Biederman DM - AIMRADIAL 2014 Endovascular - Surefire catheter
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Surefire catheter deployment via a transradial approach: feasibility and technical outcomes
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Biederman DM - AIMRADIAL 2014 Endovascular - Surefire catheter
- 1. Surefire Catheter Deployment via a Transradial Approach: Feasibility and Technical Outcomes D M B I E D E R M A N , J J T I TA N O , R S PAT E L , E K I M , F S N OWA K OW S K I , R A L O O K S T E I N , A M F I S C H M A N Icahn School of Medicine at Mount Sinai Division of Interventional Radiology New York, NY
- 2. DISCLOSURES • DM Biederman - Nothing to disclose • RS Patel - Arstasis Inc – Consulting; Sirtex Medical Inc. – Consulting; St. Jude Medical - Speaker • E Kim - Philips Healthcare – Speaker; Biocompatibles BTG – Consultant, Speaker, SAB; Onyx Pharmaceuticals – Consultant, SAB • FS Nowakowski - Nothing to disclose • RA Lookstein - Cordis Corp. – Consultant; Bayer Healthcare – Consultant; Boston Scientific Corp. – SAB, Speaker • AM Fischman Terumo Interventional Systems – Consultant, Speaker; Surefire Medical Inc. – Consultant; Philips Healthcare – Speaker; Celonova Biosciences - Consultant
- 3. TRANSCATHETER THERAPY • Chemotherapy: TACE • Radiation: TARE
- 4. TRANSCATHETER THERAPY: BENEFITS • 66 y.o. male with HCV and HCC treated with TARE Pre-Treatment Imaging Complete Response (2 months)
- 5. TRANSCATHETER THERAPY: RISKS • Non-Target delivery of Embolic agent, Chemotherapy, Radiation • Best Case: Inadequate treatment of tumor • Worst Case: Liver failure, gastric ulcers (radiation or ischemic), bowel ischemia
- 6. SUREFIRE INFUSION SYSTEM End-hole Catheter Surefire Catheter
- 8. A NOVEL CATHETER WITH GROWING INTEREST Study Site(s) Description Date COSY Mt. Sinai (NY) Feasibility and economic analysis of coiling the GDA vs. Surefire during Y90 Infusion (n=30) Publication: Fall 2014 JVIR Economic Study UCSD Surefire Infusion System as a first-line technique to protect against non-target organ embolization (NOE) as compared to coil embolization. Clinical , workflow efficiency, and economic outcomes. Publication: CVIR online 8/2014 PET post Y90 U of Tennessee Pasciak Quantitative measurements of tumor penetration and reflux of Y90 using PET/CT (n=10) Complete enrollment by 12/2014 QED USC UMD UTSW Feasibility Study of infusion endpoint & tumor response with DEBS: Surefire vs. Standard Catheter Infusion (n=24) Begin enrollment 11/2014 SPY90 (SIRTeX sponsored) Mt. Sinai (NY) Vancouver (BC) Pamplona (SP) Feasibility of SIR-Spheres Y90 delivered as a consolidated single diagnostic and therapeutic procedure (n=30) With & w/o Surefire 2015 Emission Imaging of MAA/DEB U of Tennessee Pasciak Feasibility proof-of-concept study to provide indirect post-infusion (with SIS) nuclear imaging of DEB-TACE. (n=5) Begin enrollment: 12/2014
- 9. TRANSRADIAL ACCESS & SUREFIRE • Fewer vascular complications • Lower rate of access site bleeding • Greater patient satisfaction • Immediate ambulation • No closure device • Patients with increased BMI
- 10. VESSEL ACCESS • Hydrophilic Sheath • Intra-arterial Cocktail: • 3000U Heparin • 2.5 mg Verapamil • 200 mcg Nitroglycerin
- 11. SUREFIRE TECHNIQUE • 5F Guiding catheter used in Celiac/SMA (min .054 lumen) • Liberal use of flushing • Low dose heparin, nitroglycerin and verapamil • .016 wire Fathom wire (Boston Scientific)
- 12. SUREFIRE TRA CASES # Age (y) Sex Tumor Type Tumor location Type FT (min) Dose (Gycm2) Contrast (mL) 1 59 M Metastatic leiomyosarcoma Right hepatic Y-90 17.8 225 150 3 42 F Metastatic breast angiosarcoma Right and Left Y-90 18.7 189 50 4 73 F HCC Right Hepatic Y-90 4.1 31 50 6 57 F HCC Right Hepatic Y-90 5.9 236 120 7 71 F HCC Right hepatic TACE - - 80 8 57 M HCC Right hepatic TACE 57.3 538 9 65 M HCC Right Hepatic TACE 33.6 1179 80 10 65 M HCC Left Hepatic TACE 17.1 445 80 11 67 F HCC Right Hepatic TACE 18.7 550 100 12 64 M Metastatic neuroendocrine tumor Left Hepatic Y-90 12.2 236 50 13 65 F HCC Left Hepatic TACE 24.9 259 60 14 45 F Metastatic bronchial carcinoid tumor left hepatic Y-90 - - 80 15 83 M HCC Left Hepatic TACE - - 80
- 13. CASE #1
- 14. CASE #1
- 15. CASE #2
- 16. CASE #3
- 17. CASE #3
- 18. CONCLUSION • Surefire Infusion System can be safely deployed via a transradial approach. • Pre-procedural cross-sectional imaging studies (CT/MRI) can help guide approach decision
Notas del editor
- What is the problem with the current technology? The standard of care for Y90 delivery is an end hole microcatheter system. With that ,the described rate of non target deposition of microspheres ranges currently from 1-5%. And this is despite aggressive techniques which often includes coil embolization and selective catheter placement. If radiation induced ulcers occur, they are notoriously difficult to treat.
- 66 y.o. male with HCV and HCC treated with TARE - Surefire
- Picture showing radiation ulcer
- The Surefire catheter (Surefire Medical, Westminster, CO) is an anti-reflux microcatheter (ARM) recently introduced for more precise and directed infusion of selective internal radiation therapy (SIRT) and trans-arterial chemoembolization (TACE) Safety Vessel protection Anti-reflux Cost/time reduction Alternative to embolization during mapping Efficacy? Infusion efficiency Distal penetration
- Safety Vessel protection Anti-reflux Cost/time reduction Alternative to embolization during mapping Efficacy? Infusion efficiency Distal penetration
- Contraindications: Radial artery too small <2mm Larger sheath needed (greater than 7F) AV fistula / dialysis patient Severe aortic tortuosity Barbeau D waveform
- 10 seconds on this slide
- ARM was advanced to the target hepatic artery through the guiding catheter over a .016 Fathom wire (Boston Scientific). SIRT/TACE infusion was administered in the target vessel under real time fluoroscopy. A TR band (Terumo) was used for hemostasis. Technical success, fluoroscopy time (FT), major and minor post adverse events and procedural details were recorded.
- 13 patients, mean age of 62.8 ± 10.9 years, underwent SIRT/TACE for liver tumors in which the ARM was deployed via TRA (6 SIRT, 7 TACE). Tumor pathology included: HCC (n=9), neuroendocrine (n=2), leiomyosarcoma (n=1), angiosarcoma (n=1) Technical success was 92.3% (12/13). No post procedural major or minor adverse events. Patients were followed for a median (interquartile range) of 21 (20.5) months and did not exhibit any signs of non-target chemo/radio-embolization. The failure which occurred was secondary to a replaced left hepatic artery originating from the left gastric artery, creating an oblique angle which was exaggerated when entering via TRA.
- SIR
- THERA
- TACE
- TACE