Intraoperative Applications of Artificial Intelligence in Robotic Surgery: A Scoping Review of Current Development Stages and Levels of Autonomy.

OBJECTIVE: A scoping review of the literature was conducted to identify intraoperative artificial intelligence (AI) applications for robotic surgery under development and categorize them by (1) purpose of the applications, (2) level of autonomy, (3) stage of development, and (4) type of measured outcome. BACKGROUND: In robotic surgery, AI-based applications have the potential to disrupt a field so far based on a master-slave paradigm. However, there is no available overview about this technology's current stage of development and level of autonomy. METHODS: MEDLINE and EMBASE were searched between January 1, 2010 and May 21, 2022. Abstract screening, full-text review, and data extraction were performed independently by 2 reviewers. The level of autonomy was defined according to the Yang and colleagues' classification and stage of development according to the Idea, Development, Evaluation, Assessment, and Long-term follow-up framework. RESULTS: One hundred twenty-nine studies were included in the review. Ninety-seven studies (75%) described applications providing Robot Assistance (autonomy level 1), 30 studies (23%) application enabling Task Autonomy (autonomy level 2), and 2 studies (2%) application achieving Conditional autonomy (autonomy level 3). All studies were at Idea, Development, Evaluation, Assessment, and Long-term follow-up stage 0 and no clinical investigations on humans were found. One hundred sixteen (90%) conducted in silico or ex vivo experiments on inorganic material, 9 (7%) ex vivo experiments on organic material, and 4 (3%) performed in vivo experiments in porcine models. CONCLUSIONS: Clinical evaluation of intraoperative AI applications for robotic surgery is still in its infancy and most applications have a low level of autonomy. With increasing levels of autonomy, the evaluation focus seems to shift from AI-specific metrics to process outcomes, although common standards are needed to allow comparison between systems.

Open abdominal aortic repair in the current era has more complications for occlusive disease than for aneurysm repair.

BACKGROUND: Endovascular intervention has become the first-line treatment of patients with abdominal aortic aneurysms (AAAs) or aortoiliac occlusive disease (AIOD). However, open abdominal aortic repair remains a valuable treatment option for patients who are younger, those with unfavorable anatomy, and patients for whom endovascular intervention has failed. The cohort of patients undergoing open repair has become highly selected; nevertheless, updated outcomes or patient selection recommendations have been unavailable. In the present study, we explored and compared the characteristics and postoperative outcomes of patients who had undergone open abdominal aortic repair from 2009 to 2018. METHODS: Patients who had undergone open AAA (n = 9481) or AIOD (n = 9257) repair were collected from the National Surgical Quality Improvement Program database. The primary outcome was the 30-day mortality. The secondary outcomes included 30-day return to the operating room, total operative time, total hospital stay, and postoperative complications. Unmatched and matched differences between the two groups and changes over time were analyzed. Univariate and multivariate regression analyses were conducted to assess the risk factors predicting for 30-day mortality. RESULTS: After propensity matching (n = 4980), those in the AIOD group had had a higher 30-day mortality rate (5.1% vs 4.1%; P = .021), a higher incidence of wound complications (7.4% vs 5.1%; P<.0001) and an increased 30-day return to the operating room (14.2% vs 9.1%; P < .0001). More open AIOD cases (P = .02) and fewer open AAA cases (P = .04) had been treated in the second half of the decade than in the first. The factors associated with an increased odds of 30-day mortality included advanced age, American Society of Anesthesiologists score ≥III, functional dependence, blood transfusion <72 hours before surgery, weight loss in previous 6 months, and a history of chronic obstructive pulmonary disease. CONCLUSIONS: From 2009 to 2018, the number of open AAA repairs decreased and the proportion of open abdominal AIOD cases increased. Open AIOD surgery was associated with higher 30-day mortality, increased return to the operating room, and increased wound complications vs open AAA repair. Multiple risk factors increased the odds for perioperative mortality. Thus, open abdominal aortic repair should be selectively applied to patients with fewer risk factors.

Open conversion after failed endovascular aneurysm repair is increasing and its 30-day mortality is higher than that after primary open repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) has become the preferred treatment of abdominal aortic aneurysms (AAAs). Recent studies have demonstrated that cases of EVAR failure repair and subsequent open conversion have increased. The aim of the present study was to evaluate the national trend of annual cases and assess the 30-day outcomes of conversion to open repair after failed EVAR compared with primary open repair. METHODS: The National Surgical Quality Improvement Program database was queried for relevant Current Procedural Terminology and International Classification of Diseases, Ninth and Tenth Revision, codes to identify patients who had undergone conversion to open repair or primary open repair of nonruptured AAAs from 2009 to 2018. The annual trend of cases was assessed, and the perioperative outcomes of both procedures were compared. Multivariable logistic regression analyses were conducted to identify independent perioperative factors associated with mortality. RESULTS: Of the 9635 patients with nonruptured AAAs included in the present analysis, 9250 had undergone primary repair and 385 had required open conversion. During the 10-year period, the annual number of cases of open conversion had steadily increased and that of primary repair had decreased. The incidence of postoperative complications was similar between both groups, except for cardiac arrest, which had occurred more frequently in the open conversion group. The 30-day mortality was higher in the open conversion group than in the primary group (9.6% vs 3.9%; P < .0001). Open conversion was also independently associated with higher odds of death (adjusted odds ratio [OR], 2.1; 95% confidence interval [CI], 1.8-2.4; P < .0001). When the average mortality in both groups was compared between the first and last 5 years, no difference was found (open conversion: 9.8% vs 9.5% [P = 1.00]; primary repair: 3.6% vs 4.2% [P = .19]). Other perioperative factors independently associated with mortality included increased age (OR, 1.8; 95% CI, 1.5-2.1; P < .0001), American Society of Anesthesiologists class ≥III (OR, 2.7; 95% CI, 1.1-6.6; P = .029), insulin-dependent diabetes (OR, 2.0; 95% CI, 1.2-3.3; P = .005), chronic obstructive pulmonary disease (OR, 1.4; 95% CI, 1.1-1.8; P = .006), the presence of dyspnea at rest (OR, 3.3; 95% CI, 1.8-6.1; P < .0001), and a high preoperative hematocrit (OR, 0.94; 95% CI, 0.93-0.97; P < .0001). CONCLUSIONS: Open conversion to treat nonruptured AAAs after failed EVAR was independently associated with higher mortality. Also, the annual cases of open conversion have continued to increase without any significant changes in postoperative mortality. This highlights the danger of open conversion and stresses the need for better solutions to prevent and manage EVAR failure.

Am I safe? An Interpretative Phenomenological Analysis of Vulnerability as Experienced by Patients With Complications Following Surgery.

Abdominal surgery carries with it risks of complications. Little is known about patients' experiences of post-surgical deterioration. There is a real need to understand the psychosocial as well as the biological aspects of deterioration in order to improve care and outcomes for patients. Drawing on in-depth interviews with seven abdominal surgery survivors, we present an idiographic account of participants' experiences, situating their contribution to safety within their personal lived experiences and meaning-making of these episodes of deterioration. Our analysis reveals an overarching group experiential theme of vulnerability in relation to participants' experiences of complications after abdominal surgery. This encapsulates the uncertainty of the situation all the participants found themselves in, and the nature and seriousness of their health conditions. The extent of participants' vulnerability is revealed by detailing how they made sense of their experience, how they negotiated feelings of (un)safety drawing on their relationships with family and staff and the legacy of feelings they were left with when their expectations of care (care as imagined) did not meet the reality of their experiences (care as received). The participants' experiences highlight the power imbalance between patients and professionals in terms of whose knowledge counts within the hospital context. The study reveals the potential for epistemic injustice to arise when patients' concerns are ignored or dismissed. Our data has implications for designing strategies to enable escalation of care, both in terms of supporting staff to deliver compassionate care, and in strengthening patient and family involvement in rescue processes.

Outcomes of Barotrauma in Critically Ill COVID-19 Patients With Severe Pneumonia.

BACKGROUND: Pneumomediastinum and pneumothorax are complications which may be associated with barotrauma in mechanically ventilated patients. The current literature demonstrates unclear outcomes regarding barotrauma in critically ill patients with severe COVID-19. The purpose of this study was to examine the incidence of barotrauma in patients with severe COVID-19 pneumonia and its influence on survival. STUDY DESIGN AND METHODS: A retrospective cohort study was performed from March 18, 2020 to May 5, 2020, with follow-up through June 18, 2020, encompassing critically ill intubated patients admitted for COVID-19 pneumonia at an academic tertiary care hospital in Brooklyn, New York. Critically ill patients with pneumomediastinum, pneumothorax, or both (n = 75) were compared to those without evidence of barotrauma (n = 206). Clinical characteristics and short-term patient outcomes were analyzed. RESULTS: Barotrauma occurred in 75/281 (26.7%) of included patients. On multivariable analysis, factors associated with increased 30-day mortality were elevated age (HR 1.015 [95% CI 1.004-1.027], P = 0.006), barotrauma (1.417 [1.040-1.931], P = 0.027), and renal dysfunction (1.602 [1.055-2.432], P = 0.027). Protective factors were administration of remdesivir (0.479 [0.321-0.714], P < 0.001) and receipt of steroids (0.488 [0.370-0.643], P < 0.001). CONCLUSION: Barotrauma occurred at high rates in intubated critically ill patients with COVID-19 pneumonia and was found to be an independent risk factor for 30-day mortality.

Understanding the enablers and barriers to implementing a patient-led escalation system: a qualitative study.

BACKGROUND: The management of acute deterioration following surgery remains highly variable. Patients and families can play an important role in identifying early signs of deterioration but effective contribution to escalation of care can be practically difficult to achieve. This paper reports the enablers and barriers to the implementation of patient-led escalation systems found during a process evaluation of a quality improvement programme Rescue for Emergency Surgery Patients Observed to uNdergo acute Deterioration (RESPOND). METHODS: The research used ethnographic methods, including over 100 hours of observations on surgical units in three English hospitals in order to understand the everyday context of care. Observations focused on the coordination of activities such as handovers and how rescue featured as part of this. We also conducted 27 interviews with a range of clinical and managerial staff and patients. We employed a thematic analysis approach, combined with a theoretically focused implementation coding framework, based on Normalisation Process Theory. RESULTS: We found that organisational infrastructural support in the form of a leadership support and clinical care outreach teams with capacity were enablers in implementing the patient-led escalation system. Barriers to implementation included making changes to professional practice without discussing the value and legitimacy of operationalising patient concerns, and ensuring equity of use. We found that organisational work is needed to overcome patient fears about disrupting social and cultural norms. CONCLUSIONS: This paper reveals the need for infrastructural support to facilitate the implementation of a patient-led escalation system, and leadership support to normalise the everyday process of involving patients and families in escalation. This type of system may not achieve its goals without properly understanding and addressing the concerns of both nurses and patients.

Association between lipoprotein levels and outcomes after coronary artery bypass grafting surgery: a systematic review and meta-analysis.

INTRODUCTION: Lipoprotein(a) (Lp[a]) is a variant of low-density lipoprotein (LDL) and has been associated with increased risk of vascular inflammation and thrombosis. Coronary artery bypass grafting (CABG) has been associated with local inflammation of the myocardium. It is plausible, therefore, that patients with elevated baseline Lp(a) may be prone to unfavorable clinical outcomes following CABG. We evaluate differences in outcomes between CABG patients with high and low serum Lp(a) in this meta-analysis. EVIDENCE ACQUISITION: A comprehensive literature search was performed to identify studies reporting outcomes in CABG patients stratified by preoperative Lp(a) level. When possible, the outcomes were pooled in a meta-analysis. We assessed post-operative mortality, major cardiovascular events, stroke occurrence and saphenous graft occlusion. EVIDENCE SYNTHESIS: Eight studies involving 8681 patients were included. Articles used varying cut-offs for high versus low Lp(a), and outcomes varied. In the three studies evaluating mortality, two showed no statistically significant difference between groups while one reported increased mortality associated with high Lp(a) level. Both studies investigating major adverse cardiovascular events reported higher risk in patients with high Lp(a). A study-level meta-analysis of four studies reporting saphenous vein graft occlusion incidence after CABG was performed. High (≥30 mg/dL) preoperative Lp(a) was not associated with an increased risk of graft occlusion compared with low (<30 mg/dL) preoperative Lp(a) (OR=1.88, 95% CI: 0.66-5.36; P=0.15). CONCLUSIONS: Studies evaluating the impact of Lp(a) on outcomes in CABG patients are few, with heterogenous cut-offs and outcomes. In the limited published studies, Lp(a) level was not associated with graft occlusion.

Thorax support vest to prevent sternal wound infections in cardiac surgery patients-a systematic review and meta-analysis.

OBJECTIVES: Midline sternotomy is the main surgical access for cardiac surgeries. The most prominent complication of sternotomy is sternal wound infection (SWI). The use of a thorax support vest (TSV) that limits thorax movement and ensures sternal stability has been suggested to prevent postoperative SWI. METHODS: We performed a meta-analysis to evaluate differences in clinical outcomes with and without the use of TSV after cardiac surgery in randomized trials. The primary outcome was deep SWI (DSWI). Secondary outcomes were superficial SWI, sternal wound dehiscence, and hospital length of stay (LOS). A trial sequential analysis was performed. Fixed (F) and random effects (R) models were calculated. RESULTS: A total of 4 studies (3820 patients) were included. Patients who wore the TSV had lower incidence of DSWI [odds ratio (OR) = F: 0.24, 95% confidence interval (CI), 0.13-0.43, P < 0.01; R: 0.24, 0.04-1.59, P = 0.08], sternal wound dehiscence (OR = F: 0.08, 95% CI, 0.02-0.27, P < 0.01; R: 0.10, 0.00-2.20, P = 0.08) and shorter hospital LOS (standardized mean difference = F: -0.30, -0.37 to -0.24, P < 0.01; R: -0.63, -1.29 to 0.02, P = 0.15). There was no difference regarding the incidence of superficial SWI (OR = F: 0.71, 95% CI, 0.34-1.47, P = 0.35; R: 0.64, 0.10, 4.26, P = 0.42). The trial sequential analysis, however, showed that the observed decrease in DSWI in the TSV arm cannot be considered conclusive based on the existing evidence. CONCLUSIONS: This meta-analysis suggests that the use of a TSV after cardiac surgery could potentially be associated with a reduction in sternal wound complications. However, despite the significant treatment effect in the available studies, the evidence is not solid enough to provide strong practice recommendations.

Subclinical hypothyroidism and clinical outcomes after cardiac surgery: A systematic review and meta-analysis.

Background: Subclinical hypothyroidism (SCH) is associated with major adverse cardiovascular events. Despite the recognized negative impact of SCH on cardiovascular health, research on cardiac postoperative outcomes with SCH has yielded conflicting results, and patients are not currently treated for SCH before cardiac surgery procedures. Methods: We performed a study-level meta-analysis on the impact of SCH on patients undergoing nonurgent cardiac surgery, including coronary artery bypass grafting and valve and aortic surgery. The primary outcome was operative mortality. Secondary outcomes were hospital length of stay (LOS), intensive care unit (ICU) stay, postoperative atrial fibrillation (POAF), intra-aortic balloon pump (IABP) use, renal complications, and long-term all-cause mortality. Results: Seven observational studies, with a total of 3445 patients, including 851 [24.7%] diagnosed with SCH and 2594 [75.3%] euthyroid patients) were identified. Compared to euthyroid patients, the patients with SCH had higher rates of operative mortality (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.09-6.04; P = .03), prolonged hospital LOS (standardized mean difference, 0.32; 95% CI, 0.02-0.62; P = .04), a higher rate of renal complications (OR, 2.53; 95% CI, 1.74-3.69; P < .0001), but no significant differences in ICU stay, POAF, or IABP use. At mean follow-up of 49.3 months, the presence of SCH was associated with a higher rate of all-cause mortality (incidence rate ratio, 1.82; 95% CI, 1.18-2.83; P = .02). Conclusions: Patients with SCH have higher operative mortality, prolonged hospital LOS, and increased renal complications after cardiac surgery. Achieving and maintaining a euthyroid state prior to and after cardiac surgery procedures might improve outcomes in these patients.

Deep Sternal Wound Infection and Mortality in Cardiac Surgery: A Meta-analysis.

BACKGROUND: Deep sternal wound infection (DSWI) is a rare but severe complication after cardiac surgical procedures and has been associated with increased early morbidity and mortality. Studies reporting long-term outcomes in patients with DSWI have shown contradictory results. We performed a study-level meta-analysis evaluating the impact of DSWI on short- and long-term clinical outcomes. METHODS: A systematic literature search was conducted to identify studies comparing short- and long-term outcomes of patients submitted to cardiac surgical procedures who developed DSWI and patients who did not. The primary outcome was overall mortality. Secondary outcomes were in-hospital mortality, follow-up mortality, major adverse cardiovascular events, myocardial infarction, and repeat revascularization. Postoperative outcomes were also investigated. RESULTS: Twenty-four studies totaling 407 829 patients were included. Overall, 6437 (1.6%) patients developed DSWI. Mean follow-up was 3.5 years. DSWI was associated with higher overall mortality (incidence rate ratio [IRR], 1.99; 95% CI, 1.66-2.38; P < .001), in-hospital mortality (odds ratio, 3.30; 95% CI, 1.88-5.81; P < .001), follow-up mortality (IRR, 2.02; 95% CI, 1.39-2.94; P = .001), and major adverse cardiovascular events (IRR, 2.04; 95% CI, 1.60-2.59; P < .001). No differences in myocardial infarction and repeat revascularization were found, but limited studies reported those outcomes. DSWI was associated with longer postoperative hospitalization, stroke, myocardial infarction, and respiratory and renal failure. Sensitivity analyses on isolated coronary artery bypass grafting studies and by adjustment method were consistent with the main analysis. CONCLUSIONS: Compared with patients who did not develop DSWI, patients with DSWI after cardiac surgical procedures had increased risk of death as well as short- and long-term adverse clinical outcomes.

Reduction in transfer of micro-organisms between patients and staff using short-sleeved gowns and hand/arm hygiene in intensive care during the COVID-19 pandemic: A simulation-based randomised trial.

Background: Current personal protective equipment (PPE) practices in UK intensive care units involve "sessional" use of long-sleeved gowns, risking nosocomial infection transmitted via gown sleeves. Data from the first wave of the COVID19 pandemic demonstrated that these changes in infection prevention and control protocols were associated with an increase in healthcare associated bloodstream infections. We therefore explored the use of a protocol using short-sleeved gowns with hand and arm hygiene to reduce this risk. Methods: ICU staff were trained in wearing short-sleeved gowns and using a specific hand and arm washing technique between patients (experimental protocol). They then underwent simulation training, performing COVID-19 intubation and proning tasks using either experimental protocol or the standard (long-sleeved) control protocol. Fluorescent powder was used to simulate microbial contamination, detected using photographs under ultraviolet light. Teams were randomised to use control or experimental PPE first. During the simulation, staff were questioned on their feelings about personal safety, comfort and patient safety. Results: Sixty-eight staff and 17 proning volunteers were studied. Experimental PPE completely prevented staff contamination during COVID-19 intubation, whereas this occurred in 30/67 staff wearing control PPE (p = .003, McNemar). Proning volunteers were contaminated by staff in 15/17 control sessions and in 1/17 with experimental PPE (p = .023 McNemar). Staff comfort was superior with experimental PPE (p< .001, Wilcoxon). Their personal safety perception was initially higher with control PPE, but changed towards neutrality during sessions (p < .001 start, 0.068 end). Their impressions of patient safety were initially similar (p = .87), but finished strongly in favour of experimental PPE (p < .001). Conclusions: Short-sleeved gowns with hand and forearm cleansing appear superior to sessional long-sleeved gowns in preventing cross-contamination between staff and patients.

Extended Use of Distal Embolic Protection Devices in Treatment of Distal Embolism During Lower Extremity Arterial Endovascular Interventions.

There is no consensus on the best treatment modality for acute distal embolization complications during endovascular interventions for peripheral arterial diseases. We report on 3 patients who underwent mechanical embolectomy using a distal embolic protection device (EPD). All patients showed angiographic evidence of distal embolism, which occurred during lower extremity limb salvage endovascular procedures. After embolectomy, all had complete recanalization of the involved vessel on completion angiogram, and none had any device-related complications or adverse outcomes from the embolization. This initial experience suggests that EPD can be used for both the prevention and treatment of intraoperative distal embolization during endovascular intervention of lower extremity arterial disease.

Examining the empirical evidence for IDEAL 2b studies: the effects of preceding prospective collaborative cohort studies on the quality and impact of subsequent randomized controlled trials of surgical innovations - protocol for a systematic review and case-control analysis.

Randomized controlled trials (RCTs) in surgery face methodological challenges, which often result in low quality or failed trials. The Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework proposes preliminary prospective collaborative cohort studies with specific properties (IDEAL 2b studies) to increase the quality and feasibility of surgical RCTs. Little empirical evidence exists for this proposition, and specifically designed 2b studies are currently uncommon. Prospective collaborative cohort studies are, however, relatively common, and might provide similar benefits. We will, therefore, assess the association between prior 'IDEAL 2b-like' cohort studies and the quality and impact of surgical RCTs. We propose a systematic review using two parallel case-control analyses, with surgical RCTs as subjects and study quality and journal impact factor (IF) as the outcomes of interest. We will search for surgical RCTs published between 2015 and 2019 and and prior prospective collaborative cohort studies authored by any of the RCT investigators. RCTs will be categorized into cases or controls by (1) journal (IF ≥or <5) and (2) study quality (PEDro score ≥or < 7). The case/control OR of exposure to a prior '2b like' study will be calculated independently for quality and impact. Cases will be matched 1: 1 with controls by year of publication, and confounding by peer-reviewed funding, author academic affiliation and trial protocol registration will be examined using multiple logistic regression analysis. This study will examine whether preparatory IDEAL 2b-like studies are associated with higher quality and impact of subsequent RCTs.

Association of liver dysfunction with outcomes after cardiac surgery-a meta-analysis.

OBJECTIVES: The aim of this study was to perform a meta-analysis of studies reporting outcomes in patients with liver dysfunction addressed by the model of end-stage liver disease and Child-Turcotte-Pugh scores undergoing cardiac surgery. METHODS: A systematic literature search was conducted to identify contemporary studies reporting short- and long-term outcomes in patients with liver dysfunction compared to patients with no or mild liver dysfunction undergoing cardiac surgery (stratified in high and low score group based on the study cut-offs). Primary outcome was perioperative mortality. Secondary outcomes were perioperative neurological events, prolonged ventilation, sepsis, bleeding and/or need for transfusion, acute kidney injury and long-term mortality. RESULTS: A total of 33 studies with 48 891 patients were included. Compared with the low score group, being in the high score group was associated with significantly higher risk of perioperative mortality [odds ratio (OR) 3.72, 95% confidence interval (CI) 2.75-5.03, P < 0.001]. High score group was also associated with a significantly higher rate of perioperative neurological events (OR 1.49, 95% CI 1.30-1.71, P < 0.001), prolonged ventilation (OR 2.45, 95% CI 1.94-3.09, P < 0.001), sepsis (OR 3.88, 95% CI 2.07-7.26, P < 0.001), bleeding and/or need for transfusion (OR 1.95, 95% CI 1.43-2.64, P < 0.001), acute kidney injury (OR 3.84, 95% CI 2.12-6.98, P < 0.001) and long-term mortality (incidence risk ratio 1.29, 95% CI 1.14-1.46, P < 0.001). CONCLUSIONS: The analysis suggests that liver dysfunction in patients undergoing cardiac surgery is independently associated with higher risk of short and long-term mortality and also with an increased occurrence of various perioperative adverse events.

Outcomes of Open Versus Endovascular Repair of Descending Thoracic and Thoracoabdominal Aortic Aneurysms.

BACKGROUND: Open repair is the standard of care for patients with descending thoracic and thoracoabdominal aortic aneurysms. Although effective, surgery carries a high risk of morbidity and mortality. Endovascular stent grafts were introduced to treat these aneurysms in patients considered too high risk for open repair. Early results are promising, but later results are incompletely known. Therefore, we sought to compare short- and intermediate-term outcomes of open vs endovascular repair for these aneurysms. METHODS: From 2000 to 2010, 1053 patients underwent open (n = 457) or endovascular (n = 596) repair of descending thoracic and thoracoabdominal aortic aneurysms at Cleveland Clinic. To balance patient characteristics between these groups, propensity score matching was performed, yielding 278 well-matched pairs (61% of possible pairs). End points included short- and long-term outcomes. RESULTS: In matched patients, compared with endovascular stenting, open repair achieved similar in-hospital death (n = 23 [8.3%] vs n = 21 [7.6%], P = .80) and occurrence of paralysis and stroke (n = 10 [3.6%] vs n = 6 [2.2%], P = .30), despite a longer postoperative stay (median 11 vs 6 days), more dialysis-dependent acute renal failure (n = 24 [8.6%] vs n = 9 [3.3%], P = .008), and prolonged ventilation (n = 106 [46%] vs n = 17 [6.3%], P < .0001). Open repair resulted in better 10-year survival than endovascular repair (52% vs 33%, P < .0001), and aortic reintervention was less frequent (4% vs 21%, P < .0001). Despite a decrease in the first postoperative year, average aneurysm size did not recover to normal range after endovascular stenting. CONCLUSIONS: Open repair of descending thoracic and thoracoabdominal aneurysms can achieve acceptable short-term outcomes with better intermediate-term outcomes than endovascular repair.

Reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence: DECIDE-AI.

A growing number of artificial intelligence (AI)-based clinical decision support systems are showing promising performance in preclinical, in silico evaluation, but few have yet demonstrated real benefit to patient care. Early-stage clinical evaluation is important to assess an AI system's actual clinical performance at small scale, ensure its safety, evaluate the human factors surrounding its use and pave the way to further large-scale trials. However, the reporting of these early studies remains inadequate. The present statement provides a multi-stakeholder, consensus-based reporting guideline for the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI). We conducted a two-round, modified Delphi process to collect and analyze expert opinion on the reporting of early clinical evaluation of AI systems. Experts were recruited from 20 pre-defined stakeholder categories. The final composition and wording of the guideline was determined at a virtual consensus meeting. The checklist and the Explanation & Elaboration (E&E) sections were refined based on feedback from a qualitative evaluation process. In total, 123 experts participated in the first round of Delphi, 138 in the second round, 16 in the consensus meeting and 16 in the qualitative evaluation. The DECIDE-AI reporting guideline comprises 17 AI-specific reporting items (made of 28 subitems) and ten generic reporting items, with an E&E paragraph provided for each. Through consultation and consensus with a range of stakeholders, we developed a guideline comprising key items that should be reported in early-stage clinical studies of AI-based decision support systems in healthcare. By providing an actionable checklist of minimal reporting items, the DECIDE-AI guideline will facilitate the appraisal of these studies and replicability of their findings.

The prevalence of asymptomatic COVID-19 infection in cancer patients. A cross-sectional study at a tertiary cancer center in New York City.

OBJECTIVE: Several factors raise concern for increased risk of COVID-19 in cancer patients. While there is strong support for testing symptomatic patients. The benefit of routine testing of asymptomatic patients remains contentious. We aim to evaluate the prevalence of asymptomatic COVID-19 infection in cancer patients. METHODS: Between June 1 and September 3, 2020, we obtained nasopharyngeal swab from asymptomatic cancer patients who were visiting a single tertiary-care cancer center, and tested the specimen for the presence or absence of SARS-CoV-2 RNA. We performed a descriptive statistic of data RESULTS: We tested a total of 80 patients, of which 3 (3.75%) were found positive for COVID-19. A significant proportion of the tested patients were on active immunosuppressive or immunomodulatory treatment, cytotoxic chemotherapy (n = 34), and immunotherapy (n = 16). However, all three COVID-19 positive patients were only actively on hormonal therapy. All three patients observed a minimum of 2 weeks home quarantine. None of the patients developed symptoms upon follow up and no changes were required to their treatment plan. CONCLUSIONS: Despite published evidence that cancer patients may be at increased risk of severe COVID -19 infection, our data suggest that some infected cancer patients are asymptomatic. The overall prevalence of asymptomatic COVID-19 infection in this population of cancer patients was similar to that in the general population. Therefore, since asymptomatic infections are not uncommon in patients with cancer, we recommend universal COVID-19 testing to help guide treatment decisions and prevent the spread of the disease.

Clinical Characteristics and Outcome of Pneumomediastinum in Patients with COVID-19 Pneumonia.

Introduction: Pneumomediastinum (PM) is characterized by the presence of air within the mediastinum. The association between PM and coronavirus 2019 (COVID-19) has not been well established in the current literature. We sought to summarize the limited body of literature regarding PM in patients with COVID-19 and characterize the presentation and clinical outcomes of PM in patients with severe acute respiratory syndrome (SARS)-COV-2 pneumonia at our institution to better define the incidence, prognosis, and available treatment for this condition. Materials and Methods: All patients with a proven diagnosis of COVID-19 and PM between March 18, 2020 and May 5, 2020 were identified through hospital records. Retrospective analysis of radiology records and chart review were conducted. Clinical characteristics and outcomes were collected and descriptive statistics was analyzed. Results: Thirty-six patients met inclusion criteria. Out of the 346 intubated COVID-19 patients, 34 (10%) had PM. The incidence of PM increased for the first 4 weeks of the pandemic, and then began to decrease by week 5. At the endpoint of the study, 12 (33.33%) patients were alive and 24 patients (66.67%) had died. Conclusion: PM, although a rare phenomenon, was more prevalent in COVID-19 patients compared with historical patients with adult respiratory distress syndrome. The etiology of this condition may be attributed to higher susceptibility of patients infected with SARS-CoV-2 to a combination of barotrauma and airway injury.

Consequences of Delayed Chest Closure During Lung Transplantation.

BACKGROUND: Delayed chest closure is commonly used for cardiac surgery. However, insufficient data exist to guide its management in immunosuppressed lung transplantation patients, with unclear long-term consequences. METHODS: We performed 769 lung transplantations between January 2009 and January 2016. Of these, 47 (6%) required delayed chest closure because of coagulopathy, respiratory intolerance, and hemodynamic instability. On multivariable analysis, risk factors for delayed chest closure included double-lung transplantation and longer ischemic times. To account for differences between the 2 groups, we performed propensity matching, generating 46 well-matched pairs. RESULTS: Among matched patients with appropriate antimicrobial prophylaxis, we found no difference in 30-day prevalence of pneumonia, empyema, Clostridium difficile, bloodstream, and deep wound infections. There was also no difference in 6-month composite infections. However, delayed chest closure patients received more transfusions within 5 days of transplantation (median, 7 vs 3 units; P < .001), had more intubations > 5 days (80% vs 41%, P < .001), had more severe primary graft dysfunction (39% vs 17%, P = .044), had a longer hospital stay (median, 61 vs 25 days; P < .001), and had worse pulmonary function tests 6 years after transplant (P = .019). Fortunately, estimated survival at 6 months, 1 year, and 5 years between delayed and primary chest closure groups was similar (82%, 76%, and 39% vs 84%, 75%, and 50%, respectively; P = .23). CONCLUSIONS: Use of delayed chest closure does not yield more infections or worse long-term survival. However it may be associated with increased in-hospital morbidities and worse long-term pulmonary function.

Advances in managing the noninfected open chest after cardiac surgery: Negative-pressure wound therapy.

OBJECTIVE: The objective of this study was to compare safety and clinical effectiveness of negative-pressure wound therapy (NPWT) with traditional wound therapy for managing noninfected open chests with delayed sternal closure after cardiac surgery. METHODS: From January 2000 to July 2015, 452 of 47,325 patients who underwent full sternotomy left the operating room with a noninfected open chest (0.96%), managed using NPWT in 214-with frequency of use rapidly increasing to near 100%-and traditionally in 238. Predominant indications for open-chest management were uncontrolled coagulopathy or hemodynamic compromise on attempted chest closure. Weighted propensity-score matching was used to assess in-hospital complications and time-related survival. RESULTS: NPWT and traditionally managed patients had similar high-risk preoperative profiles. Most underwent reoperations (63% of the NPWT group and 57% of the traditional group), and 21% versus 25% were emergency procedures. Reexplorations for bleeding were less common with NPWT versus traditional wound therapy (n = 63 [29%] vs 104 [44%], P = .002). Median duration of open-chest to definitive sternal closure was 3.5 days for NPWT versus 3.1 for traditionally managed patients (P[log rank] = .07). Seven patients (3.3%) were converted from NPWT to traditional therapy because of hemodynamic intolerance and 6 (2.5%) from traditional to NPWT. No NPWT-related cardiovascular injuries occurred. Among matched patients, NPWT was associated with better early survival (61% vs 44% at 6 months; P = .02). CONCLUSIONS: NPWT is safe and effective for managing noninfected open chests after cardiac surgery. By facilitating open-chest management and potentially improving outcomes, it has become our therapy of choice and perhaps has lowered our threshold for leaving the chest open after cardiac surgery.