TY - JOUR
T1 - Five-year outcomes of mechano-chemical ablation of primary great saphenous vein incompetence
AU - Thierens, Naomi D. E.
AU - Holewijn, Suzanne
AU - Vissers, Wynand H. P. M.
AU - Werson, Debbie A. B.
AU - de Vries, Jean Paul P. M.
AU - Reijnen, Michel M. P. J.
PY - 2019/7/10
Y1 - 2019/7/10
N2 - Objective The aim of the study is to report long-term results after mechano-chemical ablation for the treatment of great saphenous vein incompetence. Methods Mechano-chemical ablation was performed using the ClariVein device with polidocanol as the sclerosant. Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification, Venous-Clinical-Severity-Score (VCSS), anatomical-success, RAND-SF36 and the Aberdeen-Varicose-Vein-Questionnaire (AVVQ) were obtained by clinical examination, questionnaires and duplex ultrasonography through five years' follow-up (Clinicaltrials.gov, NCT01459263). Results Ninety-four patients (113 great saphenous veins) were included in the study. Five-year follow-up data were available for 75 limbs (66.4%). Freedom from anatomical failure was 78.7% (N = 45) with 64.6% (N = 42) having an improvement in the VCSS >= 1. A total of five reinterventions were performed through five years with a median time to reintervention of 38 months. The VCSS at five years was 2 (IQR 1; 4) and was still significantly improved compared to baseline (p <0.001). A deterioration of the VCSS was observed in 21.5%. Conclusion Through five-year follow-up, there are a significant number of anatomical and clinical failures in this series, mainly driven by partial recanalizations.
AB - Objective The aim of the study is to report long-term results after mechano-chemical ablation for the treatment of great saphenous vein incompetence. Methods Mechano-chemical ablation was performed using the ClariVein device with polidocanol as the sclerosant. Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification, Venous-Clinical-Severity-Score (VCSS), anatomical-success, RAND-SF36 and the Aberdeen-Varicose-Vein-Questionnaire (AVVQ) were obtained by clinical examination, questionnaires and duplex ultrasonography through five years' follow-up (Clinicaltrials.gov, NCT01459263). Results Ninety-four patients (113 great saphenous veins) were included in the study. Five-year follow-up data were available for 75 limbs (66.4%). Freedom from anatomical failure was 78.7% (N = 45) with 64.6% (N = 42) having an improvement in the VCSS >= 1. A total of five reinterventions were performed through five years with a median time to reintervention of 38 months. The VCSS at five years was 2 (IQR 1; 4) and was still significantly improved compared to baseline (p <0.001). A deterioration of the VCSS was observed in 21.5%. Conclusion Through five-year follow-up, there are a significant number of anatomical and clinical failures in this series, mainly driven by partial recanalizations.
KW - Chronic venous insufficiency
KW - mechano-chemical ablation
KW - quality of life
KW - venous severity score
KW - patient-reported outcomes
KW - ENDOVENOUS LASER-ABLATION
KW - RADIOFREQUENCY ABLATION
KW - CLARIVEIN
U2 - 10.1177/0268355519861464
DO - 10.1177/0268355519861464
M3 - Article
SN - 0268-3555
VL - 35
JO - Phlebology
JF - Phlebology
IS - 4
ER -