SIR TODAY 2022 | Thursday, July 14
This year’s late-breaking abstracts were presented in a session that took place on Wednesday, June 15, at 3 p.m. In this overview, SIR Today provides brief summaries of the research presented as well as quotes from presenters on the potential impact of their work.
Percutaneously induced neuroregeneration for the management of chronic painful mononeuropathies secondary to trauma
Prologo, N. Resnick, F. Prologo, E. Friedberg
Purpose: Multicentric translational research during the last twenty years has established the potential of interventional cryoneurolysis to percutaneously induce peripheral neuroregeneration. The purpose of this study is to report the results of the first eight humans treated with CT guided cryoneurolysis for the management of pain related to mononeuropathy of a peripheral mixed nerve following trauma.
Conclusion: Percutaneous CT guided cryoneurolysis may represent a new therapeutic tool for the management of neuropathic pain induced by trauma.
Presenter quote (David Prologo, MD, FSIR): The potential impact of these findings lies in the ability to percutaneously replace a damaged and painful nerve with a new, regenerated set of axons. Patients with mononeuropathic pain related to prior trauma, iatrogenic damage or other modes of injury may have a brand-new option for cure—without opioids or other pain medications.
Interventional radiologists have a unique ability to percutaneously access neural structures from the skull base to the toes. Understanding that we can further induce calculated and deliberate Wallerian degeneration with subsequent induced axonal regeneration may open new doors for a myriad of potential applications—both within the pain space and beyond.
Pivotal, prospective multicenter U.S. study of Lava, a liquid embolic agent used to treat peripheral arterial hemorrhage
Arslan, G. Siskin, Z. Haskal, N. Abi-Jaoudeh, M. Katz, R. Lookstein, M. Razavi
Purpose: The Lava™ Liquid Embolic System (Lava LES; BlackSwan Vascular, Inc, Hayward, Calif.) is an injectable, nonadhesive liquid embolic agent. Here we describe results to-date from the ongoing, prospective, single-arm, multicenter Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA) study evaluating the safety and effectiveness of the Lava LES for acute peripheral arterial hemorrhage.
Conclusion: The results thus far from the LAVA study suggest that Lava™ LES is effective and can be safely used as an embolic agent for treatment of peripheral arterial hemorrhage.
A multicenter, observational registry of patients undergoing liver tumor ablation with the NEUWAVE microwave ablation system: preliminary results of the first 305 patients
Odisio, C. Yoon, S. Huang, J. Kuban, C. Shaw, K. Anton, R. Tomihama, K. De Jong, S. Ruiter, N. Fotiadis, K. Alqararha
Purpose: To use real-world evidence to better understand the safety and efficacy of microwave ablation (MWA) for the treatment of primary and metastatic liver tumors.
Conclusion: Preliminary data from this large, multicenter, observational registry indicate that MWA is safe and effective for the treatment of liver tumors. Continued enrollment and longer follow-up will provide a better understanding of the interaction of MWA parameters (time and power) with specific patient and tumor characteristics that may support predictions of ablation outcome.
Presenter quote (Bruno Odisio, MD): The preliminary data of this large, multicenter, observational registry provides robust real-world evidence that microwave ablation is safe and effective for the treatment of live tumors.
Despite of the widespread use of microwave liver ablation in clinical practice, we still lack real-world evidence data to help us understand in a comprehensive manner the overall outcomes of this treatment modality that may be generalizable to a wide range of patients. On the preliminary results of this IR-driven study, we have confirmed the safety and efficacy of microwave ablation on a wide range of patients. The ongoing enrollment and longer follow-up of up to 5 years will also allow us to better understand the interaction of MWA parameters with specific patient and tumor characteristics that may support predictions of ablation outcomes.
Focal treatment of early-stage NSCLC using pulsed electric fields: INCITE ES Study
Jimenez, J. Fernandez, J. Flandes Aldeyturriaga, E.H.F.M. van der Heijden, W. Krimsky
Purpose: To evaluate the safety and feasibility of pulsed electric field (PEF) treatment of non-small cell lung cancer (NSCLC) tumors using a PEF system to deliver energy to soft tissue.
Conclusion: This initial series demonstrates feasibility of delivering PEF energy with a single electrode in NSCLC tumors. No PEF-related adverse events have been observed, and treatment near adjacent critical structures was feasible and without impact on the planned surgical resection.
Achieving optimal outcomes in the treatment of venous outflow obstruction: An international Delphi consensus
Hofmann, S. Black, R. de Graaf, P. Gagne, M. Gohel, M. Silver, B. Fleck
Purpose: The purpose of this study was to determine the level of consensus regarding best practices for treating venous obstructive disease.
Conclusion: This study demonstrated that while there are several areas where venous experts agree on the assessment and management of venous outflow obstruction, there are multiple domains where consensus was not achieved. This underlines that treating venous disease remains a controversial area and requires focused and coordinated research efforts across specialties to answer a number of unresolved clinical questions. The Delphi consensus has identified those areas in which these efforts should be focused.
IN.PACT AV Access Trial: clinical cohort outcomes and subgroup analyses through 36 months
Lookstein, A. Holden
Purpose: Long-term safety and effectiveness outcomes of the randomized treatment of dysfunctional arteriovenous fistulas with either percutaneous transluminal angioplasty (PTA) or drug-coated balloon (DCB) have not yet been reported.
Conclusion: The IN.PACT AV Access Study is the first pivotal trial to present 3-year clinical outcomes comparing DCB to PTA in the management of dysfunctional arteriovenous fistula. DCB demonstrated superior outcomes compared to PTA as measured by TLPP and ACPP and access circuit thrombosis.
Presenter quote (Robert A. Lookstein, MD, FSIR): The key impact of this clinical trial is that the efficacy results of the IN.PACT AV balloon in dysfunctional AV fistulae persist and provide clinical benefit up to 36-month follow-up as demonstrated by significant improvements in target lesion primary patency and access circuit primary patency. In addition, there is significant reduction in the need for repeat interventions as well as a significant reduction in the incidence of AV Access thrombosis. There is no difference in mortality between the IN.PACT AV group and the control group in this trial out to 36-month follow-up demonstrating the safety of this technology for patients on hemodialysis.
Real-world study of excimer laser sheath-assisted retrieval for patients with embedded inferior vena cava filters: Safety and efficacy across a multi-center experience
Desai, J. Kaufman, P. Truong, J. Lindquist, O. Ahmed, S. Flanagan, A. Sood, M. Garcia, R. Ryu
Purpose: Excimer laser sheath-assisted retrieval of embedded inferior vena cava (IVC) filters has been described in single-center studies, limiting the generalizability of the technique. This is a retrospective, multicenter, real-world observational study aiming to evaluate the broader safety and success of the excimer laser sheath-assisted retrieval of embedded IVC filters.
Conclusion: The results of this multicenter real-world study demonstrated high technical success and low complication rates when using the excimer laser sheath for retrieval of embedded IVC filters. This study broadens the available data on this technique, with the results suggesting that it is generalizable across broader populations for the retrieval of IVC filters that are no longer indicated, in line with regulatory guidance.
Presenter quote (Kush R. Desai, MD, FSIR): Though the use of excimer laser sheath for embedded IVC filter retrieval has been described by single centers with expertise in complex filter retrieval, the generalizability of this technique has been called into question since no multicenter data has been previously available. We performed a multicenter retrospective study of use of this device for embedded filter retrieval; despite variability in experience, technical success rates were consistently high and rates of adverse events were very low. This dataset demonstrates that excimer laser sheath can be used on a broader basis for embedded filter retrieval. This data directly led to the U.S. FDA granting the device breakthrough designation and, ultimately, approval.
If you encounter patients with chronically embedded IVC filters that are no longer indicated, the FDA has indicated in 2010 and 2014 safety communications that they should be considered for removal. Our data demonstrates that the excimer laser sheath can be used for safe, effective removal of these devices with an acceptable learning curve (four cases, on average).
Impact of mechanical thrombectomy with the FlowTriever System on pulmonary embolism patients, including those with severe pulmonary hypertension
Purpose: Broader adoption of interventional therapies for pulmonary embolism (PE) has been impeded by a scarcity of clinical evidence and by current practice guidelines, which recommend anticoagulation in most scenarios. We present interim data from the FLASH registry to evaluate outcomes at up to 6 months following mechanical thrombectomy with the FlowTriever System (Inari Medical).
Conclusion: Interim data from the FLASH registry suggest that the FlowTriever System can safely treat intermediate and high-risk PE, including in patients with severe pulmonary hypertension, and can significantly improve acute hemodynamics and patient-centered outcomes through 6 months.
Presenter quote (Reha Butros, MD): Clinical evidence supporting intervention for pulmonary embolism patients is limited, especially in high-risk subgroups. Patients with underlying pulmonary hypertension are often excluded from clinical study enrollment, exacerbating the issue. In this interim analysis of the FLASH Registry evaluating safety and effectiveness of FlowTriever mechanical thrombectomy for PE treatment, 12% of enrolled patients had PH at baseline (sPAP ≥ 70 mmHg). These patients experienced an immediate 18.3% decrease in mean pulmonary artery pressure, no major adverse events at 48 hours, and only one (1.9%) mortality at 30 days. These results are comparable to those of the full study population and suggest that PE patients with PH can be safely and effectively treated with the FlowTriever system.
This interim analysis from the FLASH Registry represents the first interventional data in this patient group and suggests that PE patients with underlying pulmonary hypertension can be safely and effectively treated with the FlowTriever system.