Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data

Understanding the causes and patient impacts of surgical adverse events will help improve systems and operational practices to avoid incidents in the future. We analyzed the adverse events data related to robotic systems and instruments used in minimally invasive surgery, reported to the U.S. FDA MAUDE database from January 2000 to December 2013. We determined the number of events reported per procedure and per surgical specialty, the most common types of device malfunctions and their impact on patients, and the causes for catastrophic events such as major complications, patient injuries, and deaths. During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant since 2007 (mean = 83.4, 95% CI, 74.2-92.7). Surgical specialties, for which robots are extensively used, such as gynecology and urology, had lower number of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9, Risk Ratio = 2.2, 95% CI, 1.9-2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it to a later time (2.5%). Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.Comment: Presented as the J. Maxwell Chamberlain Memorial Paper for adult cardiac surgery at the 50th Annual Meeting of the Society of Thoracic Surgeons in January. See Appendix for more detailed results, discussions, and related work. Updated the header

Donor tricuspid annuloplasty during orthotopic heart transplantation: Long-term results of a prospective controlled study

Background: Development of tricuspid regurgitation after orthotopic heart transplantation can cause heart failure along with renal and hepatic impairment and portends a poor prognosis. If tricuspid regurgitation causes significant symptoms, tricuspid valve repair or replacement is often required. This study was designed to study the effects of prophylactic tricuspid valve annuloplasty (TVA) during orthotopic heart transplantation on long-term survival, renal function, and amount of tricuspid regurgitation. Methods: Between April 1997 and March 1998, 60 patients (aged 18 to 70 years; 22 female) randomly received either standard bicaval orthotopic heart transplantation (group STD; n = 30) or bicaval orthotopic heart transplantation with DeVega TVA (group TVA; n = 30). Tricuspid valve annuloplasty was performed on the donor heart before implantation using pledgeted 2-0 polypropylene and sized to an annulus of 29 mm. Echocardiographic measurements, laboratory values, and hemodynamics were obtained prospectively and reviewed by an independent data analyst. Results: Follow-up of patients as of December 2003 was complete. Although there was a perioperative mortality advantage in group TVA, there was no difference between groups in long-term survival. At the end of the study, however, there was a statistical difference (group STD versus group TVA, p \u3c 0.05) with regard to cardiac mortality (7 of 30 versus 3 of 30), average amount of tricuspid regurgitation (1.5 ± 1.3 versus 0.5 ± 0.4), percentage of patients with 2+ or greater tricuspid regurgitation (34% versus 0%), serum creatinine (2.9 ± 2.0 versus 1.8 ± 0.7), and difference in serum creatinine over baseline (2.0 ± 2.1 versus 0.7 ± 0.8). Conclusions: Prophylactic DeVega TVA of the donor heart is durable and decreases the incidence of cardiac-related mortality and tricuspid regurgitation after orthotopic heart transplantation. In addition, there is improved protection of renal function. Considering the ease and safety of TVA and its advantages, it should be performed as a routine adjunct to orthotopic heart transplantation

Are interactions between epicardial adipose tissue, cardiac fibroblasts and cardiac myocytes instrumental in atrial fibrosis and atrial fibrillation?

Atrial fibrillation is very common among the elderly and/or obese. While myocardial fibrosis is associated with atrial fibrillation, the exact mechanisms within atrial myocytes and surrounding non-myocytes are not fully understood. This review considers the potential roles of myocardial fibroblasts and myofibroblasts in fibrosis and modulating myocyte electrophysiology through electrotonic interactions. Coupling with (myo)fibroblasts in vitro and in silico prolonged myocyte action potential duration and caused resting depolarization; an optogenetic study has verified in vivo that fibroblasts depolarized when coupled myocytes produced action potentials. This review also introduces another non-myocyte which may modulate both myocardial (myo)fibroblasts and myocytes: epicardial adipose tissue. Epicardial adipocytes are in intimate contact with myocytes and (myo)fibroblasts and may infiltrate the myocardium. Adipocytes secrete numerous adipokines which modulate (myo)fibroblast and myocyte physiology. These adipokines are protective in healthy hearts, preventing inflammation and fibrosis. However, adipokines secreted from adipocytes may switch to pro-inflammatory and pro-fibrotic, associated with reactive oxygen species generation. Pro-fibrotic adipokines stimulate myofibroblast differentiation, causing pronounced fibrosis in the epicardial adipose tissue and the myocardium. Adipose tissue also influences myocyte electrophysiology, via the adipokines and/or through electrotonic interactions. Deeper understanding of the interactions between myocytes and non-myocytes is important to understand and manage atrial fibrillation

Rigid Plate Fixation for Sternal Closure

Median sternotomy provides standard access in cardiac surgery. Sternal closure traditionally involves use of stainless steel wires with satisfactory results. Fixation of sternum using titanium plates with screws has been used in some institutions over the last two decades. This technique uses sternal wires in combination with a rigid plate fixation system. The wires are passed at the manubrium and xiphoid to help with approximation, while plates are used to fix the body of the sternum. The screws are passed through the outer table and penetrate the inner table of the sternum. There is increasing evidence to suggest that rigid plate fixation provides better mechanical stability of sternum; which seems to translate to less post-operative pain; better healing of sternum; lower incidence of deep sternal wound infection and sternal non-union. This approach is particularly useful in patients who have multiple risk factors predisposing them to post-operative sternal complications

Brian Fowell Buxton (15/04/1940–20/05/2022)—Outstanding Achievements and Personal Memories

Brian F. Buxton, one of Australia's greatest cardiac surgeons, died in May 2022, aged 82 years. In June 2022, a memorial celebration of Brian's life was held in Melbourne, Australia, attended by 550 colleagues and friends from many walks of life—not only “medical people” but also friends involved in Brian's sailing and hiking activities. This Special Article includes an introduction from Professor Jayme Bennetts, President of the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS), an abridged version of a memorial address by Professor James Tatoulis and contributions from two other long-term professional colleagues and personal friends of Buxton, Professor Jaishankar Raman and Professor Franklin Rosenfeldt, founding editor of Heart, Lung and Circulation. Buxton was an outstanding and pioneering surgeon, clinical leader, and good friend to many. The Brian F. Buxton Cardiac and Thoracic Aortic Surgery Unit in Melbourne, Australia, is now so named in honour of his outstanding achievements and as a legacy. Vale Brian F. Buxton

Pre-transplant depression as a predictor of adherence and morbidities after orthotopic heart transplantation

Abstract Background Psychosocial factors are useful predictors of adverse outcomes after solid organ transplantation. Although depression is a known predictor of poor outcomes in patients who undergo orthotopic heart transplantation (OHT) and is actively screened for during pre-transplant evaluation, the effects of early identification of this entity on post-transplant outcomes are not clearly understood. The purpose of this study was to evaluate the impact of pre-transplant depression on outcomes after OHT. Method In this retrospective study, 51 patients that underwent psychosocial evaluation performed by a social worker prior to the transplant and followed up in our center post-transplant were enrolled. Patients were stratified by the presence/absence of depression during the initial encounter. Primary end-points were overall survival, 1st-year hospitalizations, overall hospitalizations, rejections, and compliance with medications and outpatient appointments. Results Depressed patients were 3.5 times more likely to be non-compliant with medications; RR = 3.5, 95% CI (1.2,10.2), p = 0.046 and had higher incidence of first year hospitalizations (4.7 ± 3.1 vs. 2.2 ± 1.9, p = 0.046), shorter time to first hospitalization 25 days (IQR 17–39) vs. 100 days (IQR 37–229), p = 0.001. Patients with depression also had higher overall hospitalizations (8.3 ± 4.4 vs. 4.6 ± 4.2, p = 0.025,) and higher number of admissions for infections (2.8 ± 1.3 vs. 1.5 ± 1.4, p = 0.018) compared to patients without depression. There were no statistically significant differences in total number of rejections or compliance with outpatient appointments. Kaplan-Meier survival analysis did not reveal differences between the two groups (mean 3705 vs. 3764 days, log-rank p = 0.52). Conclusion Depression was a strong predictor of poor medication compliance and higher rates of hospitalization in transplant recipients. No difference in survival between depressed and non-depressed patients after OHT was noted

Computational chemical imaging for cardiovascular pathology: chemical microscopic imaging accurately determines cardiac transplant rejection.

Rejection is a common problem after cardiac transplants leading to significant number of adverse events and deaths, particularly in the first year of transplantation. The gold standard to identify rejection is endomyocardial biopsy. This technique is complex, cumbersome and requires a lot of expertise in the correct interpretation of stained biopsy sections. Traditional histopathology cannot be used actively or quickly during cardiac interventions or surgery. Our objective was to develop a stain-less approach using an emerging technology, Fourier transform infrared (FT-IR) spectroscopic imaging to identify different components of cardiac tissue by their chemical and molecular basis aided by computer recognition, rather than by visual examination using optical microscopy. We studied this technique in assessment of cardiac transplant rejection to evaluate efficacy in an example of complex cardiovascular pathology. We recorded data from human cardiac transplant patients' biopsies, used a Bayesian classification protocol and developed a visualization scheme to observe chemical differences without the need of stains or human supervision. Using receiver operating characteristic curves, we observed probabilities of detection greater than 95% for four out of five histological classes at 10% probability of false alarm at the cellular level while correctly identifying samples with the hallmarks of the immune response in all cases. The efficacy of manual examination can be significantly increased by observing the inherent biochemical changes in tissues, which enables us to achieve greater diagnostic confidence in an automated, label-free manner. We developed a computational pathology system that gives high contrast images and seems superior to traditional staining procedures. This study is a prelude to the development of real time in situ imaging systems, which can assist interventionists and surgeons actively during procedures

Projecting Future Climate Impact on National Australian Respiratory-Related Intensive Care Unit Demand

Background and Aims: A robust climate-health projection model has the potential to improve health care resource allocation. We aim to explore the relationship between Australian intensive care unit (ICU) demand and various measures of the long-lived large-scale climate and to develop a future nationwide climate-health projection model. Methods: We investigated patients admitted to ICUs in Australia between January 2003 and December 2019 who were exposed to long-lived large-scale combined climatic measures of temperature and humidity. We analysed the projected demand for respiratory-related ICU average length of stay (in days) per capita (ICUD/C) with four historical and one future projection dataset. These datasets included: i) Australian and New Zealand Intensive Care Society adult patient database, ii) Socioeconomic Data and Applications Center gridded global historical population, iii) Australian Bureau of Statistics national historical population, iv) Japanese 55-year Reanalysis historical climate (JRA55), and v) the fifth Coupled Model Inter-comparison Project future climate projections. Results: 148,638 patients with respiratory issues required intensive care between 2003 and 2019. The annual growth in the population density-weighted wet-bulb-globe temperature—a combined measure of temperature and humidity—is strongly correlated with the annual per capita growth ICUD/C for respiratory-related conditions (r=0.771; p<0.001). This relationship was applied to develop a model projecting future respiratory-related ICU demand with three possible future Representative Concentration Pathways (RCP). RCP2.6 (lowest carbon emission climate scenario) showed only a 33.4% increase in Australian ICUD/C demand by 2090, while the RCP8.5 (highest carbon emission climate scenario) demonstrated almost two-fold higher demand (66.1%) than RCP2.6 by 2090. Conclusions: The annual growth in population density-weighted wet-bulb-globe temperature correlates with the annual growth in Australian ICUD/C for respiratory-related conditions. A model based on possible future climate scenarios can be developed to predict changes in ICU demand in response to CO2 changes over the coming decades