Abstract
Perioperative duplex ultrasound following endothermal ablation of the saphenous vein: Is it worthless?
RT Jones and LS Kabnick
J Invasive Cardiol 2014; 26: 548–550
Fifteen years ago, radiofrequency ablation of the saphenous vein was introduced as a new and minimally invasive modality for the treatment of superficial venous insufficiency. Three years later, it was followed by endovenous laser ablation. These procedures have revolutionized the treatment of superficial venous insufficiency and have caused a dramatic shift from a highly invasive and morbid inpatient procedure, to a minimally invasive and ambulatory office procedure. Soon after their introduction, a new clinical entity was identified: endothermal heat-induced thrombosis (EHIT). This terminology, a classification system, and treatment strategies were introduced by Kabnick in 2005. Subsequently, advances in technique, along with the discovery of associated risk factors and a better understanding of the pathophysiologic process of endothermal coagulum formation, have reduced the current incidence of EHIT classes 2–4 to between 1% and 2%. Still, a paucity of data exists regarding the true incidence of clinically significant pulmonary embolism secondary to EHIT. The authors believe that the rate is less than 0.01%. Furthermore, successful thermal saphenous ablation efficacy in the perioperative period approaches 99%. Despite these excellent numbers, the standard of care is to obtain a duplex ultrasound to evaluate for the presence of EHIT within the first one to two weeks’ post endovenous thermal ablation. Given this information, the authors believe that performing duplex ultrasound in the perioperative period is wasteful and an inefficacious use of limited health-care resources. Thus, the authors advocate against routine duplex to evaluate treatment efficacy and EHIT presence during the perioperative period in asymptomatic patients.
Validation of the disease-specific quality of life Wuerzburg Wound Score in patients with chronic leg ulcer
M Engelhardt, E Spech, H Diener, H Faller, M Augustin and ES Debus
Vasa 2014; 43: 372–379
In this prospective study, 115 patients with vascular disease-associated leg ulcer (54 arterial ulcers, 61 venous ulcers) were studied (mean age 66 ± 11 years, 51% male). All patients completed the Wuerzburg Wound Score (WWS) at baseline, and after four and 12 weeks. To assess construct validity, additionally all patients completed the generic QOL questionnaires: Short Form-36 (SF-36) and Nottingham Health Profile (NHP). Construct validity and responsiveness of the WWS were tested. WWS demonstrated acceptable construct validity versus SF-36 (r = 0.5 −0.78; P < 0.001) and NHP (r = 0.36–0.68; P < 0.001). Responsiveness of the WWS was superior to SF-36 (P < 0.05) and NHP (P = 0.01). Generic as well as disease-specific QOL were more impaired in patients with arterial ulcer. The authors concluded that the WWS is a valid measure of disease-specific QOL in patients with leg ulcers and it is more sensitive than the generic instruments in detecting changes of wound healing overtime. However, further assessment of the psychometric properties of the WWS with larger patient samples is required before the test can be recommended for use clinically.
The effect of deep venous stenting on healing of lower limb venous ulcers
R George, H Verma, B Ram and R Tripathi
Eur J Vasc Endovasc Surg 2014; 48: 330–336
Retrospective review: 38-C6 patients who failed superficial venous intervention and compression underwent deep venous stenting of 44 limbs with recalcitrant venous ulcers. Thirty-one limbs were post-thrombotic and 13 limbs were non-thrombotic iliac vein lesions. At a median follow-up of 15 months, the primary and assisted primary patency rates were 94% and 97%, respectively. Sustained ulcer healing was achieved in 60% of limbs. A further 20% of ulcers had reduced in size. Recurrent ulcers developed in 13% of limbs, and half of these healed with interventions for newly developed incompetence in superficial veins. The authors concluded that endovascular interventions to the deep veins appear to be an effective adjunct in achieving the healing of recalcitrant ulcers.
A randomized trial comparing treatments for varicose veins
J Brittenden, SC Cotton, A Elders, CR Ramsay, J Norrie, J Burr, B Campbell, P Bachoo, I Chetter, M Gough, J Earnshaw, T Lees, J Scott, SA Baker, J Francis, E Tassie, G Scotland, S Wileman and MK Campbell
N Engl J Med 2014; 371: 1218–1227
The authors utilized a randomized multicenter trial involving 798 patients (11 UK centers) with primary varicose veins that underwent ultrasound-guided foam sclerotherapy, endovenous laser ablation or surgical treatments. The authors investigated six-month outcomes concerning disease-specific quality of life (QOL), generic quality of life, procedural complications and efficacy. At six months, generic QOL scores did not differ substantially between groups. However, when comparing disease-specific QOL outcomes, foam sclerotherapy patients fared worse than those patients who underwent surgery (P = 0.006). Both surgical and laser patients had equivalent disease-specific QOL scores. Overall, the endovenous laser ablation patients had the lowest frequency of procedural complications (P < 0.001); the frequency of serious adverse events, approximately 3%, was similar among the groups. The authors concluded that all treatments had similar QOL scores, complications were less frequent after laser treatment and ablation rates were lower with foam treatment.
The real cost of treating venous ulcers in a contemporary vascular practice
H Ma, TF O’Donnell Jr, NA Rosen and MD Iafrati
J Vasc Surg: Venous Lym Dis 2014; 2: 355–361
The purpose of this study was to define the actual cost of treating venous leg ulcers (VLU) and to identify factors influencing costs. A cohort of 84 patients with active VLU who were treated in a wound center by five vascular surgeons with a minimum follow-up of six months was retrospectively studied. Actual costs (not charges) were obtained for outpatient and inpatient facility, visiting nurse services, and our physician practice group to yield true cost. The proportion of healed VLUs and time to complete healing were determined to calculate time to healing as well as ulcer-free intervals. Calculations of cost/ulcer-free days and cost to complete healing for the entire follow-up period were carried out in addition to univariate analysis of factors affecting cost. The mean total cost of treating VLU during this follow-up period was $15,732. A total of 50 patients (60%) healed their VLUs without recurrence in a mean time of 122 days (range, 6–379 days) at a cost of $10,563 (range, $430–$50,967). This translated to $86/day of treatment to heal an ulcer, resulting in a cost of $42/ulcer-free day. In comparison, the total cost was threefold higher at $33,907 (range, $390–$132,730) for the patients (n = 17; 20%) who did not heal their VLUs. Significant contributing factors included outpatient facility fees ($10,332) and visiting nurse services ($11,365) related to extended treatment of the open VLU. Patients who had a recurrence of their VLU (n = 17; 20%) during the follow-up period had a total cost of $12,760. Inpatient admission for wound-related issues increased total cost to $33,629. Nearly two-thirds of admissions were for treatment of cellulitis with intravenous antibiotics. VLUs treated with surgical intervention did not significantly increase total cost ($12,304 vs. $19,503; P > .05) but significantly reduced recurrence rates (34% vs. 5%). There were three outliers who experienced complications after treatment of outflow obstruction that dramatically increased the total cost to $71,526. This economic analysis demonstrates the high true costs associated with modern treatment of VLU by aggressive medical and surgical techniques. Inpatient and outpatient facility fees, physician fees, and visiting nurse payments all contribute to the cumulative tally that results in these staggering direct costs for treatment of VLUs. The daily cost of treatment that accrues for the ongoing care of VLU patients until they are healed provides an economic rationale for initiatives that advance approaches seeking to provide more rapid wound healing. Our analysis also highlights the significant costs associated with treatment of infections and complications encountered in aggressive surgical interventions for patients with extensive chronic central venous occlusive disease. More aggressive early outpatient treatment of infections and refined criteria for selection of outflow stenting candidates may reduce total cost by preventing complications while improving outcomes.
Reflux in the below-knee great saphenous vein can be safely treated with endovenous ablation
SM Gifford, M Kalra, P Gloviczki, AA Duncan, GS Oderich, MD Fleming, S Harmsen and TC Bower
J Vasc Surg: Venous Lym Dis 2014; 2: 397–402
Intervention on the great saphenous vein (GSV) has traditionally been limited to the above-knee (AK-GSV) segment for fear of saphenous neuralgia in spite of the incompetence demonstrated in the below-knee (BK-GSV) segment. Residual symptoms and need for reintervention are reported to result in nearly half the patients if the refluxing BK-GSV is ignored. The aim of this study was to evaluate the safety of endovenous ablation of the refluxing BK-GSV. Data from consecutive patients treated with superficial venous ablation during a 48-month period from January 2010 to December 2013 were retrospectively reviewed. Demographic and procedure-related outcome and complication data were analyzed specifically for patients undergoing BK-GSV interventions. Seventy-nine limbs underwent BK-GSV ablation for reflux at this site. There were 36 women and 25 men (mean age, 55 years). Median Clinical, Etiologic, Anatomic, and Pathologic (CEAP) score was 3.4; 43 limbs were treated for symptomatic varicose veins (C 1–3) and 36 for advanced venous insufficiency (C 4–6); 14 limbs (18%) were treated for recurrent symptomatic varicose veins or venous insufficiency after prior superficial venous intervention with AK-GSV ablation, sclerotherapy, or stripping. Ablation was performed in 77 limbs (99%) with the VenaCure EVLT laser vein treatment and in two limbs by radiofrequency ablation with ClosureFAST system. The mean length of GSV ablated was 51.2 cm (range, 26–67 cm). Endovenous ablation was performed concomitantly on 22 accessory GSVs (28%) and 10 incompetent perforators (13%). Ambulatory stab phlebectomy of branch varicosities was performed simultaneously in 59 limbs (75%). Eight patients (10%) went on to have preplanned sclerotherapy treatment for small-branch varicosities. Postoperative paresthesia occurred in three patients (4%) and resolved within four weeks. Wound infection in three (4%) stab phlebectomy wounds resolved with oral antibiotic therapy. Follow-up surveillance ultrasound was available in 32 of 79 limbs that were >6 months from the procedure. Partial late recanalization was noted in four of 32 limbs, but no patient had recurrent symptoms requiring repeated endovenous ablation during this period. Consideration should be given to concomitant ablation of the BK-GSV in treatment of patients with varicose veins with reflux extending to the BK segment of the GSV to improve long-term outcomes.
Validity of International Classification of Diseases, Ninth Revision, Clinical Modification codes for estimating the prevalence of venous ulcer
ML Gloviczki, H Kalsi, P Gloviczki, M Gibson, S Cha and JA Heit
J Vasc Surg: Venous Lym Dis 2014; 2: 362–367
The American Venous Forum issued a call to reduce the prevalence of venous ulcers (VUs) by 50% in 10 years. The objectives of this study were to determine the validity of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for VU and to estimate the prevalence of VU in a well-defined geographic population (Olmsted County, MN). Rochester Epidemiology Project resources and 18 VU ICD-9-CM codes were used to identify residents with possible VUs during the two-year period 2010–2011 (n = 1551). The complete medical records in the community were reviewed for a 15% random sample (n = 227) of these residents, and on the basis of prespecified criteria, patients were categorized as a VU or non-VU case. Continuous and categorical variables were compared between groups by the two-sample t-test and χ2 test. Ninety-three patients (41%) had active or healed VUs, 83 had non-VUs, and 51 never had ulcers but had stasis skin changes or skin infection. ICD-9-CM code 454.0 best identified VU cases (sensitivity, 24%; specificity, 100%). VU patients were older and heavier and more frequently had bilateral ulcers. On the basis of the random sample review, an estimated 635 patients had healed or active VUs during the two-year period of the study. The prevalence of VUs in the Olmsted County population was estimated to be 210 per 100,000 person-years, with VU incidence (newly diagnosed ulcers) of 85 per 100,000 person-years. The authors concluded that ICD-9-CM VU codes operated poorly for VU identification. VU surveillance for estimating trends in incidence and prevalence of VUs will require better methods. New ulcers developed each year in 85 of 100,000 people, an incidence that seems to be higher than in the previous epidemiologic study in this population.
Reduction internal valvuloplasty is a new technical improvement on plication internal valvuloplasty for primary deep vein valvular incompetence
H Verma, R Srinivas, RK George and RK Tripathi
J Vasc Surg: Venous Lym Dis 2014; 2: 383–389
This group from India describes a new technique of valve leaflet closure, reduction internal valvuloplasty (RIVAL), to treat primary deep vein valvular incompetence in patients with C6 venous disease. The RIVAL method involves excision of redundant valve and suturing of the freshened edge to the wall of the valve station instead of plication at the commissural junctions. Since January 2008, RIVAL has been successfully performed on 44 incompetent deep vein valves in 18 consecutive patients (25 limbs). All patients had C6 venous ulcers of a minimum three months’ duration. On mean follow-up of one year (clinical assessment of venous ulcer healing and color-coded duplex scans at one, six, 12, 18, and 24 months) of the 44 valves repaired by reduction valvuloplasty, all 44 valves (100%) maintained full patency. Forty-two valves (95.4%) were competent, achieving a valve closure time <1 s with no reflux at the target valves on Valsalva maneuver in the reverse Trendelenburg and upright positions, and their intervalvular distances were reduced to >60% of preoperative levels. Eighty-eight percent of all ulcers (22 of 25) healed within nine weeks of surgery without any recurrence in the follow-up period. There was no valve thrombosis or resorption seen with this method. The RIVAL technique represents a significant advancement over the traditional existing valve plication techniques. It enables accurate anatomic fashioning and suturing of valve cusps and results in excellent competency and ulcer-healing rates with fewer complications in our early experience. Further follow-up is anticipated to define its long-term role in the management of C6 venous disease.