Clinical Utility of a New Predicting Score for Radiocephalic Arteriovenous Fistula Survival

Accepted Manuscript Clinical utility of a new predicting score for Radiocephalic Arteriovenous Fistula Survival Lucia I. Martinez, MD, Vicent Esteve, MD, PhD, Montserrat Yeste, MD, Vicent Artigas, MD, PhD, Secundino Llagostera, MD., Ph. D., FEBVS, Head of Vascular Surgery PII:

S0890-5096(17)30259-5

DOI:

10.1016/j.avsg.2016.09.022

Reference:

AVSG 3141

To appear in:

Annals of Vascular Surgery

Received Date: 30 June 2016 Revised Date:

23 August 2016

Accepted Date: 8 September 2016

Please cite this article as: Martinez LI, Esteve V, Yeste M, Artigas V, Llagostera S, Clinical utility of a new predicting score for Radiocephalic Arteriovenous Fistula Survival, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2016.09.022. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT Title Page:

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Full title:

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CLINICAL UTILITY OF A NEW PREDICTING SCORE FOR RADIOCEPHALIC

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ARTERIOVENOUS FISTULA SURVIVAL

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Authors:

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Lucia I. Martinez, MD1

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Vicent Esteve, MD, PhD 2

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Montserrat Yeste, MD 3

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Vicent Artigas. MD, PhD 4

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Secundino Llagostera. MD., Ph. D., FEBVS 5

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Authors affiliation:

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1. Vascular Surgery Department. Hospital of Terrassa, Consorci Sanitari de Terrassa

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(CST). Surgery Department, Universitat Autònoma de Barcelona (UAB).

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C/ Torrebonica s/n, CP 08227, Barcelona, Spain.

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2. Nephrology Department. Hospital of Terrassa, Consorci Sanitari de Terrassa (CST),

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C/ Torrebonica s/n, CP 08227, Barcelona, Spain.

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3 Vascular Surgery Department. Hospital of Terrassa, Consorci Sanitari de Terrassa

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(CST), C/ Torrebonica s/n, CP 08227, Barcelona, Spain.

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4. General Surgery Department. Hospital de la Santa Creu i Sant Pau. Carrer de Sant

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Quintí 89, 08026, Barcelona, Spain.

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5. Head of Vascular Surgery. Hospital Germans Trias i Pujol. Ctra. de Canyet s/n, CP

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08916, Barcelona, Spain.

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Lucia Martinez

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Vascular Surgery Department

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Hospital of Terrassa CST

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C/ Torrebonica s/n

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CP 08227, Barcelona, Spain

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Telephone: +34 937310007

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Fax: +34 93731095

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E-Mail: [email protected]

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Corresponding Author

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Acknowledgments: This research has been carried out within the Doctorate in Surgery

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framework of the Universitat Autònoma de Barcelona (UAB).

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ACCEPTED MANUSCRIPT Abstract

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Introduction: Radio-cephalic arteriovenous fistula (RC-AVF) is the recommended first

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choice for vascular access (VA). The CAVeA2T2 scoring system was recently published

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(ipsilateral central venous catheter access, age >73 years, vein <2.2 mm, lower limb

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angioplasty and absent intra-operative thrill). The aim of the present study was to assess

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the clinical utility of the CAVeA2T2 scoring system for predicting RC-AVFs survival in

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our centre and its subsequent application in VA management.

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Material and Methods: A single centre retrospective study. All RC-AVF performed

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between January 2010 to July 2014 were included. The CAVeA2T2 was applied.

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Primary, assisted primary and secondary patency rates were measured.

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Results: 60 RC-AVFs were analysed. Mean age: 64.3 ± 14.7 years. Mean CAVeA2T2

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score: 1.23 ± 1.2. The median fistula secondary patency was 13.7 ± 1.6 months.

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Secondary patency was at 6 weeks, 6, 12 and 24 months: 88.3%, 66.7%, 55% and

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31.7%, respectively. Increasing score (≥2) was associated with a decrease in primary

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(log-rank, X2 16.7, dif 1, p= 0,0001) and secondary patency rate survival (log-rank, X2

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5.4, dif 1, p= 0,0001). Additionally, stratification of the CAVeA2T2 score into three

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groups (scores 0-1, 2, 3+) retained its significance for primary (log-rank, X2 19.4, dif 2,

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p= 0,0001) and secondary patency rate survival (log-rank, X2 5.5, dif 2, p= 0,046) at the

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end of the study.

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Conclusion: In the present study, the CAVeA2T2 scoring system has proved to be a

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useful, easy to apply tool that is highly predictive of RC-AVF survival. Based in our

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results, we should avoid perform RC-AVFs, in those patients with CAVeA2T2 score ≥ 2

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and late nephrology referral. Prospective studies should be designed to establish the

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management of patients with a higher CAVeA2T2 score.

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Key words: Radiocephalic arteriovenous fistula, Primary patency, Vascular access.

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Manuscript

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INTRODUCTION

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The selection of the vascular access (VA) type is a complex process. Some of the

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factors involved are the characteristics of patients' vessels and the need for renal

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replacement therapy with a functioning arteriovenous fistula (AVF)1. According to

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practical guidelines 2, AVF should be created in pre-dialysis patients, and should be

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placed in the most distal site of the non-dominant upper limb. Following the surgical

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intervention, all AVFs require a maturation period, from the time of creation to first

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cannulation, which varies from four to eight weeks1,3–5. Adequately matured AVFs can

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be cannulated without complication and are associated with an excellent patency with

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low risk of thrombosis and infection, thus reducing healthcare costs6–8.

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Radio-cephalic fistula (RC-AVF) was first described by Cimino and Brescia9 in 1966

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and is still regarded as the ideal form of access, as it preserves the vascular territory and

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has a lower rate of associated comorbidities10. Nevertheless, the demographic

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characteristics of end-stage renal disease (ESRD) patients have changed considerably

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since this study was published. Presently, the progressive ageing of the population and

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the greater number of associated comorbidities have a negative effect on the patency

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and survival of RC-AVFs11,12.

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In recent years, new strategies have been devised to improve the patency of distal AVF

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such as the use of survival prediction scores but to date, evidence regarding their use is

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ACCEPTED MANUSCRIPT scarce13–15. The recently described CAVeA2T2 scoring system13 may be a useful tool to

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predict RC-AVFs patency.

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The aim of the present study was to assess the clinical utility of the CAVeA2T2 scoring

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system for predicting RC-AVFs survival in our centre and its subsequent application in

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VA management.

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MATERIAL AND METHODS

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A retrospective single-centre study was conducted from January 2010 to July 2014.

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The study was approved by the institutional ethics committee and carried out in

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conformance with the Declaration of Helsinki, to assess the clinical utility of the

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CAVeA2T2 scoring system for predicting RC-AVFs survival and its subsequent

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application in the vascular access management in our centre.

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This general hospital serves a population of 220,000 inhabitants with a periodic

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haemodialysis (HD) programme presently including 75 patients, distributed in 6 groups

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of 10-13 patients. The study group was obtained from the computerized surgical records

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of our centre. All patients who had RC-AVF construction during the study period with a

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minimum follow-up of 24 months were included. Patients with native AVs in other

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territories, vascular prostheses for HD or refered to other center for their dialysis

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treatment and then lost to follow-up, were not included.

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Demographic data and associated comorbidities

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Demographic data and associated comorbidities were obtained from a comprehensive

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review of medical histories. Demographic variables included sex, age, side of RC-AVF

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and Charlson Comorbidity Index (a predictor index of one-year mortality for a patient

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ACCEPTED MANUSCRIPT who may have a range of comorbid conditions). The data collected included aetiology

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of ESRD and the presence of traditional cardiovascular risk factors: hypertension,

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diabetes mellitus, dyslipidaemia and peripheral vascular disease.

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Preoperative assessment

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All candidates for AVF underwent a pre-surgical assessment according to protocol. This

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included a physical exploration and Doppler Ultrasonography (DUS) mapping of the

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upper extremities (Siemens Sonoline G40 Doppler Ultrasound System, Siemens

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Medical Solutions USA, Inc.) using a 10MHz linear probe.

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The physical exploration consisted of a visual assessment of functional limitations of

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both upper extremities, motor or sensory deficits, skin and subcutaneous fat thickness,

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presence of scars or oedema in the extremity, as well as the existence of collateral

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circulation in the arm or shoulder. The presence and quality of arterial pulses was

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assessed using digital palpation, including Allen’s test. Measurement of arterial

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pressures in both upper extremities and evaluation of the venous system were made with

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venous palpation with or without a tourniquet.

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DUS data analysed included: diameter (mm) of the forearm cephalic vein and diameter

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(mm) of the radial artery, systolic peak velocity (cm/s) and resistance index of the radial

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artery after the reactive hyperaemia test.

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Surgical intervention and postoperative follow-up

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All interventions were created by four vascular surgeons at our centre. The usual

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surgical technique was followed: local anaesthesia, a longitudinal incision at wrist level

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for the dissection and control of the cephalic vein and forearm. Dissection of the radial 6

ACCEPTED MANUSCRIPT artery with control of proximal and distal ends, section of the cephalic vein and ligation of

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the distal end and venous collaterals. Local heparin was administered to all patients before

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arterial clamping with vessel loop. A long arteriotomy was made and an end-to-side

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anastomosis was created using polypropylene 6/0. Declamping after drainage manoeuvres

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and assessment of intraoperative thrill.

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All patients received the same postoperative care and were visited seven days after the

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intervention to check RC-AVF function. All patients follow their usual nephrologic

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control visits at 1, 6, 12 and 24 months.

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CAVeA2T2 predictive score

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The CAVeA2T2, score was applied to all patients. Predictive variables: presence of

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ipsilateral central venous catheter, age >73 years, cephalic vein <2.2 mm, lower limb

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angioplasty and absent intraoperative thrill. Total score ranges from 0 to 7 points; 1

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point was assigned for each of the first three variables and 2 points for the latter two.

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Scores ≥ 2 points are associated with a worse survival of RC-AVF (Table I).

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Patency rates definitions

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Primary patency (interval from time of access placement to any intervention designed to

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maintain or reestablish patency, access thrombosis, or the time of measurement of

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patency), assisted primary patency (interval from time of access placement to access

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thrombosis or time of measurement of patency, including intervening manipulations,

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surgical or endovascular interventions, designed to maintain the functionality of a patent

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access) and secondary patency rates (interval from time of access placement to access

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abandonment, access thrombosis or time of measurement of patency, including

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intervening manipulations, surgical or endovascular interventions, designed to

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ACCEPTED MANUSCRIPT reestablish the functionality of thrombosed access) were measured at 6 weeks and at 6,

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12 and 24 months.

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Statistical analysis was performed using SPSS version 19.0 (SPSS Inc, Chicago, IL,

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USA). Quantitative variables were expressed as the mean ± standard deviation.

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Qualitative variables were reported as percentages or distribution of frequencies and

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compared using the chi-square statistical test or exact Fisher test as appropiate. Patency

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was analysed using the actuarial survival curves with the Kaplan Meier method and

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compared with the non-parametric log rank test, (X2). Statistical significance was set at

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p ≤ 0.05.

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RESULTS

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During the study period, a total of 82 RC-AVF were analysed, and only 60 were

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included in our study (8 had a follow-up less than 24 months, and 14 were referred to

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other center). 53.3% of patients were on a periodic HD programme, and 46.7% were in

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pre-dialysis stage. Mean age of patients was 64.7 ± 14.7 years, and 78.3% were men.

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Mean Charlson index was 6.65± 1.2 and 85% of RC-AVFs were created in the left

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upper extremity (Table II). Aetiologies of chronic kidney disease were: hypertension

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31.7%, diabetes mellitus 28.3%, glomerular disease 16.7%, multiple myeloma 5%,

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nephrectomy 1.7%, renal polycystic disease 1.6%, and idiopathic 15%. Associated

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comorbidities included hypertension 86.7%, diabetes mellitus 53.3%, dyslipidaemia

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36.7% and peripheral vascular disease 31.7%.

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Mean CAVeA2T2 score was 1.23 ± 1.2. Depending on the score obtained, the

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distribution of the patients was as follows: 38.3% scored 0, 26.7% scored 1, 11.7%

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scored 2, 20% scored 3 and 3.3% scored 4. Frequency distribution of variables was

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determined as follows: 8.3% had ipsilateral CVC, 31.7% were over 73 years old,

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ACCEPTED MANUSCRIPT cephalic vein diameter was under 2.2mm in 10%, 21.7% had history of lower limb

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angioplasty and absence of intraoperative thrill was noted in 15%.

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A total of 18 patients (30%) underwent a fistula-preserving intervention, comprising 14

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open surgical procedures (proximal re-anastomosis) and 4 endovascular procedures

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(fistuloplasty of stenotic inflow/ outflow vessels).

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Primary patency was 83.3 %, 65.7 %, 55.6 %, 22.2 %, assisted primary patency was

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90.5 %, 66.7 %, 54.8 %, 35.7 % and secondary patency was 88.3 %, 66.7 %, 55 %, 31.7

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% at 6 weeks, 6, 12 and 24 months, respectively. The median fistula secondary patency

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was 13.7 ± 1.6 months.

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Depending on total CAVeA2T2 score (<2 or ≥2), a study of RC-AVF patency rates was

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carried out. No significant differences for primary and primary assisted patency were

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observed (Table III). However, significant difference for the RC-AVF secondary

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patency was observed (Table IV) at the subsequent follow-up (6 weeks, 6, 12 and 24

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months), respectively.

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A significant lower RC-AVF primary (log-rank, X2 16.7, dif 1, p= 0,001) (Fig. 1) and

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secondary patency rate survival (log-rank, X2 5.4, dif 1, p= 0,020) (Fig. 2) was

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observed in patients with a total CAVeA2T2 score ≥2. Stratification in 3 groups (0-1, 2,

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3+) retained its significance for primary (log-rank, X2 19.4, dif 2, p= 0,001) and

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secondary patency rate survival (log-rank, X2 5.5, dif 2, p= 0,046) (Fig. 3). No

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significant differences were observed for assisted primary patency rate survival in

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patients with a total CAVeA2T2 score ≥2 (log-rank, X2 3.1, dif 1, p= 0.081) and after

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stratification by groups (log-rank, X2 3.6, dif 2, p= 0.161).

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DISCUSSION

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Although RC-AVFs are considered the VA of choice, their primary patency rate is low.

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Typically, advanced age, female sex, the presence of diabetes mellitus and peripheral

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vascular disease are some of the factors associated with worse survival of RC-AVF14,16–

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reviewed 38 studies (30 retrospective) between January 1970 and October 2002. The

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analysis showed a pooled estimated primary failure rate of 15.3% and a 1-year pooled

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estimated primary and secondary patency rate of 62.5 and 66.0%, respectively.

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In view of these findings, one of the crucial issues is to identify some of the factors

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involved in the low VA overall patency and to develop new strategies to improve their

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survival.

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There is little evidence of the utility of AVF risk scores and their application in clinical

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practice is not commonplace. Prognostic factors influencing the patency of AVFs had

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not been combined until Lok et al.14, in a prospective multicentric study of 422 patients,

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published a risk score including four clinical predictors: age >65 yr, peripheral vascular

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disease, ischaemic cardiopathy and white race. The scoring system was applied to all

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types of AVFs (RC-AVF, brachiocephalic, brachiobasilic and femoro-saphenous) and

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the results obtained were stratified in four categories: low, moderate, high and very

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high. Likewise, in a prospective 8-year study of 105 RC-AVF, Vernaglione et al.15

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obtained a worse RC-AVF primary survival in patients with ICED score > 1. The

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complex ICED score identified 19 disease categories and 11 categories of physical

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impairment, with scores from 0 to 3, increasing with severity level. However, these

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scores are not used in routine clinical practice, as external validity was not achieved.

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The CAVeA2T2 scoring system was recently developed by Bosanquet et al.13, in a

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retrospective single-centre study of 276 patients with RC-AVF. The authors analysed 18

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. In a recent metanalysis published by Rooijens et al22, the authors systematically

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ACCEPTED MANUSCRIPT variables related with the maturation and patency of RC-AVF, and proposed a score

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including the five variables that reached statistical significance. The CAVeA2T2 scoring

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system stands out for its simplicity, easy application in routine clinical practice and high

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predictive ability of RC-AVF survival. They found that patients with a total score ≥2,

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were related to a poorer secondary survival. Likewise, the inclusion or exclusion of the

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variable perioperative thrill can be useful in preoperative planning. In line with Lok et

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al.14 and Vernaglione et al.15, the authors agree that as external validity has not been

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obtained to date, it has not been extended to clinical practice.

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In the present study, the CAVeA2T2 scoring system has proved to be a useful tool,

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easily applicable and with a high predictive value of RC-AVF survival in our center.

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The preoperative assessment, surgical technique and postoperative care were similar to

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those reported by Bosanquet et al13. However, our patients were not prescribed

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postoperative antiagregant treatment. Our results observed a significant difference

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exclusively for the RC-AVF secondary patency according to groups (<2 or ≥2) at the

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subsequent follow-up. Increasing score (CAVeA2T2 ≥2) and the stratification of the

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score (0-1, 2, 3+) were associated with a decrease in primary and secondary patency

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rate survival. However, no significant differences were observed for assisted primary

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patency rate survival in patients with a total CAVeA2T2 score ≥2 and the stratification

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of the score.

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Based in these results, we support the use of the CAVeA2T2 scoring system during the

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VA selection process. A standard management protocol applying the CAVeA2T2 might

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be of value to minimize wasted time and effort and reduce the primary failure rate.

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Appropriate planning allows for the initiation of dialysis therapy at the appropriate time

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with a permanent access in place at the start of dialysis therapy.

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ACCEPTED MANUSCRIPT In order to perform a RC-AVF in patients with high score, it´s important to assess if

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there is the adequate time for the fistula to mature and sufficient time to perform another

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vascular access procedure if the first attempt fails, thus avoiding the need for temporary

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access. Therefore, in those patients with CAVeA2T2 score ≥ 2 and late nephrology

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referral we should avoid perform RC-AVFs. In line with Bosanquet et al13, our data

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have limited scope to be used as a tool for deciding if monitoring radio-cephalic fistulae

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should occur.

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Among the limitations of our study, we should mention the retrospective design and the

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short follow-up period conditioned by the recent publication of the score, as well as the

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limited sample size, due to the small number of patients and the recent introduction of

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DUS mapping in our center.

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In conclusion, in the present study the CAVeA2T2 scoring system has proved to be a

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useful, easy to apply tool that is highly predictive of RC-AVF survival. Based in our

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results, we support the use of the CAVeA2T2 scoring system during the VA selection

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process, and we should avoid perform RC-AVFs in those patients with CAVeA2T2

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score ≥ 2 and late nephrology referral. However, future prospective studies should be

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performed to decide the management of high CAVeA2T2 score patients.

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14. Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D. Risk equation

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Endovasc Surg 1996;12(2):207-13.

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17. Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous

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21. Feldman HI, Joffe M, Rosas SE, Burns JE, Knauss J, Brayman K. Predictors of successful arteriovenous fistula maturation. Am J Kidney Dis 2003;42(5):1000-12.

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22. Rooijens PPGM, Tordoir JHM, Stijnen T, Burgmans JPJ, Smet de A a. EA, Yo TI.

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Radiocephalic wrist arteriovenous fistula for hemodialysis: meta-analysis indicates

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a high primary failure rate. Eur J Vasc Endovasc Surg 2004;28(6):583-9.

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ACCEPTED MANUSCRIPT Table Legends

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Table I. CAVeA2T2 Scoring system. Score variables and score punctuation.

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Table II. Baseline demographics, comorbidities and clinical conditions: Results

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expressed as mean and standard desviation (m ± sd) or percentage (%) and

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number (n).RC- AVF: radiocephalic arteriovenous fistula.

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Table III. Primary and Assisted primary patency rates up to 2 years for

353

CAVeA2T2 score (<2 o ≥2) at 6 weeks, 6, 12 or 24 months. N= 60. Score (<2): 39.

354

Score (≥2): 21. Results expressed as percentage (%) and number (n). Statistical

355

significance * p ≤ 0.05.

356

Table IV. Secondary patency rates up to 2 years for CAVeA2T2 score (<2 o ≥2) at 6

357

weeks, 6, 12 or 24 months. Primary patency (18); Score (<2): 9. Score (≥2): 9.

358

Assisted primary patency (42); score (<2): 30. Score (≥2):12. Results expressed as

359

percentage (%) and number (n). Statistical significance * p ≤ 0.05.

362

363

364

SC

M AN U

TE D

EP

361

AC C

360

RI PT

347

365

366

367

16

ACCEPTED MANUSCRIPT Figure legends

369

Fig. 1 Kaplan–Meier curve for radio-cephalic arteriovenous fistula primary

370

patency survival according to CAVeA2T2 score: <2 o ≥2. Line 0: <2, line 1: ≥ 2. A

371

significant statistical between groups was obtained (log-rank, X2 16.7, dif 2, p= 0.001).

RI PT

368

372

Fig. 2 Kaplan–Meier curve for radio-cephalic arteriovenous fistula secondary

374

patency survival according to their CAVeA2T2 score: <2 o ≥2. Line 0: <2, line 1: ≥ 2

375

A significant statistical between groups was obtained (log-rank, X2 5.4, dif 1, p= 0.020).

SC

373

M AN U

376 377

Fig. 3 Kaplan–Meier curve for radio-cephalic arteriovenous fistula secondary

378

patency rate survival according to CAVeA2T2 score stratification: 0-1, 2 and >3. A

379

significant statistical between groups was obtained (log-rank, X2 5.5, dif 2, p= 0.046).

383

384

385

386

EP

382

AC C

381

TE D

380

387

388

389

17

ACCEPTED MANUSCRIPT

391

Table I. Variable

Score

Ipsilateral CVC access

1

RI PT

TABLES

Age >73 years

1

Vein <2.2 mm

1

No peri-operative thrill Total

395

396

397

398

7

EP

394

2

AC C

393

2

TE D

392

M AN U

History of lower limb angioplasty

SC

390

399

400

401 18

ACCEPTED MANUSCRIPT 402

Table II. Baseline variables

Results

Age (years)

64.3 ± 14.7

Male sex, % (n)

78.3 % (47)

405

Hypertension, % (n)

86.7% (52)

406

Diabetes Mellitus, % (n)

53.3% (32)

407

Dyslipidemia, % (n)

36.7% (22)

408

Peripheral vascular disease, % (n)

31.7% (19)

409

Median Charlson Index

6.6 ± 4.1

410

Left sided RC-AVF, % (n)

85% (51)

403

412 413

419 420 421

EP

418

AC C

417

TE D

414

416

SC

M AN U

411

415

RI PT

404

422 423 424 425

19

ACCEPTED MANUSCRIPT 426

Table III.

427

Primary Assisted Patency

RI PT

Primary Patency

Score <2

Score ≥ 2

p- value

Score <2

Score ≥ 2

p- value

6 weeks

100% (9)

66.7% (6)

0.058

96.7% (29)

75% (9)

0.063

6 months

77.8% (7)

55.6% (5)

0.317

76.7% (23)

41.7% (5)

0.067

12 months

66.7% (6)

44.4% (4)

0.343

63.3% (19)

33.3% (4)

0.098

24 months

33.3% (3)

11.1% (1)

40% (12)

25% (3)

0.292

432 433 434 435 436 437

EP

431

AC C

430

0.257

TE D

429

M AN U

428

SC

Follow up

438 439 440 441 20

ACCEPTED MANUSCRIPT TABLE IV

Score < 2

Score ≥ 2

p- value

6 weeks

97.4% (38)

71.4% (15)

0.003*

6 months

76.9 % (30)

47.6% (10)

0.022*

12 months

64.1% (25)

38.1% (8)

0.048*

24 months

38.5% (15)

19% (4)

0.041*

M AN U

443

RI PT

Follow up

SC

442

AC C

EP

TE D

444

21

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT