Treatment Modalities for Small Saphenous Vein Insufficiency: Systematic Review and Meta-analysis.

PURPOSE: To investigate and compare the anatomical success rates and complications of the treatment modalities for small saphenous vein (SSV) incompetence. METHODS: A systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library on the following therapies for incompetence of SSVs: surgery, endovenous laser ablation (EVLA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (UGFS), steam ablation, and mechanochemical endovenous ablation (MOCA). The search found 49 articles (5 randomized controlled trials, 44 cohort studies) reporting on the different treatment modalities: surgery (n=9), EVLA (n=28), RFA (n=9), UGFS (n=6), and MOCA (n=1). A random-effects model was used to estimate the primary outcome of anatomical success, which was defined as closure of the treated vein on follow-up duplex ultrasound imaging. The estimate is reported with the 95% confidence interval (CI). Secondary outcomes were technical success and major complications [paresthesia and deep vein thrombosis (DVT)], given as the weighted means. RESULTS: The pooled anatomical success rate was 58.0% (95% CI 40.9% to 75.0%) for surgery in 798 SSVs, 98.5% (95% CI 97.7% to 99.2%) for EVLA in 2950 SSVs, 97.1% (95% CI 94.3% to 99.9%) for RFA in 386 SSVs, and 63.6% (95% CI 47.1% to 80.1%) for UGFS in 494 SSVs. One study reported results of MOCA, with an anatomical success rate of 94%. Neurologic complications were most frequently reported after surgery (mean 19.6%) and thermal ablation (EVLA: mean 4.8%; RFA: mean 9.7%). Deep venous thrombosis was a rare complication (0% to 1.2%). CONCLUSION: Endovenous thermal ablation (EVLA/RFA) should be preferred to surgery and foam sclerotherapy in the treatment of SSV incompetence. Although data on nonthermal techniques in SSV are still sparse, the potential benefits, especially the reduced risk of nerve injury, might be of considerable clinical importance.

Visceral stent patency in fenestrated stent grafting for abdominal aortic aneurysm repair.

OBJECTIVE: Fenestrated endovascular abdominal aortic aneurysm repair (F-EVAR) has been introduced for treatment of aneurysms in which visceral arteries are incorporated. Patency of target vessels has been reported to be excellent. Results of the use of stent grafts to accommodate visceral arteries in F-EVAR are presented in this study, including an overview of factors that affect outcome. METHODS: All patients treated with fenestrated stent grafts in a single center between November 2001 and October 2011 were reviewed. Patients treated for suprarenal, juxtarenal, and infrarenal short-necked aortic aneurysms were included. Patients with thoraco-abdominal aneurysms or aneurysms treated with grafts with fixed side branches were excluded. Polytetrafluoroethylene covered stents were used routinely since June 2005. Target vessels and stents were examined using computed tomography angiography reconstructions. Primary end points were primary patency, defined as the absence of occlusion, and loss of renal function. Secondary end points were technical success, stenosis (defined as a ≥50% angiographic diameter reduction), stent fracture, and mortality. RESULTS: A total of 138 patients with a median age of 73 years (range, 50-91 years) met the inclusion criteria. Median computed tomography angiography follow-up was 13 months (range, 1-97 months). In total, 392 target vessels were provided with 140 scallops and 252 fenestrations. Visceral stents (-grafts) were placed in 254 target vessels. Technical success was obtained in 249 arteries (98.0%). Overall stent patency of target vessels was 95.7% at 1 year and 88.6% at 4 years. Renal artery stent patency was 97.4% at 1 year and 91.2% at 4 years (96.8% and 89.1% for uncovered stents; 97.3% and 92.4% for covered stents, respectively). There was no significant difference in patency between covered and uncovered stents in renal arteries (P = .71). Renal artery stenosis occurred in 26 stented arteries (11.3%) and occlusion in seven arteries. Renal artery stent stenosis occurred significantly more in uncovered than in covered stents (P = .04). Stent fractures occurred more in uncovered than in covered stents (P = .01) and was associated with a significantly lower visceral stent patency rate (P < .01). During follow-up, 13 patients developed permanent renal function impairment (9.4%), of which two required permanent dialysis (1.4%). Renal dysfunction was significantly associated with renal stent occlusion or stenosis (P < .01). CONCLUSIONS: Patency rates of visceral artery stent (-grafts) in F-EVAR were 95.7% at 1 year and 88.6% at 4 years. Patency rates were affected by stent fractures, which occurred more in uncovered compared with covered stents. Renal artery stent stenosis occurred more in uncovered compared with covered stents. Renal dysfunction was significantly associated with renal stent occlusion or stenosis.

Mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency.

OBJECTIVE: This study evaluated the feasibility, safety, and 1-year results of mechanochemical endovenous ablation (MOCA) of great saphenous vein (GSV) insufficiency. METHODS: A consecutive 106 patients were treated for primary GSV insufficiency with MOCA by the ClariVein device and polidocanol. The primary outcome measures were technical success, clinical success, and anatomic success after 1 year of follow-up. Secondary outcome measures were postprocedural pain, complications, general- and disease-specific quality of life, and time to return to work. Patients were evaluated with clinical examination and duplex ultrasonography at 6 weeks, 6 months, and 1 year after treatment. RESULTS: The technical success was 99%. The mean postprocedural pain during the first 14 days after treatment was 7.5 mm (interquartile range [IQR], 0.0-10.0 mm) per day on a 0- to 100-mm visual analog scale. The time to return to normal activities and work was 1.0 day (IQR, 0-1.0 day) and 1.0 day (IQR, 1.0-4.0 days), respectively. No major complications were recorded. At 1-year follow-up, the clinical success was 93%. The Venous Clinical Severity Score decreased significantly from 4.0 (IQR, 3.0-5.0) before treatment to 1.0 (IQR, 0-1.0) (P < .001) 1 year after MOCA. At 1 year, 88.2% of the treated GSVs remained occluded as measured by duplex ultrasonography. Twelve patients had a recanalization, of which eight were partial. Disease-specific quality of life and the RAND 36-Item Health Survey scores improved significantly at 1-year follow-up. CONCLUSIONS: MOCA is a safe and effective technique in the treatment of GSV insufficiency with good clinical and anatomic success at 1-year follow-up. The technique is related to low postprocedural pain scores, low complication rate, improved quality of life, and rapid resumption of normal activities and work.

Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins.

OBJECTIVE: Thermal ablative techniques of varicose veins carry a risk of heat-related complications, including postoperative pain. Mechanochemical endovenous ablation (MOCA) might avoid these complications and reduce postoperative pain because of the absence of thermal energy. This study evaluated postoperative pain and quality of life after radiofrequency ablation (RFA) and MOCA for great saphenous vein (GSV) incompetence. METHODS: Sixty-eight patients with unilateral GSV incompetence were treated with either RFA or MOCA in this prospective observational study. Patients monitored their pain for the first 14 postoperative days on a 100-mm visual analog scale (VAS). They also completed the general (RAND 36-Item Short-Form Health Survey) and disease-specific (Aberdeen Varicose Vein Questionnaire) quality of life questionnaires before and 6 weeks after treatment. RESULTS: Patients treated with MOCA reported significantly less postoperative pain than patients treated with RFA during the first 14 days after treatment (4.8 ± 9.7 mm vs 18.6 ± 17.0 mm; P < .001) (mean VAS over 14 days). The lower postoperative pain score was associated with a significantly earlier return to normal activities (1.2 ± 1.8 vs 2.4 ± 2.8 days; P = .02) and work resumption (3.3 ± 4.7 vs 5.6 ± 5.8 days, respectively; P = .02). At 6 weeks, patients in both groups perceived an improved change in health status and an improved disease-specific quality of life. CONCLUSIONS: MOCA is associated with significantly less postoperative pain, faster recovery, and earlier work resumption compared with RFA in the treatment of GSV incompetence. MOCA and RFA are both related to a rapid improvement in quality of life.

Midterm outcome of balloon-expandable polytetrafluoroethylene-covered stents in the treatment of iliac artery chronic occlusive disease.

PURPOSE: To evaluate the 4-year results of polytetrafluoroethylene (PTFE)-covered stents in the treatment of iliac artery occlusive disease. METHODS: Between January 2003 and September 2010, PTFE-covered stents were implanted in 115 iliac arteries of 87 patients (73 men; mean age 60 ± 11 years) in a single center. The lesions were classified as TASC II A (n=40), B (n=41), C (n=7), and D (n=27). There were 69 primary endograft placements, while 46 procedures were performed after previous bare metal stent placement (reintervention group). Follow-up consisted of clinical investigation, ankle-brachial index (ABI) measurement, and duplex ultrasound scanning. In this retrospective analysis, outcomes were reported on a per-limb basis. RESULTS: The median Rutherford classification decreased from category 3 at baseline to 0 after the procedure (p<0.001) and the ABI increased from 0.66 ± 0.24 to 0.89 ± 0.21 (p<0.001). The primary limb patency was significantly higher in the primary treatment group (p=0.03): 88.7% at 1 year, 86.4% at 2 years, and 71.5% at 4 years compared to the reintervention group (77.9%, 72.1%, and 53.0%, respectively). Univariate analysis revealed prior stent placement as the only factor associated with loss of primary patency. The freedom from target lesion revascularization (TLR) in the primary treatment group was 95.2% at 1 year, 89.6% at 2 years, and 74.4% at 4 years, which did not differ significantly from rates in the reintervention group (88.0%, 82.3%, and 63.8%, respectively). CONCLUSION: The use of PTFE-covered stents for occlusive disease in the iliac arteries is related to satisfactory limb patency rates and high freedom from TLR. Previous stent placement was related to a lower primary patency rate. Additional studies are indicated to establish subgroups that may specifically benefit from covered stents.

Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study.

PURPOSE: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. In a pilot study, 30 limbs in 25 patients (18 women; mean age 52 years) with GSV incompetence were treated with MOCA using polidocanol at 2 centers. Initial technical success, complications, patient satisfaction, and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment. RESULTS: Initial technical success of MOCA was 100%. There were no major adverse events. Minor complications consisted of 9 local ecchymoses at the puncture site and superficial phlebitis that resolved within a week in 4 limbs. Duplex ultrasonography at 6 weeks showed 26 (87%) of 30 veins were completely occluded; 3 veins showed partial recanalization in the proximal (n = 2) and distal GSV. One patient had full segment recanalization and was successfully retreated. The VCSS significantly improved at 6 weeks (p < 0.001). Patient satisfaction was high, with a median satisfaction of 8.8 on a 0-10 scale. CONCLUSION: This study showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of GSV incompetence. Larger studies with a prolonged follow-up are indicated to prove the efficacy of this technique in terms of obliteration rates.