A 75 year old female patient presented with acute-onset dyspnea and substernal chest pain. The patient was mildly hypertensive (140/69 mm Hg) with a normal heart rate (84 bpm) and hypoxemic (SaO2 87%). She had both elevated D-dimer and troponin with an electrocardiogram showing sinus rhythm and right bundle branch block. CTA showed extensive bilateral PE with evidence of right heart strain (RV/LV ratio, 1.4) (Figure 2). Echo also confirmed RV dilatation and pressure overload.

After reviewing her history and confirming she met the eligibility criteria, a decision was made to address her acute PE with the Akura system.

A pigtail catheter was advanced into the main pulmonary artery (PA) for imaging, after which an exchange was made for a 0.035-inch Supra Core wire (Abbott). The Akura system (sheath, dilator, and catheter) was advanced into the right PA (Figure 3). The initial PA pressure was 50 mm Hg based on the built-in pressure sensor. The expanded funnel engaged the clot once in the proximity of the thrombus and the clot was cleared (Figure 4). Using the bidirectional feature of the sheath, the left PA was similarly engaged and cleared. The PA pressure dropped to 32 mm Hg.

A 48-hour follow-up CTA showed the reduction in thrombus burden and the RV/LV ratio normalized at 0.96 (Figure 5).

This initial clinical experience suggests that the innovations incorporated into the Akura Thrombectomy Catheter System performed as intended, leading to improved symptoms, significant reduction in RV/LV ratio, and decreased thrombus burden. Further study will be necessary in a larger cohort to demonstrate clinical utility in a variety of VTE patients.