Kidney international, Vol. 51(1997), pp. 277—280
Stenting of central venous stenoses in hemodialysis patients: Long-term results VOLKER MlcIaEy, JOHANNES GORICH, NORBERT RILINGER, MARTIN STORCK, and DIETMAR ABENDROTH Department of Thoracic and Vascular Surgery, Department of Diagnostic Radiolo, University of U/rn, U/rn, Germany
Stenting of central venous stenoses in hemodialysis patients: Longterm results. From November 1992 through July 1996, 15 Wallstents
tioning access fistula which had been created two months to seven years prior to onset of symptoms. Eleven patients presented with were implanted for the treatment of symptomatic central arm vein massive arm swelling, two suffered from additional unilateral face obstructions in 14 hemodialysis patients (10 subclavian, 2 brachiocephalic vein stenoses, 2 subclavian vein occlusions). There were no acute complications. Al! patients were investigated by clinical examination and color-
swelling, and the last had arm swelling and localized graft
infection. All patients had chronic obstructions. Symptoms had
duplex sonography at regular three month intervals. When recurrent
lasted for two months to two years before treatment. In one
swelling predicted restenosis, phlebography was also performed. During the follow-up, high grade stenoses at the central or peripheral ends of four stents were successfully treated with five overlapping stents, giving a total of 20 Wallstent' implantations. Complete occlusion of another subclavian vein distally to the stent at 16 months required ligation of the patient's arteriovenous fistula. Life table analysis including all 20 stents revealed a cumulative primary one year (two year) stent patency of 70% (50%). The cumulative secondary one year (two year) stent patency was 100% (85%). We believe that in hemodialysis patients, PTA plus Walistent" implantation is a safe and effective procedure in the treatment of central venous
patient, an unsuccessful PTA at another institution had preceded stenting by four weeks. Venous pathology was visualized by transhrachial fine needlearteriovenography in DSA technique (Fig. 1A) immediately before intervention. Then all patients received 5000 IU heparin i.v. All stents were placed via a transfemoral route to avoid unnecessary trauma to peripheral arm veins. Guide wire passing of tight, kinking stenoses, however, sometimes had to be facilitated by rendezvous maneuvers with additional upper arm access. Two short occlusions were reopened with rotating devices (Rotacs' catheter, Fig. 1B) [13]. Only extremely tight stenoses were predilated to allow for passage of the stent equipment. After placement all stents had to be dilated with high-pressure balloons to achieve complete opening within the fibrotic venous strictures (Fig. 1C). Over-dilation of adjacent vein segments was strictly avoided. After stenting a PYT of 60 seconds to 90 seconds was
stenoses and even short occlusions. Consequent follow-up allows for timely diagnosis and treatment of restenoses, thus guaranteeing long-term patency rates comparable to those of veno-venous bypass surgery.
Stenoses and occlusions of central arm veins frequently occur
after repeated or prolonged catheterization for hemodialysis access [1, 2], especially, if the subclavian vein was used for access [3], and following catheter-associated infection [4]. If the draining vein of a functioning shunt is obstructed, extreme venous hyper-
maintained for three days by a continuous heparin infusion.
Patients were advised to take 100 mg acetylsalicylic acid a day tension with pain, incapacitating swelling, and ulceration may throughout the study period. All patients were investigated by clinical examination and occur [5, 6]. Surgical treatment (patch angioplasty or bypass procedures) may be hazardous in these often multimorbid pa- color-duplex sonography at regular three month intervals. When tients [7, 8]. Percutaneous dilation (PTA) is less invasive, however, recurrent swelling predicted symptomatic restenosis, phlebograthe long-term results are disappointing [9—12]. We therefore phy was also done. Whenever indicated interventional redo combined PTA with implantation of flexible, self-expanding stents
procedures were performed giving a total of 20 Wallstent''
(PTA+S).
implantations. Cumulative primary and secondary patency rates including all 20 stents were estimated by life table analysis [14] according to the recommendations of the International Consensus Committee on Chronic Venous Disease [15].
Methods From November 1992 through July 1996, 15 Wallstents"' were implanted for treatment of symptomatic central arm vein obstructions in 14 hemodialysis patients (10 suhclavian, 2 brachiocephalie
Results
vein stenoses, 2 subclavian vein occlusions). All patients had a history of repeated or prolonged subclavian vein catheterization Stent placement with complete opening was achieved in all for hemodialysis access. All obstructions were central to a func- cases. Besides local pain during dilation and minor hematomas at puncture sites, there were no procedure-related complications,
not even during the Rotacs"' maneuvers. All patients were Received for publication April 30, 1996 and in revised form August 16, 1996 Accepted for publication August 18, 1996
© 1997 by the International Society of Nephrology
completely free of symptoms within 24 to 48 hours after treatment. Arteriovenous (av) fistulae and grafts were used for hemodialysis after the procedure when indicated. There were no signs or symptoms of shunt dysfunction or recirculation. The localized
277
278
Mickley et al: Stenting and stenoses in hemodialysis
A
recurred in five patients (with 6 stents) after 3, 6, 7, 10, and 16 months, respectively. Complete visualization by color-duplex sonography was possible in only 10 of 20 stents. In these patients, repeat investigations during the study period revealed only a smooth neo-intima with no areas of stenosis within the stents. In three patients out of five with recurrent swelling, however, venous obstructions (2 high grade stenoses, I complete occlusion) were detected in peripheral vein segments adjacent to the widely patent stents. Phlebography was done in all five patients with recurring complaints. Ultrasound
findings were confirmed in the three cases with complete sonographic visualization of the stents. In two additional patients their very central stents could not completely be examined by sonography for anatomical reasons. These stents were also widely patent. Stenoses were located in vein segments close to the central ends of the stents. High grade stenoses at the central or peripheral ends of four stents were successfully treated with five overlapping stents. Complete occlusion of a subclavian vein distally to the stent at 16 months required ligation of the patient's av-fistula after unsuccessful interventional treatment. Life table analysis of all 20 Wallstents implanted so far (Fig. 2) gave a cumulative primary one year (two year) stcnt patency of 70% (50%). Cumulative secondary one year (two year) patency was 100% (85%).
B
•1; • C
Comment Typical clinical findings in subclavian vein obstruction are arm swelling and development of widespread subcutaneous venous collaterals around the shoulder and the upper thoracic aperture. Especially when the draining vein of a functioning av-fistula is stenosed, massive venous hypertension with pain and peripheral ulceration may develop [1, 2, 5]. Strictures of the central subclavian or inriominate vein may cause additional unilateral swelling of breast, face, and neck [16].
Before treatment exact delineation of venous pathology is indispensable. For this indication, color-duplex ultrasound is of
limited value, because neither the innominate vein nor the proximal third of the subclavian vein can be visualized with this technique [17]. Phlebography is still felt to be the gold standard for diagnosis of upper extremity venous stenoses and occlusions
[15]. In our study, sonographic pre-treatment localization of central venous strictures was not attempted. Color-coded ultra-
sound was used for follow-up examinations of stented vein Fig. 1. A. Complete occlusion of left subclavian vein 18 months after
creation of proximal cimino-fistula. Extensive collaterals around left shoul-
der and left upper thoracic aperture owing to functioning av-fistula. Guidewire already passed the occlussion. B. Transbracial RotacsTM maneuver necessary to allow for introduction of balloon catheter. C. Collaterals vanish immediatley after successful PTA and WallstentTM implantation.
segments. Only half of the stents could be completely visualized, and only three out of five restenoses were seen. In these few cases, sonographic findings were completely confirmed by arteriovenog-
raphy. The other stents and restenoses were at least in part located deep in the mediastinal part of the subclavian and
innominate veins beyond ultrasound accessibility. In these patients clinical diagnosis of restenosis was based solely on recurrent arm (and face) swelling, and was also confirmed by arteriovenography. Transbrachial fine needle-arteriovenography in DSA tech-
nique always allowed an exact delineation of the site and exten-
graft infection healed after excision of the infected prosthetic
sion of all obstructions as well as of important collaterals.
segment.
Therefore, interventional therapy could immediately follow a
Four patients died (3 from complications of their coronary artery disease, 1 from unexplained scpticemia) after 7, 8, 15 and
24 months, respectively, with patent stents. All other patients could be followed up during the whole study period (from 1 month to 3 years, median 9 months). Arm or face swelling
radiological diagnosis.
There are several options for the treatment of venous hypertension due to outflow obstruction of functioning hemodialysis access. Fistula ligation [5, 6] is the least invasive as well as the most frustrating operation, as the vascular pathology causing the
279
Mickley et al: Stenting and stenoses in hemodialysis
N=5
N=9
N=20 100%
80% 60%
40% 20%
Fig. 2. Cumulative primaly (LI) and sccondaiy
___________________________________________________________________________________ • patency of central venous stents in I I I
0%
0
3
6
9
12
18
15
Table 1. Primary one and two year patency rates of PTA, PTA + Wallstent rS, implantation, and surgery for central venous stenoses in
hemodialysis patients
Author PTA
________ [Referencel Glanz, 1987 [9] Wisselink, 1993 [12]
Surgery
#
30 15
10 26
Money, 1995 [281
19 13
Vorwerk, 1995 [29] Mickley, 1996 Wisselink, 1993 [12]
24
hemodialysis patients. Symbol I represents standard deviations.
expandable Palmaz stent [30], however, have recently been reported to allow for primary one year (two year) patency rates of
60% to 71% (60%) thus almost resembling the results after
Patient
Quinn, 1995 [281 Money, 1995 [281
PTA + Wallstent" Shoenfeld, 1994 [30]
21
27 14 13 13
12
24
Months Months 35% 36% 12% 7% 68% 71% 60% 70% 86%
10%
0%
60% 50% 66%
surgical correction [12, 28] of central venous stenoses (Table 1).
After demonstrating the favorable results of PTA+S when compared to PTA alone for postoperative central venous strictures [24], we started this prospective study in hemodialysis patients. Ten subclavian and two innominate vein stenoses and two subclavian vein occlusions were treated by immediate Wallstent implantation. Only in one patient, stenting was performed four weeks after unsuccessful PTA at another institution. During
the study period, another four patients with central venous
occlusions were operated on. Three of them presented with long 80% Money, 1995 [28] ______ subclavian vein occlusions that could not be recanalized percutaSome of the stenoses in this study were treated with Palmaz stents neously. In these cases an extra-anatomical axillary-to-internal jugular vein bypass graft was implanted. In the fourth patient, bilateral subclavian vein and superior vena caval occlusion repatients problem is not corrected. The respective extremity is thus quired construction of a subclavian artery-to-right atrial access rendered unsuitable for further shunt operations. Patch angio- graft [31]. plasty of a subclavian or innominate vein as well as orthotopic Our results confirm the earlier communications quoted above. bypass surgery [7, 8] makes clavicular or sternal osteotomy (and The Wallstent has some mechanical advantages over alternative general anesthesia) necessary and is therefore burdened with stent models that should be mentioned. It is flexible even when significant morbidity and even mortality in these chronically ill constrained on the delivery catheter, so that it can safely be used and often rnultimorbid patients. Extra-anatomical bypass (such as in a tortuous stenosis once a guide wire has been properly subclavian-to-jugular [18, 19]) is less distressing to the patient; positioned. During placement the stent will attach closely to the however, another central vein is lost for further access. In vessel wall by its own elasticity thus preventing later dislocation. consequence, non-operative, interveritional procedures that are The large but unpredictable extent of stent shortening during
appropriate to obtain and maintain central venous patency in
delivery, however, may cause some difficulty with respect to the exact positioning of the proximal end of the Wallstent'. Innomstantiating the chronic nature of their stenoses and occlusions. mate vein stenoses close to the confluence therefore should be stented via an upper extremity venous approach. If cannulation of Therefore, thrombectomy, thrombaspiration, or thrombolysis an arm vein has to be avoided in order not to further compromise alone are not likely to sufficiently restore venous patency. In selected cases with evidence of fresh thrombi causing total the outflow tract of a functioning hemodialysis access, transfemoobstruction of a former fihiforme venous stricture, however, ral implantation of a Palmaz stent should he considered [30]. During stent implantation patients were anticoagulated with thrombolysis may help to re-establish the stenosed lumen to allow hemodialysis patients have been investigated. Most of the patients present with long lasting symptoms sub-
heparin. From the first post-interventional day on, they were hemodialysis patients has been reported since the early 1980s [9, advised to take 100 mg acetylsalicylic acid a day. The same 11, 21—23]. Because of frequent restenoses arid occlusions, how- medication has been recommended by others [29]. However, ever, one year primary patency of PTA alone is less than 40% there are no reliable data on the possible value of acetylsalicylic
for additional PTA [201. PTA of central venous stenoses in
(Table 1). To reduce the number of reintervcntions, stent implan- acid or of vitamin K-antagonists to maintain long-term patency of
tation was added to PTA by different investigators [24—271. central venous stents, as comparative studies are lacking. L.ong-term results after implantation of Gianturco stents into In hemodialysis patients, PTA plus Wallstenr implantation is central veins of hemodialysis patients are not better than PTA a safe and effective procedure in the treatment of central venous [10]. The self-expandable Wallsten(' [28, 29] and the balloon- stenoses and even short occlusions. Consequent follow-up allows
280
Mickley et at: Stenting and stenoses in hemodiaiysis
for timely diagnosis and treatment of restenoses thus guarantee-
ing long-term patency rates comparable to those of surgery. Veno-venous bypass implantation should therefore be restricted to long venous occlusions.
15. PORTER JM, MONETA GL: Reporting standards in venous disease: An update. J Vase Surg 21:635—645, 1995 16. GADALLAI-J MF, EL-SHAHAWY MA, CAMPESE VM: Unilateral breast
enlargement secondary to hemodialysis arteriovenous fistula and subelavian vein occlusion. Nephron 63:351—353, 1993 17. HAIKU WD, LYNCH TG, LIEBERMAN RP, LUND GB, EDNEY JA: Utility
Reprint requests to Volker Mickley, M.D., Department of Thoracic and Vascular Surgety, University of Ulm, Steinhoeveistr. 9, D-89075 Vim, Germany.
of duplex ultrasound in the diagnosis of asymptomatic catheterinduced subelavian vein thrombosis. J Ultrasound Med 10:493—496, 1991
References 1. BARRETt N, SPENCER S, MCIv0R J, BROWN EA: Suhclavian stenosis:
a major complication of subelavian dialysis catheters. Nephroi Dial Transplant 3:423—425, 1988 2. SPINOWITZ BS, GALLER M, GOLDEN RA, PASCOFF JH, SCHECIITER L, HELD B, CHARYTON C: Subelavian vein stenosis as a complication of
subclavian catheterization for hemodialysis. Arch mt Med 157:305— 307, 1987 3. BAMBAUER R, INNIGER R, PIRRUNG KJ, SCHIEL R, DAHI,EM R: Complications and side effects associated with large-bore catheters in the subclavian and internal jugular veins. Artif Org 18:318—321, 1994 4. HERNANDEZ D, DIAZ F, SURIA 5, MACHADO M, LORENZO V, LOSADA M, GONZALEZ-POSADA JM, DE BONI5 E, DOMINGUEZ ML, RODRIGUEZ AP, TORRI::S A: Subclavian catheter-related infection is a
major risk factor for the late development of subclavian vein stenosis. Nephrol Dial Transplant 8:227—230, 1993 5. MCNALLY PG, BROWN CB, MOORHFAD PJ, RAFTERY AT: Unmasking
of subclavian vein obstruction following creation of arteriovenous fistulae for haemodialysis. A problem following subclavian line dialysis? Nephrol Dial Transplant 1:258—260, 1987 6. STONE Wi, WALL MN, POWERS, TA: Massive upper extremity edema with arteriovenous fistula for hemodialysis. Nephron 31:184—186, 1982 7. DUNCAN JM, BALDWIN RT, CARAI.IS JP, COOLEY DA: Suhelavian vein
to right atrial bypass for symptomatic venous hypertension. Ann Thorac Surg 52:1342—1343, 1991 8. MOoRE WM, HOLLIER LH, PICKET1 TK: Superior vena cava and central venous reconstruction. Surgery 110:35—41, 1991 9. GLANZ S, GORDON DH, BUTt KMH, HONG J, LIPKOWITZ GS: The
18. CURRIER CB, WIDDER 5, AI,I A, KuusIsTo E, SIDAWY A: Surgical
management of suhclavian and axillary vein thrombosis in patients with a functioning arteriovenous fistula. Surgery 100:25—28, 1986 19. HANSEN B, FEINS RS, DETMER DE: Simple extra-anatomic jugular vein bypass for subclavian vein thrombosis. J Vase Surg 2:921—923, 1985 20. NEWMAN GE, SAEED M, HIMMELSTEIN 5, COHAN RH, SCHWAB SJ:
Total central vein obstruction: Resolution with angioplasty and fibrinolysis. Kidney mt 39:761—764, 1991 21. GLANZ S, GORDON D, BUTr KMH, HONG J, ADAMSON R, SCI,AFANI
SJA: Dialysis access fistulas: Treatment of stenoses by transluminal angioplasty. Radiology 152:637—642, 1984 22. INGRAM TL, REID SH, TISNADO J, CHO SR, POSNER MP: Percutane-
ous transluminal angioplasty of brachiocephalic vein stenoses in patients with dialysis shunts. Radiology 166:45—47, 1988 23. STALTER KA, STEVENS GF, STERLING WA: Late stenosis of the subelavian vein after hemodialysis catheter injury. Surgery 100:924— 927, 1986 24. MICKI.EY V, FRIEDRICH JM, RILINGER N, STORCK M, ABENDROTH D:
PTA plus stent implantation versus PTA alone for central venous stenoses. Vase Surg 28:505—511, 1994 25. EL5ON JD, BECKER GJ, WHOLEY MH, EURMAN KO: Vena caval and
central venous stenoses: Management with Palmaz balloon-expandable intraluminal stents. J Vase Intereent Radio! 2:215—223, 1991 26. ROUSSEAU H, MORFAUX V, JOFFRE F, THAT HT, GOUDABLE C,
BARTOLI P, YONG MY: Treatment of hemodialysis arterio-venous fistula stenosis by percutaneous implantation of new intravascular stent. J intervent Radio! 4:161—167, 1989
role of percutaneous angioplasty in the management of chronic 27. VORWERK D, GUENTHER RW, BOHNDORF K, KISrI.ER D, HANDT 5, hcmodialysis fistulas. Ann Surg 206:777—781, 1987
10. QUINN SF, SCHUMAN ES, DEMLOW TA, STANDAGE BA, RAG5DALE
JW, GREEN GS, SHELEY RC: Percutaneous transluminal angioplasty
versus endovascular stent placement in the treatment of venous stenoses in patients undergoing hemodialysis: Intermediate results. J Vase Intervent Radioi 6:851—855, 1995 11. SCHWAB SJ, QUARLES D, MIDDLETON JP, COnAN RH, SAEED M, DENNIS VW: Hemodialysis-associated subelavian vein stenosis. Kidney mt 33:1156—1159, 1988 12. WISSELINK W, MONEY SR, BECKER MO, RICE KL, RAMEE SR, WHITE CJ, KAZMIER FJ, HOLLIER LH: Comparison of operative reconstruc-
tion and percutaneous balloon dilatation for central venous obstruc-
MANN H, SIEHERTH HG: Perkutane vaskulaere Endoprothesen bei Verschluessen oder Stenosen von Haemodialysc-Shunts. Dtsch Med Wschr 115:43—47, 1990 28. MONEY 5, BHATIA D, DAHARAMSY 5, MULINGTAPANG R, SHAW D,
RAIIEE 5: Comparison of surgical by-pass, percutaneous balloon dilatation (PTA), and PTA with stent placement in the treatment of central venous occlusion in the dialysis patient. One year follow-up. (abstract) IntAngiol 14:176, 1995 29. VORWERK D, GUENTHER RW, MANN H, BOHNDORF K, KEULERS P,
AI.ZEN G, SOHN M, KI5TLER D: Venous stenoses and occlusion in
hemodialysis shunts: Follow-up results of stent placement in 65
femorale Rekanalisation mit einem langsam rotierenden Kathetersys-
patients. Radiology 195:140—146, 1995 30. SIIOENFELD R, HERMANS H, NOvICK A, BRENER B, CORDERO P, EIsLNHUD D, MODY 5, GOLDENKRANZ R, PARSONNET V: Stenting of
tent Akt Radio! 3:295—297, 1993 14. RUTHERFORD RB, FLANIGAN DP, GUI'rA SK, JoIINRIIN KW, KAISMODY A, WHITTEMORE AD, BAKER iD ERNST CB, JAMIUSON C,
31. MICKIFY V: Suhclavian artery4o-right atrial haemodialysis bridge
tion. Am J Surg 166:200—205, 1993 13. SCHOLZ A, SCHUBEUS P, LANGER R, LANGER M, FELIX R: Primaere
MImIA S: Suggested standard for reports dealing with lower extremity ischemia. J Vasc Surg 4:80—94, 1986
proximal venous obstructions to maintain hemodialysis access. J Vase Surg 19:532—539, 1994
graft for superior vena eaval occlusion. Nephrol Dial Transplant 10:1361—1362, 1996