Safety of the Inari FlowTriever device for mechanical thrombectomy in patients with acute submassive and massive pulmonary embolism and contraindication to thrombolysis

Abstract

Objectives: This report evaluates the safety of percutaneous mechanical thrombectomy with the Inari FlowTriever System (Inari Medical, Irvine, California) for the treatment of acute massive/submassive pulmonary embolism (PE) specifically in therapeutically anticoagulated patients with contraindication to thrombolysis. Material and Methods: A single-center retrospective chart review was performed on patients with contraindication to thrombolysis and massive/submassive PE who underwent FlowTriever thrombectomy between 2017 and 2019. Primary outcomes included procedure or device-related complications within 30 days of discharge. Secondary outcomes included technical and clinical success defined by improvement in mean pulmonary artery pressure (PAP), oxygen saturation, and heart rate. Results: Thirteen patients with contraindication to thrombolysis received FlowTriever thrombectomy with technical success achieved in all cases. Zero major or minor adverse events, technical complications, delayed procedure-related complications, or deaths within 30 days of hospital discharge occurred. Mean PAP decreased significantly by 19.1% (32.5 ± 13.3 mmHg to 26.3 ± 12.4 mmHg; P = 0.0074, 95% confidence interval (CI) 2.0–10.5 mmHg). Oxygen saturation improved post-procedure (increased 3.9 ± 3.8%; p = 0.0032, 95% CI 1.6– 6.1%) as did heart rate (decreased 22.2 ± 17.0 bpm; P < 0.001, 95% CI 11.9–32.4 bpm). Anticoagulation was maintained throughout every procedure and all patients were closed with purse-string suture only. Conclusion: FlowTriever mechanical thrombectomy appears safe for acute PE in therapeutically anticoagulated patients with contraindications to thrombolytic therapy. These patients may experience immediate hemodynamic improvements similar to those reported in other studies. Further data are needed to prospectively evaluate long-term safety in this population.

In-Hospital Mortality and Related Outcomes for Elevated Risk Acute Pulmonary Embolism Treated With Mechanical Thrombectomy Versus Routine Care

“…Though based largely upon anecdotal experience, our rationale for performing MT appears consistent with the documented experience of other groups. [31][32][33] In order to reduce the potential selection bias of higher risk patients being preferentially referred for intervention, deliberate steps were taken to separate the time periods from which the MT and RC groups were formed. The RC group patients were selected only from the 18-month time period immediately prior to when MT was available as a treatment option at our institution.…”

Catheter Interventions for Pulmonary Embolism: Mechanical Thrombectomy Versus Thrombolytics

“…45 The high-risk population subset in FLASH also has been evaluated and demonstrated positive outcomes, with zero mortalities seen in the 63 high-risk patients at 48 hours and significant reduction in RV/LV ratio from 1.5 at baseline to 1.1 at 48 hours and 0.9 at 30 days. 47 Analysis of a subset of FLASH patients in whom intravascular ultrasound was used pre-and post-thrombectomy 48 as well as several non-industry single-center studies of FlowTriever have also been published, including single-center and multicenter evaluations, [49][50][51][52][53] showing comparable safety and effectiveness outcomes as demonstrated by the FLASH registry data. Table 2 summarizes the risks and benefits of PE treatments discussed in this review.…”