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.
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.
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.
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.
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.
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.
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.).
Objective Accurate data regarding the prevalence and associated risk factors for aneurysmal disease is essential when determining the appropriateness of screening for abdominal aortic aneurysms ...(AAA). Although women are poorly represented in most large studies of AAA prevalence, the US Preventative Services Task Force recently recommended against primary screening for AAA in women. The purpose of this analysis was to define the prevalence and risk factors associated with the development of AAA in women. Methods A free duplex ultrasound screening was offered to men and women with cardiovascular risk factors or a family history of AAA. Patients were recruited through advertising at local screening centers and screenings were performed between 2004 and 2006. Demographic information and cardiovascular and aneurysmal disease risk factors were obtained for each patient through a questionnaire. A total of 17,540 subjects were screened for AAA, including 10,012 women (mean age 69.6 years) and 7528 men (mean age 70.0 years). Univariate and multivariable logistic regression analysis was performed on the subset of women that were screened to determine risk factors for and prevalence of AAA. Results Seventy-four aneurysms were detected in women (including four aneurysms >5 cm diameter and 70 aneurysms 3 to 5 cm diameter) while 291 were detected in men, resulting in prevalence rates of 0.7% and 3.9%, respectively. Increasing age (odds ratio OR= 4.57, 95% confidence interval CI 1.98 to 10.54, P < .0001), history of tobacco use (OR = 3.29, 95% CI 1.86 to 5.80, P < .0001), and cardiovascular disease (OR= 3.57, 95% CI 2.19 to 5.84, P < .0001) were independently associated with AAA in women on univariate and multivariable analysis. Women with multiple atherosclerotic risk factors were more commonly found to have AAAs and had a prevalence rate of AAA as high as 6.4%. Conclusion Although the medical literature suggests a low prevalence rate of AAA in women in the general population, specific risk factors are associated with the development of AAA, and subgroups of women can be identified that are at a substantially increased risk of aneurysmal disease. In particular, elevated rates of AAA were found among women of advanced age (≥65 years) with a history of smoking or heart disease. These data support the notion that women with such risk factors should be considered for AAA screening.
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.
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.
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.
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.
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Objective To examine outcomes following 1000 consecutive endovenous radiofrequency ablation (RFA) closures of saphenous veins and 500 ambulatory phlebectomy procedures for chronic venous ...insufficiency. Based on the outcomes in this patient cohort, we aim to determine whether concomitant or staged phlebectomy is preferred and examine the rate and optimal treatment of complications using a dedicated treatment algorithm based on our classification system for level of closure following these procedures. Methods Between 2004 and 2012, patients with symptomatic superficial venous incompetence who underwent endovenous RFA of incompetent saphenous veins were identified as well as patients with concomitant or staged microphlebectomy. Demographics, risk factors, procedural success rate, concurrent procedures, complications, and symptom relief were recorded. Results One thousand radiofrequency ablations (95.5% great saphenous vein and accessory great saphenous veins, 4.5% small saphenous vein) were performed in the ambulatory setting (patients = 735, limbs = 916); 355 limbs with large (>3 mm) symptomatic incompetent tributaries underwent concomitant phlebectomy. Additionally, 145 limbs required phlebectomy at a later setting for persistent symptoms following saphenous RFA. Indications for treatment included lifestyle-limiting pain (94.8%), swelling (66%), lipodermatosclerosis (5.3%), ulceration (9.4%), and/or bleeding (1.4%). All patients (100%) underwent a follow-up ultrasound 24 to 72 hours following the procedure to assess for successful closure and to rule out deep venous thrombosis. The majority of patients (86.7%) had relief of their symptoms at a mean follow-up of 9 months. No patients developed postoperative deep venous thrombosis; however, saphenous closure extended partially into the common femoral vein wall in 18 patients (1.8%) and flush with the saphenofemoral junction in 47 (4.7%). One patient developed a pulmonary embolus despite a normal postoperative ultrasound. No other patients required hospital admission and no deaths occurred during the follow-up period. Conclusions The majority of patients with symptomatic chronic venous insufficiency benefit from endovenous RFA of incompetent saphenous veins with comparable results to published surgical outcomes for endovenous closure. The great majority of patients with refluxing tributary veins greater than 3 mm in diameter required phlebectomy in addition to saphenous ablation. These patients may benefit from concomitant phlebectomy along with endovenous saphenous closure.
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.
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.
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.
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.
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