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

Quick Summary
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

Study design
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

Purpose

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.

Interven)on

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

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.

Society of Interven)onal Radiology

3975 Fair Ridge Drive | Suite 400 North
Fairfax, VA 22033
(703) 460-5583

sirweb.org