Mark A. Farber

Endovascular repair of traumatic thoracic aortic injury: Clinical practice guidelines of the Society for Vascular Surgery

The Society for Vascular Surgery® pursued development of clinical practice guidelines for the management of traumatic thoracic aortic injuries with thoracic endovascular aortic repair. In formulating clinical practice guidelines, the Society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the Grading of Recommendations Assessment, Development and Evaluation methods (GRADE) to develop and present their recommendations. The systematic review included 7768 patients from 139 studies. The mortality rate was significantly lower in patients who underwent endovascular repair, followed by open repair, and nonoperative management (9%, 19%, and 46%, respectively, P < .01). Based on the overall very low quality of evidence, the committee suggests that endovascular repair of thoracic aortic transection is associated with better survival and decreased risk of spinal cord ischemia, renal injury, graft, and systemic infections compared with open repair or nonoperative management (Grade 2, Level C). The committee was also surveyed on a variety of issues that were not specifically addressed by the meta-analysis. On these select matters, the majority opinions of the committee suggest urgent repair following stabilization of other injuries, observation of minimal aortic defects, selective (vs routine) revascularization in cases of left subclavian artery coverage, and that spinal drainage is not routinely required in these cases.

Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: the VALOR trial.

OBJECTIVE This report summarizes the 30-day and 12-month results of endovascular treatment using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) for patients with thoracic aortic aneurysms (TAA) who are considered candidates for open surgical repair. METHODS The study was a prospective, nonrandomized, multicenter, pivotal trial conducted at 38 sites. Enrollment occurred between December 2003 and June 2005. Standard follow-up interval examinations were prescribed at 1 month, 6 months, 1 year, and annually thereafter. These endovascular results were compared with retrospective open surgical data from three centers of excellence. RESULTS The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial enrolled 195 patients, and 189 were identified as retrospective open surgical subjects. Compared with the open surgery group, the VALOR test group had similar age and sex distributions, but had a smaller TAA size. Patients received a mean number of 2.7 +/- 1.3 stent graft components. The diameters of 25% of the proximal stent graft components implanted were <26 mm or >40 mm. Left subclavian artery revascularization was performed before the initial stent graft procedure in 5.2% of patients. Iliac conduits were used in 21.1% of patients. In 33.5% of patients, the bare spring segment of the most proximally implanted device was in zones 1 or 2 of the aortic arch. In 194 patients (99.5%), vessel access and stent graft deployment were successful at the intended site. The 30-day VALOR results included perioperative mortality, 2.1%; major adverse advents, 41%; incidence of paraplegia, 1.5%; paraparesis, 7.2%; and stroke, 3.6%. The 12-month VALOR results included all-cause mortality, 16.1%; aneurysm-related mortality, 3.1%; conversion to open surgery, 0.5%; target aneurysm rupture, 0.5%; stent graft migration >10 mm, 3.9%; endoleak (12.2%), stent graft patency, 100%; stable or decreasing aneurysm diameter, 91.5%; and loss of stent graft integrity, four patients. No deployment-related events or perforation of the aorta by a graft component occurred. The Talent Thoracic Stent Graft showed statistically superior performance with respect to acute procedural outcomes (P < .001), 30-day major adverse events (41% vs 84.4%, P < .001), perioperative mortality (2% vs 8%, P < .01), and 12-month aneurysm-related mortality (3.1% vs 11.6%, P < .002) vs open surgery. CONCLUSIONS The pivotal VALOR 12-month trial results demonstrate that the Medtronic Talent Thoracic Stent Graft System is a safe and effective endovascular therapy as an alternative to open surgery in patients with TAA who were considered candidates for open surgical repair.

The Society for Vascular Surgery Practice Guidelines: Management of the left subclavian artery with thoracic endovascular aortic repair

The Society for Vascular Surgery pursued development of clinical practice guidelines for the management of the left subclavian artery with thoracic endovascular aortic repair (TEVAR). In formulating clinical practice guidelines, the society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the grading of recommendations assessment, development, and evaluation (GRADE) method to develop and present their recommendations. The overall quality of evidence was very low. The committee issued three recommendations. Recommendation 1: In patients who need elective TEVAR where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest routine preoperative revascularization, despite the very low-quality evidence (GRADE 2, level C). Recommendation 2: In selected patients who have an anatomy that compromises perfusion to critical organs, routine preoperative LSA revascularization is strongly recommended, despite the very low-quality evidence (GRADE 1, level C). Recommendation 3: In patients who need urgent TEVAR for life-threatening acute aortic syndromes where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest that revascularization should be individualized and addressed expectantly on the basis of anatomy, urgency, and availability of surgical expertise (GRADE 2, level C).

Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency

OBJECTIVE Although newer techniques to promote the healing of leg ulcers associated with chronic venous insufficiency are promising, improved healing rates and cost effectiveness are unproven. We prospectively followed a series of patients who underwent treatment with outpatient compression for venous stasis ulcers without adjuvant techniques to determine healing rates and costs of treatment. METHODS Two hundred fifty-two patients with clinical or duplex scan evidence of chronic venous insufficiency and active leg ulcers underwent treatment with ambulatory compression techniques. The patients were prospectively followed with wound measurements at 1-week to 2-week intervals, and the factors that were associated with delayed healing were determined. RESULTS Of all the ulcers, 57% were healed at 10 weeks of treatment and 75% were healed at 16 weeks. Ultimately, 96% of the ulcers healed, and only 1 major amputation was necessitated (0.4%). Initial ulcer size and moderate arterial insufficiency (ankle brachial index, 0.5 to 0.8; n = 34) were factors that were independently associated with delayed healing (P <.01). Patient age, ulcer duration before treatment, and morbid obesity did not significantly affect healing times. The cost of 10 weeks of outpatient treatment with compression techniques ranged from

A multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta

1444 to

The role of air plethysmography in the diagnosis of chronic venous insufficiency

2711. CONCLUSION The treatment of venous stasis ulcers with compression techniques results in reliable, cost-effective healing in most patients. Current adjuvant techniques may prove to be useful but are likely to be cost effective only in a minority of cases, particularly in patients with large initial ulcer size or arterial insufficiency.

Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms

OBJECTIVE Thoracic endovascular aortic repair (TEVAR) is applicable to a spectrum of thoracic aortic pathology with half of the procedures performed world-wide for indications other than degenerative aneurysm of the descending thoracic aorta (DTA). This multicenter, prospective study queried perioperative and one-year results of TEVAR using the commercially available GORE TAG device, in the treatment of acute complicated Type B dissection (cTBD), traumatic aortic tear (TT), and ruptured degenerative aneurysm (RDA) of the DTA. METHODS This prospective, non-randomized, literature controlled study included 59 patients; cTBD, n = 19; RDA, n = 20; TT, n = 20. The primary end-point was the composite of death and total paraplegia in subjects at <or= 30 days post-treatment compared with a cohort from current literature. Secondary end-points included adverse events related to device, procedural and systemic complications, and one-year survival. RESULTS All 59 patients had successful endoprosthesis deployment. Fifteen of 19 (79%) patients in the cTBD group had either rupture or malperfusion syndromes at presentation. Combined 30-day mortality/paraplegia rate was 13.6% (8/59), with seven (11.9%) deaths (cTBD [3], RDA [3] and TT [1]) and 1 (TT, 1.7%) case of paraplegia. The primary end-point for the TEVAR cohort was significantly lower (P = .008) when compared with a composite literature control of 800 patients (combined 30-day mortality/paraplegia of 29.6%). Thirty-day complications of any nature occurred in 48 (81%) patients; 11 (18.6%) were device related, and 43 (73%) experienced one or more systemic adverse events. Six (10%) patients required additional TEVAR implantations and 3 (5%) patients (one in each pathology group) required conversion to open surgery. Seventeen (29%) patients had endoleaks of any kind or degree through 30 days; cTBD (7), TT (2), RDA (8). Nine patients (15.3%) had perioperative strokes with two resultant deaths. During mean follow-up time of 409 +/- 309 days, an additional 12 patients died, one patient required open conversion (cTBD), and two patients had major device related events. Actuarial survival at one year was 66% (range, 52%-77%) for the entire cohort; (cTBD) 79% (range, 53%-92%), (TT) 79% (range, 53%-92%) and (RDA) 37% (range, 16%-59%). On regression analysis, age at treatment (1.05 [range, 1.01-1.09]; P = .008) and chronic obstructive pulmonary disease (COPD) (4.3 [range, 1.3-14.4]; P = .02) were predictive of death at one year. CONCLUSION This study confirmed treatment advantages for TEVAR for thoracic aortic catastrophes when compared with literature-based results of open repair. One-year treatment results indicate a low incidence of graft-related complications. TEVAR is the preferred initial treatment for the DTA catastrophes studied herein.

Treatment of superficial and perforator venous incompetence without deep venous insufficiency: is routine perforator ligation necessary?

PURPOSE The role of air plethysmography (APG) in the diagnosis of venous disease is not well defined. We conducted this study to investigate the value of APG in the diagnosis of chronic venous insufficiency and to determine its correlation with the clinical severity of disease and the anatomic distribution of reflux. METHODS We studied 186 lower extremities with duplex scanning and venography and measured the venous volume, venous filling index (VFI), ejection fraction, and residual volume fraction with APG. Limbs were categorized according to the Society for Vascular Surgery and International Society for Cardiovascular Surgery classification of clinical severity of disease and according to the anatomic distribution of valvular incompetence. RESULTS Sixty-one limbs had no evidence of disease (class 0), 60 limbs had mild disease (classes 1, 2, and 3), and 65 limbs had severe disease (classes 4, 5, and 6). According to the results of duplex scanning and venography, there was no evidence of reflux in 56 limbs. Isolated superficial venous reflux occurred in 52 limbs, and perforator reflux, alone or in conjunction with superficial reflux, occurred in 30. Deep reflux, with or without superficial reflux, was found in 25 limbs. Deep and perforator reflux, with or without superficial reflux, was found in 19 limbs. The VFI had a sensitivity of 80% and 99% positive predictive value for any type of reflux. The VFI was significantly different between groups of limbs with different clinical severities of disease or different types of reflux. The incidence of deep or perforator reflux in limbs with a normal VFI value was 7%, and it was 82% in limbs with a VFI of more than 5. Among 86 limbs with VFI values not corrected with use of a thigh tourniquet, 28% did not have evidence of deep or perforator reflux, and among 15 limbs with VFI values corrected with the use of a tourniquet, 33% had perforator reflux, deep reflux, or both. All APG parameters had low positive predictive values for severe disease or ulceration. The ejection fraction and residual volume fraction did not influence the clinical severity of disease, did not discriminate between types of reflux, and in combination with the VFI did not improve the predictive value of APG. CONCLUSIONS The VFI measured by APG is an excellent predictor of venous reflux, provides an estimate of the clinical severity of disease, and at high levels predicts deep reflux, perforator reflux, or both. Correction of an abnormal VFI with a thigh tourniquet is an unreliable predictor of the absence of deep or perforator incompetence. The predictive value of APG for severe disease or ulceration is poor. The ejection fraction and residual volume fraction, individually or in combination with the VFI, add little to the diagnostic value of APG, and their routine performance may not be clinically justified.

Endovenous Saphenous Ablation Corrects the Hemodynamic Abnormality in Patients with CEAP Clinical Class 3–6 CVI Due to Superficial Reflux

OBJECTIVE This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the Zenith fenestrated endovascular graft (Cook Medical, Bloomington, Ind) for treatment of juxtarenal abdominal aortic aneurysms (AAAs). METHODS Sixty-seven patients with juxtarenal AAAs were prospectively enrolled in 14 centers in the United States from 2005 to 2012. Custom-made fenestrated stent grafts were designed with one to three fenestrations on the basis of analysis of computed tomography data sets. Renal alignment was performed with balloon-expandable stents. Follow-up included clinical examination, laboratory studies, mesenteric-renal duplex ultrasound, abdominal radiography, and computed tomography imaging at hospital discharge and at 1 month, 6 months, and 12 months and yearly thereafter up to 5 years. RESULTS There were 54 male and 13 female patients with a mean age of 74 ± 8 years enrolled. Mean aneurysm diameter was 60 ± 10 mm. A total of 178 visceral arteries required incorporation with small fenestrations in 118, scallops in 51, and large fenestrations in nine. Of these, all 118 small fenestrations (100%), eight of the scallops (16%), and one of the large fenestrations (11%) were aligned by stents. Technical success was 100%. There was one postoperative death within 30 days (1.5%). Mean length of hospital stay was 3.3 ± 2.1 days. No aneurysm ruptures or conversions were noted during a mean follow-up of 37 ± 17 months (range, 3-65 months). Two patients (3%) had migration ≥ 10 mm with no endoleak, both due to cranial progression of aortic disease. Of a total of 129 renal arteries targeted by a fenestration, there were four (3%) renal artery occlusions and 12 (9%) stenoses. Fifteen patients (22%) required secondary interventions for renal artery stenosis/occlusion in 11 patients, type II endoleak in three patients, and type I endoleak in one patient. At 5 years, patient survival was 91% ± 4%, and freedom from major adverse events was 79% ± 6%; primary and secondary patency of targeted renal arteries was 81% ± 5% and 97% ± 2%, freedom from renal function deterioration was 91% ± 5%, and freedom from secondary interventions was 63% ± 9%. CONCLUSIONS This prospective study demonstrates that endovascular repair of juxtarenal AAAs with the Zenith fenestrated AAA stent graft is safe and effective. Mortality and morbidity are low in properly selected patients treated in centers with experience in these procedures.

Outcome-based anatomic criteria for defining the hostile aortic neck

PURPOSE We investigated whether routine ligation of incompetent perforator veins is necessary in treatment of symptomatic chronic venous insufficiency (CVI) due to combined superficial and perforator vein incompetence, without deep venous insufficiency. METHODS This was a retrospective review of prospectively collected data. Twenty-four limbs with both superficial and perforator venous incompetence but no deep venous insufficiency were identified at venous duplex scanning. Air plethysmography (APG) was performed preoperatively, to obtain venous volume (VV), venous filling index (VFI), ejection fraction (EF), and residual volume fraction (RVF) of the affected limb. Saphenous vein stripping from the groin to knee and powered transilluminated phlebectomy for varicosity ablation were performed in all patients. Postoperatively, all patients underwent duplex scanning and APG to determine the status of the perforator veins and hemodynamic improvement from surgery. RESULTS Average patient age was 55.8 years; 62% of patients were women. CVI was class 3 in 4 limbs, class 4 in 12 limbs, and class 5 and class 6 in 4 limbs each. Postoperative duplex scans demonstrated that 71% of previously incompetent perforator vessels were now competent or absent. Significant improvement in all APG values was documented after superficial surgery. VFI improved from 6.0 +/- 2.9 preoperatively to 2.2 +/- 1.3 after surgery (P <.001); EF improved from 56.3 +/- 18 to 62 +/- 21 (P =.02); and RVF improved from 40.1 +/- 19 to 28.3 +/- 18 (P =.009). Mean preoperative symptom score (5.3 +/- 1.9) was significantly improved at mean follow-up of 18.3 months (1.4 +/- 1.2; P <.001). CONCLUSION Patients with superficial and perforator vein incompetence and a normal deep venous system experienced significant improvement in APG-measured hemodynamic parameters and clinical symptom score after superficial ablative surgery alone. This suggests that ligation of the perforator veins can be reserved for patients with persistent incompetent perforator vessels, with abnormal hemodynamic parameters or continued symptoms after superficial ablative surgery.