Merits of splenectomy versus embolization for trauma patients up for debate

Continued from page 1

The SPLENIQ study group from the UK and The Netherlands found that embolization gave patients a higher life expectancy than those who had a splenectomy, Clements continued, adding that the former also proved more cost-effective.

“The most important point”, Clements underlined, is that embolization preserves function. “We do not need to think about longterm vaccination or antibiotics like we do with splenectomy patients,” he expanded, before hammering home that “no one wants a laparotomy and if we can avoid it, we are doing patients a good service.”

To conclude, Clements reiterated the speed and low cost associated with embolization for splenic trauma in stable patients, as well as the preservation of function that it facilitates. “It is quick […] effective […] has a low complication rate, fast recovery [and leaves] no visible wound,” the presenter shared, adding to his list of advantages of choosing this procedure over splenectomy.

McMonagle agreed with Clements that there is a role for embolization, but as an “adjunct” to nonoperative management which, he believes, still has a role in splenic trauma cases. “Splenectomy for trauma is one of my favourite procedures,” McMonagle then disclosed, tempering this statement by asserting that “any extreme view is bad”. For him, the choice

EU Commission proposes delay to MDR implementation

In December 2022, Europe’s health commissioner Stella Kyriakides, announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) were to be put forward in early 2023. This has now been actioned, with the EU having published a draft regulation advocating for the initial MDR implementation deadline of May 2024 to be postponed until 2027 or 2028, depending on the specific device. This measure will subsequently be voted on by the European Council and Parliament.

KYRIAKIDES INFORMED HEALTH MINISTERS from the EU’s 27 member states of the plan at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council in Brussels on 9 December, where the council members discussed the current status of the implementation of the MDR. of procedure should be made in accordance with how haemodynamically well the patient is. The haemodynamically unwell “should be in the operating room,” he argued. There is also nuance in how best to treat those who are haemodynamically well, according to McMonagle, and this stems from the implications of a patient having contrast blush or not.

The regulation—which changes the way that medical devices are certified for use in the European market—first came into effect in 2021 with an initial three-year transition period, having been delayed by one year in 2020 due to the onset of the COVID-19 pandemic.

McMonagle then imparted his belief with regard to the use of computed tomography (CT) scanning for splenic trauma patients: definitive”. In addition, the presenter asserted that “interventional radiology improves the chance of success of non-operative management”. in children: in adults:

+98%

“Unless you are a surgeon planning to operate with the lights out, you do not need a CT for a haemodynamically unwell patient”.

Those who do not go to the operating room should receive non-operative management, the presenter furthered, which means chest physiotherapy, anticoagulants and “[getting] them moving”. The success rate of this he quantified as “greater than 98%” in children, and 90% for adults. “Embolization is an adjunct”.

Speaking more on embolization, McMonagle opined that “if you do not have a blush […] There is no real reason to do [one].” Moreover, he supplemented, for injuries of a low grade (1 and 2) “it is very clear now” that embolization “does not help”. Whether it does for grade 3 injuries, McMonagle said that he did not know, and that, in contrast with Clements, for grade 4s and 5s “it possibly does but it is not

Addressing Clements’ study of 232 patients, McMonagle declared it “well powered for an acute trauma study,” and acknowledged the 97% clinical success rate at discharge, but questioned why they were “embolizing everyone”. McMonagle suggested that it could have been prudent to superselect the patients for inclusion in the study based on the presence of contrast blush, as this would have shed more light on exactly whom stands to gain most from the procedure.

“The more studies that are done, the more questions they throw up,” was McMonagle’s admission that there is still more research to do on how to best treat splenic trauma injuries. In the absence of contrast blush, the presenter offered the opinion that “the jury is still out” on embolization, but acknowledged its role in improving the success of non-operative management. Splenectomy, he reiterated, is his choice for patients who are haemodynamically unwell.

Concerns have been raised over the impact of the transition to the new regulatory regime, with the European Society of Cardiology (ESC) also calling upon ministers to act to prevent a “shortfall of essential medical devices for cardiovascular patients” in December 2022, which the Society warned could include diagnostic and ablation catheters and some stents.

“Patients rightly expect to have safe and highquality medical devices,” Kyriakides told journalists at a press conference that followed the aforementioned December 2022 Council meeting, where she acknowledged it is now a “crucial time” for the transition to the new rules.

“We have been following the progress achieved towards this goal very closely in the past months and, while the number of notified bodies have increased and actions have been taken to prepare manufacturers, this is not enough,” Kyriakides added. “In addition, we are now experiencing supply shortages on the global market. We are still feeling the impacts of the pandemic, and now also the Russian war in Ukraine, where several manufacturers of devices are located. This is creating additional complications.

“[An extension to] the transition period [will] mitigate any short-term risks. This targeted amendment will take into account the risk class of different devices and address the sell-off date. At the same time, we will work on medium- and long-term solutions to address the more structural issues that have arisen with the new rules.

“Our citizens do not only expect medical devices to be safe, they also expect them to be available. We will do everything in our power to ensure that this transition does not create any disruptions.”

Speaking to Interventional News about the position it takes, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) explained that it “welcomes the European Commission’s proposed extension of transition periods to the MDR.” Expanding upon this, the extension, according to CIRSE, is “something the society leadership also called for in a recent editorial published in CardioVascular Interventional Radiology (CVIR) in December 2022.” Moreover, for the society, “the continuous availability of safe devices for patient care, including niche indications, as well as for paediatric interventional radiology, remains the highest priority in this regard. A full statement is available at https://link.springer.com/ article/10.1007/s00270-022-03339-0”.