Registry reinforces safety, efficacy and efficiency of radial access in visceral interventions in embolization procedures

The final results of the RAVI prospective registry study demonstrated the safety and efficacy of radial access in visceral interventions in standard embolization procedures for uterine fibroids, benign prostatic hyperplasia, and hypervascular tumours. The findings of the Terumo Medical-sponsored study were presented at the Society of Interventional Radiology (SIR) 2023 annual scientific meeting (4–9 March, Phoenix, USA).

The results of the RAVI registry—the largest, prospective, multicentre, observational study in vascular and interventional radiology (VIR)— were shared on behalf of study investigators by Marcelo Guimarães, professor of radiology and surgery, Division of Vascular and Interventional

Radiology, Medical University of South Carolina (MUSC; Charleston, USA). It showed that radial access (RA) can be used as the primary access site for relevant and emerging embolization procedures, regardless of disease state (benign or malignant).

Of the 105 patients screened for the study, 99 were successfully enrolled in six US hospitals and treated between February 2020 and January 2022. In addition to MUSC, the other leading IR centres that participated were: Mount Sinai Hospital (New York); St Louis University (St Louis); University of North Carolina at Chapel Hill; Rush University (Chicago); and the University of California, Los Angeles.

74.7% complications, stroke, myocardial infarction and death at 30 days. The procedural endpoint was defined as successful completion of the intended procedure using RA (i.e. without femoral bailout), which was achieved in 100% of patients. Technical success was 100%, defined as the successful embolization of the target lesion/organ. This prospective registry confirmed the safety and efficacy of RA at 30 days’ follow-up in visceral embolization procedures. Of the 99 patients in the study, 74 (74.7%) were able to be discharged the same day of their procedure, demonstrating that RA for embolization procedures can create efficiencies in cost management. In addition, newly presented one-year results focus on 70 patients where UFE was performed. The data showed that transradial UFE allows for fast recovery, low risk of bleeding and other complications, and demonstrates sustained increase in quality of life.

The primary safety endpoints included RA-related

Injectable tissue provides significant, long-term relief for chronic back pain

A minimally invasive treatment that injects allograft disc tissue into the spine to relieve pain associated with degenerative disc disease provides significant improvement in pain and function over a sustained period, according to new research presented at the Society of Interventional Radiology (SIR) annual scientific meeting (4–9 March, Phoenix, USA).

THE TREATMENT, KNOWN AS viable disc allograft supplementation, injects specialised cells and fluid into a patient’s damaged disc. The cells of the injected fluid encourage the cells in the damaged disc to regenerate with healthy tissue.

“The significant improvement in pain and function is promising for patients living with chronic low back pain—a condition that can greatly impact a person’s quality of life,” said lead author Douglas Beall, chief of radiology at Clinical Radiology of Oklahoma (Oklahoma City, USA). “This treatment may help patients return to normal activity for a longer period of time.”

Fifty patients at nine sites participated in this three-year voluntary extension of the randomised controlled ‘Viable allograft supplemented disc regeneration in the treatment of patients with low back pain’ (VAST) trial, with 46 receiving allograft treatment and four receiving saline. The treatment group was similar to the patient population at the start of the trial in age, sex, race, ethnicity, body mass index and smoking status. Pain levels were evaluated using the visual analogue scale and functionality was measured using the Oswestry Disability Index (ODI).

Sixty percent of patients who received allograft treatment for chronic low back pain reported a greater-than-50% improvement in pain and 70% of patients reported more than a 20-point improvement in their ODI scores. There were no persistent adverse events reported.

“Existing treatment for chronic low back pain due to degenerative disc disease is often ineffective or the effects are short-lived,” said Beall. “We need better treatments for this condition since conservative care is not providing the long-term outcomes that patients deserve. Injectable allograft treatment might be the answer for many people.”

Use of allograft could even help decrease opioid use among patients with chronic low back pain, researchers said, which would be especially meaningful for younger patients who have years of function and quality of life to look forward to. In a media briefing held by SIR ahead of the annual meeting, Beall expanded on this to say that the treatment’s potential impact is “huge”, as this type of chronic back pain is “maybe one of the most common disease processes known to man”.

LEAD RESEARCHERS

“We are proud to announce the oneyear results from the biggest cohort of patients where UFE is performed using radial access,” said Guimarães. “Safety and effectiveness of this procedure, as shown in this study, should affirm our belief that radial access could become preferred for all common embolization procedures.”

Clifford Weiss and Daniel Giraldo Herrera (Johns Hopkins University School of Medicine, Baltimore, USA) presented their recent bariatric arterial embolization (BAE) study at the Society of Interventional Radiology (SIR) annual scientific meeting (4–9 March, Phoenix, USA). Their research found that the procedure was associated with “significant” weight loss that did not affect muscle mass, as detected by whole-body magnetic resonance imaging anthropometry. The authors note in the study abstract that the purpose of their research was “to evaluate the early effects of BAE on multicompartment fat and muscle body composition”, which constitutes the pilot phase of the BEATLES trial (bariatric embolization of arteries with imaging visible embolics).

BEATLES is a US Food and Drug Administration (FDA)-approved, physician-initiated investigational device exemption (IDE) study that, Weiss, Herrera, et al stipulate in their abstract, “evaluates tightly calibrated 100–200μm radiopaque microspheres” (BT-001933-01, Boston Scientific). Adult participants with obesity—defined as those with a body mass index [BMI]≥35 kg/ m²—were scanned at zero (baseline), three, and six months post-BAE from neck to knee using a Siemens Skyra 3T magnetic resonance imaging (MRI) scanner. The researched employed a dual-echo Dixon waterfat vibe protocol, and a single-slice multiecho Dixon proton liver density acquisition.

Anthropometrics were gathered using AMRA Researcher (AMRA Medical), a semi-automated cloudbased MRI segmentation tool, and statistical testing was performed via repeated measures correlation (Rrm).

Regarding the results, the researchers shared in their write-up that seven patients (six female, one male) with a mean age of 39.6±11.0 years and Centers for Disease Control and Prevention-defined class II–III obesity underwent BAE. At zero, three, and six months, mean body weight was 125.9±24.4, 113.5±21.2, and 110.7±23.3kg (Rrm=-0.694 [95% confidence interval (CI) -0.921–0.113], p value=0.012). Weight-tothigh muscle volume ratios were 10.3±1.9, 10.0±0.5, and 9.2±1.3 kg/L (Rrm=0.89 [95% CI 0.64–0.97], p value =0.001), respectively. Weiss, Herrera, et al were able to conclude that “BAE with 100–200μm microspheres is associated with significant postprocedural musclesparing weight loss via subcutaneous and intramuscular fat reduction.”