METHODS: We analyzed data from patients with AMICS presenting to multiple centers across the Gulf region between January 2020 and December 2022. Patients were grouped according to SCAI-Cardiogenic Shock Working Group classification: group 1 (SCAI shock stages B/C) and group 2 (SCAI shock stages D/E). Primary end points were survival at 6, 12, 18, and 24 months. Both univariate and multivariate statistical methods were employed in the analysis.
RESULTS: A total of 1513 patients from the Gulf Cardiogenic Shock registry, were included with 31.1% in group 1 and 68.9% in group 2. The median follow-up was 6 months. Survival rates in group 1 were 87%, 72%, 56%, and 48% at 6, 12, 18, and 24 months, respectively, whereas group 2 exhibited survival rates of 66%, 29%, 14%, and 4%, respectively, over the same periods. Survival progressively declined with advancing SCAI shock stages, with stage B having the highest survival rates and stage E the lowest (P < .001). Multivariable Cox regression analysis identified higher SCAI stages as strong predictors of increased mortality, with patients in group 2 having a more than 3-fold higher risk of mortality compared to those in group 1 (hazard ratio, 3.13; 95% CI, 2.40-4.07; P < .001). Additionally, lower left ventricular ejection fraction, advanced age, and the presence of tachyarrhythmias were associated with increased mortality risk.
CONCLUSIONS: This is the first study to validate SCAI-Cardiogenic Shock Working Group stages in a large cohort of patients with AMICS. The SCAI shock staging classification was significantly associated with higher short- and long-term mortality in this cohort, with patients in more advanced stages (D/E) experiencing markedly worse survival outcomes. These findings underscore the utility of SCAI staging in stratifying long-term risk among AMICS patients in the Gulf region. Identification of cardiogenic shock patients at SCAI stages D and E with early hemodynamic monitoring and treating them aggressively with newer mechanical circulatory support in the early stages may improve patient survival.
METHODS: Patients with acute intermediate-risk PE and a right ventricular (RV)/left ventricular (LV) diameter ratio of ≥0.9 were eligible for enrollment in this prospective, multicenter, single-arm study. The primary effectiveness end point was reduction in the RV/LV ratio at 48 hours. The primary safety end point was the rate of major adverse events (MAEs) defined as subjects who experienced major bleeding, device-related deaths, clinical deterioration, or pulmonary vascular or cardiac injury within 48 hours postprocedurally.
RESULTS: In total, 122 subjects were enrolled at 25 sites. Mean procedure time was 37.2 ± 17.7 minutes. There were statistically significant reductions in mean 48-hour postprocedural RV/LV diameter ratio (-0.45 ± 0.27; P < .001). Postprocedural mean pulmonary arterial pressure also significantly declined from 27.8 ± 7.8 mm Hg before the procedure to 21.8 ± 7.2 mm Hg (P < .001). There was a 35.5% mean reduction in clot burden as measured by the modified Miller index score. Five (4.1%) subjects developed 7 MAEs during the postprocedural 48-hour assessment period, the majority of which were access site bleeding.
CONCLUSIONS: Percutaneous mechanical aspiration thrombectomy with the AlphaVac system provided a safe and effective treatment for acute intermediate-risk PE with a significant reduction in RV/LV ratio and clot burden with a low rate of adverse events.