The VIVA Foundation, a not-for-profit organization dedicated to advancing vascular medicine through education and research, announced results from three Late-Breaking Clinical Trials presented this afternoon at VIVA 2026, held at Bellagio Las Vegas.
For 24 years, VIVA (Vascular InterVentional Advances) has set the benchmark for premier education and clinical excellence in peripheral vascular disease. Known for delivering the most up-to-date, practice-changing data, VIVA brings together the latest science, technological innovation, and international expertise.
Predictors of Major Bleeding in Acute Intermediate-Risk Pulmonary Embolism: Analysis From the HI-PEITHO Randomized Study
Presented by Michael N. Young, MD
The randomized HI-PEITHO study demonstrated that patients with acute intermediate-risk pulmonary embolism (PE) had reduced risk of defined clinical outcomes when treated with ultrasound-facilitated catheter-directed thrombolysis (USCDT) using the EKOS Endovascular System plus anticoagulation (AC) versus standard-of-care AC alone, with no excess major bleeding risk. The impact of potential predictors on major bleeding in the entire study cohort was assessed in post hoc analyses. Major bleeding assessment was based on International Society on Thrombosis and Haemostasis (ISTH) criteria as determined by a blinded Clinical Events Committee and occurring within 30 (+7) days of randomization in the intention-to-treat cohort. The overall major bleeding rate was low, and there was no significant difference between study groups (4.0% USCDT vs 3.0% AC; 2-sided P=0.64). No intracranial hemorrhage occurred in either group. Univariable and multivariable logistic regression were used to assess predictors of major bleeding. Four variables had significant (P<0.05) main or interaction effects in multivariable analysis: cancer, RV/LV ratio, baseline National Early Warning Score (NEWS), and sex. Of these, NEWS <7 was associated with reduced major bleeding risk for patients treated with USCDT, whereas cancer and RV/LV ≥1.5 were associated with increased risk for patients treated with anticoagulation alone. The other 20 variables that were assessed did not independently affect major bleeding. Multivariable analysis suggests that baseline factors differentially impact bleeding risk for patients treated with USCDT or anticoagulation alone.
Functional Recovery After Acute Intermediate-High Risk Pulmonary Embolism: Relationship Between 6-Minute Walk Distance and Wearable-Derived Step-Based Activity in the STORM-PE RCT
Presented by Robert Lookstein, MD, MHCDL
The STORM-PE RCT is the first RCT to include a consumer wearable cohort enabling evaluation of real-world, step-based actigraphy measures and correlation with clinic-based functional capacity (6MWD) during functional recovery after acute intermediate-high risk PE. Patients randomized to treatment with computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation or anticoagulation alone were screened for eligibility and consented for the wearable cohort; enrolled patients were asked to wear a Garmin VenuSq® smartwatch through the 90-day follow-up visit. Wearable data were transmitted from the watch to a digital health platform. Wearable-derived outcomes included daily total step count, walking bout characteristics (length, number, and duration), and daily peak 10-minute step count recorded within two prespecified epochs (days 8-28 and 8-91). High compliance was defined as wear time ≥10 hours per day for ≥9 compliant days (≥3 days per week) within these epochs. A correlation analysis was performed with measured 6MWD performed at 30- and 90-day follow-up visits.
Among 100 randomized patients, 65 enrolled in the wearable cohort (CAVT=33, AC=32). All actigraphy measures were positively correlated with 30-day 6MWD in both the full wearable and high-compliance cohorts during 8-28d. Notable correlations observed in the high compliance cohort (N=33) included median daily step count (r=0.44, P=0.010), walking bout length (r=0.57, P<0.001), bout number (r=0.41, P=0.018), bout duration (r=0.42, P=0.014) and daily peak 10-minute step count (r=0.47, P=0.006). Associations between 90-day 6MWD and step-based actigraphy measures were attenuated.
Novel consumer wearable PE evidence from STORM-PE is the first to show significant correlations between consumer wearable-derived, step-based actigraphy measures and 6MWD. Correlations with 6MWD were strongest with temporally matched wearable and clinically assessed data at 30 days, with attenuation by 90 days. These findings may support feasibility and clinical utility of integrating consumer wearable monitoring into post-PE recovery studies as a complementary measure of functional recovery alongside clinically assessed exercise capacity.
Safety and Effectiveness of the Laguna Thrombectomy System™ for Treatment of Pulmonary Embolism: Outcomes From the TRUST Pivotal Study
Presented by Jay Mathews, MD, MS
Purpose: Pulmonary embolism (PE) is a major cause of morbidity and early mortality, with RV failure driving clinical deterioration. Mechanical thrombectomy offers rapid hemodynamic improvement and reduction in right heart strain without thrombolytic-associated bleeding risks. The Laguna Thrombectomy System™, an intermediate and large-bore platform consisting of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System, was studied through a prospective, single-arm, multicenter, pivotal, IDE study called TRUST to evaluate its safety and effectiveness for the treatment of acute intermediate-risk PE.
Materials and Methods: Subjects with an RV/LV ratio > 0.9 on CTA, systolic blood pressure > 90 mmHg, heart rate ≤ 120 bpm, CTA evidence of proximal PE, and with PE symptom duration ≤ 14 days were eligible for enrollment. The primary safety endpoint was a composite of major adverse events (MAE) within 48 hours post-procedure. The primary effectiveness endpoint was a reduction in RV/LV ratio assessed by CTA at 48 hours post-procedure compared to baseline. Study oversight included an imaging core laboratory and a clinical events committee.
Results: All 107 subjects underwent successful thrombectomy using study devices. The MAE rate was 0.9% (1/107), driven by a single bleeding event; no device‑related deaths, pulmonary vascular injuries, cardiac injuries, or cardio‑respiratory deterioration occurred. The single bleeding event was not related to the investigational device. Mean RV/LV ratio improved from 1.66 to 1.12 at 48 hours (mean reduction 0.53, 95% CI 0.447–0.622), representing a 32% relative improvement. Mean duration of thrombectomy was 38 minutes.
Conclusions: TRUST demonstrates that the Laguna Thrombectomy System delivers rapid RV strain reversal, significant pulmonary hemodynamic improvement, and meaningful symptom reduction with a very low rate of major adverse events. These results support its role as a high‑performing, safe, and effective non‑thrombolytic mechanical thrombectomy treatment option for intermediate‑risk PE.
About the VIVA Foundation
The VIVA Foundation is a nonprofit organization dedicated to advancing vascular medicine through education and research. Bringing together experts in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery, the Foundation provides multidisciplinary education designed to improve patient care and advance innovative therapies for vascular disease worldwide.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/.
Media personnel should contact press@viva-foundation.org with questions.
