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| Journal of Vascular Access 2004; 5: 16 - 18 |
| ProCol® vascular bioprosthesis for vascular access: Midterm results |
A. Hatzibaloglou1, I. Velissaris1, D. Kaitzis1, D. Grekas1, A. Avdelidou1, D. Kiskinis1
11st Surgical and 1st Medical Department, AHEPA University Hospital, Thessaloniki - Greece
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Search Medline for articles by:
 A. Hatzibaloglou
I. Velissaris
D. Kaitzis
D. Grekas
A. Avdelidou
D. Kiskinis
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ABSTRACT
Background/Aims: This study aimed to evaluate the safety and efficacy of the ProCol‚ vascular bioprostheses as vascular access (VA) material, especially in patients with a history of prior failed access.
Methods: During a 20-month period, 25 arteriovenous (AV) bovine vein grafts were placed in 24 hemodialysis (HD) patients for VA. All patients presented with failed autologous access sites.
Results: Graft placement was successful in all patients with no procedure-related complications. Follow-up from 6-26 months gave primary 6-month, 12-month and 24-month patency rates of, respectively, 90%, 80% and 70%. Graft characteristics in cannulation and hemostasis were very satisfying.
Conclusion: Our midterm results demonstrated that the ProCol‚ vascular bioprosthesis was a promising material for VA with good patency and low complication rates. (The Journal of Vascular Access 2004; 5: 16-18)
Key Words. Vascular access, Bridge grafts, Bovine veins
INTRODUCTION
In patients with end-stage chronic renal failure, our aim is to provide safe and reliable long-term vascular access (VA). Therefore, we create native arterio-venous (AV) fistulas and only when this is impossible do we place AV bridge grafts for hemodialysis (HD) VA. Until recently, we had experience only with polytetrafluoroethylene (PTFE) grafts, which carry a risk of possible complications after their placement including thrombosis, infection, and aneurysm and pseudoaneurysm formation. In order to minimize these complications and the related morbidity in uremic patients, we tried grafts made from mesenteric bovine vein (ProCol®) VA as a possibly more biocompatible material.
PATIENTS AND METHODS
From October 2001 through to May 2003, 25 AV ProCol® grafts were placed in 24 consecutively enrolled HD patients (14 females and 10 males, aged 28-71 yrs). All patients presented with native AV fistulas impairment and the creation of a new endogenous AV fistula was technically impossible. Three patients had thrombosed transposed basilic vein-brachial artery AV fistulas. The AV grafts had a straight configuration between the brachial artery and the axillary vein in the upper arm, except one that was placed in the forearm between the radial artery and the cephalic vein. Arterial and venous anastomoses of the grafts were performed with 6-0 running prolene sutures.
RESULTS
Graft placement was successful in all patients with no procedure-related complications. One patient died from myocardial infarction 15 days after the procedure. The patients were followed-up from 6-26 months, median 12 months. Twenty patients were on antiplatelet medication. The first use of the graft for HD took place 4 weeks after its placement, although the minimum interval that this graft can be punctured is 2 weeks post-implant. All patients were in an HD program of 4 hr/3x/week, using two needles.
One AV graft thrombosis occurred 15 days after its placement and an attempted thrombectomy was unsuccessful. The patencies of the AV grafts were calculated according to the Kaplan-Meier method (Fig. 1).
The 6-month, 12-month and 24-month patency rates of the bovine vein grafts were, respectively, 90%, 80% and 70%. No aneurysm or pseudoaneurysm formation occurred, but in one patient, we removed the graft due to infection 7 months after placement.
DISCUSSION
During the last 20 yrs, a rapid growth in end-stage renal disease programs has been followed by an increase in problems and in morbidity related to VA for HD. In our department, we make every effort to place a primary AV fistula, because of the relative freedom from short- and long-term associated complications. Our first choice is an anastomosis between the radial artery and the cephalic vein in the distal forearm and our second choice is an upper arm anastomosis, between the cephalic vein and the brachial artery. When fistula creation in the above sites is impossible, the patient is considered for subcutaneous transposition of the basilic vein and anastomosis of the latter to the brachial artery. According to our experience, the transposed basilic vein-brachial artery AV fistula is an excellent second or third choice for VA with good patency rates and without the infectious complications seen in synthetic bridge grafts (1). We strongly recommend that fistula creation using the basilic vein should be considered before an AV bridge graft placement. We reserve the latter for patients only with limiting factors for a primary AV fistula, the most common being the lack of a suitable native vein and for those with failed autologous AV fistulas. In our department, AV grafts are placed in 10% of HD patients. Until recently, we had experience only with PTFE as graft material. The prevalence of PTFE bridge grafts is much higher in the US and many reports from the US show that the 3-yr patency of PTFE grafts is between 45% and 60% (2-4). The relative risk of endogenous AV fistula failure is much lower than that of PTFE grafts (5, 6). Our results are similar to those of the USA.
The ProCol® vascular bioprosthesis seems to be a promising graft for VA. The 1-yr 80% patency rate is comparable to the patency of the classic radial-cephalic fistula and transposed basilic vein-brachial artery fistula (1, 7). It has excellent handling and suturing characteristics and affords anastomotic conformation in difficult cases. The ease of cannulation and hemostasis are also advantages that have been observed in the dialysis clinic, as well as the high flow rates during dialysis. Our midterm results show that the graft is associated with satisfactory patency rates and low complication rates.
There are few, but significant, reports concerning ProCol® use for VA. Lawson et al tested the safety and patency of ProCol® for HD access in high-risk patients, who had experienced multiple failed PTFE grafts and concluded that it was a safe alternative to PTFE with superior patency rates (8). Bourquelot reported the long-term results for ProCol® use for VA in patients with a history of prior failed access and significant circulatory complications associated with the remaining vasculature (9). The study demonstrated a cumulative patency of 52% at 3 yrs and 46% at 5 yrs. Bourquelot suggested that ProCol® compared to ePTFE could provide almost twice the utility for this difficult recipient population. Finally, Bacchini et al (10) presented 1-yr investigative results comparing the ProCol‚ bioprosthesis to ePTFE grafts in patients receiving their first prosthetic access graft subsequent to a failed native AV fistula. They found better survival with the bovine veins than with ePTFE.
Our midterm results demonstrate that the ProCol® vascular bioprosthesis is a promising material for VA. A large number of patients with complex and difficult access issues may be able to look forward to longer dialysis free periods without major interventions. However, the safety and long-term efficacy of this material needs to be proven through controlled randomized trials.
Address for correspondence:
Yiannis Velissaris, MD
1st Surgical and 1st Medical Department
AHEPA University Hospital
Thessaloniki - Greece
eliss@otenet.gr
REFERENCES
1. Hatjibaloglou A, Grekas D, Megalopoulos A, et al. Transposed basilic vein-brachial arteriovenous fistula: an alternative vascular access for hemodialysis. Artif Organs 1992; 16: 623-5.
2. Munda R, First MR, Alexander JW, Linneman CC, Fidler JP, Kittur D. Polytetrafluoroethylene graft survival in hemodialysis. JAMA 1983; 249: 219-22.
3. Bell DD, Rosental JJ. Arteriovenous graft life in chronic hemodialysis. A need for prolongation. Arch Surg 1988; 123: 1169-72.
4. Haimov M, Burrows L, Schanzer H, et al. Experience with arterial substitutes in the construction of vascular access for hemodialysis. J Cardiovasc Surg 1980; 21: 149-54.
5. Hirth RA, Turenne MN, Woods JD, et al. Predictors of type of vascular access in hemodialysis patients.
JAMA 1996; 276: 1303-8.
6. Woods JD, Tureene MN, Strawderman RL, et al. Vascular access survival among incident hemodialysis patients in United States. Am J Kidney Dis 1997; 30: 50-7.
7. Wilson SE, Stabile BE. Current status of vascular access techniques. Surg Clin North Am 1982; 62: 531-40.
8. Lawson HJ, Stephenson RG, Mercer CM, Gray LJ. Midterm results of the ProCol‚ vascular bioprosthesis in high risk vascular access patients. 28th Global: Vascular and Endovascular Issues, Techniques and HorizonsTM.
9. Bourquelot DP. ProCol‚ vascular bioprosthesis for vascular access: long-term results. 28th Global: Vascular and Endovascular Issues, Techniques and HorizonsTM.
10. Bacchini G, Del Vecchio L, Andrulli S, Pontoriero G, Locatelli F. Survival of prosthetic grafts of different materials after impairment of a native arteriovenous fistula in hemodialysis patients. ASAIO J 2001; 47: 30-3.
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