Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Importance: Mechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit. Objective: To examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use. Design, Setting, and Participants: This cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020. Exposures: Therapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only. Main Outcomes and Measures: Use of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use. Results: Among the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only. Conclusions and Relevance: This study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.

The Total Artificial Heart: Where Are We?

The total artificial heart (TAH) is a device that replaces the failing ventricles. There have been numerous TAHs designed over the last few decades, but the one with the largest patient experience is the SynCardia temporary TAH. The 50-mL and 70-mL sizes have been approved in the United States, Europe, and Canada as a bridge to transplantation. It is indicated in patients with severe biventricular failure or structural heart issues that preclude the use of a left ventricular assist device. The majority of the patients implanted are Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2. The 1-year survival in experienced centers that have implanted over 10 TAHs is 73%. The risk factors for death include older age, need for preimplantation dialysis, and malnutrition. The most common causes of death are multiple organ failure, usually the result of physiologic deterioration before implantation, and neurologic dysfunction. The device allows the patient to be discharged home and managed as an outpatient. Proper patient selection, the timing of intervention, patient care, and device management are essential for a suitable outcome. In addition, the CARMAT TAH is another device that will soon be studied in a clinical trial in the United States. The BiVACOR TAH is a revolutionary design utilizing electromagnetic levitation that is expected to enter a clinical trial in the next few years.

Current and Future Considerations in the Use of Mechanical Circulatory Support Devices: An Update, 2008-2018.

Our review in the 2008 volume of this journal detailed the use of mechanical circulatory support (MCS) for treatment of heart failure (HF). MCS initially utilized bladder-based blood pumps generating pulsatile flow; these pulsatile flow pumps have been supplanted by rotary blood pumps, in which cardiac support is generated via the high-speed rotation of computationally designed blading. Different rotary pump designs have been evaluated for their safety, performance, and efficacy in clinical trials both in the United States and internationally. The reduced size of the rotary pump designs has prompted research and development toward the design of MCS suitable for infants and children. The past decade has witnessed efforts focused on tissue engineering-based therapies for the treatment of HF. This review explores the current state and future opportunities of cardiac support therapies within our larger understanding of the treatment options for HF.

Mechanical circulatory support: 60 years of evolving knowledge.

Since the 1950s when the first devices for mechanical circulatory support were developed, there has been an impressive evolution of their technology. The first pioneering pumps were used to rescue acute complications after cardiac surgery. Advances in technology, increased knowledge of flow dynamics, and a more appropriate selection of the patients who actually need this support have contributed to significantly improve the benefits of this therapy. Today, mechanical circulatory support is an essential tool for the treatment of advanced heart failure. This strategy is used either as a bridge to heart transplantation or as a destination therapy for patients who do not meet the transplant criteria. A third indication is the bridge to recovery option for those patients in whom the improvement in cardiac function may be so important that the pump can be removed and the transplantation circumvented. In addition, mechanical circulatory support has fostered marked improvements in several clinical aspects affecting both patient health and quality of life. Despite the improvements in the technology of the devices of the last generation, severe adverse effects are still the Achilles heel of mechanical circulatory support therapy. This review summarizes the history, the technology, the clinical outcomes, and the possible future directions of this therapy.

Advancing the Science of Myocardial Recovery With Mechanical Circulatory Support: A Working Group of the National, Heart, Lung and Blood Institute.

The medical burden of heart failure (HF) has spurred interest in clinicians and scientists to develop therapies to restore the function of a failing heart. To advance this agenda, the National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group of experts on June 2-3, 2016, in Bethesda, Maryland, to develop recommendations for the NHLBI aimed at advancing the science of cardiac recovery in the setting of mechanical circulatory support (MCS). MSC devices effectively reduce volume and pressure overload that drives the cycle of progressive myocardial dysfunction, thereby triggering structural and functional reverse remodeling. Research in this field could be innovative in many ways, and the Working Group specifically discussed opportunities associated with genome-phenome systems biology approaches, genetic epidemiology, bioinformatics and precision medicine at the population level, advanced imaging modalities including molecular and metabolic imaging, and developing minimally invasive surgical and percutaneous bioengineering approaches. These new avenues of investigations could lead to new treatments that target phylogenetically conserved pathways involved in cardiac reparative mechanisms. A central point that emerged from the NHLBI Working Group meeting was that the lessons learned from the MCS investigational setting can be extrapolated to the broader HF population. With the precedents set by the significant impact of studies of other well controlled and tractable subsets on larger populations, such as the genetic work in both cancer and cardiovascular disease, the work to improve our understanding of cardiac recovery and resilience in MCS patients could be transformational for the greater HF population.

Novel percutaneous mechanical circulatory support devices and their expanding applications.

INTRODUCTION: Temporary mechanical circulatory support (MCS) is a common supportive therapy in cardiogenic shock and high-risk coronary intervention. The proliferation of new percutaneous MCS devices allows support to be instituted rapidly without surgical cutdown. The recent literature exploring the indications, benefits, and risks of each is reviewed. Areas discussed: Current applications of percutaneous MCS devices, including intra-aortic balloon pumps (IAPB), Impella, TandemHeart, and VA ECMO are discussed. Studies investigating each were identified through a combination of online database queries and direct extraction of single studies cited in previously-identified papers. Information on unpublished trials and registries was found on ClinicalTrials.gov. Expert commentary: Direct VADs provide a higher level of hemodynamic support compared to IABP and their early use will continue to expand. The development of percutaneous RV support systems may allow more patients to receive such therapy faster. VA ECMO is being used increasingly in CPR and in outreach programs.

Role of Durable Mechanical Circulatory Support for the Management of Advanced Heart Failure.

In the past decade, there has been a dramatic evolution in the field of mechanical circulatory support. Device-related complications continue to burden the field and will be a major obstacle for achieving therapeutic noninferiority compared with cardiac transplant. Selected patients with end-stage systolic heart failure enjoy an average survival of 80% at 1 year post-ventricular assist device implant, vastly better than survival rates of 25% to 50% on chronic inotrope support. Early patient referral to an advanced heart failure specialist before the onset of significant end-organ dysfunction and malnutrition is critical for achieving good operative outcomes.

The future of mechanical circulatory support for advanced heart failure.

PURPOSE OF REVIEW: Mechanical circulatory support (MCS) has become the main focus of heart replacement therapy for end stage heart failure patients. Advances in technology are moving towards miniaturization, biventricular support devices, complete internalization, improved hemocompatibility profiles, and responsiveness to cardiac loading conditions. This review will discuss the recent advances and investigational devices in MCS for advanced heart failure. RECENT FINDINGS: The demand for both short-term and long-term durable devices for advanced heart failure is increasing. The current devices are still fraught with an unacceptably high incidence of gastrointestinal bleeding and thromboembolic and infectious complications. New devices are on the horizon focusing on miniaturization, versatility for biventricular support, improved hemocompatibility, use of alternate energy sources, and incorporation of continuous hemodynamic monitoring. SUMMARY: The role for MCS in advanced heart replacement therapy is steadily increasing. With the advent of newer generation devices on the horizon, the potential exists for MCS to surpass heart transplantation as the primary therapy for advanced heart failure.

Use of mechanical circulatory support in patients undergoing percutaneous coronary intervention: insights from the National Cardiovascular Data Registry.

BACKGROUND: Little is known about the contemporary use of intra-aortic balloon pump (IABP) and other mechanical circulatory support (O-MCS) devices in patients undergoing percutaneous coronary intervention (PCI) in the setting of cardiogenic shock. METHODS AND RESULTS: We identified 76 474 patients who underwent PCI in the setting of cardiogenic shock at one of 1429 National Cardiovascular Data Registry CathPCI participating hospitals from 2009 to 2013. Temporal trends and hospital-level variation in the use of IABP and O-MCS were evaluated. No mechanical circulatory support was used in 41 286 (54%) patients, 29 730 (39%) received IABP only, 2711 (3.5%) received O-MCS only, and 2747 (3.6%) received both IABP and O-MCS. At the start of the study period, 45% of patients undergoing PCI in the setting of cardiogenic shock received an IABP and 6.7% received O-MCS. The proportion of patients receiving IABP declined at an average rate of 0.3% per quarter, whereas the rate of O-MCS use was unchanged over the study period. The predicted probability of IABP use varied significantly by site (hospital median 42%, interquartile range 33% to 51%, range 8% to 85%). The probability of O-MCS use was <5% for half of hospitals and >20% in less than one-tenth of hospitals. CONCLUSIONS: In this large national registry, the use of IABP in the setting of PCI for cardiogenic shock decreased over time without a concurrent increase in O-MCS use. The probability of IABP and O-MCS use varied across hospitals, and the use of O-MCS was clustered at a small number of hospitals.

Perioperative mechanical circulatory support in children: an analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

OBJECTIVES: Analyses of mechanical circulatory support (MCS) in pediatric heart surgery have primarily focused on single-center outcomes or narrow applications. We describe the patterns of use, patient characteristics, and MCS-associated outcomes across a large multicenter cohort. METHODS: Patients (aged <18 years) in the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database (2000-2010) were included. The characteristics and outcomes of those receiving postoperative MCS were described, and bayesian hierarchical models were used to examine variations in the adjusted MCS rates across institutions. RESULTS: Of 96,596 operations (80 centers), MCS was used in 2.4%. The MCS patients were younger (13 vs 195 days, P < .0001) and more often had STS-defined preoperative risk factors (57.2% vs 32.7%, P < .0001). The operations with the greatest MCS rates included the Norwood procedure (17%) and complex biventricular repairs (arterial switch, ventricular septal defect, and arch repair [14%]). More than one half of the MCS patients did not survive to hospital discharge (53.2% vs 2.9% of non-MCS patients; P < .0001). MCS-associated mortality was greatest for truncus arteriosus and Ross-Konno operations (both 71%). The hospital-level MCS rates adjusted for patient characteristics and case mix varied by 15-fold across institutions, with both high- and low-volume hospitals having substantial variation in MCS rates. CONCLUSIONS: Perioperative MCS use varied widely across centers. The MCS rates were greatest overall for the Norwood procedure and complex biventricular repairs. Although MCS can be a life-saving therapy, more than one half of MCS patients will not survive to hospital discharge, with mortality >70% for some operations. Future studies aimed at better understanding the appropriate indications, optimal timing, and management of MCS could help to reduce the variation in MCS use across hospitals and improve outcomes.

[Long-term mechanical circulatory support: where do we stand in 2013?]. / Assistance circulatoire chronique: le point en 2013.

With the advent of new technologies, experience with long-term mechanical circulatory support (MCS) is rapidly growing. Candidates to MCS are selected based on concepts, strategies and classifications that are specific to this indication. As results drastically improve, supported by stronger scientific evidence, the trend is towards earlier implantation. An adequate pre-implant follow-up is mandatory in order to avoid missing the best window of opportunity for implantation. While on chronic support, the hemodynamic profile of patients with continuous-flow ventricular assist devices is unique and remarkably influenced by the hydration status. Optimal management of these patients from the pre-implant phase to the long-term support phase requires a multidisciplinary approach that is similar to that already long validated for organ transplantation.

Pharmacotherapy for mechanical circulatory support: a comprehensive review.

OBJECTIVE: To provide a comprehensive review of the pharmacotherapy associated with the provision of mechanical circulatory support (MCS) to patients with end-stage heart failure and guidance regarding the selection, assessment, and optimization of drug therapy for this population. DATA SOURCES: The MEDLINE/PubMed, EMBASE, and Cochrane databases were searched from 1960 to July 2010 for articles published in English using the search terms mechanical circulatory support, ventricular assist system, ventricular assist device, left ventricular assist device, right ventricular assist device, biventricular assist device, total artificial heart, pulsatile, positive displacement, axial, centrifugal, hemostasis, bleeding, hemodynamic, blood pressure, thrombosis, antithrombotic therapy, anticoagulant, antiplatelet, right ventricular failure, ventricular arrhythmia, anemia, arteriovenous malformation, stroke, infection, and clinical pharmacist. STUDY SELECTION AND DATA EXTRACTION: All relevant original studies, meta-analyses, systematic reviews, guidelines, and reviews were assessed for inclusion. References from pertinent articles were examined for content not found during the initial search. DATA SYNTHESIS: MCS has advanced significantly since the first left ventricular assist device was implanted in 1966. Further advancements in MCS technology that occurred in the latter decade are changing the overall management of endstage heart failure care and cardiac transplantation. These pumps allow for improved bridge-to-transplant rates, enhanced survival, and quality of life. Pharmacotherapy associated with MCS devices may optimize the performance of the pumps and improve patient outcomes, as well as minimize morbidity related to their adverse effects. This review highlights the knowledge needed to provide appropriate clinical pharmacy services for patients supported by MCS devices. CONCLUSIONS: The HeartMate II clinical investigators called for the involvement of pharmacists in MCS patient assessment and optimization. Pharmacotherapeutic management of patients supported with MCS devices requires individualized care, with pharmacists as part of the team, based on the characteristics of each pump and recipient.

[Assisted circulation: an overview from a clinical perspective]. / Assistierte Zirkulation: ein Uberblick aus klinischer Sicht.

A higher grade cardiac failure is associated with poor prognosis. In addition to medical conservative treatment and traditional cardiac surgery, in the past years different forms of an assisted circulation evolved. Short-term devices serve to bridge an acute life-threatening situation. The chosen system is dependent on the anticipated clinical course. It is possible to fall back on slightly assisting techniques up to a complete takeover of the cardiac pump function. In the case of severe cardiac failure, the question for transplantation has to be addressed because transplantation is the treatment of choice to date. For an assisted circulation in cases of chronic congestive failure, devices of different generations are available. First generation pulsatile systems are used for assistance of the left ventricle and results have been shown to be superior to medical therapy (REMATCH). With second generation continuous-flow systems, results regarding infections, thromboembolism and also quality of life appear to be further improved. Contact-free centrifugal pumps as third generation systems are in clinical evaluation. So-called "total artificial hearts" are successfully used for bridge-to-transplantation. Taken together, a graded safe treatment of cardiac failure is available today. In the near future, it could be possible to reach results similar to those of cardiac transplantation.

Temas de actualidad en insuficiencia cardiaca / Advances in heart failure

En el presente artículo se presentan los avances más destacados en el campo de la insuficiencia cardiaca en el último año. Se exponen las principales novedades en el manejo de la insuficiencia cardiaca crónica tanto en los aspectos más relevantes de los nuevos modelos de gestión del paciente con insuficiencia cardiaca crónica como en los avances farmacológicos y en el uso y la indicación de dispositivos en estos pacientes. También se revisan los nuevos adelantos en el abordaje de la insuficiencia cardiaca en su fase más avanzada, con especial énfasis en la fase aguda. Los nuevos enfoques del manejo quirúrgico de la insuficiencia cardiaca, incluyendo en este apartado las nuevas aportaciones en el campo delas asistencias circulatorias, merecen un papel destacado en esta actualización (AU)

This article reports on the most significant developments in the field of heart failure in the past year. Principal innovations in the management of chronic heart failure are explained, including the most important features of new management models for patients with chronic heart failure and the main advances in drug therapy and in the use of and indications for cardiac devices in these patients. In addition, recent progress in the treatment of advanced heart failure, with particular emphasis on acute heart failure, is reviewed. Novel approaches to the surgical management of patients with heart failure, including new contributions in the field of the circulatory support, are also highlighted in this update (AU)

Pediatric circulatory support: current strategies and future directions. Biventricular and univentricular mechanical assistance.

Mechanical circulatory support is gaining increased recognition as a viable treatment option for pediatric patients who suffer from congenital or acquired heart disease. Historically, the treatment options have been very limited for pediatric patients, but recent technological advances, combined with new research into circulatory support devices, are seeking alternative therapeutics options for infants and children. We present a review of the technological advances of mechanical circulatory support in the pediatric population, including the recent emergence of a new class of circulatory support devices for pediatric patients with single ventricle physiology. The National Heart, Lung, and Blood Institute pediatric circulatory support program is discussed, in addition to the use of adult devices in pediatric applications, the Berlin Heart Excor, and several other blood pumps in development for bridge-to-transplant and bridge-to-recovery support. These devices have the potential to generate a paradigm shift in the treatment of the pediatric patients with heart failure--a shift is likely already be underway.

Assisting the failing heart.

Anesthesiologists increasingly encounter patients who have a spectrum of heart failure ranging from stable chronic heart failure to acute heart failure to cardiogenic shock. Improved medical therapy has increased the survival of patients who have chronic heart failure but not of patients who have acute heart failure. New surgical techniques and mechanical devices may offer alternatives to certain patients who have refractory heart failure This article provides an overview of established and newer pharmacologic and nonpharmacologic therapies and surgical interventions to manage patients who have heart failure, including the perioperative management of heart transplantation and ventricular assist devices.

Current and future considerations in the use of mechanical circulatory support devices.

Heart failure (HF) is a major public health problem in the United States, and its prevalence is likely to increase with the aging U.S. population. Mechanical circulatory support (MCS) utilizing bladder-based blood pumps generating pulsatile flow has been reserved for patients with severe HF failing medical therapy. As MCS technology has advanced to include rotary blood pumps, so has our understanding of the biological and clinical responses to MCS, which in turn has altered the risk/benefit profile of this therapy. This may lead to paradigm shifts in device usage from support of end-stage HF to temporary support for recovery of cardiac function and earlier usage, to, ultimately, prevention of disease progression. This review serves to explore the current state and future opportunities of MCS within our larger understanding of the epidemiology, pathophysiology, and treatment options for HF.