ArticlesEffectiveness of haemodialysis access with an autologous tissue-engineered vascular graft: a multicentre cohort study
Introduction
Evolution of diagnostic tests (eg, electrocardiogram and CT angiography), drugs (eg, β blockers and statins), and interventional devices (eg, catheter-based technologies) has advanced cardiovascular medicine to an extent that few people could have imagined in the 1950s or 1960s. By contrast, the specialty of open vascular surgery has remained virtually unchanged. Modern techniques for peripheral and coronary bypass differ little from the first leg vascular bypass (1948) or the first successful coronary artery bypass (1967).1 Similarly, development of cardiovascular biomaterials has been surprisingly slow over the past 50 years.2 The expanded polytetrafluoroethylene (ePTFE) material used in Scribner's first chronic-use prosthetic blood vessel (1961) is essentially identical to the graft used nowadays, despite pronounced deficiencies compared with native veins or arteries.3, 4, 5, 6
Bell and colleagues7, 8 postulated that cell-seeded living grafts could be grown in vitro, which was the most radical advancement for prosthetic graft design. 20 years later, Shin'oka and colleagues9, 10 were the first to apply the theory clinically with successful use of cell-seeded polymers to repair congenital defects in the low-pressure pulmonary outflow tracts of paediatric patients. However, neither Shin'oka's nor Bell's approach had sufficient mechanical strength to warrant application of the graft to adult arterial bypass. Moreover, other researchers who used similar polymer-based approaches were unable to show clinically relevant burst strength with human cells.11, 12
We postulated that the application of cardiovascular biomaterials for tissue engineering has fundamental flaws because the synthetic or chemically modified scaffolds would interfere with, rather than guide, the natural assembly of key structural proteins. In 1998, we reported a new process called sheet-based tissue engineering and showed that with human cells, we could produce blood vessels with supraphysiological burst strength without the need for chemical modification, fixation, synthetic scaffolds, or exogenous biomaterials.13 We have since reported expanded preclinical results and the first human use of a completely biological tissue-engineered vascular graft.14, 15 In the first clinical report,14 we documented early (0–3 months) safety results for the first six patients implanted with the graft as an arteriovenous shunt for haemodialysis access, and we now present results of 6-month effectiveness for the full cohort of ten patients.
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Patients
Ten patients with end-stage renal disease who had been receiving haemodialysis were enrolled from Instituto Argentino de Diagnóstico y Tratamiento, Buenos Aires, Argentina, and Department of General, Vascular, and Transplant Surgery, Katowice, Poland, between September, 2004, and April, 2007. All patients were older than 21 years and had had a previous haemodialysis access failure. All patients had a functioning access that the attending nephrologist and vascular surgeon judged to have a high
Results
Cells were successfully isolated from all patients and vessels were built with a mean burst pressure of 3512 mm Hg (SD 873, range 2348–4617). Ten patients with varying demographic indicators were enrolled in the study (table). Mean duration of haemodialysis before the study was 50·8 months (SD 31·6) at implantation. One patient withdrew from the study before implantation because of ill health; nine patients received the vascular graft and were monitored after implantation (figure 1).
Patient 1
Discussion
We have shown effective haemodialysis access with a completely biological and autologous vascular graft, which had primary patency in about three-quarters of patients 1 month after implantation and three-fifths of patients 6 months after implantation. Primary patency in this proportion of patients approaches the objectives of the Dialysis Outcomes Quality Initiative17 of about 76% 3 months after implantation across all patient populations for native vein fistulas.
Our arteriovenous shunt
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