Abstract
Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of Laser, Surgery and Foam Sclerotherapy (CLASS) randomised controlled trial
J Brittenden, SC Cotton, A Elders, et al. Health Technol Assess 2015; 19: 1–342
A total of 798 patients with primary varicose veins (foam, n = 292; surgery, n = 294; endovenous laser ablation (EVLA), n = 212) participated in a randomized control trial; patients were randomized all three treatment options. The following were established as primary outcomes: Disease-specific (Aberdeen Varicose Vein Questionnaire (AVVQ)) and generic (European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36), physical and mental component scores) quality of life at six months. Cost-effectiveness as cost per quality adjusted life-year (QALY) gained. Secondary outcomes looked at quality of life at six weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. The results were similar to other randomised controlled trials (RCTs) in relation to participants’ baseline characteristics and post-treatment improvement in outcomes. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at six months but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons. The trial-based cost-effectiveness analysis revealed that foam had the highest probability of being cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was discovered to cost £26,107 per QALY gained and was less costly and generated slightly more QALYs than surgery. Markov modeling using trial costs and the limited recurrence data available suggested that, at five years, EVLA had the highest probability (≈79%) of being cost-effective at conventional thresholds, followed by foam (≈17%) and surgery (≈5%). With regard to secondary outcomes, health gains at six weeks (p < 0.005) were greater for EVLA than for foam (EQ-5D, p = 0.004). There were fewer procedural complications in the EVLA group (1%) than after foam (7%) and surgery (8%) (p < 0.001). Following foam or EVLA than following surgery participants returned to activities more quickly (p < 0.05). There were no differences in VCSS between the three treatments. Truncal ablation rates were higher for surgery (p < 0.001) and EVLA (p < 0.001) than for foam. Surgery and EVLA had similar ablative rates. The authors concluded from their study that EVLA should be considered as the treatment of choice.
Embolization techniques for high-flow arteriovenous malformations with a dominant outflow vein
AM Conway, K Qato, J Drury and RJ Rosen. J Vasc Surg: Venous and Lym Dis 2015; 3: 178–183
A retrospective review was performed from November 2010 to May 2014 on all patients with a high-flow arteriovenous malformation (AVM) and associated dominant outflow vein (DOV) who underwent transvenous embolization of the DOV. Indications, techniques, complications, and outcomes were reviewed. Fourteen patients (five males; 36%) underwent transvenous embolization of high-flow AVMs with a DOV. Median age was 41.6 years. The AVM was located on an extremity in eight patients (57%) and in the pelvis in six patients (43%). The indication for the procedure was pain in 11 patients (79%), swelling in 3patients (21%), a nonhealing wound in 1 patient (7%), and impotence in 1 patient (7%). The median number of prior procedures to treat the AVM was 2.5 (0–13). Transvenous embolization with coils was performed in 13 patients (93%). The Amplatzer vascular plug and Amplatzer septal occluder (St. Jude Medical, St. Paul, MN) were used in four patients (29%). Concurrent percutaneous puncture embolization of the AVM nidus was used in seven patients (50%) and transcatheter arterial embolization in eight patients (57%). Technical angiographic success was seen in all patients. Five patients (36%) experienced a complete response to treatment, whereas eight (57%) experienced a partial response. Seven patients (50%) required further procedures for residual symptoms. The authors concluded that AVMs with a DOV can be successfully treated by a transvenous approach. Percutaneous puncture embolization of the nidus or draining vein and transcatheter arterial embolization may assist in reducing flow.
Systematic review of compression following treatment for varicose veins
J El-Sheikha, D Carradice, S Nandhra, et al. Br J Surg 2015. Epub ahead of print, DOI: 10.1002/bjs.9788
Seven randomised controlled trials (RCTs) comparing different durations and methods of compression fulfilled the inclusion criteria. The treatments varied from open surgery (three trials), foam sclerotherapy (two trials), and endovenous laser ablation (EVLA) (two trials). Ten different products were used in six general regimens for 0 to 42 days. One study suggested that seven days rather than two days of compression hose following EVLA was associated with superior quality of life and less pain. Another study reported that, following surgery, application of a compression hose after three days of bandaging was associated with a slightly longer recovery than no compression. One study recorded stocking compliance at only 40%. The quality and heterogeneity of the studies precluded meta-analysis. The authors concluded that there is currently little quality evidence upon which to base any recommendations concerning compression following treatment for varicose veins.
The effect of stent placement for May–Thurner syndrome combined with symptomatic superficial venous reflux disease
M Yin, X Huang, C Cui, et al. J Vasc Surg: Venous and Lym Dis 2015; 3: 168–172
The current study aimed to determine whether it is necessary to correct May–Thurner syndrome (MTS) simultaneously with superficial venous reflux disease (S-VRD) in limbs of combined symptomatic MTS/S-VRD. A retrospective analysis of patients with S-VRD combined with MTS was conducted in a single institution from January 2001 to December 2010. Doppler ultrasound and phlebography were performed in patients with VRD. Computed tomography angiography or transfemoral venography was selectively performed in patients with severe symptoms or findings on phlebography suggestive of MTS. MTS was found in 207 patients. Among these, 121 patients were successfully treated with stent placement combined with endovenous laser ablation (EVLA); the remaining 86 patients, who were treated with EVLA for S-VRD alone, served as a control group. Clinical results, venous reflux, and quality of life were evaluated before and after treatment. Stent patency was followed up with Doppler ultrasound. There was no significant difference in age, female to male ratio, clinical symptoms, comorbidities, or percentage with S-VRD between the two groups. A total of 125 stents were placed in 121 patients in the EVLA + stent group. The rate of technical success was 100%. Follow-up periods ranged from 1 to 91months (mean, 70.4 ± 21.3 months). The four-year primary patency rate was 93.3%. The incidence of pain, edema, and ulceration was decreased significantly in the stent +EVLA group. However, there was a high rate of S-VRD recurrence in the EVLA-alone group. Quality of life improved significantly in the EVLA + stent group; improvements included relief of pain, edema, and fatigue and increased physical activity. For deep venous reflux, there was no significant improvement after stent placement for MTS. The investigators concluded that stent placement is an effective and durable treatment of MTS combined with symptomatic S-VRD; it results in a high level of long-term patency and a significant relief of pain, edema, and ulceration. Furthermore, correction of MTS plays an important role in decreasing the recurrence rate of S-VRD after EVLA.
Hospital-associated venous thromboembolism in children: incidence and clinical characteristics
CM Takemoto, S Sohi, K Desai, et al. J Pediatr 2014; 164: 332–338
From 1994 to 2009, a retrospective analysis of pediatric patients, 21 years or less, with John Hopkins’ hospital-associated venous thromboembolism (VTE) was studied. In 90,485 admissions (rate 30 per 10,000 admissions), there were 270 episodes of hospital-associated VTE. Young adults (18–21 years) and adolescents (14–17 years) had significantly increased rates of VTE compared with children (2–9 years) (incidence rate ratio (IRR) 7.7, 95% CI 5.1–12.0; IRR 4.3, 95% CI 2.7–6.8, respectively). A central venous catheter (CVC) was present in 50% of patients, and a surgical procedure was performed in 45% of patients before VTE diagnosis. For patients without a CVC, trauma was the most common admitting diagnosis. CVC-related VTE was diagnosed most frequently in infants (<1 year old) and in patients with malignancy. Renal and cardiac diseases were associated with the highest rates of VTE (51 and 48 per 10,000, respectively). Rates were significantly higher among those with ≥4 medical conditions compared with those with 1 medical condition (IRR 4.0, 95% CI 1.4–8.9). The authors concluded that the older pediatric population and multiple medical conditions were associated with increased rates of hospital-associated VTE.
Venous duplex and pathologic differences in thrombus characteristics between de novo deep vein thrombi and endovenous heat-induced thrombi
BJ Santin, JM Lohr, TW Panke, et al. J Vasc Surg: Venous and Lym Dis 2015; 3: 184–189
In spite of the few studies of the ultrasound differentiation between endovenous heat-induced thrombi (EHIT) and deep vein thrombi (DVT), there remains a paucity of literature regarding the evaluation of ultrasound examination and pathologic differentiation. Six Yorkshire cross swine underwent femoral vein thrombosis by suture ligation or endovenous radiofrequency ablation. At one week after the procedure, each femoral vein was imaged by color Duplex ultrasound and sent for histologic interpretation for differentiation between EHIT and DVT. Five blinded vascular surgery faculty, two vascular surgery fellows and three vascular surgery residents reviewed the ultrasound images. Thrombi associated with radiofrequency ablation demonstrated a greater degree of hypercellular response, fibroblastic reaction and edema (3.42 vs. 2.92; 3.75 vs. 2.42; 2.83 vs. 1.33). Specimens harvested from the iatrogenic induced DVT swine demonstrated a more prolific response to trichrome staining (3.42 vs. 2.67). Evidence of revascularization was found in all of the EHIT specimens but in 33% of DVT specimens. On the basis of histologic findings, the pathologist predicted correct modality 92% of the time. Subgroup analysis comparing paired specimens from each swine failed to demonstrate any marked pathologic differences. Recorded ultrasound images from EHIT and DVT samples were reviewed by fellows, residents and vascular surgery staff to determine whether clot was stationary or free-floating (n = 111; 93%), evidence of retracted or adherent vein (n = 105; 88%) and absence of color flow (n = 102; 85%). The degree of occlusion (partial vs. total) and degree of distention of a visualized vein were least likely to be agreed on by reviewers (n = 95; 79% each, respectively). In subgroup (DVT vs. EHIT) analyses, the percentage agreement was greatest among vascular surgery fellows (89% and 92%) compared with residents (82% and 79%) and faculty (78% and 77%). The study concluded that it is possible to differentiate the thrombus origin on pathologic examination but not clinically on ultrasound. Wide variability exists for ultrasound diagnosis of EHIT and de novo DVT. Care must be taken in evaluating post-treatment duplex scans to not assign diagnosis of EHIT when DVT may well be present and extending into the deep venous system. The modulation of collagen production in the treatment of DVT may be helpful in preventing vascular dysfunction and reducing the post-thrombotic changes. Further studies on injury after radiofrequency ablation and laser ablation are needed.
Prevalence and risk factors for post thrombotic syndrome after deep vein thrombosis in children: a cohort study
R Kumar, V Rodriguez, JM Matsumoto, et al. Thromb Res 2015; 135: 347–351
Using the Mayo Clinic Master Diagnostic Index, all pediatric patients (age 0 to 18 years) with a potential deep vein thrombosis based on ICD-8 codes over the 15-year period, 1995 to 2009 were identified. A validated post thrombotic syndrome (PTS) survey instrument was mailed to eligible patients. Baseline clinical and radiographic characteristics were abstracted from patient medical records and tested as potential predictors of PTS. Ninety patients participated. The mean age at DVT diagnosis and survey completion was 12.8 (±6.1) and 19.3 (±7.7) years, respectively; 59% of the patients reported mild PTS whereas 13% reported moderate-to-severe PTS. The most frequent PTS symptom and sign, respectively, were pain (34%) and dilated blood vessels (40%). On multivariate analysis, predictor of PTS was the number of thrombosed vein segments (OR 1.40; 95% CI: 1.05–1.86). The authors concluded that greater than 70% of children with DVT report subsequent symptoms or signs of PTS, though only 13% report clinically significant, moderate-to-severe PTS. The number of thrombosed vein segments at diagnosis and time duration between incident DVT and survey completion were independent predictors of PTS.
Utilization of venous duplex scanning and postoperative venography in patients with subclavian vein thrombosis
MS Orlando, KC Likes, YW Lum and JA Freischlag J Vasc Surg: Venous and Lym Dis 2015; 3: 173–177
The purpose of this study was to review preoperative and postoperative duplex scans and postoperative venograms in patients with subclavian vein thrombosis who underwent first rib resection and scalenectomy (FRRS) during 2005 to 2013. Preoperative venous duplex scans revealed no compression (NC), venous compression (VC, >50% decrease in velocity on abduction), venous ablation (VA, 0 velocity on abduction), and acute thrombus (AT, 0 velocity on abduction and adduction). Correlation with two-week postoperative venograms (open, stenosis requiring dilation, or occluded) and postoperative (2 to 4 months, 6 to 8 months, and 12 months) duplex scans was performed. Of 215 patients treated with FRRS for effort thrombosis, 140 had an ipsilateral preoperative duplex scan and postoperative venogram. Twenty-nine patients (21%) had VC, 70 (50%) had VA, 8 (5.7%) had AT, and 33 (24%) had NC. Patients with preoperative NC or VC were more likely to have an open vein on venography (P = .014). Six to eight months after FRRS, patients with preoperative VA were more likely to have compression or ablation (P = .009); no difference was seen at one year. Patency rates at last follow-up were 100% in the preoperative VC and AT groups, 96% in those with VA, and 94% in patients with no preoperative compression. The 128 preoperative scans of the asymptomatic side revealed that 67 patients (52%) had NC, 29 (23%) had VC, 32 (25%) had VA, and 0 had AT. Patients with NC (P = .027), VC (P = .017), or VA (P = .008) were significantly more likely to have the same result on the opposite side. The authors concluded that postoperative duplex scans reveal that VC and VA resolve during the year after FRRS, obviating the need for repeated venography or intervention. Patency rates are excellent in all patients when postoperative venography directs intervention. Patients with NC, VC, or VA on preoperative scans often show the same result on the opposite side.