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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.

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.

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.

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.

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 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).

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.