Proposal of a New Adverse Event Classification by the Society of Interventional Radiology Standards of Practice Committee

Khalilzadeh, Omid; Baerlocher, Mark O.; Shyn, Paul B.; Connolly, Bairbre; Devane, A. Michael; Morris, Christopher S.; Cohen, Alan M.; Midia, Mehran; Thornton, Raymond H.; Gross, Kathleen A.; Caplin, Drew; Aeron, Gunjan; Misra, Sanjay; Patel, Nilesh H.; Walker, T. Gregory; Martinez-Salazar, G; Silberzweig, James E.; Nikolic, Boris

doi:10.1016/j.jvir.2017.06.019

Cited by 567 publications

(275 citation statements)

References 22 publications

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“…Complications were recorded and classified according to the Society of Interventional Radiology Adverse Event Severity Scale, which was designed to translate to the surgical Clavien‐Dindo scale . The severity scale is based on the degree of care escalation, ranging from mild events requiring no therapy or unsubstantial therapy to patient death.…”

Section: Methodsmentioning

confidence: 99%

Percutaneous cryoablation for the treatment of extra‐abdominal desmoid tumors

Tremblay

Lea

Neilson

et al. 2019

Journal of Surgical Oncology

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Background Desmoid tumors are rare locally invasive, benign neoplasms that develop along aponeurotic structures. Current treatment is complicated by associated morbidity and high recurrence rates. Methods A retrospective, single‐institution review identified 23 patients (age: 16‐77) with extra‐abdominal desmoid tumors who received CT‐guided percutaneous cryoablation as either a first‐line (61%) or salvage (39%) treatment in 30 sessions between 2014 and 2018. Median maximal lesion diameter was 69 mm (range: 11‐209). Intent was curative in 52% and palliative in 48%. Contrast‐enhanced cross‐sectional imaging was obtained before and after treatment in addition to routine clinical follow‐up. Results Technical success was achieved in all patients. The median follow‐up was 15.4 months (3.5‐43.4). Symptomatic improvement was demonstrated in 89% of patients. At 12 months, the average change in viable volume was −80% (range −100% to + 10%) and response by modified response evaluation criteria in solid tumors (mRECIST) was CR 36%, PR 36%, and SD 28% No rapid postablation growth or track seeding was observed. Four patients underwent repeat cryoablation for either residual or recurrent disease. Two patients sustained a major procedural complication consisting of significant neuropraxia. Conclusion Cryoablation for desmoid tumors demonstrates a high degree of symptom improvement and local tumor control on early follow‐up imaging with relatively low morbidity.

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Section: Methodsmentioning

confidence: 99%

Percutaneous cryoablation for the treatment of extra‐abdominal desmoid tumors

Tremblay

Lea

Neilson

et al. 2019

Journal of Surgical Oncology

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“…The primary outcome measures were safety, defined as procedure‐related morbidity consisting of postembolization syndrome (right upper quadrant pain, fever, nausea/vomiting), decrease in renal function, sepsis (life‐threatening organ dysfunction caused by a dysregulated host response to infection), and adverse events (abscess formation, bleeding, malignant transformation). Complications were graded according to the Society of Interventional Radiology Classification System for Complications by Outcome (SIR). Minor complications were classified as: A, no therapy, no consequence; and B, nominal therapy, no consequence, including overnight admission for observation only.…”

Section: Methodsmentioning

confidence: 99%

Safety and efficacy of transarterial embolization of hepatocellular adenomas

Rosmalen

Klompenhouwer

Graeff

et al. 2019

British Journal of Surgery

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Background Hepatocellular adenoma (HCA) larger than 5 cm in diameter has an increased risk of haemorrhage and malignant transformation, and is considered an indication for resection. As an alternative to resection, transarterial embolization (TAE) may play a role in prevention of complications of HCA, but its safety and efficacy are largely unknown. The aim of this study was to assess outcomes and postembolization effects of selective TAE in the management of HCA. Methods This retrospective, multicentre cohort study included patients aged at least 18 years, diagnosed with HCA and treated with TAE. Patient characteristics, 30‐day complications, tumour size before and after TAE, symptoms before and after TAE, and need for secondary interventions were analysed. Results Overall, 59 patients with a median age of 33.5 years were included from six centres; 57 of the 59 patients were women. Median tumour size at time of TAE was 76 mm. Six of 59 patients (10 per cent) had a major complication (cyst formation or sepsis), which could be resolved with minimal therapy, but prolonged hospital stay. Thirty‐four patients (58 per cent) were symptomatic at presentation. There were no significant differences in symptoms before TAE and symptoms evaluated in the short term (within 3 months) after TAE (P = 0·134). First follow‐up imaging was performed a median of 5·5 months after TAE and showed a reduction in size to a median of 48 mm (P < 0·001). Conclusion TAE is safe, can lead to adequate size reduction of HCA and, offers an alternative to resection in selected patients.

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“…Remote intrahepatic tumor was defined as the appearance of a new lesion in the liver [37]. Adverse events were classified as mild, moderate, severe, disabling and patient death according to the new adverse event classification proposed by the Society of Interventional Radiology [38].…”

Section: Follow-up and Study Endpointsmentioning

confidence: 99%

Computed tomography-guided percutaneous microwave ablation with artificial ascites for problematic hepatocellular tumors

Wang

Zhang

et al. 2020

International Journal of Hyperthermia

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2020)Computed tomography-guided percutaneous microwave ablation with artificial ascites for ABSTRACT Background: The aim of this study was to assess the feasibility, safety and efficacy of computed tomography (CT)-guided percutaneous microwave ablation with artificial ascites for problematic hepatocellular tumors. Methods: Forty-eight patients with 61 problematic hepatocellular carcinomas who underwent CTguided percutaneous microwave ablation with artificial ascites were reviewed retrospectively. Lesions less than 5 mm away from the gastrointestinal system, diaphragm, pericardium or kidney were defined as problematic tumors with the potential risk of thermal damage. Microwave ablation was performed after artificial ascites was established between tumors and the adjacent high-risk organs. The technical effectiveness of microwave ablation, local tumor progression and complications was assessed. Results: Microwave ablation with artificial ascites was successfully performed in all 61 tumors. The technical effectiveness rate was 100% with contrast-enhanced CT performed immediately after the ablation procedure. Local tumor progression occurred in three (6%) of the 48 patients during the follow-up period (mean, 15 months; range, 6-24 months). No major complications related to the procedure occurred. Conclusion: CT-guided percutaneous microwave ablation with artificial ascites is a feasible, safe and effective choice for treating problematic hepatocellular tumors, avoiding potential thermal damage to the adjacent high-risk organs. ARTICLE HISTORY

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Proposal of a New Adverse Event Classification by the Society of Interventional Radiology Standards of Practice Committee

Abstract: This study proposed an AE classification system that outperformed the existing SIR classification in the studied domains.

Cited by 567 publications

References 22 publications

Percutaneous cryoablation for the treatment of extra‐abdominal desmoid tumors

Percutaneous cryoablation for the treatment of extra‐abdominal desmoid tumors

Safety and efficacy of transarterial embolization of hepatocellular adenomas

Computed tomography-guided percutaneous microwave ablation with artificial ascites for problematic hepatocellular tumors

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