No-touch technique for radiocephalic arteriovenous fistula – surgical technique and preliminary results

Introduction

Radiocephalic autogenous arteriovenous fistulas (RC-AVFs) are the first choice for the vascular dialysis access (1-2-3-4-5). This is a logical choice, as further fistulas can be created proximally if needed (i.e. brachio-cephalic/basilic fistula) and the risk of steal syndrome is reduced (2, 4, 6, 7). Autogenous fistulas demonstrate higher patency and lower infection rates as well as fewer general complications than fistulas created with synthetic material (8). Even so, the primary and secondary failure rates of the conventional RC-AVF may be high due to thrombosis and occlusion, failure to mature, and low fistula flow. Primary patency at 1 year is described to be around 58-63% in several studies but varies widely (9-10-11-12-13). Vein size is considered to be an important prognostic value for patency and eventual functional fistula. Former studies have shown that cephalic veins diameter of 2.0 mm or less have very high failure rates and should not be considered for RC-AVF (5, 10, 14-15-16-17). Some authors as well as a recent review recommend that patients selected for RC-AVF should have cephalic veins of at least 2.0-2.5 mm or greater in diameter (13, 14, 16, 18). Heavily calcified radial arteries as well as peripheral atherosclerotic disease, diabetes, and obesity are also considered to have a negative impact on the prognosis of new fistulas, but there is a lack of data regarding the artery quality as well as the effect of pre-procedural Doppler ultrasound (DUS) investigation on patency (2, 7, 14).

The ‘No-Touch technique’ (NTT) for vein harvesting was developed by Souza et al to increase patency in coronary bypass surgery (19-20-21). By using vein grafts dissected with the adherent fat and connective tissue (vein pedicle or fat vein), direct contact with the vein is avoided and sterile water flush is not used, thereby preventing potential damage to the vein wall as well as spasm (19). A long-term follow-up study on the use of NTT in cardiac surgery showed increased graft patency compared with standard techniques (22). It is postulated that the NTT preserves the vein endothelium, cause minimal damage to the vein wall and the feeding vessels (vasa-vasorum), and prevents vessel spasm during surgery (19, 22, 38).

The aim of this pilot study was to investigate the feasibility of NTT in RC-AVF creation and to present the early and mid-term results of 31 consecutive patients who received an RC-AVF using the NTT.

Patients and methods

We report a single-center prospective study. Between February 2011 and April 2012, 45 patients had surgical procedures to create a vascular access for hemodialysis at Örebro University Hospital (Fig. 1). Six patients had previous radiocephalic fistula surgery in both arms. Six other patients had a cephalic distal vein of less than 1 mm and two patients had no continuity in the vein system. Thirty-one consecutive patients (69%) who were referred for fistula surgery had at least one forearm without former fistula surgery and were included consecutively in this study (17 men, mean age 63 years, range 35-84). Referral indications were based on the National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines (KDOQI) (2, 6). As part of the routine pre-operative examination, all the patients underwent a standardized DUS examination without the use of a tourniquet and with measurements of mean vein and arterial diameter along the vascular tree. Arterial atherosclerosis was estimated during DUS and graded as minor or significant. The evaluation of the patients was made by a senior vascular surgeon together with a senior nephrologist. Inclusion criteria were no previous fistula surgery in the relevant arm, at least 1 mm distal arm vein diameter measured by DUS, and a continuous upper arm vein run-off. The exclusion criteria were prior RC fistula surgery in that arm, veins diameter less than 1 mm, or absence of a continuous venous system. Vessels were marked preoperatively with the use of ultrasound and all but one was performed under general anesthesia. All of the surgical procedures were performed by at least one member of a two-surgeon team (TH, DS). Immediate surgical technical success was obtained in all patients as verified by clinical examination and stethoscope auscultation before leaving the surgical suite.

Fig. 1 -

At 2 and 5 weeks, all patients were examined clinically and underwent a DUS with flow measurements to evaluate the fistula flow. Patients were followed until fistula failure or patient death. In our institute usually, a failure to mature or a decreasing flow rate in a fistula detected at the dialysis center leads to a DUS examination and if needed, fistulography. Percutaneous transluminal angioplasty (PTA) interventions were made to maintain the flow in the fistula when the flow was insufficient for dialysis or showed tendency to decrease over time as recommended in the KDOQI guidelines (2, 6). The same guidelines were followed with regard to target flow, function, and general management.

Function and patency definitions

Function start (functional fistula or fistula ready to use) was defined as three consecutive successful cannulations that achieved dialysis blood flow of at least 400 ml/min and maintained dialysis for 4 h or less (23). Primary patency was defined as the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency. Secondary patency (including secondary assisted patency) was defined as the interval from the time of access placement until access abandonment, thrombosis, or the time of patency measurement, including surgical or endovascular interventions designed to maintain or reestablish functionality and follow the reporting standards of the society for vascular surgery (23).

The preoperative patient characteristics and comorbidities are described in Table I. Fistula patency data are described as cumulative patency rates derived from the life table method as stated in the study by Rutherford et al (37) for all patients and after dividing the patients into two groups (vein diameter >2 mm and ≤2 mm), as recommended by the Society of Vascular Surgery reporting guidelines (15, Tab. II).

TABLE I -

Flow chart of the study.

Patients characteristics and preoperative data

Characteristics	Number
Total patients	31
Mean age (years), range	63 (35-84)
Gender, Males	17
Comorbidities
Diabetes mellitus	15
Hypertension	30
Smoking	4
Peripheral arteriosclerosis disease	9
Preoperative data
Preoperative distal vein size (mm; mean, range)	2.4 mm (1-4.1)
Preoperative distal artery size (mm; mean, range)	2.2 mm (1.1-3.4)

TABLE II -

Life table of primary and secondary fistula patencies in all patients subjected to radiocephalic fistula surgery and after dividing the patients into subgroups (preoperative vein diameter of >2 mm or ≤2 mm)

Interval (months)	No. at risk at the beginning of interval	No. failed during interval	Lost to follow-up during interval	Interval failure rate	Cumulative patency rate	Standard error
Primary fistula patency, all patients
0-1	31	5	0	0.161	83.9%	6.05%
1-6	26	6	1	0.235	64.1%	7.53%
6-12	19	3	0	0.158	54.0%	8.40%
Primary fistula patency, vein >2 mm
0-1	19	3	0	0.158	84.2%	7.68%
1-6	16	3	1	0.194	67.9%	9.62%
6-12	12	3	0	0.250	50.9%	10.30%
Primary fistula patency, vein ≤2 mm
0-1	12	2	0	0.167	83.3%	9.82%
1-6	10	3	0	0.300	58.3%	11.91%
6-12	7	0	0	0.000	58.3%	14.23%
Secondary fistula patency, all patients
0-1	31	1	0	0.032	96.8%	3.12%
1-6	30	4	1	0.136	83.7%	6.18%
6-12	25	1	0	0.040	80.3%	7.13%
Secondary fistula patency, vein >2 mm
0-1	19	1	0	0.053	94.7%	4.99%
1-6	18	2	1	0.114	83.9%	7.93%
6-12	15	0	0	0.000	83.9%	8.69%
Secondary fistula patency, vein ≤2 mm
0-1	12	0	0	0.000	100.0%	0.00%
1-6	12	2	0	0.167	83.3%	9.82%
6-12	10	1	0	0.100	75.0%	11.86%

Vein and artery preoperative characteristics

Preoperatively, the mean distal vein diameter measured by DUS was 2.4 mm (range 1.0-4.1 mm) and the mean radial artery size was 2.2 mm (range 1.1-3.4 mm). Twelve ­patients had a cephalic vein size of 2 mm or less in diameter, 12 patients had a radial artery of 2 mm or less in diameter, and four patients had both a thin cephalic vein and a thin radial artery (≤2 mm in diameter). Nine patients had significant atherosclerotic changes in the radial artery as evaluated and documented by DUS.

The study was approved by the regional ethical committee and registered in a clinical trial register (Researchweb.org study nr 94021).

No touch technique: surgical aspects

A video of the No Touch method is avaliable online as supplementary material at vascular-access.info. Surgery was performed with optical loop magnification (×2.5).

1.

After a 4-5 cm skin incision in the distal arm, diathermy and scissors were used to dissect around the fat tissue. The vein located, and by diathermy dissection was isolated with a 1-3 mm tissue pedicle around it (Figs. 2, 3). At that stage, care was taken to avoid direct contact with the vein and no diathermy was used near the vein itself to avoid thermal damage. Surgical clips were used for significant feeding vessels and ligation for vein branches. The vein was thus dissected with a fat pedicle around it, but not yet ligated.

2.

The radial artery was dissected by diathermy and scissors on the medial and lateral side until a pedicle of artery with its satellite veins was isolated by vessel loops for proximal and distal control (Fig. 4). The patient then received 5000 international units of heparin (LEO Pharma A/S, Ballerup, Denmark) intravenously and the vein was ligated distally.

3.

The artery was opened by using a 3.0 mm Beaver knife (Beaver-Visitec International, Frenchs Forest, Australia). A 6-8 mm longitudinal anterior arterotomy was performed using Potts scissors. Both vessels were prepared for the anastomosis while preserving the pedicle around it (Fig. 5).

4.

Vein to artery anastomosis (end-to side) was created with a 7.0 or 8.0 non-absorbable, monofilament, continuous suture (Figs. 6, 7).

5.

Back flow and then in-flow was restored. Flow was evaluated by using an adequate probe (5-7 mm) connected to a transit-time flowmeter (Medistim Butterfly Flowmeter; Medistim ASA, Oslo, Norway).

6.

The wound closure done using subcutaneous separate sutures and the skin was approximated by intra-cutis absorbable sutures. The fistula was then examined for thrill both by palpation and auscultation.

Fig. 2 - Fig. 3 -Fig. 4 -Fig. 5 -Fig. 6 -Fig. 7 -

Results

During the pilot study period, all RC-AVFs were created with NTT and no RC-AVF was created using the conventional technique. One patient died before the 6-month follow-up, whereas the other patients were followed up to 1 year postoperatively.

Function start was achieved in 23 of the 27 (85%) patients who required hemodialysis. The mean time to function start was 127 days (range 33-476).

Function start failure was attributed to one patient’s refusal to use the fistula, two fistulas that failed to mature, and a patient death that occurred before cannulation of the fistula was attempted. Five patients underwent kidney transplantation during this period.

In the group of patients with veins diameter of 2 mm or less, three patients occluded and four patients were kidney transplanted; one was still at predialytic stage and two fistulas abandoned due to insufficient flow (but open). Two of the occluded fistulas in this group had achieved function start before they occluded and one occluded early before the patient has started hemodialysis.

Perioperative and postoperative flow measurements

At the end of the surgical procedure, the mean fistula flow rate was 170 ml/min (range 20-500 ml/min). At 2 and 5 postoperative weeks, the mean fistula flow rates were 780 ml/min (230-1500 ml/min) and 875 ml/min (270-1630 ml/min), ­respectively.

Primary and secondary fistula patency

In the total patient cohort (n = 31), the 30-day primary patency proportion was 84% and secondary patency proportion was 97% (Fig. 8, Tab. II). At 6 months, the primary patency proportion was 64% and secondary patency proportion was 84%. At 1 year, the primary patency proportion was 54% and secondary patency proportion was 80%. In patients who had a cephalic vein diameter of 2 mm or less (n = 12), 1-year primary patency was 58% and secondary patency was 75%. The primary and secondary patencies in patients with vein diameter more than 2 mm were comparable with patients with vein diameter 2 mm or less.

Fig. 8 -

Interventions

In one patient, an injury occurred to the back wall of the artery during the procedure and the fistula failed later the same day. Reoperation was performed the following day, but the fistula was occluded and the patient subsequently received a brachio-cephalic fistula. In total, 16 primary patency interventions (13 PTAs) were made in this cohort. Of these, five were performed in the upper arm vein (not in the surgical field), three in the lower arm vein (near anastomosis), and five in the artery or anastomosis itself. Other primary interventions included one coiling of collateral veins combined with the PTA, one open revision (neo-anastomosis), and three thrombectomies (one combined with PTA). Secondary interventions included four PTAs (one artery, one upper arm vein, one artery and anastomosis, and one artery together with lower arm vein), one open thrombectomy, and three open revisions (two neo-anastomosis and one upper arm vein revision). There were two tertiary interventions (PTA), one to the radial artery, and the other one to the radial artery as well as the upper arm vein.

Complications

There were no major complications related to the technique or surgery. Ten patients had a slight temporary paresthesia in the operative region and the medial aspect of the thumb, which had practically disappeared at 1 year of follow-up. Local skin infections treated by antibiotics occurred in two patients; one of them needed a local wound revision due to resistant infection. The revision showed no evidence of deep infection and resolved clinically over time.

Discussion

The main finding of this study is that an NTT for creation of RC-AVF is feasible and can be done in patients with small veins with good short and midterm results. These results are encouraging, as the need for dialysis treatment is increasing and the reported failure rate is high (13, 24). The overall patency in this study is very good, as it should be viewed in light of the fact that this is a consecutive group of patients treated under the notion of ‘if you have a distal cephalic vein, a RC-AVF should be built’ approach. The study group includes patients with multiple comorbidities that might influence patency rates, including obesity, general atherosclerosis, hypertension, and diabetes.

Some authors recommended a minimum vein diameter of 2.0-2.5 mm, and others reported even high failure rate for veins at a size of 1.6-2.0 mm (9, 13, 16, 17). Twenty-two patients had small arteries or veins and an RC-AVF fistula creation by conventional technique in these patients is doubtful by present guidelines and common practice (2, 5, 9, 11, 13, 14, 25-26-27-28-29-30). Patients with small veins (≤2 mm) did not suffer higher failure rate (Fig. 8). The results in this group were favorable and might indicate that RC-AVF can be achieved and function with NTT even in patients with small veins. Our preliminary results thus show that even very small veins (as well as small and atherosclerotic arteries) might develop into a full functional RC-AVF. Considering the pathologies leading to interventions, some patients were treated in the upper arm vein due to outflow stenosis. We consider these issues not to be solved by NTT, as the pathology does not lie in the operative field.

The NTT is a well-established technique within cardiac surgery, but this trial demonstrates that it can be applied for RC-AVF. There are several differences from conventional fistula surgery in the creation of the fistula: both the vein and the artery are prepared with cushion of surrounding tissue. They are neither distended nor directly manipulated with surgical instruments. The postulated benefit of NTT might be that less vein wall damage occurs, preventing intimal hyperplasia that is considered as a major cause for failure. The technique preserves the feeding vessels, reduces the degree of spasm, and the vein remains in a natural constitution until the maturation of the fistula (19-20-21-22). One might also hypothesize that NTT causes less inflammatory impact and thus the endothelial damage is also reduced indirectly (31-36). With regard to the cephalic vein, one might think that only a limited amount of fatty tissue surrounds the vein. However, our experience is that it is possible to dissect the vessel with an intact fat pedicle, albeit significantly less fat tissue is seen compared with the great saphenous vein.

The major limitation of this study is the small number of patients. Another limitation and possible explanation of these results might be the fact that all fistulas were created by a team of at least one of two surgeons. Another explanation might be the tight control of this study group and high early intervention rates.

Conclusion

The results from this pilot study applying NTT on primary radiocephalic fistulas show that by using this vessel-preserving technique, a patency rate comparable to earlier literature is seen in a consecutive patient group, including forearms with small cephalic veins and small, atherosclerotic radial arteries. This method offers the potential to create a RC-AVF in patients who are not usually considered appropriate for a distal arm fistula. The method is shown feasible and should be evaluated in randomized controlled trials.

Skin incision medial to the vein marked pre-operatively. The vein being exposed with the surrounding tissue in situ.

Dissection of the vein with its surrounding tissue (pedicle). Feeding vessels (vasa-vasorum) seen clearly on the pedicle.

Vein (blue vessel loop) and artery (red vessel loop) dissected by No Touch Technique. Notice the lack of vein spasm.

The vein is prepared for end-to-side anastomosis.

Anastomsosis by parachute technique.

The radiocephalic fistula completed just before flow measurement.

Primary and secondary patencies curves by the life table method outlined in Table II in all patients subjected to radio-cephalic fistula surgery, and after dividing the patients into subgroups (preoperative vein diameter of >2 mm or ≤2 mm).

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