Presentation Authors: Srinath Kotamarti*, Buddima Ranasinghe, Frederick Greenstein, Antonio Montgomery, Unni Mooppan, Ervin Teper, David Silver, Ariel Schulman, Brooklyn, NY
Introduction: Cryoablation has assumed a growing role in the treatment of both primary, locally-recurrent and metastatic tumors. However, reporting of procedural complications remains segregated by organ system and physician specialty. We examined urologic and non-urologic device-related adverse events during cryoablation reported to a national administrative database to understand the full spectrum of possible complications.
Methods: We reviewed reports on cryoablation procedures submitted to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2015 and 2018. Cases were stratified by solid organ and device malfunction and a standardized MAUDE complication reporting system was used to evaluate direct patient impact. Logistic regression was used to compare complications between renal, prostate, and non-Urologic cases.
Results: 406 cases were identified: 80 renal, 13 prostate, 42 non-urologic, and 271 without specified organ. 306 (75.4%) cases utilized the Galil system. Reports were found to be related to thermal injury, instrument malfunction/failure, computer failure, gas issue, or unrelated to the device. 68 (16.7%) of reported cases were not completed due to the complication. 5 deaths (1.2%) were appreciated (MAUDE 4), 93 (22.9%) major complications (MAUDE 3-4), and 32 (7.9%) minor complications (MAUDE 2). The manufacturer evaluated the device in 305 (75.1%) cases and accepted blame in 159. On univariate analysis, renal cases were associated with decreased odds of being reported with MAUDE 2-4 complications (OR = 0.449, p= 0.025). Conversely, prostate and non-urologic sites were insignificantly predictive of complication level.
Conclusions: Cryoablation for any tumor, urologic or not, is associated with a diverse set of procedure-related complications. Further study will be required as the usage of cryoablation continues to increase. Urologists performing cryoablation or referring patients for this therapy should be aware to maximize procedural efficacy and safety.