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Efficacy, safety, and clinical outcomes of incompetent perforator vein ablation using 1470nm laser bare tip fiber
JVIR
’
Scientific Session
4:42 PM
Wednesday
Abstract No. 314
Efficacy, safety, and clinical outcomes of incompetent perforator vein ablation using 1470nm laser bare tip fiber M. Chehab, P.K. Dixit, E. Antypas, M. Juncaj, C. Wong, M. Bischoff; Radiology, Oakland University William Beaumont School of Medicine, Royal Oak, MI Purpose: To describe the technique, efficacy, and safety of Endovenous Laser Ablation (EVLA) of incompetent perforator veins (IPV) using a bare tip fiber 1470nm laser alone or in combination with microplebectomy or sclerotherapy in the management of chronic venous insufficiency (CVI) with a competent saphenous system or prior saphenous interruption. Materials and Methods: 171 IPV were ablated in 101 limbs in 87 patients. Outcomes included sonographic occlusion of IPV, subjective changes to patient symptomatology, procedure related side effects (pain, hyperpigmentation) and complications (burns, major bleeds, infections, deep vein thrombosis or paresthesias). Correlation of IPV ablation failure with clinical, perforator and treatment characteritics was assessed using univariate (ANOVA) analysis. Results: 123 IPV were seen in the setting of prior saphenous interruption (76 radiofrequency ablation, 38 surgical stripping, 10 EVLA, 3 sclerotherapy). 48 were seen in the setting of a competent saphenous system. 91 IPV ablations were combined with microphlebectomy, 25 with sclerotherapy and 55 IPV were ablated alone. At 1 and 3 months follow up, 92 and 98% of ablated IPV were sonographically occluded. 10 IPV failed ablation with statistically significant correlation with higher CEAP score (p¼.002) and history of prior GSV interruption (p¼.042). Clinically, 82% and 96% of patients noted complete resolution of insufficiency symptoms at 1 and 3 months respectively. Complications included 5 patients with new onset paresthesias and one nonocclusive DVT. No skin burns, major bleeds or infections or were encountered. Conclusion: EVLA of IPV is effective at achieving IPV closure at 3 months can can be safely perfomed alone or in combination with microphlebectomy or sclerotherapy.
Abstract No. 315
Improvement in varicose vein symptoms: quantifying with the VVSymQ™, an electronic patient-reported outcome (EPRO) instrument N.M. Khilnani; Interventional Radiology, NY Presbyterian Hosptial-Weill Conrell Medical College, New York, NY Purpose: Symptom relief is a patient-centric way to assess treatment success for varicose veins. The VVSymQ™ instrument is an EPRO instrument that assesses duration of 5 varicose vein symptoms (heaviness, achiness, swelling, throbbing and itching) on a scale of 0 to 5 each day. It was developed following FDA PRO guidelines by modifying the VEINES-Qol/Sym (VQS) and was evaluated for content validity, reproducibility, and ability to detect change. Materials and Methods: Content validity for the VVSymQ™ instrument was first established by focus group and patient interviews. Psychometric properties were assessed by use in C25 patients along with VQS, VCSS, PA-V3, and CIVIQ-20
S143
before and after treatment to ablate great saphenous veins (GSV).The tool was used before/in follow up in a 40-patient validation study and subsequently as a daily electronic diary in two Phase 3 (n¼511) (data not shown) randomized trials of polidocanol foam for GSV ablation. VQS and PA-V3PROs as well as CEAP and VCSS were also compared. Results: The VVSymQ™ instrument demonstrated excellent reproducibility (ICC¼0.96) and suitable internal consistency reliability (Cronbach’s alpha¼0.78) in the validation study. It discriminated among known groups created from VCSS (po0.05), and demonstrated moderate to strong construct validity with CIVIQ-20 and VQS at baseline. Pre- and post-treatment change scores for the VVSymQ™ instrument yielded moderate to strong correlations (r ¼0.56) with the CIVIQ-20 total score. Compliance with the VVSymQ™ daily diary in the validation study was high (Z97%) for each of the 3 assessment periods. Conclusion: Taken together, these data demonstrate the construct validity of the VVSymQ™ PRO instrument, which performed well with respect to reliability, construct validity, and ability to detect change when assessing response to treatment for varicose veins.
Scientific Session 38 AVMs Wednesday, March 4, 2015 5:00 PM – 6:00 PM Room: 303 5:00 PM
Abstract No. 316
Sclerotherapy of low-flow vascular malformations: a tertiary-care center retrospective review J. Woodley-Cook, K. Tan, M. Simons; Vascular and Interventional Radiology, University Hospital Network, Toronto, ON, Canada Purpose: We aim to describe the successes and challenges of treating low-flow vascular malformations of the hand and feet and to quantify the frequency and types of complications following sclerotherapy. Materials and Methods: Retrospective review of patients with low-flow vascular malformations (VMs) of the hands and feet from our tertiary care center from July 2004 - July 2014 was performed. Sclerotherapy agents included 3% sodium tetradecyl sulfate (STS), bleomycin, and doxycycline. Data collection was achieved through consultation notes and review of imaging studies. Complications were classified according to the Society of Interventional Radiology Clinical Practice Guidelines as major or minor. Radiographic and clinical images will be used to illustrate key points. Results: A total of 66 patients were identified with an average age of at first diagnosis of 29.2 years (range 3 - 71) and average age of first sclerotherapy session of 33.3 years (range 4 - 71). There were 22 males (33.3%) and 44 females (66.7%). The
WEDNESDAY: Scientific Sessions
4:51 PM
’
’
Scientific Session
4:42 PM
Wednesday
Abstract No. 314
Efficacy, safety, and clinical outcomes of incompetent perforator vein ablation using 1470nm laser bare tip fiber M. Chehab, P.K. Dixit, E. Antypas, M. Juncaj, C. Wong, M. Bischoff; Radiology, Oakland University William Beaumont School of Medicine, Royal Oak, MI Purpose: To describe the technique, efficacy, and safety of Endovenous Laser Ablation (EVLA) of incompetent perforator veins (IPV) using a bare tip fiber 1470nm laser alone or in combination with microplebectomy or sclerotherapy in the management of chronic venous insufficiency (CVI) with a competent saphenous system or prior saphenous interruption. Materials and Methods: 171 IPV were ablated in 101 limbs in 87 patients. Outcomes included sonographic occlusion of IPV, subjective changes to patient symptomatology, procedure related side effects (pain, hyperpigmentation) and complications (burns, major bleeds, infections, deep vein thrombosis or paresthesias). Correlation of IPV ablation failure with clinical, perforator and treatment characteritics was assessed using univariate (ANOVA) analysis. Results: 123 IPV were seen in the setting of prior saphenous interruption (76 radiofrequency ablation, 38 surgical stripping, 10 EVLA, 3 sclerotherapy). 48 were seen in the setting of a competent saphenous system. 91 IPV ablations were combined with microphlebectomy, 25 with sclerotherapy and 55 IPV were ablated alone. At 1 and 3 months follow up, 92 and 98% of ablated IPV were sonographically occluded. 10 IPV failed ablation with statistically significant correlation with higher CEAP score (p¼.002) and history of prior GSV interruption (p¼.042). Clinically, 82% and 96% of patients noted complete resolution of insufficiency symptoms at 1 and 3 months respectively. Complications included 5 patients with new onset paresthesias and one nonocclusive DVT. No skin burns, major bleeds or infections or were encountered. Conclusion: EVLA of IPV is effective at achieving IPV closure at 3 months can can be safely perfomed alone or in combination with microphlebectomy or sclerotherapy.
Abstract No. 315
Improvement in varicose vein symptoms: quantifying with the VVSymQ™, an electronic patient-reported outcome (EPRO) instrument N.M. Khilnani; Interventional Radiology, NY Presbyterian Hosptial-Weill Conrell Medical College, New York, NY Purpose: Symptom relief is a patient-centric way to assess treatment success for varicose veins. The VVSymQ™ instrument is an EPRO instrument that assesses duration of 5 varicose vein symptoms (heaviness, achiness, swelling, throbbing and itching) on a scale of 0 to 5 each day. It was developed following FDA PRO guidelines by modifying the VEINES-Qol/Sym (VQS) and was evaluated for content validity, reproducibility, and ability to detect change. Materials and Methods: Content validity for the VVSymQ™ instrument was first established by focus group and patient interviews. Psychometric properties were assessed by use in C25 patients along with VQS, VCSS, PA-V3, and CIVIQ-20
S143
before and after treatment to ablate great saphenous veins (GSV).The tool was used before/in follow up in a 40-patient validation study and subsequently as a daily electronic diary in two Phase 3 (n¼511) (data not shown) randomized trials of polidocanol foam for GSV ablation. VQS and PA-V3PROs as well as CEAP and VCSS were also compared. Results: The VVSymQ™ instrument demonstrated excellent reproducibility (ICC¼0.96) and suitable internal consistency reliability (Cronbach’s alpha¼0.78) in the validation study. It discriminated among known groups created from VCSS (po0.05), and demonstrated moderate to strong construct validity with CIVIQ-20 and VQS at baseline. Pre- and post-treatment change scores for the VVSymQ™ instrument yielded moderate to strong correlations (r ¼0.56) with the CIVIQ-20 total score. Compliance with the VVSymQ™ daily diary in the validation study was high (Z97%) for each of the 3 assessment periods. Conclusion: Taken together, these data demonstrate the construct validity of the VVSymQ™ PRO instrument, which performed well with respect to reliability, construct validity, and ability to detect change when assessing response to treatment for varicose veins.
Scientific Session 38 AVMs Wednesday, March 4, 2015 5:00 PM – 6:00 PM Room: 303 5:00 PM
Abstract No. 316
Sclerotherapy of low-flow vascular malformations: a tertiary-care center retrospective review J. Woodley-Cook, K. Tan, M. Simons; Vascular and Interventional Radiology, University Hospital Network, Toronto, ON, Canada Purpose: We aim to describe the successes and challenges of treating low-flow vascular malformations of the hand and feet and to quantify the frequency and types of complications following sclerotherapy. Materials and Methods: Retrospective review of patients with low-flow vascular malformations (VMs) of the hands and feet from our tertiary care center from July 2004 - July 2014 was performed. Sclerotherapy agents included 3% sodium tetradecyl sulfate (STS), bleomycin, and doxycycline. Data collection was achieved through consultation notes and review of imaging studies. Complications were classified according to the Society of Interventional Radiology Clinical Practice Guidelines as major or minor. Radiographic and clinical images will be used to illustrate key points. Results: A total of 66 patients were identified with an average age of at first diagnosis of 29.2 years (range 3 - 71) and average age of first sclerotherapy session of 33.3 years (range 4 - 71). There were 22 males (33.3%) and 44 females (66.7%). The
WEDNESDAY: Scientific Sessions
4:51 PM
’