Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Vascular Access: Results From a European, Multicenter, Single-Arm Retrospective Analysis
| Autor: | Alexandros Mallios, Simone Zilahi de Gyurgyokai, Pedro Ponce, Alessio Spinelli, Konstantinos Stavroulakis, Rami El Hage, Dimitrios Karnabatidis, Pierleone Lucatelli, Panagiotis Kitrou, Raphaël Coscas, Konstantinos Katsanos, Tobias Steinke, Ounali Jaffer, Theodosios Bisdas, Roberto Cancellieri, Stavros Spiliopoulos |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Time Factors Vena Cava Superior Paclitaxel medicine.medical_treatment Vascular access Constriction Pathologic Venous stenosis chemistry.chemical_compound Arteriovenous Shunt Surgical Renal Dialysis Angioplasty Retrospective analysis medicine Humans Radiology Nuclear Medicine and imaging Vascular Patency Dialysis Retrospective Studies business.industry Infant Middle Aged Surgery Europe Treatment Outcome chemistry Child Preschool Central veins Cardiology and Cardiovascular Medicine business Angioplasty Balloon |
| Zdroj: | Journal of Endovascular Therapy. 28:442-451 |
| ISSN: | 1545-1550 1526-6028 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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