Robert B. McLafferty

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.

The hemodynamics and diagnosis of venous disease

The venous system is, in many respects, more complex than the arterial system and a thorough understanding of venous anatomy, pathophysiology, and available diagnostic tests is required in the management of acute and chronic venous disorders. The venous system develops through several stages, which may be associated with a number of development anomalies. A thorough knowledge of lower extremity venous anatomy, anatomic variants, and the recently updated nomenclature is required of all venous practitioners. Effective venous return from the lower extremities requires the interaction of the heart, a pressure gradient, the peripheral muscle pumps of the leg, and competent venous valves. In the absence of pathology, this system functions to reduce venous pressure from approximately 100 mm Hg to a mean of 22 mm Hg within a few steps. The severe manifestations of chronic venous insufficiency result from ambulatory venous hypertension, or a failure to reduce venous pressure with exercise. Although the precise mechanism remains unclear, venous hypertension is thought to induce the associated skin changes through a number of inflammatory mechanisms. Several diagnostic tests are available for the evaluation of acute and chronic venous disease. Although venous duplex ultrasonography has become the standard for detection of acute deep venous thrombosis, adjuvant modalities such as contrast, computed tomographic, and magnetic resonance venography have an increasing role. Duplex ultrasonography is also the most useful test for detecting and localizing chronic venous obstruction and valvular incompetence. However, it provides relatively little quantitative hemodynamic information and is often combined with measurements of hemodynamic severity determined by a number of plethysmographic methods. Finally, critical assessment of venous treatment modalities requires an understanding of the objective clinical outcome and quality of life instruments available.

Patient recovery after infrainguinal bypass grafting for limb salvage

PURPOSE The outcome of infrainguinal bypass surgery for limb salvage has traditionally been assessed by graft patency rates, limb salvage rates, and patient survival rates. Recently, functional outcome of limb salvage surgery has been assessed by patient ambulatory status and independent living status. These assessments fail to consider the adverse long-term patient effects of delayed wound healing, episodes of recurrent ischemia, and need for repeat operations. An ideal result of infrainguinal bypass surgery for limb salvage includes an uncomplicated operation, elimination of ischemia, prompt wound healing, and rapid return to premorbid functional status without recurrence or repeat surgery. The present study was performed to determine how often this ideal result is actually achieved. METHODS The records of 112 consecutive patients who underwent initial infrainguinal bypass surgery for limb salvage 5 to 7 years before the study were reviewed for operative complications, graft patency, limb salvage, survival, patient functional status, time to achieve wound healing, need for repeat operations, and recurrence of ischemia. RESULTS The mean patient age was 66 years. The mean postoperative follow-up was 42 months (range, 0 to 100.1 months). After operation 99 patients (88%) lived independently at home and 103 (92%) were ambulatory. There were seven perioperative deaths (6.3%), and wound complications occurred in 27 patients (24%). By life table, the assisted primary graft patency and limb salvage rates of the index extremity 5 years after operation were 77% and 87%, respectively, and the patient survival rate was 49%. At last follow-up or death, 73% of the patients (72 of 99) who lived independently at home before the operation were still living independently at home, and 70% (72 of 103) of those who were ambulatory before the operation remained ambulatory. Wound (operative and ischemic) healing required a mean of 4.2 months (range, 0.4 to 48 months), and 25 patients (22%) had not achieved complete wound healing at the time of last follow-up or death. Repeat operations to maintain graft patency, treat wound complications, or treat recurrent or contralateral ischemia were required in 61 patients (54%; mean, 1.6 reoperations/patient), and 26 patients (23.2%) ultimately required major limb amputation of the index or contralateral extremity. Only 16 of 112 patients (14.3%) achieved the ideal surgical result of an uncomplicated operation with long-term symptom relief, maintenance of functional status, and no recurrence or repeat operations. CONCLUSIONS Most patients who undergo infrainguinal bypass surgery for limb salvage require ongoing treatment and have persistent or recurrent symptoms until their death. A significant minority have major tissue loss despite successful initial surgery. Clinically important palliation is frequently achieved by bypass surgery, but ideal results are distinctly infrequent.

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

Special iliac artery considerations during aneurysm endografting.

BACKGROUND The feasibility of endograft exclusion of abdominal aortic aneurysms (AAA) has been established. However, the technical challenges of graft delivery through tortuous or diseased iliac arteries and the treatment of associated iliac aneurysmal disease have received little attention. METHODS Over 19 months, 74 patients underwent endoluminal repair of AAA and/or iliac artery aneurysms. Iliac anatomy that required special consideration during endografting was reviewed. RESULTS Of the 74 patients, 35 (47%) had iliac anatomy that required special attention. Thirteen patients (18%) had aneurysmal involvement of a common iliac artery. Eleven of these patients required endograft extension into the external iliac artery (EIA) and hypogastric coil embolization due to the proximity of the aneurysm to the hypogastric origin. Eleven patients with ectatic, nonaneurysmal iliac arteries required aortic cuffs to achieve a distal seal in these oversized vessels. Iliac artery tortuosity or stenosis were complicating factors in 27 of the 74 patients (36%), requiring the use of brachial guidewire tension in 2 patients to facilitate tracking of the delivery device. Five patients with severely splayed aortic bifurcations required crossed placement of the iliac limbs to prevent kinking of the endograft. Occlusive atherosclerotic disease of the EIA mandated preprocedural dilatation and stenting in 3 patients and postprocedural surgical EIA reconstruction in another 5 patients. Three patients who underwent successful endograft placement required subsequent endovascular repair of traumatized EIAs. CONCLUSIONS Iliac artery anatomy plays a significant role in the endoluminal treatment of infrarenal abdominal aortic aneurysms, complicating the procedure in up to 47% of patients with otherwise suitable anatomy. A variety of supplemental procedures, both surgical and endovascular, may be required to facilitate endograft placement. A special understanding of these constraints and proper planning is required for optimal therapy.

Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients

OBJECTIVE The effects of a new long-term subcutaneous vascular access device were studied in access-challenged patients who were poor candidates for fistulas or grafts due to venous obstruction. Bacteremia rates, patency, and function of the Hemodialysis Reliable Outflow (HeRO) Vascular Access Device (Hemosphere Inc, Minneapolis, Minn) were evaluated. METHODS The HeRO device consists of a 6-mm expanded polytetrafluoroethylene graft attached to a 5-mm nitinol-reinforced silicone outflow component designed to bypass venous stenoses and enter the internal jugular vein directly, providing continuous arterial blood flow into the right atrium. The HeRO device was studied in a multicenter clinical trial to test the hypothesis that access-challenged patients would experience a statistically significant reduction in bacteremia rates compared with a tunneled dialysis catheter (TDC) literature control of 2.3/1000 days. HeRO-related bacteremia rates, adequacy of dialysis, patency, and adverse events were analyzed. RESULTS The HeRO device was implanted in 36 access-challenged patients who were followed for a mean 8.6 months (9931 HeRO days). The HeRO-related bacteremia rate was 0.70/1000 days. All HeRO-related bacteremias occurred during the bridging period when a TDC was still implanted before HeRO graft incorporation. HeRO adequacy of dialysis (mean Kt/V) was 1.7. HeRO primary patency was 38.9%, and secondary patency was 72.2%. CONCLUSIONS In access-challenged patients, a statistically significant reduction in HeRO-related bacteremia was noted compared with TDC literature. The device had similar function and patency compared with conventional arteriovenous graft literature.

Algorithm for the diagnosis and treatment of endoleaks.

BACKGROUND Endoluminal grafting of abdominal aortic aneurysms (AAA) has shown promising early results. However, endoleaks present a new and challenging obstacle to successful aneurysm exclusion. We report our experience with primary, persistent endoleaks and provide an algorithm for their diagnosis and management. METHODS Over a 19-month period, 73 patients underwent endoluminal repair of their AAAs using a modular bifurcated endograft as part of a US FDA Investigational Device Exemption trial. Spiral computed tomography (CT) scanning was performed prior to discharge after repair to evaluate for complete aneurysm exclusion. If no endoleak was present on that initial CT scan, color-flow duplex scanning was performed at 1 month, with repeat CT scanning at 6 months and 1 year. If the initial CT scan revealed the presence of an endoleak, repeat CT scanning was performed at 2 weeks, 1 month, and 3 months, or until the endoleak resolved. Any patient with an endoleak that persisted beyond 3 months underwent angiographic evaluation to localize the source of the leak. RESULTS At 1 month, 62 patients (85%) had successful aneurysm exclusion. The remaining 11 patients (15%) had primary endoleaks, 8 (11%) of which persisted beyond 3 months, prompting angiographic evaluation. In 2 patients the endoleak was related to a graft-graft or graft-arterial junction. One was from the endograft terminus in the common iliac artery and was successfully embolized, along with its outflow lumbar artery. The other required placement of an additional endograft component across a leaking graft-graft junction to successfully exclude the aneurysm. The remaining six endoleaks were due to collateral flow through the aneurysm sac. In 4 cases this was lumbar to lumbar flow fed by hypogastric artery collaterals to the inflow lumbar artery. In the remaining 2 patients the endoleak was found to be due to flow between a lumbar and inferior mesenteric artery. Resolution of the endoleak by coil embolization of the feeding hypogastric artery branch in 1 patient was unsuccessful due to rapid recruitment of another hypogastric branch. Two of the six collateral flow endoleaks have resolved spontaneously without treatment, while the remaining cases have been followed up without evidence of aneurysm expansion. CONCLUSION Systematic postoperative surveillance facilitates proper diagnosis and treatment of endoleaks. This involves serial CT scans to detect the presence of endoleaks, followed by angiography to determine their etiology and guide treatment, if clinically indicated.

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.

Late clinical and hemodynamic sequelae of isolated calf vein thrombosis

PURPOSE Despite the frequent occurrence of isolated calf vein thrombosis (ICVT), little is known about the long-term clinical and hemodynamic sequelae of this condition. This study was conducted to determine late clinical symptoms and vascular laboratory abnormalities in patients after ICVT. METHODS Of 146 patients in whom ICVT was documented by color flow duplex scanning between 1989 and 1994, 37 were reexamined. Data included history, physical examination, venous recovery time (VRT), and duplex valve closure time (DVCT). A control group with no history of venous disease also underwent identical clinical and hemodynamic testing. RESULTS Thirty-seven patients (18 male and 19 female) with a median age of 56 years (range, 22 to 76 years) were examined at a mean follow-up of 3.4 years (range, 2.2 to 5.8 years) after the diagnosis of ICVT in 39 extremities. Seventeen subjects (34 extremities) were recruited as normal controls. Presenting symptoms at the time of ICVT included calf pain in 17 patients, calf swelling in seven, pain and swelling in seven, pulmonary symptoms in four, pulmonary symptoms and calf pain in one, and no symptoms in one. In the patients with ICVT, VRT was abnormal in 23% of extremities with ICVT and in 9% of extremities without ICVT. None of the extremities in the control group had an abnormal VRT (p < 0.05). DVCT was abnormal in one or more venous segments in 26% of extremities diagnosed with ICVT and in 6% of control extremities (p < 0.05). Follow-up clinical examination in patients with ICVT revealed 13 (35%) with reticular veins, 10 (27%) with varicose veins, two (5.4%) with edema, one (2.7%) with pigmentation and ulcer (contralateral extremity to ICVT with a previous history of proximal deep venous thrombosis), 13 (35%) with mild discomfort, and one (2.7%) with severe pain. All symptoms attributable to ICVT were mild in nature except in one patient who had severe pain and no physical or hemodynamic vascular laboratory abnormalities at follow-up. CONCLUSION At an average of 3.4 years after ICVT, approximately one third of patients showed evidence of mild to moderate venous valvular insufficiency, but mostly in segments not involved with ICVT, and few had significant clinical symptoms attributable to venous disease.