A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

Midterm Results of the Supera Stent for the Treatment of Femoropopliteal Occlusive Disease.

BACKGROUND: The Supera (Abbott Vascular, Santa Clara, CA) stent is an interwoven nitinol, shape-memory stent with high strength and flexibility characteristics which are purported to increase resistance to kinking and compression. The purpose of this study was to review single-center outcomes of the use of this stent in the femoropopliteal segment. METHODS: We performed a single-center, retrospective analysis of patients who underwent Supera stent placement for femoropopliteal occlusive disease from 2016-2019. Data was collected on patient demographics and procedural details. Follow-up imaging data, including duplex imaging and ankle-brachial indices, and clinical data were abstracted from encounter notes. RESULTS: Sixty-two patients with 72 unique Supera stent placements were identified. Mean age was 76 and 69% were male. 56% of patients had severe calcification and 11% had moderate calcification. 48% of lesions were Trans-Atlantic Inter-Society Consensus Document C or D lesions. Primary patency rates at 12, 24, and 36 months were 85%, 82%, and 75%, respectively. Primary patency was not affected significantly by lesion length, degree of calcification, number of outflow vessels, concomitant interventions, or stent size. CONCLUSIONS: These results demonstrate sustained primary patency with the Supera stent over a 3-year interval in treatment of patients with femoropopliteal occlusive disease, including in the setting of severely calcified vessels.

Preoperative thrombolysis is associated with improved vein patency and functional outcomes after first rib resection in acute Paget-Schroetter syndrome.

INTRODUCTION: Most patients with acute Paget-Schroetter syndrome (PSS) present in one of two manners: (1) thrombosis managed initially with thrombolysis and anticoagulation and then referred for surgery, and (2) initial treatment with anticoagulation only and later referral for surgery. Definitive benefits of thrombolysis in the acute period (the first 2 weeks after thrombosis) over anticoagulation alone have not been well reported. Our goal was to compare patients managed with early thrombolysis and anticoagulation followed by first rib resection (FRR) and later postoperative venography with venoplasty (PTA) with those managed with anticoagulation alone followed by FRR and PTA using vein patency assessed with venography and standardized outcome measures. METHODS: We reviewed a prospectively collected database from 2000 to 2019. Two groups were compared: those managed with early thrombolysis at our institution (Lysis) and those managed with anticoagulation alone (NoLysis). All patients underwent FRR. Venography was routinely performed before and after FRR. Standardized outcome measures included Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores and Somatic Pain Scale. RESULTS: A total of 50 Lysis and 50 NoLysis patients were identified. Pre-FRR venography showed that thrombolysis resulted in patency of 98% of veins, whereas 78% of NoLysis veins were patent. After FRR, postoperative venography revealed that 46 (92%) patients in the Lysis group and 37 (74%) patients in the NoLysis group achieved vein patency. Thrombolysis was significantly associated with final vein patency (odds ratio: 17 [4-199]; P < .001). Lysis patients had a trend toward lower QuickDASH scores from pre-FRR to post-FRR compared with NoLysis patients with a mean difference of -16.4 (±19.7) vs -5.2 (±15.6) points (P = .13). The difference in reduction of Somatic Pain Scale scores was not statistically significant. CONCLUSIONS: Thrombolysis as initial management of PSS, combined with anticoagulation, followed by FFR and VenoPTA resulted in improved final vein patency and may lead to an improved functional outcome measured with QuickDASH scores. Therefore, clinical protocols using thrombolysis as initial management should be considered when planning the optimal treatment strategy for patients with acute PSS.

Comparison of Angiographic and Intravascular Ultrasound Vessel Measurements in Infra-Popliteal Endovascular Interventions: The Below-the-Knee Calibration Study.

BACKGROUND: Endovascular revascularization (ER) via percutaneous transluminal angioplasty (PTA) and stenting are viable options for revascularization in below-the-knee (BTK) peripheral arterial disease. Two-dimensional angiography has been the standard of practice for estimating vessel size and selecting treatment devices during ER. However, in other vascular territories, intravascular ultrasound (IVUS) offers better visualization of the lumen dimensions. PURPOSE: To compare angiographic and intravascular ultrasound reference vessel (lumen) measurements in below-the-knee peripheral artery interventions. METHODS: Twenty consecutive patients were enrolled in the BTK Calibration study from 2 sites in the United States and Australia. Patients with at least one diseased segment in a native infra-popliteal artery (below-the-knee) and a clinical indication for endovascular therapy (EVT) were included with no limitations with regard to vessel diameter or lesion length. Digital subtraction angiography and IVUS imaging were collected pre- and post-PTA and images were sent to an independent core lab for standardized quantitative analysis of the normal-looking reference vessel dimensions when available. The results were presented as least square means with 95% confidence intervals and a p-value of <0.05 was considered significant. RESULTS: The overall (N = 19) mean reference vessel diameter for QVA was 2.98 ± 1.24 mm vs. 3.47 ± 0.72 mm for IVUS (mean difference was -0.50 mm, (95% CI: -0.80, -0.20; p = 0.14). As expected, in the proximal segments (N = 12), the mean reference vessel diameters were larger: for QVA, it was 3.17 ± 1.34 mm vs. 3.55 ± 0.76 mm in IVUS, (mean difference was -0.38 mm, (95% CI: -0.79, 0.03; p = 0.40); while in the distal segments (N = 7), mean reference vessel diameters were smaller: for QVA, it was 2.64 ± 1.06 mm vs. 3.33 ± 0.67 mm in IVUS, (mean difference was -0.69 mm, (95% CI: -1.04, 0.34; p = 0.17). We observed a greater degree of acute gain in cases where the treatment balloon size correlated with the IVUS measured reference size. CONCLUSION: Angiography underestimates infrapopliteal reference vessel lumen size even when quantitatively assessed. Adjunctive IVUS imaging use in guiding BTK procedures could help ensure adequate sizing and possibly impact immediate post-procedure indices.

Endovenous microfoam ablation of below knee superficial truncal veins is safe and effective in patients with prior saphenous treatment across a wide range of CEAP classes.

OBJECTIVE: Patients requiring thermal or chemical ablation of below knee (BK) truncal veins often have their proximal saphenous veins treated initially and comprise a study population with multilevel, refractory chronic venous insufficiency. The study objective was to assess the outcomes after microfoam ablation of BK truncal and tributary veins in patients with a history of proximal great saphenous vein (GSV) ablation or stripping. METHODS: A retrospective review of a prospectively maintained database was performed. All the patients who had undergone endovenous chemical ablation with commercially manufactured polidocanol microfoam for symptomatic BK truncal vein reflux after a previous saphenous ablation or stripping were identified. The patients had undergone duplex ultrasound scanning 48 to 72 hours after the procedure; those who had not adhered to the recommended follow-up protocol were excluded. The demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, venous clinical severity score (VCSS), procedure details, adverse thrombotic events, and follow-up data were abstracted. RESULTS: Between April 2018 and April 2021, 201 limbs were treated for symptomatic superficial truncal vein reflux with microfoam ablation. Of the 201 limbs, 68 in 49 patients met the inclusion criteria for the present study. The veins treated included the BK GSV (n = 45) and small saphenous vein (n = 23). The median follow-up was 97 days (range, 33-457 days) for the entire cohort. Most patients (63%) had a preoperative CEAP classification of C4 to C6. The median preoperative VCSS was 12.5. All the limbs that had undergone microfoam ablation in this cohort had a previously treated proximal ipsilateral GSV, with either thermal ablation or stripping. The median postoperative VCSS after BK treatment decreased to 10 (P < .001). The closure rate at the last follow-up was 96%. The overall symptomatic relief was 78% at the last follow-up. The absolute ulcer healing rate during the study period was 64% (16 of 25 ulcers had healed). One patient had developed thrombus extension into the popliteal vein, which resolved with anticoagulation therapy. One asymptomatic patient had developed nonocclusive thrombus in a gastrocnemius vein after small saphenous vein ablation. Because she was asymptomatic, anticoagulation therapy was not prescribed. Postoperative pain, phlebitis, and swelling were reported in 12%, 12%, and 2% of patients, respectively, and all had resolved at the last follow-up visit. Three limbs treated with chronic oral anticoagulant agents had had recanalized truncal veins during the study period after initial closure. No pulmonary emboli or neurologic adverse events were reported. No symptoms of saphenous or sural nerve injury had occurred. CONCLUSIONS: Endovenous chemical ablation with commercially manufactured polidocanol microfoam of BK truncal veins is a safe and effective treatment for patients with severe, refractory chronic venous insufficiency and prior saphenous interventions. This technique results in excellent overall closure rates and symptomatic relief with low adverse venous thrombotic events, across a wide range of CEAP classes.

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

BACKGROUND: Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation. OBJECTIVES: Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. METHODS: REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. RESULTS: A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. CONCLUSIONS: Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Adjunctive techniques to minimize thrombotic complications following microfoam sclerotherapy of saphenous trunks and tributaries.

OBJECTIVE: Thrombus extension into the deep venous system following superficial vein chemical ablation with Varithena polidocanol microfoam has been reported. The objective of this study was to assess the effect of intraoperative improved techniques during treatment for patients with symptomatic varicose veins and their impact on extension of thrombus into deep veins. METHODS: A retrospective review of a prospectively maintained database was performed. All patients who underwent endovenous chemical ablation with polidocanol microfoam (Varithena, Boston Scientific, Marlborough, Mass) for symptomatic superficial axial and tributary vein reflux were identified. Patients had postoperative duplex (48-72 hours) scanning after the procedure; those who did not adhere to the recommended follow-up were excluded. Demographic data, CEAP Classification, Venous Clinical Severity Score, procedure details, and follow-up data were abstracted. RESULTS: Between April 2018 and August 2020, 157 limbs in 122 patients were treated with Varithena microfoam; 129 limbs in 99 patients met our inclusion criteria. Veins treated included the great saphenous vein (n = 89), anterior accessory saphenous vein (n = 15), small saphenous vein (n = 14), and tributary veins (n = 56). Adjunctive techniques during treatment included intraoperative elevation of the limb to greater than 45°, ultrasound mapping and digital occlusion of large perforator veins, limitation of foam volume per session, injection of sterile saline before treatment, and compression of the limb in the elevated position. The preoperative Venous Clinical Severity Score was 11.4 and decreased after treatment to 9.7. The immediate closure rate was 95% with 81% overall symptomatic relief at last follow-up. The mean follow-up was 113.5 days for the entire cohort; two limbs (1.5%) required postoperative anticoagulation for thrombus extension into the deep venous system (common femoral vein n = 1; popliteal vein n = 1) postoperatively for a mean of 22 days. Both resolved with anticoagulation. One asymptomatic limb developed a femoral vein deep venous thrombosis and one symptomatic late deep venous thrombosis was noted 4 months after the procedure. Postoperative pain and phlebitis were reported in 15.6% and 14.8% of patients, respectively, and all had resolved at last follow-up. No pulmonary emboli were noted and no neurologic or visual adverse events were recorded. CONCLUSIONS: Adjunctive techniques during microfoam ablation decreased thrombotic complications in our series compared with those reported in earlier phase III clinical trials. Excellent early closure and symptomatic improvement were also noted. Endovenous microfoam ablation with Varithena is a safe and effective nontumescent, nonthermal alternative to laser and radiofrequency ablation.

High resolution, 3-dimensional Ferumoxytol-enhanced cardiovascular magnetic resonance venography in central venous occlusion.

BACKGROUND: Although cardiovascular magnetic resonance venography (CMRV) is generally regarded as the technique of choice for imaging the central veins, conventional CMRV is not ideal. Gadolinium-based contrast agents (GBCA) are less suited to steady state venous imaging than to first pass arterial imaging and they may be contraindicated in patients with renal impairment where evaluation of venous anatomy is frequently required. We aim to evaluate the diagnostic performance of 3-dimensional (3D) ferumoxytol-enhanced CMRV (FE-CMRV) for suspected central venous occlusion in patients with renal failure and to assess its clinical impact on patient management. METHODS: In this IRB-approved and HIPAA-compliant study, 52 consecutive adult patients (47 years, IQR 32-61; 29 male) with renal impairment and suspected venous occlusion underwent FE-CMRV, following infusion of ferumoxytol. Breath-held, high resolution, 3D steady state FE-CMRV was performed through the chest, abdomen and pelvis. Two blinded reviewers independently scored twenty-one named venous segments for quality and patency. Correlative catheter venography in 14 patients was used as the reference standard for diagnostic accuracy. Retrospective chart review was conducted to determine clinical impact of FE-CMRV. Interobserver agreement was determined using Gwet's AC1 statistic. RESULTS: All patients underwent technically successful FE-CMRV without any adverse events. 99.5% (1033/1038) of venous segments were of diagnostic quality (score ≥ 2/4) with very good interobserver agreement (AC1 = 0.91). Interobserver agreement for venous occlusion was also very good (AC1 = 0.93). The overall accuracy of FE-CMRV compared to catheter venography was perfect (100.0%). No additional imaging was required prior to a clinical management decision in any of the 52 patients. Twenty-four successful and uncomplicated venous interventions were carried out following pre-procedural vascular mapping with FE-CMRV. CONCLUSIONS: 3D FE-CMRV is a practical, accurate and robust technique for high-resolution mapping of central thoracic, abdominal and pelvic veins and can be used to inform image-guided therapy. It may play a pivotal role in the care of patients in whom conventional contrast agents may be contraindicated or ineffective.

Multidisciplinary Care for Critical Limb Ischemia: Current Gaps and Opportunities for Improvement.

Critical limb ischemia (CLI), defined as ischemic rest pain or nonhealing ulceration due to arterial insufficiency, represents the most severe and limb-threatening manifestation of peripheral artery disease. A major challenge in the optimal treatment of CLI is that multiple specialties participate in the care of this complex patient population. As a result, the care of patients with CLI is often fragmented, and multidisciplinary societal guidelines have not focused specifically on the care of patients with CLI. Furthermore, multidisciplinary care has the potential to improve patient outcomes, as no single medical specialty addresses all the facets of care necessary to reduce cardiovascular and limb-related morbidity in this complex patient population. This review identifies current gaps in the multidisciplinary care of patients with CLI, with a goal toward increasing disease recognition and timely referral, defining important components of CLI treatment teams, establishing options for revascularization strategies, and identifying best practices for wound care post-revascularization.

Underutilization of Thrombolytic Therapy for Patients Diagnosed with Acute Deep Venous Thrombosis in the Outpatient Setting.

BACKGROUND: Catheter-directed thrombolysis (CDT) has been shown to be a safe and effective treatment for the management of acute iliofemoral deep venous thrombosis (DVT). The potential benefits of this therapy include more rapid resolution of symptoms and possible reduction in the long-term sequelae. Many patients diagnosed with DVT in the inpatient setting have contraindications to lytic therapy, but less is known regarding the suitability of thrombolysis for outpatients diagnosed with acute DVT. We sought to determine the proportion of patients who were candidates for thrombolytic therapy and referred to a vascular specialist for evaluation. METHODS: A manual search of an outpatient vascular laboratory associated with a tertiary medical center was performed to identify all patients referred for the purpose of ruling out DVT between January 2013 and December 2014. Vascular laboratory studies conducted for evaluation of venous insufficiency were excluded. The electronic medical records were reviewed to evaluate for contraindications for thrombolysis. RESULTS: Over a 2-year period, there were 689 referrals to the outpatient vascular laboratory for the evaluation of patients with suspected DVT. Of the 689 referrals, 47 (6.8%) were found to have acute DVT, and 66 (9%) were found to have chronic DVT. Of the 47 patients with acute DVT, 41 involved the lower extremities. Fifteen of the 41 patients (37%) with extensive acute iliofemoral DVT had no absolute or major contraindications for CDT. Of these 15 patients, only 33% were referred to a vascular specialist (4 to vascular surgery and 1 to IR). Two patients (13%) agreed to and underwent successful CDT. CONCLUSIONS: Although the majority of patients with acute lower extremity DVT diagnosed in the outpatient vascular laboratory were not candidates for thrombolysis, one-third of those who may have benefited from CDT were referred to a vascular specialist to discuss lytic therapy. Given the potential benefits of CDT, it is imperative that patients with acute iliofemoral or extensive femoral DVT be offered an evaluation by a vascular specialist to optimize outcomes after this diagnosis.

Contemporary outcomes of elective iliocaval and infrainguinal venous intervention for post-thrombotic chronic venous occlusive disease.

BACKGROUND: Patients with iliofemoral deep venous thrombosis are at risk for development of post-thrombotic syndrome. Iliac vein stenting has been shown to significantly improve clinical outcomes in patients with venous outflow obstruction, although many studies include a heterogeneous population with several different venous pathologic processes. Our objective was to evaluate the results of iliocaval and infrainguinal venous intervention for venous outflow obstruction due to post-thrombotic chronic venous occlusive disease. METHODS: All patients treated at a single institution for symptomatic iliocaval venous occlusive lesions with and without infrainguinal extension between 2008 and 2015 were retrospectively analyzed. Nonthrombotic iliac vein lesions were excluded from analysis. All patients with symptomatic post-thrombotic occlusion of the iliac vein or inferior vena cava (IVC) and a Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) score of 3 or greater were included. Demographics of the patients, presence of IVC filters at presentation, presenting CEAP score, postintervention CEAP score, primary and secondary patency, wound healing and subjective clinical improvement outcomes, and procedural details were recorded in a database. RESULTS: There were 105 patients with symptomatic iliocaval venous occlusive lesions identified, of which 31 patients (42 limbs) met inclusion criteria. Presenting symptoms included pain or swelling (100%); venous claudication (81%); and CEAP class 3 (76%), 4 or 5 (14%), or 6 (10%). All patients presented with either subacute (>30 days [35%]) or chronic (>90 days [65%]) iliocaval venous thrombosis. Procedural technical success with venous recanalization was achieved in 100% of cases and in 46% of IVC filter retrieval attempts. Overall clinical improvement was achieved in 84% of patients; complete clinical resolution was obtained in 42% and a decrease in CEAP score in 65%. At a mean follow-up of 14.7 months (range, 2-49 months), primary and secondary 1-year patency was 66% and 75% overall, and primary patency was equivalent between patients requiring isolated iliac venous stenting and those requiring infrainguinal stent extension (68% vs 65%, respectively; P = .74, not significant). Patients who presented with IVC filters had a higher rate of complete clinical resolution if the filter could be removed (100%) compared with those patients in whom the filter could not be removed (17%; P < .01). CONCLUSIONS: Treatment of chronic venous occlusive disease with iliocaval and infrainguinal venous stenting is associated with acceptable 1-year patency rates, healing of venous ulcers, and a significant reduction in symptoms and CEAP score. Patients who underwent successful removal of indwelling IVC filters showed improved clinical outcomes compared with those in whom the IVC filter could not be removed.

Contemporary outcomes after venography-guided treatment of patients with May-Thurner syndrome.

OBJECTIVE: Patients with May-Thurner syndrome (MTS) present with a spectrum of findings ranging from mild left leg edema to extensive iliofemoral deep venous thrombosis (DVT). Whereas asymptomatic left common iliac vein (LCIV) compression can be seen in a high proportion of normal individuals on axial imaging, the percentage of these persons with symptomatic compression is small, and debate exists about the optimal clinical and diagnostic criteria to treat these lesions in patients with symptomatic venous disease. We evaluated our approach to venography-guided therapy for individuals with symptomatic LCIV compression and report the outcomes. METHODS: All patients with suspected May-Thurner compression of the LCIV between 2008 and 2015 were analyzed retrospectively. Patients with chronic iliocaval lesions not associated with compression of the LCIV were excluded from analysis. Criteria for intervention included LCIV compression in the setting of (1) leg edema/venous claudication with associated venographic findings (collateralization, iliac contrast stagnation, and contralateral cross cross-filling), or (2) left leg deep venous thrombosis. Outcome measures included presenting Clinical, Etiology, Anatomy, Pathophysiology (CEAP) score, postintervention CEAP score, primary patency, and secondary patency. Technical success was defined as successful stent implantation without intraoperative device complications, establishment of in-line central venous flow, and less than 30% residual LCIV stenosis. RESULTS: Of the 63 patients evaluated, 32 (51%) had nonthrombotic MTS and presented with leg edema (100%) or venous claudication (47%). Thirty-one patients (49%) had thrombotic MTS and presented with acute (26%) or chronic (71%) DVT, leg edema (100%), or venous claudication (74%). The mean presenting CEAP score was 3.06 and 3.23 for nonthrombotic and thrombotic MTS, respectively. Forty-four patients (70%) underwent successful intervention with primary stenting (70%) or thrombolysis and stenting (30%); 14 nonthrombotic MTS patients were treated conservatively with compression therapy alone, and 5 thrombotic MTS patients were treated with lysis or angioplasty alone. Clinical improvement and decrease in CEAP score occurred in 95% and 77% of stented patients compared with 58% and 32% of nonstented patients. Complete symptom resolution was achieved in 48% of patients overall, or 64% of stented patients and only 21% of nonstented patients. Complications included two early reocclusions. Primary and secondary 2-year patency rates were 93% and 97% (mean follow-up, 20.3 months) for stented patients. CONCLUSIONS: Venography-guided treatment of MTS is associated with excellent 1-year patency rates and a significant reduction in symptoms and CEAP score. Treating symptomatic MTS patients on the basis of physiologically relevant venographic findings rather than by intravascular ultrasound imaging alone results in excellent long-term patency and clinical outcomes but may result in undertreatment of some patients who could benefit from stent implantation.

Direct Cervical Carotid Angioplasty with Flow Reversal: A Single-Center Report from the Roadster Trial.

BACKGROUND: Carotid stent and/or angioplasty (CAS) via the transfemoral route with distal protection carries twice the risk of stroke and/or death when compared with carotid endarterectomy (CEA) in multiple randomized trials. Potential causes for this include disadvantaged aortic arch anatomy and the need to traverse the lesion to place a distal protection device. This report describes the technique and our experience with direct CAS using flow reversal for embolic protection. METHODS: University of California at Los Angeles (UCLA) division of Vascular and Endovascular surgery was a participant in the multi-institutional Roadster Trial of high-risk patients. We are reporting on our experience with 8 patients who met high-risk criteria. Using a small supraclavicular cutdown, the Michi sheath from Silk Road Medical was inserted into the common carotid artery. This provides a working channel for internal CAS as well as a side port to reverse and divert blood flow to the femoral vein, for embolic protection. All patients qualified as medically high risk because of a combination of factors including advanced age, smoking history, hypertension, diabetes, coronary artery disease, or hostile neck anatomy. RESULTS: All 8 patients had 3 or more risk factors including age >75 years (6 of 8), smoking (6 of 8), hypertension (7 of 8), overt coronary artery disease (4 of 8), diabetes (2 of 8), and chronic obstructive pulmonary disease (1 of 8). All stenoses were in the 80-99% category, and all were asymptomatic. All patients tolerated temporary clamping with flow reversal with no electroencephalogram changes. There were no deaths, strokes, transient ischemic attacks, or myocardial infarctions. All patients were discharged on the first postoperative day. Follow-up ranged from 7 to 21 months. One patient developed in-stent restenosis (asymptomatic). CONCLUSIONS: Direct CAS with flow reversal appears to be a safe, less invasive alternative to CEA.

Bovine carotid artery (Artegraft) as a hemodialysis access conduit in patients who are poor candidates for native arteriovenous fistulae.

Our experience with bovine carotid artery graft (BCAG) for hemodialysis access (Artegraft, North Brunswick, New Jersey) is presented. A review of all patients who underwent placement of BCAG for hemodialysis access at our institution was performed. Between January 2012 and June 2013, 17 BCAGs were placed in 17 patients. Indications included skin compromise, recurrent expanded polytetrafluoroethylene (ePTFE) and catheter infections, immunosuppression, groin placement, and surgeon's choice. Actuarial primary, primary-assisted, and secondary patency rates at 18 months were 73.3%, 67%, and 89%, respectively. One immunosuppressed patient developed a vancomycin-resistant enterococcus graft infection and required removal 2 months following the initial procedure. We conclude that BCAG can be used as an alternative to ePTFE for angioaccess in patients with no available superficial vein in high-risk patients with low morbidity and good functional patency. Our 1-year patency rates were superior to ePTFE as reported in the contemporary peer-reviewed literature.

Current treatment of renal artery aneurysms may be too aggressive.

OBJECTIVE: Most studies recommend repair of renal artery aneurysms (RAAs) >2 cm in diameter in asymptomatic patients, but other studies have suggested that their natural history may be more benign. We hypothesized that rupture and death in patients with asymptomatic RAAs is low and that current recommendations for RAA treatment at 2 cm may be too aggressive. METHODS: Retrospective review of all RAAs treated at a tertiary care medical center from 2002 to 2012. RESULTS: Fifty-nine RAA were identified in 40 patients (mean age at diagnosis, 56 years; male:female ratio, 17:23); 31 were saccular, 8 were fusiform, and 5 were bilobed. Twenty-nine patients were asymptomatic; the remainder of patients presented with hematuria (n = 4), abdominal pain (n = 3), difficult-to-control hypertension (n = 3), or flank pain (n = 2). Aneurysm location included the main renal artery bifurcation (n = 35), main trunk (n = 7), primary branch (n = 6), pole artery (n = 6), and secondary branch (n = 1). Operative management of RAAs included vein patch (n = 6), prosthetic patch (n = 4), primary repair (n = 3), plication (n = 1), patch and implantation (n = 1), and ex vivo repair (n = 1). Eight asymptomatic RAAs were treated surgically (mean RAA diameter = 2.4 ± 0.1 cm, range, 2-3 cm), with the remaining 33 asymptomatic RAAs being managed conservatively (mean RAA diameter = 1.4 ± 0.1 cm, range, 0.6-2.6 cm). Mean hospital length of stay was 4 days, with no late postoperative complications and 0% mortality. Non-operated patients were followed for a mean of 36 ± 9 months, with no late acute complications and 0% mortality. Mean RAA growth rate of patients with multiple imaging studies was 0.60 ± 0.16 mm/y. CONCLUSIONS: The rate of aneurysm rupture and death in our untreated RAA patients is zero, the growth rate is 0.60 ± 0.16 mm/y, and there were no adverse outcomes in asymptomatic RAAs >2 cm that were observed. We may currently be too aggressive in treating asymptomatic RAAs.

Is heparin reversal required for the safe performance of percutaneous endovascular aortic aneurysm repair?

BACKGROUND: Percutaneous endovascular aneurysm repair (PEVAR) can be performed with high technical success rates and low morbidity rates. Several peer-reviewed papers regarding PEVAR have routinely combined heparin reversal with protamine before sheath removal. The risks of protamine reversal are well documented and include cardiovascular collapse and anaphylaxis. The aim of this study is to review outcomes of patients who underwent PEVAR without heparin reversal. METHODS: All patients who underwent percutaneous femoral artery closure after PEVAR between 2009-2012 without heparin reversal were reviewed. Only patients who underwent placement of large-bore (12- to 24-French) sheaths were included. Patient demographics, comorbidities, operative details, and complications were reported. RESULTS: One hundred thirty-one common femoral arteries were repaired using the Preclose technique in 76 patients. Fifty-five patients underwent bilateral repair and 21 underwent unilateral repair. The mean age was 73.9±9.1 years. The mean heparin dose administered was 79±25.4 U/kg. The mean patient body mass index was 27.5±4.8 kg/m2. Ultrasound-guided arterial puncture was performed in all patients. Average operative times were 196.5±103.3 min, and the mean estimated blood loss was 277.6 mL. Four femoral arteries (3%) required open surgical repair after failed hemostasis with ProGlide closure (Abbott Vascular, Abbott Park, IL). Two patients required deployment of a third ProGlide device with successful closure. Two patients had small (<3 cm) groin hematomas that had resolved at the time of the postoperative computed tomography scan. No pseudoaneurysms or arteriovenous fistulas developed in our patient cohort. No early or late thrombotic complications were noted. One patient (1.3%) with a ruptured aneurysm died 48 hours after endovascular repair unrelated to femoral closure. CONCLUSIONS: PEVAR may be performed with low patient morbidity after therapeutic heparinization without heparin reversal. Femoral artery repair after the removal of large-diameter sheaths using the Preclose technique can be performed in this setting with minimal rates of early and late bleeding or thrombosis.

Management of endovenous heat-induced thrombus using a classification system and treatment algorithm following segmental thermal ablation of the small saphenous vein.

OBJECTIVE: We evaluated our experience with segmental radiofrequency ablation (RFA) of the small saphenous vein (SSV), a less common procedure than great saphenous vein ablation, and developed a classification system and algorithm for endovenous heat-induced thrombus (EHIT), based on modifications of our prior algorithm of EHIT following great saphenous ablation. METHODS: Endovenous ablation was performed on symptomatic patients with incompetent SSVs following a minimum of 3 months of compression therapy. Demographic data, risk factors, CEAP classification, procedure details, and follow-up data were recorded. A four-tier classification system and treatment algorithm was developed, based on EHIT proximity to the popliteal vein. RESULTS: Eighty limbs (in 76 patients) were treated with RFA of the SSV between January 2008 and August 2012. Duplex ultrasound was performed between 24 and 72 hours postprocedure in all patients. Ablation was successful in 98.7% (79/80) of procedures. Sixty-eight (85%) patients had level A closures (≥ 1 mm caudal to popliteal vein) and 10 patients (13%) had level B closures (flush with popliteal vein) and were observed. Two limbs (3%) had EHIT extending into the popliteal vein (level C) and were treated with outpatient low-molecular-weight heparin anticoagulation. Thrombus retracted to the level of the saphenopopliteal junction in both patients following a short course of anticoagulation. No patient developed an occlusive deep vein thrombosis (DVT) (level D). Mean follow-up period was 6.2 months; no patient had small saphenous recanalization, occlusive DVT, or pulmonary embolus. The presence or absence of the Giacomini vein was not predictive of level B and C closure. CONCLUSIONS: RFA of the SSV in symptomatic patients has a high success rate with a low risk of DVT. A classification system and treatment protocol based on the level of EHIT in relation to the saphenopopliteal junction is useful in managing patients. The approach to patients with thrombus flush with the popliteal vein or bulging has not been previously defined; our outcomes were excellent, using our treatment algorithm.