Intravascular Ultrasound Assessment and Correlation With Angiographic Findings of Arterial Dissections Following Auryon Laser Atherectomy and Adjunctive Balloon Angioplasty: Results of the iDissection Auryon Laser Study.

BACKGROUND: Femoropopliteal arterial angiographic dissections with the use of the Auryon laser atherectomy system (previously the B-laser) have been infrequent and non-flow limiting. However, the pattern of these dissections (depth and arc) using intravascular ultrasound remains unknown. MATERIALS AND METHODS: We prospectively enrolled 29 patients in the iDissection Auryon study. The primary objective was to define the occurrence of new adventitial injury with intravascular ultrasound (IVUS). Secondary objectives included distal embolization and bailout stenting as judged by the operator because of 30% or more residual narrowing and/or NHLBI (National Heart, Lung, and Blood Institute) angiographic dissection C and higher. Core laboratory analysis was carried on all cases except for 1 patient (that crossed over to Jetstream atherectomy). Dissections were classified according to the iDissection classification as involving the intima (A), media (B), and adventitia (C) and ≤ 180-° arc (1) or >180-° arc (2). Overall, 22 of 29 patients had an embolic filter (per protocol). RESULTS: Median lesion and treated lengths were 100.0 and 150.0 mm, respectively. Vessel diameter by IVUS was 6.5 ± 1.5 mm. Chronic total occlusion (CTO) was present in 24.1% of cases. The arc of calcium was: no calcium in 27.6%, <90° in 13.8%, 90° to 180° in 20.7%, and >180° in 34.4%. Lesion severity was reduced to a median of 14% post laser and adjunctive percutaneous transluminal angioplasty (PTA) from a baseline of 76%. Bailout stenting occurred in 6 of 28 (21.4%) patients (3 for dissections, 2 for residual >30%, and 1 for both) and primary stenting in 1 of 28 (3.6%). By IVUS, there were 9 new dissections post laser (1 adventitial; 3≥180°) and 21 new dissections post laser and PTA (3 adventitial; 1≥180°). No distal embolization requiring treatment was seen and no macrodebris ≥2 mm was recovered in the filters. CONCLUSION: The Auryon laser atherectomy system had minimal rate of adventitial injury despite complex disease with relatively low bailout stent rate and no clinically significant macrodebris.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Optimal Vessel Sizing and Understanding Dissections in Infrapopliteal Interventions: Data From the iDissection Below the Knee Study.

PURPOSE: To investigate if imaging with intravascular ultrasound (IVUS) yields a more accurate estimate of vessel diameter and the presence of dissections than angiography after intervention in the infrapopliteal arteries. MATERIALS AND METHODS: A prospective, single-center study enrolled 20 consecutive patients (mean age 74.1±12.4 years; 12 women) with infrapopliteal disease who were treated with percutaneous transluminal angioplasty (PTA; n=10) or orbital atherectomy (OA) followed by PTA (n=10). The majority of patients were hypertensive and half were diabetic. The overall lesion length was 7.3±6.3 cm, and the diameter stenosis was 80.3%±22.1%. The baseline characteristics did not differ between the groups. Vessel diameters were measured using IVUS from the internal elastic lamina (IEL) to the IEL. IVUS was performed at baseline, post PTA or OA, and post OA+PTA. Quantitative vascular angiography (QVA) and IVUS were analyzed by a core laboratory. Dissections on cine images were categorized based on the National Heart Lung and Blood Institute (NHLBI) classification, while the arc and depth were used to characterize dissections on IVUS images. RESULTS: Mean vessel diameter by QVA was 2.9±0.6 vs 4.0±1.0 mm by IVUS according to the core laboratory (mean difference 1.1±0.9, p<0.001). On angiography, there were 7 dissections after PTA (6 C, 1 D), 1 dissection after OA (1 B), and 2 dissections after OA+PTA (1 A, 1 B; p=0.028 vs post PTA). IVUS uncovered 3.8 times more dissections than seen on angiography. There were 23 dissections after PTA (18 intima, 3 media, 2 adventitia), 12 dissections after OA (8 intima, 1 media, 3 adventitia), and 11 dissections following OA+PTA (7 intima, 1 media, 3 adventitia; p=0.425 vs PTA). Bailout stenting (all due to angiographic dissections ≥C) was necessary in 6 of the PTA cohort and none of the OA+PTA group. CONCLUSION: In addition to underestimating the infrapopliteal vessel diameter by ~25%, angiography underappreciated the presence and severity of post-intervention dissections vs IVUS, particularly in the OA+PTA group.

Meta-Analysis-Derived Benchmarks of Patency and Target Lesion Revascularization of Percutaneous Balloon Angioplasty from Prospective Clinical Trials of Symptomatic Femoropopliteal In-Stent Restenosis.

PURPOSE: To establish historic benchmarks of patency and target lesion revascularization (TLR) in a study-level meta-analysis of prospective studies of balloon angioplasty in treating femoropopliteal in-stent restenosis (ISR). MATERIALS AND METHODS: Data from the balloon angioplasty control arms of 4 randomized multicenter trials (1 Food and Drug Administration-approved study in the United States and 3 conducted in Europe) and 1 European prospective registry were included. Trials included patients with Rutherford stage 1-5 disease or Fontaine ischemia classification states IIb, III, IV and femoropopliteal ISR lesion lengths of 4-27 cm. A two-stage meta-analysis was conducted with study-specific estimates obtained from the randomized trials at the first stage and an analysis that pooled all study-specific estimates at the second stage. The Breslow-Day test of homogeneity was performed on patency and TLR at 6 months and 1 year. RESULTS: Analysis of the balloon-angioplasty control arms of the 5 prospective trials identified 303 patients (mean lesion length, 144.5 mm ± 88.0; vessel diameter, 4.9 mm ± 0.7). Six- and 12-month duplex ultrasound patency rates were 60.7% and 33%, respectively. Six- and 12-month TLR rates with and without "bailout" stent placement considered as TLR were 37.9% and 55.4% and 27.0% and 42.6%, respectively. CONCLUSIONS: It is feasible to derive 6-month and 1-year patency and TLR benchmark data from existing prospective trials of balloon angioplasty in femoropopliteal ISR. However, the study is limited by the lack of data from larger prospective trials with longer-term follow-up.

Single-Center Study Evaluating Long-Term Major Adverse Outcomes with the Use of Paclitaxel-Coated Balloons in Treating Infrainguinal Arterial Disease.

Paclitaxel drug-coated balloons (DCB) have been shown to reduce target lesion revascularization (TLR) rate, but recently an association between paclitaxel and an increase in mortality at 5-year was reported. We reviewed the 5-year mortality and freedom from TLR rates from a single center among patients that received DCB. Consecutive patients that received DCB from July 8, 2015 to November 27, 2019 with follow-up obtained from medical records and review of official death certificates were reviewed. The primary objective was total mortality and TLR rates with cumulative exposure to paclitaxel-coated balloons. Demographic, angiographic, clinical, and procedural variables were collected. Causes of mortality were classified according to death certificates. Descriptive analysis was performed on all variables. Kruskal-Wallis test was used to compare the total length of DCBs in those who were alive and those who died by the end of study. Kaplan-Meier (KM) was used to plot the freedom from mortality up to 5 years. A total of 91 symptomatic patients received the Lutonix balloon at index to treat femoropopliteal arterial disease and subsequently received either Lutonix or in.PACT during the follow-up phase for additional procedures. Age was 68.4 ± 10.8 years (56.0% males). Critical limb ischemia was present in 20.9%. There was no statistical difference in mortality between the median total number of balloons used among patients who were alive versus those who died (2.5 vs. 3.0, p -value = 0.89). Also, there was no statistical difference in the total length of DCB balloons used between those who were alive and those who died at the end of the study (p-value = 0.39). There were no in-hospital amputation or death. At 5-year follow-up KM freedom from TLR was 78.5%. A total of 13 patients died during follow-up. Of these 10 received only the Lutonix balloon and 3 did receive both Lutonix and In.PACT. The yearly KM freedom from mortality for the Lutonix only cohort were 92.7, 89.1, 85.5, 83.6, and 81.8% at 1, 2, 3, 4, and 5 years, respectively. Freedom from TLR and mortality at 5 years appears to be favorable with the use of DCB, predominantly Lutonix balloon in this cohort. This data needs to be supported prospectively by a larger number of patients.

Jetstream Atherectomy in Treating Femoropopliteal In-Stent Restenosis: Meta-Analysis of the JETSTREAM-ISR and JET-ISR Trials.

BACKGROUND: We present the results of a patient-level meta-analysis of the two currently completed and core-lab adjudicated prospective trials of Jetstream atherectomy system (Boston Scientific) in femoropopliteal in-stent restenosis (FP-ISR) and compare the findings to a published, prespecified 6-month performance goal of target-lesion revascularization (TLR) with angioplasty alone. METHODS: The JETSTREAM-ISR (n = 29 patients; n = 32 lesions) was a two-center feasibility study that evaluated Jetstream atherectomy in FP-ISR. The JET-ISR (n = 60 patients; n = 60 lesions) was a 10-center investigational device exemption study that evaluated the same. Both trials were investigator-initiated, prospective, single-arm designs, with core lab assessments of stent-device interaction and with nearly identical inclusion/exclusion criteria and data definitions. The primary endpoint was TLR, which was analyzed using proportional and Kaplan-Meier analyses. RESULTS: A total of 92 lesions were treated in 89 patients. Kaplan-Meier freedom from TLR at 6 months was 78.5% (95% confidence interval, 69.9-87.1). Proportional TLR was 21.2% (18/85 limbs). The performance goal of TLR (bailout stent included as TLR) was set at 37.9% at 6 months with balloon angioplasty alone. TLR rate derived from the meta-analysis was significantly lower than the TLR rate set for the historic control accounting for the 95% confidence interval lower bound (P<.01). There was no device-stent interaction and no amputation. Distal embolization occurred in 11/92 (12.0%) (filters used in 76.1% of all cases) and bailout stenting was performed in 8.7%. CONCLUSION: In this meta-analysis, Jetstream atherectomy in treating FP-ISR had a high freedom from TLR despite no adjunctive drug-coated balloon use. Randomized trials are needed to confirm these findings.

WIRION EPS Filter with Jetstream Atherectomy of Femoropopliteal Arterial Disease: A Single Center Experience.

BACKGROUND: The WIRION EPS filter was recently approved by the Food and Drug Administration (FDA) to be used in conjunction with all atherectomy devices when treating infrainguinal peripheral arterial disease. The safety of this filter with Jetstream atherectomy (JA) in a real world setting remains unclear. METHODS: Consecutive patients from the practice of one operator who underwent JA under WIRION EPS when treating femoropopliteal arteries were enrolled in this retrospective analysis. The primary safety endpoint was the ability of the filter to capture macrodebris with no dissection or thrombosis at the filter site and no filter-related major adverse events. Descriptive analysis on demographics, clinical, procedural and angiographic variables was done using mean ±â€¯SD for continuous variables and percentages for categorical variables. RESULTS: 37 patients were enrolled in this study between June 2016 and September of 2018 (64.9% males, age 68.7 ±â€¯9.0, BMI 27.7 ±â€¯5.4). TASC II classification of the treated lesions were 51.4% B, 24.3% A, 21.6% C, and 2.7% D. At the filter site, spasm occurred in 1/37 (2.7%), while dissection did not occur (0%). Embolization within the filter was found in 51.4% of patients: 14/37 (37.8%) macro debris and 5/35 (13.5%) micro debris. Clinically significant embolization distal to the filter that required treatment with more than a simple aspiration was 1/37 (2.7%). CONCLUSION: WIRION EPS filter use with Jetstream atherectomy was safe and was associated with a low rate of significant distal embolization that required more than a simple aspiration to treat.

Femoropopliteal Arterial Dissections Post Flex Vessel Prep and Adjunctive Angioplasty: Results of the Flex iDissection Study.

BACKGROUND: Luminal gain post balloon angioplasty (PTA) is in part due to the occurrence of dissections. The depth and extent of dissections, however, can influence the short- and long-term outcomes of a procedure. Focal force and scoring balloons have been used to reduce angiographic dissections post PTA. The role of the Flex Vessel Prep (VP) system (VentureMed Group), a dynamic, microincision, non-balloon based system, prior to PTA in reducing and/or limiting severe dissections has not been fully characterized. METHODS: In this prospective pilot study, a total of 15 patients were evaluated by angiography and intravascular ultrasound (IVUS) following treatment of femoropopliteal de novo or no-stent restenosis with the Flex VP system and PTA. Eagle Eye Platinum ST IVUS catheters were used in this study. No atherectomy devices were allowed. Cine and IVUS images were obtained at baseline, after Flex, and following adjunctive PTA. Angiographic and IVUS core labs analyzed the images. RESULTS: Mean patient age was 74.6 ± 11.7 years. Diabetes and claudication were present in 40% and 73.3%, respectively. Median baseline, post-Flex, and postadjunctive PTA stenosis severities were 77.0%, 60.0%, and 34.0%, respectively (P=.07 and P<.001 for baseline vs post Flex and post Flex vs post PTA, respectively). Lesion length was 63.6 ± 32.5 mm. Using PACSS classification for calcium grading, grades 3 and 4 were 6.7% and 40.0%, respectively. Total dissections identified on IVUS post-Flex microincisions were 14 compared with 3 dissections on angiogram (P=.35) (ratio, 4.7 to 1). Post adjunctive angioplasty, there were 49 dissections on IVUS vs 6 on angiogram (P<.01) (ratio, 8.2 to 1). Of these dissections and when compared with baseline, 3 and 37 dissections were new on IVUS post Flex and PTA, respectively. Of these dissections, 2/3 and 7/37 were ≥180° in circumference post Flex and post PTA, respectively. Also, 1/3 and 8/37 dissections involved the media and/or adventitia as seen on IVUS post Flex and PTA, respectively. The majority of dissections post PTA following Flex VP involved mostly the intima (71.4%) and were <180° in circumference (77.6%). CONCLUSION: Dissections are grossly under-appreciated on angiogram when compared with IVUS. Dissections on IVUS post PTA following the Flex VP system involved mostly the intima, with <180° in width. The clinical significance of these findings needs to be further explored.

Safety of the Atlas Gold Balloon in Treating Iliofemoral Veins: Experience From a Single Center.

BACKGROUND: We report on intraprocedural and up to 1-year outcomes on the safety of the Atlas Gold balloon (Bard) in iliofemoral venous interventions. METHODS: All patients who underwent iliofemoral vein compression treatment in our laboratory from September 1, 2013 to May 30, 2017 were identified and medical records were reviewed. The primary safety endpoint was the intraprocedural freedom from major device-related serious adverse events (≥95%) for the Atlas Gold balloon in iliofemoral venous treatment. RESULTS: Seventy-seven patients with iliac vein compression underwent intervention. Predilation was performed in 20 patients with the Atlas Gold balloon (mean diameter, 12.1 mm). The mean pressure was 5.2 atm (range, 3.0-14.0 atm). Post-stent dilation was performed in 61 patients treated with the Atlas Gold balloon (mean diameter: 17.0 mm; range: 12 to 22 mm), with a mean pressure of 6.8 atm (range, 2.0-20.0 atm). There was no stent thrombosis, target-lesion revascularization (TLR), or target-vessel revascularization (TVR) at 1 month. Symptom improvement was reported in 89% of patients. There were 58 patients assessed for patency in the total cohort at 262.7 days, of which 48 patients were postdilated with the Atlas Gold balloon. All stents were patent at 1 year, and there was no stent thrombosis, TLR, or TVR in the cohort treated with the Atlas Gold balloon. Symptom improvement continued at 1 year (37/45 Atlas Gold cohort). CONCLUSION: All patients postdilated with the Atlas Gold balloon exceeded the 95% safety benchmark set in this study. No balloon perforation, vessel laceration, or balloon-related intravascular events occurred.

Intravascular Ultrasound Assessment and Correlation With Angiographic Findings Demonstrating Femoropopliteal Arterial Dissections Post Atherectomy: Results From the iDissection Study.

BACKGROUND: Dissections occur post atherectomy of the infrainguinal arteries. We hypothesized that angiography under-estimates their presence significantly. METHODS: In this prospective pilot study, a total of 15 patients were evaluated by intravascular ultrasound (IVUS) following treatment of femoropopliteal de novo or non-stent restenosis using atherectomy. Eagle Eye Platinum ST IVUS catheters (Philips) were used in this study. Thirteen Jetstream XC atherectomy devices (Boston Scientific) and 2 investigational B-laser atherectomy devices (Eximo Medical) were used. Cine and IVUS images were obtained at baseline, after atherectomy, and after adjunctive balloon angioplasty. Angiographic and IVUS core labs analyzed the images. RESULTS: Mean age was 70.6 ± 8.0 years. Diabetes and claudication were present in 60% and 73%, respectively. Mean baseline, post-atherectomy, and post-adjunctive angioplasty stenosis severity was 71.4%, 38.1%, and 19.7%, respectively (P<.001 for both baseline vs post atherectomy and post atherectomy vs adjunctive angioplasty). Lesion length was 108.5 ± 43.1 mm. Forty-six dissections were identified on IVUS post atherectomy vs 8 dissections on angiogram (P<.01) (ratio, 5.75 to 1). Post adjunctive angioplasty, there were 39 dissections on IVUS vs 11 on angiogram (P<.01) (ratio, 3.55 to 1). Of these dissections, 13% and 30.8% were ≥180° in circumference post atherectomy and adjunctive balloon angioplasty, respectively (P=.047). Also, 39.1% and 33.3% involved the media and/or adventitia as seen on IVUS post atherectomy and adjunctive balloon angioplasty, respectively (P=.58). Longer lesions correlated with more dissections post atherectomy on IVUS (P=.03), but not on angiogram (P=.28). CONCLUSION: Dissections post atherectomy are grossly under-appreciated on angiogram when compared to IVUS. A multicenter registry correlating these findings with clinical outcomes is needed.

Predictors of common femoral artery access site complications in patients on oral anticoagulants and undergoing a coronary procedure.

BACKGROUND: It is unclear whether patients on oral anticoagulants (OAC) undergoing a procedure using common femoral artery access have higher adverse events when compared to patients who are not anticoagulated at the time of the procedure. METHODS: We retrospectively reviewed data from consecutive patients who underwent a cardiac procedure at a tertiary medical center. Patients were considered (group A) fully or partially anticoagulated if they had an international normalized ratio (INR) ≥1.6 on the day of the procedure or were on warfarin or new OAC within 48 h and 24 h of the procedure, respectively. The nonanticoagulated group (group B) had an INR <1.6 or had stopped their warfarin and new OAC >48 h and >24 h preprocedure, respectively. The index primary end point of the study was defined as the composite end point of major bleeding, vascular complications, or cardiovascular-related death during index hospitalization. The 30-day primary end point was defined as the occurrence of the index primary end point and up to 30 days postprocedure. RESULTS: A total of 779 patients were included in this study. Of these patients, 27 (3.5%) patients were in group A. The index primary end point was met in 11/779 (1.4%) patients. The 30-day primary composite end point was met in 18/779 (2.3%) patients. There was no difference in the primary end point at index between group A (1/27 [3.7%]) and group B (10/752 [1.3%]; P=0.3155) and no difference in the 30-day primary composite end point between group A (2/27 [7.4%]) and group B (16/752 [2.1%]; P=0.1313). Multivariable analysis showed that a low creatinine clearance (odds ratio [OR] =0.56; P=0.0200) and underweight patients (<60 kg; OR =3.94; P=0.0300) were independent predictors of the 30-day primary composite end point but not oral anticoagulation (P=0.1500). CONCLUSION: Patients on OAC did not have higher 30-day major adverse events than those who were not anticoagulated at index procedure.