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January 26, 2022

Systematic Review Evaluates Incidence, Outcomes, and Management of Venous Stent Migration

January 26, 2022—In a systematic review of published data from the last 25 years on recorded events of stent migration, Sayed et al found that migration events may be underreported due to a significant risk of publication bias. Although formal statistical analysis could not be performed based on the level and paucity of data, there were significantly more reported cases of migration of shorter-length and smaller-diameter stents, and stents placed in the central and renal veins may have a higher risk of migration. This review was published online in Journal of Vascular Surgery: Venous and Lymphatic Disorders.

Key Findings

  • Between 1994 and 2020, 31 articles (29 case reports, two case series) were identified, providing data for 54 venous stent migration events.
  • In most reported cases, stents were ≤ 60 mm long, and stents were > 14 mm in diameter in only three reports; none of the articles reported migration of stents > 100 mm long.
  • The iliocaval segment had the highest incidence of migration, followed by the central and renal veins.
  • Retrieval was attempted in 85.5% of cases (65.2% endovascular, 34.8% open), with 100% of attempts having a satisfactory outcome.

Following MOOSE and PRISMA guidelines, investigators searched MEDLINE, EMBASE, and PubMed for all reported cases or case series of iliofemoral/iliocaval and thoracic central venous stent placement complicated by dislodgment from the primary site or migration to the right heart and pulmonary artery in adults aged ≥ 16 years. The systematic review was registered in PROSPERO.

Two investigators independently assessed the full text of each article to determine if it met inclusion criteria, with a third reviewer mediating in case of disagreement. Data were extracted on study type, publication year, number of cases reported, demographic data, indication for stenting, primary stent location, stent type, number of stents dislodged, stent size, migration site, diagnostic imaging, time from primary stent placement to migration, presenting symptoms, major complications, retrieval method, and short-term outcomes.

Due to the small sample size and significant heterogeneity of the data, statistical analysis was not conducted.

Thirty-one articles met inclusion criteria; 29 were case reports and two were case series, with a total of 52 cases describing 54 venous stent migration events. Of the 54 migrated stents, the indication for stenting was central venous obstruction in 38.8%, postthrombotic syndrome in 20.3%, nutcracker syndrome in 12.9%, inferior vena cava stenosis in 9%, iliac vein compression in 7.9%, and hepatic vein after transjugular intrahepatic portosystemic shunt in 1.1%.

The iliocaval segment was found to have the highest incidence of stent migration (48.1% [26/54 stents]), which the investigators noted may reflect the fact that this location is the most common for stent placement, followed by the central (38.8% [21/54]) and renal (12.9% [7/54]) veins. The investigators also postulated that there may be a higher risk of migration after stent placement in the central and renal veins given the relatively high percentage of cases of migration in these locations; however, they note that the data are not strong enough to draw any significant conclusions regarding relative risk. 

Twenty-seven studies provided data for the type of stent used (49 of 54 migrated stents), and all but one of these studies reported length and diameter. Most (93.8% [46/54]) were bare-metal stents and 6.1% (3/54) were covered stents; 82.6% (38/46) stents were < 60 mm, and all but three of the studies reported stents ≤ 14 mm (3.6% [44/47]). None of the articles reported migration of stents > 100 mm long.

The time interval between placement and migration (29/31 studies) was ≤ 30 days in 13.8%, ≤ 6 months in 41.6%, and > 6 months in 22.2%. The longest interval from placement to presentation was 1 year.

All 31 articles included data regarding retrieval, with retrieval attempted in 85.5% of cases, primarily through endovascular means (65.2% vs 34.8% for open surgery; P < .001). Immediate outcomes were reported as satisfactory in 100% of attempts.

Based on these data, the authors encourage the use of longer stents of the correct size where clinically appropriate, with significant attention focused on the appropriateness of stent placement for the initial indication. They also emphasize that this study is significantly limited by the potential for reporting bias, highlighting the need for registries to record these events.

ENDOVASCULAR TODAY ASKS…

We asked study coauthors Stephen Black, MD, FRCS; Gerry O’Sullivan, MD; and Kush Desai, MD, about the results and their implications:

Stent migration is a potentially catastrophic complication of venous stenting, and you note that training efforts are encouraged. What are three hallmarks that should be emphasized during training to reduce this risk?

1. Patient selection: This is of paramount importance, particularly with nonthrombotic iliac vein lesions (NIVLs). We know that clinically silent iliac vein compression is present in a significant portion of the population, and obviously no stent is needed in these cases. Many patients are currently referred with “left iliac vein compression” based on cross-sectional studies with no symptoms whatsoever. Equally, however, stents are being placed for dubious indications such as “ankle swelling,” which is not likely to improve with stent placement. Clear identification of those NIVL patients likely to benefit from stent placement is key, including patients with venous claudication, significant edema that extends into the thigh, venous stasis ulceration that does not completely respond to superficial vein therapy, and chronic pelvic pain in selected females. The workup must include the elimination of alternative explanations for symptoms.

2. Use proper intraprocedural imaging techniques: Use venography and intravascular ultrasound (IVUS) in a complementary manner. Identify venographic findings that suggest hemodynamically significant lesions (eg, collaterals, internal iliac vein reflux). Use IVUS to demonstrate that the compression is fixed through the respiratory cycle and with Valsalva maneuvers, as well as to select the stent size and length.

3. Proper stent size selection (both diameter and length): IVUS is critical here. Size the stent off a normal reference segment; in most NIVL cases, this should be the external iliac vein. In our experience, most patients should get a 14- or 16-mm-diameter stent. Do not select stent size off of prestenotic dilation in the common iliac vein—this may lead to gross oversizing. Selection of stent length can be aided by marker catheters on IVUS; the stent should extend caudally well into the normal external iliac vein so that it is well anchored. We typically do not place stents shorter than 120 mm in length.

In the authors’ experience of nearly 2,000 stent implantations, we have not seen a single case of stent migration following the procedure. In experienced hands, this potentially devastating complication should be extremely rare.

The article concludes that robust venous registries are needed to further evaluate factors related to stent migration. What might this registry landscape look like (eg, industry-run postmarket registry, society registries, government/other large real-world databases), and what would the ideal follow-up means, frequency, and duration include?

The current data suffer from underreporting; it is likely that more migrations have occurred than have been currently reported. Vigilance is now mandatory given that on-label devices for iliofemoral venous obstruction have only recently come to market in the United States, where the majority of NIVL treatment occurs. To that end, postmarket studies, such as an FDA 522 postmarket surveillance study, are a good first step in capturing clinical activity and events in the treatment of iliofemoral obstruction, with mandated short- and medium-term imaging and clinical follow-up. This would include abstraction of intraprocedural data (including venography and IVUS) and follow-up data (duplex ultrasound and clinical metrics) to determine outcomes and adverse event rates. However, it is imperative that all parties–governing bodies such as the FDA, industry, and users—commit to proper postmarket data collection.

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