STS INTERMACS Database: The Key to Conduct Single-Arm Trials in Advanced Heart Failure Patients.

BACKGROUND: Safe introduction of novel mechanical circulatory support (MCS) devices into clinical practice is a challenging process. Single-arm trials using a control arm from existing database is an effective alternative that could be applied for regulatory approval. This study analyzes the capability of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database to establish objective performance criteria and select patient population that could be used for future single-arm MCS trials. METHODS: Patients with INTERMACS profiles IM1-2 and IM3-5, who underwent implantation of isolated left ventricular assist devices between 2014 and 2017, were included. Both cohorts were further stratified into shock and nonshock groups using surrogate markers of shock (extracorporeal membrane oxygenation, temporary ventricular assist device, vasopressor infusions). Survival, transplantation rates, adverse events, 6-minute walk test, and quality-of-life measures were obtained for all 4 groups at 6 and 12 months. RESULTS: Total of 7907 patients were divided into IM1-2 (n = 3909), IM3-5 (n = 3998), shock (n = 3469), and nonshock (n = 3040) groups. Recategorization occurred in 11% of patients from the IM3-5 group into the shock group. Overall, patients in the shock group had similar outcomes to the IM1-2 group (1-year survival: 86% vs 85%; P = .74). Patients in the nonshock group also had similar outcomes to the IM3-5 (1-year survival: 90% vs 90%; P = .43). CONCLUSIONS: The INTERMACS database can successfully establish objective performance criteria and concurrent control group for single-arm trials that could be used to support regulatory approval of new, less invasive MCS. INTERMACS data allow reliable comparisons of outcomes and adverse events.

Creation of a COVID-19 Based Educational Curriculum: A Blueprint for Redesigning Surgical Education During Times of National Crisis.

Objective: To create a COVID-19 based educational curriculum for surgical residents. Background Data: The COVID-19 pandemic has resulted in disruptions to operative volume and clinical education for surgery residents. This has placed a greater importance on didactic education. However, in the face of pandemic-related uncertainty, focusing on a traditional educational curriculum may be a challenge for surgical residents. Methods: A dedicated resident educational team was created. This team identified specific surgical resident needs, evaluated institutional resources, created a curriculum and timeline, determined a feasible implementation format, and assessed resident opinions on the impact of the curriculum via anonymous survey. Results: A 1-month long COVID-19 based curriculum was developed, which covered (1) advanced critical care and resuscitation techniques pertinent to patients with COVID-19, (2) institutional physician experience in the COVID-units, (3) ethical dilemmas in resource management, (4) triaging of operative cases during the pandemic, and (5) published and ongoing COVID-19-related surgical research. In the postimplementation survey, a majority of residents reported that the curriculum helped improve their ability to take care of patients during the pandemic, provided an opportunity for questions, alleviated anxieties and concerns, and that they preferred the COVID-19 curriculum over traditional surgical topics. Conclusions: In the midst of national crisis and significant clinical disruption, real-time adjustments to surgical education can and should occur to address resident needs. The results of our study may serve as a blueprint for implementing rapid change to resident education in the future.

Choosing the appropriate left ventricular assist device for your patient.

The increasing incidence of advanced heart failure and severe donor organ shortage for cardiac transplant has led to the development of implantable left ventricular assist devices (LVAD) for long-term mechanical circulatory support. There has been tremendous improvement in the device technology of LVADs, and there are a number of devices in use throughout the world. This article reviews the evidence behind each device and their unique features that can help when choosing a durable LVAD for an individual patient.

An ambulatory counterpulsation system-a potential option for extended mechanical support.

As the incidence of heart failure increases, an organ shortage for cardiac transplant worsens. There has been development of both short and long-term mechanical circulatory devices for this population, each with unique advantages and different adverse event profiles. The long-term devices provide excellent mechanical circulatory support but are associated with significant morbidity. The intravascular ventricular assist system (iVAS) is a minimally invasive, ambulatory, counterpulsation heart assist system developed to provide long-term support for patients with advanced heart failure while avoiding the surgical trauma of a left ventricular assist device and minimizing the risks of infection and hemocompatibility-related adverse events. Initial experience with the iVAS shows promising evidence for its use as a long-term mechanical circulatory support device.

Robotic-Assisted Third-Time Redo Mitral Valve Replacement.

Robotic-assisted approaches in cardiac surgery are becoming an increasingly common form of minimally invasive surgery. Recent literature has shown robotic-assisted techniques to be superior to traditional sternotomy in infection rates, bleeding, length of hospital stay, and postoperative quality of life. Although there are growing numbers of centers performing robotic mitral valve (MV) surgery, this approach is usually reserved for first-time MV repair. This case report describes a patient with two previous MV surgical procedures complicated by a late paravalvular leak that was unsuccessfully treated with four Amplatzer devices (AGA Medical, Inc, Plymouth, MN). A successful, totally endoscopic, robotic-assisted, third-time reoperative MV replacement was performed in this challenging patient.