Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results

Figures

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  Figure 1. Flow diagram of patient enrollment and follow-up.

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  Figure 2. Kaplan-Meier analysis of freedom from mortality. Kaplan-Meier time-to-event analysis was performed to evaluate freedom from mortality over time. ∗One additional death occurred at day 291.

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  Figure 3. RV echocardiographic parameters at baseline and 48 hours, 30 days, and 6 months postthrombectomy. (A) Right ventricular (RV) to left ventricular (LV) ratio at baseline and follow-up times (P < .0001 for available paired assessments; Wilcoxon signed-rank test). (B) RV systolic pressure at baseline and follow-up times (P < .0001 for available paired assessments; Wilcoxon signed-rank test). (C) Distribution of patients’ RV function at baseline and follow-up times (P < .0001 for available paired assessments; McNemar-Bowker’s test). (D) Distribution of RV size at baseline and follow-up times (P < .0001 for available paired assessments; McNemar-Bowker’s test). The sample sizes below each posttreatment timepoint represent the number of patients who had paired measurements with baseline values.

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  Figure 4. Dyspnea score distribution at baseline, 48 hours, 30 days, and 6 months postthrombectomy. Dyspnea was assessed at baseline and at follow-up visits at 48 hours, 30 days, and 6 months postthrombectomy using the modified Medical Research Council assessment tool (higher score = worse dyspnea). The proportion of patients with each score (0-4) is presented, showing a significant change in score distribution (P < .0001 for available paired assessments; McNemar-Bowker’s test). Mean ± SD and median (IQR) values for each timepoint are shown in the table below the graph (P < .0001 for available paired assessments; Wilcoxon signed-rank test). The sample sizes below each posttreatment timepoint represent the number of patients who had paired measurements with baseline values.

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  Figure 5. Six-minute walk test distance and Borg dyspnea and fatigue scores pre- and postwalk at 48 hours, 30 days, and 6 months postthrombectomy. (A) Increase in median 6MWT distance over time. Box and whisker with half-violin plot demonstrates median 6MWT distance in meters (middle bar) and IQR [Q1, Q3] as outer bounds of boxes, with mean indicated as a light blue dot and outliers indicated as black dots. Trend over time analysis was performed using a generalized linear mixed effects model (P < .001). (B) Borg dyspnea score and (C) Borg fatigue score pre- and post-6MWT at follow-up visits. Median scores pre- and post-6MWT at each follow-up visit are shown. Box and whisker plot presents median Borg scores (middle bar) and IQR (Q1-Q3) as outer bounds of boxes, with mean indicated as a light blue dot and outliers indicated as black dots. Trend over time analysis was performed using a generalized linear mixed effects model. Trend over time for dyspnea pre-6MWT: P = .004; post-6MWT: P < .001. Trend over time for fatigue pre-6MWT: P = .064; post-6MWT: P < .001. The sample sizes below each timepoint represent all available data. 6MWT, 6-minute walk test.

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  Figure 6. Total PEmb-QoL score at 30 days and 6 months postthrombectomy. Box and whisker with half-violin plot demonstrates median PEmb-QoL scores (middle bar) and IQR (Q1-Q3) as outer bounds of boxes, with mean indicated as a light blue dot and outliers indicated as black dots. Trend over time analysis was performed using a generalized linear mixed effects model (P < .001). The sample sizes below each timepoint represent all available data. PEmb-QoL, Pulmonary Embolism Quality of Life.

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  Central Illustration. Summary of patient enrollment, follow-up metrics, and 6-month clinical and functional outcomes for the fully enrolled US cohort of the FLASH registry in pulmonary embolism. The FLASH registry enrolled 800 patients with acute pulmonary embolism across 50 US sites who were undergoing treatment with mechanical thrombectomy using the FlowTriever System and followed them through 6 months postthrombectomy. Follow-up completion and mean duration of follow-up are reported, along with 6-month all-cause mortality. Clinical and functional outcomes assessed from baseline through 6 months include echocardiographic measurements of RV size and function, dyspnea using the modified Medical Research Council score, exercise capacity using the 6-minute walk test, quality of life using the PEmb-QoL score, and prevalence of chronic disease outcomes including CTEPH or CTED. CTED, chronic thromboembolic disease; CTEPH, chronic thromboembolic pulmonary hypertension; FLASH, FlowTriever All-comer Registry for Patient Safety and Hemodynamics; PEmb-QoL, Pulmonary Embolism Quality of Life; RV, right ventricular.