Intermittent pneumatic compression: Physiologic and clinical basis to improve management of venous leg ulcers

Venous leg ulcers (VLUs) are a significant health problem that afflicts 1% of the population at some point during their lifetime. Intermittent pneumatic compression (IPC) is widely used to prevent deep venous thrombosis. However, IPC seems to have application to a broader base of circulatory diseases. The intermittent nature of pulsatile external compression produces beneficial physiologic changes, which include hematologic, hemodynamic, and endothelial effects, which should promote healing of VLUs. Clinical studies of the management of VLUs show that IPC increases overall healing and accelerates the rate of healing, leading to current guideline recommendations for care of patients with VLUs. Proper prescription of IPC to improve the management of patients with VLUs requires further definition. It seems that application of IPC in combination with sustained graduated compression improves outcome in patients with the most advanced venous disease

Bilateral nonthrombotic subclavian vein obstruction causing upper extremity venous claudication

Venous complications of thoracic outlet obstruction are frequently the result of acute axillosubclavian vein thrombosis, leading to symptoms consistent with venous claudication, including pain, swelling, and cyanotic discoloration. Nonthrombotic subclavian vein obstruction, however, is an uncommon cause of veno-occlusive symptoms. We report the case of a patient who, while running, developed pain consistent with venous claudication in her left arm and subsequently in her right arm. Clinical and hemodynamic evaluation revealed nonthrombotic subclavian vein obstruction, which was relieved by thoracic outlet decompression following first rib resection

Elective endovascular and open repair of abdominal aortic aneurysms in octogenarians

ObjectivesEndovascular aortic aneurysm repair (EVAR) is an increasingly popular treatment option for patients with abdominal aortic aneurysms (AAA), although open repair is considered the standard by virtue of its durability. Octogenarians, as a subgroup, may stand to benefit the most by EVAR. The purpose of this study is to review operative results and durability of open AAA repair and EVAR in octogenarians.MethodsFrom May 1996 to August 2006, 150 patients aged ≥80 years underwent elective repair of their infrarenal AAA. Eighty-one underwent EVAR and 69 had open repair. Demographic data, aneurysm specifics, comorbidities, operative morbidity and mortality, intensive care unit and hospital length of stay, and late outcomes were analyzed.ResultsIn the EVAR group, 27 of 81 (33%) patients died during a mean follow-up of 25 months. In the open repair group, 34 of 69 (49%) patients died during a mean follow-up of 43 months. The median survival time for EVAR was 350 weeks (range, 145-404 weeks) compared with 317 weeks (range, 233-342 weeks) for the open repair group. A Kaplan-Meier log-rank analysis showed no difference in early or long-term survival between EVAR and open repair (P = .13). EVAR was associated with decreased blood loss, decreased length of intensive care unit and hospital stays, and a greater number of patients discharged to home.ConclusionsEVAR and open repair are comparable in safety and efficacy in octogenarians. Operative repair outcomes remain acceptable. Mid- and long-term survival are similar, indicating no survival advantage of one procedure compared with the other

Is transcranial Doppler a worthwhile addition to screening tests for cerebrovascular disease?

Abstract Purpose: Carotid duplex imaging has become the standard diagnostic evaluation for patients with suspected cerebrovascular disease. Transcranial Doppler ultrasonography expands the noninvasive diagnostic capabilities to the intracranial circulation. The purpose of this study was to evaluate the results of routine transcranial Doppler studies on patients referred for noninvasive cerebrovascular evaluation. Methods: A total of 670 patients had routine transcranial Doppler examinations as part of their noninvasive cerebrovascular evaluation. Patients were categorized clinically and according to their severity of extracranial internal carotid artery stenosis (30% velocity difference between sides, flow reversal, and velocities ± 2 SD from normal). Results: Forty-eight percent of the patients were women, and 52% were men. The average age was 65.5 years. Fifty-four percent of the patients were white, 42% were black, 3% were Hispanic, and 1% were other. Forty-eight percent presented with hemispheric symptoms, 34% had no symptoms, and 18% had nonhemispheric symptoms. Forty-five percent (304 of 670) had an interpretable transcranial Doppler examination. The ability to insonate the basal cerebral arteries through the temporal bone was significantly reduced in women ( p < 0.0001), black patients ( p < 0.0001), and older patients ( p < 0.0001). The results of forty-four percent of interpretable examinations were normal, 19% demonstrated side-to-side velocity differences, 13% showed collateral pathways, 11% showed velocities ± 2 SD, 10% showed an intracranial stenosis, and 4% showed reversed flow pattern. Although 56% of the patients had notable findings, no patient had their diagnostic or therapeutic plan altered by the transcranial Doppler results. Conclusion: Less than 50% of the patients referred for first-time cerebrovascular examination had access for an interpretable transcranial Doppler examination. Though the number of positive findings is reasonably high, no material impact on diagnostic or treatment plans was seen in the patients in this series. These results indicate that selection criteria for examination of the intracranial arteries should be refined and that transcranial Doppler scanning should not be incorporated as part of the "routine" noninvasive cerebrovascular examination. (J VASC SURG 1995;21:90-7.

A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein

BackgroundGreat saphenous vein (GSV) incompetence is the most common cause of superficial venous insufficiency. Radiofrequency catheter ablation (RFA) is superior to conventional ligation and stripping, and endovenous laser treatment (EVL) has emerged as an effective alternative to RFA. This randomized study evaluated RFA and EVL for superficial venous insufficiency due to GSV incompetence and compared early and 1-year results.MethodsBetween June 2006 and May 2008, patients with symptomatic primary venous insufficiency due to GSV incompetence were randomized to RFA or EVL. Patients with bilateral disease were randomized for treatment of the first leg and received the alternative method on the other. Pretreatment examination included a leg assessment using the Venous Clinical Severity Score (VCSS) and CEAP classification. Patients completed the Chronic Venous Insufficiency Questionnaire 2 (CIVIQ2). RFA was performed with the ClosurePlus system (VNUS Medical Technologies, Sunnyvale, Calif). EVL was performed with the EVLT system (AngioDynamics Inc, Queensbury, NY). Early (1-week and 1-month) postoperative results of pain, bruising, erythema, and hematoma were recorded. Duplex ultrasound (DU) imaging was used at 1 week and 1 year to evaluate vein status. VCSS scores and CEAP clinical class were recorded at each postoperative visit, and quality of life (QOL) using CIVIQ2 was assessed at 1 month and 1 year.ResultsThe study enrolled 118 patients (141 limbs): 46 (39%) were randomized to RFA and 48 (40%) to EVL, and 24 (20%) had bilateral GSV incompetence. At 1 week, one patient in the RFA group had an open GSV and was deemed a failure. More bruising occurred in the EVL group (P = .01) at 1 week, but at 1 month, there was no difference in bruising between groups. At 1 year, DU imaging showed evidence of recanalization with reflux in 11 RFA and 2 EVL patients (P = .002). The mean VCSS score change from baseline to 1 week postprocedure was higher for RFA than EVL (P = .002), but there was no difference between groups at 1 month (P = .07) and 1 year (P = .9). Overall QOL mean score improved over time for all patients (P < .001). CEAP clinical class scores of ≥3 were recorded in 21 RFA (44%) and 24 EVL patients (44%) pretreatment, but at 1-year, 9 RFA (19%) and 12 EVL patients (24%) had scores of ≥3 (P < .001). This represented a significant improvement in all patients compared with baseline.ConclusionBoth methods of endovenous ablation effectively reduce symptoms of superficial venous insufficiency. EVL is associated with greater bruising and discomfort in the perioperative period but may provide a more secure closure over the long-term than RFA

Endovascular therapy for advanced post-thrombotic syndrome: Proceedings from a multidisciplinary consensus panel

Patients with advanced post-thrombotic syndrome (PTS) and chronic iliac vein obstruction suffer major physical limitations and impairment of health-related quality of life. Currently there is a lack of evidence-based treatment options for these patients. Early studies suggest that imaging-guided, catheter-based endovascular therapy can eliminate iliac vein obstruction and saphenous venous valvular reflux, resulting in reduced PTS severity; however, these observations have not been rigorously validated. A multidisciplinary expert panel meeting was convened to plan a multicenter randomized controlled clinical trial to evaluate endovascular therapy for the treatment of advanced PTS. This article summarizes the findings of the panel, and is expected to assist in developing a National Institutes of Health-sponsored clinical trial and other studies to improve the care of patients with advanced PTS

The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum

The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) have developed clinical practice guidelines for the care of patients with varicose veins of the lower limbs and pelvis. The document also includes recommendations on the management of superficial and perforating vein incompetence in patients with associated, more advanced chronic venous diseases (CVDs), including edema, skin changes, or venous ulcers. Recommendations of the Venous Guideline Committee are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system as strong (GRADE 1) if the benefits clearly outweigh the risks, burden, and costs. The suggestions are weak (GRADE 2) if the benefits are closely balanced with risks and burden. The level of available evidence to support the evaluation or treatment can be of high (A), medium (B), or low or very low (C) quality. The key recommendations of these guidelines are: We recommend that in patients with varicose veins or more severe CVD, a complete history and detailed physical examination are complemented by duplex ultrasound scanning of the deep and superficial veins (GRADE 1A). We recommend that the CEAP classification is used for patients with CVD (GRADE 1A) and that the revised Venous Clinical Severity Score is used to assess treatment outcome (GRADE 1B). We suggest compression therapy for patients with symptomatic varicose veins (GRADE 2C) but recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation (GRADE 1B). We recommend compression therapy as the primary treatment to aid healing of venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A). For treatment of the incompetent great saphenous vein (GSV), we recommend endovenous thermal ablation (radiofrequency or laser) rather than high ligation and inversion stripping of the saphenous vein to the level of the knee (GRADE 1B). We recommend phlebectomy or sclerotherapy to treat varicose tributaries (GRADE 1B) and suggest foam sclerotherapy as an option for the treatment of the incompetent saphenous vein (GRADE 2C). We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C2; GRADE 1B), but we suggest treatment of pathologic perforating veins (outward flow duration ≥500 ms, vein diameter ≥3.5 mm) located underneath healed or active ulcers (CEAP class C5-C6; GRADE 2B). We suggest treatment of pelvic congestion syndrome and pelvic varices with coil embolization, plugs, or transcatheter sclerotherapy, used alone or together (GRADE 2B)

Interim analysis results from the RESTORE-CLI, a randomized, double-blind multicenter phase II trial comparing expanded autologous bone marrow-derived tissue repair cells and placebo in patients with critical limb ischemia

Cell therapy is a novel experimental treatment modality for patients with critical limb ischemia (CLI) of the lower extremities and no other established treatment options. This study was conducted to assess the safety and clinical efficacy of intramuscular injection of autologous tissue repair cells (TRCs).A prospective, randomized double-blinded, placebo controlled, multicenter study (RESTORE-CLI) was conducted at 18 centers in the United States in patients with CLI and no option for revascularization. Enrollment of 86 patients began in April 2007 and ended in February 2010. For the prospectively planned interim analysis, conducted in February 2010, 33 patients had the opportunity to complete the trial (12 months of follow-up), and 46 patients had completed at least 6 months of follow-up. The interim analysis included analysis of both patient populations. An independent physician performed the bone marrow or sham control aspiration. The aspirate was processed in a closed, automated cell manufacturing system for approximately 12 days to generate the TRC population of stem and progenitor cells. An average of 136 ± 41 × 10 total viable cells or electrolyte (control) solution were injected into 20 sites in the ischemic lower extremity. The primary end point was safety as evaluated by adverse events, and serious adverse events as assessed at multiple follow-up time points. Clinical efficacy end points included major amputation-free survival and time to first occurrence of treatment failure (defined as any of the following: major amputation, death, de novo gangrene, or doubling of wound size), as well as major amputation rate and measures of wound healing.There was no difference in adverse or serious adverse events between the two groups. Statistical analysis revealed a significant increase in time to treatment failure (log-rank test, = .0053) and amputation-free survival in patients receiving TRC treatment, (log-rank test, = .038). Major amputation occurred in 19% of TRC-treated patients compared to 43% of controls ( = .14, Fisher exact test). There was evidence of improved wound healing in the TRC-treated patients when compared with controls at 12 months.Intramuscular injection of autologous bone marrow-derived TRCs is safe and decreases the occurrence of clinical events associated with disease progression when compared to placebo in patients with lower extremity CLI and no revascularization options