David L. Gillespie

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 C(2); 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 C(5)-C(6); 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).

Revision of the venous clinical severity score: Venous outcomes consensus statement: Special communication of the American Venous Forum Ad Hoc Outcomes Working Group

In response to the need for a disease severity measurement, the American Venous Forum committee on outcomes assessment developed the Venous Severity Scoring system in 2000. There are three components of this scoring system, the Venous Disability Score, the Venous Segmental Disease Score, and the Venous Clinical Severity Score (VCSS). The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. However, as a descriptive instrument, the CEAP classification responds poorly to change. The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment. Based on initial experiences with the VCSS, an international ad hoc working group of the American Venous Forum was charged with updating the instrument. This revision of the VCSS is focused on clarifying ambiguities, updating terminology, and simplifying application. The specific language of proven quality-of-life instruments was used to better address the issues of patients at the lower end of the venous disease spectrum. Periodic review and revision are necessary for generating more universal applicability and for comparing treatment outcomes in a meaningful way.

Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery ® and the American Venous Forum.

Thomas F. O’Donnell Jr, MD, Marc A. Passman, MD, William A. Marston, MD, William J. Ennis, DO, Michael Dalsing, MD, Robert L. Kistner, MD, Fedor Lurie, MD, PhD, Peter K. Henke, MD, Monika L. Gloviczki, MD, PhD, Bo G. Eklof, MD, PhD, Julianne Stoughton, MD, Sesadri Raju, MD, Cynthia K. Shortell, MD, Joseph D. Raffetto, MD, Hugo Partsch, MD, Lori C. Pounds, MD, Mary E. Cummings, MD, David L. Gillespie, MD, Robert B. McLafferty, MD, Mohammad Hassan Murad, MD, Thomas W. Wakefield, MD, and Peter Gloviczki, MD

Damage control resuscitation for vascular surgery in a combat support hospital.

BACKGROUND Hemorrhage from extremity wounds is a leading cause of potentially preventable death during modern combat operations. Optimal management involves rapid hemostasis and reversal of metabolic derangements utilizing damage control principles. The traditional practice of damage control surgery favors a life over limb approach and discourages elaborate, prolonged vascular reconstructions. We hypothesized that limb preservation could be successful when the damage control approach combines advanced resuscitative strategies and modern vascular techniques. METHODS Trauma Registry records at a Combat Support Hospital from April to June 2006 were retrospectively reviewed. Patients with life-threatening hemorrhage (defined as >4 units of packed red blood cells) who underwent simultaneous revascularization for a pulseless extremity were included. Data collection included the initial physiologic parameters in the emergency department (ED), total and 24-hour blood product requirements, and admission physiology and laboratory values in the intensive care unit (ICU). Outcome measures were survival, graft patency, and amputation rate at 7 days. RESULTS Sixteen patients underwent 20 vascular reconstructions for upper (3) or lower extremity (17) wounds. Patients were hypotensive (blood pressure 105/60 +/- 29/18), acidotic (pH 7.27 +/- 0.1; BD -7.50 +/- 5.5), and coagulopathic (international normalized ratio 1.3 +/- 0.4) on arrival to the ED and essentially normal upon admission to the ICU, 4 hours later. Vein grafts (19/20, 95%) were used preferentially. Prosthetic grafts (1), shunting and delayed repair (4) or amputation (1) were infrequent. Heparin was not used or limited to a half dose (5/20, 25%). Tourniquets (12/16, 75%) and fasciotomies (13/16, 81%) were routine. Most (75%) received recombinant factor VIIa in the ED and in the operating room. All survived with normalized physiology on arrival in the ICU. Twenty-four-hour crystalloid use averaged 7.1 +/- 3.2 L, whereas packed red blood cells averaged 23 +/- 18 units, and 88% were massively transfused. Median operative time was 4.5 hours (range, 1.7-8.4 hours). CONCLUSIONS Aggressive damage control resuscitation maneuvers in critically injured casualties successfully permitted prolonged, complex extremity revascularization with excellent early limb salvage and graft patency. Recombinant VIIa and liberal resuscitation with fresh whole blood, plasma, platelets and cryoprecipitate, while minimizing crystalloid, allowed limb salvage and did not result in early graft failures.

Acute venous disease: Venous thrombosis and venous trauma

Acute venous disorders include deep venous thrombosis, superficial venous thrombophlebitis, and venous trauma. Deep venous thrombosis (DVT) most often arises from the convergence of multiple genetic and acquired risk factors, with a variable estimated incidence of 56 to 160 cases per 100,000 population per year. Acute thrombosis is followed by an inflammatory response in the thrombus and vein wall leading to thrombus amplification, organization, and recanalization. Clinically, there is an exponential decrease in thrombus load over the first 6 months, with most recanalization occurring over the first 6 weeks after thrombosis. Pulmonary embolism (PE) and the post-thrombotic syndrome (PTS) are the most important acute and chronic complications of DVT. Despite the effectiveness of thromboembolism prophylaxis, appropriate measures are utilized in as few as one-third of at-risk patients. Once established, the treatment of venous thromboembolism (VTE) has been defined by randomized clinical trials, with appropriate anticoagulation constituting the mainstay of management. Despite its effectiveness in preventing recurrent VTE, anticoagulation alone imperfectly protects against PTS. Although randomized trials are currently lacking, at least some data suggests that catheter-directed thrombolysis or combined pharmaco-mechanical thrombectomy can reduce post-thrombotic symptoms and improve quality of life after acute ileofemoral DVT. Inferior vena caval filters continue to have a role among patients with contra-indications to, complications of, or failure of anticoagulation. However, an expanded role for retrievable filters for relative indications has yet to be clearly established. The incidence of superficial venous thrombophlebitis is likely under-reported, but it occurs in approximately 125,000 patients per year in the United States. Although the appropriate treatment remains controversial, recent investigations suggest that anticoagulation may be more effective than ligation in preventing DVT and PE. Venous injuries are similarly under-reported and the true incidence is unknown. Current recommendations include repair of injuries to the major proximal veins. If repair not safe or possible, ligation should be performed.

The effectiveness of a damage control resuscitation strategy for vascular injury in a combat support hospital: results of a case control study.

OBJECTIVES Major vascular injury is a leading cause of potentially preventable hemorrhagic death in modern combat operations. An optimal resuscitation approach for military trauma should offer both rapid hemorrhage control and early reversal of metabolic derangements. The objective of this report is to establish the use and effectiveness of a damage control resuscitation (DCR) strategy in the setting of wartime vascular injury. METHODS A retrospective two-cohort case control study was performed using the Joint Theater Trauma Registry to identify patients with an extremity vascular injury treated at two different points in time: group 1 (n = 16) from April to June 2006 when DCR concepts were put into practice and group 2 (n = 24) 1 year later in a period when DCR strategies were not employed. RESULTS Baseline demographics, injury severity, admission physiology, and operative details were similar between groups 1 and 2. Group 1 patients received more total blood products (23 vs. 12 units, p < 0.05), fresh frozen plasma (16 vs. 7 units, p < 0.01), cryoprecipitate (11 vs. 1.2 units, p < 0.05), whole blood (19% vs. 0%, p = 0.06), and early recombinant factor VIIa (75% vs. 0%, p < 0.001) than group 2 patients. Group 1 patients had a more complete early physiologic recovery after vascular reconstruction (heart rate: 38 vs. 12, p < 0.001; systolic blood pressure, 39 vs. 14, p < 0.001; base deficit: 7.36 vs. 2.72, p < 0.001; International Normalized Ratio, 0.3 vs. 0.1, p < 0.001). There was no significant difference in early amputation rates (group 1: 6.2% vs. group 2: 4.2%) or 7-day mortality (0% in both groups). CONCLUSIONS This study was the first to use the Joint Theater Trauma Registry for follow-up on an established clinical practice guideline. DCR goals appear now to be met during the management of acute wartime vascular injuries with effective correction of physiologic shock. The overall impact of this resuscitation strategy on long-term outcomes such as limb salvage and mortality remains to be determined.

Histopathologic Evaluation of an Expanded Polytetrafluoroethylene-Nitinol Stent Endoprosthesis in Canine Iliofemoral Arteries☆

PURPOSE The authors assess a new ePTFE-nitinol stent for its long-term patency, healing, and properties of endothelialization. MATERIALS AND METHODS Adult greyhounds (n = 18) underwent bilateral iliofemoral placement of an endoprosthesis (Hemobahn) consisting of a nitinol stent lined with an ultrathin expanded polytetrafluoroethylene (ePTFE) material. Histologic and quantitative morphometric analyses were performed on devices explanted at 2 weeks and 1, 3, 6, and 12 months. The source of endothelialization was examined in four additional devices modified by sealing either the proximal and distal ends or the entire graft with poly(tetrafluoroethylene-co-hexafluoropropylene) (FEP), a nonporous laminate to prevent potential transgraft endothelial cell migration. RESULTS Device patency assessed with both intravascular ultrasound and histologic study showed minimal arterial stenosis, irrespective of implant duration. The neointima at less than 3 months consisted of fibrin and inflammatory infiltrate; at later time points, it was composed of mostly smooth muscle cells. Flow surfaces were more than 75% endothelialized by 3 months, which was nearly complete by 6 months. Modified endoprostheses entirely enveloped with FEP resulted in endothelialization of only the proximal and distal ends; the middle regions showed nonocclusive thrombi. Conversely, devices wrapped proximally and distally showed nearly complete endothelialization. CONCLUSIONS This ePTFE-nitinol endoprosthesis demonstrated long-term patency at up to 1 year after implantation and showed early and nearly complete endothelialization by 6 months. The design promoted rapid endothelialization of flow surfaces, particularly in the midregion of the device possibly by transgraft migration.

Percutaneous arterial closure in peripheral vascular disease: a prospective randomized evaluation of the Perclose device.

BACKGROUND Patients with peripheral vascular disease have been excluded from initial studies of percutaneous suture-mediated closure devices (SMCD) despite representing a significant proportion of those requiring endovascular intervention. We sought to determine whether these devices could be safely used in patients with peripheral vascular disease. METHODS Patients were stratified into two groups and five subgroups on the basis of indication for arteriography, and they were prospectively randomized at the end of the procedure to receive either the SMCD or manual compression. Ankle-brachial index was determined and duplex ultrasound scanning of the accessed femoral artery was performed, before and after the procedure. Ultrasound data included peak systolic velocity, minimum intraluminal vessel diameter, and presence or absence of calcified plaque. Time to hemostasis, ambulation, and discharge were recorded, and major or minor complications were noted. RESULTS Of 102 patients included in the study, 52 patients were randomized to receive the SMCD. There was no difference in ankle-brachial index, minimum intraluminal vessel diameter, or peak systolic velocity in the accessed vessel after closure with SMCD or manual compression. Time to hemostasis, ambulation, and discharge was significantly less in the SMCD group (P =.001). Presence of calcified plaque was not associated with complications (P =.146). In the SMCD group, hemostasis was achieved with 49 of 52 devices (94.2%). There were six complications (5.9%), two of which were major and required operative intervention. All complications were hemorrhagic and not occlusive. There was no difference in overall complication rate between SMCD (7.7%) and manual compression (4.0%) groups (P =.678). No infection was noted in any of the 102 patients. CONCLUSIONS Suture-mediated percutaneous arterial closure can be safely performed in patients with peripheral vascular disease, even in the presence of calcified plaque. This closure technique enables shorter time to hemostasis, ambulation, and hospital discharge. There are observed differences in minor, but not major, complication rates for MC versus percutaneous arterial closure in patients with peripheral vascular disease, but these differences did not achieve statistical significance in this small series.

Resident involvement is associated with worse outcomes after major lower extremity amputation

BACKGROUND Despite the recent major changes in vascular and general surgery training, there has been a paucity of literature examining the effect of these changes on training and surgical outcomes. Amputations represent a common cross-section in core competencies for general surgery and vascular surgery trainees. This study evaluates the effect of trainee participation on outcomes after above-knee and below-knee amputations. METHODS The American College of Surgeons-National Surgical Quality Improvement Program (NSQIP) database (2005 to 2010) was queried using Current Procedural Terminology codes (American Medical Association, Chicago, Ill) for below-knee amputation (27880, 27882) and above knee-amputation (27590, 27592). Resident involvement was defined using the NSQIP variable and was narrowed to postgraduate year 1 to 5. Variables associated with resident involvement were identified, and mortality, morbidity, intraoperative transfusion, and operative time (75th percentile vs the bottom three quartiles) were evaluated as distinct categoric end points in logistic regression. Included in the model were variables with a P value <.1 on χ(2) or independent t-test, as appropriate. Significance was defined at P < .05. RESULTS Residents were involved in 6587 of 11,038 amputations (62%). After adjustment for preoperative and intraoperative factors on logistic regression, there was a significant increase in major morbidity (odds ratio [OR], 1.27; 95% confidence interval [CI], 1.14-1.42; P < .001), intraoperative transfusion (OR, 1.78; 95% CI, 1.50-2.11; P < .001), and operative time (OR, 1.64 95% CI, 1.46-1.84; P < .001) in resident cases. CONCLUSIONS Resident involvement was associated with increased odds of major morbidity after amputation and also with increased operative time and risk for intraoperative transfusions.

Call to action to prevent venous thromboembolism

Deep venous thrombosis and pulmonary embolism, together called venous thromboembolism, remain a serious national health problem. Estimates suggest that over 900,000 cases occur in the United States per year, with 300,000 deaths per year. Because of the significant and serious nature of this problem, a workshop was held in May of 2006, which resulted in the Acting U.S. Public Health Service Surgeon Generals Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. On September 15, 2008, Acting Surgeon General, Rear Admiral Steven K. Galson, MD, MPH, and Elizabeth Nabel, MD, Director National Heart, Lung, and Blood Institute, announced the Call to Action. The Call to Action highlights public awareness about the risk factors, triggering events, and symptoms of venous thrombosis and pulmonary embolism, and encourages the development of evidence based practices for screening, prevention, diagnosis, and treatment of venous thrombosis and pulmonary embolism. It is designed to encourage new scientific investigation in an effort to obtain needed evidence to fill in the gaps of knowledge about venous thrombosis and pulmonary embolism. This knowledge should be quickly and easily disseminated to the public and put into practice by health professionals. The Surgeon Generals Call to Action represents one of the most important advances in the field of venous thromboembolism and sets the stage for multidisciplinary efforts to combat this serious national health problem.