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Open in new tab Download slide OBJECTIVES Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America [294 (39.4%)], Europe [264 (35.4%)] or Asia [141 (18.9%)]. Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3 and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because of lack of funding. Left ventricular assist device trials [odds ratio (OR) 3.65, 95% confidence interval (CI) (1.65–8.00) P  = 0.001], valve surgery trials [OR 4.30, 95% CI (2.33–8.00) P  < 0.001], aortic surgery trials [OR 2.86 95% CI (1.22–6.43) P  = 0.012], phase 2 [OR 3.02, 95% CI (1.31–7.93) P  = 0.015] and phase 4 trials [OR 3.62, 95% CI (1.43–10.23) P  = 0.010] were at higher risk of premature termination while trials performed in Asia [OR 0.18, 95% CI (0.07–0.39) P  ≤ 0.001] and Europe [OR 0.49, 95% CI (0.30–0.80) P  = 0.004] were less likely to be terminated prematurely. CONCLUSIONS Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on left ventricular assist device, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely. [ABSTRACT FROM AUTHOR]

Simultaneous bilateral total knee arthroplasty (SBTKA) may present a higher risk for postoperative complications than unilateral surgery. The authors retrospectively identified 561 patients who underwent SBTKA between 2013 and 2015. The cohort was stratified according to the following appropriateness of care criteria (AOCC): (1) age younger than 70 years; (2) absence of cardiac disease; (3) controlled diabetes; and (4) body mass index less than 30 kg/m2. The authors created an AOCC score, with 0 representing the most ideal candidates and 4 representing the least ideal candidates. The cohort included 140 (25%) ideal candidates with a score of 0; the cohort also included 299 (53%) non-ideal candidates with a score of 1, 105 (19%) with a score of 2, 14 (2%) with a score of 3, and 3 (1%) with a score of 4. Ideal candidates had the shortest mean length of stay at 3.6±1.2 days. Length of stay was longer for patients with an AOCC score of greater than 2 compared with those with an AOCC score of 2 or less (5.2±4.3 vs 3.8±1.6 days, P<.001). Ideal candidates were discharged to home more often than other patients (26% vs 13%, P<.001). Although there was no difference in 90-day all-cause complications between ideal and non-ideal candidates (13% vs 16%, P=.400), medical complications trended strongly (6% vs 11%, P=.086). Appropriateness of care criteria for SBTKA patients were associated with shorter length of stay, higher rates of home discharge, and a trend toward lower complication rates. Simultaneous bilateral total knee arthroplasty can offer better outcomes in a subgroup of patients appropriately selected for surgery. Physicians can use these results to counsel their patients about risks and benefits of undergoing SBTKA. [Orthopedics. 2018; 41(5):293-298.]. [ABSTRACT FROM AUTHOR]

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

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., Competing Interests: The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (© 2024 The Author(s).)

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.