Chief of Interventional Radiology Hoag Hospital, United States
Purpose: We evaluated the safety, efficacy, and procedural outcomes of a novel percutaneous biopsy tract cautery device.
Materials and Methods: In this IRB-approved, HIPAA-compliant study, we retrospectively reviewed 120 consecutive patients undergoing percutaneous solid organ and/or mass biopsy with tract cautery closure using SinglePass Kronos. The PACS system was searched for biopsies during the study period (2024-2025). Key procedural and clinical factors were recorded, including biopsy site, procedure time, bedrest/discharge time, complications, required treatments, and deaths. Hematologic parameters were compared in a 65 matched-pairs subset via Wilcoxon signed-rank test.
Results: Patients were 49.2% male and 50.8% female with a mean age of 62.0 ± 17.9 years. Biopsy sites included liver (74; 61.7%), kidney (28; 23.3%), abdominal/mesenteric (10; 8.3%), and lung (5; 4.2%). Indications were most often liver mass (38; 31.7%), medical liver (33; 27.5%), and medical renal (25; 20.8%). Patients on blood thinners (21; 17.5%) stopped such medications per Society of Interventional Radiology guidelines. Procedures were ultrasound- (52.5%) or CT-guided (47.5%). Mean procedural time was 17 ± 7 minutes. Average bedrest and discharge times were 2.9 ± 1.2 and 2.9 ± 1.2 hours, respectively. Four self-limited, intraprocedural hematomas - all medical renal biopsies - stabilized on the procedural table after cautery. There were no device-related complications or adverse events. There were no readmissions for bleeding, transfusion, intervention, or surgery within the 30-day follow-up. Five deaths during follow-up were all hospice patients; there were no procedure-related deaths. There was a paradoxical increase in post- versus pre-procedural hemoglobin (11.9 ± 2.1 vs. 11.6 ± 2.1 g/dL respectively, p=0.0019), carrying no clinical significance.
Conclusion: This novel cautery device provided effective tract closure during percutaneous biopsy with rapid recovery and no major bleeding events, significant complications, or related deaths. These findings support device deployment in common high-risk biopsy settings, particularly hepatic and renal. There may be advantages over conventional closure methods. Prospective studies with larger cohorts and longer-term outcomes should be performed to confirm safety, rare complication rates, and cost-effectiveness.