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Thomas M Proebstle - One of the best experts on this subject based on the ideXlab platform.
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three year follow up results of the prospective european multicenter cohort study on cyanoacrylate embolization for treatment of refluxing great saphenous veins
2021Co-Authors: Thomas M Proebstle, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, Jens Alm, A H DaviesAbstract:Abstract Objective Cyanoacrylate closure of refluxing saphenous veins has demonstrated excellent safety and effectiveness results in feasibility and pivotal studies. This article provides the 36-month follow-up results of a prospective, multicenter, nonrandomized cohort study. Methods A total of 70 patients were enrolled in a prospective, multicenter study conducted at seven centers in four European countries and underwent treatment of a solitary refluxing great saphenous vein with endovenous cyanoacrylate embolization without the use of Tumescent Anesthesia or postprocedure compression stockings. The primary effectiveness end point was freedom from recanalization (closure rate) of the great saphenous vein at 6 months. Safety was assessed by occurrence of adverse events after the procedure and during the 6-month follow-up period. Quality of life and clinical improvement parameters were measured before and after the procedure and through a 12-month follow-up period. Anatomic success and clinical improvement were assessed through 36 months after the procedure. Results Of 70 treated patients, 64 (91%) were available for the 3-year follow-up. The closure rates by Kaplan-Meier life table methods at 6-, 12-, 24-, and 36-month time points were 91.4%, 90.0%, 88.5%, and 88.5%, respectively. Through 36 months, the improvement in change of the mean venous clinical severity score over time was statistically significant by dropping from 4.3 at baseline to 0.9 at the 36-month follow-up (P Conclusions The 3-year follow-up results of the prospective, multicenter eSCOPE study demonstrated the continued anatomic and clinical effectiveness of cyanoacrylate embolization over an extended follow-up period.
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thirty sixth month follow up of first in human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence
2017Co-Authors: Jose I Almeida, Daniel J Cher, Julian J Javier, Claudia Bautista, Edward G. Mackay, Thomas M ProebstleAbstract:Abstract Objective The objective of this study was to evaluate the long-term safety and effectiveness of endovenous cyanoacrylate (CA)-based closure of incompetent great saphenous veins. Methods This was a prospective, single-arm, single-center feasibility study conducted at the Canela Clinic (La Romana, Dominican Republic) to assess the effectiveness and safety of a CA-based adhesive for great saphenous vein closure at 36 months after treatment. Thirty-eight subjects were treated by injection of small boluses of CA under ultrasound guidance and without the use of perivenous Tumescent Anesthesia or postprocedure graduated compression stockings. Periodic scheduled follow-up was performed during 36 months. Results At month 36, there were 29 subjects who were available for follow-up. Complete occlusion of the treated veins was confirmed by duplex ultrasound in all subjects with the exception of two subjects showing recanalization at month 1 and month 3. Kaplan-Meier analysis revealed an occlusion rate at month 36 of 94.7% (95% confidence interval, 87.9%-100%). The mean Venous Clinical Severity Score (VCSS) improved from 6.1 ± 2.7 at baseline to 2.2 ± 0.4 at month 36 ( P Conclusions CA adhesive appears to be an effective and safe treatment for saphenous vein closure, with long-term occlusion rates comparable to those of other thermal and nonthermal methods and with no reported serious adverse events.
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two year follow up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence
2015Co-Authors: Jose I Almeida, Daniel J Cher, Julian J Javier, Claudia Bautista, Edward G. Mackay, Thomas M ProebstleAbstract:ObjectivesTo evaluate the safety and effectiveness of endovenous cyanoacrylate-based embolization of incompetent great saphenous veins.MethodsIncompetent great saphenous veins in 38 patients were embolized by cyanoacrylate bolus injections under ultrasound guidance without the use of perivenous Tumescent Anesthesia or graduated compression stockings. Follow-up was performed over a period of 24 months.ResultOf 38 enrolled patients, 36 were available at 12 months and 24 were available at 24 months follow-up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all patients except for one complete and two partial recanalizations observed at, 1, 3 and 6 months of follow-up, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836–1.0) at 24 months follow-up. Venous Clinical Severity Score improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.3 ± 1.1, 1.5 ± 1.4 and 2.7 ± 2.5 at 6, 12 and 24 months, respectively (p < .0001). Edema ...
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the european multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins
2015Co-Authors: Thomas M Proebstle, Daniel J Cher, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, A H DaviesAbstract:Objective Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. Methods A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither Tumescent Anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. Results In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P Conclusions Endovenous CA embolization of refluxing GSVs is safe and effective without the use of Tumescent Anesthesia or compression stockings.
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the european multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins
2015Co-Authors: Thomas M Proebstle, Daniel J Cher, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, Jens Alm, A H DaviesAbstract:Objective Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. Methods A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither Tumescent Anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. Results In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P Conclusions Endovenous CA embolization of refluxing GSVs is safe and effective without the use of Tumescent Anesthesia or compression stockings.
M C Mooij - One of the best experts on this subject based on the ideXlab platform.
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ten year follow up of a randomized controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation 980 nm using local Tumescent Anesthesia
2021Co-Authors: Celine A M Eggen, P Pronk, Menno T W Gaastra, M C Mooij, Tamana Alozai, Cagdas Unlu, Michiel A Schreve, Clarissa J Van VlijmenAbstract:OBJECTIVE The long-term results of saphenofemoral ligation and stripping (SFL/S) were compared with 980-nm bare fiber endovenous laser ablation (EVLA) for the treatment of great saphenous vein (GSV) incompetence. METHODS This was a single-center, randomized, controlled trial with a follow-up time of 10 years. Patients with GSV incompetence were randomised to undergo SFL/S or EVLA under Tumescent Anesthesia. The primary outcome was recurrence of groin-related varicose veins seen on duplex ultrasound imaging and clinical examination. The secondary outcomes were (changes or improvement in) CEAP clinical class, venous symptoms, cosmetic results, quality of life, reinterventions, and complications. RESULTS Between June 2007 and December 2008, 122 patients (130 limbs) were included; of these, 68 limbs were treated with SFL/S and 62 limbs with EVLA. The 10-year estimated freedom from groin recurrence as seen on duplex ultrasound imaging was higher in the SFL/S group (73% vs 44% in the EVLA group; P = .002), and the same trend was seen for clinically evident recurrence (77% vs 58%, respectively; P = .034). Nine reinterventions (17%) were deemed necessary in the SFL/S group vs 18 (36%) in the EVLA group (P = .059). All reinterventions in the SFL/S group consisted of foam sclerotherapy. Reinterventions in the EVLA group included foam sclerotherapy (n = 5), crossectomy (n = 2), and endovenous procedures (n = 11). There was no significant difference in quality of life and relief of venous symptoms. Cosmetic appearance improved, with a better cosmetic rating in the SFL/S group compared with the EVLA group (P = .026). One patient in the SFL/S group had a persisting neurosensory deficit remaining at 10 years. CONCLUSIONS This study showed no clear long-term advantage of EVLA with a 980-nm wavelength and bare-tip fiber over high ligation and stripping of the GSV under local Tumescent Anesthesia.
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five year follow up of a randomized controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation 980 nm using local Tumescent Anesthesia
2016Co-Authors: S A Gauw, James A Lawson, Clarissa Van Vlijmenvan Keulen, P Pronk, Menno T W Gaastra, M C MooijAbstract:Objective The objective of this study was to compare the long-term results (groin-related recurrence, great saphenous vein [GSV] occlusion rate, Clinical class, Etiology, Anatomy, and Pathophysiology [CEAP] staging, and quality of life [QoL]) after the treatment of a GSV incompetence by saphenofemoral ligation and stripping (SFL/S) with endovenous laser ablation bare fiber, 980 nm (EVLA). Methods Patients with GSV insufficiency and varicose veins were randomized to either undergo SFL/S or EVLA, both of which were performed under Tumescent Anesthesia. The long-term results, which included the anatomic occlusion rate, varicose vein recurrence at the saphenofemoral junction (SFJ), relief of venous symptoms and QoL, were compared up to 5 years after treatment. Results A total of 130 legs of 121 patients were treated with either SFL/S (n = 68) or EVLA (n = 62). In the first 12 months, three recanalizations of the GSV were observed after EVLA. Up to 5 years later, more recurrent varicose veins caused by neoreflux in incompetent tributaries of the SFJ were observed in after EVLA (31%; 19/61) compared with SFL/S (7%; 4/60; P P P Conclusions At the 5-year follow-up, a significantly higher varicose vein recurrence rate originated at the SFJ region after EVLA compared with SFL/S. There were no differences in the relief of venous symptoms, CEAP staging, or general QoL between the groups.
A H Davies - One of the best experts on this subject based on the ideXlab platform.
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three year follow up results of the prospective european multicenter cohort study on cyanoacrylate embolization for treatment of refluxing great saphenous veins
2021Co-Authors: Thomas M Proebstle, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, Jens Alm, A H DaviesAbstract:Abstract Objective Cyanoacrylate closure of refluxing saphenous veins has demonstrated excellent safety and effectiveness results in feasibility and pivotal studies. This article provides the 36-month follow-up results of a prospective, multicenter, nonrandomized cohort study. Methods A total of 70 patients were enrolled in a prospective, multicenter study conducted at seven centers in four European countries and underwent treatment of a solitary refluxing great saphenous vein with endovenous cyanoacrylate embolization without the use of Tumescent Anesthesia or postprocedure compression stockings. The primary effectiveness end point was freedom from recanalization (closure rate) of the great saphenous vein at 6 months. Safety was assessed by occurrence of adverse events after the procedure and during the 6-month follow-up period. Quality of life and clinical improvement parameters were measured before and after the procedure and through a 12-month follow-up period. Anatomic success and clinical improvement were assessed through 36 months after the procedure. Results Of 70 treated patients, 64 (91%) were available for the 3-year follow-up. The closure rates by Kaplan-Meier life table methods at 6-, 12-, 24-, and 36-month time points were 91.4%, 90.0%, 88.5%, and 88.5%, respectively. Through 36 months, the improvement in change of the mean venous clinical severity score over time was statistically significant by dropping from 4.3 at baseline to 0.9 at the 36-month follow-up (P Conclusions The 3-year follow-up results of the prospective, multicenter eSCOPE study demonstrated the continued anatomic and clinical effectiveness of cyanoacrylate embolization over an extended follow-up period.
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the european multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins
2015Co-Authors: Thomas M Proebstle, Daniel J Cher, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, A H DaviesAbstract:Objective Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. Methods A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither Tumescent Anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. Results In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P Conclusions Endovenous CA embolization of refluxing GSVs is safe and effective without the use of Tumescent Anesthesia or compression stockings.
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the european multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins
2015Co-Authors: Thomas M Proebstle, Daniel J Cher, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, Jens Alm, A H DaviesAbstract:Objective Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. Methods A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither Tumescent Anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. Results In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P Conclusions Endovenous CA embolization of refluxing GSVs is safe and effective without the use of Tumescent Anesthesia or compression stockings.
Andreas Nowak - One of the best experts on this subject based on the ideXlab platform.
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treatment of elderly patients with advanced lipedema a combination of laser assisted liposuction medial thigh lift and lower partial abdominoplasty
2014Co-Authors: Uwe Wollina, Birgit Heinig, Andreas NowakAbstract:BACKGROUND Lipedema is a rare female disorder with a characteristic distribution of adipose tissue hypertrophy on the extremities, with pain and bruising. In advanced stages, reduction of adipose tissue is the only available effective treatment. In elderly patients with advanced lipedema, correction of increased skin laxity has to be considered for an optimal outcome. METHODS We report on a tailored combined approach to improve advanced lipedema in elderly females with multiple comorbidities. Microcannular laser-assisted liposuction of the upper legs and knees is performed under Tumescent Anesthesia. Medial thigh lift and partial lower abdominoplasty with minimal undermining are used to correct skin laxity and prevent intertrigo. Postsurgical care with nonelastic flat knitted compression garments and manual lymph drainage are used. RESULTS We report on three women aged 55-77 years with advanced lipedema of the legs and multiple comorbidities. Using this step-by-step approach, a short operation time and early mobilization were possible. Minor adverse effects were temporary methemoglobinemia after Tumescent Anesthesia and postsurgical pain. No severe adverse effects were seen. Patient satisfaction was high. CONCLUSION A tailored approach may be useful in advanced lipedema and is applicable even in elderly patients with multiple comorbidities.
Daniel J Cher - One of the best experts on this subject based on the ideXlab platform.
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thirty sixth month follow up of first in human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence
2017Co-Authors: Jose I Almeida, Daniel J Cher, Julian J Javier, Claudia Bautista, Edward G. Mackay, Thomas M ProebstleAbstract:Abstract Objective The objective of this study was to evaluate the long-term safety and effectiveness of endovenous cyanoacrylate (CA)-based closure of incompetent great saphenous veins. Methods This was a prospective, single-arm, single-center feasibility study conducted at the Canela Clinic (La Romana, Dominican Republic) to assess the effectiveness and safety of a CA-based adhesive for great saphenous vein closure at 36 months after treatment. Thirty-eight subjects were treated by injection of small boluses of CA under ultrasound guidance and without the use of perivenous Tumescent Anesthesia or postprocedure graduated compression stockings. Periodic scheduled follow-up was performed during 36 months. Results At month 36, there were 29 subjects who were available for follow-up. Complete occlusion of the treated veins was confirmed by duplex ultrasound in all subjects with the exception of two subjects showing recanalization at month 1 and month 3. Kaplan-Meier analysis revealed an occlusion rate at month 36 of 94.7% (95% confidence interval, 87.9%-100%). The mean Venous Clinical Severity Score (VCSS) improved from 6.1 ± 2.7 at baseline to 2.2 ± 0.4 at month 36 ( P Conclusions CA adhesive appears to be an effective and safe treatment for saphenous vein closure, with long-term occlusion rates comparable to those of other thermal and nonthermal methods and with no reported serious adverse events.
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two year follow up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence
2015Co-Authors: Jose I Almeida, Daniel J Cher, Julian J Javier, Claudia Bautista, Edward G. Mackay, Thomas M ProebstleAbstract:ObjectivesTo evaluate the safety and effectiveness of endovenous cyanoacrylate-based embolization of incompetent great saphenous veins.MethodsIncompetent great saphenous veins in 38 patients were embolized by cyanoacrylate bolus injections under ultrasound guidance without the use of perivenous Tumescent Anesthesia or graduated compression stockings. Follow-up was performed over a period of 24 months.ResultOf 38 enrolled patients, 36 were available at 12 months and 24 were available at 24 months follow-up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all patients except for one complete and two partial recanalizations observed at, 1, 3 and 6 months of follow-up, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836–1.0) at 24 months follow-up. Venous Clinical Severity Score improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.3 ± 1.1, 1.5 ± 1.4 and 2.7 ± 2.5 at 6, 12 and 24 months, respectively (p < .0001). Edema ...
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randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins veclose
2015Co-Authors: Nick Morrison, Kathleen Gibson, Scott Mcenroe, Ted King, Robert H Weiss, Daniel J Cher, Mitchel P. Goldman, Andrew JonesAbstract:Background Whereas thermal ablation of incompetent saphenous veins is highly effective, all heat-based ablation techniques require the use of perivenous subfascial Tumescent Anesthesia, involving multiple needle punctures along the course of the target vein. Preliminary evidence suggests that cyanoacrylate embolization (CAE) may be effective in the treatment of incompetent great saphenous veins (GSVs). We report herein early results of a randomized trial of CAE vs radiofrequency ablation (RFA) for the treatment of symptomatic incompetent GSVs. Methods Two hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE (n = 108) with the VenaSeal Sapheon Closure System (Sapheon, Inc, Morrisville, NC) or RFA (n = 114) with the ClosureFast system (Covidien, Mansfield, Mass). After discharge, subjects returned to the clinic on day 3 and again at months 1 and 3. The study's primary end point was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory. Statistical testing focused on showing noninferiority with a 10% delta conditionally followed by superiority testing. No adjunctive procedures were allowed until after the month 3 visit, and missing month 3 data were imputed by various methods. Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day 3. Additional assessments included general and disease-specific quality of life surveys and adverse event rates. Results All subjects received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary end point analyses, which used various methods to account for the missing data rate (14%), showed evidence to support the study's noninferiority hypothesis (all P P = .07 in the predictive model). Pain experienced during the procedure was mild and similar between treatment groups (2.2 and 2.4 for CAE and RFA, respectively, on a 10-point scale; P = .11). At day 3, less ecchymosis in the treated region was present after CAE compared with RFA ( P Conclusions CAE was proven to be noninferior to RFA for the treatment of incompetent GSVs at month 3 after the procedure. Both treatment methods showed good safety profiles. CAE does not require Tumescent Anesthesia and is associated with less postprocedure ecchymosis.
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the european multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins
2015Co-Authors: Thomas M Proebstle, Daniel J Cher, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, A H DaviesAbstract:Objective Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. Methods A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither Tumescent Anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. Results In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P Conclusions Endovenous CA embolization of refluxing GSVs is safe and effective without the use of Tumescent Anesthesia or compression stockings.
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the european multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins
2015Co-Authors: Thomas M Proebstle, Daniel J Cher, Sameh Dimitri, Lars Melholt Rasmussen, M S Whiteley, James Lawson, Jens Alm, A H DaviesAbstract:Objective Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking. Methods A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither Tumescent Anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months. Results In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P Conclusions Endovenous CA embolization of refluxing GSVs is safe and effective without the use of Tumescent Anesthesia or compression stockings.
