Sources of Error in Interventional Radiology: How, Why, and When
Sebastian Mafeld, George Oreopoulos, E L S Musing, Tze Chan, Arash Jaberi, Dheeraj Rajan
Can Assoc Radiol J. 2020 Nov;71(4):518-527. doi: 10.1177/0846537119899226. Epub 2020 Mar 4.
In the United States, it is suggested that 210 000-400 000+ deaths can be associated with preventable harm in hospitals, which would make medical errors the third leading cause of mortality. In reality, death from preventable error is likely lower, however, less attention has been paid to these estimates.
The different types of error are defined: error of commission, omission, communication, and diagnosis. The causes of these errors in IR include an incomplete/inaccurate clinical picture as IR is a referral-based specialty, the dysfunction of equipment and technology, the treatment of the hospital sickest patients, the challenges of a minimally invasive approach to fixing complications, and the unintentional retention of foreign bodies. The top 3 preventable adverse events, according to Dagli et al., which analyzed 46 660 patient encounters and a total of 111 potentially preventable adverse events, are malpositioned or poorly secured devices, device misuse or malfunction, and adjacent organ injury. Regarding litigation, a recent study from the United States analyzed 1312 medical malpractice cases of which 184 met the criteria for study inclusion. Vascular injury during angiography or interventional procedures to be the most common complication to result in litigation (58.9%). The second most common cause was the incorrect placement of inferior vena cava filters.
There are many systematic and individual factors leading to medical errors. Therefore, when considering error in IR, a root cause analysis must account for the operator, patient, team, and environment. The use of error classification systems is recommended, such as those created by the Society of Interventional Radiology (SIR) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
Long-Term Outcomes of Endovascular Interventions in More than 500 patients with Budd-Chiari Syndrome
Naren Hemachandran, Shalimar, Subrat Acharya, Saurabh Kedia, Deepak Gunjan, Anoop Saraya, Raju Sharma, Shivanand Gamanagatti
J Vasc Interv Radiol. 2020 Nov 17;S1051-0443(20)30763-6. doi: 10.1016/j.jvir.2020.08.035.
Budd-Chiari Syndrome (BCS) is a hepatic venous outflow obstruction for which IR plays a vital role in restoring venous flow. This single-center retrospective study evaluated the clinical outcome of 510 patients having undergone interventional radiology treatments for BCS over a 19 year period.
The endovascular procedures analyzed suprahepatic inferior vena cava (IVC) and/or hepatic vein (HV) occlusion with recanalization (angioplasty and/or stent) or transjugular intrahepatic portosystemic shunt (TIPS) creation. Patients were selected through a BCS electronic database from January 2001 to December 2019. To note that for TIPS creation, a modified technique with 2 overlapping stents (1 uncovered and 1 covered) was used because no dedicated TIPS stent was available. The mean follow-up duration was 40.6 months ± 41.9 (median, 28.7 mo; range, 0.5–231 mo).
There was an overall high technical success (96%) with 2.8% major adverse events. After 1 month, a complete response was seen in 383 patients (84.7%), partial response in 54 patients (12%), and no response in 15 patients (3.3%). There was a 19% restenosis rate after an initial successful endovascular intervention, of which 86% were treated successfully. The 1-year and 5-year survival probabilities in the recanalization and TIPS groups were 96% and 89% and 90% and 76%, respectively.
The study has limitations including lack of randomization due to its retrospective nature, lack of pressure gradient measurements before and after endovascular interventions, and patients lost to follow-up, amongst others. Overall, it highlights the safety and efficacy of endovascular intervention for the management of BCS.
Genicular Artery Embolization for Osteoarthritis Related Knee Pain: A Systematic Review and Qualitative Analysis of Clinical Outcomes
Leigh C Casadaban, Jacob C Mandell, Yan Epelboym
Cardiovasc Intervent Radiol. 2021 Jan;44(1):1-9. doi: 10.1007/s00270-020-02687-z. Epub 2020 Nov 1.
Symptomatic osteoarthritis (OA) of the knee is a leading cause of disability. One of the potential treatments to relieve symptomatology is genicular artery embolization (GAE). The hypothesis behind the treatment is that embolizing the angiographically hyperemic vessels of the affected knee may reduce the transport of proinflammatory and catabolic mediators and decrease stimulation of sensory nerves.
This study is a systematic review of three cohort studies without control groups published between 2017 and 2019 from three countries. Outcomes were measured using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). VAS score is a 10-point or 100-point score in millimeters and the WOMAC score is a self-administered questionnaire with 24 items in three subsections (pain, stiffness, and physical function) commonly used for hip and knee osteoarthritis.
186 knees in 133 patients with mild-to-moderate (94%) or severe (6%) OA underwent embolization with either imipenem/cilastatin sodium (85%) or embozene (15%). On average, 2–3 vessels were treated per knee. Technical success was 100%. Average VAS improved from baseline at 1 day, 1 week, 1 month, 3 months, 4 months, 6 months, 1 year, and 2 years (66.5 at baseline vs 33.5, 32.7, 33.8, 28.9, 29.0, 22.3, 14.8, and 14.0, respectively). Average WOMAC scores improved from baseline at 1, 3, 4, 6, 12 and 24 months (45.7 at baseline vs 24.0, 31.0, 14.8, 14.6, 8.2, and 6.2). The 12 cases of severe OA showed initially improved VAS, however, it was not sustained. There were very few minor adverse events, puncture site erythema (11%) and hematoma (10%) being the most common.
GAE is therefore a promising treatment for mild-to-moderate OA-related pain. However, the limited data for severe OA suggests a non-durable response. Moreover, the comparison between the three studies was challenging due to variable definitions of clinical success, amongst other discrepancies. Future studies are encouraged, especially with a control group for the placebo effect.
Trans-Arterial Embolization for Liver Hemangiomas: It’s a New Dawn; It’s a New Day; It’s a New Life?
Tiago Bilhim, Jafar Golzarian, Otto M van Delden
Cardiovasc Intervent Radiol. 2021 Jan;44(1):92-94. doi: 10.1007/s00270-020-02707-y. Epub 2020 Nov 17.
Many IRs and hepatic surgeons feel that trans-arterial embolization (TAE) has no role when treating liver hemangiomas. However, recently, two systematic reviews and meta-analyses have raised awareness of the potential role of TAE for liver hemangiomas. These studies reviewed the data from 1284–1450 patients. Major adverse events were reported in less than 3% and minor adverse events and minor adverse events in 33%–37% of cases. Both concluded that TAE was effective, reducing the size of hemangiomas in approximately 90% of treated patients, with a volume reduction of 45%–80%. Complete resolution of symptoms was reported in 7.4% of cases, partial symptomatic relief in 91.1% of cases, and persistent or recurrent symptoms in 1.5% of cases.
The authors highlight that interventional radiologists should not question if they should perform TAE for liver hemangiomas, but rather, how they should do it. The most recent meta-analysis compared outcomes with different embolization techniques. The traditional technique of bland TAE with polyvinyl alcohol (PVA) particles, gelfoam, and/or coils induced a reduction in size < 1 cm, frequently insufficient for symptomatic improvement, with many patients experiencing an increase in size and persisting symptoms. However, embolization with lipiodol mixed with bleomycin, pingyangmycin or ethanol was shown to induce a significantly greater size reduction of the liver hemangiomas; roughly 4–5 cm.
Not all patients will respond to TAE. Other treatments in IR exist such as percutaneous sclerotherapy or ablation. Further research is encouraged to define the ideal candidate for a successful TAE. The 10 cm cutoff has been previously proposed as a maximum to allow successful TAE. Moreover, comparative studies between TAE and surgery with rigorous long-term reporting of symptomatic relief and tumor size reduction should be performed to have a clear perspective on the potential role of TAE in the invasive management of patients with symptomatic liver hemangiomas.
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