- Email: [email protected]
Midterm outcomes of brachial arterio-arterial prosthetic loop as permanent hemodialysis access
Midterm outcomes of brachial arterio-arterial prosthetic loop as permanent hemodialysis access Haitham Ali, MD, Ahmed Elbadawy, MD, and Mahmoud Saleh, MD, Assiut, Egypt
ABSTRACT Objective: The objective of this study was to report the midterm outcomes of the brachial arterio-arterial prosthetic loop (AAPL) as an alternative permanent vascular access in strictly selected patients with end-stage renal disease. Methods: This single-center prospective observational study was conducted between January 2014 and June 2017 and included 89 brachial AAPL procedures. Primary, assisted primary, and secondary patency rates were calculated using Kaplan-Meier analysis. Results: Exhausted peripheral veins were the most common indication for brachial AAPL. Patients were followed up for a mean period of 28.7 6 4.9 months. Nineteen grafts developed thrombosis, 13 grafts developed pseudoaneurysms, 9 grafts developed hematoma, and 6 grafts were abandoned because of infection. The primary, assisted primary, and secondary patency rates were 62% 6 5.2%, 71.2% 6 4.9%, and 89.6% 6 3.3% at 24 months, respectively. Conclusions: Brachial AAPL can offer a simple, safe, and efficient alternative as a permanent hemodialysis access in a selected subset of end-stage renal disease patients, with acceptable durability and rate of complications. Because of its unique specifications, cooperation between vascular surgeons and dialysis staff is mandatory. (J Vasc Surg 2019;-:1-7.) Keywords: Arterio-arterial; Alternative dialysis access; Brachial artery prosthetic loop; Exhausted peripheral veins; Central venous occlusive disease
Hemodialysis (HD) was developed as a successful treatment of end-stage renal disease (ESRD) for patients awaiting transplantation.1 A well-functioning vascular access (VA) is one of the most important cornerstones of efficient HD and consequently patients’ security and well-being.2 There is a nearly universal agreement that autogenous arteriovenous fistula is the most preferred VA in terms of durability, complications, and total cost of maintenance compared with prosthetic arteriovenous graft or cuffed tunneled central venous catheter.3-7 However, there has been an increase in the number of patients with ESRD, life expectancy, and associated comorbid conditions, including severe heart failure and advanced peripheral arterial disease. This has yielded a subgroup of challenging patients in whom creation of conventional autogenous or prosthetic VA is not feasible.7,8 Therefore, the need for complex or exotic VA is continuing to increase. However, there is no clear consensus on what type of access to create and when to create it.9
From the Vascular and Endovascular Surgery Department, Assiut University Hospitals. Author conflict of interest: none. Correspondence: Haitham Ali, MD, Vascular and Endovascular Surgery Department, Assiut University Hospitals, 71515 Assiut, Egypt (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.10.081
In this study, we report the midterm outcomes of the brachial arterio-arterial prosthetic loop (AAPL) as an alternative permanent VA in strictly selected patients with ESRD.
METHODS This single-center, prospective observational study was approved by our Institutional Review Board and conducted between January 2014 and June 2017. During that period, 3846 HD access procedures were performed in the study institution, which is a high-volume, tertiary referral university hospital. Among these procedures, 89 brachial AAPLs (2.3%) were performed in 89 patients. Brachial AAPLs were offered only for a strictly selected subset of ESRD patients in whom construction of conventional arteriovenous access was not feasible or potentially harmful. These indications were one or more of the following: a) Cardiac dysfunction (New York Heart Association class III-IV, associated with an ejection fraction <30%) as the significant hemodynamic changes provided by arteriovenous accesss would further deteriorate their cardiac condition. The decision in this subset of patients was made by a multidisciplinary team including cardiologists, nephrologists, and vascular surgeons. b) Limb-related factors. The patient’s four limbs should fulfill any of the following criteria: - Exhausted peripheral veins of both upper and lower extremities suitable to perform either arteriovenous fistula or arteriovenous graft. Peripheral veins were considered exhausted if they were 1
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thrombosed, fibrotic, or recanalized, as documented by duplex ultrasound (DUS). - Unrecostructable central venous occlusive disease. Central veins were considered unreconstructible in cases of repeated occlusion after successful recanalization and stenting or failed attempts of recanalization, and confirmed by either computed tomography or conventional venography. - Peripheral arterial disease with significant perfusion deficits (Wound, Ischemia, and foot Infection [WIfI] ischemia grades 2-3) according to the WIfI classification system,10 as creation of arteriovenous access carries the risk of severe steal syndrome. Exclusion criteria included: a) brachial artery peak systolic velocity (PSV) <50 cm/s, b) diameter <3.0 mm, and/or c) circumferential calcification. In addition to physical examination, pulse assessment, and bilateral upper extremity blood pressure measurement, all patients underwent a preoperative DUS evaluation (Philips HD 5; Philips Healthcare, Eindhoven, The Netherlands) to verify brachial artery diameter, PSV, degree of atherosclerosis and calcification, and depth from the skin. Computed tomography angiography was indicated only in cases of questioned arterial occlusive disease. All eligible patients were fully informed about the nature of this VA and provided written informed consent on agreement. Operative technique. All cases were performed under ultrasound-guided supraclavicular brachial plexus nerve block. A 6- to 8-cm continuous longitudinal skin incision was made on the medial aspect of the middle third of the arm overlying the course of the brachial artery. After creation of a skin flap with subcutaneous fatty tissue below the dermis, the brachial artery was identified by dividing the fibrous extensions of the biceps tendon, then opening the sheath surrounding the neurovascular bundle. The artery was then dissected away from the adjacent veins and nerves, especially the median nerve, and isolated. A 6-mm expanded polytetrafluoroethylene graft (LifeSpan; LeMaitre Vascular, Burlington, Mass) was tunneled subcutaneously in a loop fashion over the anteromedial aspect of the arm with the assistance of three small counterincisions. Systemic heparinization (2500 units) was given after brachial artery exposure and graft tunneling. Clamping was applied to the proximal and distal ends of the artery, and the artery was then transected. The graft was anastomosed to the proximal followed by the distal transected end of the artery in an end-to-end configuration using 6-0 polypropylene sutures (Fig 1). After release of the clamps, good brachial and radial pulsations were felt to ensure adequacy of the procedure. Finally, the wound was closed with a subcutaneously placed surgical drain for 1-2 days.
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ARTICLE HIGHLIGHTS d
d
d
Type of Research: Single-center, prospective cohort study Key Findings: A brachial arterio-arterial prosthetic loop was created in strictly selected 89 patients with end-stage renal disease. Exhausted peripheral veins were the most common indication. The primary, assisted primary, and secondary patency rates were 62% 6 5.2%, 71.2% 6 4.9%, and 89.6% 6 3.3% at 24 months, respectively. Take Home Message: The brachial arterio-arterial prosthetic loop can offer a simple, safe, and efficient alternative as a permanent hemodialysis access in selected subset of end-stage renal disease patients, with acceptable durability and rate of complications.
Postoperative management. Following the procedure, patients were prescribed lifelong aspirin 75 mg/d and intravenous prophylactic antibiotics for 2 days. They were discharged on the second postoperative day in the absence of early complications. The first needle puncture of the graft was carried out not before 2 weeks following the procedure. Strict instructions were given to the nephrologists about the prerequisites of this unique VA. They were advised to: -Limit the puncture attempts as multiple punctures are associated with inadequate hemostasis and increased possibility of pseudoaneurysm formation; - Rotate the cannulation sites (stepladder technique) to avoid pseudoaneurysm formation; - Place the arterial line of the dialysis machine in the proximal limb directed upward and the venous line in the distal limb directed downward; - Continue heparin administration until 30 minutes before finishing the HD session; - Adjust the temperature of the reinfused blood to avoid peripheral vasospasm; - Keep away from high-flow dialysis (>400 mL/min) to avoid possible painful reperfusion; - Refrain from providing any medications through the access to avoid intra-arterial injection; and - Compress the puncture sites for at least 15 to 20 minutes after needle removal. Follow-up protocol and study outcomes. Patients were followed up 1 month after the procedure and every 3 months thereafter at our outpatient clinic. Clinical examination and DUS of the brachial AAPL were performed to assess patency, flow volume, and possible graft-related events. Criteria for identifying a failing graft included any of the following: a) focal PSV within the graft or at the site of proximal or distal anastomosis >300 cm/s; b) PSV ratio across the
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Fig 1. Schematic illustration of the brachial arterioarterial prosthetic loop (AAPL). PTFE, Polytetrafluoroethylene.
stenosis >3.5; and/or c) uniformly low PSV <45 cm/s throughout the entire graft. Failing grafts underwent pre-emptive balloon angioplasty to reduce the risk of graft thrombosis. Study outcome measures were defined according to the Society for Vascular Surgery (SVS) reporting standards,11 and the European Society for Vascular Surgery (ESVS) clinical practice guidelines,7 namely: a) primary patency defined as the interval from the time of access placement until any intervention designed to maintain or to restore patency, access abandonment, or the time of measurement of patency; b) assisted primary patency defined as the interval from the time of access placement until access abandonment or the time of measurement of patency including intervening manipulations (surgical or endovascular) designed to maintain patency; and c) secondary patency defined as the interval from the time of access placement until access abandonment or the time of measurement of patency including intervening manipulations (surgical or endovascular) designed to restore patency. Statistical analysis. Statistical analysis was performed using SPSS 24.0 (IBM Corp, Armonk, NY) and MedCalc 16.8 (MedCalc Software, Ostend, Belgium). Statistics were based on the analysis of 89 patients with 178 central veins and 356 limbs. Descriptive statistics were used, with continuous variables expressed as mean 6 standard deviation or median and interquartile range, and categorical variables expressed as frequency and percentage. Patency rates were analyzed on an intention-to-treat
basis using Kaplan-Meier survival curve and reported as proportion 6 standard error. A P value < .05 was considered statistically significant.
RESULTS Between January 2014 and June 2017, 89 patients with 89 brachial AAPLs were enrolled in the study. Patients’ demographics and their dialysis history are summarized in Table I. Indications for construction of the brachial AAPL are listed in Table II. The mean diameter of the brachial artery was 4.2 6 0.6 mm, the mean operative time was 86.1 6 21.3 minutes, and the mean cannulation time was 17.1 6 5.0 days. Perioperative surgically related complications occurred in 10 patients (11.2%) and are detailed in Table III. Two grafts (2.2%) developed early thrombosis on the first postoperative day; patency was restored by surgical thrombectomy using Fogarty thrombectomy catheter (LeMaitre Vascular), followed by completion angiography to exclude a possible technical error. Three grafts (3.4%) developed superficial wound infection and were treated with appropriate antibiotic therapy according to culture and sensitivity results. Other complications were managed successfully with the appropriate medical and surgical treatment without resulting in loss of any VA. Fifteen days after the procedure, one patient (1.1%) was hospitalized because of severe chest infection and died in this context. Efficient HD was achieved in all patients as demonstrated by successful adjustment of blood withdrawal
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Table I. Patients’ demographics and dialysis history
Table II. Procedural details
Age, years
Indicationa
Mean 6 SD
50.9 6 10.3
Range
34-70
Cardiac dysfunction (NYHA class III-IV, EF <30%)
49 (16)
Exhausted peripheral veins
Male sex
55 (61.8)
Unreconstructable CVOD
Diabetes
53 (59.6)
PAD (WIfI ischemia grades 2-3)
Median (IQR)
Hypertension
68 (76.4)
Dyslipidemia
11 (12.4)
Coronary heart disease
20 (22.5)
32 (36)
Brachial artery diameter, mm Mean 6 SD
24 (27.0)
Range Median (IQR)
Range Median (IQR)
4.8 6 2.5 1-11 5 (3)
Mean 6 SD Range Median (IQR)
4.6 6 2.1 2-10 4 (4)
BMI, Body mass index; HD, hemodialysis; IQR, interquartile range; SD, standard deviation; VAs, vascular accesses. Values are reported as number (%) unless otherwise indicated.
at a rate of 200 to 250 mL/min and duration of HD for an average of 12 hours per week over three dialysis settings. All patients were followed up for a mean period of 28.7 6 4.9 months (median, 27 months; range, 24-40 months). Kaplan-Meier analysis yielded an overall primary patency rate of 87.5% 6 3.5%, 71.5% 6 4.8%, and 62% 6 5.2% at 6, 12, and 24 months, respectively (Fig 2). During regular DUS surveillance, eight failing brachial AAPLs (9%) were encountered with significant anastomotic stenosis, most probably due to intimal hyperplasia. These stenotic lesions were negotiated with angled-tip 0.035-inch Radifocus guidewires (Terumo Medical Corp, Somerset, NJ) and dilated using high-pressure balloons (Dorado [Bard Peripheral Vascular, Tempe, Ariz]; Mustang [Boston Scientific, Marlborough, Mass]). The diameter of the balloon was selected to be 10% to 15% larger than the diameter of the index brachial artery. A typical balloon angioplasty consisted of two inflations of 3 minutes each, up to 20 atm of pressure. Preemptive balloon angioplasty increased the assisted primary patency rate to 90.9% 6 3.1%, 79.5% 6 4.3%, and 71.2% 6 4.9% at 6, 12, and 24 months, respectively (Fig 2). In addition, another 17 grafts (19.1%) developed thrombosis at a mean time of 12.8 6 7.5 months (median, 12 months; range, 3-24 months), causing only mild ischemic symptoms (pale, cold hands, without sensory loss or muscle weakness) that were well tolerated in all cases. Those grafts were managed by surgical
4.2 6 0.6 3-5.5 4.1 (0.9)
Operative time, minutes Mean 6 SD Range Median (IQR)
No. of previous permanent VAs
12/356 (3.4)
57 (64)
19 (21.3)
Mean 6 SD
132/178 (74.2)
Left
Obesity (BMI >30 kg/m ) Duration of HD, years
288/356 (80.9)
Right
14 (15.7)
Current smoking
14/89 (15.7)
Side
Cerebrovascular disease 2
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86.1 6 21.3 60-150 90 (15)
Cannulation time, days Mean 6 SD Range Median (IQR)
17.1 6 5.0 14-30 14 (5)
CVOD, Central venous occlusive disease; EF, ejection fraction; IQR, interquartile range; NYHA, New York Heart Association; PAD, peripheral arterial disease; SD, standard deviation; WIfI, Wound, Ischemia, and foot Infection classification system. Values are reported as number (%) or n/N (%) unless otherwise indicated. a Statistics were based on the analysis of 89 patients with 178 central veins and 356 limbs.
Table III. Perioperative and late morbidity or mortality Perioperative complications Mortality
1 (1.1)
Thrombosis
2 (2.2)
Seroma
1 (1.1)
Hematoma
4 (4.5)
Superficial wound infection
3 (3.4)
Deep wound infection
0 (0)
Late complications Mortality Thrombosis
4 (4.5) 17 (19.1)
Graft infection
6 (6.7)
Pseudoaneurysm
13 (14.6)
Hematoma
9 (10.1)
Distal embolization
0 (0)
Intra-arterial injection
0 (0)
Painful reperfusion
0 (0)
Values are reported as number (%).
thrombectomy followed by completion angiography of the entire access circuit to identify any residual thrombus load and potential underlying cause of graft thrombosis. Anastomotic stenosis was detected in 13 grafts and
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Fig 2. Kaplan-Meier analysis of primary (solid line), assisted primary (dashed line), and secondary (dotted line) patency rates.
underwent balloon angioplasty. Reinterventions were successful in restoring graft patency in 16 grafts (16/19; 84.2%) and consequently achieved a secondary patency rate of 97.7% 6 1.6%, 93.2% 6 2.7%, and 89.6% 6 3.3% at 6, 12, and 24 months, respectively (Fig 2). In spite of strict instructions, consecutive puncture of the graft led to development of pseudoaneurysm in 13 grafts (14.6%), which were managed by aneurysm excision and reconstruction of the destroyed graft segment by interposition expanded polytetrafluoroethylene graft. Nine grafts (10.1%) developed hematoma and were managed either conservatively (six grafts) or by surgical evacuation (three grafts). Six brachial AAPLs (6.7%) were abandoned because of graft infection with no need for arterial reconstruction. No instances of distal embolization, intra-arterial injection, or painful reperfusion were encountered during the follow-up period. During the study period, five patients (5.6%) died at a mean time of 11.6 6 7.1 months (range, 1-18 months). None of these deaths were related to the VA.
DISCUSSION The number of patients undergoing HD is growing annually, and it is believed that this trend will continue. Therefore, it is increasingly common to encounter patients with exhausted options for conventional VA.9
Cuffed tunneled central venous catheters are by no means an ideal alternative, being associated with high morbidity and mortality.12-14 The use of an artery as permanent VA in HD is not a new concept. However, versatile sites, techniques, and configurations have been described. In 1964, Nayman15 placed two plastic cannulas in both ends of a divided radial artery and connected both cannulas using a clip-on spring junction on the skin surface. Some vascular surgeons reported successful needle puncture of subcutaneously transposed radial,16,17 brachial,8,18 and superficial femoral arteries.19-21 Others have described the use of femoropopliteal22,23 and proximal to distal brachial bypass graft for dialysis.24-26 In 2005, Bünger et al27 first reported axillaryaxillary interarterial prosthetic loop over the anterior chest wall. Others described a similar technique in the lower limb between common femoral artery and either the superficial or deep femoral artery28-30 and in the upper arm using brachial AAPL.31 In this study, we reported the results of 89 brachial AAPLs created as permanent VA in a selected subset of patients undergoing HD. The achieved primary, assisted primary, and secondary patency rates were 87.5%, 90.9%, and 97.7% at 6 months; 71.5%, 79.5%, and 93.2% at 1 year; and 62%, 71.2%, and 89.6% at 2 years, respectively. These results are comparable to those of Khafagy
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et al,31 who reported the results of 35 brachial AAPLs and achieved primary and secondary patency rates of 87.9% and 90.7% at 1 year and 70.4% and 80.3% at 2 years, respectively. In a systematic review including eight arterio-arterial studies, however, different in sites and configurations, Grima et al32 reported primary patency rates ranging from 67% to 94.5% at 6 months and 38.8% to 61% at 3 years and secondary patency rates ranging from 83% to 93% at 6 months and 67.6% to 87% at 3 years. Despite the promising results of this study, arterioarterial HD access should be reserved for a selected subset of ESRD patients with inappropriate venous capital, such as exhausted peripheral veins of both upper and lower extremities and/or unreconstructable CVOD. Other considerable indications are the risk of aggravating cardiac dysfunction and threatening ischemia of the extremity with other conventional VA.7,29,33 Compared with conventional VA, arterio-arterial access has many advantages: a) a vein is not required, so there is no risk of stenosis or obstruction of the venous pathway and subsequent venous hypertension; b) distal perfusion is not decreased, so there is no risk of steal syndrome; and c) cardiac load is not increased,29,34 so it is an interesting option for patients with cardiac dysfunction as it causes no or only little disruption of the patient’s hemodynamics because the blood is returned to the same compartment from which it is removed, so that the pressure in that compartment is not affected.35 However, this access bears some caveats because of its distinctive hemodynamics. Thrombosis of arterio-arterial access could acutely endanger the arterial blood supply to the affected extremity, especially in accesses involving axillary or common femoral arteries.27,29,34 Interestingly, brachial AAPLs were constructed over the mid-brachial artery distal to the origin of the profunda brachii artery, which provides rich collateralization in case of graft thrombosis, thus resulting in well-tolerated mild ischemic symptoms in almost all cases. Moreover, schematized change and prolonged compression of the access site have to be considered to guard against development of pseudoaneurysm.8,29 Many drugs that have the potential of inducing ischemic injury if given intra-arterially should never be used.34 The potential liability for distal embolization can be avoided by adequate heparinization throughout the dialysis setting and careful handling by well-trained nephrologists and nursing staff. In contrast to the axillary artery, use of the brachial artery as a potential site of AAPL has many advantages: a) it is superficial in position, thus allowing the operation to be performed under either local or regional anesthesia; b) it does not preclude a future axillary AAPL in case of failure of the brachial one; c) less incidence of limb-threatening ischemic symptoms in case of graft thrombosis; d) accessible location of the brachial artery
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to deal with potential complications, such as pseudoaneurysms; and e) it is more convenient for both patients, especially women, and nursing staff.31 Close cooperation between vascular surgeons and dialysis staff is essential to achieve the best use and preservation of arterio-arterial access and to avoid potential complications.8 Lack of scientific evidence on the use of arterio-arterial access clearly shows the need for a multicenter study including a large number of patients to reach consensus on the ideal site, technique, configuration, and postoperative antithrombotic agents (antiplatelets vs anticoagulants) concerning this unique VA.32,36 Limitations of this study are that it is a single-center, single-arm study with a relatively small number of patients and a short follow-up period.
CONCLUSIONS The brachial AAPL can offer a simple, safe, and efficient alternative as a permanent HD access in a selected subset of ESRD patients, with acceptable durability and rate of complications. Because of its unique specifications, cooperation between vascular surgeons and dialysis staff is mandatory. The authors wish to thank Elsevier illustration services for preparation of the illustration for this manuscript.
AUTHOR CONTRIBUTIONS Conception and design: HA, AE Analysis and interpretation: HA, AE, MS Data collection: HA, MS Writing the article: HA Critical revision of the article: HA, AE, MS Final approval of the article: HA, AE, MS Statistical analysis: HA Obtained funding: Not applicable Overall responsibility: HA
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Submitted Aug 10, 2019; accepted Oct 16, 2019.
ABSTRACT Objective: The objective of this study was to report the midterm outcomes of the brachial arterio-arterial prosthetic loop (AAPL) as an alternative permanent vascular access in strictly selected patients with end-stage renal disease. Methods: This single-center prospective observational study was conducted between January 2014 and June 2017 and included 89 brachial AAPL procedures. Primary, assisted primary, and secondary patency rates were calculated using Kaplan-Meier analysis. Results: Exhausted peripheral veins were the most common indication for brachial AAPL. Patients were followed up for a mean period of 28.7 6 4.9 months. Nineteen grafts developed thrombosis, 13 grafts developed pseudoaneurysms, 9 grafts developed hematoma, and 6 grafts were abandoned because of infection. The primary, assisted primary, and secondary patency rates were 62% 6 5.2%, 71.2% 6 4.9%, and 89.6% 6 3.3% at 24 months, respectively. Conclusions: Brachial AAPL can offer a simple, safe, and efficient alternative as a permanent hemodialysis access in a selected subset of end-stage renal disease patients, with acceptable durability and rate of complications. Because of its unique specifications, cooperation between vascular surgeons and dialysis staff is mandatory. (J Vasc Surg 2019;-:1-7.) Keywords: Arterio-arterial; Alternative dialysis access; Brachial artery prosthetic loop; Exhausted peripheral veins; Central venous occlusive disease
Hemodialysis (HD) was developed as a successful treatment of end-stage renal disease (ESRD) for patients awaiting transplantation.1 A well-functioning vascular access (VA) is one of the most important cornerstones of efficient HD and consequently patients’ security and well-being.2 There is a nearly universal agreement that autogenous arteriovenous fistula is the most preferred VA in terms of durability, complications, and total cost of maintenance compared with prosthetic arteriovenous graft or cuffed tunneled central venous catheter.3-7 However, there has been an increase in the number of patients with ESRD, life expectancy, and associated comorbid conditions, including severe heart failure and advanced peripheral arterial disease. This has yielded a subgroup of challenging patients in whom creation of conventional autogenous or prosthetic VA is not feasible.7,8 Therefore, the need for complex or exotic VA is continuing to increase. However, there is no clear consensus on what type of access to create and when to create it.9
From the Vascular and Endovascular Surgery Department, Assiut University Hospitals. Author conflict of interest: none. Correspondence: Haitham Ali, MD, Vascular and Endovascular Surgery Department, Assiut University Hospitals, 71515 Assiut, Egypt (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.10.081
In this study, we report the midterm outcomes of the brachial arterio-arterial prosthetic loop (AAPL) as an alternative permanent VA in strictly selected patients with ESRD.
METHODS This single-center, prospective observational study was approved by our Institutional Review Board and conducted between January 2014 and June 2017. During that period, 3846 HD access procedures were performed in the study institution, which is a high-volume, tertiary referral university hospital. Among these procedures, 89 brachial AAPLs (2.3%) were performed in 89 patients. Brachial AAPLs were offered only for a strictly selected subset of ESRD patients in whom construction of conventional arteriovenous access was not feasible or potentially harmful. These indications were one or more of the following: a) Cardiac dysfunction (New York Heart Association class III-IV, associated with an ejection fraction <30%) as the significant hemodynamic changes provided by arteriovenous accesss would further deteriorate their cardiac condition. The decision in this subset of patients was made by a multidisciplinary team including cardiologists, nephrologists, and vascular surgeons. b) Limb-related factors. The patient’s four limbs should fulfill any of the following criteria: - Exhausted peripheral veins of both upper and lower extremities suitable to perform either arteriovenous fistula or arteriovenous graft. Peripheral veins were considered exhausted if they were 1
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thrombosed, fibrotic, or recanalized, as documented by duplex ultrasound (DUS). - Unrecostructable central venous occlusive disease. Central veins were considered unreconstructible in cases of repeated occlusion after successful recanalization and stenting or failed attempts of recanalization, and confirmed by either computed tomography or conventional venography. - Peripheral arterial disease with significant perfusion deficits (Wound, Ischemia, and foot Infection [WIfI] ischemia grades 2-3) according to the WIfI classification system,10 as creation of arteriovenous access carries the risk of severe steal syndrome. Exclusion criteria included: a) brachial artery peak systolic velocity (PSV) <50 cm/s, b) diameter <3.0 mm, and/or c) circumferential calcification. In addition to physical examination, pulse assessment, and bilateral upper extremity blood pressure measurement, all patients underwent a preoperative DUS evaluation (Philips HD 5; Philips Healthcare, Eindhoven, The Netherlands) to verify brachial artery diameter, PSV, degree of atherosclerosis and calcification, and depth from the skin. Computed tomography angiography was indicated only in cases of questioned arterial occlusive disease. All eligible patients were fully informed about the nature of this VA and provided written informed consent on agreement. Operative technique. All cases were performed under ultrasound-guided supraclavicular brachial plexus nerve block. A 6- to 8-cm continuous longitudinal skin incision was made on the medial aspect of the middle third of the arm overlying the course of the brachial artery. After creation of a skin flap with subcutaneous fatty tissue below the dermis, the brachial artery was identified by dividing the fibrous extensions of the biceps tendon, then opening the sheath surrounding the neurovascular bundle. The artery was then dissected away from the adjacent veins and nerves, especially the median nerve, and isolated. A 6-mm expanded polytetrafluoroethylene graft (LifeSpan; LeMaitre Vascular, Burlington, Mass) was tunneled subcutaneously in a loop fashion over the anteromedial aspect of the arm with the assistance of three small counterincisions. Systemic heparinization (2500 units) was given after brachial artery exposure and graft tunneling. Clamping was applied to the proximal and distal ends of the artery, and the artery was then transected. The graft was anastomosed to the proximal followed by the distal transected end of the artery in an end-to-end configuration using 6-0 polypropylene sutures (Fig 1). After release of the clamps, good brachial and radial pulsations were felt to ensure adequacy of the procedure. Finally, the wound was closed with a subcutaneously placed surgical drain for 1-2 days.
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ARTICLE HIGHLIGHTS d
d
d
Type of Research: Single-center, prospective cohort study Key Findings: A brachial arterio-arterial prosthetic loop was created in strictly selected 89 patients with end-stage renal disease. Exhausted peripheral veins were the most common indication. The primary, assisted primary, and secondary patency rates were 62% 6 5.2%, 71.2% 6 4.9%, and 89.6% 6 3.3% at 24 months, respectively. Take Home Message: The brachial arterio-arterial prosthetic loop can offer a simple, safe, and efficient alternative as a permanent hemodialysis access in selected subset of end-stage renal disease patients, with acceptable durability and rate of complications.
Postoperative management. Following the procedure, patients were prescribed lifelong aspirin 75 mg/d and intravenous prophylactic antibiotics for 2 days. They were discharged on the second postoperative day in the absence of early complications. The first needle puncture of the graft was carried out not before 2 weeks following the procedure. Strict instructions were given to the nephrologists about the prerequisites of this unique VA. They were advised to: -Limit the puncture attempts as multiple punctures are associated with inadequate hemostasis and increased possibility of pseudoaneurysm formation; - Rotate the cannulation sites (stepladder technique) to avoid pseudoaneurysm formation; - Place the arterial line of the dialysis machine in the proximal limb directed upward and the venous line in the distal limb directed downward; - Continue heparin administration until 30 minutes before finishing the HD session; - Adjust the temperature of the reinfused blood to avoid peripheral vasospasm; - Keep away from high-flow dialysis (>400 mL/min) to avoid possible painful reperfusion; - Refrain from providing any medications through the access to avoid intra-arterial injection; and - Compress the puncture sites for at least 15 to 20 minutes after needle removal. Follow-up protocol and study outcomes. Patients were followed up 1 month after the procedure and every 3 months thereafter at our outpatient clinic. Clinical examination and DUS of the brachial AAPL were performed to assess patency, flow volume, and possible graft-related events. Criteria for identifying a failing graft included any of the following: a) focal PSV within the graft or at the site of proximal or distal anastomosis >300 cm/s; b) PSV ratio across the
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Fig 1. Schematic illustration of the brachial arterioarterial prosthetic loop (AAPL). PTFE, Polytetrafluoroethylene.
stenosis >3.5; and/or c) uniformly low PSV <45 cm/s throughout the entire graft. Failing grafts underwent pre-emptive balloon angioplasty to reduce the risk of graft thrombosis. Study outcome measures were defined according to the Society for Vascular Surgery (SVS) reporting standards,11 and the European Society for Vascular Surgery (ESVS) clinical practice guidelines,7 namely: a) primary patency defined as the interval from the time of access placement until any intervention designed to maintain or to restore patency, access abandonment, or the time of measurement of patency; b) assisted primary patency defined as the interval from the time of access placement until access abandonment or the time of measurement of patency including intervening manipulations (surgical or endovascular) designed to maintain patency; and c) secondary patency defined as the interval from the time of access placement until access abandonment or the time of measurement of patency including intervening manipulations (surgical or endovascular) designed to restore patency. Statistical analysis. Statistical analysis was performed using SPSS 24.0 (IBM Corp, Armonk, NY) and MedCalc 16.8 (MedCalc Software, Ostend, Belgium). Statistics were based on the analysis of 89 patients with 178 central veins and 356 limbs. Descriptive statistics were used, with continuous variables expressed as mean 6 standard deviation or median and interquartile range, and categorical variables expressed as frequency and percentage. Patency rates were analyzed on an intention-to-treat
basis using Kaplan-Meier survival curve and reported as proportion 6 standard error. A P value < .05 was considered statistically significant.
RESULTS Between January 2014 and June 2017, 89 patients with 89 brachial AAPLs were enrolled in the study. Patients’ demographics and their dialysis history are summarized in Table I. Indications for construction of the brachial AAPL are listed in Table II. The mean diameter of the brachial artery was 4.2 6 0.6 mm, the mean operative time was 86.1 6 21.3 minutes, and the mean cannulation time was 17.1 6 5.0 days. Perioperative surgically related complications occurred in 10 patients (11.2%) and are detailed in Table III. Two grafts (2.2%) developed early thrombosis on the first postoperative day; patency was restored by surgical thrombectomy using Fogarty thrombectomy catheter (LeMaitre Vascular), followed by completion angiography to exclude a possible technical error. Three grafts (3.4%) developed superficial wound infection and were treated with appropriate antibiotic therapy according to culture and sensitivity results. Other complications were managed successfully with the appropriate medical and surgical treatment without resulting in loss of any VA. Fifteen days after the procedure, one patient (1.1%) was hospitalized because of severe chest infection and died in this context. Efficient HD was achieved in all patients as demonstrated by successful adjustment of blood withdrawal
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Table I. Patients’ demographics and dialysis history
Table II. Procedural details
Age, years
Indicationa
Mean 6 SD
50.9 6 10.3
Range
34-70
Cardiac dysfunction (NYHA class III-IV, EF <30%)
49 (16)
Exhausted peripheral veins
Male sex
55 (61.8)
Unreconstructable CVOD
Diabetes
53 (59.6)
PAD (WIfI ischemia grades 2-3)
Median (IQR)
Hypertension
68 (76.4)
Dyslipidemia
11 (12.4)
Coronary heart disease
20 (22.5)
32 (36)
Brachial artery diameter, mm Mean 6 SD
24 (27.0)
Range Median (IQR)
Range Median (IQR)
4.8 6 2.5 1-11 5 (3)
Mean 6 SD Range Median (IQR)
4.6 6 2.1 2-10 4 (4)
BMI, Body mass index; HD, hemodialysis; IQR, interquartile range; SD, standard deviation; VAs, vascular accesses. Values are reported as number (%) unless otherwise indicated.
at a rate of 200 to 250 mL/min and duration of HD for an average of 12 hours per week over three dialysis settings. All patients were followed up for a mean period of 28.7 6 4.9 months (median, 27 months; range, 24-40 months). Kaplan-Meier analysis yielded an overall primary patency rate of 87.5% 6 3.5%, 71.5% 6 4.8%, and 62% 6 5.2% at 6, 12, and 24 months, respectively (Fig 2). During regular DUS surveillance, eight failing brachial AAPLs (9%) were encountered with significant anastomotic stenosis, most probably due to intimal hyperplasia. These stenotic lesions were negotiated with angled-tip 0.035-inch Radifocus guidewires (Terumo Medical Corp, Somerset, NJ) and dilated using high-pressure balloons (Dorado [Bard Peripheral Vascular, Tempe, Ariz]; Mustang [Boston Scientific, Marlborough, Mass]). The diameter of the balloon was selected to be 10% to 15% larger than the diameter of the index brachial artery. A typical balloon angioplasty consisted of two inflations of 3 minutes each, up to 20 atm of pressure. Preemptive balloon angioplasty increased the assisted primary patency rate to 90.9% 6 3.1%, 79.5% 6 4.3%, and 71.2% 6 4.9% at 6, 12, and 24 months, respectively (Fig 2). In addition, another 17 grafts (19.1%) developed thrombosis at a mean time of 12.8 6 7.5 months (median, 12 months; range, 3-24 months), causing only mild ischemic symptoms (pale, cold hands, without sensory loss or muscle weakness) that were well tolerated in all cases. Those grafts were managed by surgical
4.2 6 0.6 3-5.5 4.1 (0.9)
Operative time, minutes Mean 6 SD Range Median (IQR)
No. of previous permanent VAs
12/356 (3.4)
57 (64)
19 (21.3)
Mean 6 SD
132/178 (74.2)
Left
Obesity (BMI >30 kg/m ) Duration of HD, years
288/356 (80.9)
Right
14 (15.7)
Current smoking
14/89 (15.7)
Side
Cerebrovascular disease 2
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86.1 6 21.3 60-150 90 (15)
Cannulation time, days Mean 6 SD Range Median (IQR)
17.1 6 5.0 14-30 14 (5)
CVOD, Central venous occlusive disease; EF, ejection fraction; IQR, interquartile range; NYHA, New York Heart Association; PAD, peripheral arterial disease; SD, standard deviation; WIfI, Wound, Ischemia, and foot Infection classification system. Values are reported as number (%) or n/N (%) unless otherwise indicated. a Statistics were based on the analysis of 89 patients with 178 central veins and 356 limbs.
Table III. Perioperative and late morbidity or mortality Perioperative complications Mortality
1 (1.1)
Thrombosis
2 (2.2)
Seroma
1 (1.1)
Hematoma
4 (4.5)
Superficial wound infection
3 (3.4)
Deep wound infection
0 (0)
Late complications Mortality Thrombosis
4 (4.5) 17 (19.1)
Graft infection
6 (6.7)
Pseudoaneurysm
13 (14.6)
Hematoma
9 (10.1)
Distal embolization
0 (0)
Intra-arterial injection
0 (0)
Painful reperfusion
0 (0)
Values are reported as number (%).
thrombectomy followed by completion angiography of the entire access circuit to identify any residual thrombus load and potential underlying cause of graft thrombosis. Anastomotic stenosis was detected in 13 grafts and
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Fig 2. Kaplan-Meier analysis of primary (solid line), assisted primary (dashed line), and secondary (dotted line) patency rates.
underwent balloon angioplasty. Reinterventions were successful in restoring graft patency in 16 grafts (16/19; 84.2%) and consequently achieved a secondary patency rate of 97.7% 6 1.6%, 93.2% 6 2.7%, and 89.6% 6 3.3% at 6, 12, and 24 months, respectively (Fig 2). In spite of strict instructions, consecutive puncture of the graft led to development of pseudoaneurysm in 13 grafts (14.6%), which were managed by aneurysm excision and reconstruction of the destroyed graft segment by interposition expanded polytetrafluoroethylene graft. Nine grafts (10.1%) developed hematoma and were managed either conservatively (six grafts) or by surgical evacuation (three grafts). Six brachial AAPLs (6.7%) were abandoned because of graft infection with no need for arterial reconstruction. No instances of distal embolization, intra-arterial injection, or painful reperfusion were encountered during the follow-up period. During the study period, five patients (5.6%) died at a mean time of 11.6 6 7.1 months (range, 1-18 months). None of these deaths were related to the VA.
DISCUSSION The number of patients undergoing HD is growing annually, and it is believed that this trend will continue. Therefore, it is increasingly common to encounter patients with exhausted options for conventional VA.9
Cuffed tunneled central venous catheters are by no means an ideal alternative, being associated with high morbidity and mortality.12-14 The use of an artery as permanent VA in HD is not a new concept. However, versatile sites, techniques, and configurations have been described. In 1964, Nayman15 placed two plastic cannulas in both ends of a divided radial artery and connected both cannulas using a clip-on spring junction on the skin surface. Some vascular surgeons reported successful needle puncture of subcutaneously transposed radial,16,17 brachial,8,18 and superficial femoral arteries.19-21 Others have described the use of femoropopliteal22,23 and proximal to distal brachial bypass graft for dialysis.24-26 In 2005, Bünger et al27 first reported axillaryaxillary interarterial prosthetic loop over the anterior chest wall. Others described a similar technique in the lower limb between common femoral artery and either the superficial or deep femoral artery28-30 and in the upper arm using brachial AAPL.31 In this study, we reported the results of 89 brachial AAPLs created as permanent VA in a selected subset of patients undergoing HD. The achieved primary, assisted primary, and secondary patency rates were 87.5%, 90.9%, and 97.7% at 6 months; 71.5%, 79.5%, and 93.2% at 1 year; and 62%, 71.2%, and 89.6% at 2 years, respectively. These results are comparable to those of Khafagy
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et al,31 who reported the results of 35 brachial AAPLs and achieved primary and secondary patency rates of 87.9% and 90.7% at 1 year and 70.4% and 80.3% at 2 years, respectively. In a systematic review including eight arterio-arterial studies, however, different in sites and configurations, Grima et al32 reported primary patency rates ranging from 67% to 94.5% at 6 months and 38.8% to 61% at 3 years and secondary patency rates ranging from 83% to 93% at 6 months and 67.6% to 87% at 3 years. Despite the promising results of this study, arterioarterial HD access should be reserved for a selected subset of ESRD patients with inappropriate venous capital, such as exhausted peripheral veins of both upper and lower extremities and/or unreconstructable CVOD. Other considerable indications are the risk of aggravating cardiac dysfunction and threatening ischemia of the extremity with other conventional VA.7,29,33 Compared with conventional VA, arterio-arterial access has many advantages: a) a vein is not required, so there is no risk of stenosis or obstruction of the venous pathway and subsequent venous hypertension; b) distal perfusion is not decreased, so there is no risk of steal syndrome; and c) cardiac load is not increased,29,34 so it is an interesting option for patients with cardiac dysfunction as it causes no or only little disruption of the patient’s hemodynamics because the blood is returned to the same compartment from which it is removed, so that the pressure in that compartment is not affected.35 However, this access bears some caveats because of its distinctive hemodynamics. Thrombosis of arterio-arterial access could acutely endanger the arterial blood supply to the affected extremity, especially in accesses involving axillary or common femoral arteries.27,29,34 Interestingly, brachial AAPLs were constructed over the mid-brachial artery distal to the origin of the profunda brachii artery, which provides rich collateralization in case of graft thrombosis, thus resulting in well-tolerated mild ischemic symptoms in almost all cases. Moreover, schematized change and prolonged compression of the access site have to be considered to guard against development of pseudoaneurysm.8,29 Many drugs that have the potential of inducing ischemic injury if given intra-arterially should never be used.34 The potential liability for distal embolization can be avoided by adequate heparinization throughout the dialysis setting and careful handling by well-trained nephrologists and nursing staff. In contrast to the axillary artery, use of the brachial artery as a potential site of AAPL has many advantages: a) it is superficial in position, thus allowing the operation to be performed under either local or regional anesthesia; b) it does not preclude a future axillary AAPL in case of failure of the brachial one; c) less incidence of limb-threatening ischemic symptoms in case of graft thrombosis; d) accessible location of the brachial artery
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to deal with potential complications, such as pseudoaneurysms; and e) it is more convenient for both patients, especially women, and nursing staff.31 Close cooperation between vascular surgeons and dialysis staff is essential to achieve the best use and preservation of arterio-arterial access and to avoid potential complications.8 Lack of scientific evidence on the use of arterio-arterial access clearly shows the need for a multicenter study including a large number of patients to reach consensus on the ideal site, technique, configuration, and postoperative antithrombotic agents (antiplatelets vs anticoagulants) concerning this unique VA.32,36 Limitations of this study are that it is a single-center, single-arm study with a relatively small number of patients and a short follow-up period.
CONCLUSIONS The brachial AAPL can offer a simple, safe, and efficient alternative as a permanent HD access in a selected subset of ESRD patients, with acceptable durability and rate of complications. Because of its unique specifications, cooperation between vascular surgeons and dialysis staff is mandatory. The authors wish to thank Elsevier illustration services for preparation of the illustration for this manuscript.
AUTHOR CONTRIBUTIONS Conception and design: HA, AE Analysis and interpretation: HA, AE, MS Data collection: HA, MS Writing the article: HA Critical revision of the article: HA, AE, MS Final approval of the article: HA, AE, MS Statistical analysis: HA Obtained funding: Not applicable Overall responsibility: HA
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Submitted Aug 10, 2019; accepted Oct 16, 2019.