Performance of a novel artificial intelligence software developed to derive coronary fractional flow reserve values from diagnostic angiograms.

BACKGROUND: Although invasive measurement of fractional flow reserve (FFR) is recommended to guide revascularization, its routine use is underutilized. Recently, a novel non-invasive software that can instantaneously produce FFR values from the diagnostic angiograms, derived completely from artificial intelligence (AI) algorithms has been developed. We aim to assess the accuracy and diagnostic performance of AI-FFR in a real-world retrospective study. METHODS: Retrospective, three-center study comparing AI-FFR values with invasive pressure wire-derived FFR obtained in patients undergoing routine diagnostic angiography. The accuracy, sensitivity, and specificity of AI-FFR were analyzed. RESULTS: A total of 304 vessels from 297 patients were included. Mean invasive FFR was 0.86 vs. 0.85 AI-FFR (mean difference: -0.005, P  = 0.159). The diagnostic performance of AI-FFR demonstrated sensitivity of 91%, specificity 95%, positive predictive value 83% and negative predictive value 97%. Overall accuracy was 94% and the area under curve was 0.93 (95% CI 0.88-0.97). 105 lesions fell around the cutoff value (FFR = 0.75-0.85); in this sub-group, AI-FFR demonstrated sensitivity of 95%, and specificity 94%, with an AUC of 0.94 (95% CI 88.2-98.0). AI-FFR calculation time was 37.5 ±â€…7.4 s for each angiographic video. In 89% of cases, the software located the target lesion and in 11%, the operator manually marked the target lesion. CONCLUSION: AI-FFR calculated by an AI-based, angio-derived method, demonstrated excellent diagnostic performance against invasive FFR. AI-FFR calculation was fast with high reproducibility.

Latest Developments in Robotic Percutaneous Coronary Interventions.

Since the first robotic-assisted percutaneous coronary intervention procedure (R-PCI) was performed in 2004, there has been a steady evolution in robotic technology, combined with a growth in the number of robotic installations worldwide and operator experience. This review summarises the latest developments in R-PCI with a focus on developments in robotic technology, procedural complexity, tele-stenting and training methods, which have all contributed to the global expansion in R-PCI.

Door to balloon time in primary percutaneous coronary intervention in ST elevation myocardial infarction: every minute counts.

OBJECTIVES: This study examines relationships between door to balloon (D2B) time and subsequent admissions due to heart failure (HF), acute coronary syndrome (ACS), and mortality for up to 1 year. BACKGROUND: Current guidelines set 90-min for D2B time for primary percutaneous coronary intervention (PPCI) as a goal, which has been shown to reduce mortality and adverse events. METHODS: Using the MDclone ADAMS system integrated with our electronic medical records, we conducted retrospective analysis of all patients admitted due to ST-elevation myocardial infarction from home, without any history of HF or coronary disease, and who underwent PPCI during 2013-2019. Data on D2B time, baseline clinical and demographic characteristics, and outcomes of HF, ACS and mortality were collected. Adjusted HR for each of the outcomes was calculated by multivariate Cox model. RESULTS: A total of 826 patients were included in the final analysis. D2B had no significant effect on incidence of heart failure admissions for up to 1-year follow-up. D2B had a significant effect on mortality at 180 days, showing a 30% increase for each 30-min increase (HR 1.308; CI, 1.046-1.635) as for ACS at 90 days (HR 1.307; 1.025-1.638). The 30-min D2B cutoff showed a significant increase in ACS recurrence throughout the follow-up period at 90 days (HR 2.871, 1.239-6.648), 180 days (HR 2.607, 1.255-5.413), and 1 year (HR 1.886, 1.073-3.317). CONCLUSIONS: Patients with shorter D2B times had significantly reduced mortality and recurrence of ACS, with no effect on heart failure admission incidence.

Robotics, imaging, and artificial intelligence in the catheterisation laboratory.

The catheterisation laboratory today combines diagnosis and therapeutics, through various imaging modalities and a prolific list of interventional tools, led by balloons and stents. In this review, we focus primarily on advances in image-based coronary interventions. The X-ray images that are the primary modality for diagnosis and interventions are combined with novel tools for visualisation and display, including multi-imaging co-registration modalities with three- and four-dimensional presentations. Interpretation of the physiologic significance of coronary stenosis based on prior angiographic images is being explored and implemented. Major efforts to reduce X-ray exposure to the staff and the patients, using computer-based algorithms for image processing, and novel methods to limit the radiation spread are being explored. The use of artificial intelligence (AI) and machine learning for better patient care requires attention to universal methods for sharing and combining large data sets and for allowing interpretation and analysis of large cohorts of patients. Barriers to data sharing using integrated and universal protocols should be overcome to allow these methods to become widely applicable. Robotic catheterisation takes the physician away from the ionising radiation spot, enables coronary angioplasty and stenting without compromising safety, and may allow increased precision. Remote coronary procedures over the internet, that have been explored in virtual and animal studies and already applied to patients in a small pilot study, open possibilities for sharing experience across the world without travelling. Application of those technologies to neurovascular, and particularly stroke interventions, may be very timely in view of the need for expert neuro-interventionalists located mostly in central areas.

Israeli underground hospital conversion for treating COVID-19 patients.

OBJECTIVE: This paper describes how a large academic medical center solved the challenges of war preparedness and subsequently adapted them for the COVID-19 pandemic. SETTING: A 1,000-bed academic medical center in Northern Israel has faced two extreme challenges since 2006: operating under missile attack during the 2006 Second Lebanon War, and rapid establishment of a scalable infrastructure for COVID-19 patients. The first challenge led to construction of a dual-use facility: a parking lot during peacetime, and a fully functioning fortified underground emergency hospital (FUEH) in times of emergency. Several drills have confirmed readiness for various scenarios including conventional and unconventional warfare, and treating isolated patients during the Ebola and SARS threats. RESULTS: The hospital achieved preparedness for patient care during the COVID-19 pandemic, including all facilities and personnel, including infrastructure, laboratories, and innovations, to maintain standard patient care and separate COVID-19 treatment facilities. The hospital's second challenge represented by the COVID-19 pandemic led to adaptation of the FUEH as a key strategic facility in Northern Israel for treating hundreds of COVID-19 patients. Each solution was supported by innovations targeted for specific purposes and needs. CONCLUSIONS: The function and unique mechanisms used to leverage use of a dual facility was proven viable for several emergency conditions, including the COVID-19 pandemic. Infrastructure and technological flexibility is essential when planning for handling different emergencies situations.

Analyzing Medical Research Results Based on Synthetic Data and Their Relation to Real Data Results: Systematic Comparison From Five Observational Studies.

BACKGROUND: Privacy restrictions limit access to protected patient-derived health information for research purposes. Consequently, data anonymization is required to allow researchers data access for initial analysis before granting institutional review board approval. A system installed and activated at our institution enables synthetic data generation that mimics data from real electronic medical records, wherein only fictitious patients are listed. OBJECTIVE: This paper aimed to validate the results obtained when analyzing synthetic structured data for medical research. A comprehensive validation process concerning meaningful clinical questions and various types of data was conducted to assess the accuracy and precision of statistical estimates derived from synthetic patient data. METHODS: A cross-hospital project was conducted to validate results obtained from synthetic data produced for five contemporary studies on various topics. For each study, results derived from synthetic data were compared with those based on real data. In addition, repeatedly generated synthetic datasets were used to estimate the bias and stability of results obtained from synthetic data. RESULTS: This study demonstrated that results derived from synthetic data were predictive of results from real data. When the number of patients was large relative to the number of variables used, highly accurate and strongly consistent results were observed between synthetic and real data. For studies based on smaller populations that accounted for confounders and modifiers by multivariate models, predictions were of moderate accuracy, yet clear trends were correctly observed. CONCLUSIONS: The use of synthetic structured data provides a close estimate to real data results and is thus a powerful tool in shaping research hypotheses and accessing estimated analyses, without risking patient privacy. Synthetic data enable broad access to data (eg, for out-of-organization researchers), and rapid, safe, and repeatable analysis of data in hospitals or other health organizations where patient privacy is a primary value.

Occluded mammary graft post-coronary bypass surgery: do we need to look for the second one? A case report.

BACKGROUND: Anatomic variations of the left internal mammary artery (LIMA) can influence coronary artery bypass surgical technique as well as posing definite difficulties in the interpretation of angiographic findings. We present an unusual anatomic variant of two LIMAs originating from the left subclavian artery discovered post-coronary artery bypass grafting surgery. CASE SUMMARY: A 60-year-old man post-LIMA grafting of the left anterior descending (LAD) coronary artery underwent diagnostic cardiac catheterization. Selective angiography revealed occluded LIMA; therefore, it was decided to proceed with percutaneous coronary intervention (PCI) to the occluded native LAD. Once antegrade flow in the LAD was restored, retrograde filling of a vessel corresponding to the previously grafted LIMA was also detected. Additional contrast injection in the left subclavian artery (LSCA) showed a second patent LIMA originating from the distal segment of the LSCA. DISCUSSION: This patient has an unusual anatomic variant of two LIMAs originating from the LCSA. The proximal rudimentary LIMA was misinterpreted as an occluded arterial graft while the second, well-developed LIMA connected to the LAD had an unusually distal origin and had therefore been overlooked. This anatomical variant should be kept in mind when the internal mammary graft seems to be occluded.

[RAMBAM - WHERE MEDICINE, TECHNOLOGY AND HUMANITY INTERTWINE].

INTRODUCTION: In this issue, we present a series of articles written by Rambam's physicians, which reflect the scope of research that takes place in the hospital. This incorporates physicians, nurses and related professions, and progress in health care attained through research and technology-based medicine. A central part of our values is a combination of medicine, technology and humanity. Thanks to our unique location in close proximity to the Technion's Baruch and Ruth Rappaport Faculty of Medicine, our commitment to the combination of research and medicine has a unique impact. We invest in the development and promotion of the physician-researcher and the allied health professions involved in the research. We provide a range of research grants throughout the researchers' careers. The "Futures" grant is for a young doctor who wants to be exposed to basic or applied research under the guidance of a senior scientist. The "Ofakim" grant is intended for the senior physician in his initial steps, who is interested in establishing research activity. The "Nitzotz" grant is intended for an entrepreneur who has an idea for a product and wants to build a prototype, as a first step towards establishing a medical technology company. The "Maof" grant is intended for the nurse-investigator, and there are additional grants for other disciplines. In addition, there is a variety of national and international sources to fund research on a competitive basis in all fields, and we encourage our teams to turn to these sources. Cooperation with our neighboring universities, the Technion and the University of Haifa, with the industry around us and with other research and educational institutions, is of paramount importance for the continued development of the basic, applied and clinical research culture on our campus. We recently published an article describing the reasons why Israel has become a medical start-up country in many fields, and one of the leading reasons is the combination of clinical medicine, research and industry. The papers presented in this issue reflect our wide interest in the entire scope of medical professions. It spans internal medicine, surgery, nephrology, cardiology and cardiac surgery, genetics, organ transplantation and other topics. I wish you an interesting and joyful reading of this special issue.

Acute Kidney Injury After Primary Angioplasty: Is Contrast-Induced Nephropathy the Culprit?

BACKGROUND: Acute kidney injury (AKI) following primary percutaneous coronary intervention (pPCI) is frequently interpreted as contrast-induced AKI but may result from other insults. We aimed to determine the causal association of contrast material exposure and the incidence of AKI following pPCI using a control group of propensity score-matched patients with ST-segment-elevation myocardial infarction who were not exposed to contrast material. METHODS AND RESULTS: We studied 2025 patients with ST-segment-elevation myocardial infarction who underwent pPCI and 1025 patients receiving fibrinolysis or no reperfusion who were not exposed to contrast material during the first 72 hours of hospital stay (control group). AKI was defined as creatinine of ≥0.5 mg/dL or >25% rise within 72 hours. AKI rates were similar in the pPCI and control groups (10.3% versus 12.1%, respectively; P=0.38). Propensity score matching resulted in 931 matched pairs with PCI and no PCI, with balanced baseline covariates (standardized difference <0.1). Among propensity score-matched patients, AKI rates were not significantly different with and without PCI (8.6% versus 10.9%, P=0.12). In the pPCI cohort, independent predictors of AKI included age ≥70 years, insulin-treated diabetes mellitus, diuretic therapy, anterior infarction, baseline estimated glomerular filtration rate, and variables related to the presence of pump failure (higher Killip class, intra-aortic balloon pump use) and reduced left ventricular ejection fraction but not contrast material dose. A risk score based on the PCI cohort had similar discriminatory capacity for AKI in the control group (C statistic 0.81±0.02 and 0.78±0.02, respectively; P=0.26). CONCLUSIONS: The development of AKI in patients with ST-segment-elevation myocardial infarction undergoing pPCI is mainly related to older age, baseline estimated glomerular filtration rate, heart failure, and hemodynamic instability. Risk for AKI is similar among ST-segment-elevation myocardial infarction patients with and without contrast material exposure.

Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial.

OBJECTIVES: This study sought to compare the outcomes of patients undergoing drug-eluting stent implantation according to lesion location within or outside the proximal left anterior descending (LAD) artery. BACKGROUND: Proximal LAD artery involvement is considered uniquely in revascularization guidelines. The impact of LAD lesion location on long-term outcomes after revascularization is poorly understood in context of current percutaneous coronary intervention and medical therapy. METHODS: Among 8,709 patients enrolled in PROTECT (Patient Related Outcomes with Endeavor Versus Cypher Stenting Trial), a multicenter percutaneous coronary intervention trial, we compared the outcomes of 2,534 patients (29.1%) (3,871 lesions [31.5%]) with stents implanted in the proximal LAD to 6,172 patients (70.9%) (8,419 lesions [68.5%]) with stents implanted outside the proximal LAD. RESULTS: At the 4-year follow-up, death rates were the same (5.8% vs. 5.8%; p > 0.999), but more myocardial infarctions occurred in the proximal LAD group (6.2% vs. 4.9%; p = 0.015). The rate of clinically driven target vessel failure (TVF) (14.8% vs. 13.5%; p = 0.109), major adverse cardiac event(s) (MACE) (15.0% vs. 13.7%; hazard ratio: 1.1; 95% confidence interval: 0.97 to 1.31; p = 0.139), and stent thrombosis (2.1% vs. 2.0%; p = 0.800) were similar. Drug-eluting stent type had no interaction with MACE or TVF. In multivariate analysis, the proximal LAD was a predictor of myocardial infarction (p = 0.038) but not of TVF (p = 0.149) or MACE (p = 0.069). CONCLUSIONS: In this study of contemporary percutaneous coronary intervention, proximal LAD location was associated with higher rates of myocardial infarction during the long-term follow-up, but there were no differences in stent thrombosis, death, TVF, or overall MACE. This finding may suggest that, in the drug-eluting stent era, proximal LAD no longer confers a different prognosis than other lesion sites. (Randomized Study Comparing Endeavor With Cypher Stents [PROTECT]; NCT00476957).

Heart failure in patients with diabetes undergoing primary percutaneous coronary intervention.

INTRODUCTION: Diabetes mellitus is associated with increased risk after acute coronary syndromes. Primary percutaneous coronary intervention is the most effective method of reperfusion for acute ST-elevation myocardial infarction and can limit the ischaemic damage to the left ventricle. However, there are few data on the impact of diabetes mellitus on the risk of heart failure following primary percutaneous coronary intervention. METHODS: We studied 958 ST-elevation myocardial infarction patients treated with primary percutaneous coronary intervention, of whom 263 (27.5%) had diabetes mellitus, with 67 (7.0%) treated with insulin. The primary end points of the study were re-admission for heart failure. Secondary end points were all-cause mortality and recurrent infarctions. The follow-up period was 5 years after hospital discharge. RESULTS: The cumulative incidence of re-admission for heart failure was 8.4%, 15.2% and 26.7% in patients without diabetes mellitus, non-insulin-treated and insulin-treated diabetes mellitus, respectively. Compared with patients without diabetes mellitus, the adjusted hazard ratio for heart failure was 1.95 (95% confidence intervals 1.30-2.93) and 3.09 (95% confidence intervals 1.71-5.60) in non-insulin-treated and insulin-treated diabetes mellitus, respectively. The corresponding hazard ratios for mortality were 1.03 (95% confidence intervals 0.68-1.55) and 2.04 (95% confidence intervals 1.22-3.42), respectively. There was a J-shaped association between fasting glucose levels in the acute phase and risk of mortality (P=0.0001) and a direct association with heart failure (P=0.03). CONCLUSION: Despite modern treatment of ST-elevation myocardial infarction and high levels of guideline-based medical care, diabetes mellitus had an independent adverse effect on the risk of re-admissions for heart failure, which was particularly high among insulin-treated patients.

The Long and Winding Road to Innovation.

Medicine is developing through biomedical technology and innovations. The goal of any innovation in medicine is to improve patient care. Exponential growth in technology has led to the unprecedented growth of medical technology over the last 50 years. Clinician-scientists need to understand the complexity of the innovation process, from concept to product release, when working to bring new clinical solutions to the bedside. Hence, an overview of the innovation process is provided herein. The process involves an invention designed to solve an unmet need, followed by prototype design and optimization, animal studies, pilot and pivotal studies, and regulatory approval. The post-marketing strategy relative to funding, along with analysis of cost benefit, is a critical component for the adoption of new technologies. Examples of the road to innovation are provided, based on the experience with development of the transcatheter aortic valve. Finally, ideas are presented to contribute to the further development of this worldwide trend in innovation.

Moral dilemmas faced by hospitals in time of war: the Rambam Medical Center during the second Lebanon war.

Rambam Medical Center, the only tertiary care center and largest hospital in northern Israel, was subjected to continuous rocket attacks in 2006. This extreme situation posed serious and unprecedented ethical dilemmas to the hospital management. An ambiguous situation arose that required routine patient care in a tertiary modern hospital together with implementation of emergency measures while under direct fire. The physicians responsible for hospital management at that time share some of the moral dilemmas faced, the policy they chose to follow, and offer a retrospective critical reflection in this paper. The hospital's first priority was defined as delivery of emergency surgical and medical services to the wounded from the battlefields and home front, while concomitantly providing the civilian population with all elective medical and surgical services. The need for acute medical service was even more apparent as the situation of conflict led to closure of many ambulatory clinics, while urgent or planned medical care such as open heart surgery and chemotherapy continued. The hospital management took actions to minimize risks to patients, staff, and visitors during the ongoing attacks. Wards were relocated to unused underground spaces and corridors. However due to the shortage of shielded spaces, not all wards and patients could be relocated to safer areas. Modern warfare will most likely continue to involve civilian populations and institutes, blurring the division between peaceful high-tech medicine and the rough battlefront. Hospitals in high war-risk areas must be prepared to function and deliver treatment while under fire or facing similar threats.

Decision-support information system to manage mass casualty incidents at a level 1 trauma center.

Mass casualty incidents are probably the greatest challenge to a hospital. When such an event occurs, hospitals are required to instantly switch from their routine activity to conditions of great uncertainty and confront needs that exceed resources. We describe an information system that was uniquely designed for managing mass casualty events. The web-based system is activated when a mass casualty event is declared; it displays relevant operating procedures, checklists, and a log book. The system automatically or semiautomatically initiates phone calls and public address announcements. It collects real-time data from computerized clinical and administrative systems in the hospital, and presents them to the managing team in a clear graphic display. It also generates periodic reports and summaries of available or scarce resources that are sent to predefined recipients. When the system was tested in a nationwide exercise, it proved to be an invaluable tool for informed decision making in demanding and overwhelming situations such as mass casualty events.