. Baseline diameter stenosis was 80.2 ± 16.4%, post laser 57.4 ± 21.7% and post final treatment 24.0 ± 23.1% (p value < 0.0050). The primary performance endpoint showed a procedure success rate of 37/68 (63.8%). Bailout stenting occurred in 1/61 lesions (1.6%). Rutherford Becker category was 100% RB IV or higher at baseline versus 35.3% at 30-day. At 30 days, there was no target vessel revascularization and patency was 88.9% (PSVR ≤ 2.4). In conclusion, the Auryon laser is safe and relatively effective in treating BTK lesions with minimal complications.

Retrograde distal access versus femoral access for below the knee angioplasty.

The prevalence of peripheral artery disease (PAD) in the general population is about 12% to 14% and it increases with age. PAD increased from 164 million people in 2000 to 202 million people in 2010. More than two-thirds of people with PAD are based in low- or middle-income countries. Critical limb ischaemia (CLI) occurs in 1% to 2% of people with intermittent claudication over five years. One third of people with CLI have isolated below the knee (BTK) lesions. CLI and isolated BTK lesions are associated with a higher incidence of limb loss when compared with people with multilevel arterial disease. Endovascular procedures such as angioplasty (with or without stenting) are widely used to treat isolated BTK lesions, aiming to improve blood flow and limb salvage. The technical success of any angioplasty procedure depends on the ability to cross the target lesion. Failed attempts are underestimated in the literature and failures in the real world appear to be higher than reported. People with isolated BTK lesions undergoing angioplasty by conventional femoral access present a high failure rate to cross these lesions. Retrograde distal access may provide some advantages that can lead to successful crossing of the target lesion. To evaluate the benefits and harms of retrograde distal access versus conventional femoral access for people undergoing below the knee angioplasty. The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 26 September 2022. We planned to include randomised or quasi-randomised controlled trials comparing people undergoing retrograde distal access versus people undergoing conventional femoral access (ipsilateral antegrade or contralateral retrograde) for BTK angioplasty. Two review authors independently assessed identified studies for potential inclusion in the review. We used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions. Our primary outcomes were technical success of angioplasty procedure and major procedural complications. Our secondary outcomes were mortality rate, amputation-free survival, primary patency, minor procedural complications and wound healing. We planned to use GRADE to assess the certainty of the evidence for each outcome. We identified no randomised or quasi-randomised controlled trials that met the inclusion criteria. We identified no randomised or quasi-randomised controlled trials that compared retrograde distal access versus femoral access for BTK angioplasty. High-quality studies that compare retrograde distal access versus conventional femoral access for BTK angioplasty are needed.

Randomized clinical trial to compare the efficacy of self-expanding bare metal nitinol stent and balloon angioplasty alone for below-the-knee lesions following successful balloon angioplasty: 1-year clinical outcomes.

This prospective, multicenter, randomized study aimed to compare the 1-year clinical outcomes after primary stenting with self-expanding bare metal nitinol stent (SENS) and plain old balloon angioplasty (POBA) in patients with critical limb ischemia (CLI) and below-the-knee (BTK) lesions. Overall, 119 patients with CLI and BTK lesions were randomized to POBA alone (POBA group, 61 patients) or primary stenting with SENS (stenting group, 58 patients) after achieving acceptable POBA results in target BTK lesions. Clinical outcomes including amputation and revascularization rates were prospectively compared for 1 year. After 1 year, similar incidence rates of individual clinical endpoints, including cardiac death (6.5% vs. 5.1%, p > 0.999), myocardial infarction (1.6% vs. 0.0%, p > 0.999), repeat revascularization (19.6% vs. 18.9%, p = 0.922), target lesion revascularization (13.1% vs. 17.2%, p = 0.530), and amputation (4.9% vs. 0.0%, p = 0.244), were observed. POBA appeared to have acceptable treatment outcomes compared with primary stenting with SENS after 1 year in CLI patients with BTK lesions undergoing percutaneous transluminal angioplasty (PTA).

A comparison of below-knee vs above-knee endovenous ablation of varicose veins

ObjectiveVaricose veins have a significant impact on quality of life and can commonly occur in the thigh and calves. However, there has been no large-scale investigation examining the relationship between anatomic distribution and outcomes after varicose vein treatment. This study sought to compare below-the-knee (BTK) and above-the-knee (ATK) varicose vein treatment outcomes. MethodsEmploying the Vascular Quality Initiative Varicose Vein Registry, 13,731 patients undergoing varicose vein ablation for either BTK or ATK lesions were identified. Outcomes were assessed using patient-reported outcomes (PROs) and the Venous Clinical Severity Score (VCSS). Continuous variables were compared using the t-test, and categorical variables were analyzed using the χ2 test. Multivariable logistic regression was used to estimate the odds of improvement after intervention. The multivariable model controlled for age, gender, race, preoperative VCSS composite score, and history of deep vein thrombosis. ResultsPatients who received below-knee treatment had a lower preoperative VCSS composite (7.0 ± 3.3 vs 7.7 ± 3.3; P < .001) and lower PROs composite scores (11.1 ± 6.4 vs 13.0 ± 6.6; P < .001) compared with those of patients receiving above-knee treatment. However, on follow-up, patients receiving below-knee intervention had a higher postoperative VCSS composite score (4.4 ± 3.3 vs 3.9 ± 3.5; P < .001) and PROs composite score (6.1 ± 4.4 vs 5.8 ± 4.5; P = .007), the latter approaching statistical significance. Patients receiving above-knee interventions also demonstrated more improvement in both composite VCSS (3.8 ± 4.0 vs 2.9 ± 3.7; P < .001) and PROs (7.1 ± 6.8 vs 4.8 ± 6.6; P < .001). Multivariable logistic regression analysis similarly revealed that patients receiving above-knee treatment had significantly higher odds of improvement in VCSS composite in both the unadjusted (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.28-1.65; P < .001 and adjusted (OR, 1.31; 95% CI, 1.14-1.50; P < .001) models. Patients receiving above-knee treatment also had a significantly higher odds of reporting improvement in PROs composite in both the unadjusted (OR, 1.85; 95% CI, 1.64-2.11; P < .001) and adjusted (OR, 1.65; 95% CI, 1.45-1.88; P < .001) models. ConclusionsTreatment region has a significant association with PROs and VCSS composite scores after varicose vein interventions. Preoperatively, there were significant differences in the composite scores of VCSS and PROs with patients receiving BTK treatment exhibiting less severe symptoms. Yet, the association appeared to reverse postoperatively, with those receiving BTK treatments exhibiting worse PROs, worse VCSS composites scores, and less improvement in VCSS composite scores. Therefore, BTK interventions pose a unique challenge compared with ATK interventions in ensuring commensurate clinical improvement after treatment.

Association Between Systemic ImmuneInflammation Index and Long-Term Mortality in Patients with Critical Limb-Threatening Ischemia Undergoing Endovascular Therapy Below the Knee

Introduction: Endovascular interventions have been increasingly used for the treatment of patients suffering from below-the-knee (BTK) ischemic lesions. Yet, there is a paucity of data regarding long-term adverse events in patients with critical limb ischemia (CLI) undergoing endovascular revascularization for BTK lesions. Recently introduced systemic immune-inflammation index (SII) is a reliable indicator of poor outcomes in various cardiovascular conditions. Herein, we aimed to investigate the prognostic role of the SII on mortality in patients with CLI undergoing endovascular revascularization for BTK lesions. Patients and Methods: The records of 112 patients with symptomatic CLI undergoing endovascular revascularization for BTK lesions between January 2015 and December 2019 were analyzed. Patients were divided into groups with low and high SII values based on an SII cut-off value derived from a ROC analysis. For each group, procedural details and follow-up outcomes were analyzed. Results: The mean follow-up time was 40.3 ± 19.9 months. According to our data, patients with high SII values had higher rates of mortality compared to patients with low SII values (65.2% vs 30.3%, p&lt; 0.001). To determine the SII cut-off value for predicting mortality, the ROC curve was drawn, and the best cut-off value was determined as 966 by using the Youden index, (AUC= 0.658, 95% CI= 0.556-0.760, p= 0.004). Cox multivariate regression analysis also identified the SII score as an independent predictor of mortality. Conclusion: SII is an independent predictor of mortality, especially among patients with CLI who underwent endovascular revascularization for BTK lesions.

Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee

Background: Current endovascular treatments of below the knee (BTK) popliteal or tibial/peroneal arteries including investigational drug-coated balloons have limited long-term efficacy. Objectives: This Phase 2 trial assessed the feasibility of adventitial deposition of temsirolimus to reduce neointimal hyperplasia and clinically relevant target lesion failure (CR-TLF) 6 months after BTK arterial revascularization. Methods: This prospective, multicenter, double-blinded, comparative, dose-escalation trial enrolled 61 patients with Rutherford 3 to 5 symptoms undergoing endovascular revascularization of ≥1 angiographically significant BTK lesions. Perivascular infusion after completion of arterial revascularization was randomized into control (saline) vs low-dose (0.1 mg/mL) temsirolimus groups for the first 30 patients. In the second part of the trial, patients were randomized to control versus high-dose (0.4 mg/mL) temsirolimus groups. Primary and secondary efficacy endpoints were target lesion (TL) transverse-view vessel area loss percentage (TVAL%) and CR-TLF at 6 months, respectively. CR-TLF was defined as a composite of ischemia-driven major amputation of the target limb, clinically driven target lesion revascularization (CD-TLR), and clinically relevant TL occlusion. The primary safety endpoint was freedom from major adverse limb events or perioperative death (MALE+POD) at 30 days. Results: There was no discernable difference in effect between temsirolimus doses; therefore, the low- and high-dose cohorts were pooled for the analyses. The principal analysis on the per protocol (PP) group of 53 patients revealed superior primary efficacy of the treatment arm, with reduction in TVAL% of 13.9% absolute (37.3% relative) and the rate of CR-TLF reduced by 27.1% absolute (51.3% relative), at 6 months. Subgroup analysis of all Trans-Atlantic Inter-Society Consensus (TASC) B to D lesions (N=36) revealed TVAL% reduction of 22.3% absolute (48.3% relative) and the rate of CR-TLF reduced by 39.2% absolute (56.6% relative). Freedom from 30-day MALE+POD was 100% in all groups. Conclusions: This hypothesis-generating trial suggests that adventitial infusion of temsirolimus in BTK arteries improves TVAL% and CR-TLF with no adverse safety signals through 6 months, supporting the move to a Phase 3 trial. Clinical Impact There remain gaps in the endovascular treatment of patients with atherosclerotic lesions of below-the-knee (BTK) arteries. The TANGO trial evaluated the use of sub-adventitial temsirolimus with the Bullfrog micro-infusion device during BTK interventions. The therapy was safe and effective. Compared with controls, vessel lumen area patency was improved, and target lesion failure was less frequent. The effects were most appreciable in subjects with higher baseline TASC lesions (B, C, or D). Sub-adventitial temsirolimus offers the potential to improve the results of BTK interventions in this challenging patient population.

The relationship between sarcopenia and one-year mortality in patients with critical limb ischemia undergoing endovascular therapy below the knee.

Critical limb ischemia (CLI) is a progressive form of peripheral artery disease (PAD). Patients with CLI have poor long-term prognosis. The aim of this study was to investigate the value of sarcopenia in terms of 1-year mortality in patients with below-the-knee lesions who underwent endovascular treatment for CLI. A total of 190 patients with critical limb ischemia who underwent endovascular treatment (EVT) for below-the-knee (BTK) lesions were enrolled in this study. Sarcopenia was defined using the psoas muscle index (PMI). PMI was obtained by calculating the average psoas muscle area (APMA) of the left and right psoas muscles at the third lumbar vertebra level and dividing by the square of the height (cm2/m2). The primary endpoint of the study was 1-year mortality and the secondary endpoint was 1-year amputation. Patients were divided into 2 groups according to presence of sarcopenia. We detected sarcopenia in 64 patients. The mean age, height, and EF were higher in sarcopenia group. The psoas muscle area, weight, psoas muscle index, body-mass index, albumin level, and GFR were lower in sarcopenia group. The incidence of amputation (11.9% vs 29.7%, p = 0.003) and mortality (15.1% vs 35.9%, p = 0.001) were higher in patients with sarcopenia. Univariate and multivariate logistic regression analyses were used to determine the independent predictors of amputation and mortality. The survival curve for 1-year using the sarcopenia was analyzed using the Kaplan-Meier method, and statistical analysis was performed with the log-rank test. The presence of sarcopenia, glomerular filtration rate level, and low ejection fraction were found to be independent predictors of mortality. Sarcopenia was associated with 1-year mortality in patients with CLI undergoing EVT for BTK lesions. Also, patients with sacropenia had higher 1-year amputation rates. Sarcopenia may be a simple method to help patient selection, assessment, and intervention strategy for EVT and may improve patient outcomes.

Phoenix atherectomy for patients with peripheral artery disease.

Endovascular atherectomy enables minimally invasive plaque removal in peripheral artery disease (PAD). We aimed to evaluate the safety and the long-term effectiveness of the Phoenix atherectomy for the treatment of complex and calcified lesions in PAD patients. Consecutive all-comer patients with PAD underwent the Phoenix atherectomy. Device safety in terms of perforation and distal embolisation were evaluated. Lesion calcifications were categorised by the Peripheral Arterial Calcium Scoring System (PACSS) and lesion complexity was assessed by the Transatlantic Inter-Society Consensus (TASC). Clinically driven target lesion revascularisation (TLR) was assessed. A total of 558 lesions were treated in 402 consecutive patients. Clinical follow-up was available at 15.7±10.2 months for 365 (91%) patients. Of 402 patients, 135 (33.6%) had claudication, 37 (9.2%) had ischaemic rest pain and 230 (57%) exhibited ischaemic ulcerations. Lesions were mostly identified in the femoropopliteal segments (55%), followed by below-the-knee (BTK) segments (32%). Complex TASC C/D lesions and moderate to severe calcifications (PACSS score ≥2) were present in 331 (82%) and 323 (80%) patients, respectively. The mean lesion length was 20.6±14.3 cm. Five (1%) perforations and 10 (2%) asymptomatic embolisations occurred. Bail-out stenting was performed in 4%, 16% and 3% of patients with common femoral artery, femoropopliteal and BTK lesions, respectively. During follow-up, 5 (3.9%) patients with claudication and 52 (21.9%) patients with critical limb-threatening ischaemia (CLTI) died (hazard ratio [HR] 3.7; p<0.001). Freedom from TLR was 87.5% (112 of 128) in patients with claudication and 82.3% (195 of 237) in patients with CLTI, respectively (HR 1.8; p=0.03). The Phoenix atherectomy can be safely performed in patients with complex lesions with a relatively low rate of bail-out stenting and clinically acceptable TLR rates. DRKS00016708.

Early outcomes of excimer laser atherectomy for below-the-knee lesions in patients with diabetic foot

Objective: To evaluate the clinical outcomes of excimer laser atherectomy (ELA) in the treatment of diabetic foot with below-the-knee(BTK) lesions. Methods: The clinical data of 11 patients with diabetic foot with BTK lesions who underwent ELA at Department of Vascular Surgery,Zhongshan Hospital of Fudan University and Department of Vascular and Wound Treatment Center,Jinshan Hospital of Fudan University from September 2019 to May 2021 were retrospectively analyzed.There were 10 males and 1 female,aged 70.5 years(range:41 to 83 years).There were 20 lesions in 12 limbs,including 19 chronic total occlusion.All of the limbs were classified as Rutherford class 5 and suffered ulceration.The surgical efficacy,complications and ankle brachial index(ABI) after operation were record. Results: All patients underwent the operation successfully,the technical success rate was 12/12.No distal embolization,flow-limiting dissection,perforation or bailout stenting was occurred.The follow-up period was 8.2 months(range:3 to 13 months).The ABI increased from 0.58(range:0.24 to 1.57) before operation to 0.88(range:0.68 to 1.05) after operation.At 3 months after the operation,1 limb (1/12) underwent endovascular operation again due to restenosis,ulcers were healed in 5 limbs(5/12),and no amputation (limb/toe),death or loss of follow-up patients.Six months after the operation,2 patients were lost to follow-up and 2 died,ulcers were healed in 6 limbs(6/8),1 limb (1/8) underwent toe amputation due to prolonged healing of ulcers of toe. Conclusion: ELA is feasible and effective in the treatment of DF with BTK lesions,providing a new option of debulking atherectomy in such a group of patients.

Predictive impact of the Global Limb Anatomic Staging System (GLASS) on perioperative outcomes in patients with chronic limb-threatening ischaemia with isolated below-the-knee lesions.

Although the global vascular guidelines recently proposed the Global Limb Anatomic Staging System (GLASS) as an anatomical classification for chronic limb-threatening ischaemia (CLTI), prediction of perioperative outcomes using the GLASS classification in patients with CLTI due to isolated below-the-knee (BTK) lesions has not been well studied.This retrospective study included 585 patients with CLTI due to isolated BTK lesions who underwent endovascular therapy (EVT). The severity of arterial lesions was graded using the GLASS infrapopliteal (IP) and inframalleolar (IM) classifications and defined as follows: non-severe IP, 0-3; severe IP, 4; non-severe IM, P0-1; and severe IM, P2. The outcome measures were technical failure, defined as recanalisation failure of the target artery path, and perioperative failure, defined as a composite of all-cause death, major amputation, or repeat revascularisation within 30days.Technical and perioperative failures occurred in 9.4% (n = 55) and 9.9% (n = 58) patients, respectively. Compared to patients with non-severe IP and IM, those with both severe IP and IM were significantly associated with technical and perioperative failures (odds ratio [OR]: 13.87 [95% confidence interval (CI) 4.69-41.02, P < 0.001] and OR: 2.18 [95% CI 1.08-4.38, P = 0.041], respectively).The GLASS classification may have predictive value for technical and perioperative failure in patients with CLTI due to isolated BTK lesions after EVT.

Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries

Purpose: To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI). Materials and Methods: The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months. Results: Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1–16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months. Conclusion: The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions. Clinical Trial Registration: ClinicalTrials.gov identifier NCT02942966.

Safety and Effectiveness of Endovascular Therapy for the Treatment of Peripheral Artery Disease in Patients with and without Diabetes Mellitus.

This study investigated the distribution of risk factors, lesion characteristics and endovascular revascularization (EVR) strategies in patients with peripheral arterial disease (PAD) with vs without diabetes mellitus (DM). Data were collected within the RECcording COurses of vasculaR Diseases (RECCORD) registry. Demographic data, lesion localization (iliac vs femoropopliteal vs below-the-knee (BTK)) and lesion complexity score (LCS) based on number of affected segments, and lesion length (< 10 vs 10-20 vs > 20cm), EVR strategies and peri-procedural complications were analysed in 786patients with and 1337 without diabetes mellitus. Patients with diabetes mellitus were older (71.6 ± 9.6 vs 69.4 ± 10.5years, P < .001) and had higher LCS and more often BTK lesions (P < .05 for all). Lesions were treated less frequently with stents (48.7 vs 59.6%, P < .001) in patients with diabetes mellitus, whereas a non-significant trend was noticed for higher DCB treatment rates (48.3 vs 44.4%, P = .07). Post-interventional ankle-brachial index (ABI) increase was similar (from .77 ± .28 to .92 ± .25 with diabetes mellitus and from .74 ± .21 to .90 ± .20 without diabetes mellitus, P < .001 for both). Peri-/post-procedural complications were low in both groups (4.6%). Patients with diabetes mellitus, who undergo endovascular revascularization are older, have more comorbidities and higher target lesion complexity. However, treatment success rates are similar and complication rates are low.

Orbital Atherectomy Prior to Drug-Coated Balloon Angioplasty in Calcified Infrapopliteal Lesions: A Randomized, Multicenter Pilot Study

Purpose: Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower long-term patency. Materials and Methods: This was a prospective, randomized, multicenter pilot trial that included adult subjects with calcified lesions located from the popliteal segment below the knee (BTK) joint to within 5 cm above the ankle with ≥70% diameter stenosis by angiography. Patients were randomized 1:1 to undergo orbital atherectomy (OA) with adjunctive drug-coated balloon (DCB) angioplasty versus plain balloon angioplasty (BA) and DCB angioplasty (control). The periprocedural and 12 month outcomes of both procedures were compared. Results: Overall, 66 subjects (OA + DCB = 32 vs control = 34) were included in an intention to treat analysis. Baseline demographics and lesion characteristics were well-balanced. The mean lesion length was 101.3 mm (SD = 72.8 mm) and 78.8 (SD = 61.0 mm) in the OA + DCB and control groups, respectively, with almost all lesions having severe calcification per the Peripheral Academic Research Consortium (PARC) criteria. Chronic total occlusions (CTOs) were present in 43.8% and 35.3% of the patients in the OA + DCB and control groups, respectively. The technical success of OA + DCB versus DCB was 81.8% and 89.2%, respectively, with 3 slow flow/no reflow, 1 perforation, 1 severe dissection occurred in OA + DCB group, and one distal embolization occurred in the control group. The target lesion primary patency rate was numerically higher in the OA + DCB versus control group at 6 (88.2% vs 50.0%, p=0.065) and 12 month follow-up (88.2% vs 54.5%, p=0.076). The 12 month freedom from major adverse events, clinically-driven target lesion revascularization, major amputation, and all-cause mortality rates were similar between both groups. Conclusion: The results of the Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified BTK (OPTIMIZE BTK) pilot study indicated that utilization of OA + DCB is safe for infrapopliteal disease. Further prospective adequately powered studies should investigate the potential benefit of combined OA + DCB for BTK lesions.

Association Between CRP/Albumin Ratio and Long-Term Mortality in Patients With cHronIc Limb-Threatening Ischemia Undergoing EndovaScular Therapy Below The Knee: The ACHILES-BTK Registry

Chronic limb-threatening ischemia (CLTI), which presents with ischemic rest pain, ulceration, or gangrene, is a complex form of peripheral artery disease that can cause mortality and amputation. C-reactive protein (CRP), an inflammatory marker, indicates vascular inflammation resulting from the cytokine-dependent inflammatory process in the arterial wall, and arterial atherosclerosis resulting from the inflammation. Lower albumin levels are also associated with peripheral artery disease. We investigated the association between CRP/Albumin ratio (CAR) and long-term mortality in patients with CLTI. A total of 172 patients who underwent endovascular treatment (EVT) for below the knee (BTK) lesions were enrolled in this study. Patients with acute infection requiring antibiotic therapy, chronic inflammatory disease, end-stage liver disease, malignancy were excluded from the study. Besides, patients with pre-follow-up intervention to the same vascular bed were also excluded from the study. The primary endpoint of the study was all-cause mortality. Patients were divided into 2 groups according to mortality. A total of 70 patients (40.6%) died during 32 ± 21 months of follow-up in the present study. The major amputation rate was 21.5%. The mortality (+) group was older and had higher rates of congestive heart failure, chronic kidney disease, history of stroke, and CRP levels. Moreover, statin and ACE inhibitor/angiotensin receptor blocker (ACE/ARB) use, GFR, and albumin levels were lower in the mortality (+) group. CAR was significantly higher in the mortality (+) group when comparing both groups (3.25 [1.46 - 7.86] vs. 9.75 [4.5 - 17.71], P < 0.001). CAR, congestive heart failure, chronic kidney disease, history of stroke, ACE/ARB, or statin use were independent predictors of all-cause mortality in multivariable Cox regression analysis. CAR was associated with mortality in CLTI patients undergoing EVT for BTK lesions. CAR may be a simple method to help patient selection, assessment, and intervention strategy for EVT and may improve patient outcomes.

The role of atherectomy in BTK lesions: a systematic review.

The aim of this paper was to evaluate the current role of atherectomy techniques (ATH) in treatment of peripheral arterial disease (PAD) at below the knee (BTK) arteries. The PubMed and Embase were searched (last search on 11 September 2021) for studies reporting on the early and mid-term outcomes of ATH in BTK vessels. Analysis included the data from six studies, with a total of 1062 PAD patients treated with various ATH techniques. We compared them the ATH outcomes with the contemporaneous outcomes of plain balloon angioplasty alone or with bailout stenting. Early safety and efficacy were accessed with perioperative and 30-day technical success (TS) rate, which included the primary patency of the treated BTK arterial segment. Evaluation of clinical performance was based on target limb revascularization (TLR) and on major limb adverse events (MALEs) rates. The current body of literature mainly includes retrospective observational studies, and the level of derived evidence is low. The mean perioperative and 30-day TS rate was 87.3%. The mean reported TLR and MALEs rates at 12 months were 6.6% and 4.7% respectively. The relevant rates in studies reporting at 24 months were 24.3% and 31.7% while in studies reporting at 36 months the rates were 37.0% and 23.0% respectively. Based in low-quality evidence, it seems that ATH in BTK vessels has a high safety, high efficacy profile and durable outcomes at 12 months. In the mid-term, the clinical success of ATH is compromised by increased TLR and MALEs rates. Comparison of ATH with other endovascular techniques in BTK treatment of PAD shows a slight lead of ATH at 1-year and equivalent clinical performance in the mid-term. Overall, ATH has a significant and potentially predominant role in treatment of BTK vessels.

Intravascular Lithotripsy for Treatment of Calcified Infrapopliteal Lesions: Results from the Disrupt PAD III Observational Study

Purpose: To evaluate the safety and effectiveness of the Shockwave S4 intravascular lithotripsy (IVL) catheter in an “all-comers” cohort of patients with calcified infrapopliteal lesions. Materials and Methods: The Disrupt PAD III Observational Study (NCT02923193) is a prospective, nonrandomized, multicenter single-arm study designed to assess the “real-world” acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified, stenotic peripheral arteries. Patients were eligible for enrollment if they had claudication or critical limb ischemia (CLI) and at least moderate calcification as assessed by angiography. This subanalysis includes consecutive patients enrolled with angiographic core lab-assessed treatment of infrapopliteal arteries using the Shockwave S4 IVL catheter. Results From July 2018 to August 2020, 101 patients with 114 calcified infrapopliteal arteries treated with the S4 IVL catheter were enrolled at 15 sites in 3 countries. CLI was present in 69.3% of patients. The anterior tibial and tiboperoneal trunk were the most commonly treated vessels with an overall mean reference vessel diameter (RVD) of 3.1±0.8 mm, minimum lumen diameter (MLD) of 0.5±0.6 mm, and a corresponding diameter stenosis of 83.4%±15.8% by core lab assessment. Mean lesion length was 64.7±54.7 mm with moderate to severe calcification in 69.3% of lesions by the Peripheral Academic Research Consortium (PARC) criteria. Adjunctive calcium-modifying technology, defined as scoring or cutting balloon and/or atherectomy, was used in 22.7% of procedures. The average acute gain at the end of the procedure was 2.0±0.7 mm with a residual stenosis <50% achieved in 99.0% of lesions and a mean residual stenosis of 23.3±12.5%. There were no flow-limiting dissection, embolization, slow flow/no-reflow, or abrupt closure events at the end of the procedure. Conclusion This subanalysis of the PAD III Observational Study represents the largest report to-date of IVL treatment of heavily calcified below-the-knee (BTK) lesions in a “real-world” patient cohort. The use of S4 IVL demonstrated consistent acute safety and effectiveness outcomes consistent with prior IVL peripheral studies. These consistent outcomes were achieved with the initial use of the S4 IVL catheter for treatment of complex BTK lesions.

Stenting versus balloon angioplasty alone in patients with below-the-knee disease: A propensity score-matched analysis.

Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.

A novel technique of percutaneous intraluminal cracking using a puncture needle for severe calcified lesions of below-the-knee and below-the-ankle arteries.

Endovascular therapy has recently become acceptable for the reconstruction of below-the-knee (BTK) and below-the-ankle (BTA) arterial lesions. However, we have sometimes experienced BTK or BTA lesions with calcifications that are too severe for balloon catheters to cross or expand despite successful guidewire passage. In this study, we assessed the feasibility and safety of the novel inner PIERCE technique for breaking down the calcium burden of BTK and BTA arterial lesions. We retrospectively reviewed the records of patients who had undergone endovascular therapy between August 2018 and December 2019. The inner PIERCE technique was performed in those cases where low-profile balloon catheters were unable to pass through the target lesions or balloon indentation did not disappear beyond the rated burst pressure. An externalized guidewire system was established in 8 cases via bidirectional approaches, and a 20-gauge needle was directly inserted through the guidewires from the distal puncture site. In 10 cases of successful antegrade wiring, the tibial or pedal arteries distal to the lesion site were punctured for a retrograde guidewire approach to the lesion. The needle was slowly rotated and advanced across the lesion. We found that all lesions were severely calcified and 83.3% had chronic total occlusion. The inner PIERCE procedure allowed successful passage of the needle and subsequent low-profile balloon catheters in all cases. Optimal balloon dilatation was achieved in 94.4% of the cases using this technique. No procedure-related adverse events were observed. The novel inner PIERCE technique is a safe and feasible method for disrupting calcified BTK and BTA lesions.