Thomas Powell1, Arjun Jayaraj2, Seshadri Raju1. 1. The RANE Center for Venous & Lymphatic Diseases, St. Dominic Hospital, Jackson, MS. 2. The RANE Center for Venous & Lymphatic Diseases, St. Dominic Hospital, Jackson, MS. Electronic address: jayaraj.arjun2015@gmail.com.
Abstract
OBJECTIVES: Dedicated venous stents have not been utilized in the management of symptomatic chronic iliofemoral venous obstruction (CIVO) until recently. The Bard Venovo stent is one such stent noted to have increased chronic outward force and radial resistive force compared to the Wallstent. This study evaluates outcomes following the use of the Bard Venovo stent compared to a matched cohort of limbs that underwent stenting with the Wallstent-Z stent (composite) configuration. METHODS: A review of contemporaneously entered EMR data on 167 patients / 167 limbs with initial iliofemoral stents placed over 2 years from 2019 to 2020 for quality-of-life (QOL) impairing CIVO that had failed conservative therapy was performed. Visual Analog Scale (VAS) pain score (0-10), Grade of swelling (0-4), Venous Clinical Severity Score (0-27) [VCSS] and the CIVIQ 20 instrument (QOL) were evaluated pre- and post-intervention to assess the impact of stenting. Kaplan Meier analysis was used to examine primary, primary assisted and secondary stent patencies while analysis of variance with repeated measured was used to compare clinical outcomes. RESULTS: 167 limbs underwent Bard Venovo stenting in 56 men / 111 women. The median age was 61 years. Laterality was right/left in 70/97 limbs. Post thrombotic syndrome (PTS) was seen in 84 limbs and non thrombotic iliac vein lesion/May Thurner syndrome (NIVL/MTS) in 83 limbs. At 6 months, VCSS improved from 7 to 4 in limbs with a unilateral Venovo (UV) stent compared with 5 to 4 in the composite Wallstent - Z stent group (p=0.9). Grade of swelling improved from 3 to 1 in the UV group and from 3 to 1 in the composite group (p=0.6), while VAS pain score improved from 7 to 2 in the UV group compared to 5 to 0 in the composite group (p=0.007). At 12 months, ulcers healed in 53% (8/15) in the UV group and 56% (5/9) in the composite group (p=0.7). Global CIVIQ scores improved from 58 to 28 in the UV group compared to 59 to 40 in the composite group (p=0.6). Cumulative primary, primary assisted and secondary patencies at 18 months were 81%, 97% and 98%, respectively when compared to 87%, 98% and 100% in the composite group (p>0.4). No difference in reintervention rates was noted between the two groups (p=0.5). CONCLUSIONS: In patients undergoing stenting for quality-of-life impairing chronic iliofemoral venous obstruction the Bard Venovo venous stent is comparable to the composite Wallstent - Z stent configuration with regards to clinical outcomes, quality of life improvement and stent patencies. Further study is however required to confirm this improvement over the long term.
OBJECTIVES: Dedicated venous stents have not been utilized in the management of symptomatic chronic iliofemoral venous obstruction (CIVO) until recently. The Bard Venovo stent is one such stent noted to have increased chronic outward force and radial resistive force compared to the Wallstent. This study evaluates outcomes following the use of the Bard Venovo stent compared to a matched cohort of limbs that underwent stenting with the Wallstent-Z stent (composite) configuration. METHODS: A review of contemporaneously entered EMR data on 167 patients / 167 limbs with initial iliofemoral stents placed over 2 years from 2019 to 2020 for quality-of-life (QOL) impairing CIVO that had failed conservative therapy was performed. Visual Analog Scale (VAS) pain score (0-10), Grade of swelling (0-4), Venous Clinical Severity Score (0-27) [VCSS] and the CIVIQ 20 instrument (QOL) were evaluated pre- and post-intervention to assess the impact of stenting. Kaplan Meier analysis was used to examine primary, primary assisted and secondary stent patencies while analysis of variance with repeated measured was used to compare clinical outcomes. RESULTS: 167 limbs underwent Bard Venovo stenting in 56 men / 111 women. The median age was 61 years. Laterality was right/left in 70/97 limbs. Post thrombotic syndrome (PTS) was seen in 84 limbs and non thrombotic iliac vein lesion/May Thurner syndrome (NIVL/MTS) in 83 limbs. At 6 months, VCSS improved from 7 to 4 in limbs with a unilateral Venovo (UV) stent compared with 5 to 4 in the composite Wallstent - Z stent group (p=0.9). Grade of swelling improved from 3 to 1 in the UV group and from 3 to 1 in the composite group (p=0.6), while VAS pain score improved from 7 to 2 in the UV group compared to 5 to 0 in the composite group (p=0.007). At 12 months, ulcers healed in 53% (8/15) in the UV group and 56% (5/9) in the composite group (p=0.7). Global CIVIQ scores improved from 58 to 28 in the UV group compared to 59 to 40 in the composite group (p=0.6). Cumulative primary, primary assisted and secondary patencies at 18 months were 81%, 97% and 98%, respectively when compared to 87%, 98% and 100% in the composite group (p>0.4). No difference in reintervention rates was noted between the two groups (p=0.5). CONCLUSIONS: In patients undergoing stenting for quality-of-life impairing chronic iliofemoral venous obstruction the Bard Venovo venous stent is comparable to the composite Wallstent - Z stent configuration with regards to clinical outcomes, quality of life improvement and stent patencies. Further study is however required to confirm this improvement over the long term.