Retrospec)ve Study in 23 Pa)ents of the Self-Expanding Sinus-XL Stent for Treatment of Malignant Superior Vena Cava Obstruc)on Caused by Non-Small Cell Lung Cancer RFS Journal Primer

BOTTOM LINE Implantation of the self-expanding Sinus-XL stent for treatment of SVC obstruction caused by NSCLC is a safe and effective treatment in the palliative setting MAJOR POINTS The Sinus-XL stent uses a closed-cell design that exerts high radial force and prevents extrinsic compression, both critical for application in SVC obstruction. In 24 of 25 patients, clinical symptoms improved in at lease one category according to te International Consensus Committee on Chronic Venous Disease Three minor complications occurred one patient developed a thrombosis of the left brachiocephalic vein during the procedure, one patients stent migrated into the right atrium after deployment, and one patients had transient impaired venous drainage of the left upper extremity. One major complication occurred - this patients stent occluded secondary to progressive tumor growth and subsequently developed a pulmonary embolism, dying the day after the procedure CRITICISM

Small sample size: n = 23 Disproportionate number of patients had Stage IV NSCLC versus Stage IIIA and IIIB Study focused solely on the Sinus-XL stent without including any other type of stent

Quick Summary

IRB-approved Retrospective Study 23 patients undergoing interventional treatment for SVC obstruction caused by NSCLC Time range: October 2009 and December 2012 INCLUSION CRITERIA Patients with stage IIIA, IIIB, or IV NSCLC Interventions performed within 24 hours after diagnosis of acute SVC obstruction All patients were treated with the Sinus-XL stent EXCLUSION CRITERIA Patients with chronic symptoms caused by SVC obstruction Patients beyond 24 hours after initial diagnosis of SVC obstruction Patients with lung malignancies other than NSCLC

Study design

To evaluate the self-expanding nitinol Sinus-XL stent for the treatment of SVC obstruction caused by NSCLC and to evaluate clinical outcomes according to the International Consensus Committee on Chronic Venous Disease and complications according to SIR classiYication. Purpose

26 Sinus-XL stents were implanted in 23 patients Stent diameter

20 mm 20 stents 22 mm 5 stents 24 mm 1 stent

Stent length 40 mm 8 stents 60 mm 18 stents

In all patients, the stenosis was completely covered by the stent without evidence of stent foreshortening Residual stenosis > 30% in 18 patients after stent implantation, all of whom underwent PTA during the procedure

20 mm balloon 4 patients 22 mm balloon 1 patient 24 mm balloon 3 patients

No residual stenosis > 30% remained Techinal success was therefore 100%

Left brachiocephalic vein was covered by the stent in 7 cases and the right brachiocephalic vein was covered in 1 case

Interven)on

Outcome

Mean follow-up time was 66 days 83 days (range of 1 305 days) 1 patient was lost to follow-up

22 of 23 patients showed clinical improvement of symptoms in at least one category according to the International Consensus Committee on Chronic Venous Disease Primary patency rate of 95.7% and secondary patency rate of 100%

In 1 patient, a stent occlusion occurred secondary to progressive tumor growth after 44 days. Recanalization was successful and a 2nd and 3rd stent were placed. During the reintervention, the patient had a pulmonary embolism due to an appositional thrombus occurring at the tip of the jugular sheath. Despite immediate thrombolysis, the patient died 1 day after stent recanalization.

3 minor complications occurred 1 patient developed a thrombosis of the left brachiocephalic vein during the procedure and was successfully treated with TPA 1 patients stent migrated into the right atrium after deployment and was successfully repositioned and stabilized with a second stent 1 patient had transient impaired venous drainage of the left upper extremity

One major complication occurred (patient with pulmonary embolism as discussed above)

Credits

SUMMARY BY: Justin Shafa, MSIV The George Washington University School of Medicine and Health Sciences FULL CITATION: Mokry T, Bellemann N, Stamp U, et al. Clinical Study: Retrospec)ve Study in 23 Pa)ents of the Self-Expanding Sinus-XL Stent for Treatment of Malignant Superior Vena Cava Obstruc)on Caused by NonSmall Cell Lung Cancer. Journal Of Vascular And Interven4onal Radiology [serial online]. March 1, 2015;26:357-365. Available from: ScienceDirect, Ipswich, MA.

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