Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients

Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients

Patients are randomly assigned to a study group. Depending on the study group, either an arteriovenous fistula or tunneled cuffed catheter (TCC) will be implanted, followed by continuous evaluation of the patients during the first year after initiating the vascular access. The evaluation includes statistical evaluation of all events, including loss of access, thrombosis, infection, loss of patency, increase in co-morbidities, e.g. congestive heart failure as well as quality of life. The implantation of the TCC is a standard procedure and it will be used only in accordance with the approved instructions of use on subjects who have signed an informed consent form. The surgery is a standard operation and it will be performed by specialized surgeons on subjects who have signed an informed consent form (No grafts will be used; implantation of a standard TCC, used at the Department of Nephrology). Both, an arteriovenous fistula or a TCC, will be used for routine chronic haemodialysis

Patients with diagnosed end stage kidney disease and indication for chronic dialysis rely on a well-functioning access for dialysis. For long term haemodialysis there are three possibilities: arteriovenous fistulae, arteriovenous grafts and tunneled cuffed catheters. For the last decades, the preferred form of vascular access for every eligible patient was based on the "Fistula First Breakthrough Initiative", nowadays NVAII (National Vascular Access Improvement Initiative), implemented by the US-American CMS (Centers for Medicare & Medicaid Services). Although the "fistula first" dogma evolved to the more patient-centered recommendation "right access, for the right patient, at the right time for the right reasons" of the latest KDOQI guidelines from 2019, fistula still is seen as the "better" access compared with tunneled catheters whenever possible. The generally low quality of catheter care in previous retrospective publications make meaningful comparisons between fistula and catheter populations difficult. There are no prospective studies on this subject so far. In this study, we address differences between two dialysis vascular access types in elderly (Age 60 and older) and/or multimorbid patients (Charlson Comorbidity Index score of >6)

Inclusion Criteria:

• Aged ≥60 years or <60 years with a CCI Score >6
• Patients with CKD G5 A1-3 with indication for hemodialysis
• Stable clinical condition
• Eligibility for both arteriovenous fistula on the upper extremities and TCC
• Availability for follow-up
• Written informed consent

Exclusion Criteria:

• Uncontrolled infection and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening
• Poor overall health or malignancy not in remission at screening
• Major surgery within 12 weeks before screening
• Pre-existent vascular access
• Patient not eligible for any one of the vascular access options
• Endovascular arteriovenous fistula