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1
Unidad de Radiología
Vascular-Intervencionista, Hospital Virgen de la Salud, Complejo Hospitalario
de Toledo, Avda. de Barber s/n, 45004 Toledo, Spain.
2
Servicio de Oncología
Médica, Hospital Virgen de la Salud, Toledo,
Complejo Hospitalario de Toledo, 45004 Toledo, Spain.
Received July 17, 2000;
accepted after revision February 27, 2001.
Address correspondence to C. Lanciego.
Abstract
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SUBJECTS AND METHODS. Wallstent prostheses (n = 73) of various lengths (5-14 cm; median, 7 cm) and diameters (10-16 mm; median, 16 mm) were inserted in 52 cancer patients (51 men, 1 woman; age range, 44-78 years; mean, 63 years) who were diagnosed and confirmed by cavography or phlebography as having superior vena cava syndrome. A single stent was sufficient in 37 patients, two stents were required in 11, three stents in two, and four stents in another two patients. Contraindications for the procedure were severe cardiopathy or coagulopathy.
RESULTS. Resolution of symptoms was achieved in all patients within 72 hr. At follow-up, six obstructions, one partial migration to the right atrium, two incorrect placements, and four stent "shortenings" were noted. All were successfully resolved by repeated stenting. Symptom-free survival ranged from 2 days to 17 months (mean, 6.4 months). At the time of this writing, eight patients are alive and have patent stents. The rest have died from their cancer.
CONCLUSION. The Wallstent vascular endoprosthesis is an effective initial treatment in superior vena cava syndrome of neoplastic origin. Morbidity and complications are minimal. Clinical relief of symptoms is rapid; therefore, the Wallstent endoprosthesis is highly recommended as the first choice for palliative treatment of superior vena cava syndrome, especially because the clinical decision for subsequent chemotherapy or radiotherapy or surgery is not in any way prejudiced.
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The traditional treatment has been radiotherapy, chemotherapy, or both [3]. Bypass surgery, despite being used in some centers until quite recently, is not justified because of the near-terminal status of these patients [4, 5].
Initial technical success using radiotherapy and chemotherapy does not exceed 90% in most studies, and some studies have found 46% effectiveness for radiotherapy in non—small cell tumors and 62-80% for chemotherapy in patients with small cell carcinoma [6, 7]. The use of chemotherapy and radiotherapy in combination is controversial and is under revision because of the many side effects and the low response rates (mean survival at 2 years of only 5%) [7].
Over the past 10 years, the endovascular stent has been used as an additional tool in the treatment of superior and inferior vena cava syndrome [8,9,10,11,12,13]. To date, most of the series in the literature consider the use of stents to be a coad-juvant treatment in the event of little or no response to radiotherapy or chemotherapy, or if the syndrome recurs after conventional treatment. More recent thinking, however, suggests that stents may be used as the first-line therapeutic measure in all cases because stenting does not interfere with subsequent antitumor treatments and provides urgently needed relief of symptoms; the response is immediate and spectacular, with the disappearance of symptoms within 24-72 hr (Fig. 1A,1B). Furthermore, stenting eliminates the protracted waiting time of 3-4 weeks needed to assess effectiveness when chemotherapy or radiotherapy is the first choice of treatment.
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After the first stent implantation for vena cava syndrome by Charnsangavej et al. [8] in 1986, initially in experimental animals and subsequently in 1992 in the first series of patients [9,10,11,12,13], different types of endovascular prostheses have been tried. We report here our 7-year experience with the Wallstent endoprosthesis (Boston Scientific, Schneider Europe, Bulach, Switzerland) in the palliative treatment of superior vena cava syndrome of malignant origin. The study was prospective and was undertaken jointly with the oncology department of our institution with a view to stenting being made available as an alternative to chemotherapy, radiotherapy, and surgery as the initial approach for the palliative relief of symptoms (Fig. 2A,2B,2C,2D).
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The classification of superior vena cava syndrome proposed by Stanford et al. [14] is as follows: type I, up to 90% superior vena cava stenosis with patency of the azygous vein; type II, more than 90% superior vena cava stenosis with a patent azygous vein flowing into the right atrium; type III, more than 90% superior vena cava stenosis with reversal of the azygous blood flow; and type IV, complete obstruction of the superior vena cava and one or more of the major caval tributaries. According to the classification of Stanford et al., superior vena cava syndrome in our patients was type II, type III, and type IV in 28, 13, and 11 patients, respectively.
All patients had obstruction greater than 75% of the vessel's normal caliber, but 42 (81%) of the 52 of patients had a significant network of collateral veins. To ensure proper measurement and evaluation of the degree and extent of the stenosis (as well as of the response after implantation), we used digital subtraction equipment with associated measurement software (Digitron 3D; Siemens Medical Systems, Erlangen, Germany). Because the software was automated and computerized, routine pressure readings were not considered necessary (Fig. 3A,3B,3C,3D).
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Stent Placement
Each patient gave informed consent before the procedure. All procedures
were performed with the patient under local anesthesia without sedatives or
general anesthesia. Blood pressure, electrocardiograms, and oxygen saturation
were continuously monitored. The basilic vein was used both for the
phlebocavography and for stent insertion. Access via the common femoral vein
was not necessary in any patient. In one patient we could not recanalize the
superior vena cava via the basilic vein at the level of the elbow flexure, and
the subclavian vein was successfully used instead. In the first few patients
(n = 11), between 1993 and 1994, the stents were placed bilaterally
in the right and left brachiocephalic veins. Beginning in 1995, single stents
were placed in the superior vena cava and the right innominate vein, or in the
superior vena cava and the left innominate vein, irrespective of whether the
other venous axis was affected. Table
1 summarizes the clinical data of patients with respect to single
or bilateral stenting, the number of stents and their positioning, the levels
of complications, the use of additional coadjuvant therapy, and the
effectiveness of the treatment in terms of survival.
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The Wallstent insertion technique is well established (Figs. 4A,4B,4C,4D and 5) and well described in the literature. We highlight only the slight modifications in the technique that we introduced. We used the 9-French introducer (Super-Arrow-flex set; Arrow International, Reading, PA) for the vein selected for stent insertion. The hydrophilic 0.035-inch Radiofocus guidewire (Terumo, Tokyo, Japan) was inserted and passed through the stenosis. We then used the 5-French multipurpose catheter (Angio-dynamics, Queensbury, NY) followed by an Amplatz-type rigid guide (Amplatz-Superstiff; Boston Scientific International, Watertown, MA) for the final placement of the Wallstent. No antibiotics were used. Heparin was not administered before or during the procedure, and prior balloon dilatation was not routinely used. Only 13 patients required balloon dilatation (Powerflex; Cordis Europe, Roden, The Netherlands) to create an aperture larger than the diameter of the stent selected for placement. In these patients the choice of the balloon diameter was only 1 mm larger than the normal vessel diameter. Only six patients required dilatation when the initial expansion of the stent did not equal greater than 50% of the vessel's original diameter.
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Wallstents were used in all patients and varied in length (3-8 cm) and diameter (10-16 mm). The most commonly used was 6 cm x 14-16 mm (nominal length and diameter, respectively). Of the 46 prostheses, the rolling membrane method of release was used, and the Easy System Wallstent was used for the other 27 stents. Two prostheses initially designed for biliary use were inserted to treat the complications that arose in one patient.
In 37 patients, only one stent was necessary; 11 patients received two stents, two patients received three stents, and another two patients received four prostheses.
Patient follow-up was conducted through the medical oncology department, the members of which were not involved in stent placement, thus ensuring objectivity of assessment. Severe cardiac or coagulation disorders or both were considered the only contraindications.
All patients received anticoagulation treatment. Immediately after the procedure, the patients began receiving a continuous infusion of heparin at full dosage for 1 week. Over the next 4-6 months, patients received oral anticoagulant agents in the form of derivatives of coumarin. For safety and comfort, this regimen was changed (after the 10th patient) to that of an oral antiplatelet aggregation treatment with dipyridamole in place of the coumarin type oral anticoagulants. Only two patients in this second modified phase continued to receive the older oral anticoagulant therapy because of their concomitant disorders (both had been receiving coumarin for protracted periods as a result of cardiac valve replacements).
During a 48- to 72-hr period after stent implantation, simple anteroposterior and lateral radiographs were taken of the thorax to ensure that the prosthesis was correctly positioned and expanded. Another radiograph was taken for the same purpose on the seventh day after implantation. Usually no phlebocavography was necessary during follow-up, but phlebocavography was performed to rule out possible reobstruction if signs and symptoms of a recurrence of the superior vena cava syndrome were detected.
After the endovascular procedure, all patients received their scheduled treatment of radiotherapy, chemotherapy, or only palliative care for relief of symptoms.
Evaluation of Symptom Response
Vena cava repermeability was evaluated by monitoring symptom response
(Table 2). Five signs and
symptoms were assessed: dyspnea; cervicofacial edema and edema of the upper
and lower limbs, or both; a superficial subcutaneous collateral venous
network; jugular engorgement; and headache. Because most if not all of these
symptoms are either subjective (dyspnea and headache) and nonquantifiable
(except for jugular engorgement) or objective and measurable (edema and
collateral venous network), the following point system was devised to measure
response: 0, no response; 1, partial response (incomplete disappearance of the
sign or symptom); and 2, complete response (disappearance of the sign or
symptom).
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Response was assessed at intervals of 1, 2, 12, and 24 hr and up to 2-7 days after the procedure. During these 7 days after stent placement, no other medications such as diuretics or corticosteroids were administered because these could have influenced the patient's response. Patients who had furosemide or steroids administered within 72 hr of the prosthesis implantation were excluded from the symptom evaluation. This occurred in one patient who had been inadvertently premedicated with corticoids plus diuretics 12 hr before stent implantation. This patient's data were eliminated from the symptom response evaluation (Table 2).
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After the endovascular procedure, 36 patients continued to receive the scheduled antitumor treatment: 22 patients received only chemotherapy, two received only mediastinal radiotherapy, and 12 received radiotherapy plus chemotherapy. The chemotherapy regimes most used were cisplatin plus etoposide and regimes based on anthracyclines. The radiation dose ranged between 4000 and 5000 cGy. The other 16 patients received only symptomatic relief or maintenance.
All patients were regularly monitored. Survival time after intervention averaged 6.4 months (range, 2 days—17 months) during which the patients remained symptom-free. As of September 2000, 44 patients had died in the natural course of the neoplasia, and eight were still alive with their disease but with patent stents. Those patients still alive represent a mean survival time of 3.1 months (range, 15 days—7 months).
Evaluation of symptom response (summarized in Table 2) was done by the clinical and nursing staff of the medical oncology department. The main findings were complete response in almost 80% and partial response in approximately 20% of patients with respect to jugular engorgement and collateral circulation in the first 72 hr after stenting. The headache remitted completely in 67% of patients and partially in 33% within the first 24-48 hr. The cervicofacial edema and edema of the upper limbs (which affected all patients) were the symptoms that responded best. In all patients the symptoms disappeared within 48-72 hr after implantation of the prosthesis. Dyspnea was the most resistant symptom; it remitted completely in only 39% of patients, with partial remission in 61%.
During follow-up of the 52 patients, only six obstructions of the
endoprostheses were detected (primary patency, 92%), with one patient having
partial migration of the stent with no consequences to the right atrium. In
two patients, we found poor positioning of the stent during placement (one
with an excessive angle) and four episodes of shortening of the prosthesis,
two of which occurred in the same patient. All complications were resolved by
a second intervention (secondary patency, 100%). The cases of partial
obstruction due to thrombosis (n = 2) were resolved by thrombolysis
and balloon dilatation, and one case of invasion of the mesh by the tumor (at
the fourth month) was resolved with a second coaxial prosthesis. The two cases
of total obstruction—one due to thrombosis (eighth day) and the other to
invasion by the tumor (
second month)—were also resolved with coaxial
prostheses. The patients in whom stents were shortened or poorly positioned
were also easily relieved with coaxial prostheses.
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Lung cancer is the most frequent cause of vena cava syndrome and is responsible for more than 70% of cases. Radiotherapy and chemotherapy are the standard forms of treatment; recently, a combination of the two has been proposed [7]. Symptom improvement of 75-90% has been observed by some investigators, although others have obtained less hopeful results (46% success with radiotherapy for non—small cell carcinoma and 62-80% with chemotherapy for small cell carcinoma) [6, 7]. Conventional therapies require 2-4 weeks to show effectiveness [3, 7, 16]. Further, vena cava syndrome recurs in 20-50% of situations and, at that stage, only symptomatic treatment is possible. Some investigators propose a more aggressive radiotherapy (8 Gy three times a week for 3 weeks) and have achieved responses of up to 90% [17]. However, one must consider the many complications of high-dose radiation therapy, which include tumor necrosis with concomitant fever, bleeding, and perforation of the superior vena cava. Other deleterious effects include nausea, vomiting, anorexia, skin irritation, and esophagitis. These effects on the quality of life of a patient whose life expectancy is only 6 months may be considered unacceptable and counterproductive because radiotherapy can induce fibrotic changes that further constrict the vessels. A secondary effect of radiation fibrosis is that collaterals do not develop in this scarred tissue [18]. This effect would not be surprising because radiotherapy cannot easily discriminate between tumor and adjacent normal tissue [16].
After the introduction by Charnsangavej et al. [8] of endoprostheses in dogs to treat obstruction of the vena cava, the development of endovascular stents continued, and stenting emerged as a promising new therapy during the early 1990s [19,20,21,22,23,24,25,26]. Over a period of 7 years we implanted 73 stents in 52 cancer patients. The procedure is easy to perform and was well tolerated by the patients. Complications were minimal and, in terms of symptom relief, the results were encouraging. We found 100% disappearance of facial edema and edema of the limbs, 80% remission of circulatory symptoms or those involving collateral veins and jugular vein engorgement, and effective relief of headache (present in 59% of patients) in 67% of cases within the first 24-48 hr. The only refractory symptom was dyspnea, with complete remission in 39% of cases and partial remission in 61%. Dyspnea was probably refractory because in our patients it had several causes. Atelectasis, lymphangitis, and other conditions related to the tumor, but not associated with mechanical obstruction of the vena cava, may have been decisive.
No doubts exist that these endovascular prostheses benefit patients in terms of symptom relief. However, debate continues as to whether the stent should be used de novo (i.e., before implementing radiotherapy or chemotherapy), exist as an option only if obstruction recurs, or be used after failure of radiotherapy and chemotherapy. The concept of stenting de novo has not attracted much support. However, a 1997 article by Nicholson et al. [16] appears to defend this innovative approach. That article compared the poor results of radiotherapy with those obtained with metal stents and indicated that endovascular stents might be the first choice of treatment in the initial approach to the superior vena cava syndrome. The possibility of conducting randomized, prospective comparative studies is limited. To our knowledge, only two studies [16, 27] compare the use of endovascular stents with radiotherapy. Both studies were retrospective and used small patient groups (<25 patients). Furthermore, the study by Tanigawa et al. [27] suffers from the lack of homogeneity of study group assignment and, above all, the use of the Gianturco stent (Cook Europe, Bjaeverskor, Denmark), which has many complications because its design provides less resistance and less radial expansion. These limitations have been overcome by, among others, the Wallstent, which is now the most commonly used.
The other, more complete, study, conducted by Nicholson et al. [16], emphasizes some ethical problems. For example, it would only be possible to randomize patients into two groups, one group to be treated with stent plus radiotherapy or chemotherapy and the other to be treated with radiotherapy or chemotherapy alone. Current ethical considerations would not permit a group of patients with superior vena cava syndrome to be treated by stent alone except patients who were not scheduled for radiotherapy or chemotherapy or in whom radiotherapy or chemotherapy was ineffective. Although we have considerable experience using stents to treat the symptoms of vena cava syndrome, further trials would be necessary before we could recommend stent treatment as an alternative therapy on its own. However, as shown in our series, the placement of metal stents does not interfere with the subsequent application of radiotherapy, chemotherapy, or both. We agree with Dyet et al. [21] and Irving et al. [11], who conclude that stent placement incurs a marginal increase in the overall treatment costs of these cancer patients. Considering the clear benefits in symptom relief, the procedure is fully justified for quality-of-life improvement in near-terminal and terminal patients because they have a life expectancy of only weeks or even days.
Anticoagulation treatment after stent implantation is another controversial subject. In our series we started with a regime of heparin for 3-4 days followed by anticoagulation using derivatives of coumarin for 3-4 months. However, after our experience with the first 10 patients, we used antiplatelet aggregation with dipyridamole in place of oral coumarin derivatives, mainly for patient convenience. We observed no greater problems of thrombosis with the antiplatelet aggregation therapy than we did with the anticoagulation regime; we believe that antiplatelet aggregation with ticlopidine or even aspirin may be sufficient as a prophylactic measure [28].
With respect to whether to use one prosthesis for each of the two venous brachiocephalic trunks or only one prosthesis to induce trunk repermeability, we initially (1993-1995) used Wallstents of 12-14 mm placed bilaterally. We soon discovered that a single 16- or 14-mm Wallstent placed via a brachiocephalic vein into the superior vena cava relieved the most distressing symptoms rapidly and allowed existing collateral veins on the nonstented side to drain more effectively, thereby reducing swelling. Table 1 shows that the group of patients treated with bilateral venous stents presents a higher incidence of complications with a slightly lower survival despite receiving more coadjuvant therapy. Nicholson et al. [16] arrived at exactly the same conclusion. In our study, we had no incidents of bilaterally placed stents obstructing each other. If the tandem placement is well positioned with sufficient distal separation between the extremes, the improved aperture on the superior vena cava can favor patency and the maintenance of the stent's position.
Another technical question recently raised by Miller et al. [29] is that of the best route for stent insertion. Classically, the route has been via the femoral vein, but these authors proposed the subclavian vein as being simpler. However, in our experience the basilic vein at the flexure of the elbow is effective, not only in the diagnostic procedure but also for the stent insertion. This route carries minimal trauma for the patient, and we have not had any complications such as thrombosis.
The survival time of our patients after the procedure was slightly longer than 6 months (mean, 6.4 months), and our results show equivalency with those of other authors [16, 28,29,30,31]. However, as we stated previously, a short life expectancy is not a contraindication for implanting the prosthesis. On the contrary, because the stent offers significant symptomatic relief, withholding it would seriously affect the patient's end-stage quality of life.
Finally, the existing literature seems to show no significant difference between the Gianturco Z stent, the Palmaz stent (Johnson & Johnson, Warren, NJ), and the Wallstent with respect to symptom response or with respect to the frequency of associated complications [19, 30,31,32]. Nevertheless, in our experience the Wallstent is superior for use in these locations because of its greater adaptability to the curves of the vessels and its ease of handling. However, this is a personal choice; the complications recorded in our study were similar to those cited by other researchers [16, 28, 33].
In conclusion, over a protracted period our results with endovascular stents in the initial treatment of superior vena cava syndrome of malignant cause are excellent. The most dramatic aspect is the immediate relief of symptoms. The immediate and short-term complications that can arise are minimal and easily resolved. Other forms of treatment, such as radiotherapy and chemotherapy, either fail to achieve an equivalent effect or take much longer, which, for these patients with a short life expectancy, adversely affects their quality of life for whatever little time remains. Percutaneous implantation of vascular endoprostheses appears fully justified in terminally ill patients (irrespective of their life expectancy) because of the rapid disappearance of clinical symptoms. Furthermore, because the implant does not interfere with subsequent conventional antitumor treatments, the endoluminal stent should be the initial therapeutic option.
Acknowledgments
We thank the nursing and auxiliary staff of the
Vascular—Interventional Radiology Unit and the Oncology Department,
without whose constant help and dedication to patient care this study would
not have been possible. Editorial assistance was by Peter R. Turner of
t-SciMed (Reus, Spain).
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