Liver microwave ablation: a systematic review of various FDA-approved systems

Abstract

Objectives: The aim of the present study is to analyze preclinical and clinical data on the performance of the currently US Food and Drug Administration (FDA)-approved microwave ablation (MWA) systems.

Methods: A review of the literature, published between January 1, 2005, and December 31, 2016, on seven FDA-approved MWA systems, was conducted. Ratio of ablation zone volume to applied energy R(AZ:E) and sphericity indices were calculated for ex vivo and in vivo experiments.

Results: Thirty-four studies with ex vivo, in vivo, and clinical data were summarized. In total, 14 studies reporting data on ablation zone volume and applied energy were included for comparison R(AZ:E). A significant correlation between volume and energy was found for the ex vivo experiments (r = 0.85, p < 0.001) in contrast to the in vivo experiments (r = 0.54, p = 0.27).

Conclusion: Manufacturers' algorithms on microwave ablation zone sizes are based on preclinical animal experiments with normal liver parenchyma. Clinical data reporting on ablation zone volume in relation to applied energy and sphericity index during MWA are scarce and require more adequate reporting of MWA data.

Key points: • Clinical data reporting on the ablation zone volume in relation to applied energy during microwave ablation are scarce. • Manufacturers' algorithms on microwave ablation zone sizes are based on preclinical animal experiments with normal liver parenchyma. • Preclinical data do not predict actual clinical ablation zone volumes in patients with liver tumors.

Keywords: Ablation techniques; Electromagnetic radiation; Liver diseases; Microwaves; Tumor volume.

Fig. 1

Flow chart of article selection process

Fig. 2

Bubble chart of the ratio of ablation zone volume (mL) to applied energy (kJ) R(AZ:E) for 22 subgroups in animal studies of all devices with adequate volume/energy representation. The sizes of the bubbles are determined by the sample size of the subgroup