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.

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.

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.

Shockwave™ Lithoplasty in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience.

BACKGROUND: Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center. METHODS: This is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR). RESULTS: A total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients. CONCLUSION: The combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease.

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.

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.

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.

The role of precise imaging with intravascular ultrasound in coronary and peripheral interventions.

Angiography remains a widely utilized imaging modality during vascular procedures. Angiography, however, has its limitations by underestimating the true vessel size, plaque morphology, presence of calcium and thrombus, plaque vulnerability, true lesion length, stent expansion and apposition, residual narrowing post intervention and the presence or absence of dissections. Intravascular ultrasound (IVUS) has emerged as an important adjunctive modality to angiography. IVUS offers precise imaging of the vessel size, plaque morphology and the presence of dissections and guides interventional procedures including stent sizing, assessing residual narrowing and stent apposition and expansion. IVUS-guided treatment has shown to yield superior outcomes when compared to angiography-only guided therapy. The cost-effectiveness of the routine use of IVUS during vascular procedures needs to be further studied.

Location of Dissections Post Balloon Angioplasty in Patients With Femoropopliteal Arterial Disease as Seen on Intravascular Ultrasound.

We reviewed images from our intravascular ultrasound core lab to define the various locations of dissections in femoropopliteal arteries post balloon angioplasty in relation to plaque morphology.

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.

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.

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.

Dissections in Peripheral Vascular Interventions: A Proposed Classification Using Intravascular Ultrasound.

Dissections following interventions in the infrainguinal arteries occur very frequently and are mostly under-appreciated on angiographic imaging. Media and external elastic lamina injury can contribute to loss of patency, and intravascular ultrasound (IVUS) can identify this type of injury. The circumference of injury also has been proposed to be a predictor of outcome. We therefore propose a classification combining depth of injury from intima to adventitia with circumference of dissection. This classification exhibits six dissection grades (A1, A2, B1, B2, C1, and C2) as seen on IVUS (the "iDissection" classification).

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.

Detecting Venous Reflux Using a Sixty-Degree Reverse Trendelenburg (RT-60) Position in Symptomatic Patients With Chronic Venous Disease.

BACKGROUND: The optimal technique to detect venous reflux requires a patient to be standing with weight on one leg while the other leg is scanned for superficial venous reflux (standing position [SP] technique). This represents a significant hardship for a subset of patients who are unable to stand and adequately maintain their balance. This study examines the predictability of identifying venous reflux using a reverse Trendelenburg 60° (RT-60) when compared with the SP in the great saphenous vein (GSV) and small saphenous vein (SSV). METHODS: After obtaining informed consent, consecutive symptomatic patients were studied for venous reflux in the GSV and SSV using both SP and RT-60 during the same visit to the diagnostic laboratory. Reflux was analyzed in both SSV (proximal, mid, and distal segments) and GSV (proximal, mid-thigh, distal-thigh, and below-the-knee segments). Reflux was defined as duration of retrograde venous flow >0.5 seconds following rapid cuff deflation. Patients with heart failure, prior limb surgery, history of deep vein thrombosis, cellulitis, known severe pulmonary hypertension, end-stage renal disease, lymphedema, or trauma were excluded. We calculated the percentage of segments that had reflux on RT-60 out of those with reflux on SP, and the percentage of no reflux on RT-60 out of those with no reflux on SP. RESULTS: A total of 33 patients (56 limbs, 252 segments) were included in this analysis. Mean age was 65 ± 12.4 years and 54.5% were male. All patients were symptomatic (mean clinical, etiology, anatomy, pathophysiology [CEAP] class, 3.5). Deep venous reflux was present in 3/33 patients (9.1%). Of the patients enrolled, 93.9% noted worsening swelling of their lower extremities with standing up and 53.6% of limbs were CEAP class IV or higher. All limbs with no reflux on RT-60 had no reflux using the SP and 48/49 limbs (98%) with reflux on SP also had reflux on the RT-60. CONCLUSION: RT-60 appears to capture 98% and 100% of positive and negative reflux scans on SP, respectively, when GSV and SSV were evaluated. These findings, however, may not apply to the remainder of the venous system of the lower extremity, where SP may continue to be the standard for venous reflux evaluation.