A UK-led global study shows COVID-19 patients who undergo surgery are at increased risk of postoperative death and pulmonary complications.
Mortality rates for coronavirus patients after surgery approached those of the most seriously ill patients admitted to intensive care after contracting the virus in the community.
Experts at the University of Birmingham-led National Institute for Health Research (NIHR) Global Health Research Unit on Global Surgery published their findings in The Lancet. The study was an international, multicentre, cohort study at 235 hospitals in 24 countries, and included 1128 patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery.
The study showed that pulmonary complications occurred in 577 (51·2%) patients, in whom the 30-day mortality was 38·0% (219 of 577), which accounted for 81·7% (219 of 268) of all deaths. Independent risk factors for mortality included male sex, age 70 years or older, American Society of Anesthesiologists (ASA) physical status classification grades 3–5, surgery for malignant disease, emergency surgery, and major surgery. Overall 30-day mortality was 23·8% (268 of 1128 patients).
The findings are based on data collected mostly in Europe (chiefly Italy and Spain), and North American hospitals. The UK accounted for 43% (484) of all patients in the study.
Differences in mortality rates between emergency and elective surgery were stark, with mortality rates of 25.6% (214 of 835 deaths) and 18.9% (53 of 280 deaths) respectively.
Dr Aneel Bhangu, lead author, from the University of Birmingham and consultant colorectal surgeon at University Hospitals Birmingham NHS Foundation Trust, UK told Medscape News UK: "We need to use this data to better protect patients coming for surgery over the next 24 months." He expressed concern over the impact of cancellation of non-urgent surgical procedures in the past 12 weeks. "Re-starting surgery is the NHS’s next major priority," he said. "This needs to be done at a global level," he said, and "the NHS can lead the way".
The study is based on the first 1128 patients who had surgery at participating hospitals between January 1st and March 31st 2020. However, Dmitri Nepogodiev, doctoral research fellow in public health and surgery at the University of Birmingham and one of the study’s co-authors told Medscape News UK: "As we’ve gone along more and more hospitals have been joining the study. Currently we have data on over 20,000 patients from more than 730 hospitals in 73 countries." He was amazed by the response. "We never thought this would be that popular, but I think it just reflects that many people have identified that there is a real need for evidence. There’s been a lot of discussion and speculation, but mainly based on expert opinion."
Dr Nepogodiev agreed with Dr Bhangu about rates of cancelled surgery, estimated to be around 28 million procedures globally. "That will have a huge impact on patients, who will be left waiting for operations for potentially a very long time. For some of these patients, their conditions will deteriorate, and for some patients with cancer their disease might progress."
Dr Nepogodiev defended cancellations in the initial stages of the pandemic. "It was the right decision to cancel operations, because patients are at such high risk if they get COVID-19 around the time of surgery. However, going forward, it's not going to be feasible to keep cancelling operations." Asked whether there were any groups of patients that wouldn't now be operated on in light of the findings, he said: "That would have to be decided on a case-by-case basis. It is a decision made by the surgeon and the patient together." He added that the study data "helps surgeons and patients to make decisions in an evidence-based manner" and that clearly "if you fell into one of the high-risk groups that had been identified (male over 70 years, ASA grades 3-5, with malignant disease, or having major or emergency surgery) then you might want to think carefully about whether you want to have that operation at that point, or whether you want maybe to wait". The study showed that the increased risks associated with SARS-CoV-2 infection should be balanced against the risks of delaying surgery in individual patients.
Medscape News UK spoke to Mr Ewen Griffiths, a consultant upper gastro-intestinal and general surgeon at Queen Elizabeth Hospital, Birmingham, who was involved in the data collection process for the study. He was asked what ethical implications the findings have for surgeons, and whether the findings will make ethical decisions more difficult. "No; I don’t think so," he said. "This vital information regarding the outcome of patients contracting COVID-19 in the postoperative period will make it easier to give proper informed consent for the operations performed on patients. I think patients will value this information to make decisions about whether they want to go ahead with more minor elective surgery. It’s the major cancer operations which are trickier, as they cannot be easily delayed without affecting outcome. The study results provide a very strong case for making clean, COVID-free environments in a separate hospital for time-sensitive surgery, like cancer operations and separating this completely from emergency patients coming in with COVID-19 symptoms."
This point was also made by Dr Nepogodiev who said: "We need to think about ways of organising care to minimise risk to patients, so if there are things we can do to reduce the risk of patients getting infected, then they should be implemented, and we can go ahead with operating on these patients without worrying about excess risk. Screening is going to be an important part of it as well, so when patients are coming for surgery, we need to be sure that they’re not already infected, if they are already infected then it’s probably not the best time for them to be operated on. You might have heard about the setting up of dedicated surgical centres for elective care (hot and cold sites) where you separate your coronavirus treatment area from your elective surgery area to reduce cross infection."
The study pointed out that when hospitals resume routine surgery, it is likely to be in environments that remain exposed to SARS-CoV-2…. hospital-acquired infection would remain a challenge. Strategies are urgently required to minimise in-hospital SARS-CoV-2 transmission and mitigate the risk of postoperative pulmonary complications in SARS-CoV-2-infected patients whose surgery cannot be delayed.
Providing independent comment on the study, Professor Anthony Mundy, professor of urology and consultant urological surgeon at University College London Hospitals, London said: "This is a very interesting and very important paper that all surgeons should read. It shows what everybody suspected, and that is that postoperative pulmonary complications occur in at least 50% of patients with perioperative COVID-19 infection, and that the mortality is high - much higher than would be expected in normal circumstances."
Prof Mundy added: "There has always been the worry that even if patients test negative for COVID-19 preoperatively, there might still be a risk that they may contract the disease postoperatively. We have suspected that this is true but this paper is the first-ever piece of objective evidence - everything up until now has been expert opinion. This study shows that, particularly for those patients in the at-risk category, elective surgery should wait unless there is a very good reason for advising patients to accept that risk." He cautioned: "Even the most enthusiastic patient, desperate to have their operation, might baulk at an incidence of postoperative pulmonary complications occurring in 50%, with mortality in the over 70 age group of almost 40%."
Despite the outcomes being worse than originally thought for postoperative survival with COVID-19, the authors have all talked about this study providing positivity in the COVID-19 climate. Mr Griffiths said: "I think for me as a surgeon, who hasn’t done much surgery in the last few months, the study has allowed me to focus on something positive during the pandemic and it has been a pleasure to coordinate a team of trainees to collect the data from the Queen Elizabeth Hospital and also to use my skills in upper gastrointestinal cancer surgery research to help the wider CovidSurg group."
When asked whether there were any surprises in the findings, Mr Griffiths said: "I’ve found it pretty amazing that so many clinicians, surgeons, trainees, and researchers from all around the world came together so quickly to collect massive amounts of high-quality data on this patient group. Study approvals for this important research were swift and efficient, as it was prioritised for urgent research by [the relevant] research and audit departments. I’m hoping that these swift decisions on research and the barriers that came down to allow this ground-breaking research to be performed will continue into the future."
Dr Nepogodiev was similarly positive about the way the study evolved. "I think one of the positive things from the pandemic has been that it's helped to bring people together and to work collaboratively to try and address common problems. We’ve been very fortunate to have a group of collaborators from around the world who have worked really hard to make this happen."
Dr Bhangu was clear about what he hoped would result from the publication of this study. "As with other parts of the COVID-19 response, we need urgently to launch a randomised trial testing whether various drug combinations will prevent patients who are undergoing an operation from developing COVID-19 after surgery."