Comparison of Aspiration Catheters with Modified Standard Catheters for Treatment of Large Pulmonary Embolism Using an In-vitro Patho-Physiological Model

Abstract

Purpose: The presented in-vitro study provides a comparison of various catheters for mechanical treatment of large-burden pulmonary embolism (PE) under standardized conditions, using a new test rig. Dedicated aspiration catheters (JETi®, Penumbra Indigo®, Aspirex®) were compared with standard catheters (Pigtail, Multi-Purpose, Balloon Catheter) applied for embolus fragmentation. Materials and Methods: Emboli prepared from porcine blood were washed into the test rig which consists of anatomical models of the pulmonary artery (PA) and of the right heart in combination with a pulsatile drive system. For all catheters, the duration of the recanalization procedure and the weight percentage (wt%) of the remaining, removed and washed-down clot fractions were evaluated. For aspiration catheters, the aspirated volume was measured. Results: All catheters achieved full or partial recanalization. The aspiration catheters showed a significantly (p < 0.05) lower procedure time (3:15 min ± 4:26 min) than the standard fragmentation catheters (7:19 min ± 4:40 min). The amount of thrombus removed by aspiration was significantly (p < 0.001) higher than that by fragmentation, averaging 86.1 wt% ± 15.6 wt% and 31.7 wt% ± 3.8 wt%, respectively. Nonetheless, most of the residue was fragmented into pieces of ≥ 1 mm and washed down. Only in 2 of 36 tests, a residual thrombus of 11.9 wt% ± 5.1 wt% remained in the central PA. Conclusion: Comparison under standardized in-vitro patho-physiological conditions showed that embolus fragmentation with standard catheters is clearly inferior to aspiration with dedicated catheters in the treatment of large-burden PE, but can still achieve considerable success. Level of Evidence: No level of evidence, experimental study.