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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_905_Библиотеки_им_академика_М_И_Перельмана.pdf
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I. A. Laskowski et al.
received U.S. Food and Drug Administration (FDA) approval in 2016. This system consists of an IVL generator, a connector cable, and a cath­eter (Fig.21.15a). The IVL catheter comprises an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy and an integrated balloon (Fig.21.15b). The IVL catheter is available in multiple sizes ranging from 2.5mm to 12mm and compatible with a 5 French to 8 French sheath and has working lengths of 110cm and 135 cm to treat aorta to tibial and peroneal vessels (Fig.21.16).
The IVL catheter contains an ination lumen, a guidewire lumen, and the lithotripsy emitters (Fig.21.16). The ination lumen is used for ina­tion and deation of the balloon with a 50:50 saline: contrast medium mixture. The guidewire lumen enables the use of a 0.014-inch guidewire to facilitate the advancement of the catheter to and through the target stenosis. The system is designed as “over-the-wire” (OTW) with a 110 cm or 135 cm shaft working length, and a
minimum of a 5 French sheath is required at the access site. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the bal­loon to aid in the positioning of the balloon dur­ing treatment. The balloon is designed to provide an expandable segment of a known length and diameter at a specic pressure. The proximal hub has three ports: one for ination/deation of the balloon, one for the guidewire lumen, and one for connection to the IVL connector cable. The IVL catheter will deliver a maximum of 300 pulses or 10cycles of 30 pulses per cycle for L6 and M5+ catheters and 160 pulses or 8cycles of 20 pulses per cycle for S4. It is recommended not to exceed 180 pulses in the same treatment segment.

Procedural Steps

The insertion site is accessed in a standard fash­ion using a micro-puncture system under ultra-
Fig. 21.15 Shockwave medical peripheral IVL system (a) with IVL catheter (b). (Reproduced with permission from Shockwave Medical)
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Fig. 21.16 Shockwave peripheral IVL catheter balloons. (Reproduced with permission from Shockwave Medical)
sound guidance, followed by upsizing to an appropriately sized sheath. Angiography is per­formed to localize and delineate the arterial lesion (Figs. 21.17a and 21.18a). Appropriate anticoagulation is initiated. A balloon catheter size is then selected in a 1:1 ratio with the refer­ence vessel diameter. The IVL catheter is pre­pared by lling a 20 mL syringe with 5 mL of half-strength contrast medium and attaching the syringe to the ination port on the catheter hub. The syringe is pulled back at least 3 times to release vacuum and allow the uid to replace the air in the catheter. The guidewire port of the IVL catheter is then ushed with saline, and the protective sheath from the catheter is removed, and the IVL connector cable is inserted into a sterile sleeve and attached to the IVL generator. The 0.014-inch guidewire is used to traverse the treatment site under uoroscopic guidance. The
IVL catheter is then loaded over the guidewire and advanced through the sheath to the treatment site using the marker bands to aid in positioning. Once the IVL catheter is positioned and con­rmed with uoroscopy, the IVL balloon is inated up to 4atm, and IVL is activated for up to 20 pulses for S4 and 30 pulses for M5+ and L4 by pressing the activation button (Figs.21.17b-c and
21.18b). The balloon is then inated up to 6atm
under uoroscopy. Then, the balloon is deated, and additional treatments can be performed as needed by repositioning the IVL and repeating the sequence as necessary. If multiple inations are required due to a lesion length greater than the IVL balloon length, the recommended bal­loon overlap is at least 1 cm. After treatment, completion angiography is performed to assess post-intervention results (Figs. 21.17d and
21.18c).
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Fig. 21.17 Right lower extremity angiography demon­strating severe long segment calcied stenoses of the anterior tibial artery and tibioperoneal trunk (a) treated with 4 mm × 60 mm IVL catheter with a total of 300
a
pulses (b-c). Completion angiography illustrating signi­cant luminal expansion of the treated vessels with no residual stenoses (d)
Fig. 21.18 Angiography illustrating severely calcied left iliac arterial system (a) treated with the IVL (b) alone. Completion angiography demonstrates signicantly improved ow to the left iliac arterial system (c)
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Clinical Evidence ofIntravascular Lithotripsy inPeripheral Artery Disease
The DISRUPT PAD I and II were multi-center retrospective studies of prospectively collected data to investigate the short-term safety and ef­cacy of the IVL for treating calcied, occlusive femoropopliteal lesions [51, 52]. The results showed 100% procedural success with a dra­matic reduction in stenosis severity, high acute gain, and minimal vessel injury. There were no major adverse events or revascularizations after the index procedure, and vessel patency was durable out to 6months, with primary patency rates of 82.1%. The DISRUPT PAD III RCT trial was the rst randomized controlled study comparing the outcomes of IVL and percutane­ous transluminal angioplasty (PTA) to prepare the lesions before drug-coated balloon (DCB) or stenting for occlusive femoropopliteal lesions [53]. Compared to the PTA group, the IVL group had higher procedural success and bal­loon/stent expansion with signicantly lower residual stenosis and ow- limiting dissection rates (Table21.1 and Fig.21.19). Two-year fol­low-up results revealed signicantly higher pri­mary patency in the IVL group versus PTA group (70.3% vs. 51.3%; P = 0.003) [54]. DISRUPT PAD III observational study (OS) was a prospective, non-randomized, multi-cen­ter, single-arm study conducted to assess the real-world acute performance of IVL in the treatment of calcied, stenotic peripheral arter­ies that may not qualify for inclusion in the RCT [55]. Of the 1531 lesions treated in the iliac, common femoral, supercial femoral, popliteal, and infrapopliteal arteries, 90% presented with moderate or severe calcication, with an aver­age calcied length of 115mm. The use of IVL resulted in a nal residual diameter stenosis of 24% with only 0.7% and 0.2% experiencing nal dissections (Type D–F) and perforations, respectively (Table 21.1 and Fig. 21.19). Notably, there were no instances of emboliza­tion, thrombus formation, no-reow or abrupt closure.
Table 21.1 Summary of DISRUPT PAD III RCT and OS trials
DISRUPT
PAD III RCT No. 306 (153 IVL) 1367 Vessel SFA/popliteal Iliac, CFA, SFA/
Dissection (type D-F) Perforation 0% 0.2% Embolization 0% 0% Slow ow/ no-reow Abrupt closure 0% 0% Thrombus 0% 0%
Fig. 21.19 Efcacy of IVL in reducing the residual diameter stenosis in Disrupt PAD III RCT and OS studies
0% 0.7%
0% 0%
DISRUPT PAD III OS
popliteal, Infrapopliteal
The sub-analysis of the DISRUPT PAD III OS study showed promising results in the use of IVL in calcic infrapopliteal lesions, with 100% suc­cessful IVL catheter delivery and no ow- limiting dissection, perforation, distal embolization, slow ow, no-reow, or abrupt closure [56]. The Disrupt BTK study was a prospective, non­randomized, multi-center feasibility, and safety trial composed of 20 patients (mean age
79.0±9.6years; 14 men) with Rutherford cate­gory 1 to 5 ischemia with moderate to severe cal­cied infrapopliteal stenosis treated with IVL and followed for 30 days [57]. IVL catheter delivery was successful in 95%, with a 46.5% acute reduction in percent diameter stenosis of
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target lesions, one dissection, and 2 stents placed. None of the subjects experienced thrombus for­mation, abrupt closure, distal embolization, or perforation, with no composite of major adverse events at 30days. There were no device-related complications. The results of this pilot study demonstrated that calcied, stenotic infrapopli­teal arteries can be safely and successfully treated with intravascular lithotripsy. The effect of IVL on calcic plaque under the stent strut has also been reported in the carotid, mesenteric, and lower extremity arterial systems. While IVL can modify the calcic plaque under a peripheral stent, improving stent expansion, the long-term impact of this approach will need to be examined in larger clinical studies.

Conclusion

IVL represents a promising endovascular tech­nique for limb salvage and improved outcomes in patients with calcied PAD. Clinical evidence underscores its safety and effectiveness in achiev­ing luminal gain and enhancing vessel patency with minimal risk of complications. However, further research is warranted to elucidate its long­term benets and applicability in specic patient populations.

The May–Thurner Syndrome

The May–Thurner Syndrome (MTS) is compres­sion of the left common iliac vein from the right iliac artery and vertebral body. This condition was rst described by an autopsy study per­formed by May and Thurner in 1957 [58]. The clinical condition of left iliac vein stenosis was described by Cockett [59].

Anatomy

The left iliac vein is present between the body of the lumber vertebra and the right iliac artery (Fig.21.20). This causes a physiologic stenosis
I. A. Laskowski et al.
Fig. 21.20 Left common iliac vein compression by right common iliac artery
which is very common. A CT scan study shows that 25% of asymptomatic patients have 50% ste­nosis and two-thirds of asymptomatic patients have 25% stenosis [60]. When this stenosis becomes exaggerated and causes clinical symp­toms, it is diagnosed as MTS.
Clinical Presentation
MTS is present two times more commonly in women as compared to men. MTS has two dis­tinct clinical presentations which include throm­botic vs non-thrombotic.
Patients with non-thrombotic MTS have chronic left lower extremity symptoms of venous insufciency. Nonspecic symptoms of chronic venous disease include heaviness, achiness, swelling, throbbing, and itching (HASTI Symptoms). A signicant number of patients have venous claudication which is dened as pain and stiffness of the leg with exercise and improvement with rest and elevation.
Swelling of the lower extremity is a common condition with differential diagnosis of venous insufciency, deep venous thrombosis, lymph­edema, heart failure, medications, leg injury, morbid obesity, and prolonged inactivity in a sit­ting position.
Chronic venous disease is a common disorder that has manifestations ranging from varicose veins to venous ulcerations. Chronic venous dis­ease is best classied by CEAP classication
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which includes clinical, etiological, anatomic, and pathophysiological categories. Non­thrombotic MTS patients can have concomitant lower extremity varicose veins due to primary supercial venous reux along with left iliac vein obstruction.
Thrombotic MTS occurs due to deep venous obstruction of the left iliac vein from left iliac vein stenosis. Deep venous thrombosis can occur due to a history of thrombophilia or transient risk factors such as pregnancy, surgery, prolonged immobilization, or oral contraceptive pills. Thrombotic MTS is often diagnosed with acute ileo-femoral DVT. These patients present with acute pain and swelling of the left lower extrem­ity. In more severe cases, patients can present with phlegmasia cerulea dolens. Some patients with thrombotic MTS present with chronic left ileo-femoral DVT.These patients have a history of DVT which was treated with anticoagulation in the past and have chronic post-phlebitic syn­drome. These patients have venous claudication with severe venous stasis changes in the left leg.
Multiple other conditions cause iliac vein and IVC stenosis and thrombosis. These conditions include iliac vein and IVC thrombosis due to thrombophilia; iliac vein and IVC stenosis due to congenital webs and atresia; external compres­sion due to malignancy; a catheter or IVC lter­associated stenosis and thrombosis. These conditions necessitate the same diagnostic stud­ies and often similar treatment approaches as MTS.
Imaging Studies
1. Duplex scan is the most important initial diag-
nostic study. Duplex scan for suspected patients in the vascular lab involves lower extremity duplex and iliac vein and inferior vena cava scan. A lower extremity duplex scan is useful for the diagnosis of deep venous thrombosis and deep and supercial venous reux. An inferior vena cava and iliac vein study is useful to determine any deep venous thrombosis in this segment. The extent of left iliac vein stenosis is harder to determine by duplex scan.
2. Contrast CT scan with venography has higher sensitivity and specicity to detect left iliac vein stenosis and deep venous thrombosis. CT scan is also useful to determine external causes of compression of the iliac vein by malignancy, uterine broid, lymphadenopa­thy, or hematoma.
3. Magnetic resonance venography is an alterna­tive to CT venography. This study is rarely used due to the length of time it takes to do the test as compared to a contrast CT scan.
4. Venography: Venogram of iliac veins and inferior vena cava can be done by femoral vein, popliteal vein, and jugular vein based on the treatment plan. A venogram will show severe iliac vein stenosis and occlusion; how­ever, it will miss moderate iliac vein stenosis even in multiple projections.
5. Intravascular Ultrasound (IVUS): IVUS is the gold standard for diagnosis of MTS. IVUS provides information regarding the degree and length of stenosis. This information is useful for accurate deployment of stents. It should be noted that physiologic stenosis of 50% is present in many asymptomatic patients. Treatment with iliac vein stents should be done in patients with severe symp­toms that interfere with the patient’s activities.
Treatment ofMTS
Non-thrombotic MTS often presents with lower extremity chronic venous disease. These patients are initially treated with compression stockings, leg elevation, exercise involving ambulation, and weight loss if needed. Patients are evaluated with a lower extremity venous duplex scan. Patients who have signicant saphenous venous reux and fail conservative treatment are rst treated with radiofrequency ablation of the saphenous vein. Patients who continue to have swelling of the left lower extremity undergo a duplex scan of iliac veins and IVC. These patients who have severe symptoms undergo venogram and IVUS procedures. We do a venogram for non­thrombotic patients by accessing the common femoral vein by ultrasound guidance. A 6 Fr
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Fig. 21.21 (a) Venogram showing severe common iliac vein stenosis (black arrow), White arrows showing lling of collateral veins. (b) Venogram after left common iliac vein stent placement
sheath is placed in the femoral vein, and veno­gram is performed in AP and oblique projections. Venogram generally shows patent left iliac vein and IVC with no signicant stenosis. Stenosis on venogram is only seen if it is severe (Fig.21.21a). Next 6 Fr sheath is exchanged over wire for 9 Fr sheath. IVUS is performed over 0.035 guide wire (Fig.21.22a). In patients with severe symptoms and with the presence of over 50% stenosis on IVUS, a left common iliac vein stent is placed. IVUS is useful to determine the extent of the iliac vein stent. Generally, Wallstent, Zilver Vena, or Abre stent are deployed. The diameter of the stents is 14–16 mm, and the length of stents ranges from 60 to 100mm. Extending the stent beyond the stenosis into IVC is desirable (Fig. 21.21b). Angioplasty of the iliac vein is done using a 14 to 16-mm balloon. A completion IVUS is done (Fig.21.22b). Patients are on bed rest for 2hours and then discharged home. Post­procedure patients are placed on anticoagulation for 4weeks. They are then placed on antiplatelet for 6months. Patients undergo duplex scans at 1
month and 6months to conrm the patency of the stent. This procedure has been shown to improve patient symptoms with a 4-year patency of 93% [61].
Thrombotic MTS presents with either acute ileo-femoral vein DVT or chronic ileo-femoral vein DVT.Clinical presentation and management of these two conditions differ.
Patients with acute thrombotic MTS present with severe acute pain and swelling of the left lower extremity. These patients are often unable to ambulate due to the extent of pain. Duplex scan is done which will conrm ileo-femoral vein acute DVT.The initial treatment of acute throm­botic MTS is leg elevation in the Trendelenburg position and high-dose intravenous heparin pro­tocol if the patient has no contraindication for anticoagulation. For patients who have respira­tory distress or hypoxia, a contrast CT scan of the chest is done to check for pulmonary embolism. Some patients also undergo CT venography to determine the extent of thrombosis. The patient is then booked in the angio-suite for mechanical
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ba
Fig. 21.22 (a) IVUS shows the left common iliac vein (curved arrow) and right common iliac artery (top arrow). (b) IVUS of left common iliac vein after stent
thrombectomy, thrombolysis, angioplasty, and stenting. Placement of temporary or removable IVC lters is considered in patients who have limited lung reserve due to pulmonary embolism or free-oating thrombus. Most patients do not require IVC lter placement.
In the angio-suite, patients are placed in the supine position and a duplex scan is done for patency of femoral and popliteal veins. The pro­cedure is most commonly performed under con­scious sedation; however, some patients require monitored anesthesia care or general anesthesia. We can access the left popliteal vein percutane­ously with ultrasound guidance with the patient in a supine position with the leg bent. Initially, a 6 Fr sheath is placed, and a venogram is done to a patent segment of the femoral vein. A glide wire along with a glide catheter is used to go through the thrombosed femoral and iliac vein up to IVC. Next 6 Fr sheath is exchanged over a wire for a 9 Fr sheath. We use 8 Fr Angiojet-Zelante catheters for thrombolysis and mechanical thrombectomy of femoral and iliac vein throm­bosis. Initially, a power pulse is used for throm­bolysis with up to 10mg of tissue plasminogen activator (TPA). TPA is allowed to dwell in the thrombus for 20 minutes. Next mechanical thrombectomy is done with multiple passes
through the thrombus. A repeat venogram is done to assess the extent of clearance. In some cases, clot maceration is done with repeat mechanical thrombectomy. IVUS is done to access the extent of left iliac vein stenosis, and stenting of the iliac vein is done from IVC to the distal extent of ste­nosis [64, 65].
After the procedure anticoagulation with hep­arin is continued. This is later switched to Lovenox, DOAC, or Coumadin for 6 months. The patient is also evaluated for thrombophilia and if present will need lifelong anticoagulation. This procedure has replaced catheter-directed thrombolysis in our institution which takes 1 to 2days of treatment in the intensive care and mul­tiple visits to the angio-suite.
Patients with acute thrombotic MTS can also be treated with an indigo penumbra 8 Fr suction device and an Inari 13-F ClotTriever device. ClotTriever device has the advantage that it can be used for chronic thrombotic MTS.
Chronic thrombotic MTS presents with post­phlebitic syndrome with leg pain, swelling, advanced chronic venous stasis, and venous clau­dication. These patients undergo diagnostic stud­ies including venous duplex and CT venography. Patients are initially seen in an outpatient setting and are brought to the angio-suite electively.
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ClotTriever procedure involves percutaneous access of the patent distal femoral or popliteal vein under ultrasound guidance. Initially, a 6 Fr sheath is placed and a venogram is done to access the thrombosed segment. Using a glide wire and catheter thrombosed segment of the femoral and iliac vein is crossed up to IVC. Next 13 Fr ClotTriever sheath is placed, and the funnel is deployed. Next ClotTriever catheter is placed into IVC over the guide wire proximal to the thrombus. The coring element and collection bag are opened, and the coring element is pulled back to remove the clot from the vessel wall. If resis­tance is met during thrombectomy, coring ele­ment is disengaged and re-engaged beyond the stenosis. The area of iliac vein stenosis is treated with angioplasty. After the thrombectomy, iliac stenosis is stented. The main advantage of this system is that it can treat both acute and chronic deep venous thrombosis. This system also does not require thrombolytic treatment. The results of the ClotTriever device have been outlined in the Cloud Registry which shows 91% of patients have near complete thrombectomy (determined by Marder score) with an adverse event rate of
0.2%. Patients had immediate improvement of symptoms as shown by the Villalta scale before and after the procedure [62, 63].
Patients with thrombotic MTS who are treated with iliac stents have 2-year primary assisted and secondary patency of 88 and 96% [66].
Conservative Treatment
Many patients with isolated left leg swelling and non-thrombotic MTS elect not to have interven­tional treatment. These patients are treated with compression stockings, leg elevation, and exer­cise as tolerated. Some of these patients with chronic swelling have components of lymph­edema, and they can be managed by manual lym­phatic drainage and/or venous and lymphatic pumps.
In our clinical practice, we have also treated patients with acute thrombotic MTS with long­term anticoagulation and conservative treatment. We have seen some of these patients recover with minimal sequelae. CAVENT trial [67] showed a lower incidence of postphlebitic syndrome in
patients with ileo-femoral DVT treated with catheter- directed thrombolysis (CDT) as com­pared to anticoagulation alone. ATTRACT [68] trial showed no improvement with CDT as com­pared to anticoagulation. Both of these trials were not specic for MTS and did not employ newer technology.
Patients with chronic thrombotic MTS can also be treated conservatively. These patients require anticoagulation if they have thrombo­philia or recurrent DVTs. Some patients without thrombophilia can be treated with a 6-month course of anticoagulation and then it can be stopped.
Conclusions
MTS presents with left lower extremity swelling with venous claudication symptoms. Imaging studies including venous duplex, venogram, and IVUS are useful for the diagnosis of MTS.Physiologic stenosis of the left iliac vein is common and therefore accurate diagnosis requires a combination of clinical criteria and imaging study. Patients with non-thrombotic MTS are treated with left common iliac vein angioplasty and stent placement. Patients with acute and chronic thrombotic MTS are treated with thrombectomy of the ileo-femoral segment along with iliac vein angioplasty and stent. These patients require long-term anticoagulation. Some patients with less severe symptoms can be treated conservatively.
Evaluation ofaPatient forHemodialysis Access
Hemodialysis is the most prevalent form of renal replacement therapy (RRT), with the others being peritoneal dialysis and kidney transplant. For patients receiving hemodialysis, their longevity is proportional to the quality of their dialysis, which in turn is proportional to the quality of access to their vasculature. It is important that the vascular access for hemodialysis be reliable, ade­quate to deliver prescribed dialysis, suitable to patient’s given needs, and with low complication rates. The options for vascular access include:
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1. Arteriovenous stula: a surgical connection between an artery and a vein. This is usually in the upper extremity, but can be performed in the lower extremity.
2. Arteriovenous graft: a conduit is connected between an artery and a vein. The conduit is directly accessed for dialysis.
3. Central venous catheter: a exible, double lumen tube inserted into a large, central vein.
The National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) has provided evidence-based guidelines for hemodialysis vascular access since 1996, with the most recent update being in 2019 [69].
These are commonly referred to as the “KDOQI guidelines” and form the basis for much of the decision-making regarding the care of chronic kidney disease (CKD) patients and their vascular access. The Work Group which wrote the guidelines was multidisciplinary and included nephrologists, radiologists, vascular surgeons, and vascular access nurses. While the emphasis of the previous guidelines published in 2006 was “stula rst,” an important new con­cept introduced in the most recent update is that of the End-Stage Kidney Disease (ESKD) Life-Plan.
The ESKD Life-Plan is an individualized roadmap of the patient’s vascular access needs over their lifetime. It helps prepare for, create, and preserve access for dialysis, as well as for the next vascular access before the current one fails. This considers the patient’s current and antici­pated medical, functional, and psychosocial sta­tus to determine the optimal dialysis modalities and access options. Important factors to assess include:
1. Patient goals, preferences, and life
expectancy.
2. Comorbidities and functional status.
3. Vascular anatomy and suitability for different
access types.
4. Prior access history and complications.
5. Social support and logistics.
Keeping this ESKD Life-Plan in mind, the access surgeon’s goal should be to provide the right access, in the right patient, at the right time, for the right reasons. This involves a collabora­tive process between the patient, their care part­ners, and the multidisciplinary care team. This shared decision-making approach ensures the Life-Plan aligns with the patient’s goals, prefer­ences, and values. The Life-Plan requires regular review and updates as the patient’s condition, needs, and desires can change over time.
Pre-Access Evaluation by theSurgeon
Initial evaluation of a patient for new hemodialy­sis access emphasizes physical exam.
1. Arterial. (a) Character of peripheral pulses, including
brachial, radial, and ulnar arteries.
(b) Allen test, assess adequacy of palmar
arch collateralization.
2. Venous. (a) Assess for edema, arm size, and collateral
veins which could indicate central venous obstruction.
(b) Visible, palpable veins such as cephalic
and basilic veins.
(c) Look for older, failed, previous stulas or
grafts.
3. Pump. (a) Assess for signs of heart failure.
Vein mapping should routinely be obtained. This could be performed in the ofce by the sur­geon or can be done in a peripheral vascular lab. Mapping includes vessel diameter, depths, and quality. While there is not a strict minimum vein or artery diameter on vessel mapping, arteries and veins <2 mm in diameter should undergo careful evaluation for quality and feasibility to create a functioning access. There are emerging studies that can be done to be more inclusive for traditionally excluded vessels.
KDOQI Guidelines for Access Selection