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Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study)
This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with tempera...
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| Published in: | Journal of vascular surgery 2003-08, Vol.38 (2), p.207-214 |
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| container_title | Journal of vascular surgery |
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| creator | Lurie, F Creton, D Eklof, B Kabnick, L.S Kistner, R.L Pichot, O Schuller-Petrovic, S Sessa, C |
| description | This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure).
Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit.
Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12;
P = .02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (
P < .01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (
P < .05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months.
In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping. |
| doi_str_mv | 10.1016/S0741-5214(03)00228-3 |
| format | article |
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Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit.
Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12;
P = .02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (
P < .01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (
P < .05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months.
In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping.]]></description><identifier>ISSN: 0741-5214</identifier><identifier>EISSN: 1097-6809</identifier><identifier>DOI: 10.1016/S0741-5214(03)00228-3</identifier><identifier>PMID: 12891099</identifier><identifier>CODEN: JVSUES</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Adult ; Biological and medical sciences ; Catheter Ablation - adverse effects ; Catheter Ablation - methods ; Diseases of the cardiovascular system ; Female ; Humans ; Male ; Medical sciences ; Middle Aged ; Postoperative Complications ; Prospective Studies ; Quality of Life ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Recovery of Function ; Saphenous Vein - surgery ; Treatment Outcome ; Varicose Veins - surgery ; Vascular Surgical Procedures - adverse effects ; Vascular Surgical Procedures - methods ; Vascular Surgical Procedures - rehabilitation</subject><ispartof>Journal of vascular surgery, 2003-08, Vol.38 (2), p.207-214</ispartof><rights>2003 The Society for Vascular Surgery and The American Association for Vascular Surgery</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c504t-870e939a7995b964a80cd475c33d0361f6e3fe3fd71a9fd615c492d131782363</citedby><cites>FETCH-LOGICAL-c504t-870e939a7995b964a80cd475c33d0361f6e3fe3fd71a9fd615c492d131782363</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15007976$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12891099$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lurie, F</creatorcontrib><creatorcontrib>Creton, D</creatorcontrib><creatorcontrib>Eklof, B</creatorcontrib><creatorcontrib>Kabnick, L.S</creatorcontrib><creatorcontrib>Kistner, R.L</creatorcontrib><creatorcontrib>Pichot, O</creatorcontrib><creatorcontrib>Schuller-Petrovic, S</creatorcontrib><creatorcontrib>Sessa, C</creatorcontrib><title>Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study)</title><title>Journal of vascular surgery</title><addtitle>J Vasc Surg</addtitle><description><![CDATA[This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure).
Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit.
Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12;
P = .02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (
P < .01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (
P < .05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months.
In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping.]]></description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Catheter Ablation - adverse effects</subject><subject>Catheter Ablation - methods</subject><subject>Diseases of the cardiovascular system</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Postoperative Complications</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Recovery of Function</subject><subject>Saphenous Vein - surgery</subject><subject>Treatment Outcome</subject><subject>Varicose Veins - surgery</subject><subject>Vascular Surgical Procedures - adverse effects</subject><subject>Vascular Surgical Procedures - methods</subject><subject>Vascular Surgical Procedures - rehabilitation</subject><issn>0741-5214</issn><issn>1097-6809</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><recordid>eNqFkdtq3DAQhkVpabZpH6FFNy3ZC7cjy7asq1BCeoCFFDbkVmilcVDxWq5kL6Rv1LfsOLs0lwWBxOib0_8z9lbARwGi-bQFVYmiLkV1AXINUJZtIZ-xlQCtiqYF_Zyt_iFn7FXOPwGEqFv1kp2JstUE6hX78yPFPKKbwgF5soOP-_AbPc_T7B947DhS6IBDnDN9-xC7hL9mHBx97vowYbJTiAO_cH3Mc0I-pujQ02vND5gypfXh_shQdaqbwjiG4Z4HCvCMPfWmfiMhOEx8jOPcn0pe391s7nDLt8ss69fsRWf7jG9O9zm7_XJ9e_Wt2Nx8_X71eVO4GqqpaBWgltoqreudbirbgvOVqp2UHmQjugZlR8crYXXnG1G7SpdeSKHaUjbynH04lqVFaNE8mX3IDvveDkgiGCVrAVUrCayPoCMFc8LOjCnsbXowAsxikXm0yCz6G5Dm0SKz5L07NZh3e_RPWSdPCHh_Amx2tu_IFRfyE1cDKK2WSS-PHJIah4DJZEcakvohkajGx_CfUf4CgPaxQQ</recordid><startdate>20030801</startdate><enddate>20030801</enddate><creator>Lurie, F</creator><creator>Creton, D</creator><creator>Eklof, B</creator><creator>Kabnick, L.S</creator><creator>Kistner, R.L</creator><creator>Pichot, O</creator><creator>Schuller-Petrovic, S</creator><creator>Sessa, C</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20030801</creationdate><title>Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study)</title><author>Lurie, F ; Creton, D ; Eklof, B ; Kabnick, L.S ; Kistner, R.L ; Pichot, O ; Schuller-Petrovic, S ; Sessa, C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c504t-870e939a7995b964a80cd475c33d0361f6e3fe3fd71a9fd615c492d131782363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Catheter Ablation - adverse effects</topic><topic>Catheter Ablation - methods</topic><topic>Diseases of the cardiovascular system</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Postoperative Complications</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Recovery of Function</topic><topic>Saphenous Vein - surgery</topic><topic>Treatment Outcome</topic><topic>Varicose Veins - surgery</topic><topic>Vascular Surgical Procedures - adverse effects</topic><topic>Vascular Surgical Procedures - methods</topic><topic>Vascular Surgical Procedures - rehabilitation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lurie, F</creatorcontrib><creatorcontrib>Creton, D</creatorcontrib><creatorcontrib>Eklof, B</creatorcontrib><creatorcontrib>Kabnick, L.S</creatorcontrib><creatorcontrib>Kistner, R.L</creatorcontrib><creatorcontrib>Pichot, O</creatorcontrib><creatorcontrib>Schuller-Petrovic, S</creatorcontrib><creatorcontrib>Sessa, C</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of vascular surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lurie, F</au><au>Creton, D</au><au>Eklof, B</au><au>Kabnick, L.S</au><au>Kistner, R.L</au><au>Pichot, O</au><au>Schuller-Petrovic, S</au><au>Sessa, C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study)</atitle><jtitle>Journal of vascular surgery</jtitle><addtitle>J Vasc Surg</addtitle><date>2003-08-01</date><risdate>2003</risdate><volume>38</volume><issue>2</issue><spage>207</spage><epage>214</epage><pages>207-214</pages><issn>0741-5214</issn><eissn>1097-6809</eissn><coden>JVSUES</coden><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-1</notes><notes>ObjectType-News-3</notes><notes>content type line 23</notes><abstract><![CDATA[This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure).
Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit.
Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12;
P = .02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (
P < .01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (
P < .05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months.
In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping.]]></abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>12891099</pmid><doi>10.1016/S0741-5214(03)00228-3</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of vascular surgery, 2003-08, Vol.38 (2), p.207-214 |
| issn | 0741-5214 1097-6809 |
| language | eng |
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| source | BACON - Elsevier - GLOBAL_SCIENCEDIRECT-OPENACCESS |
| subjects | Adult Biological and medical sciences Catheter Ablation - adverse effects Catheter Ablation - methods Diseases of the cardiovascular system Female Humans Male Medical sciences Middle Aged Postoperative Complications Prospective Studies Quality of Life Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Recovery of Function Saphenous Vein - surgery Treatment Outcome Varicose Veins - surgery Vascular Surgical Procedures - adverse effects Vascular Surgical Procedures - methods Vascular Surgical Procedures - rehabilitation |
| title | Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study) |
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