Venoarterial extracorporeal membrane oxygenation is a viable option as a bridge to heart transplant.

OBJECTIVE: Venoarterial extracorporeal membrane oxygenation is a rescue therapy for patients in cardiogenic shock. We hypothesize that patients bridged to heart transplant with extracorporeal membrane oxygenation have decreased survival. METHODS: The United Network of Organ Sharing database was retrospectively reviewed from January 1, 1999, to March 31, 2018, for heart transplant recipients. Recipients bridged with any form of mechanical support and those without support were compared with recipients bridged with extracorporeal membrane oxygenation. The primary end point was restricted mean survival time through 16.7 years. RESULTS: Of 26,918 recipients, 15,076 required no pretransplant mechanical support (56.0%). Support patients included 9321 with left ventricular assist devices (34.6%), 53 with right ventricular assist devices (0.2%), 258 with total artificial hearts (1.0%), 686 with biventricular assist devices (2.6%), 1378 with intra-aortic balloon pumps (5.1%), and 146 who required extracorporeal membrane oxygenation (0.5%). In the first 16.7 years post-transplant, compared with recipients bridged with extracorporeal membrane oxygenation, estimated adjusted restricted mean survival time was higher in patients who required no mechanical support (16.6 months [14.0-19.4]) and patients with a left ventricular assist device (16.5 months [99% confidence interval, 13.9-19.2]), an intra-aortic balloon pump (11.2 months [8.3-14.7]), or a biventricular assist device (6.6 months [3.6-10.3]). Restricted mean survival time in patients with a right ventricular assist device or a total artificial heart was similar to patients with extracorporeal membrane oxygenation. CONCLUSIONS: Recipients bridged with extracorporeal membrane oxygenation were estimated to survive 16.6 months less than nonmechanical circulatory support recipients. Bridge to heart transplant with extracorporeal membrane oxygenation is a viable option, and these patients should be considered transplant candidates.

Contemporary Left Ventricular Assist Device Outcomes in an Aging Population: An STS INTERMACS Analysis.

BACKGROUND: Survival, functional outcomes, and quality of life after left ventricular assist device (LVAD) are ill-defined in elderly patients, and with new-generation devices. OBJECTIVES: This study sought to evaluate survival, functional outcomes, and quality of life after LVAD in contemporary practice. METHODS: Adults receiving durable LVADs between January 1, 2010, and March 1, 2020, were identified from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The primary outcome was adjusted survival; secondary outcomes included quality of life rated using a visual analogue scale (where 0 represents "worst health" and 100 "best health"); 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age. Median follow-up was 15 months (IQR: 6-32 months). RESULTS: The cohort comprised 68.9% (n = 16,808) patients aged <65 years, 26.3% (n = 6,418) patients aged 65-75 years, and 4.8% (n = 1,182) patients aged >75 years, who were predominantly male (n = 19,119, 78%) and on destination therapy (n = 12,425, 51%). Competing outcomes analysis demonstrated mortality (70% CIs) of 34% (33%-34%), 54% (54%-55%), and 66% (64%-68%) for patients aged <65, 65-75, and >75 years, respectively, which improved during the study in patients aged >75 years. Newer-generation devices were associated with reduced late mortality (HR: 0.35; 95% CI: 0.25-0.49). Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age (all P < 0.01). Median 6-minute walk distance increased from 0 feet (IQR: 0-665 feet) to 1,065 feet (IQR: 642-1,313 feet) (P < 0.001), and quality of life improved from 40 (IQR: 15-60) to 75 (IQR: 60-90) (P < 0.001) after LVAD in all age groups. CONCLUSIONS: In elderly patients, LVADs are associated with increased functional capacity, similar improvements in quality of life, and fewer complications compared with younger patients.

Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review.

The regulatory landscape for device-based heart failure (HF) therapies has seen a major shift in the last 7 years. In 2013, the U.S. Food and Drug Administration released guidance for early feasibility and first-in-human studies, thereby encouraging device innovation, and in 2016 the U.S. Congress authorized the Breakthrough Devices Program to expedite access for Americans to innovative devices indicated for diagnosis and treatment of serious illnesses, such as HF. Since December 2016, there has been an increase in the number of HF devices for which manufacturers are seeking approval through the breakthrough designation pathway. This has led to a rapid uptake in the development and evaluation of device-based HF therapies. This article reviews the current and future landscape of device therapies for chronic HF and associated comorbidities and the regulatory environment that is driving current and future innovation.

High-frequency operation of pulsatile ventricular assist devices: A computational study on circular and elliptically shaped pumps.

Pulsatile positive displacement pumps as ventricular assist devices were gradually replaced by rotary devices due to their large volume and high adverse event rates. Nevertheless, pulsatile ventricular assist devices might be beneficial with regard to gastrointestinal bleeding and cardiac recovery. Therefore, aim of this study was to investigate the flow field in new pulsatile ventricular assist devices concepts with an increased pump frequency, which would allow lower stroke volumes to reduce the pump size. We developed a novel elliptically shaped pulsatile ventricular assist devices, which we compared to a design based on a circular shape. The pump size was adjusted to deliver similar flow rates at pump frequencies of 80, 160, and 240 bpm. Through a computational fluid dynamics study, we investigated flow patterns, residence times, and wall shear stresses for different frequencies and pump sizes. A pump size reduction by almost 50% is possible when using a threefold pump frequency. We show that flow patterns inside the circular pump are frequency dependent, while they remain similar for the elliptic pump. With slightly increased wall shear stresses for higher frequencies, maximum wall shear stresses on the pump housing are higher for the circular design (42.2 Pa vs 18.4 Pa). The calculated blood residence times within the pump decrease significantly with increasing pump rates. A smaller pump size leads to a slight increase of wall shear stresses and a significant improvement of residence times. Hence, high-frequency operation of pulsatile ventricular assist devices, especially in combination with an elliptical shape, might be a feasible mean to reduce the size, without any expectable disadvantages in terms of hemocompatibility.

HFSA/SAEM/ISHLT Clinical Expert Consensus Document on the Emergency Management of Patients with Ventricular Assist Devices.

Mechanical circulatory support is now widely accepted as a viable long-term treatment option for patients with end-stage heart failure (HF). As the range of indications for the implantation of ventricular assist devices grows, so does the number of patients living in the community with durable support. Because of their underlying disease and comorbidities, in addition to the presence of mechanical support, these patients are at a high risk for medical urgencies and emergencies (Table 1). Thus, it is the responsibility of clinicians to understand the basics of their emergency care. This consensus document represents a collaborative effort by the Heart Failure Society of America, the Society for Academic Emergency Medicine, and the International Society for Heart and Lung Transplantation (ISHLT) to educate practicing clinicians about the emergency management of patients with ventricular assist devices. The target audience includes HF specialists and emergency medicine physicians, as well as general cardiologists and community-based providers.

Left ventricular assist devices in the treatment of advanced heart failure.

The left ventricular assist device (LVAD) is becoming the standard of care in treating patients with advanced heart failure. This article describes available LVADs, their clinical indications, and important caveats when caring for this complex patient population.

Advanced Therapies for Advanced Heart Failure in Women.

Women with advanced heart failure (HF) are underrepresented in trials of short-term and durable mechanical circulatory support although they derive similar benefit. In acute HF, intensive medical and interventional therapies are effective but underutilized. The smaller, newer generation, left ventricular assist devices (LVADs) have increased the feasibility of durable support in women. Women frequently present late, with more comorbidities, emphasizing the need for timely referral. Compared with men, the stroke risk is higher in women with an LVAD. Increased representation in clinical trials and a better understanding of the psychosocial issues affecting women is essential.

First Use of HeartMate 3 in a Failing Fontan Circulation.

The failing Fontan circulation can be challenging to support with ventricular assist devices, mostly because of the variety of causes of failure, some of which cannot be addressed by VAD therapy alone. A new ventricular assist device, the HeartMate 3 (Abbott, Chicago, IL), was recently approved for use in adults in the United States and is now widely available, with excellent survival results in two-ventricle patients. This case report describes the first successful implantation of the HeartMate 3 in a 22-year-old man with a failing Fontan circulation and the possible benefits this device may have in supporting this ever-growing population of young adults with single ventricles.

Prevention and Infection Management in Mechanical Circulatory Support Device Recipients.

There are currently no guidelines for the management of infection and its prevention in mechanical circulatory support (MCS) device recipients. The International Society of Heart and Lung Transplantation (ISHLT) has initiated a multidisciplinary collaboration for the creation of a consensus document to guide clinicians in infection prevention and management in MCS patients. Most medical centers use local protocols that are based on expert opinion. MCS recipients are debilitated and have some immunological dysfunction. Over the years there have been technical advancements with smaller devices and drivelines with improved durability. The pulsatile devices have been replaced with newer-generation continuous-flow devices. Patient are living longer with MCSs for bridge to transplant (BTT) and destination therapy (DT). MCS centers have improved patient management by introducing standardized driveline protocols, leading to reduced infection rates among MCS recipients.

Rotary piston blood pumps: past developments and future potential of a unique pump type.

INTRODUCTION: The design of implantable blood pumps is either based on displacement pumps with membranes or rotary pumps. Both pump types have limitations to meet the clinical requirements. Rotary piston blood pumps have the potential to overcome these limitations and to merge the benefits. Compared to membrane pumps, they are smaller and with no need for wear-affected membranes and valves. Compared to rotary pumps, the blood flow is pulsatile instead of a non-physiological continuous flow. Furthermore, the risk of flow-induced blood damage and platelet activation may be reduced due to low shear stress to the blood. AREAS COVERED: The past developments of rotary piston blood pumps are summarized and the main problem for long-term application is identified: insufficient seals. A new approach with seal-less drives is proposed and current research on a simplified rotary piston design is presented. Expert commentary: The development of blood pumps focuses mainly on the improvement of rotary pumps. However, medical complications indicate that inherent limitations of this pump type remain and restrict the next substantial step forward in the therapy of heart failure patients. Thus, research on different pump types is reasonable. If the development of reliable drives and bearings succeeds, rotary piston blood pumps become a promising alternative.

Classification of Implantable Rotary Blood Pump States With Class Noise.

A medical case study related to implantable rotary blood pumps is examined. Five classifiers and two ensemble classifiers are applied to process the signals collected from the pumps for the identification of the aortic valve nonopening pump state. In addition to the noise-free datasets, up to 40% class noise has been added to the signals to evaluate the classification performance when mislabeling is present in the classifier training set. In order to ensure a reliable diagnostic model for the identification of the pump states, classifications performed with and without class noise are evaluated. The multilayer perceptron emerged as the best performing classifier for pump state detection due to its high accuracy as well as robustness against class noise.

Clinical management of patients with acute heart failure.

Acute heart failure is a common and serious complication of congenital and acquired heart disease, and it is associated with significant morbidity, mortality, and costs. When a patient is admitted to the hospital with acute heart failure, there are several important goals for the hospital admission, including maintaining adequate perfusion, establishing the underlying aetiology for the heart failure, patient and family education, and discharge from the hospital in a stable condition. The pathway to home discharge is variable and may include inotropic therapy, mechanical circulatory support, and/or heart transplantation. This review will cover the epidemiology, presentation, and management of acute heart failure in children.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention).

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines.

The evolution of temporary percutaneous mechanical circulatory support devices: a review of the options and evidence in cardiogenic shock.

Temporary percutaneous mechanical circulatory support (MCS) devices were introduced in the 1960s and have developed into a diverse portfolio of options currently available for left, right, and biventricular support. Patients undergoing high-risk percutaneous coronary interventions (PCI), patients with acute myocardial infarction (AMI), and patients with cardiogenic shock in particular may benefit from these options. In this review, we will discuss the currently available devices and the evidence supporting their use in cardiogenic shock.

Biventricular Berlin Heart EXCOR pediatric use across the united states.

BACKGROUND: Biventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival. METHODS: All EXCOR Pediatric devices (Berlin Heart, Inc, The Woodlands, TX) placed in North America between May 2007 and December 2010 comprised the study cohort of 204 patients (128 [63%] LVADs and 76 [37%] BiVADs). The following patient cohorts were analyzed to determine the effect of BiVAD use on survival: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 patients, patients with abnormal bilirubin levels, patients who received previous extracorporeal membrane oxygenation (ECMO), and patients with a 10-mL pump size. RESULTS: There were more patients with BiVADs in INTERMACS profile 1 (63% compared with 46%; p = 0.018). The incidence of major bleeding, neurologic and renal dysfunction, and infection was similar between BiVAD and LVAD groups. White race, abnormal glomerular filtration rate (GFR), sites with experience of less than 5 implantations, and use of 10-mL pumps were predictors of mortality in patients who received BiVADs. BiVADs were not associated with improved survival in any patient cohort; however, they were associated with increased mortality in patients who had undergone ECMO before receiving a VAD. CONCLUSIONS: BiVAD support was not associated with improved survival in any identified subset of patients. Although not randomized, these results (which were corrected for multiple possible risk factors) suggest that some children supported with BiVADs might have done better with LVADs alone. Further prospective studies will be needed to identify patient cohorts that will be better served with BIVAD support.