Classification of Documented Goals of Care Among Hospitalized Patients with High Mortality Risk: a Mixed-Methods Feasibility Study.

BACKGROUND: The ability to classify patients' goals of care (GOC) from clinical documentation would facilitate serious illness communication quality improvement efforts and pragmatic measurement of goal-concordant care. Feasibility of this approach remains unknown. OBJECTIVE: To evaluate the feasibility of classifying patients' GOC from clinical documentation in the electronic health record (EHR), describe the frequency and patterns of changes in patients' goals over time, and identify barriers to reliable goal classification. DESIGN: Retrospective, mixed-methods chart review study. PARTICIPANTS: Adults with high (50-74%) and very high (≥ 75%) 6-month mortality risk admitted to three urban hospitals. MAIN MEASURES: Two physician coders independently reviewed EHR notes from 6 months before through 6 months after admission to identify documented GOC discussions and classify GOC. GOC were classified into one of four prespecified categories: (1) comfort-focused, (2) maintain or improve function, (3) life extension, or (4) unclear. Coder interrater reliability was assessed using kappa statistics. Barriers to classifying GOC were assessed using qualitative content analysis. KEY RESULTS: Among 85 of 109 (78%) patients, 338 GOC discussions were documented. Inter-rater reliability was substantial (75% interrater agreement; Cohen's kappa = 0.67; 95% CI, 0.60-0.73). Patients' initial documented goal was most frequently "life extension" (N = 37, 44%), followed by "maintain or improve function" (N = 28, 33%), "unclear" (N = 17, 20%), and "comfort-focused" (N = 3, 4%). Among the 66 patients whose goals' classification changed over time, most changed to "comfort-focused" goals (N = 49, 74%). Primary reasons for unclear goals were the observation of concurrently held or conditional goals, patient and family uncertainty, and limited documentation. CONCLUSIONS: Clinical notes in the EHR can be used to reliably classify patients' GOC into discrete, clinically germane categories. This work motivates future research to use natural language models to promote scalability of the approach in clinical care and serious illness research.

An early artificial implantable kidney prototype demonstrates short-term viability in a porcine model without immunosuppression.

Dialysis remains an imperfect treatment for over two million patients with renal failure worldwide. This bioreactor may lead to the completely implantable, continuous filtration system they need.

Patient sequentially receives a left ventricular assist device and a porcine kidney transplant.

As a second porcine kidney xenotransplant case in a human recipient to date, this breakthrough technology offers an option even to patients with complex multiorgan failures, who may not be candidates for a conventional organ transplant.

Researchers propose ice 3D printing as a method to create internal channels in artificial organs.

By freezing water droplets into smooth, even columns, researchers from Carnegie Mellon University created complex internal channels that may eventually render viable complex artificial tissue.

Engineers use a porcine heart scaffold to create a bio-robotic model of the right ventricle.

The simulator can provide a dynamic and sophisticated platform to further aid in the study of the right heart in an era where numerous technologies are rapidly emerging in this space.

FDA Modernization Act 2.0 allows for alternatives to animal testing.

On December 29, 2022, President Biden signed into law the FDA Modernization Act 2.0. The bill essentially refutes the Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. While for the past century, the mandate was intended to ensure certain quality and safety standards for drugs and medical devices, recent advancements in science have begun to offer increasingly viable alternatives to animal testing. For certain areas such as organ replacement therapies, non-animal testing may not prove to be an adequate alternative in the foreseeable future.

The convergence between artificial organ technology and simulation in surgery.

Scientists are creating high-fidelity, physiologic simulation platforms that enable the testing of various artificial organs, which may offer a valuable alternative to animal testing in the future.

Impella RP Flex with SmartAssist receives FDA pre-market approval.

This approval follows an ongoing trend toward less invasive and more versatile mechanical circulatory support platforms.

Three-dimensional bioprinting of artificial organs: How close are we to its clinical application?

A patient recently received a 3D-printed outer ear made out of her own cells. An endoscopic 3D bioprinter was able to print biomaterials in situ. In this decade, we may at last see the application of 3D bioprinters in the creation of complex, clinically viable artificial organs.

A multimillion-dollar DARPA grant awarded to a team developing artificial whole blood product.

Each year, countless individual die from not having immediate access to life-saving blood products. A multi-institutional team was awarded a $46.4 million grant to create an artificial alternative.

Researchers successfully engineer endovascular probes for brain recording at a microscopic scale.

A neural probe capable of recording single-cell resolution was implanted using an endovascular approach through micrometer-scale vasculature. Overall, this, among other developments, are enabling safer and more specific targeting of neurologic conditions, but their overall ethical implications remain to be further discussed.

Quality and readability of online patient information on the left ventricular assist device.

BACKGROUND: As patients seek online health information to supplement their medical decision-making, the aim of this study is to assess the quality and readability of internet information on the left ventricular assist device (LVAD). METHODS: Three online search engines (Google, Bing, and Yahoo) were searched for "LVAD" and "Left ventricular assist device." Included websites were classified as academic, foundation/advocacy, hospital-affiliated, commercial, or unspecified. The quality of information was assessed using the JAMA benchmark criteria (0-4), DISCERN tool (16-80), and the presence of Health On the Net code (HONcode) accreditation. Readability was assessed using the Flesch Reading Ease score. RESULTS: A total of 38 unique websites were included. The average JAMA and DISCERN scores of all websites were 0.82 ± 1.11 and 52.45 ± 13.51, respectively. Academic sites had a significantly lower JAMA mean score than commercial (p < 0.001) and unspecified (p < 0.001) websites, as well as a significantly lower DISCERN, mean score than commercial sites (p = 0.002). HONcode certification was present in 6 (15%) websites analyzed, which had significantly higher JAMA (p < 0.001) and DISCERN (p < 0.016) mean scores than sites without HONcode certification. Readability was fairly difficult and at the level of high school students. CONCLUSIONS: The quality of online information on the LVAD is variable, and overall readability exceeds the recommended level for the public. Patients accessing online information on the LVAD should be referred to sites with HONcode accreditation. Academic institutions must provide higher quality online patient literature on LVADs.

Subacute groin complications related to ECMO cannulation are associated with longer hospitalizations.

Subacute groin complications associated with extracorporeal membrane oxygenation (ECMO) cannulation are well recognized, yet their effects on clinical outcomes remain unknown. This single-center, retrospective study reviewed all patients receiving venoarterial ECMO from 01/2017 to 02/2020. Cohorts analyzed included transplanted patients (TPs) and non-transplanted patients (N-TPs) who did or did not develop ECMO-related subacute groin complications. Standard descriptive statistics were used for comparisons. Logistic regressions identified associated risk factors. Overall, 82/367 (22.3%) ECMO patients developed subacute groin complications, including 25/82 (30.5%) seromas/lymphoceles, 32/82 (39.0%) hematomas, 18/82 (22.0%) infections, and 7/82 (8.5%) non-specified collections. Of these, 20/82 (24.4%) underwent surgical interventions, most of which were muscle flaps (14/20, 70.0%). TPs had a higher incidence of subacute groin complications than N-TPs (14/28, 50.0% vs. 68/339, 20.1%, P = 0.001). Seromas/lymphoceles more often developed in TPs than N-TPs (10/14, 71.4% vs. 15/68, 22.1%, P = 0.001). Most patients with subacute groin complications survived to discharge (60/68, 88.2%). N-TPs who developed subacute groin complications had longer post-ECMO lengths of stay than those who did not (34 days, IQR 16-53 days vs. 17 days, IQR 8-34 days, P < 0.001). Post-ECMO length of stay was also longer among patients who underwent related surgical interventions compared to those who did not (50 days, IQR 35-67 days vs. 29 days, IQR 16-49 days, P = 0.007). Transplantation was the strongest risk factor for developing subacute groin complications (OR 3.91, CI95% 1.52-10.04, P = 0.005). Subacute groin complications and related surgical interventions are common after ECMO cannulation and are associated with longer hospital stays. When surgical management is warranted, muscle flaps may reduce lengths of stay compared to other surgical interventions.

Extracorporeal Life Support for Respiratory Failure in Patients With Electronic Cigarette or Vaping Product Use-Associated Lung Injury.

OBJECTIVES: Electronic cigarette or vaping product use-associated lung injury is a clinical entity that can lead to respiratory failure and death. Despite the severity of electronic cigarette or vaping product use-associated lung injury, the role of extracorporeal life support in its management remains unclear. Our objective was to describe the clinical characteristics and outcomes of patients with electronic cigarette or vaping product use-associated lung injury who received extracorporeal life support. DESIGN: We performed a retrospective review of records of electronic cigarette or vaping product use-associated lung injury patients who received extracorporeal life support. Standardized data were collected via direct contact with extracorporeal life support centers. Data regarding presentation, ventilatory management, extracorporeal life support details, and outcome were analyzed. SETTING: This was a multi-institutional, international case series with patients from 10 different institutions in three different countries. PATIENTS: Patients who met criteria for confirmed electronic cigarette or vaping product use-associated lung injury (based on previously reported diagnostic criteria) and were placed on extracorporeal life support were included. Patients were identified via literature review and by direct contact with extracorporeal life support centers. MEASUREMENTS AND MAIN RESULTS: Data were collected for 14 patients ranging from 16 to 45 years old. All had confirmed vape use within 3 months of presentation. Nicotine was the most commonly used vaping product. All patients had respiratory symptoms and radiographic evidence of bilateral pulmonary opacities. IV antibiotics and corticosteroids were universally initiated. Patients were intubated for 1.9 days (range, 0-6) prior to extracorporeal life support initiation. Poor oxygenation and ventilation were the most common indications for extracorporeal life support. Five patients showed evidence of ventricular dysfunction on echocardiography. Thirteen patients (93%) were placed on venovenous extracorporeal life support, and one patient required multiple rounds of extracorporeal life support. Total extracorporeal life support duration ranged from 2 to 37 days. Thirteen patients survived to hospital discharge; one patient died of septic shock. CONCLUSIONS: Electronic cigarette or vaping product use-associated lung injury can cause refractory respiratory failure and hypoxemia. These data suggest that venovenous extracorporeal life support can be an effective treatment option for profound, refractory respiratory failure secondary to electronic cigarette or vaping product use-associated lung injury.

HCV-Positive Allograft Use in Heart Transplantation Is Associated With Increased Access to Overdose Donors and Reduced Waitlist Mortality Without Compromising Outcomes.

BACKGROUND: Because of ongoing shortages of donors for heart transplantation, the use of donor candidates whose availabilities are the result of drug overdoses (ODs) has become increasingly prevalent, even though these donors carry a high preponderance of the now curable hepatitis C virus (HCV). This study investigated temporal trends and regional variabilities in HVC-positive (HCV+) allograft use in heart transplantation and assessed the relationship between the use of HCV+ graft donors and the use of OD donors as well as assessing waitlist and post-transplant outcomes. METHODS AND RESULTS: A retrospective review of the United Network for Organ Sharing database assessed adults listed for heart transplantation. Patients were stratified both temporally into pre-HCV and HCV eras related to HCV+ graft use trends and regionally by degree of HCV+ allograft use. Regions of high HCV+ donor use were associated with an increase in OD donor access by 7.8% across eras compared to 0.4% in low HCV+ donor-use regions. One-year waitlist mortality decreased from 4.7% to 2.5% across eras in high HCV+ donor-use regions (P= 0.001) and remained roughly the same as before in low HCV+ donor-use regions (3.0% vs 2.4%; P= 0.244.). Post-transplant survival at 1 year remained similar across eras. CONCLUSIONS: HCV+ donor allograft use can help to optimize donor use, decreasing waitlist mortality without compromising early survival. Ongoing assessment is essential to ensure long-term safety and efficacy of using HCV+ donors.

The Aveir Leadless Pacing System receives FDA approval.

The Aveir leadless system is now the second device on the market in the United States to offer safe and reliable pacemaking capabilities to patients who experience significant bradycardia and arrhythmias.

A man in a completely locked-in state produces intelligible sentences using a brain-computer interface.

Patients with amyotrophic lateral sclerosis may enter into a completely locked-in state without any capability for communication using neuromuscular output. Using an auditory-guided neurofeedback-based strategy with implantable sensors in the motor cortex, scientists were able to help a patient in this state produce intelligible sentences.

Surgeon who implanted the world's first artificial trachea found guilty of causing bodily harm.

Dr. Paolo Macchiarini was a celebrated researcher for his development of an artificial trachea until his integrity and outcomes came under the medico-legal spotlight.

The FDA expands indications for the Vercise™ deep brain stimulation systems.

Deep brain stimulation technology offers symptomatic relief to patients with intractable tremor as an adjunct to traditional medical therapy. Their expanding indications signify the devices' growing potential and versatility.

Pioneer interview: Lyle D. Joyce, MD, PhD.

Lyle D. Joyce, MD, PhD is an adult cardiac surgeon who helped pioneer the artificial heart technology throughout his career. In 1982, he and Dr. William DeVries implanted Jarvik-7 total artificial heart (TAH) in a patient named Barney Clark, which was the first ever destination therapy TAH. Artificial Organs discussed with Dr. Joyce how he came to embark on this career path, his experiences in the operating room during these early days, and what advice he has for the future generation.