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Endovascular Stenting as the First Step in the Overall Management of Malignant Superior Vena Cava Syndrome

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AJR:193, August 2009 549 exceeds 90%. It is common to observe 46% efficacy for RT in non–small cell lung carci- noma (NSCLC) and 62–80% for chemother- apy in patients with small cell lung carcino- ma (SCLC) [6, 7]. The use of chemotherapy and RT in combination is controversial and is currently under revision because of the many side effects and the low response rates (mean survival at 2 years = 5%) [7]. Placement of endovascular stents to man- age SVC syndrome and inferior vena cava
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  AJR:193, August 2009 549 exceeds 90%. It is common to observe 46% efficacy for RT in non–small cell lung carci-noma (NSCLC) and 62–80% for chemother-apy in patients with small cell lung carcino-ma (SCLC) [6, 7]. The use of chemotherapy and RT in combination is controversial and is currently under revision because of the many side effects and the low response rates (mean survival at 2 years = 5%) [7].Placement of endovascular stents to man-age SVC syndrome and inferior vena cava syndrome has been used over the past 15 years as an additional tool for the palliative treatment of these patients [8–14]. To date, most of the patient series described in the lit-erature consider the use of stents to be a co-adjuvant treatment with RT or chemotherapy if there had been little or no response to RT or chemotherapy or if the clinical syndrome recurred after conventional treatment.Earlier this decade, however, some investi-gators suggested that stents may be used as the Endovascular Stenting as the First Step in the Overall Management of Malignant Superior Vena Cava Syndrome Carlos Lanciego 1 Cristina Pangua 2 Jose Ignacio Chacón 2 Javier Velasco 1 Rafael Cuena Boy 3 Antonio Viana 4 Sara Cerezo 5 Lorenzo García García 1 Lanciego C, Pangua C, Chacón JI, et al. 1 Interventional Radiology Unit, Department of Radiology, Hospital Virgen de la Salud, Complejo Hospitalario de Toledo, Avda. de Barber 30, 45004 Toledo, Spain. Address correspondence to C. Lanciego (clanciego@eresmas.com). 2 Servicio de Oncología Médica, Complejo Hospitalario de Toledo, Toledo, Spain. 3 Unidad de Investigación-Estadística of the Hospital Virgen de la Salud, Complejo Hospitalario de Toledo, Toledo, Spain. 4 Servicios de Oncología Médica del Hospital de Talavera, Toledo, Spain. 5 Hospital La Mancha Centro-Alcázar de San Juán, Ciudad Real, Spain. Vascular and Interventional Radiology ã Original Research AJR   2009; 193:549–5580361–803X/09/1932–549© American Roentgen Ray Society S uperior vena cava (SVC) syndrome is caused by obstruction of the flow of venous blood from the up-per body into the right atrium. In 95% of the cases, the obstruction is due to an underlying malignant disease, usually ad-vanced-stage lung cancer. Obstruction of the SVC causes congestion and edema of the face and upper thorax [1, 2]. Other symptoms are often associated with the disorder such as dys-pnea, dysphagia, cognitive dysfunction, and se-vere headache. These symptoms result from cerebral venous hypertension that can arise due to blockage of the venous blood flow return.The traditional treatment for SVC syn-drome has been radiation therapy (RT), che-motherapy, or both [3]. Bypass surgery, de-spite having been used in some centers until recently, is not justified because SVC syn-drome is not a terminal disease [4, 5].Initial technical success using RT and che-motherapy to manage SVC syndrome rarely Keywords:  endovascular stenting, hemodynamics, lung cancer, oncologic imaging, stents, superior vena cava syndromeDOI:10 . 2214/AJR.08.1904Received October 3, 2008; accepted after revision January 15, 2009. OBJECTIVE.  Self-expandable metal stents were inserted in cancer patients with superior vena cava (SVC) syndrome to assess their effectiveness as a primary treatment for symptom relief. SUBJECTS AND METHODS.  Between January 1993 and June 2008, Wallstent pros-theses ( n = 208) were inserted in 149 cancer patients (137 men, 12 women; median age, 65 years; age range, 44–84 years) diagnosed as having SVC syndrome. A single stent was suf-ficient to restore vessel patency in 102 patients, two stents in 36, three stents in 10, and four stents in one. Survival data were calculated using Kaplan-Meier curves and multivariate anal-ysis using the Cox regression method. RESULTS.  Complete resolution of symptoms was achieved in 123 patients within 72 hours, partial resolution in 22 patients, and no response in only four patients. At follow-up, 30 complications were noted: 16 obstructions, four cases of thrombosis, one partial stent mi-gration to the right atrium, two cases of incorrect stent placement, six stent “shortenings,” and one case in which stent expansion was insufficient. All complications except two were successfully resolved by repeat stenting or by angioplasty. The median symptom-free sur-vival was 6 months (range, 2 days–43 months). As of June 2008, eight patients were alive with patent stents. CONCLUSION.  The Wallstent vascular endoprosthesis is an effective initial treatment in patients with SVC syndrome of neoplastic srcin: Morbidity and complications are mini-mal, and clinical relief of symptoms is very rapid. Because the clinical decision for subse-quent elective chemotherapy or radiation therapy is not prejudiced, stenting is a very effective initial step in the overall palliative treatment of patients with SVC syndrome. Lanciego et al. Endovascular Stenting to Manage SVC SyndromeVascular and Interventional RadiologyOriginal Research    D  o  w  n   l  o  a   d  e   d   f  r  o  m   w  w  w .  a   j  r  o  n   l   i  n  e .  o  r  g   b  y   1   0   3 .   1   0 .   6   4 .   2   7  o  n   0   5   /   1   4   /   1   3   f  r  o  m    I   P  a   d   d  r  e  s  s   1   0   3 .   1   0 .   6   4 .   2   7 .   C  o  p  y  r   i  g   h   t   A   R   R   S .   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y  ;  a   l   l  r   i  g   h   t  s  r  e  s  e  r  v  e   d  550 AJR:193, August 2009 Lanciego et al. first-line therapeutic measure in all patients with SVC syndrome because stenting does not interfere with subsequent antitumor treat-ments. Also, the stent provides urgent relief of symptoms [15–17], the response is imme-diate and spectacular, and symptoms are al-leviated within 24–72 hours after placement. Further, if chemotherapy, RT, or both are the first-choice treatment of symptom relief, the protracted waiting time of 3–4 weeks to as-sess treatment effectiveness is eliminated.We report our 15-year experience with the Wallstent endoprosthesis (Boston Scientif-ic) in the palliative management of SVC syn-drome of malignant srcin. The database was prospective and undertaken jointly with the oncology departments at our institution and two other hospitals that work closely with our referral center unit. The objective of the data-base is to make stent placement available as an alternative to chemotherapy, RT, or surgery as the initial approach for the palliative relief of symptoms caused by SVC syndrome. Subjects and Methods All procedures used in the study were in accord with good clinical practice and were approved by our hospital’s clinical review board.Between January 1993 and June 2008, 208 stents were implanted for the treatment of 149 cancer patients with SVC syndrome. The study group included 137 men and 12 women, all of whom had a clinical diagnosis of SVC syndrome confirmed by phlebocavography; the median age was 65 years (range, 44–84 years). The causes of SVC syndrome were mainly lung cancer: SCLC, also known as “oat cell carcinoma,” in 49 patients and NSCLC (epidermoid lung carcinoma or ade-nocarcinoma) in 78 patients. Mediastinal adenop-athy resulted from different tumors in 19 other pa-tients: sarcoma of the uterus in one, breast cancer in eight, esophageal carcinoma in one, larynx car-cinoma in two, cervical carcinoma in four, renal carcinoma in two, and carcinoma of the penis in one. There was one case of mesothelioma and two cases of double tumor (laryngeal and NSCLC) presenting together. The degree to which large thoracic veins were involved was highly variable; according to the classification of Stanford et al. [18], types I, II, III, and IV were noted in 14, 60, 41, and 34 cases, respectively. Stent Placement Technique The Wallstent insertion technique is well es-tablished and well described in the literature. We highlight only the slight modifications to the tech-nique that we have introduced. We used a 9-French introducer (Super Arrow-Flex set, Arrow Interna-tional) for the vein selected for the route of stent insertion. A hydrophilic 0.035-inch guidewire (Ra-diofocus, Terumo) was inserted and passed through the stenosis. We then used a 5-French catheter (Multipurpose catheter, AngioDynamics) followed by an Amplatz-type rigid guide (Amplatz-Super stiff, Boston Scientific) for the final placement of the Wallstent. No antibiotics were administered. Heparin was administered IV during the procedure as a single bolus of between 3,000 and 5,000 IU. After the deployment of the stent, the angiographic end point of success was when the vessel steno-sis was resolved; this change was accompanied, in most cases, by an evident decrease in the collateral venous network (Fig. 1).Only 14 cases required balloon dilatation (Pow-erflex, Cordis) before stent placement and 43 cases required dilatation after stent placement when the initially placed stent did not achieve a widening of > 50% of the vessel’s srcinal diameter.Wallstents were used in all cases and varied in length (3–8 cm) and diameter (10–16 mm). The most commonly used Wallstent was 6 cm × 14–16 mm (nominal length and diameter, respective-ly). For 75 prostheses, the easy system method of release was used and the uni system was used for the other 71 stents. Three prostheses initially designed for biliary use (shorter with a narrow-er bore) were inserted to treat complications that arose in two patients.In 102 cases, only one stent was necessary to re-solve SVC syndrome, whereas 36 patients needed two stents, 10 needed three stents, and one patient needed four. C Fig. 1— 68-year-old man with small cell carcinoma and severe stenosis of superior vena cava (SVC) with marked development of collateral veins. Patient had one Wallstent endoprosthesis (Boston Scientific) implanted in right innominate vein and SVC. A,  Superior venacavogram shows stenosis of SVC and collateral network of veins that have developed in neck and via hemiazygos vein. B,  Image shows placement of Wallstent (diameter, 16 mm; length, 6 cm). Scale: mm. C,  Image shows use of angioplasty balloon to help achieve greater initial expansion of stent. Scale: mm. D,  Final superior venacavogram obtained after right unilateral stent placement shows collateral venous network is no longer present and good angiographic results. DAB    D  o  w  n   l  o  a   d  e   d   f  r  o  m   w  w  w .  a   j  r  o  n   l   i  n  e .  o  r  g   b  y   1   0   3 .   1   0 .   6   4 .   2   7  o  n   0   5   /   1   4   /   1   3   f  r  o  m    I   P  a   d   d  r  e  s  s   1   0   3 .   1   0 .   6   4 .   2   7 .   C  o  p  y  r   i  g   h   t   A   R   R   S .   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y  ;  a   l   l  r   i  g   h   t  s  r  e  s  e  r  v  e   d  AJR:193, August 2009 551 Endovascular Stenting to Manage SVC Syndrome Of the 208 stents inserted in our series of pa-tients, 182 were first-time placements and the re-maining 26 (nine immediate and 25 in follow-up) were second coaxial stents inserted to treat unex-pected complications.All patients had an obstruction of > 75% of the vessel’s lumen; a significant network of collater-al veins was present in 135 of the 149 patients (91%). To ensure proper measurement and evalu-ation of the degree and extent of the stenosis as well as of the response after implantation, digi-tal subtraction equipment with associated mea-surement software was installed (Digitron 3D, Siemens Healthcare) for use in most but not all cases. Because this system was automated and computerized, routine pressure readings were not considered necessary.Each patient gave informed consent before the procedure. In all cases the procedures were per-formed with the patient under local anesthesia without any sedatives. Blood pressure, ECG, and oxygen saturation were continuously monitored. Double venous access was achieved using the ba-silic vein for both phlebocavography and stent in-sertion. Access via the common femoral vein was needed in two cases. We were unable to recanalize the SVC in the course of the manipulations via the basilic vein at the level of the elbow flexure; in-stead, the femoral vein was used quite successfully using the “through-and-through” technique. This commonly used technique involves using a guide-wire that confers a degree of external rigidity to the vein to enable the stent, or the balloon in angio-plasty, to be introduced and to proceed through and beyond the stenosis. In the first few cases ( n  = 12) between 1993 and 1994, the stents were placed bi-laterally in the right and left brachiocephalic veins and involving the SVC. From 1995 onward, single stents were placed in the SVC and right innomi-nate vein or the SVC and left innominate vein ir-respective of whether the contra lateral venous axis was affected.Table 1 summarizes the locations of stenoses, clinical data of the patients with respect to the number of stents and stent positioning, the cause of SVC syndrome, whether additional coadjuvant therapies were used, and the effectiveness of treat-ment in terms of patient survival.Of the 43 patients who received treatment be-fore stenting, 24 had received chemotherapy, four, mediastinal RT; nine, chemotherapy and RT; and six, surgery for treatment of the neoplasia but not for SVC syndrome. The remaining 106 patients had not received any antitumor treatment to alle-viate SVC syndrome before stenting.After the endovascular stenting procedure, all patients received their scheduled treatment of chemotherapy or RT or of palliative care alone for symptom relief. TABLE 1: Characteristics of 149 Cancer Patients With Superior Vena Cava (SVC) Syndrome CharacteristicValueSex (no. of patients)F12M137Age (y)Median65Range44–84Cause of SVC syndrome (no. of patients)NSCLC78SCLC49Mediastinal adenopathy (no. of patients)Double tumor (laryngeal and NSCLC)2Other tumors19Mesothelioma1Stanford classification a  (no. of patients)Type I14Type II60Type III41Type IV34Stenosis location (no. of patients)SVC72SVC and right innominate vein15SVC and left innominate vein13SVC and right and left innominate veins49Treatment before stent placement (no. of patients)None106RT4Chemotherapy24Chemotherapy and RT9Surgery6Treatment after stent placement (no. of patients)None62RT11Chemotherapy44Chemotherapy and RT32Anticoagulant therapy (no. of patients)None6Anticoagulation with coumarin derivatives15Antiaggregation146Type of Wallstent endoprosthesis b  (no. of patients)Easy75Uni71Others3No. of stents per patient (no. of patients)110223631041 Note—RT = radiation therapy, NSCLC = non–small cell lung carcinoma, SCLC = small cell lung carcinoma. a The classification of SVC syndrome proposed by Stanford et al. [18] is as follows: type I, up to 90% SVC stenosis with patency of the azygos vein; type II, more than 90% SVC stenosis with a patent azygos vein flowing into the right atrium; type III, more than 90% SVC stenosis with reversal of azygos blood flow; and type IV, complete obstruction of the SVC and one or more of the major caval tributaries. b Boston Scientific.    D  o  w  n   l  o  a   d  e   d   f  r  o  m   w  w  w .  a   j  r  o  n   l   i  n  e .  o  r  g   b  y   1   0   3 .   1   0 .   6   4 .   2   7  o  n   0   5   /   1   4   /   1   3   f  r  o  m    I   P  a   d   d  r  e  s  s   1   0   3 .   1   0 .   6   4 .   2   7 .   C  o  p  y  r   i  g   h   t   A   R   R   S .   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y  ;  a   l   l  r   i  g   h   t  s  r  e  s  e  r  v  e   d  552 AJR:193, August 2009 Lanciego et al. Follow-Up and Evaluation of Symptom Response Patients underwent follow-up in the medical oncology department of our hospital, the mem-bers of which were not involved in stent place-ment, thereby ensuring objectivity of assessment. Pulmonary insufficiency and severe cardiac or co-agulation abnormalities were considered the only contraindications.All but six of the patients received anticoagulant treatment. Immediately after the procedure, the pa-tients were placed on a continuous infusion of hep-arin at full dosage for 1 week. Over the next 4–6 months, they received oral anticoagulant agents in the form of coumarin derivatives at weight-ad- justed doses to keep the international normalized ratio above 2; here, we refer to this treatment as the “classical treatment.” For patient safety and comfort this regimen was changed after the 15th patient to a modern oral antiaggregant treatment, which we describe here as the “current treatment,” with dipyridamole in place of the coumarin-type oral anticoagulants. Only five patients were main-tained in this second phase with the older “clas-sical” oral anticoagulant therapy schedule because of concomitant pathologies and the advisability of continuing with coumarin. They had been on cou-marin-type anticoagulants for protracted periods because of cardiac valve replacement.Over the first 48- to 72-hour period after stent implantation, simple anteroposterior and later-al radiographs of the thorax were obtained to en-sure that the prosthesis was correctly positioned and had fully expanded. Another radiography ex-amination was performed for the same purpose on the seventh day after implantation. Usually phle-bocavography was not necessary during follow-up, but it was performed if signs and symptoms of SVC syndrome recurrence were detected because of possible reobstruction.Vena cava patency was evaluated by monitoring symptom response. Five signs and symptoms were assessed: dyspnea; cervicofacial edema and ede-ma of the upper limbs; superficial–subcutaneous collateral venous network; jugular engorgement; and headache. Because most of these symptoms except jugular engorgement are either subjective (dyspnea and headache) or nonquantifiable or ob- jectively measurable signs (edema and collateral venous network), a simple scale or points score was devised to measure response: 0, no response; 1, partial response (incomplete disappearance of the sign or symptom); or 2, complete response (disappearance of the sign or symptom).Not all of the patients had all five signs and symptoms. Some had only four or even three; the most variable were dyspnea and headache. Howev-er, evaluation of response to stenting was scored as the number of srcinal symptoms that resolved af-ter the procedure—for example, five of the srcinal five symptoms present, four of four, and so on.Response was assessed at intervals of 1, 2, 12, and 24 hours and up to 2–7 days after the proce-dure. During the first 7 days after stent placement, medications such as diuretics or corticosteroids were neither required nor administered as prophy-laxis; thus, the patients’ observed responses could not have been influenced by those drugs. Statistical Analysis Description of the data were with means, SDs, ranges, and percentages. The Kaplan-Meier meth-od and log-rank test were used to calculate and compare survival curves of groups as a function of the values of the following variables: patient sex, patient age, stenosis location, main complications such as thrombosis and obstruction, anticoagu-lant therapy, treatment before and after stenting, tumor type, other complications such as occlu-sion of the stent caused by tumor growth to cover the stent’s mesh, complications immediately after stenting such as stent shortening or partial migra-tion, number of stents per patient, type of Wall-stent, and type of angiography for SVC syndrome classification according to Stanford et al. [18]. A probability value of  p  < 0.05 was considered sig-nificant. Further, the association between survival and each of these variables was studied using the adjusted multivariate model of proportional risks (Cox’s regression) to calculate the adjusted hazard ratio and 95% CI. The proportionality-of-hazards assumption was checked using diagnostic plots based on Schoen-feld residuals plots against time for each covari-able and using the comparisons of survival curves versus time between the groups formed as a func-tion of the values of the covariables. In the final model, we retrieved all the variables with statisti-cally significant coefficients and those that were not significant whose removal from the model pro-voked a clinically relevant change in the coeffi-cients of the variables that were significant. Anal-yses were performed with SPSS software (version 11.0, SPSS) for Microsoft Windows. Results Stent placement was successful in all pa-tients. Clinical success was evident in 123 patients who showed partial disappearance of symptoms within 24 hours of the procedure and complete disappearance within 72 hours. Partial response (i.e., persistence of one or more signs or symptoms) was seen in 22 pa-tients and no resolution of signs and symp-toms caused by SVC syndrome in only four patients; however, even in the latter group of patients, at least one symptom improved.After the procedure, 87 patients continued to receive scheduled antitumor treatment: 44 received chemotherapy; 11, mediastinal RT; and 32, RT and chemotherapy. The most used chemotherapy regimes were cisplatin plus etoposide and regimes based on anthra-cyclines. The radiation dose ranged between 4,000 and 5,000 Gy. The remaining 62 pa-tients received only support or maintenance for symptom relief.All patients were regularly monitored. After the intervention, the survival time averaged 6 months (range, 2 days–43 months) and all patients had improvement in at least one of their symptoms before stenting. Of the study group patients, 134 died as a result of the natu-ral history of the neoplasia, whereas eight were alive as of June 2008, still with their neoplasia but with clinical resolution of their SVC syn-drome symptoms as a result of continued pat-ency of the stents or, possibly, as a result of spontaneous increase in collateral blood flow. Seven patients were lost to follow-up. Of the patients who died, three still had clinical evidence of SVC syndrome at the time of death, which was probably due to ob-struction of the stent. However, obstruction was not confirmed by radiologic imaging be-cause of the patient’s status before death.The patients who were still alive as of June 2008 ( n  = 8) represent a median sur-vival time of 10.6 months (range, 15 days–36 months). Of the seven patients lost to follow-up, all had a good response to stenting up to the time of loss to follow-up (three in the third month and four in the sixth month after the procedure) and were without clinical evi-dence of SVC syndrome recurrence.Symptom response was evaluated by clin-ical and nursing staff of the medical oncol-ogy department. The main findings were complete response in almost 80% and partial response in approximately 15% of patients with respect to jugular engorgement and col-lateral circulation within the first 72 hours af-ter stenting. Headache resolved completely in 70% of patients and partially in 30% within the first 24–48 hours after stent placement. Cervicofacial edema and edema of the up-per limbs, which affected 100% of the pa-tients, were the symptoms that responded best to the procedure. In all patients, those symptoms disappeared within 48–72 hours after implantation of the prosthesis. Dyspnea was the symptom that was most resistant and resolved completely in only 45% of patients, whereas partial remission was achieved in 60% of the patients.    D  o  w  n   l  o  a   d  e   d   f  r  o  m   w  w  w .  a   j  r  o  n   l   i  n  e .  o  r  g   b  y   1   0   3 .   1   0 .   6   4 .   2   7  o  n   0   5   /   1   4   /   1   3   f  r  o  m    I   P  a   d   d  r  e  s  s   1   0   3 .   1   0 .   6   4 .   2   7 .   C  o  p  y  r   i  g   h   t   A   R   R   S .   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y  ;  a   l   l  r   i  g   h   t  s  r  e  s  e  r  v  e   d
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