Gerald Beathard Annual State of the Art Lecture Innovations in Vascular Access - Have We Moved Forward? Maurizio Gallieni Nephrology and Dialysis Unit Ospedale S. Carlo Borromeo, ASST Santi Paolo e Carlo, University of Milano, Milano, Italy
Major breakthroughs in dialysis access o Tenckhoff PD catheter o Scribner s shunt o AV fistula o PTFE grafts o Percutaneous placement of central venous catheters for acute dialysis o Tunneled CVCs o Ultrasound technology (pre-operative evaluation, US-guided cannulation, surveillance) o Angioplasty
Every breakthrough has some limitation o Tenckhoff PD catheter - Dislocation o Scribner s shunt Thrombosis, infection o AV fistula Early failure, low maturation rates o PTFE grafts Thrombosis, proximal stenosis o CVC Infection, thrombosis o Angioplasty recurrence of stenosis
Why we need innovation in the field of hemodialysis vascular access We continue to face an epidemic of arteriovenous fistula maturation failure, a proliferation of relatively ineffective interventions such as angioplasty and stent placement, an extremely high incidence of catheter use, and more doubts rather than guidance with regard to the role (or lack thereof) of surveillance Riella MC, Roy-Chaudhury P. Nature Reviews Nephrol 2013; 9, 348-357
What has changed from 1966 (Brescia et al. AV fistula) o Number of patients o Increased late referrals? o Comorbidities o Age o Grafts and CVC became available o In the USA, Fistula First and VA centers o Evidence based medicine (undeveloped in VA) o Dedicated Societies (ASDIN, VASA, VAS, JSDA, et al.) o The Journal of Vascular Access
Current state of vascular access AJKD 2015; 65: 905-915 Background: Since the bundled end-stage renal disease prospective payment system began in 2011 in the United States, some hemodialysis practices have changed substantially, raising the question of whether vascular access practice also has changed.
Vascular access use, United States - DOPPS Pisoni et al. AJKD 2015; 65: 905-915
Vascular access use, by DOPPS Country Pisoni et al. AJKD 2015; 65: 905-915
Incident patients vascular access use, by DOPPS Country Pisoni et al. AJKD 2015; 65: 905-915
Incident patients vascular access use, by DOPPS Country (Early referrals - > 4 months of pre-hd nephrology care) Pisoni et al. AJKD 2015; 65: 905-915
AJKD 2015; 65: 905-915 Conclusions: AVF use has increased, with catheter use decreasing among prevalent US HD patients. However, AVF use at dialysis therapy initiation remains low, suggesting that reforms affecting pre-dialysis care may be necessary to incentivize improvements in fistula rates at dialysis therapy initiation as achieved for prevalent hemodialysis patients.
The Effective Dialysis Access Center Team Model Surgery Nephrology Patient Access Coordinator Radiology Dialysis Center Courtesy of Dr. Ingemar Davidson
Areas of innovation Education / training Simulation training the new standard? Certification Focus on pre-dialysis care Procedures AVF endovascular/percutaneous techniques Devices Grafts Tissue engineered grafts Early cannulation grafts Catheters (new desing) Drug eluting angioplasty balloons, stents and stent-grafts Surveillance devices Venipuncture Pharmacological innovations Sirolimus wraps Pancreatic elastase (PRT-201)
Providers of training in vascular access 1. Universities Medical School Fellowship Post-graduate training 2.Scientific Societies ASDIN VASA? VAS? Radiology Societies? Surgery Societies? 3.Independent providers Vascular access centers Others organizations?
o Knowledge, skills, and an appropriate attitude are the mainstays for a successful dialysis access training program curriculum and at the core of the human factor training philosophy. o Education and training will reduce gaps in knowledge and technical skills, before exposing patients to procedure-related risk. o Much of skills can be learned in the simulation environment before exposing patients to procedures. o Rigorous testing and certification adds value to the participants and validates the training program.
Clinical Trial Endpoints for Dialysis Vascular Access
The JVA is a tool for fostering innovation in vascular access, available to members of ASDIN and the other affiliated societies
Conclusions o Many new devices and approaches for improving vascular access, but progress is slow. o Innovation is a priority and should follow the principle of finding solutions for clinically relevant unresolved issues. o There are many unresolved issues o I believe that the role of Scientific Societies, such as ASDIN, in shaping the future of vascular access care is crucial. o Collaboration between the existing societies in different continents is also a great opportunity o I thank the ASDIN board for their decision to partner with the Journal of Vascular Access, which I envision as the common voice of all those involved with vascular access care and research.