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 (AngioDynamics, Inc., Latham, New York) 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. We present the 30-day efficacy and safety findings from the ongoing Auryon BTK study. Patients with chronic limb-threatening ischemia were prospectively enrolled in the Auryon BTK study between March 2022 and February 2023 in 4 US centers after obtaining written informed consent. The primary safety end point included major adverse limb events + postoperative death 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% men, 58.3% with diabetes, 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 de novo disease. The baseline diameter stenosis was 80.2 ± 16.4%, after laser 57.4 ± 21.7%, and after final treatment 24.0 ± 23.1% (p <0.0050). The primary performance end point showed a procedure success rate of 37 of 68 (63.8%). Bailout stenting occurred in 1 of 61 lesions (1.6%). The RB category was 100% RB IV or higher at baseline versus 35.3% at 30 days. At 30 days, there was no target vessel revascularization and the patency was 88.9% (Peak Systolic Velocity Ratio (PSVR) ≤2.4). In conclusion, the Auryon laser is safe and relatively effective in treating BTK lesions with minimal complications.

Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.

Background: The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report. Methods: There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05. Results: Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window. Conclusion: JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms. Clinical Trial Registration: NCT03206762.

Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.

Background: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease. Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core lab-adjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat. Results: Mean lesion length was 10.8±4.3 cm for JET + PCB and 11.2±7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P<0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P<0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327). Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream.

Femoropopliteal Arterial Dissections Following FLEX VP and Balloon Angioplasty Versus Balloon Angioplasty Alone: Intravascular Ultrasound Assessment and Correlation With Angiographic Findings.

BACKGROUND: The Flex VP is a longitudinal micro-incision catheter approved for vessel prepping of femoropopliteal arteries and arteriovenous fistulas. In this study, we evaluated the presence of deep dissections (adventitia) using IVUS in patients undergoing Flex VP followed by angioplasty (PTA) versus PTA alone. METHODS: 17 patients (20 limbs) with femoropopliteal artery (FP) disease were prospectively and consecutively included (10 limbs received PTA followed by 10 limbs that received FLEX VP microincision catheter treatment followed by adjunctive PTA). Dissections post PTA, FLEX VP and FLEX VP+ PTA were evaluated using intravascular ultrasound (iDissection classification) and angiographically (NHLBI classification) by core laboratory. The evaluated segment of the vessel was prespecified at 10 cm at the most severe lesion location. Statistical differences were analyzed between the 2 groups at each appropriate procedural point for dissections, minimal luminal diameter (MLD), minimal luminal area (MLA), and residual stenosis. Statistical significance was determined by a p-value <0.05. RESULTS: Baseline demographics and angiographic variables were similar between the PTA vs FLEX VP + PTA groups with the exception of more males (87.5 % vs 33.3 %, p = 0.0274) and longer treated length (median 300 mm vs 150 mm, p = 0.0240) in the FLEX VP + PTA group. Lesion length, chronic total occlusions, angiographic and IVUS evaluated segment length for dissections, calcium severity and final balloon pressures and inflation duration were all similar between the 2 groups. Angiographic dissections were similar between the 2 groups but the increase in severe dissections from index to post POBA on IVUS (involving the adventitia) were significantly more for PTA when compared to FLEX VP + PTA (0 to 12 and 0 to 1 respectively, p = 0.0353). Bailout stenting was statistically similar for PTA as compared to FLEX VP + PTA per core lab evaluation (50 % vs 20 %, p = 0.3498). Minimal luminal area (MLA) gain by IVUS was similar between the 2 groups following FLEX VP + PTA vs PTA (7.4 mm2 vs 6.5 mm2, p = 0.7250). No serious major adverse events occurred in either group. CONCLUSION: Vessel prepping with the FLEX VP + PTA vs PTA yielded lower rates of adventitial dissections as seen on IVUS. The long-term outcomes of these findings remain unclear.

Auryon Laser in Treating Symptomatic Infrainguinal Arterial Disease: 1-Year Outcome.

BACKGROUND: The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the EX-PAD-03 investigational device exemption study and the Auryon single-center experience (SCE) in treating infrainguinal arteries. In this study, we present the 1-year outcomes of the Auryon SCE study on TLR in all comers at a single center. METHODS: The Auryon SCE was a retrospective study that evaluated the outcomes of all comers treated with the Auryon laser for infrainguinal arterial disease. There was no TLR seen at 6-month follow-up. We present the TLR rate at 1 year in the same cohort of patients. TLR rates were obtained from medical record review of patients enrolled in the study who had completed office visit follow-up at 1 year. Secondary endpoints included unplanned major amputation and total mortality. Kaplan-Meier survival analysis was performed to estimate the freedom from TLR rate following index procedure. Statistical differences were analyzed for ankle-brachial index (ABI) between baseline and 1 year. RESULTS: A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, with 66.1% males, 48.2% diabetics, and 25% demonstrating limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis, 29.6%). Stenting was performed in 24/70 lesions (34.3%), with 11/70 (15.7%) bailout procedures. Embolic filters were used in 26/65 procedures (40%). The majority of treated lesions were femoropopliteal (90.0%); of all procedures, 29.2% had 2 or more prior interventions. Drug-coated balloon usage was 47.1% Lutonix (BD/Bard), 27.1% In.Pact (Boston Scientific), and 1.4% both in all lesions treated. Distal embolization occurred in 1/65 procedures (1.5%). At 1 year, mortality occurred in 3/56 patients (5.4%). Of 65 limbs treated, 2 (3.1%) had major amputation at 1 year. The probability of freedom from TLR was 83.7%. CONCLUSION: In a realworld cohort of patient with complex disease, the Auryon laser had excellent freedom from TLR at 1 year.

Auryon Laser in Peripheral Arterial Interventions: A Single-Center Experience (Auryon-SCE).

BACKGROUND: The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the investigational device exemption study. At present, real-world data are not available. In this study, we analyze major adverse events and 6-month outcomes with the Auryon laser system in treating infrainguinal arterial disease in all comers at a single center. METHODS: Consecutive patients treated with the Auryon laser between September 2017 and March 2021 were retrospectively reviewed from a single operator at a single center. Demographic, procedural, angiographic, and outcome data were extracted from patients' medical records. Descriptive and survival analyses were performed. The study's primary endpoint was the assessment of freedom from TLR at 6-month follow-up. Secondary endpoints included acute procedural results, distal embolization, bailout stenting (dissection type D or higher by National Heart, Lung, and Blood Institute [NHLBI] classification, and/or residual narrowing >30%), unplanned major amputation, death, or vascular complications. RESULTS: A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, 66.1% were males, 48.2% were diabetics, and 25% had limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis in 28.6%). The majority of treated vessels were femoropopliteal (88.6%) and 29.2% had 2 or more prior interventions. Mean stenosis was 91.3 ± 9.7% at baseline, 56.0 ± 17.3% post laser, and 11.4 ± 11.2% post final treatment. Lesion length was 117.1 ± 101.2 mm and treated length was 174.0 ± 116.0 mm. Bailout stenting occurred in 11/70 lesions (15.7%). There were no NHLBI type D dissections post laser and 1 type D dissection post laser + percutaneous transluminal angioplasty. A total of 47.1% received Lutonix drug-coated balloons (BD/Bard), 27.1% received In.Pact drug-coated balloons (Boston Scientific), and 1.4% received both. The probability of freedom from TLR per procedure was 95.6% at 6 months. CONCLUSION: In a real-world cohort of patients with complex disease, the Auryon laser had excellent freedom from TLR at 6 months, although these findings need to be replicated in a randomized trial.

Venovo Venous Stent in Treating Iliac Vein Compression: A Single-Center Experience.

BACKGROUND: The Venovo venous stent (BD/Bard Peripheral Vascular) is indicated to treat iliofemoral veno-occlusive disease. We present our own experience with the Venovo venous stent in treating iliac vein compression (ILVC). METHODS: In this retrospective cohort, we included consecutive patients treated with the Venovo venous stent for ILVC at our center. Stent deployment and sizing were guided by intravascular ultrasound (IVUS). Minimal luminal areas at the compression before and after treatment were measured by IVUS. Clinical improvement was determined by symptoms reported by patients and the Clinical Etiologic Anatomic and Pathophysiologic (CEAP) score. The primary safety endpoint was freedom from acute venothromboembolic disease, stent migration, perforation, acute/subacute closure, and vascular complications. The primary safety endpoint was target-lesion revascularization at 1 year. RESULTS: A total of 50 consecutive patients (57 Venovo stents, 36 women, mean age, 59.8 ± 16.3 years) were included. IVUS-measured mean percent stenosis at the compression site was 64.8% ± 12.8%. Mean total stent length and diameter were 78.0 ± 54.0 mm and 17.1 ± 1.9 mm, respectively. The primary safety endpoint was met in all subjects. Procedural technical success was 100% (successful deployment with no complications). At 1 year, 83.8% of patients reported improvement in their symptoms. Freedom from total occlusion at 1 year was 100% (data available for n = 30 patients). Target-lesion revascularization (TLR) was 2% at 1 year due to 1 patient who had stent explantation from worsening ipsilateral left leg and back pain. CONCLUSION: In this single-center experience, the Venovo venous stent was safe and effective in treating ILVC with 98% freedom from TLR at a follow-up of 1 year. Improvement in symptoms was reported in the majority of patients.

Predicting Significant Iliac Vein Compression Using a Probability Scoring System Derived From Minimal Luminal Area on Computed Tomography Angiography in Patients 65 Years of Age or Younger.

BACKGROUND: The presence of 50% or more stenosis on intravascular ultrasound (IVUS) is considered diagnostic of iliac vein compression (ILVC) by most operators. We have previously developed a scoring system combining minimal luminal area (MLA) at the compression site and age to predict ILVC as seen on IVUS. We present a revised and improved scoring system following an additional number of patients and limited to patients 65 years of age and younger. METHODS: Patients were included from retrospective (n = 52) and prospective (n = 18) registries of consecutive patients who underwent computed tomography angiography (CTA) of the pelvis with venous filling and IVUS within a few weeks apart to evaluate for symptomatic ILVC at a single cardiovascular practice. Quantitative vascular analysis was performed on all images obtained. MLA and age were used to calculate a score derived from a previously published logistic regression formula. Patients >65 years in age were excluded. The predicted findings from the score were compared with the actual presence of compression on IVUS. The revised scoring system is based on a score of < or ≥ 0.533824 and MLA (mm²) of <140, ≥140 to <200, and ≥200. The negative predictive value (NPV) and positive predictive value (NPV and PPV) of each cut-off in predicting ILVC on IVUS were calculated. RESULTS: A total of 70 symptomatic patients were included (mean age, 52.6 ± 12.3 years). The model offered the following: accuracy = 54/70 (77.1%); sensitivity = 51/52 (98.1%); specificity = 3/18 (16.7%); PPV = 51/66 (77.3%); and NPV = 3/4 (75.0%). CONCLUSION: A scoring system using MLA on CTA and age provides a fairly accurate diagnostic test to predict the presence of significant ILVC as seen on IVUS.

Two-Year Outcomes of Endovascular Interventions of the Common Femoral Artery: A Retrospective Analysis From Two Medical Centers.

BACKGROUND: Treatment of common femoral artery (CFA) disease has been traditionally surgical. Recent data indicate that an endovascular option is feasible in treating CFA disease but there remains significant controversy about the endovascular versus surgical approach to treatment. Newer modalities of therapy have emerged to treat the CFA including atherectomy and drug coated balloons. We retrospectively reviewed data on the long-term outcome of endovascular treatment of CFA from 2 medical centers. METHODS: Consecutive patients with CFA disease treated by 6 operators using endovascular techniques from January 1, 2012 to December 31, 2017 were reviewed and analyzed. Two-year follow up was completed using medical records. Demographic, clinical, procedural and angiographic variables were collected. The primary endpoint of the study was target lesion revascularization (TLR). Secondary endpoints included target vessel revascularization (TVR), mortality, unplanned major and minor amputations and 30-day periprocedural adverse events. Descriptive analysis was performed on all variables. Kaplan-Meier for freedom from TLR was plotted. The study was approved by the Ethics Committee at our center. RESULTS: A total of 89 patients (116 limbs) were included at Index. There were males 57.3%, diabetics 42.7%. Mean age was 65.1 ± 16.3 years. Critical limb ischemia (CLI) was present in 27.7%. Disease distribution was classified by the Medina classification: 1-0-0 (CFA only) 48.3%, 1-0-1 (CFA + profunda) 6.9%, 1-1-1 (CFA+ profunda + origin of superficial femoral artery) 16.4%, 1-1-0 (CFA and origin of SFA) 28.4%. Denovo disease was present in 70.7%. Atherectomy was used in 104/116 limbs (89.7%). Drug coated balloons (DCB) in 15.5%, and stenting in 22.4%. Baseline stenosis 81.2 ± 13.1%, lesion length was 42.0 ± 14.5 mm. Final stenosis was 13.3 ± 11.0. Major bleeding occurred in 2.6%. At 2-year mortality was 9.0% (none related to procedure), CLI was 5.9% and no unplanned major or minor amputations. At 2-year KM analysis showed a probability of freedom from TLR of 72.2%. At 2-year the following TLRs were noted for various devices used: PTA 50%, orbital atherectomy 0%, jetstream 29.2%, laser 36.4%, and SilverHawk/TurboHawk 23.1% (p = 0.0476). CONCLUSION: Endovascular treatment of CFA predominantly with atherectomy in this cohort, is feasible and with acceptable outcomes considering a low percentage of DCB use. A randomized trial is needed to validate these findings and explore the added role of DCB and atherectomy on clinical outcomes when compared to endarterectomy.

Predicting Iliac Vein Compression With Computed Tomography Angiography and Venography: Correlation With Intravascular Ultrasound.

BACKGROUND: Intravascular ultrasound (IVUS) is considered the gold standard in diagnosing common iliac vein (CIV) compression. The presence of >50% surface area reduction by IVUS is considered significant compression by most operators. Thus, we evaluated the role of computed tomography angiography (CTA) and venography in diagnosing CIV compression when compared to IVUS. METHODS: All patients who underwent CTA of the pelvis with venous filling phase, IVUS, and venography within a few weeks apart to evaluate for symptomatic CIV compression from one cardiovascular practice were retrospectively reviewed. Quantitative vascular analysis was performed on all images obtained to determine (1) percent stenosis (PS) by venogram; and (2) minimal lumen area (MLA) and PS by CTA and IVUS at the compression site (using ipsilateral distal CIV as reference area). Spearman's rank correlation, paired t-tests, or signed rank tests were performed as appropriate to compare between values of MLA and PS among the three different imaging modalities. RESULTS: A total of 96 patients were included (62.5% females; mean age, 62.3 ± 14.8 years). A significant correlation was found between MLA-CTA and MLA-IVUS (Spearman's rho, 0.27; P=.01) and PS-CTA and PS-IVUS (Spearman's rho, 0.327; P<.01). A significant correlation was also found between PS-venogram and PS-IVUS (Spearman's rho, 0.471; P<.001). MLA-CTA and MLA-IVUS had a median difference of +41 mm² (95% CI, 25.0-57.5; P<.001) whereas PS-CTA and PS-IVUS were not statistically different (median difference, -5.6 mm²; 95% CI, -12.2 to 0.7). Furthermore, PS-IVUS and PS-venogram had a median difference of +15.2% (95% CI, 10.4-20.1; P<.001). CONCLUSION: PS-venogram correlates with PS-IVUS, but venogram underestimates the PS by an average of 15.2%. In contrast, PS-CTA and PS-IVUS are not statistically different despite an over-estimation of MLA by CTA when compared to IVUS. Therefore, we conclude that PS-CTA and not PS-venogram can be used to predict PS on IVUS.

Long-term outcomes with Jetstream atherectomy with or without drug coated balloons in treating femoropopliteal arteries: A single center experience (JET-SCE).

BACKGROUND: The long-term outcome of Jetstream atherectomy (JA) with or without adjunctive drug coated balloons (DCB) in a real-world setting remains unknown. We report 16-month target lesion revascularization (TLR) rates on patients treated for femoropopliteal (FP) artery disease with JA in a single center by one operator. METHODS: From 1/1/12 to 8/24/16 a total of 311 procedures were performed with atherectomy by a single operator at a single center. Of these procedures, 75 met inclusion and exclusion criteria. This report evaluates the outcomes of these 75 patients treated at index and who were followed up to 16 months. The primary endpoint of the study was clinically driven TLR. Patients were stratified by the use of DCB (vs angioplasty (PTA)) post-JA. TLR was calculated by excluding bailout stenting as TLR. Survival analysis for TLR over time was plotted. RESULTS: 75 patients (49.3% male, mean age 68.0 years, 54.7% diabetes) with de novo or restenotic FP lesions whose symptoms were classified as Rutherford category I-V were enrolled. Adjunctive PTA was performed on 50 patients (26 de novo, 13 in-stent restenosis, 3 non-stent restenosis, 8 mixed lesions) and adjunctive DCB (LUTONIX® 24, IN.PACT® 1) on 25 patients (21 de novo, 1 in-stent restenosis, 2 non-stent restenosis, 1 mixed lesion) (p = 0.0249). There was no difference in the median treated length between the adjunctive PTA (15 cm) and DCB (10 cm) groups (p = 0.0530). The estimated freedom from TLR (fTLR) was significantly higher with atherectomy and adjunctive DCB compared to atherectomy with adjunctive PTA at 12 months (94.7% vs 68.0%, p = 0.002) and 16 months (94.4% vs 54%; p = 0.002). CONCLUSIONS: In a single center cohort of JA reflecting real-world practice, JA with DCB had a superior TLR rate up to 16-month follow-up when compared to JA with PTA in treating all comers FP arterial disease.