HOLLYWOOD, FL—Rapid advances in endovascular therapy mean that a wealth of research is undertaken each year with the goal of improving patient outcomes, including more than 140 posters and abstracts that are being presented as part of ISET 2019. These abstracts have been selected by ISET coordinators after a blinded peer review process and are on display in the in Great Hall 4 and in the foyer area outside of Great Hall 1-3 on the third floor. The research roundup below includes highlights from some of this year’s featured abstracts.
An abstract by Misra and colleagues focuses on the preliminary results and trial design of a phase 1 randomized clinical trial using autologous adipose-directed mesenchymal stem cells (AMSCs) for increasing maturation and preventing venous stenosis formation in arteriovenous fistulas used for hemodialysis. The study, which took place at a single institution, included 16 patients who underwent placement of an RCF or BCF, and the researchers reported no adverse events linked to cell delivery. “Adventitial delivery of AMSCs is safe and the efficacy of the therapy will be presented as 1-year data becomes available on these patients,” the authors wrote.
In another abstract, Hannallah and colleagues retrospectively analyzed the hospital utilization and economic impact of catheter-based intervention (CBI) compared with systemic anticoagulation (SAA) alone for treating acute massive and submassive pulmonary embolism (PE). Overall hospital and ICU length of stay and rates of readmission were examined for the 82 patients included in the study. “Interestingly, no significant difference in length of hospital or ICU stay was noted between the groups,” the researchers wrote. However, they found that 30-day readmission rates were almost three times greater in the SAA group than in the CBI group. “Our study suggests that CBI, when compared with SAA for the treatment of massive and submissive PE, can avoid potential readmissions, thereby increasing hospital financial reimbursement rates and preventing potentially negative health ratings.”
One-year data from the MIMICS-2 study, as well as interim 2-year data, are also being presented at ISET. MIMICS-2 examines the safety and efficacy of BioMimics 3D, a nitinol stent with a 3D helical centerline designed to generate swirling blood flow and elevate wall shear stress in the stented segment and improve biomechanical performance. There were 271 participants in the study, and primary safety and effectiveness endpoints were met, according to Sullivan and colleagues. Premarket approval was granted in October 2018. “Emerging 2-year data show consistency with MIMICS-RCT data, which support the hypothesis that a helical centerline stent promotes naturally antiproliferative swirling flow, providing a clinically important point of differentiation in stent selection,” the researchers stated.
Arslan and Ozen are presenting their midterm experience of below-the-ankle revascularization cases in the setting of Rutherford class 5 and 6 patients. The study included 347 patients who underwent lower extremity arterial revascularization between January 2013 and September 2017. The technical success rate of inline flow recanalization was 96.8%, and the overall limb salvage rate was 88% during an average follow-up period of 16.7 months. “Below-the-ankle recanalization interventions are technically feasible, and midterm clinical outcomes are favorable,” the authors stated. They added, “A randomized clinical trial may help to further identify role of below-the-ankle interventions in improving limb salvage rates.”
Initial and 6-month results from a study assessing safety and efficacy of a novel laser-based atherectomy catheter are being presented by Rosenfield and colleagues. The Eximo B-Laser atherectormy system (Eximo Medical Ltd, Israel) is novel 355-nm solid-state Nd:YAG short-pulse laser that uses 4 catheters (one with aspiration ports and one with both aspiration port and an “off-center” feature) containing an array of optical fibers surrounded by a blunt blade for atherectomy, developed for treatment of de novo and restenotic infrainguinal PAD, including ISR, the authors wrote. The study results presented are from an IDE pivotal study that took place at 8 US sites and 3 EU sites and included 97 patients with peripheral arterial disease with 107 lesions treated with the B-Laser. Baseline stenosis was 85.7% ± 12.2%, and there was an average of 33.6% ± 14.2% reduction in residual stenosis that was not influenced by the degree of calcification, lesion length, or lesion type. Data regarding adverse events and deaths were promising. “The B-Laser atherectomy system demonstrates a high level of safety and efficacy for de novo and restenotic infrainguinal arterial lesions,” the authors concluded.