Long-term results of a prospective, single-arm evaluation of everolimus-eluting bioresorbable vascular scaffolds in infrapopliteal arteries.

OBJECTIVES: The aim of this study was to perform a long-term evaluation of an everolimus eluting, bioresorbable vascular scaffold (BVS) in the treatment of de novo atherosclerotic disease within crural arteries. METHODS: A prospective, single-arm study was performed enrolling patients with chronic lower limb ischemia between 2013 and 2018. RESULTS: Fifty-five limbs in 48 patients (56% male; mean age 82.1 ± 8.0 years, range 65-97) were treated for critical limb ischemia (72.7%) or severe claudication (27.3%). Seventy-one scaffolds were used to treat 61 lesions with a mean length of 20.1 ± 10.8 mm. During a mean follow-up period of 35.2 ± 20.4 months, 22 (45.8%) patients had died. No late or very-late scaffold thrombosis was observed. Overall, clinical improvement was observed in 90.9% and a limb-salvage rate of 100% was observed. Binary restenosis was detected in 11/71(15.5%) scaffolds. Primary patency and freedom from clinically driven target lesion revascularization rates at 12, 24, 36, 48, and 60 months were 90.8% (95% confidence interval 80.7-95.8), 90.8% (80.7-95.8), 79.7% (65.8-88.4), 76.3% (61.1-86.2), 72.3% (55.5-83.4) and 97.2% (89.2-99.3), 97.2% (89.2-99.3), 90.7% (78.7-96.1), 90.7% (78.7-96.1), and 90.7% (78.7-96.1), respectively. CONCLUSIONS: This long-term study shows excellent rates of patency and freedom from target lesion revascularization using the absorb BVS below-the-knee. This proof of concept study lays the foundation for the next generation of BVS to be evaluated in infrapopliteal arteries.

Endovascular treatment of critical lower limb ischemia caused by giant cell arteritis.

Giant cell arteritis (GCA) is a well-known cause of cranial vasculitis often presenting with headache and jaw claudication. Here we report the case of a woman suffering GCA who presented with critical lower limb ischemia. Despite best medical therapy, she developed progressive calf claudication and ulceration of the right foot. The findings on workup were highly suggestive of GCA involving the superficial femoral artery. The limb was successfully revascularized with angioplasty and placement of a drug-eluting stent. GCA is an important cause of lower limb ischemia and should be considered in patients without evidence of atherosclerosis. Endovascular intervention is a feasible treatment of critical limb ischemia due to GCA and has been shown to be safe in this case.

Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries.

PURPOSE: To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease. METHODS: A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality. RESULTS: Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%-75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%). CONCLUSION: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.

Anterior Lumbar Interbody Fusion in Left-sided Inferior Vena Cava and Right-sided Aortic Arch.

Spinal fusion via anterior lumbar interbody fusion (ALIF) can offer symptomatic relief to patients that suffer severe low back pain, radiculopathy, and claudication. However, a detailed working knowledge of the thoracic, abdominal, and lumbar anatomy, particularly of the vasculature, is vital. We report the case of a 68-year-old man who presented with radiculopathy and progressively worsening low back pain despite 9 months of unsuccessful conservative therapy and pain management. Preoperative computed tomography and magnetic resonance imaging revealed a rare anatomical variation, with an anomalous left-sided inferior vena cava and anomalous aorta. The patient was surgically treated with ALIF at L4,5 and L5 S1 via an altered surgical window. Given the anomalous anatomy of the patient, instead of performing the procedure after mobilizing both of the transposed abdominal great vessels, the inferior vena cava and the abdominal aorta, the ALIF was uneventfully performed in the window between these vessels. There were no perioperative or postoperative complications. At 12-week postoperative follow-up, X-ray imaging demonstrated successful implantation of ALIF cages with no recurrence of symptoms. A detailed working knowledge of anatomy is important, particularly if anatomical variations are present. This has implications for preoperative surgical planning, which is integral to the safety and the success of procedures.

Utility of Adjunctive Digital Subtraction Venography for the Treatment of Saphenous Vein Insufficiency.

PURPOSE: To report the use of adjunctive venography for the treatment of superficial venous reflux. METHODS: Two hundred consecutive patients (mean age 60.9 years, range 33-86; 128 women) with chronic venous disease underwent saphenous or perforator vein ablation in 268 limbs (305 venous trunks) guided by adjunctive venography and fluoroscopy in addition to ultrasound between October 2010 and May 2016. Intraprocedural venograms were independently evaluated by 2 vascular specialists to identify the presence of venous anomalies and the need for fluoroscopy-guided maneuvers to successfully complete venous ablation. Intraprocedural venography results were compared with preoperative venous duplex scan reports to ascertain if the duplex study could be of value in identifying preoperatively any anatomical variants that may pose a technical challenge to the operator. RESULTS: In this cohort, 542 venograms (2.0/limb) were performed with a mean duration of 4.9±9.1 minutes (range 1-48). Two thirds of patients (132, 66%) had anomalies or abnormalities within the target vein; more than a third (88, 44%) required an endovascular maneuver to successfully complete the ablation and 17% (34) of cases were impossible to complete without adjunctive fluoroscopic guidance. Per-patient comparison of intraprocedural venography with preoperative venous duplex reports identified 21 (11%) patients with abnormalities detected on ultrasound (23 anomalies) compared with 123 (64%) on venography (193 anomalies). This gave ultrasound a 17.1% sensitivity, 100% specificity and positive predictive value, and 40.7% negative predictive value. CONCLUSION: Venography is a valuable addition to ultrasound to facilitate complete ablation of insufficient saphenous veins in selected patients with complex anatomy.

Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Arteries Below the Knee: 12-Month Clinical and Imaging Outcomes.

OBJECTIVES: The aim of this study was to investigate the midterm performance of an everolimus-eluting, bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, California) for the treatment of focal tibial and distal popliteal lesions. BACKGROUND: Drug-eluting stents are used below the knee to improve technical success and durability, but the ongoing presence of a permanent metal scaffold may have deleterious effects on the local vessel. METHODS: Tibial and distal popliteal angioplasty with scaffold placement was performed using an everolimus-eluting, bioresorbable scaffold (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, 12, and 24 months to detect binary restenosis and evaluate safety, restenosis, and clinical improvement. RESULTS: Thirty-eight limbs in 33 patients were treated for critical limb ischemia (68.4%) or severe claudication (31.6%). Fifty scaffolds were used to treat a total of 43 lesions, with a mean length of 19.2 ± 11.6 mm. During a mean follow-up period of 12.0 ± 3.9 months, 5 patients died, and all others were available for follow-up. Among the 38 treated limbs, clinical improvement was present in 30 (79%). Binary restenosis was detected in 3 of 50 scaffolds (6%). Using the Kaplan-Meier method, rates of primary patency were 96% and 84.6% at 12 and 24 months, respectively, and rates of freedom from clinically driven target lesion revascularization were 96% and 96% at 12 and 24 months, respectively. Complete wound healing occurred in 64% of those treated for tissue loss, with no major amputation and a limb-salvage rate of 100%. CONCLUSIONS: Twelve-month follow-up demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.

A Real-World Experience With the Supera Interwoven Nitinol Stent in Femoropopliteal Arteries: Midterm Patency Results and Failure Analysis.

PURPOSE: To evaluate the safety and midterm patency of the Supera interwoven nitinol stent in a real-world population and determine deployment and patient-related factors that may predispose to loss of patency. METHODS: A retrospective analysis was conducted of 111 consecutive limbs from 97 patients (mean age 75.3 years; 68 men) with severe atherosclerotic disease of the superficial femoral and popliteal arteries that were treated with Supera stents between June 2012 and October 2014. Half the patients had claudication (56%); the remainder had rest pain (19%) and tissue loss (26%). Forty-eight (43%) lesions were chronic total occlusions, and more than half were classified as TransAtlantic Inter-Society Consensus C (22%) or D (30%). RESULTS: All 146 Supera stents (1.32 stents per limb) were deployed successfully, extending over a mean length of 175.5±130.5 mm to treat lesions averaging 151.5±127.1 mm long. At 30 days, Kaplan-Meier estimated freedom from death, target lesion revascularization, and amputation was 97.3%. Primary patency and freedom from clinically driven target lesion revascularization rates were 87.1% and 95.0% at 6 months, respectively, and 78.9% and 87.6% at 12 months, respectively. Four distinct mechanisms for failure were identified in the 13 limbs in which patency was lost; stent intussusception (n=4), compromised inflow or outflow (n=2), gross oversizing (n=1), and neoplastic thrombophilia (n=1); the cause of 5 occlusions could not be identified. CONCLUSION: In this heterogeneous group that included long and complex atheromatous femoropopliteal lesions, the Supera stent achieved excellent clinical and patency results at 1 year. Further improvement may be achieved through careful patient selection and the avoidance of deployment pitfalls.

A Microscopic and Biomarker Evaluation of Embolic Filter Debris Collected During Carotid Artery Stenting.

PURPOSE: To evaluate and characterize debris retrieved from the cerebral embolic protection devices (EPDs) used during carotid artery stenting (CAS) and compare debris size, volume, tissue types, cellular composition, and protein biomarker expression in symptomatic and asymptomatic patients. METHODS: Distal protection filters were retrieved from 22 consecutive patients (mean age 71.6 years, range 52-85; 16 men) undergoing elective CAS between July 2012 and February 2014 for >70% internal carotid artery stenosis (mean 85.4% ± 10.3%). Six patients were symptomatic. The debris within each EPD was visually characterized using stereomicroscopy and then processed for histology and immunohistochemistry. Biomarkers were immunohistochemically measured to evaluate plaque stability [matrix metalloproteinase-9 (MMP-9)], inflammation [glycoprotein CD68 and interleukin-6 (IL-6)], or phenotype [smooth muscle (SM)-actin and type IV collagen]. The immunohistochemical results were measured using semiquantitative grading criteria based on both staining intensity and distribution in the samples. RESULTS: Macroscopic debris was visible in 5/22 EPDs; 3 of the 5 filters came from symptomatic patients. Microscopic debris was detected in all filters and ranged in size from 0.01 to 8.57 mm(2). Debris consisted of calcified, fibrous, and necrotic tissue, as well as fibrin and foam cells with no significant difference between the symptomatic and asymptomatic groups. There was no association between the degree or type of embolic material and stenosis severity, carotid tortuosity, calcium grade, soft plaque, or arch type. Symptomatic patients had a larger volume of debris (8.24 vs 0.58 mm(3), p<0.01), mean particle size (1.30 vs 0.32 mm(2), p<0.001), and expression of biomarkers IL-6 (2.17 vs 0.81, p<0.05), CD68 (2.00 vs 0.38, p<0.01), SM-actin (1.00 vs 0.25, p=0.055), type IV collagen (1.17 vs 0.25,p=0.082), and MMP-9 (1.00 vs 0.06, p<0.05). CONCLUSION: Histological analysis revealed particulate embolization in all EPDs used during CAS. Symptomatic patients had a larger volume of embolic debris, mean particle size, and the biomarkers associated with inflammation, necrotic core, and diminished fibrous cap.

An Endovascular-First Approach to the Treatment of Critical Limb Ischemia Results in Superior Limb Salvage Rates.

PURPOSE: To evaluate the effect of a shift to a primary endovascular revascularization (ER) strategy for patients presenting with critical limb ischemia (CLI) after a change in staff at our center in 2008 altered our revascularization strategy. METHODS: Between 2004 and 2012, 344 critically ischemic limbs were treated in 279 patients (mean age 74.0±11.4 years; 179 men) during 546 separate hospital admissions. Limbs were analyzed according to (1) their principal revascularization strategy and (2) their date of presentation [early (2004-2008) or late (2008-2012)]. RESULTS: Compared with the open revascularization (OR) and no revascularization (NR) groups, the ER group had an increased freedom from major amputation (92.3% vs 80.0% OR vs 69.3% NR, p<0.001), reduced hospital stay (15.2 vs OR 31.6 vs NR 25.9 days, p<0.001), intensive care unit (ICU) stay (2.3 vs OR 23.7 vs NR 7.2 hours, p=0.033), and operating time for ER vs OR (157.9 vs 316.8 minutes, respectively; p<0.0001). There was also a significant decrease in limbs requiring minor amputations (23.2% vs OR 29.3% vs NR 37.6%, p=0.041) and mean number of admissions/limb compared to OR (1.5 vs OR 1.9 vs NR 1.5, p=0.007). The late era saw the treatment of a larger number of limbs (223 vs 121) compared with the earlier time period. This institutional shift resulted in increased freedom from major amputation (87.4% vs 74.4%, p<0.01), reduced ICU stay (3.45 vs 16.98 hours, p<0.01), and shorter length of stay (20.9 vs 31.5 days, p<0.01) between the 2 eras, respectively. CONCLUSION: A shift to an endovascular-first treatment strategy is associated with fewer major amputations and shorter length of stay.

Initial experience with the absorb bioresorbable vascular scaffold below the knee: six-month clinical and imaging outcomes.

PURPOSE: To investigate a new bioresorbable vascular scaffold for the treatment of focal tibial and distal popliteal lesions. METHODS: Tibial and distal popliteal angioplasty was performed in 15 limbs of 14 patients (9 men; median age 82 years) with critical limb ischemia (CLI, n=7) or severe claudication. The 18 lesions (mean length 22.2±14.0 mm) were implanted with 22 everolimus-eluting bioresorbable scaffolds (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, and 12 months to detect restenosis and evaluate safety, midterm restenosis rate, and clinical improvement. RESULTS: Immediate technical success was 100%, although a single limb suffered 2 scaffold thromboses on the first day; it was salvaged with repeat endovascular intervention. All patients were available for surveillance examinations during a follow-up of 6.1±3.9 months; no patient died. Of the 15 limbs in the analysis, clinical improvement was present in 12 (4 of 7 CLI patients); there was no amputation, bypass surgery, or evidence of binary restenosis on follow-up sonographic examination. CONCLUSION: Midterm follow-up for this small pilot sample demonstrates acceptable safety and patency results, together with freedom from all major adverse limb events, using the Absorb bioresorbable vascular scaffold below the knee.

Fenestrated aortic arch stent-graft malfunction with endovascular salvage.

PURPOSE: To describe a case of a fenestrated aortic stent-graft device malfunction in the aortic arch, which left the stent-graft deployed and almost irretrievable had it not been for an escalating series of endovascular salvage maneuvers. CASE REPORT: A 47-year-old man presented with a rapidly enlarging 6.9-cm thoracic aneurysm that was a complication of a chronic type B aortic dissection. A 2-piece, custom-made, tapered, fenestrated thoracic endoprosthesis (innominate scallop plus single carotid) was planned to seal from the innominate origin to immediately above the celiac axis after staged left carotid to subclavian bypass. Blood pressure control with rapid ventricular pacing aided deployment of the proximal, fenestrated stent-graft component with both openings accurately positioned over their respective branch vessel ostia. Attempted retrieval of the nosecone was hampered by a release failure of the single conformance tie that connects the stent-graft to its central cannula. This left the stent-graft fully deployed with the nosecone irretrievable beyond a point immediately distal to the small fenestration. A series of endovascular salvage maneuvers ensued, ranging from simple actions to manipulate and balloon dilate the graft through to more complex attempts to break the tie and lasso the nosecone using snares. Finally, attempts at antegrade retrieval of the nosecone straightened the device and released the offending tie, allowing case completion. CONCLUSION: This is a rare but cautionary example of the potential pitfalls of translating endograft technology from the abdominal aorta to the hostile environment of the aortic arch. It is likely that a combination of the arch curvature and hemodynamic forces, combined with the narrowed true lumen, contributed to failure of the trigger-wire tie release mechanism. Consideration of these endovascular salvage maneuvers may benefit interventional specialists who treat such diseases of the aortic arch.

Adjunctive ultrasonography to minimize iodinated contrast administration during carotid artery stenting: a randomized trial.

PURPOSE: To report a single-center, prospective randomized controlled trial that compared contrast use during ultrasound-assisted carotid artery stenting (CAS) to CAS procedures without ultrasound. METHODS: Between August 2010 and November 2011, 22 patients (18 men; mean age 72.8 years, range 62-84) with 25 severe symptomatic (n=3) or asymptomatic (n=22) carotid stenoses undergoing an endovascular intervention were randomly allocated (~1.1) to ultrasonography-assisted (n=13) or stand-alone (n=12) CAS. The primary endpoints were contrast use and number of selective cerebral injections. Secondary endpoints were procedure time, fluoroscopy time, any stroke, renal function assessment, major adverse cardiac events (MACE), and death. RESULTS: In the study period, 23 of 25 scheduled CAS procedures (12 ultrasound-assisted, 11 control) were completed in 20 patients; 2 procedures were aborted owing to friable plaque and difficult guidewire access, respectively. There were no deaths, stroke, MACE, or precipitation of dialysis-dependent renal failure in either group. Iodinated contrast usage was reduced by 61% (45.4±24.4 vs. 17.8±11.9 mL, p=0.002) and number of selective cerebral contrast injections by 49% (8.3 vs. 4.2, p=0.002). Neither time taken to complete the procedure (32.5 vs. 35.4 minutes, p=0.38) nor fluoroscopy time (14.5 vs. 13.9 minutes, p=0.54) differed significantly between the groups. Creatinine levels remained stable after CAS and did not differ between groups. CONCLUSION: Ultrasonography-assisted CAS is feasible and safe. Its use can significantly lower the usage of iodinated contrast and the number of selective cerebral circulation injections while not prolonging the length of the procedure or the fluoroscopy time.

Endovascular reconstruction of the occluded aortoiliac segment using "double-barrel" self-expanding stents and selective use of the Outback LTD catheter.

PURPOSE: To present the early and midterm results of endovascular stent reconstruction of the occluded aortoiliac segment with selective use of the Outback LTD re-entry catheter. METHODS: Between April 2004 and February 2010, 8 patients (5 women; mean age 58.4 years, range 47-68) with occlusion of the infrarenal aorta extending to the common or external iliac arteries underwent endovascular reconstruction with double-barrel self-expanding stents. Indications for treatment were severe claudication in 6 and ulceration in 2 patients. RESULTS: The technical success rate was 100%, facilitated by the use of the Outback LTD catheter for accurate wire re-entry in 3 cases. There was no in-hospital mortality. One patient had a major complication (femoral artery dissection, brachial artery thrombosis, and retroperitoneal hematoma) unrelated to the re-entry device. Mean operating time was 137 minutes (range 70-253) and length of stay was 1.5 days (range 1-2). During a mean follow-up of 12.5 months (range 6-29), primary patency was 100% with no secondary interventions. CONCLUSION: Total endovascular reconstruction of the occluded infrarenal aorta that extends into the iliac arteries is durable at midterm follow-up. Adjunctive use of the Outback LTD re-entry catheter can facilitate technical success.