Background <p>Percutaneous ultrasound (US)-guided core-needle biopsies (CNBs) is increasingly used to obtain tumor tissue across all anatomic regions to guide personalized cancer treatment; however, data with particular attention on serious adverse events (SAEs) and appropriate observation times to detect clinically-relevant SAEs are limited. We aimed to assess the incidence, influencing factors, and temporal manifestation of SAEs after US-guided CNB of tumors in the thorax and abdomen to identify patient safety measures with a focus on observation time that will allow safe post-biopsy patient discharge.</p> Methods <p>This retrospective review of a prospectively collected single-institutional database included 7.494 patients who underwent percutaneous US-guided automated CNBs of 522 thoracic and 6.972 abdominal tumors between 1992 and 2022. The database was reviewed to identify biopsy-related SAEs of Clavien-Dindo (CD) grade ≥ 2, which were classified as acute (&lt; 6&#xa0;h), subacute (6–24&#xa0;h), or delayed (&gt; 24&#xa0;h). CD and CIRSE ≥ 2 scales were compared for counting biopsy-related SAEs.</p> Results <p>Among a total of 29 (0.39%) SAEs CD grade ≥ 2, 28% (8/29) were acute, 62% (18/29) subacute, 10% (3/29) delayed, 90% (26/29) bleeding-related, and 10% (3/29) pneumothorax-related. Treatments were erythrocyte transfusion (12x), surgical bleeding control (10x), transarterial coiling (4x), and chest tube placement (3x). Incidences of ≥ 1% were observed for bleeding after spleen (1.6%) and kidney (1.3%) biopsy (other sites: 0-0.4%) and for pneumothorax after transpleural biopsy (1.6%) of intrapulmonal nodules. Bleeding risk associated significantly with INR, number of needle passes, double antiplatelet medication, and, in liver biopsy, with a hypervascular tumor type (<i>p</i> &lt; 0.05). CIRSE classification added 7 prolonged observational stays without treatment (CIRSE grade 2/3), raising the SAE rate from 0.39% to 0.48%. No patient death occurred.</p> Conclusions <p>Our results support the safety of the procedure but also highlight potential risks. SAE incidences vary by biopsy site and site-independent factors, and most SAEs occur within 6-24-hours after biopsy, suggesting need for risk-adjusted observation times, either for &lt; 6-hours or 24-hours, to allow safe patient discharge. Further prospective studies are needed to validate our findings and to define reasonable thresholds for low and high SAE risks that could tailor aftercare time in a pragmatic and clinically-relevant sense.</p> Clinical trial number <p>Not applicable.</p>

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Incidence, timing, and risk factors of severe complications after percutaneous ultrasound-guided tumor biopsy: a proposal for safe aftercare based on 30 years´ experience

  • Hauke Weilert,
  • Caspar-Carl Schröder,
  • Peter Wohlmuth,
  • Alexander König,
  • Andreas H. Mahnken,
  • Axel Stang

摘要

Background

Percutaneous ultrasound (US)-guided core-needle biopsies (CNBs) is increasingly used to obtain tumor tissue across all anatomic regions to guide personalized cancer treatment; however, data with particular attention on serious adverse events (SAEs) and appropriate observation times to detect clinically-relevant SAEs are limited. We aimed to assess the incidence, influencing factors, and temporal manifestation of SAEs after US-guided CNB of tumors in the thorax and abdomen to identify patient safety measures with a focus on observation time that will allow safe post-biopsy patient discharge.

Methods

This retrospective review of a prospectively collected single-institutional database included 7.494 patients who underwent percutaneous US-guided automated CNBs of 522 thoracic and 6.972 abdominal tumors between 1992 and 2022. The database was reviewed to identify biopsy-related SAEs of Clavien-Dindo (CD) grade ≥ 2, which were classified as acute (< 6 h), subacute (6–24 h), or delayed (> 24 h). CD and CIRSE ≥ 2 scales were compared for counting biopsy-related SAEs.

Results

Among a total of 29 (0.39%) SAEs CD grade ≥ 2, 28% (8/29) were acute, 62% (18/29) subacute, 10% (3/29) delayed, 90% (26/29) bleeding-related, and 10% (3/29) pneumothorax-related. Treatments were erythrocyte transfusion (12x), surgical bleeding control (10x), transarterial coiling (4x), and chest tube placement (3x). Incidences of ≥ 1% were observed for bleeding after spleen (1.6%) and kidney (1.3%) biopsy (other sites: 0-0.4%) and for pneumothorax after transpleural biopsy (1.6%) of intrapulmonal nodules. Bleeding risk associated significantly with INR, number of needle passes, double antiplatelet medication, and, in liver biopsy, with a hypervascular tumor type (p < 0.05). CIRSE classification added 7 prolonged observational stays without treatment (CIRSE grade 2/3), raising the SAE rate from 0.39% to 0.48%. No patient death occurred.

Conclusions

Our results support the safety of the procedure but also highlight potential risks. SAE incidences vary by biopsy site and site-independent factors, and most SAEs occur within 6-24-hours after biopsy, suggesting need for risk-adjusted observation times, either for < 6-hours or 24-hours, to allow safe patient discharge. Further prospective studies are needed to validate our findings and to define reasonable thresholds for low and high SAE risks that could tailor aftercare time in a pragmatic and clinically-relevant sense.

Clinical trial number

Not applicable.