Endovascular AV Fistula Creation

Transcription

1 Endovascular AV Fistula Creation with magnetic catheters ASDIN Orlando, Feb 2015 William E. Cohn, MD Director, Center for Technology Innovation Texas Heart Institute, St. Luke s Episcopal Hospital Professor of Surgery Baylor College of Medicine Professor of Bioengineering, University of Houston TEXAS HEART INSTITUTE at St. Luke sepiscopal Hospital In the interest of maintaining academic integrity, I would like to disclose the following conflicts I am a founder and board member of TVA Medical, an early stage medical device company that has developed the technology described in this presentation, and in which I have a financial interest. Hemodialysis Market CMS spends $47 billion per year on end-stage renal disease This presentation describes devices and procedures that are not approved by the FDA for clinical use in the United States Key Growth drivers: Diabetes Hypertension Cardiovascular disease 1 USRDS 2012 Annual Report (2010 data) 2 Gilbertson DT, et al. Projecting the number ofpatients with end-stage renal disease in the United States to the year2015. J Am Soc Nephrol Dec;16(12): Meichelboeck, W 7th International Congress of Vascular Access Society, Istanbul, May 2011 ASDIN

2 3-4 hours of hemodialysis 4 times/week can maintain the anuric patient but every patient needs a reliable way to be connected to the dialysis machine Dual lumen central venous catheters are easy to use and provide great access Dual lumen central venous catheters are easy to use and provide great access but catheter infections and sepsis remain serious limitations Prosthetic AV grafts under the skin are relatively easy to construct ASDIN

3 but they are easily infected and often develop thrombosis, requiring multiple re-interventions There is overwhelming consensus that the best option is a native arterio-venous fistula AV fistulas are clinically and economically superior Mortality Infection rate Reoperation rate Annual Cost Infection Sepsis Series Series Central Venous Catheter 73%-84% $90K AV Graft 40% $79K Surgical AV Fistula 34% $64K There is overwhelming consensus that the best option is a native arterio-venous fistula 1 Rates reported are per patient per year. Mortality at 3 years 2 Perl J., et al. Hemodialysis Vascular Access Modifies the Association between Dialysis Modality and Survival. JASN June 1, 2011 vol. 22 no Woo K., et al. Influence of Vascular Access Type on Sex and Ethnicity-Related Mortality in Hemodialysis-Dependent Patients. Perm J 2012 Spring;16(2):4-9 Challenges with Surgical AV Fistulas Penetrating trauma occasionally results in AV fistula formation Primary failure rate % Mean maturation time months Average time to usable AVF 3* 5-12 months Average interventions for successful AVF Occlusions (thrombosis) 5, % AV Fistulas are operator dependent, have a high failure rate, require frequent interventions to maintain functionality, and often take months before they are useable for hemodialysis * Mean time to useable AV fistula defined as time from referral for vascular access to dialysis 1 Kimball, et al. Efficiency of the kidney disease outcomes quality initiative guidelines for preemptive vascular access in an academic setting. Journal of Vascular Surgery. Vol 54, No Peterson W., et al. Disparities in Fistula Maturation Persist Despite Preoperative Vascular Mapping. Clin J Am Soc Nephrol March; 3(2): Lee, T. et al. Tunneled Catheters in Hemodialysis Patients: Reasons and Subsequent Outcomes. American Journal of Kidney Diseases, Vol 46, No 3 (September), 2005: pp Biuckians A, Scott EC, Meier GH, et al. The natural history of autologous fistulas as first-time dialysis access in the KDOQI era. J Vasc 17Surg 2008; 47: Dember LM, Beck GJ, Allon M, et al. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA 2008; 299: Stolic R. Most Important Chronic Complications of Arteriovenous Fistulas for Hemodialysis. Med Princ Pract Diagnosis and management of acute traumatic arteriovenous fistulakamal Nagpal, MS MRCS,1 Kamran Ahmed, MRCS,1 and RJ Cuschieri, FRCS2, Int J Angiol Winter; 17(4): ASDIN

4 Endovascular Catheter-based AVF Human deep venous anatomy Advantages Percutaneous, non-surgical No implant left behind No incision so reduced wound infections and complications Facilitates AV fistula placement by interventional and endovascular specialties in outpatient setting Potential to improve AVF success rates: No vessel trauma No surgical anastomosis Investigational device. This product is not approved for marketing by FDAand is not available for commercial sale. Paired magnetic catheters with electrosurgical cutting capabilities Paired magnetic catheters with electrosurgical cutting capabilities RF electrode Venous catheter Arterial catheter Paired magnetic catheters with electrosurgical cutting capabilities Strong rare-earth NdFeBo magnets ASDIN

5 Venous catheter introduced and advanced to site chosen for AVF Arterial catheter introduced and advanced to same location Catheters rotated to allow magnetic alignment Venous electrode deployed and energized for 1.2 seconds with RF Arterial injection shows widely patent AVF without extravasation 24 hours post-procedure ASDIN

6 2/18/2015 ASDIN month post procedure 3 months post procedure 3 months post procedure 3 months post procedure 1 year post procedure 1 year post procedure 6

7 2/18/ year post procedure 2 years post procedure 2 years post procedure Multiple Cannulation Options Forearm cephalic + upper arm cephalic Forearm cephalic + median cubital / basilic Forearm cephalic + basilic 40 FLEX Study Study Design and Baseline Characteristics Primary endpoints: Technical success Fistula patency and vein maturation at 8-12 weeks with angiography and ultrasound Adverse events Total (N=33) Average Age, yrs (SD) Male (%) Average BMI (SD) Secondary endpoint: BMI > 25 (%) Creation of usable hemodialysis access (at least Diabetes (%) 75% of dialysis sessions for at least 4 weeks duration) PVD (%) ASDIN (11.4) 20/33 (61%) 24.3 (3.8) 10/33 (30%) 19/33 (58%) 2/33 (6.1%) 7

8 2/18/2015 FLEX Study Summary 100% Endo-AVF compares favorably with Surgical AVF Clinical Results 97% 96% 96% 96% 95% Demonstrated clinical success 90% 97% technical fistula success (32/33) 85% 96% patency at 6 months + 80% Avg. procedure time 49 min 75% Surgical AVF AVF Failures 30-60% Thrombosis 17-25% 27 patients initiated dialysis or dialysis ready 70% Other Failures 25 patients > 1 month dialysis 65% 60% Technical AVF fistula success 6 24 hrs N=33 Dialysis initiation or ready N=26 N=28 Dialysis with endoavf > 1 month N=26 Catheter-based endoavf Successful AVFs Successful endo AVFs 96% Avg. 58 days to AVF maturation 1 serious device-related adverse event; mitigated with procedure change* Data reported per-protocol, not intent to treat. + 1 patient developed venous hypertension at 37 days from a central vein stenosis. Patient received balloon angioplasty. EndoAVF occluded at 106 days. *1 patient developed pseudoaneurysm during procedure due to arm motion from neuromuscular stimulation. Pseudoaneurysm was resolved with thrombin injection. A procedure modification to limit arm motion mitigated this risk in subsequent cases. Data for surgical AVF is based on the 60% AVF failure rate at 4 months reported in the DAC study. endoavf data is based on 6 month data (n=26) Novel Endovascular Access Trial Endo AVFs are usable > 4 months faster PRIMARY OBJECTIVE % reduction in time to a useable fistula 140 To characterize the safety of the FLEX system (6 months) in up to 70 patients with CKD who require a hemodialysis vascular access STUDY DESIGN Multi-center, prospective, single-arm study. Canada, Australia, and New Zealand PRIMARY ENDPOINT savf endoavf Percentage of patients who experience one or more serious device-related adverse events during the first 6 months following AVF creation ADDITIONAL DATA COLLECTED Fistula efficacy: The percentage of AV fistulas that can provide prescribed hemodialysis aimed to achieve a spkt/v of > 1.2 or Urea Reduction Ratio (URR) of > 65% using 2 needle cannulation for 67% of the dialysis sessions over 4 consecutive week period within 6 months of fistula creation Primary patency 0 Time to AVF Maturation Interventions Ultrasound flow rates Novel Endovascular Access Trial 1st NEAT study 6 months PRIMARY OBJECTIVE To characterize the safety of the FLEX system (6 months) in up to 70 patients with CKD who require a hemodialysis vascular access STUDY DESIGN Multi-center, prospective, single-arm study. Canada, Australia, and New Zealand PRIMARY ENDPOINT Percentage of patients who experience one or more serious device-related adverse events during the first 6 months following AVF creation ADDITIONAL DATA COLLECTED Fistula efficacy: The percentage of AV fistulas that can provide prescribed hemodialysis aimed to achieve a spkt/v of > 1.2 or Urea Reduction Ratio (URR) of > 65% using 2 needle cannulation for 67% of the dialysis sessions over 4 consecutive week period within 6 months of fistula creation Primary patency Interventions Ultrasound flow rates 48 ASDIN

9 2/18/2015 Conclusions NEAT patient with Dr. Lok and Dr. Rajan ASDIN 2015 Percutaneous catheter-based creation of AV fistulas is a new technique that has the potential to change the way dialysis access is created The technique is safe, reproducible, and prescriptive By putting this technique in the hands of interventional and endovascular specialist, earlier and more frequent creation of AVF may decrease dependence on central venous catheters. Early clinical data suggests that in-situ catheter-based AVFs may be superior to surgical AVF with respect to patency, need for reintervention, and time to usability. Additional study is needed. Initiating North American/Australian/New Zealand study. Charmaine Lok M.D. principle investigator; Dheeraj Rajan M.D. Co-PI 9