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Socioeconomics
Original research
A national survey of venous sinus stenting practices for idiopathic intracranial hypertension
  1. Kyle M Fargen1,
  2. Carol Kittel2,
  3. Matthew R Amans3,
  4. Waleed Brinjikji4,
  5. Ferdinand Hui5
  1. 1 Neurological Surgery and Radiology, Wake Forest University, Winston-Salem, North Carolina, USA
  2. 2 Neurological Surgery, Wake Forest University, Winston-Salem, North Carolina, USA
  3. 3 Radiology and Biomedical Imaging, UCSF, San Francisco, California, USA
  4. 4 Radiology and Neurosurgery, Mayo Clinic, Rochester, MN, USA
  5. 5 Neuroscience Institute, Queen's Medical Center, University of Hawaii, Honolulu, HI, USA
  1. Correspondence to Dr Kyle M Fargen, Neurological Surgery and Radiology, Wake Forest University, Winston-Salem, NC 55905, USA; kfargen{at}wakehealth.edu

Abstract

Background Little is currently known about physician opinions and preferences on venous sinus stenting (VSS) for idiopathic intracranial hypertension (IIH), practice patterns, or clinical volumes.

Methods A 19 question online survey was designed and distributed to physician members of the Society of Neurointerventional Surgery (SNIS).

Results A total of 107 individual survey responses were obtained (14% of SNIS members). The majority of respondents (85%) indicated that they had performed at least one VSS procedure independently during their careers. Mean (SD) and median (range) career case volumes were 20.9 (33.8) and 10.0 (0.0–200.0), respectively. On a 1–10 scale, most respondents reported a high level of interest in treating IIH patients with VSS (median 8), a high level of comfort/expertise in treating IIH patients with VSS (median 9), and that VSS was effective in the long term reduction of symptoms and papilledema in IIH patients (median 8). Fifty-nine per cent of respondents reported increasing VSS volumes compared with previous years. A major complication during a VSS procedure, including two deaths, was reported by 11% of respondents.

Conclusions This is the first study designed to understand the opinions and practices of neurointerventionists regarding VSS for IIH. Overall physician opinion on VSS was quite positive, supported by increasing procedural volumes reported by most over the past few years. However, only a small percentage of respondents had substantial experience with VSS and major complications were not rare.

  • Intervention
  • Intracranial Pressure
  • Stent
  • Stenosis
  • Vein

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

https://doi.org/10.1136/neurintsurg-2022-018832

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    Key messages

    • There are few published data on physician opinions on the effectiveness of venous sinus stenting (VSS), average case volumes, or procedural trends over time.

    • Overall physician opinion on VSS was quite positive with most reporting a high level of interest in the procedure, a high degree of comfort with performing the procedure, and that VSS was highly effective for patients with idiopathic intracranial hypertension.

    • While survey responses indicated widespread acceptance among neurointerventionists, only a small percentage of physicians had substantial experience with VSS.

    • The majority reported increasing VSS volumes over time, which has important implications for organized neurointervention as well as research and device development.

    Introduction

    Venous sinus stenting (VSS) has emerged as an effective surgical treatment option for idiopathic intracranial hypertension (IIH) with associated venous sinus stenosis. Meta-analyses of small series of VSS have demonstrated an excellent safety profile with improvement in headaches, pulsatile tinnitus, papilledema, and visual symptoms in the majority of patients.1–3 However, severe complications, including death, have been reported in 1–2% of patients treated with VSS.4 Importantly, very few published recommendations are available5 to guide interested physicians in selecting patients for treatment or for advice on the technical aspects of stenting. The absence of standards or guidelines could imply highly variable practice patterns among different physicians with varying preferences and management strategies.

    Little is known about physician opinions on the effectiveness of VSS, average case volumes among practicing neurointerventionists, procedural trends over time, or techniques used. This information is important in understanding physician expertise to promote patient safety, to address research and device innovation needs, and to comprehend the future of VSS in IIH. This study surveyed neurointerventionists regarding opinions on VSS, practice preferences, and case volumes to answer these questions.

    Methods

    Institutional review board approval was obtained prior to study initiation. An informal survey writing committee of four members, with representatives from the specialties of neurosurgery and neurointerventional radiology and geographically distant, assembled the survey. The writing group finalized a 19 question online survey through SurveyMonkey, designed with a completion time of approximately 5 min to optimize the response rate (online supplemental materials). The study purpose, methods, benefits, and risks were posted on the Society of Neurointerventional Surgery (SNIS) connect website for SNIS members, along with a link to the online survey. No compensation was offered to participants. No requests to complete the survey were placed on public social media platforms. Response IP addresses were recorded anonymously through SurveyMonkey and respondents were restricted to completion of one survey. Reminder postings were sent periodically during the study period, which lasted 4 weeks (October–November 2021).

    Statistical methods

    Statistical analyses were performed using IBM SPSS Statistics (V.26), R: a language and environment for statistical computing (R Foundation for Statistical Computing, V.3.6.1, Vienna Austria), and RStudio: integrated development for R (V.1.3.959, RStudio Inc, Boston, Massachusetts, USA). Fisher’s exact tests were performed to assess all between group statistical comparisons, using an α level of 0.05 for determination of significance.

    Results

    A total of 107 individual survey responses were obtained for a response rate of approximately 14% based on the estimated total SNIS physician sample size (approximately 800 physicians). Ninety-seven per cent of respondents completed the whole survey. Selected respondent characteristics are shown in table 1. The majority of respondents (72.0%) were early to mid career, with 3–19 years of independent practice.

    View this table:
    Table 1

    Personal and practice characteristics of respondents

    Case volumes

    The majority of respondents (84.9%) indicated that they had performed at least one VSS procedure independently during their careers. Among all respondents, 2088 total VSS cases were reported. Only four physicians reported having performed more than 100 VSS procedures (3.0%). Mean (SD) and median (range) career case volumes were 20.9 (33.8) and 10.0 (0.0–200.0), respectively (figure 1).

    Figure 1
    Figure 1

    Smooth line histogram showing number of total cases reported by respondents.

    Table 1 shows responses regarding case volume trends over the past few years compared with previously. The majority of respondents (58.6%) indicated that VSS case volumes had increased over the past few years, with over a quarter reporting they had more than doubled (27.6%).

    Opinions on VSS interest, efficacy, and expertise

    On a scale of 1 (completely uninterested) to 10 (very interested), most respondents reported a high level of interest in treating IIH patients with VSS (median 8.0 (IQR 5.0–10.0)). On a scale of 1 (very uncomfortable) to 10 (very comfortable), most respondents reported a high level of comfort/expertise in treating IIH patients with VSS (9.0 (7.0–10.0)). Additionally, most respondents believed that VSS was effective for the long term reduction of symptoms and papilledema in IIH patients (8.0 (7.0–9.0)) on a 1–10 scale (1=very ineffective, 10=highly effective).

    Patient selection

    Most respondents (50.6%) reported that non-invasive venographic imaging (MR venography/CT venography) was “very important” in selecting patients for diagnostic venography, with a minority (5.7%) reporting that these imaging modalities were “not important.” Similarly, the degree of opening pressure (OP) elevation was reported as “very important” in more than 50% of respondents, with a small fraction (2.3%) indicating that OP was “not important.” Most commonly used trans-stenosis gradient thresholds for selecting patients for stenting are shown in table 1. Most respondents indicated using a gradient threshold of ≥8 mm Hg (52.9%). There was no difference in career stage between those stenting for higher (8 or 10 mm Hg) gradients compared with those using lower gradients (4 or 6 mm Hg; p=0.93).

    Only a small percentage of respondents (13.7%) indicated that they had performed venography or VSS in patients with a predominant complaint of CSF leak (no significant IIH symptoms or papilledema). In contrast, a plurality of respondents (59.8%) indicated that they had performed venography or VSS in patients with a predominant complaint of pulsatile tinnitus in the absence of significant IIH symptoms or papilledema.

    Stenting practices

    Most practitioners reported performing venography and VSS under separate procedures (65.1%), while a minority report intraprocedural conversion from conscious (or minimal) sedation for venography to general anesthesia for stenting during the same procedure (17.4%). A minority of respondents indicated that they performed both venography and stenting under general anesthesia during the same procedure (17.4%).

    Nearly three-quarters of respondents (73.6%) usually stented the lateral transverse sinus only, with a single 30–40 mm stent. The remaining respondents stented the entire transverse sinus, with two telescoped stents (10.3%) or a single long 70–80 mm stent (16.1%). Most respondents had only rarely (29.9%) or never (65.5%) performed superior sagittal sinus stenting. Similarly, nearly all respondents only rarely (20.7%) or never (78.2%) performed internal jugular vein stenting. In fact, only four respondents commonly performed superior sagittal sinus stenting, all with ≥6 years of experience; while this sample is small, there was no difference in career stage between those respondents that commonly versus rarely or never performed superior sagittal sinus stenting (p=0.18).

    Post-stenting care

    Almost all respondents placed patients on dual antiplatelet agents after VSS (95.5%). Dual antiplatelet therapy for 12 weeks or longer was the most common treatment (79.3%). Only 4.5% of respondents used aspirin monotherapy or anticoagulation instead of dual antiplatelet therapy. Follow-up imaging after VSS was variable, with 23.0% reporting they did not routinely order follow-up imaging after VSS. Of those that did routinely order imaging, the most common was CT imaging (39.1%), followed by MRI (21.8%), and catheter venography (16.1%).

    Life threatening complications

    Nine respondents reported having at least one patient who suffered a life threatening complication after VSS and entered text into the comment box regarding this complication (11%). These included acute subdural hematomas with or without subarachnoid hemorrhage in six patients (one death), venous infarct and intraparenchymal hemorrhage in one patient, subarachnoid hemorrhage in one patient, and acute periprocedural stent thrombosis (resulting in death). Overall, two deaths were reported. There was no association between reporting a life threatening complication and gradient most commonly used (p=0.17) or years of practice (p=0.52). Life threatening complications were, however, more commonly reported in those respondents with 50 or more total career cases compared with those with less than 50 total procedures (p=0.006; table 2).

    View this table:
    Table 2

    Comparison of survey answers based on experience

    Practices of the most experienced providers

    Table 2 shows the practices of the 12 respondents (14%) that had performed 50 or more VSS procedures compared with less experienced providers (<50 procedures). Compared with less experienced physicians, the most experienced respondents tended to have lower gradient thresholds for selecting candidates for VSS (p=0.02), reported that OP was less important in patient selection (p=0.02), more commonly stented the superior sagittal sinus (p<0.001), and more commonly performed VSS for predominant pulsatile tinnitus than less experienced physicians (p<0.001).

    Discussion

    This is the first study to survey US neurointerventional physicians regarding VSS practices for treating idiopathic intracranial hypertension. A number of notable observations were found. First, the majority of respondents indicated that they were highly interested in performing VSS procedures, believed VSS was highly effective in IIH patients, and were highly comfortable with VSS procedures. Second, most respondents indicated that their procedural volumes had increased over the past few years, commensurate to the high level of interest and belief in procedural efficacy. However, most respondents were relatively inexperienced in VSS, with the majority having performed ≤10 procedures during their careers. In fact, only 14% of respondents had performed at least 50 VSS procedures during their career, with <3% having performed over 100 cases. Compared with less experienced practitioners, those more experienced in VSS tended to more commonly stent the superior sagittal sinus, use lower trans-stenosis gradient thresholds, and find OP to be less important in selecting patients for venography than their less-experienced counterparts.

    Prior to the present study, little has been published on VSS trends due to challenges in obtaining accurate data. For example, a recent study published in 20206 studied US trends of both optic nerve sheath fenestration and shunting for IIH patients but the authors directly stated that they did not include VSS due to methodological difficulties, likely related to challenges in accurately querying procedural codes. To date, there are essentially no cross sectional or national database studies reporting on procedural incidence or trends, nor registries tracking VSS procedures. This survey was designed to answer some of these questions while additionally querying physician preferences in the selection and treatment of patients.

    Our survey suggests widespread adoption of VSS among neurointerventionalists, with 85% having performed the procedure as an independent operator. In addition, the majority of operators also reported that VSS was a growing part of their practice, with nearly 60% reporting volume increases in just the past few years, and about 30% reporting volumes more than doubling in the same period of time. This growth trajectory is expected to continue due to the high level of respondent interest in the procedure and widespread belief in the long term efficacy for treating papilledema, coupled with an increasing incidence of IIH with rising obesity rates.6 7 Furthermore meta-analyses suggest that VSS effectiveness, failure rates, and complications are favorable (and potentially superior) to optic nerve sheath fenestration and shunting procedures,3 which will naturally lead to more referrals from clinicians over time.

    This growth trajectory has important implications for organized neurointervention as well as research and development. Focused attention on research to identify the best strategies in patient selection and stent construct (sizing, location) are needed. Identifying risk factors for treatment failure, which at this point are poorly understood,8 9 will help us better counsel patients regarding the risks and benefits of the procedure. Educational courses for those interested in developing an IIH practice could be provided. A focus on technique and device innovation specifically for venous sinus disease will be necessary. Some headway has already been made in this realm: most neurointerventionists currently use biliary or carotid stents for VSS and recently the River stent (Serenity Medical Inc), a stent designed specifically for VSS, has completed enrollment in its signature trial.10 Similar focused attention on venous catheterization and stenting technologies may contribute to making VSS a safer and more effective treatment in the future. Ultimately, prospective randomized trials, such as the Operative Procedures versus Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP),11 will be necessary to provide definitive evidence for efficacy and safety.

    While meta-analyses and systematic reviews suggest that VSS is a safe and highly effective treatment for patients with IIH and concomitant venous sinus stenosis,1–3 there are limited published recommendations on the selection and treatment of IIH patients with VSS,5 and few manuscripts providing helpful technical advice12 13 for interested individuals. In the absence of published guidelines or studies evaluating the superiority of treatment or selection practices, the data obtained from this survey can help shed light on practices guided by experience. Although the sample of experienced physicians represented in this survey was small, some notable practice differences in patient selection and treatment compared with less experienced respondents were identified. The most experienced physicians were significantly more likely to use a lower gradient threshold for selecting patients for candidacy, more commonly stented the superior sagittal sinus, and reported that OP was less important for patient selection. Additionally, the data suggest that more experienced physicians may be more likely to perform venography and stenting as separate procedures and are more likely to stent the entire transverse sinus instead of just the focal point of stenosis, although these did not reach statistical significance. Some authors have opined that stenting the entire transverse sinus and potentially upfront stenting of the superior sagittal sinus, if any stenosis or gradient is present in the caudal superior sagittal sinus at the time of venography, may reduce the risk of future stent adjacent and remote superior sagittal sinus stenosis, respectively.13–15 These opinions, which seem more prevalent in the more experienced respondents, are not supported in published evidence but based on observations from high volume practices.

    There is a subset of patients that present with loud pulsatile tinnitus or skull base CSF leaks with rhinorrhea or otorrhea, but without a major component of headache or papilledema. We now understand that pulsatile tinnitus is frequently a result of transverse sinus, sigmoid sinus, or internal jugular venous anomalies or stenosis.16 There is also increasing evidence suggesting that patients who develop spontaneous CSF leaks (skull base or spinal) often have underlying IIH, leading some authors to question whether most patients with CSF leaks have contributing underlying intracranial hypertension.17 18 In addition, internal jugular vein stenosis is now being recognized as a contributor to symptomatic intracranial venous congestion.19 We believe that many of these patients should be considered as having a cranial venous outflow, IIH spectrum condition and can often be treated similarly to traditional IIH patients. This perspective is supported by the fact that experienced respondents more commonly performed VSS for patients with pulsatile tinnitus (p<0.001). However, jugular vein stenting and VSS for CSF leaks have yet to be widely adopted by even high volume operators. Given the close pathophysiologic relationship between IIH and these spectrum entities, further research into the benefits of stenting in these patients may be fruitful.

    While the majority of respondents reported a high degree of comfort/expertise in performing VSS (median 9 out of 10), the discrepancy between subjective physician expertise/comfort and case volumes was notable. Intracranial venous access is only rarely performed in routine practice by most neurointerventionists and its technical nuances are not necessarily obvious to physicians unaccustomed to this approach, yet paradoxically most reported a high degree of comfort and expertise with stenting even though they were relatively inexperienced. Although this may be only natural as new promising techniques are developed, this discrepancy may imply that the pervasive opinion on VSS in the neurointerventional community is that it is a ‘simple’ and safe procedure. However, there is a known 1–2% major complication rate even in experienced hands,4 and in this survey, 11% of respondents reported a major complication during a VSS procedure, with two reported deaths. Having a life threatening complication from VSS was more commonly reported in higher volume operators, which may naturally be expected due to a higher denominator of cases, or could be secondary to other nuanced factors that this survey was unable to identify. The purpose of this study was not to accurately report on complication rates or risk factors in the community, however the study does highlight that significant complications, including death, are not extraordinary events. As VSS becomes more commonplace, attention to expertise and clinical volume metrics going forward may be one means of ensuring adequate patient selection and safe VSS practices, similar to other procedures, such as thrombectomy or aneurysm treatment.

    This study had a number of additional important limitations. First, this was a survey study with a limited response rate (14% of SNIS members). The sample size was, however, comparable with other published nationwide studies in the neurointerventional space.20 21 Selection bias is another limitation of this methodology. Theoretically, individuals with more interest in VSS are more likely to respond to a survey than those less interested, which may skew the results. The survey questions were not validated, as no prior IIH stenting surveys were available. The survey was not designed to capture annual procedural volumes. Specific technical preferences, such as sheath, catheter, or stent devices used, were not assessed to keep the survey concise, which limits conclusions that can be made about technical practice variations.

    Conclusions

    This is the first study to survey neurointerventional physicians on opinions and practices regarding VSS for IIH. Overall physician opinion on VSS was quite positive, with most reporting a high level of interest in the procedure, a high degree of comfort with performing the procedure, and that VSS was highly effective for IIH patients. These beliefs are supported by increasing procedural volumes. However, only a small percentage of respondents had substantial experience with VSS and major complications were not rare.

    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

    Ethics statements

    Patient consent for publication

    Ethics approval

    This study involves human participants and institutional review board approval was obtained at Wake Forest, No IRB00077430. Participants gave informed consent to participate in the study before taking part.

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    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Contributors Concept: KMF. Survey design: KMF, MRA, WB, and FH. Statistical analysis: CK. Manuscript composition: all authors. Guarantor: KMF.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.