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Recanalization After Endovenous Thermal Ablation
161.e1
Abstracts
Journal of Vascular Surgery: Venous and Lymphatic Disorders January 2017
Posterior Tibial Vein Approach to Catheter-Directed Thrombolysis for Iliofemoral Deep Venous Thrombosis Scott Bendix, MD,1 Ryan Nolan,1 William Oppat, MD1. 1ProvidenceProvidence Park Hospital. Background: Deep venous thrombosis (DVT) remains a significant cause of morbidity in the American population. Catheter-directed thrombolysis for acute iliofemoral DVT is an effective therapy not only to restore venous patency but also to reduce the development of the post-thrombotic syndrome (PTS). We hypothesized that access for the delivery of thrombolytics is most effective with infusion distal to the thrombus burden. Our data demonstrate that posterior tibial vein cannulation has comparable short- and long-term outcomes for treatment of acute iliofemoral DVT and femoral-popliteal DVT without significant morbidity. Methods: All patients treated at a single institution between 2009 and 2015 undergoing mechanical and chemical thrombolysis were retrospectively observed. Patients were divided into groups by access site, including contralateral and ipsilateral femoral vein, popliteal vein, and posterior tibial vein. Preoperative demographics, intraoperative data, and postoperative outpatient charts were analyzed. Primary end points included evidence of incompetence by duplex ultrasound and the development of complications of PTS. Results: Fifty-eight patients underwent mechanical and chemical thrombolysis, and 51 patients met inclusion criteria: 27 posterior tibial veins, 20 popliteal veins, and 4 femoral veins were accessed; 55% of patients were female, and the mean age was 57.3 years. Secondary diagnoses included 30 patients with phlegmasia, 9 patients with inferior vena cava thrombosis, and 7 patients with May-Thurner syndrome; 40 patients had unilateral DVT, whereas 11 patients had bilateral involvement. After lysis, 44 patients underwent percutaneous venous angioplasty and 11 patients underwent venous stenting. All patients were maintained with systemic anticoagulation postoperatively (41% for 6-month duration and 43% lifelong). Mean operative times were slightly longer in the posterior tibial approach (156.7 vs 130.6 minutes; P ¼ .08), and mean fluoroscopy time was higher in the posterior tibial group (17.5 vs 13.7 minutes; P ¼ .17). Overall 90-day morbidity was 9.8%, and no deaths were recorded. Patency of the deep venous system was similar between the posterior tibial and popliteal or femoral approaches (95% vs 88%; P ¼ .29); 21.5% developed PTS. There was no difference for development of PTS between the posterior tibial and popliteal or femoral approaches (22% vs 20.8%; P ¼ .52). There was no difference in development of chronic nonocclusive DVT (37% vs 35%; P ¼ .61). Median follow-up was 8.7 months (range, 0.4-58.9). Conclusions: The posterior tibial vein approach to catheterdirected thrombolysis is a safe and sensible option for the treatment of iliofemoral and femoral-popliteal DVT. A larger cohort will be necessary to demonstrate superiority of tibial vein access in femoral-popliteal DVT.
Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins Roshan Bootun, BSc, MBBS, MRCS,2 David Epstein,1 Sarah Onida, BSc, MBBS, MRCS,2 Marta Ortega-Ortega,1 Alun Davies, BA, BMBCh, MA, DM, CST, FHEA, FEBVS, FACPh, FRCS, DSc2. 1 University of Granada; 2Imperial College London. Background: During the past decade, the treatment of varicose veins has changed dramatically with the increasing use of endovenous ablation, which has now become the “gold standard.” Novel, nonthermal methods have also recently been introduced and are competing with the more traditional endothermal technologies. However, evidence of the cost-effectiveness of these newer methods is lacking. Therefore, the cost-effectiveness of current technologiesdconservative care (CONS), surgery (high ligation and stripping [HL/S]), ultrasound-guided foam sclerotherapy, endovenous laser ablation (EVLA), and radiofrequency ablation (RFA)dand emerging technologiesdmechanochemical ablation (MOCA) and cyanoacrylate glue occlusion (CAE)dfor treatment of varicose veins during 5 years was analyzed. Methods: A decision model was constructed. Effectiveness was measured by reintervention on the truncal vein, re-treatment of residual varicosities, and quality-adjusted life years during 5 years. Costs were estimated from systematic review, National Health Service unit costs, and
manufacturers’ list prices. Sensitivity analysis and probabilistic sensitivity analysis were carried out. Results: At 5 years, CONS has the lowest overall cost and quality of life per person during 5 years; HL/S, EVLA, RFA, and MOCA have similar costs and effectiveness; and CAE has the highest overall cost but is no more effective than other therapies. Conclusions: At a threshold of £20,000/quality-adjusted life year, as used in the United Kingdom, the probabilities of treatment being costeffective during 5 years are as follows: EVLA, 0.316; RFA, 0.265; ultrasound-guided foam sclerotherapy, 0.136; MOCA, 0.111; CONS, 0.170; HL/S, 0.002; and CAE, 0.000. Further evidence on the effectiveness and health-related quality of life associated with MOCA and CAE is needed.
Endovenous Thermoablation of Great Saphenous Vein Reflux Using 1470-nm Diode Laser with Radial Double-Ring Fiber in Patient with Parkes Weber Syndrome: A Case Report Nara Cavalcante, MD, Jayme Junior. Background: Parkes Weber syndrome is a congenital vascular malformation consisting of capillary, venous, lymphatic, and arteriovenous malformations. It offers well-defined clinical manifestations and evolution, and its complications have high morbidity for these patients, frequently with chronic ulcers and even amputation of the affected limb. The treatment of arterial complications is often performed by embolization, and there are no reports in the literature of treatment of the superficial venous system by thermoablation. The objective of this study was to report a case of treatment complications in a lower limb from a patient with Parkes Weber syndrome with embolization and thermoablation. Methods: This is a case report. Results: J.J.S. (20 years old, female, brown) was seen in service 2 years ago with an ulcerated lesion on the medial aspect of the left ankle. She had a history of prior surgery for osteoarthritis and two previous embolizations of arteriovenous malformations and the tibial posterior artery in the left lower limb. There was no report of other clinical complications. Physical vascular examination of the lower limb showed absence of the posterior tibial pulse and palpable dorsalis pedis pulse. Duplex ultrasound scan showed spontaneous pulsatile flow and reflux after a decompression maneuver in the great saphenous vein and collateral varicose veins. Arteriography showed some “nidus” throughout the member, with the largest in the distal third of the leg. The patient underwent embolization of the arteriovenous malformation in the thigh and, 2 months later, in the leg. It was associated with elastic compression. The leg ulcer evolved with healing, but after almost 60 days, the ulcerative lesion recurred. It was recently chosen to treat the great saphenous vein reflux with thermoablation using a 1470-nm laser with double-ring fiber and tumescent local anesthesia. There was complete healing of the ulcerated lesion in <4 weeks, and the control duplex ultrasound scan performed in 24 hours and 30 days showed left great saphenous vein occlusion. Conclusions: The treatment of great saphenous vein reflux with thermoablation is easy to perform and appears to have a favorable prognosis in patients with Parkes Weber syndrome, but the long-term results are not yet well defined.
Recanalization After Endovenous Thermal Ablation Ahmad Alsheekh, MD, Anil Hingorani, MD, Enrico Ascher, MD, Natalie Marks, Afsha Arshina. Background: Endovenous thermal ablation in the form of radiofrequency ablation (RFA) or laser therapy has quickly ascended to a prime position in the treatment of reflux within the lower extremity superficial venous system. Whereas there are good data examining the rates of thrombotic complications, there is a relative paucity of data examining their rates of recurrence. Methods: Data analysis was performed for 1475 thermal ablations in 485 patients from 2012 to 2015 with superficial venous reflux. Data were collected from office visits and venous duplex ultrasound scans 1 week after the procedure and every 3 months for the first year and every 6 months thereafter. Recanalization was defined by duplex ultrasounddemonstrated patency of the targeted vein with >500 ms. RFA was used in 1027 patients and laser in 448 patients. Targeted veins were the great saphenous vein (GSV; 778), short saphenous vein (SSV; 401), accessory vein (140), and calf perforators (156). Data for recurrence were
Journal of Vascular Surgery: Venous and Lymphatic Disorders
Abstracts
161.e2
Volume 5, Number 1 correlated with age, gender, laterality, presenting symptoms, and targeted vein. Analysis was performed using the c2 and Student t-tests. Results: The overall average classification of the presenting symptoms by clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification was 3.9. There was a significant difference in the age between RFA (61.1 years) and laser (74.6 years; P < .001). We analyzed the results of venous duplex ultrasound scans on the veins 1 week after the thermal ablation and found that women (2.6%) had higher failure of obliteration than men (1.9%; P ¼ .018). Excluding perforator veins, there was no statistical difference at 1 week between RFA and laser for recurrences (P ¼ .96). At 1 week, perforator veins had the highest failure of obliteration (16.6%), followed by accessory veins (2.9%), compared with the other veins (P < .001). Failure of obliteration rate for the GSV and SSV was 0.8% and 0.8%, respectively (P ¼ .98). There was no significant correlation of failure of obliteration after thermal ablation at 1 week with age, laterality, and presenting symptoms. Excluding perforating veins, after a mean followup period of 13.5 6 12 months, there was no statistical difference with recurrence rates between RFA (10%) and laser (8.8%; P ¼ .54). Recanalization rates for GSV and SSV were 7.7% and 8.5%, respectively (P ¼ .63). Perforators and accessory veins had the highest recanalization rate, 41.2% and 14.8%, respectively (P < .001). Not including the perforator veins, only 56% of patients with recanalization after the follow-up period were symptomatic (pain, swelling, or ulcers). There was no significant correlation of obliteration at time of last follow-up with respect to age, gender, laterality, and presenting symptoms. Conclusions: These data do suggest low overall rates of recurrence after thermal ablation of the GSV and SSV. At midterm follow-up, accessory veins had almost double the rate of recurrence compared with the GSV and SSV, and the perforator veins had almost five times the rate of recurrence. Excluding perforator veins, there was no significant difference between RFA and laser in terms of recurrence.
Sclerotherapy and Vein Gluing Combined as a Single-Catheter Procedure for Saphenous Veins Johann Ragg. Angioclinic Vein Centers Europe. Background: Gluing of veins is discussed as being superior to thermoocclusive methods or sclerotherapy as it may achieve immediate and permanent vein closure without any symptoms during vein regression. Furthermore, no tumescent anesthesia is required. However, approved gluing methods use continuous placement of larger amounts of aggressive and hardly resorbable cyanoacrylate (VenaSeal [Medtronic, Santa Rosa, Calif], VariClose [Biolas Inc, Ankara, Turkey], VenaBlock [Invamed, Ankara, Turkey]). The effect depends on external manual compression. Segmental glue application is preferred by some investigators to save glue and to accelerate the procedure, but this leaves native endothelium and thus a source of relapse. These drawbacks could be overcome by a new modality that combines segmental or point-wise gluing and catheter sclerotherapy (ScleroGlue project). Methods: Twenty-four patients (16 women, 8 men; 42-69 years) with great saphenous vein insufficiency and diameters of 8 to 24 mm
Fig 1. Case example: male, 53 yrs., insufficient left GSV Ø 8.1 - 8.5 mm, additional targets: 3 medial perforator veins (1 thigh, 2 lower leg), several tributaries (lower leg). Single treatment by ScleroGlue technique, access from distal lower leg, no external compression, all additional targets reached, no additional punctures. A) pre, B) glue spot at day 1 (same scale, walls well attached), aspect pre vs day 14 showing regression of varices.
(mean, 9.4 mm) underwent combined sclerotherapy (Aethoxysklerol 1%, 1+4 with air) and gluing by a double-catheter access including the VariClose gluing system. Besides the great saphenous vein, additional associated targets (refluxive side branches >6 mm in diameter [n ¼ 22] and perforator veins >6 mm in diameter [n ¼ 12]) were included in the treatment plan. First sclerofoam was applied with a polytetrafluoroethylene catheter (PhleboCath, 1.9/2.3 mm in diameter) during withdrawal, and then cyanoacrylate glue was injected during the spasm phase of the target vein while continuously withdrawing the gluing catheter (1.2/1.6 mm in diameter). No manual compression was applied. There were no external compression media (stockings, bandages) used after the treatment. Results: All cases (24/24) showed immediate saphenous occlusion and elimination of reflux. All auxiliary targets (39/39) were successfully reached by microfoam and occluded. The amount of glue used for saphenous veins was 10 to 33 mg (mean, 16.1 mg) per centimeter of vein. Procedural time from first puncture to patient mobilization was 11 to 23 minutes (mean, 15.1). Conclusions: The ScleroGlue combines reliable endothelium denaturation by catheter-delivered sclerofoam with initial and permanent lumen minimization by point-wise gluing, achieved without any external compression and using low quantities of glue. The procedure is fast and requires no anesthesia except for the puncture site. Further studies will be started in December 2016 also including nonacrylate glues.
Early Vein Straightening and Tenting After Iliofemoral Venous Stent Deployment: Anatomic Assessment and Clinical Implications Mahmood Razavi, MD,1 Kenneth Ouriel, MD, MBA,2 William Marston, MD,3 Stephen Black, MD4. 1St Joseph Hospital Orange; 2Syntactx; 3 University of North Carolina; 4Guy’s and St Thomas’ Hospital. Background: The use of stents to treat symptomatic iliofemoral venous outflow obstruction is increasing on a global level. The complications associated with iliofemoral venous stenting are different from those observed in arteries. Straightening and tenting of the stented vessel are two such complications. Methods: The feasibility phase of An Evaluation of the Veniti VICI Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction (VIRTUS) study enrolled 30 subjects with symptomatic iliofemoral venous obstruction in the United States and Europe. Subjects underwent baseline and poststenting multiplanar contrast venography. The degree of straightening was assessed by an independent core laboratory, as was the amount of “tenting” at the peripheral end of the stent. Straightening was assessed on the venographic obliquity with the greatest degree of visually estimated curvature at baseline, expressed as the angle inscribed by the three points: the midpoint along the length of the stent (apex) and the two ends. Angulation was measured at the same three levels on the prestenting venogram, and straightening was expressed as the decrease in angulation. Tenting was expressed as the angle formed along the greater curve of the caudal stent margin, inscribed by the three points: the stent-venous interface (apex) and 2 cm in cranially and caudally along the greater curve of the vein. Patients were excluded if the segment was occluded at baseline or inadequately visualized, leaving 22 segments suitable for angulation and 29 for tenting measurements. Results: The 30-patient study population comprised 24 women and 6 men. Nonthrombotic and post-thrombotic indications were present in 11 (37%) and 19 (63%), respectively. The obstruction involved the common iliac vein (CIV) alone in 11 cases, the external iliac vein (EIV) alone in 4 cases, and both the CIV and EIV in 15 cases. No lesions were localized to the common femoral vein. In aggregate, stent deployment did not result in straightening of the stented segments, with a mean of 21 6 15 degrees at baseline and 20 6 13 degrees after stenting (P ¼ .877). Straightening (defined by $30-degree decrease in angulation after stenting) occurred in 2 of 22 cases (9%). Tenting at the peripheral margin of the stent was significant ($30 degrees) in 5 of 29 cases (17%). The degree of straightening and tenting was similar in postthrombotic and nonthrombotic cases and was not dependent on the location of the stent (EIV vs CIV or common femoral vein). Core laboratory 12-month duplex ultrasound documented one stent occlusion (3%) that occurred in a subject without significant straightening or tenting.
Abstracts
Journal of Vascular Surgery: Venous and Lymphatic Disorders January 2017
Posterior Tibial Vein Approach to Catheter-Directed Thrombolysis for Iliofemoral Deep Venous Thrombosis Scott Bendix, MD,1 Ryan Nolan,1 William Oppat, MD1. 1ProvidenceProvidence Park Hospital. Background: Deep venous thrombosis (DVT) remains a significant cause of morbidity in the American population. Catheter-directed thrombolysis for acute iliofemoral DVT is an effective therapy not only to restore venous patency but also to reduce the development of the post-thrombotic syndrome (PTS). We hypothesized that access for the delivery of thrombolytics is most effective with infusion distal to the thrombus burden. Our data demonstrate that posterior tibial vein cannulation has comparable short- and long-term outcomes for treatment of acute iliofemoral DVT and femoral-popliteal DVT without significant morbidity. Methods: All patients treated at a single institution between 2009 and 2015 undergoing mechanical and chemical thrombolysis were retrospectively observed. Patients were divided into groups by access site, including contralateral and ipsilateral femoral vein, popliteal vein, and posterior tibial vein. Preoperative demographics, intraoperative data, and postoperative outpatient charts were analyzed. Primary end points included evidence of incompetence by duplex ultrasound and the development of complications of PTS. Results: Fifty-eight patients underwent mechanical and chemical thrombolysis, and 51 patients met inclusion criteria: 27 posterior tibial veins, 20 popliteal veins, and 4 femoral veins were accessed; 55% of patients were female, and the mean age was 57.3 years. Secondary diagnoses included 30 patients with phlegmasia, 9 patients with inferior vena cava thrombosis, and 7 patients with May-Thurner syndrome; 40 patients had unilateral DVT, whereas 11 patients had bilateral involvement. After lysis, 44 patients underwent percutaneous venous angioplasty and 11 patients underwent venous stenting. All patients were maintained with systemic anticoagulation postoperatively (41% for 6-month duration and 43% lifelong). Mean operative times were slightly longer in the posterior tibial approach (156.7 vs 130.6 minutes; P ¼ .08), and mean fluoroscopy time was higher in the posterior tibial group (17.5 vs 13.7 minutes; P ¼ .17). Overall 90-day morbidity was 9.8%, and no deaths were recorded. Patency of the deep venous system was similar between the posterior tibial and popliteal or femoral approaches (95% vs 88%; P ¼ .29); 21.5% developed PTS. There was no difference for development of PTS between the posterior tibial and popliteal or femoral approaches (22% vs 20.8%; P ¼ .52). There was no difference in development of chronic nonocclusive DVT (37% vs 35%; P ¼ .61). Median follow-up was 8.7 months (range, 0.4-58.9). Conclusions: The posterior tibial vein approach to catheterdirected thrombolysis is a safe and sensible option for the treatment of iliofemoral and femoral-popliteal DVT. A larger cohort will be necessary to demonstrate superiority of tibial vein access in femoral-popliteal DVT.
Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins Roshan Bootun, BSc, MBBS, MRCS,2 David Epstein,1 Sarah Onida, BSc, MBBS, MRCS,2 Marta Ortega-Ortega,1 Alun Davies, BA, BMBCh, MA, DM, CST, FHEA, FEBVS, FACPh, FRCS, DSc2. 1 University of Granada; 2Imperial College London. Background: During the past decade, the treatment of varicose veins has changed dramatically with the increasing use of endovenous ablation, which has now become the “gold standard.” Novel, nonthermal methods have also recently been introduced and are competing with the more traditional endothermal technologies. However, evidence of the cost-effectiveness of these newer methods is lacking. Therefore, the cost-effectiveness of current technologiesdconservative care (CONS), surgery (high ligation and stripping [HL/S]), ultrasound-guided foam sclerotherapy, endovenous laser ablation (EVLA), and radiofrequency ablation (RFA)dand emerging technologiesdmechanochemical ablation (MOCA) and cyanoacrylate glue occlusion (CAE)dfor treatment of varicose veins during 5 years was analyzed. Methods: A decision model was constructed. Effectiveness was measured by reintervention on the truncal vein, re-treatment of residual varicosities, and quality-adjusted life years during 5 years. Costs were estimated from systematic review, National Health Service unit costs, and
manufacturers’ list prices. Sensitivity analysis and probabilistic sensitivity analysis were carried out. Results: At 5 years, CONS has the lowest overall cost and quality of life per person during 5 years; HL/S, EVLA, RFA, and MOCA have similar costs and effectiveness; and CAE has the highest overall cost but is no more effective than other therapies. Conclusions: At a threshold of £20,000/quality-adjusted life year, as used in the United Kingdom, the probabilities of treatment being costeffective during 5 years are as follows: EVLA, 0.316; RFA, 0.265; ultrasound-guided foam sclerotherapy, 0.136; MOCA, 0.111; CONS, 0.170; HL/S, 0.002; and CAE, 0.000. Further evidence on the effectiveness and health-related quality of life associated with MOCA and CAE is needed.
Endovenous Thermoablation of Great Saphenous Vein Reflux Using 1470-nm Diode Laser with Radial Double-Ring Fiber in Patient with Parkes Weber Syndrome: A Case Report Nara Cavalcante, MD, Jayme Junior. Background: Parkes Weber syndrome is a congenital vascular malformation consisting of capillary, venous, lymphatic, and arteriovenous malformations. It offers well-defined clinical manifestations and evolution, and its complications have high morbidity for these patients, frequently with chronic ulcers and even amputation of the affected limb. The treatment of arterial complications is often performed by embolization, and there are no reports in the literature of treatment of the superficial venous system by thermoablation. The objective of this study was to report a case of treatment complications in a lower limb from a patient with Parkes Weber syndrome with embolization and thermoablation. Methods: This is a case report. Results: J.J.S. (20 years old, female, brown) was seen in service 2 years ago with an ulcerated lesion on the medial aspect of the left ankle. She had a history of prior surgery for osteoarthritis and two previous embolizations of arteriovenous malformations and the tibial posterior artery in the left lower limb. There was no report of other clinical complications. Physical vascular examination of the lower limb showed absence of the posterior tibial pulse and palpable dorsalis pedis pulse. Duplex ultrasound scan showed spontaneous pulsatile flow and reflux after a decompression maneuver in the great saphenous vein and collateral varicose veins. Arteriography showed some “nidus” throughout the member, with the largest in the distal third of the leg. The patient underwent embolization of the arteriovenous malformation in the thigh and, 2 months later, in the leg. It was associated with elastic compression. The leg ulcer evolved with healing, but after almost 60 days, the ulcerative lesion recurred. It was recently chosen to treat the great saphenous vein reflux with thermoablation using a 1470-nm laser with double-ring fiber and tumescent local anesthesia. There was complete healing of the ulcerated lesion in <4 weeks, and the control duplex ultrasound scan performed in 24 hours and 30 days showed left great saphenous vein occlusion. Conclusions: The treatment of great saphenous vein reflux with thermoablation is easy to perform and appears to have a favorable prognosis in patients with Parkes Weber syndrome, but the long-term results are not yet well defined.
Recanalization After Endovenous Thermal Ablation Ahmad Alsheekh, MD, Anil Hingorani, MD, Enrico Ascher, MD, Natalie Marks, Afsha Arshina. Background: Endovenous thermal ablation in the form of radiofrequency ablation (RFA) or laser therapy has quickly ascended to a prime position in the treatment of reflux within the lower extremity superficial venous system. Whereas there are good data examining the rates of thrombotic complications, there is a relative paucity of data examining their rates of recurrence. Methods: Data analysis was performed for 1475 thermal ablations in 485 patients from 2012 to 2015 with superficial venous reflux. Data were collected from office visits and venous duplex ultrasound scans 1 week after the procedure and every 3 months for the first year and every 6 months thereafter. Recanalization was defined by duplex ultrasounddemonstrated patency of the targeted vein with >500 ms. RFA was used in 1027 patients and laser in 448 patients. Targeted veins were the great saphenous vein (GSV; 778), short saphenous vein (SSV; 401), accessory vein (140), and calf perforators (156). Data for recurrence were
Journal of Vascular Surgery: Venous and Lymphatic Disorders
Abstracts
161.e2
Volume 5, Number 1 correlated with age, gender, laterality, presenting symptoms, and targeted vein. Analysis was performed using the c2 and Student t-tests. Results: The overall average classification of the presenting symptoms by clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification was 3.9. There was a significant difference in the age between RFA (61.1 years) and laser (74.6 years; P < .001). We analyzed the results of venous duplex ultrasound scans on the veins 1 week after the thermal ablation and found that women (2.6%) had higher failure of obliteration than men (1.9%; P ¼ .018). Excluding perforator veins, there was no statistical difference at 1 week between RFA and laser for recurrences (P ¼ .96). At 1 week, perforator veins had the highest failure of obliteration (16.6%), followed by accessory veins (2.9%), compared with the other veins (P < .001). Failure of obliteration rate for the GSV and SSV was 0.8% and 0.8%, respectively (P ¼ .98). There was no significant correlation of failure of obliteration after thermal ablation at 1 week with age, laterality, and presenting symptoms. Excluding perforating veins, after a mean followup period of 13.5 6 12 months, there was no statistical difference with recurrence rates between RFA (10%) and laser (8.8%; P ¼ .54). Recanalization rates for GSV and SSV were 7.7% and 8.5%, respectively (P ¼ .63). Perforators and accessory veins had the highest recanalization rate, 41.2% and 14.8%, respectively (P < .001). Not including the perforator veins, only 56% of patients with recanalization after the follow-up period were symptomatic (pain, swelling, or ulcers). There was no significant correlation of obliteration at time of last follow-up with respect to age, gender, laterality, and presenting symptoms. Conclusions: These data do suggest low overall rates of recurrence after thermal ablation of the GSV and SSV. At midterm follow-up, accessory veins had almost double the rate of recurrence compared with the GSV and SSV, and the perforator veins had almost five times the rate of recurrence. Excluding perforator veins, there was no significant difference between RFA and laser in terms of recurrence.
Sclerotherapy and Vein Gluing Combined as a Single-Catheter Procedure for Saphenous Veins Johann Ragg. Angioclinic Vein Centers Europe. Background: Gluing of veins is discussed as being superior to thermoocclusive methods or sclerotherapy as it may achieve immediate and permanent vein closure without any symptoms during vein regression. Furthermore, no tumescent anesthesia is required. However, approved gluing methods use continuous placement of larger amounts of aggressive and hardly resorbable cyanoacrylate (VenaSeal [Medtronic, Santa Rosa, Calif], VariClose [Biolas Inc, Ankara, Turkey], VenaBlock [Invamed, Ankara, Turkey]). The effect depends on external manual compression. Segmental glue application is preferred by some investigators to save glue and to accelerate the procedure, but this leaves native endothelium and thus a source of relapse. These drawbacks could be overcome by a new modality that combines segmental or point-wise gluing and catheter sclerotherapy (ScleroGlue project). Methods: Twenty-four patients (16 women, 8 men; 42-69 years) with great saphenous vein insufficiency and diameters of 8 to 24 mm
Fig 1. Case example: male, 53 yrs., insufficient left GSV Ø 8.1 - 8.5 mm, additional targets: 3 medial perforator veins (1 thigh, 2 lower leg), several tributaries (lower leg). Single treatment by ScleroGlue technique, access from distal lower leg, no external compression, all additional targets reached, no additional punctures. A) pre, B) glue spot at day 1 (same scale, walls well attached), aspect pre vs day 14 showing regression of varices.
(mean, 9.4 mm) underwent combined sclerotherapy (Aethoxysklerol 1%, 1+4 with air) and gluing by a double-catheter access including the VariClose gluing system. Besides the great saphenous vein, additional associated targets (refluxive side branches >6 mm in diameter [n ¼ 22] and perforator veins >6 mm in diameter [n ¼ 12]) were included in the treatment plan. First sclerofoam was applied with a polytetrafluoroethylene catheter (PhleboCath, 1.9/2.3 mm in diameter) during withdrawal, and then cyanoacrylate glue was injected during the spasm phase of the target vein while continuously withdrawing the gluing catheter (1.2/1.6 mm in diameter). No manual compression was applied. There were no external compression media (stockings, bandages) used after the treatment. Results: All cases (24/24) showed immediate saphenous occlusion and elimination of reflux. All auxiliary targets (39/39) were successfully reached by microfoam and occluded. The amount of glue used for saphenous veins was 10 to 33 mg (mean, 16.1 mg) per centimeter of vein. Procedural time from first puncture to patient mobilization was 11 to 23 minutes (mean, 15.1). Conclusions: The ScleroGlue combines reliable endothelium denaturation by catheter-delivered sclerofoam with initial and permanent lumen minimization by point-wise gluing, achieved without any external compression and using low quantities of glue. The procedure is fast and requires no anesthesia except for the puncture site. Further studies will be started in December 2016 also including nonacrylate glues.
Early Vein Straightening and Tenting After Iliofemoral Venous Stent Deployment: Anatomic Assessment and Clinical Implications Mahmood Razavi, MD,1 Kenneth Ouriel, MD, MBA,2 William Marston, MD,3 Stephen Black, MD4. 1St Joseph Hospital Orange; 2Syntactx; 3 University of North Carolina; 4Guy’s and St Thomas’ Hospital. Background: The use of stents to treat symptomatic iliofemoral venous outflow obstruction is increasing on a global level. The complications associated with iliofemoral venous stenting are different from those observed in arteries. Straightening and tenting of the stented vessel are two such complications. Methods: The feasibility phase of An Evaluation of the Veniti VICI Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction (VIRTUS) study enrolled 30 subjects with symptomatic iliofemoral venous obstruction in the United States and Europe. Subjects underwent baseline and poststenting multiplanar contrast venography. The degree of straightening was assessed by an independent core laboratory, as was the amount of “tenting” at the peripheral end of the stent. Straightening was assessed on the venographic obliquity with the greatest degree of visually estimated curvature at baseline, expressed as the angle inscribed by the three points: the midpoint along the length of the stent (apex) and the two ends. Angulation was measured at the same three levels on the prestenting venogram, and straightening was expressed as the decrease in angulation. Tenting was expressed as the angle formed along the greater curve of the caudal stent margin, inscribed by the three points: the stent-venous interface (apex) and 2 cm in cranially and caudally along the greater curve of the vein. Patients were excluded if the segment was occluded at baseline or inadequately visualized, leaving 22 segments suitable for angulation and 29 for tenting measurements. Results: The 30-patient study population comprised 24 women and 6 men. Nonthrombotic and post-thrombotic indications were present in 11 (37%) and 19 (63%), respectively. The obstruction involved the common iliac vein (CIV) alone in 11 cases, the external iliac vein (EIV) alone in 4 cases, and both the CIV and EIV in 15 cases. No lesions were localized to the common femoral vein. In aggregate, stent deployment did not result in straightening of the stented segments, with a mean of 21 6 15 degrees at baseline and 20 6 13 degrees after stenting (P ¼ .877). Straightening (defined by $30-degree decrease in angulation after stenting) occurred in 2 of 22 cases (9%). Tenting at the peripheral margin of the stent was significant ($30 degrees) in 5 of 29 cases (17%). The degree of straightening and tenting was similar in postthrombotic and nonthrombotic cases and was not dependent on the location of the stent (EIV vs CIV or common femoral vein). Core laboratory 12-month duplex ultrasound documented one stent occlusion (3%) that occurred in a subject without significant straightening or tenting.