(241) Characteristics and Outcomes of Patients Undergoing Kidney Ablation Via the NEUWAVE Microwave Ablation System from an Innovative Linkage of Device-Generated and Electronic Health Record Data

Publication Number: 574

Background: The NEUWAVE(TM) Microwave Ablation System is used for the ablation of soft tissue including the partial or complete ablation of renal lesions. Daily, NEUWAVE systems transmit device-generated data to Ethicon (“Call Home” data) containing technical information on each NEUWAVE ablation including tissue type, energy (power) delivered, ablation time, and number/type of probes used.

Objectives: To gain better understanding of patients undergoing microwave ablation (MWA) for renal lesions via the NEUWAVE MWA system using an innovative approach to link device-generated and electronic health record data.

Methods: Through a partnership with a large aggregator of integrated delivery network electronic health records (EHR), we created a privacy-compliant linkage between Call Home data and the EHR database. We supplied the aggregator with a limited dataset of Call Home records from 2013-2020, including only information on the institution at which each ablation was performed, ablation date, ablated tissue type (kidney), and an assigned random ID. A 5-step probabilistic linkage was performed, which resulted in the identification of an institution/date/ablated tissue combination in the EHR and a matched combination in the Call Home data. Using the linked dataset, we measured patient demographics, lesion characteristics, baseline renal insufficiency, selected 30-day complications, pre-ablation/90-day post ablation eGFR, and device-generated data on ablation parameters.

Results: From the 76 unique patients in the EHR who had an exact 1:1 linkage with ≥1 Call Home record for kidney ablation, patients with a previous kidney ablation (n=5) and those without ≥30 days of pre-ablation data in the EHR (n=1) were excluded from the final sample of 70 patients. Patients had a mean (SD) age of 66 (12.5) years; 30.0% female; 88.6% Caucasian; 67.1% documented renal cell carcinoma; median duration of available pre/post-ablation EHR data of 6.5/2.2 years. Baseline renal insufficiency was reported in 25 (36%) patients; 30-day complications included urine retention, thrombosis, bleeding, and retroperitoneal infection in 4 (5.7%), 3 (4.4%), 2 (2.9%), and 1 (1.4%) patients, respectively. Median eGFR was 76.3 ml/min pre-ablation versus 60.0 ml/min within 90-days post-ablation (78% of patients reporting). Most patients had one (61%) or two (27%) ablation activations during the ablation procedure with the PR15 probe type used most often (74.1%) followed by the LK15 (12.9%). The median ablation procedure time was 10 minutes with a median power of 65 watts.

Conclusions: Linkage of MWA device-generated data with EHR data can be accomplished. Such linkages provide insights into the real-world use of MWA for renal lesions in community settings and other points of care.