The Valley Hospital

BACKGROUND:With catheter-based interventions increasingly requiring large-bore venous access, reliable closure methods for 16-17F sheaths are essential. Current manual compression techniques can prolong recovery, delay ambulation and discharge candidacy, and cause patient discomfort. The VASCADE MVP XL Venous Vascular Closure System is designed to address this gap. OBJECTIVE:The AMBULATE EXPAND trial was a prospective, single-arm, multi-center pivotal study designed to evaluate the safety and efficacy of the investigational device for closure of large-bore femoral venous access sites, and to generate evidence for customary regulatory review. METHODS:This trial (February-September of 2025) enrolled patients undergoing non-emergent procedures requiring a single 16-17F outer diameter (OD) sheath and optional smaller sheaths. The primary efficacy endpoint was time to ambulation. The primary safety endpoint was the 30-day rate of major access-site complications. Secondary endpoints included time to hemostasis, total post-procedure time, discharge eligibility, device success, and 30-day rate of minor access-site complications. RESULTS:A total of 77 patients were enrolled with none lost to follow-up. The study met both primary efficacy and safety endpoints. The mean time to ambulation was 3.2 h, and mean time to hemostasis was 2.7 min. The mean total post-procedure and time to discharge eligibility were 3.3 and 3.4 h, respectively. Device success was achieved in 98.7% of access sites. The primary safety endpoint of major venous access site closure-related complications over 30 days was 0%. Minor venous access site closure-related complications were also 0%. CONCLUSIONS:The study results demonstrate that the VASCADE MVP XL device provides safe and effective percutaneous closure of femoral venous access sites after catheter-based procedures using 16-17F OD sheaths. Compared to standard performance goals from manual compression, the VASCADE MVP XL significantly reduced time to ambulation, hemostasis, discharge eligibility, and overall post-procedure time.

Background Atrial arrhythmias, including atrial flutter (AFL) and atrial fibrillation (AF), are frequent complications following hematopoietic stem cell transplantation (HSCT). Despite their clinical importance, the prognostic implications of these arrhythmias post-HSCT remain unclear. Methods We conducted a retrospective cohort study using the TriNetX Research Network to evaluate outcomes of AFL and AF in HSCT recipients between January 2015 and December 2024. Adult patients (≥18 years) with incident AFL or AF post-HSCT were included. Patients with pre-existing AFL or AF were excluded. Propensity score matching was applied to balance baseline characteristics, resulting in two cohorts of 218 patients each. The primary outcome was all-cause mortality at 1, 3, and 5 years. Secondary outcomes included heart failure, stroke or transient ischemic attack (TIA), and acute myocardial infarction (AMI). Kaplan-Meier survival analysis and Cox proportional hazards regression were used to evaluate mortality, while logistic regression was used for secondary outcomes. Results Of 15,432 HSCT patients screened, 4,341 met inclusion criteria, and 436 were matched for analysis (218 AFL, 218 AF). At 5 years, AFL was associated with significantly lower all-cause mortality compared to AF (35.3% vs. 51.1%; HR 0.68; 95% CI 0.54-0.87; p = 0.002). Similar trends were observed at 3 years (30.8% vs. 44.7%; p = 0.003). Kaplan-Meier analysis demonstrated a survival advantage for AFL patients (5-year survival: 40.6% vs. 20.5%; log-rank p = 0.018). Rates of heart failure (48.9% vs. 50.4%; p = 0.788), stroke/TIA (7.4% vs. 9.1%; p = 0.522), and AMI (6.5% vs. 6.5%; p = 1.000) were comparable between groups. Conclusions In HSCT recipients, AFL was associated with significantly lower all-cause mortality at 3 and 5 years compared to AF, while the incidence of cardiovascular complications was similar between cohorts. These findings highlight the prognostic importance of arrhythmia type and emphasize the need for tailored management strategies to optimize outcomes in this high-risk population.

Background Chronic limb-threatening ischemia (CLTI) represents the most severe form of peripheral artery disease, yet long-term cardiovascular outcomes after endovascular revascularization compared with claudication remain poorly defined. Methods Using the TriNetX global research network (114 health care organizations), adults undergoing endovascular lower-extremity revascularization for CLTI or intermittent claudication were identified. Propensity score matching for demographics, comorbidities, and cardiovascular medications yielded 3727 matched pairs. Major adverse cardiovascular events (all-cause mortality, myocardial infarction, or stroke) and secondary outcomes were assessed at 1, 3, and 5 years. Results At 5 years, patients with CLTI experienced a significantly higher risk of major adverse cardiovascular events compared with those with claudication (34.9% vs 30.7%; P < .001), along with greater all-cause mortality (18.7% vs 15.6%; P < .001), heart failure hospitalization (15.0% vs 13.0%; P = .001), major bleeding (15.1% vs 13.3%; P = .002), and acute kidney injury (26.4% vs 22.2%; P < .001). Rates of stroke or transient ischemic attack were similar between groups, whereas repeat revascularization was lower among patients with CLTI (45.9% vs 51.2%; P = .002). These findings were consistent at 1- and 3-year follow-up. Conclusions Chronic limb-threatening ischemia patients undergoing endovascular revascularization experience significantly worse short- and long-term cardiovascular outcomes compared with claudication, underscoring the need for intensified cardiovascular risk stratification and secondary prevention in this high-risk population following peripheral intervention.