An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry

Clinical question

Is sacroplasty an effective and safe procedure for reducing pain and improving function in the treatment of patients with sacral insufficiency fractures?

Take away point

Sacroplasty effectively and safely reduced painful sacral insufficiency fractures while maintaining patient-reported outcomes over 6 months.

Reference

An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry. Beall D. P et al. Journal of Vascular and Interventional Radiology, Volume 34, Issue 9, 1477 – 1484. doi.org/10.1016/j.jvir.2023.05.024

Click here for the abstract

Study design

Multicenter, prospective, single-arm registry.

Funding Source

D.P.B. reports compensation from Medtronic related to consultancy, research, and teaching; grants from Benvenue, Alphatech Spine, Medical Metrics, Liventa, Vexim, and Mesoblast; grants and personal fees from Medtronic, Halyard, Vivex, and Vertiflex; consultancy fees from Dfine and Osseon; and other from Lilly, Smith & Nephew, Biomet, Vertiflex, Synthes, and Integral Spine Solutions. N.H.S. reports compensation related to royalties from Globus and consulting, research, and teaching from Medtronic.

Setting

10 sites in the United States consisting of small community practices, radiology group practices, multispecialty group practices, and large academic medical centers.

Figure 2

Mean Numerical Rating Scale scores at the 1-, 3-, and 6-month time points.

Summary

    Sacral insufficiency fractures (SIFs) are painful fractures of the sacrum that can occur in patients with osteoporosis or neoplastic involvement. These fractures often go undiagnosed and are a common source of low back pain in elderly patients. Sacroplasty has been shown to be an effective and safe treatment for sacral fractures with minimal adverse effects. However, no prospective observational trials (registries) have reported basic safety and efficacy data. The authors performed a multicenter, prospective, single-arm registry study with 102 patients to assess the efficacy and safety of sacroplasty for the treatment of sacral insufficiency fractures.

    The study included 102 patients presenting with SIF. Patient-reported outcome (PRO) data was collected via phone call surveys at the 1-, 3-, and 6-month mark after the initial sacroplasty procedure. The PROs obtained included pain, assessed using the Numerical Rating Scale (NRS), and function, assessed using the Roland-Morris Disability Questionnaire (RMDQ). The minimal clinically important difference was defined as a change of greater than or equal to 2 points from baseline on the NRS for pain and greater than or equal to 5 points from baseline on the RMDQ for function. The secondary endpoints were cement leakage, adverse effects, hospital readmission, new neurologic deficits, and death.

    Patients were analyzed using frequencies for categorical variables and means for continuous variables, while PROs were reported at baseline, 1, 3, and 6 months. Generalized estimating equation models were used to analyze the effects of time on repeated measurements for pain and function. Post hoc tests with Bonferroni adjustments were used to compare the mean differences between PROs.

    The most common treated levels were both S1 and S2, and prior to cement augmentation, nonsurgical management was attempted in 93.1% of the patients, and 78.4% of patients with sacral fractures had an osteoporosis diagnosis. The study demonstrated statistically significant (P < .001) improvements in NRS and RMDQ scores at 6 months compared to baseline. Mean RMDQ scores decreased from 17.7 to 5.2 over a 6-month period and mean NRS scores decreased from 7.8 to 0.9 over the same period. Out of the 102 patients, only one experienced an adverse effect of cement extravasation leading to new neurologic deficits. Cement leakage was observed in 17.7% of the patients but remained asymptomatic except for one patient with new-onset neurological deficits. There were no patient deaths, and hospital readmission after sacroplasty occurred in 8 of the 102 patients (7.8%) at 6 months and one patient each after 1 and 3 months.

Commentary

    The purpose of the study was to provide prospective observational data on the efficacy and safety of sacroplasty for treating sacral insufficiency fractures using patient-reported outcomes. The study used a prospective registry approach, enabling the collection of real-world data from a diverse patient population across the United States. Considering the inherent limitations of a registry study the methods and study approach was well-structured. The statistical model and equation models used to analyze the data appear to be appropriate. However, the study does not provide further detail on the statistical analysis process. The presented outcomes are convincing, indicating significant improvements in pain and function following sacroplasty in SIF patients. The study’s results align with data from previous studies and meta-analyses. Areas of improvement include a clearer explanation of the statistical analyses and independent radiographic evaluations of patients. Overall, the paper provides compelling evidence that support the safety and efficacy of sacroplasty for patients with SIF.

Post author

Aric Patel, MS
University of New England College of Osteopathic Medicine

Double-Barrel Nitinol Stent Placement for Iliocaval Reconstruction: The Effect of Deployment Sequence and Direction

Clinical question

What is the influence of biomechanical forces on deployment outcomes of synchronous parallel stent deployment versus asynchronous or antiparallel stent deployment in cases of chronic, bilateral iliocaval occlusion?

Take away point

Synchronous parallel deployment is most likely to provide the desired stent configuration and shows superior clinical outcomes when performing double-barrel nitinol stent placement for treatment of chronic, bilateral iliocaval occlusion due to a balance in biomechanical forces.

Reference

Li N, Huber T, Campos L, Yamada K, Kaufman J, Farsad K, Bochnakova T. Double-Barrel Nitinol Stent Placement for Iliocaval Reconstruction: The Effect of Deployment Sequence and Direction on Final Configuration. J Vasc Interv Radiol. 2023 Sep;34(9):1511-1515.e1. doi: 10.1016/j.jvir.2023.05.018. Epub 2023 May 15. PMID: 37196821.

Click here for abstract.

Study design

In-vivo experimental with ex-vivo assessment utilizing swine models.

Funding Source

No reported funding.

Setting

Single academic center

Figure

Graphic illustration of the three (3) different double-barrel self-expanding nitinol venous stent deployment strategies across the iliocaval confluence (synchronous parallel, asynchronous parallel, and synchronous antiparallel) and their associated technical outcome tested in this study using a swine animal model.

Summary

    Despite the widespread use of double-barrel stents in venous interventions for chronic bilateral iliocaval occlusion, the differences in deployment outcomes between synchronous parallel stent deployment and asynchronous or parallel deployment, as well as the underlying biomechanical interactions of the stents, are not well understood.

    Using a live swine model, the diameters of the inferior vena cava (IVC) and common iliac veins were measured. Subsequently, 14 mm diameter double-barrel nitinol stents were deployed using three different techniques: (1) asynchronous parallel deployment from bilateral common femoral accesses, (2) antiparallel, synchronous deployment with the right common iliac stent deployed from the right internal jugular access and the left common iliac stent deployed from the left common femoral access, and (3) synchronous parallel deployment from bilateral common femoral accesses.

    Initial stent expansion was assessed under fluoroscopy, and all deployment strategies underwent simultaneous balloon angioplasty to 12 mm before being reassessed for their diameters. Following this, the peripheral IVC and bilateral common iliac veins were harvested and examined ex-vivo. The assessment was qualitative in nature, as statistical analysis was not performed due to the small sample size.

    Synchronous parallel stent deployment successfully achieved the desired double-barrel stent configuration due to an equilibrium among various biomechanical forces, including radial resistive force, chronic outward force, and crush resistance. However, both asynchronous parallel and antiparallel deployment strategies exhibited irreversible stent deployment issues, resulting in a crushed configuration due to unequal forces that compromised proper stent expansion.

    The authors recommend the use of intravascular ultrasound and multiprojection venography to confirm stent expansion and positioning. They also suggest that designing stents to mitigate force imbalances could be beneficial.

Commentary

    In this study, the authors investigated techniques and biomechanical forces impacting venous stent deployment. Although performed in a swine model, the principles are expected to apply to stent deployment in humans. This research has the potential to benefit patient care through technique optimization and product development. While study limitations may prevent direct correlation with human patient care, conducting future studies with larger sample sizes and controlled designs to allow for statistical analyses could be beneficial. In the interim, the principles demonstrated in this study can help achieve better stent placement and reduce potential complications.

Post author

Ryan R. Babayev, MD, MSc
Diagnostic Radiology Resident
Hartford Hospital
@RyanBabayevMD

Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis

Clinical Question

Is middle meningeal artery embolization (MMAE) via liquid embolic agents a safe and effective alternative to conventional neurosurgery for treating chronic subdural hematomas?

Take Away Point

MMAE demonstrated 100% success rate, significantly lower reoperation, recurrence, and mortality rates compared to conventional neurosurgery.

Reference

Mowla A, Abdollahifard S, Farrokhi A, Yousefi O, Valibeygi A, Azami P. Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. J Vasc Interv Radiol. 2023;34(9):1493-1500.e7. doi:10.1016/j.jvir.2023.05.010

Click here for abstract

Study Design

Systematic review and meta-analysis of 14 studies containing 276 patients

Funding Source

No reported funding

Setting

Academic, Keck School of Medicine, Los Angeles, CA
Academic, Shiraz Research Center for Neuromodulation and Pain, Shiraz, Iran
Academic, Shiraz University of Medical Sciences, Shiraz, Iran
Academic, Fasa University of Medical Sciences, Fasa, Iran

Figure

Figure E1.Heterogeneity, proportion, and 95% confidence interval related to the success rate of chronic subdural hematoma treatment following middle meningeal artery liquid embolization after excluding the study by Fan et al. CI = confidence interval. (Fan G, Wang H, Ding J, et al. Application of absolute alcohol in the treatment of traumatic intracranial hemorrhage via interventional embolization of middle meningeal artery. Front Neurol 2020; 11:824.)

Summary

    Chronic subdural hematoma (cSDH) is one of the most common neurological conditions encountered in the elderly, with some requiring neurosurgical intervention due to the severity of the nonspecific symptoms. Middle meningeal artery (MMA) has been stated to be the predominant supplier contributing to the prevalence of cSDH, and multiple studies have studied the efficacies and safety of MMAE as an alternative option.

    The authors performed a systematic review and meta-analysis. Initially, 628 studies were retrieved using Preferred Reporting Items for Systematic Reviews and Meta-Analyses Criteria. The researchers ultimately extracted 14 eligible articles comprising of 276 patients undergoing 305 embolization procedures. They then evaluated the clinical success rate, adverse events rates, recurrence rates, reoperation rate, and reduction in size of cSDH.

    The results of the study demonstrated the following: Mean age of 66 years, 100% technical success rate, 1% adverse event rate, 3% recurrence rate, 4% reoperation rate, 94% reduction rate in the size of the hematoma, 78% achieving complete elimination of the hematoma, 0% mortality rate. All of these results were within the 95% confidence interval.

    These results demonstrated highly favorable results when compared to invasive neurosurgical interventions. For example, the article demonstrated that the recurrence rates of common neurosurgical techniques ranged from 11.7-28.1% compared to MMAE’s 3%. The reoperation rate with conventional methods was up to 26.4% compared to to MMAE’s 4%.

Commentary

    The authors in this study evaluated the efficacy and safety of MMAE and demonstrated extremely favorable outcomes when compared to conventional neurosurgical techniques. Most notably they report a 100% success rate and 0% mortality rate. The findings of this study can help patients who are poor surgical candidates, and as the article briefly alluded to, can significantly limit the risk associated with longer hospital stays.

Post author

Naeem Patel, DO
Radiology Resident, PGY4
Department of Radiology, Interventional Radiology Division
Hartford Hospital, Hartford, CT
@Naeemp7Patel