Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.

PURPOSE: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. METHODS: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. RESULTS: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. CONCLUSION: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

Clinical outcome of an extended proximal seal zone with the AFX endovascular aortic aneurysm system.

OBJECTIVE: Despite improvements in endograft technology, operator skill, and patient selection, endovascular aneurysm repair continues to be associated with device-related complications. A retrospective, observational study was undertaken to evaluate the clinical outcome and imaging findings of a unique device having externally-mounted, conformable graft material. METHODS: Infrarenal abdominal aortic aneurysms were treated with the Endologix, Inc AFX endovascular aortic aneurysm system (Irvine, Calif) endograft in 108 consecutive patients over a 25-month period at two U.S. clinical sites. Baseline characteristics and procedural outcomes were reviewed by independent monitors. Serial computed tomography (CT) imaging assessments were performed by an independent core laboratory. Aortic neck characteristics and graft apposition were analyzed from center line-reformatted CT data sets in 37 patients in an imaging cohort comprising subjects with high-resolution baseline and follow-up CT imaging for precise assessment of aortic neck characteristics. The mean follow-up was 11 ± 5 months overall, 9 ± 6 months in patients with core laboratory imaging, and 5 ± 2 months for patients in the imaging cohort. RESULTS: Among the 108 patients, 103 (95%) had intact aneurysms and five (4.6%) were treated for rupture; 80 (74%) were male and 28 (26%) were female. On average, 2.3 ± 0.7 endograft components were implanted per patient and no adjunctive proximal neck bare stents were used. There were no perioperative deaths in patients with intact aneurysms; two patients who presented with ruptured aortic aneurysms (40%) died. Major adverse events occurred within 30 days of implantation in two patients (1.9%) with intact aneurysms. Type II endoleaks were evident on completion angiography in 18 patients (16.7%). Core laboratory analysis of CT studies identified two patients with type Ia endoleaks (2.3%), two with type III endoleaks (2.3%), and five with type II endoleaks (5.7%). Aneurysm-related secondary procedures were required in five patients over the first year of follow-up (4.6%). No patient developed endograft limb occlusion or aneurysm rupture and there were no open surgical conversions. In the imaging cohort, 360° graft-to-aortic wall apposition was continuous over a length of 25 ± 17 mm and extended the seal zone an average of 5 mm beyond the end of the anatomic neck. Early sac regression was correlated with neck length (P = .019) and graft-to-aortic apposition surface area (P = .039). CONCLUSIONS: The real-world use of the AFX endograft was associated with a low rate of device-and procedure-related complications. The ability to achieve an extended seal zone beyond the anatomical neck might in part contribute to positive outcomes, including the low type Ia and type II endoleak rate. These findings suggest that the AFX device might offer some advantages over other currently marketed endografts, but confirmation awaits the availability of longer-term outcome data.

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

PURPOSE: To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). METHODS: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. RESULTS: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. CONCLUSION: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.

Endovascular repair of a chronic aortocaval fistula using a thoracic aortic endoprosthesis.

Penetrating abdominal trauma with injury to the aorta and vena cava usually requires emergent intervention and is frequently lethal. Formation of a chronic aortocaval fistula (ACF) is an uncommon late complication of these injuries. We report a case of an ACF presenting 17 years after a gunshot wound to the abdomen, with progressive congestive heart failure as the presenting symptom. The ACF was successfully treated with an endoprosthesis designed for the thoracic aorta.

Crossing chronic total occlusions with the Ocelot system: the initial European experience.

AIMS: The aim of the study was to determine the safety, efficacy and feasibility of a new chronic total occlusion (CTO) device using optical coherence tomography (OCT) technology, the Ocelot catheter (Avinger, Inc., Redwood City, CA, USA), for crossing of SFA CTOs following guidewire failure. METHODS AND RESULTS: Prospective, multicentre, market preference testing. Thirty-three patients with confirmed CTO (99-100% stenosis by visual estimate) of their superficial femoral artery (SFA) were treated between September 28, 2011, and December 9, 2011, at three European centres. Ocelot crossed 94% (31/33) of CTOs, allowing guidewire placement in the distal true lumen. All (100%) lesions were treated without any major adverse safety events. Procedural time and contrast dose were significantly reduced (p<0.0001) when compared with a similar, non-OCT-guided CTO crossing device (Wildcat catheter; Avinger, Inc.). Overall physician feedback on the catheter performance was positive with an 87% average rating of excellent or good across seven categories. Performance ratings of Ocelot's OCT imaging guidance were consistently positive with an 86% average rating of excellent or good across five OCT categories. CONCLUSIONS: The Ocelot catheter combines advanced CTO crossing technology with real-time OCT guidance. When compared with a similar non-OCT-guided catheter, crossing efficacy and safety profile improved. Total procedure time and contrast volumes were significantly reduced. The Ocelot is a safe, efficient and effective tool for crossing CTOs.

Recurrence of chronic venous ulcers on the basis of clinical, etiologic, anatomic, and pathophysiologic criteria and air plethysmography.

INTRODUCTION: Leg ulcers associated with chronic venous insufficiency (CVI) frequently recur after healing. The risk of recurrence has not been well defined for patients in different anatomic and hemodynamic groups. We reviewed the risk of ulcer recurrence on the basis of clinical, etiologic, anatomic, and pathophysiologic criteria and hemodynamic characteristics of the affected limb as assessed with air plethysmography (APG). METHODS: Ninety-nine limbs with class 6 CVI were assessed clinically and with standing duplex ultrasound scanning and APG for the definition of clinical, etiologic, anatomic, and pathophysiologic criteria. Leg ulcers were treated with high-pressure compression protocols. Surgical correction of venous abnormalities was offered to patients with appropriate conditions. After ulcer healing, the limbs were placed in compressive garments and followed at 6-month intervals for ulcer recurrence. RESULTS: The mean patient age was 54.3 years, and 46% of the patients were female. Corrective venous surgery was performed in 37 limbs. The mean follow-up time for all 99 limbs was 28 months. The ulcer recurrence rate with life table was 37% +/- 6% at 3 years and 48% +/- 10% at 5 years. The patients who underwent venous surgery had a significantly lower recurrence rate (27% +/- 9% at 48 months) than did those patients who had not undergone surgery (67% +/- 8% at 48 months; P =.005). The patients with deep venous insufficiency (DVI; n = 51) had significantly higher recurrence rates (66% +/- 8% at 48 months) than did the patients without DVI (n = 48; 29% +/- 9% at 48 months; P =.006). This difference was significant even after accounting for the effects of surgery (P =.03). The hazard ratio of ulcer recurrence increases by 14% for every unit increase in the venous filling index (VFI; P =.001). This remains significant even after accounting for the effects of surgery (P =.001). The combination of DVI and a VFI of more than 4 mL/s yields a risk of ulcer recurrence of 43% +/- 9% at 1 year and 60% +/- 10% at 2 years. CONCLUSION: Leg ulcers associated with CVI have a high rate of recurrence. Ulcer recurrence is significantly increased in patients with DVI and in patients who do not have venous abnormalities corrected surgically. The VFI obtained from APG is useful in the prediction of increased risk for recurrence, particularly in association with anatomic data.