Panagiotis M Kitrou1, Tobias Steinke2, Rami El Hage3, Pedro Ponce4, Pierleone Lucatelli5, Konstantinos Katsanos1, Stavros Spiliopoulos6, Alessio Spinelli7, Theodosios Bisdas8, Konstantinos Stavroulakis9, Ounali Jaffer10, Alexandros Mallios3, Simone Zilahi de Gyurgyokai5, Roberto Cancellieri5, Raphael Coscas11, Dimitrios Karnabatidis1. 1. Interventional Radiology, Patras University Hospital, Patras, Greece. 2. Fachzentrum für Gefäßchirurgie, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany. 3. Vasular Surgery, Paris Saint Joseph Hospital, Paris, France. 4. Fresenius Medical Care Portugal/Nephrocare, Lisbon, Portugal. 5. Vascular and Interventional Radiology Unit, Department of Radiological Oncological and Anatomopathological Sciences, Sapienza University of Rome, Italy. 6. Second Department of Radiology, Interventional Radiology Unit, School of Medicine, National and Kapodistrian University of Athens, "Attikon" University General Hospital, Athens, Greece. 7. U.O.S.D. of Interventional Radiology, Hospital "S. Eugenio" Rome, ASL Roma, Italy. 8. Third Clinic of Vascular Surgery, Athens Medical Center, Athens, Greece. 9. Department of Vascular and Endovascular Surgery, Ludwig-Maximilians-University (LMU), Munich, Germany. 10. Department of Diagnostic and International Radiology, Barts NHS Trust, Royal London Hospital, London, UK. 11. Department of Vascular Surgery, Ambroise Paré University Hospital, Boulogne-Billancourt, France.
Abstract
INTRODUCTION: This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS). MATERIALS AND METHODS: Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2-4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8-12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP. RESULTS: IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5-2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55-0.92), p=0.006; 5-7 mm group vs 8-12 mm group, p=0.025]. CONCLUSION: In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.
INTRODUCTION: This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS). MATERIALS AND METHODS: Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2-4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8-12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP. RESULTS: IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5-2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55-0.92), p=0.006; 5-7 mm group vs 8-12 mm group, p=0.025]. CONCLUSION: In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.
Entities:
Keywords:
angioplasty; central veins; dialysis; paclitaxel