CardioVascular and Interventional Radiology

Success Rate and Complications of Sharp Recanalization for Treatment of Central

Venous Occlusions
--Manuscript Draft--

Manuscript Number: CVIR-D-17-00275

Full Title: Success Rate and Complications of Sharp Recanalization for Treatment of Central
Venous Occlusions

Article Type: Clinical Investigation

Abstract: Purpose: Evaluate success and safety of needle (sharp) recanalization as a method to
re-establish access in patients with chronic central venous occlusions. Materials and
Methods: 31 consecutive patients who underwent this procedure were retrospectively
reviewed to establish success rate and associated complications. In all cases a 21 or
22 Gauge needle was used to restore connection between two chronically occluded
segments after conventional wire and catheter techniques had failed. The needle was
guided toward a target placed through a separate access by fluoroscopic guidance.
When successful, the procedure was completed by placing a catheter, ballooning the
segment, and/or stenting. Results: The procedure was successful in 37 of the 39
patients (95%). The vast majority of the treated lesions were in the SVC and/or right
innominate vein. Occlusions ranged in length between 10-110 mm and the average
length of occluded venous segment was 40 mm in the treated group. There were four
minor (SIR classification B) complications involving pain management after the
procedure. There were two major (SIR classification D) complications. Conclusions:
Sharp recanalization is a safe procedure for patients who have exhausted standard
wire and catheter techniques. The operator performing this procedure should be
familiar with potential complications so that they can be addressed urgently if needed.

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4 Success Rate and Complications of Sharp Recanalization for Treatment of Central Venous
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7 Occlusions
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10 Shortened Title: Sharp Recan of Occluded Veins
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Article Type: Clinical Investigation
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17 Abstract:
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20 Purpose: Evaluate success and safety of needle (sharp) recanalization as a method to re-establish
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access in patients with chronic central venous occlusions. Materials and Methods: 31 consecutive
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25 patients who underwent this procedure were retrospectively reviewed to establish success rate
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27 and associated complications. In all cases a 21 or 22 Gauge needle was used to restore
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30 connection between two chronically occluded segments after conventional wire and catheter
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32 techniques had failed. The needle was guided toward a target placed through a separate access by
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35 fluoroscopic guidance. When successful, the procedure was completed by placing a catheter,
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37 ballooning the segment, and/or stenting. Results: The procedure was successful in 37 of the 39
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40 patients (95%). The vast majority of the treated lesions were in the SVC and/or right innominate
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42 vein. Occlusions ranged in length between 10-110 mm and the average length of occluded
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venous segment was 40 mm in the treated group. There were four minor (SIR classification B)
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47 complications involving pain management after the procedure. There were two major (SIR
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49 classification D) complications. Conclusions: Sharp recanalization is a safe procedure for
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52 patients who have exhausted standard wire and catheter techniques. The operator performing this
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4 procedure should be familiar with potential complications so that they can be addressed urgently
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7 if needed.
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10 Keywords:
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Venous Occlusion; Sharp Recanalization; SVC syndrome
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17 Introduction:
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20 Patients on chronic hemodialysis frequently develop central venous occlusions with a reported
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incidence of 29%[1]. Venous occlusions are associated with increased hemorrhage from the
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25 dialysis shunt after cannulation, upper extremity and facial swelling, and an increased rate of
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27 shunt thrombosis[2]. Treatment of these occlusion traditionally involves wire and catheter
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30 techniques followed by angioplasty with or without stenting. Patients who fail traditional
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32 recanalization methods have limited treatment options such as femoral catheters and grafts as
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35 well as last resort sites such as translumbar and transhepatic venous access. These options put
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37 patients at increased risk of infections and complications[3].
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Ferrell et al. first described sharp venous recanalization in 1999, restoring access in 5 patients[4].
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43 The technique involves crossing an occluded segment of the vessel with the use of a needle
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45 followed by re entry into the lumen. Standard wire and catheter techniques are used along with
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48 angioplasty and/or placement of a stent to re-establish flow. The procedure was initially
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50 performed utilizing an 18G needle, but transition was made to a smaller 21 G system.
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4 Several groups have published small case series of up to 33 such patients[5-8]. In this
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7 retrospective study we analyzed all patients who underwent sharp recanalization over a 3 year
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9 period to assess for success and safety of the procedure.
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16 Materials and Methods:
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19 This is an IRB approved retrospective study. For this type of study formal consent is not
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22 required. Thirty-nine patients were referred to interventional radiology between 5/17/2012 and
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24 2/29/2016 due to chronic occlusion of their central veins. Diagnosis was always made after
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failure of conventional techniques on a prior procedure at an outside institution. Of these
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29 patients, 36(92%) were on chronic hemodialysis with five receiving their treatments through
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31 groin access. The patients ranged in age between 29 and 81 years of age with a mean of 56 years.
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34 There was a slight majority of female patients(54%) (Table 1).
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37 All patients had a CT of the chest obtained before the procedure. The majority of the patients
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40 (thirty-five) had a contrast enhanced study (CT venogram). Four patients had a non-contrast
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42 study due to lack of IV access. In cases where the patients had a long history of femoral catheter
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access, cross sectional imaging of the abdomen and pelvis were included as well to assess for
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47 patency of lower extremity veins for additional routes of access. The information from the CT
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49 was then used to plan elements of the procedure such as initial access site, total length of
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52 occlusion, and patency of collateral pathways of drainage such as the azygos and internal
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54 mammary veins (Figure 1).
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4 On the day of the procedure the selected vein was punctured under ultrasound guidance and a
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7 venogram was obtained(Figure 2A). A repeat attempt at crossing the occluded segment with
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9 traditional catheter and wire techniques was then attempted and while there were numerous cases
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12 where conventional techniques were successful, for the purpose of this article, only cases in
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14 which the sharp recanalization had to be resorted to are being reported.
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17 Upon failure of conventional techniques, a vascular sheath was advanced as close to the site of
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20 occlusion as feasible. Next, a target was established distal to the occlusion. The target varied but
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22 was usually a balloon or snare advanced from a separate access site. Alternatively, an existing
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25 intraluminal device such as a stent or pacemaker wire was used based on the pre-procedure CT
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27 examination.
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A manually angulated 21 or 22 Gauge Chiba needle (Cook, Bloomington, IN) was used to carry
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33 out the sharp recanalization by slow advancement through the occlusion. Advancement of the
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35 needle was made with diligent attention to repeated rotation of the C-arm to obtain depth
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38 information with regards to the needle and target(Figure 2B). The patient who was receiving
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40 moderate (conscious) sedation was asked to report any new pain. It was noted early on that the
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43 patient should only have a small amount of pain in the chest at the beginning and end of the
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45 sharp recanalization when the vessel wall was being punctured.
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Once at the target, an 0.018 guidewire was advanced through the Chiba needle(Figure 2C). This
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51 wire was then advanced into the IVC for confirmation of the intraluminal location and to avoid
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53 mistaken placement in the pericardium or other structures that superimpose the right atrium and
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4 SVC on a frontal fluoroscopic projection. If difficulty was met with advancing the wire into the
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7 IVC, a snare was used from a femoral vein approach to capture the wire. In all cases, the tract
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9 was dilated with a balloon subsequently (Figure 2D).
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13 If the re-established vessel lumen demonstrated adequate flow without contrast extravasation, the
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15 procedure was terminated(Figure 2E). Stenting was undertaken when slow flow, greater than
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17 30% luminal narrowing or contrast extravasation was suspected. Alternatively, if the patient was
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20 scheduled for a Hemodialysis Reliable Outflow (HeRO) Vascular Access Device (Hemosphere
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22 Inc, Minneapolis, MN) graft a non-tunneled catheter with or without a stent was placed and the
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25 patient was transported to the OR suites the same day.
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28 Results:
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31 The procedure was successful in 37 of the 39 patients (95%). The vast majority of the treated
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34 lesions were in the SVC and/or right innominate vein. Table 2 further details lesion location.
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36 Occlusions ranged in length between 10-110 mm and were measured in 5 mm increments using
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39 the balloon markers as a tool to calibrate the images. The average length of occluded venous
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41 segment was 40 mm in the treated group.
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Indication for venous recanalization was symptomatic management in 28 of 39 patients (72%)
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47 and temporary catheter placement in 11 patients (28%). 8 covered and 14 non-covered stents
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49 were used. The stent diameter ranged from 8 mm - 14mm, and stent length ranged from 40mm to
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52 80mm.
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4 There were four minor (SIR classification B) complications involving pain management after the
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7 procedure. There were two major (SIR classification D) complications. The first, a pericardial
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9 hematoma, was noted during the procedure in a patient suffering from a groin line infection. The
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12 patient had findings of tamponade including a narrowed pulse pressure and tachycardia after re-
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14 entry into the SVC. The balloon which was previously used to dilate the tract was re-inflated to
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17 gain control of the hemorrhage and the patient stabilized allowing for discussion of the case with
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19 the cardiothoracic surgery service. A decision was made to place a pericardial drain after
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21 consultation. A drain was placed yielding 120 ml of sanguineous fluid and the patients vital
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24 signs normalized. A covered stent was placed prior to completion of the procedure with
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26 placement of a non-tunneled dialysis catheter. The patient was observed in the ICU overnight
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29 and after a capping trial, the drain was removed the following day. He was returned to the IR
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31 suite for conversion of the non-tunneled catheter to a tunneled dialysis catheter three days later.
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A second complication occurred as an indirect consequence of the procedure. After uneventful
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37 sharp recanalization and placement of a non-tunneled access for HeRO graft placement, the
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39 patient was transferred to the OR for the graft placement. Unfortunately, the patient suffered a
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42 myocardial infarction during anesthesia induction in the OR. He was given anticoagulants
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44 emergently and developed a small right hemothorax. The hemothorax remained stable after
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47 withdrawal of anticoagulation, however, since the patient needed continued anticoagulation for
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49 his infarction, he was returned to the interventional suite and a covered stent was placed. He was
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52 discharged from the hospital after 19 days.
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4 Discussion:
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8 Sharp recanalization of chronic vascular occlusions can be attempted after conventional crossing
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10 techniques have been exhausted. Our data suggests sharp recanalization is safe and effective in
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13 crossing complete occlusions of the SVC and more proximal central veins. The costs versus
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15 benefits must be weighed in each patient, but in patients with symptomatic venous occlusions
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17 such as SVC syndrome or those in which vascular access is limited, this procedure can help
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20 relieve symptoms and provide additional dialysis options.
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23 Limitations of the study include its retrospective nature and the inherent presence of a selection
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26 bias toward the right sided access for the procedure, which are shorter in length and less tortuous
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28 in their course. Other limitations include the small number of patients and the lack of direct
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comparison with other techniques, such as radiofrequency guidewire recanalization.
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34 Conclusions:
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37 Patients on long-term dialysis frequently exhaust their accesses due to poor flow and/or
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40 infection. Maintenance of upper extremity access is preferred since it is associated with fewer
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42 infections. With sharp recanalization, we have a new tool to extend or renew the use of the upper
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extremity accesses. Although practiced for over a decade, this report represents one of the largest
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47 case series published to date, demonstrating the high success rate of this procedure along with a
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4 Patients on hemodialysis with limited access will have a new route to follow with increased
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7 awareness of the safety of this procedure. This will in turn hopefully lead to decreased utilization
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8 All authors declare that they have no conflicts of interest.
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8 References:
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11 1. Lumsden AB, MacDonald MJ, Isiklar H, et al. Central venous stenosis in the
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hemodialysis patient: incidence and efficacy of endovascular treatment. Cardiovasc Surg.
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16 1997;5(5):504-9.
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18 2. Kundu, S. Central Venous Obstruction Management. Semin Intervent Radiol.
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21 2009;26(2):115-21
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23 3. Ong S, Barker-Finkel J, Allon M. Long-term outcomes of arteriovenous thigh grafts in
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26 hemodialysis patients: a comparison with tunneled dialysis catheters. Clin J Am Soc
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28 Nephrol. 2013;8(5):804-9.
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4. Farrell T, Lang EV, Barnhart W. Sharp recanalization of central venous occlusions. J
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33 Vasc Interv Radiol. 1999;10(2 Pt 1):149-54.
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35 5. Athreya S, Scott P, Annamalai G, et al. Sharp recanalization of central venous
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38 occlusions: a useful technique for haemodialysis line insertion. Br J Radiol.
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40 2009;82(974):105-8.
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43 6. Goo, Dong Erk, et al. Use of a Rosch-Uchida needle for recanalization of refractory
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45 dialysis-related central vein occlusion. American Journal of Roentgenology.
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48 2010;194(5):1352-6.
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50 7. Honnef D, Wingen M, Gnther RW, et al. Sharp central venous recanalization by means
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52 of a TIPS needle. Cardiovasc Intervent Radiol. 2005;28(5):673-6.
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4 8. Gupta H, Murphy TP, Soares GM. Use of a puncture needle for recanalization of an
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7 occluded right subclavian vein. Cardiovasc Intervent Radiol. 1998;21(6):508-11.
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7 Figure 1A. Coronal 3D reformatted image from the patient's CT venogram demonstrates
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9 numerous venous collaterals in the right chest and arm.
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14 Figure 1B. Coronal slab 3D view of the same study demonstrated the short segment occlusion at
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17 the proximal aspect of the stent (arrowhead). A small collateral (arrow) is seen to which was
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19 used as a second access to facilitate the sharp recanalization.
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24 Figure 2A. Venogram through initial access (patients dialysis graft) shows suspected area of
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26 occlusion along with several collaterals.
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31 Figure 2B. Access established through the collateral vein observed from the CT venogram
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34 (figure 1B). The needle is advanced through the existing stent to maintain an intraluminal
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36 pathway.
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41 Figure 2C. Needle has been advanced into the patent segment. This is confirmed by passage of
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43 an 0.018 wire into the right atrium
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48 Figure 2D. The tract is dilated with a 4 x 20 mm balloon (Sterling; Boston Scientific, Natick,
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51 Massachusetts) and 12 x 40 mm balloon(not shown) (Conquest; Bard Medical, Covington, GA).
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4 Figure 2E. Final venogram through the dialysis access shows rapid flow through new stent
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7 Fluency (Fluency; Bard Medical, Covington, GA), without opacification of the collaterals.
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8 Table I. Patient Characteristics
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10 Number of patients 39
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12 Sex
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14 Male 18
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16 Female 21
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19 Mean age, years 56 (range 29-81)
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21 Diabetes 20
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23 Hypertension 31
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8 Table 2. Occluded venous segment treated
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11 Left SC 1
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13 Left SC and BC 1
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15 Left BC 4
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17 Left Ax 1
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19 Right SC 2
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21 Right SCand BC 2
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23 Right BC 16
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Right Ax 1
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Right IJ and BC 2
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28 Right BC and SVC 1
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30 Ax=Axillary; BC=brachiocephalic; IJ=Internal Jugular;
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SC=Subclavian; SVC=Superior Vena Cava
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Figure 1A Click here to download Figure Figure 1A.tif
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