Safety of nifedipine GITS in stable angina: The ACTION trial

Aim: We describe the safety profile of nifedipine GITS as assessed from adverse events reported in the ACTION trial in which 7,665 patients with stable, symptomatic coronary artery disease were randomly assigned nifedipine GITS or placebo and followed for a mean of 4.9 years. Methods: All adverse events were coded using the COSTART coding dictionary. The incidence rate for each event was calculated as the number of patients with the event concerned divided by the total time 'at risk'. Hazard ratios comparing nifedipine with placebo and their 95% confidence intervals were obtained by Cox proportional-hazards analysis. Results: As reported previously, nifedipine significantly reduced the incidence of cardiovascular events and procedures [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.83-0.95]. Apart from the known side effects of nifedipine, which include peripheral oedema, vasodilatation, hypotension, asthenia, constipation, leg cramps, non-specific respiratory complaints, impotence and polyuria, and which were reported more frequently in patients assigned nifedipine, the incidence rates of most other adverse events were similar. There were no differences in the occurrence of gastrointestinal haemorrhage, myocardial infarction and suicide. The rate of occurrence of death or new cancer excluding non-melanoma skin cancer for patients with no history of cancer at baseline was 2.53/100 patient years for patients assigned nifedipine and 2.37/100 patient years for patients assigned placebo (HR 1.06, 95% CI 0.93-1.22). Conclusion: Overall nifedipine GITS was well tolerated by patients with stable symptomatic angina

A Review on the Current Applications of Artificial Intelligence in the Operating Room

Background. Artificial intelligence (AI) is an era upcoming in medicine and, more recently, in the operating room (OR). Existing literature elaborates mainly on the future possibilities and expectations for AI in surgery. The aim of this study is to systematically provide an overview of the current actual AI applications used to support processes inside the OR. Methods. PubMed, Embase, Cochrane Library, and IEEE Xplore were searched using inclusion criteria for relevant articles up to August 25th, 2020. No study types were excluded beforehand. Articles describing current AI applications for surgical purposes inside the OR were reviewed. Results. Nine studies were included. An overview of the researched and described applications of AI in the OR is provided, including procedure duration prediction, gesture recognition, intraoperative cancer detection, intraoperative video analysis, workflow recognition, an endoscopic guidance system, knot-tying, and automatic registration and tracking of the bone in orthopedic surgery. These technologies are compared to their, often non-AI, baseline alternatives. Conclusions. Currently described applications of AI in the OR are limited to date. They may, however, have a promising future in improving surgical precision, reduce manpower, support intraoperative decision-making, and increase surgical safety. Nonetheless, the application and implementation of AI inside the OR still has several challenges to overcome. Clear regulatory, organizational, and clinical conditions are imperative for AI to redeem its promise. Future research on use of AI in the OR should therefore focus on clinical validation of AI applications, the legal and ethical considerations, and on evaluation of implementation trajectory

Optimizing patient selection for laparoscopic and open colorectal cancer resections: A national surgical quality improvement program-matched analysis

The aim of this study was to identify patients undergoing colorectal cancer (CRC) resection who might benefit specifically from either an open or laparoscopic approach. From the NSQIP database (2012-2013), patients who underwent laparoscopic colectomy (LC) or open colectomy (OC) for CRC were identified. The two groups were matched and compared in terms of any, medical, and surgical complications. A wide range of patient characteristics were collected and analyzed. Interaction analysis was performed in a multivariable regression model to identify risk factors that may make LC or OC more beneficial in certain subgroups of patients. Overall, OC (n 5 6593) was associated with a significantly higher risk of any [odds ratio (OR) 2.03, 95% confidence interval (CI) 1.87-2.20], surgical (OR 1.98, 95% CI 1.82-2.16), and medical (OR 1.71, 95% CI 1.51-1.94) complications than LC (n 5 6593). No subgroup of patients benefited from an open approach. Patients with obesity (BMI > 30) (P 5 0.03) and older age (>65 years) (P 5 0.01) benefited more than average from a laparoscopic approach. For obese patients, LC was associated with less overall complications (OC vs LC: OR 1.92 obese vs 1.21 nonobese patients). For elderly patients, LC was more preferable regarding the risk of medical complications (OC vs LC OR of 1.91 vs 1.34 for younger patients). No subgroup of CRC patients benefited specifically more from an open colorectal resection. This supports that the laparoscopic technique should be performed whenever feasible. For the obese and elderly patients, the benefits of the laparoscopic approach were more pronounced

Six Sigma in surgery: how to create a safer culture in the operating theatre using innovative technology

Safe delivery of patient care in the operating theatre is complex and co-dependent of many individual, organisational, and environmental factors, including patient, task and technology, individual, and human factors. The Six Sigma approach aims to implement a data-driven strategy to reduce variability and consequently improve safety. Analytical data platforms such as a Black Box ought to be embraced to support process optimisation and ultimately create a higher level of Six Sigma safety performance of the operating theatre team

Identification of Meaningful Data for Providing Real-Time Intraoperative Feedback in Laparoscopic Surgery Using Delphi Analysis

Background. Surgeons are at risk of being overwhelmed with information while performing surgery. Initiatives focusing on the use of medical data in the operating room are on the rise. Currently, these initiatives require postprocessing of data. Although highly informative, data cannot be used to influence preventable error in real time. Ideally, feedback is provided preemptive. Aims. First, to identify which information is considered to be relevant for real-time feedback during laparoscopic surgery according to surgeons. Second, to identify the optimal routing for providing such feedback, and third, to decide on optimal timing for feedback to alarm users during laparoscopic surgery. Methods. A Delphi study of 3 iterations was conducted within the Amsterdam UMC, location AMC. A total of 25 surgeons and surgical residents performing laparoscopy were surveyed using 5-point Likert scales. Consensus was obtained when 80% of answers fitted the same answering category. Results. Delphi round 1 resulted in 198 unique ideas within 5 scenarios. After round 3, consensus was obtained on 102 items. Feedback most relevant during laparoscopic surgery refers to equipment like the gas insufflator, diathermy, and suction device. Feedback should be delivered via an additional monitor. Surgeons want to be instantly alarmed about aberrations in patients’ vital parameters or combinations of vital parameters, preferably via a designated section on a monitor in their field of vision. Conclusions. Surgeons performing laparoscopy are uniform in their opinion that they need to be alarmed immediately when patients’ vital parameters are becoming aberrant. Surgeons state that information regarding supporting equipment is best displayed on an additional monitor