Is It the Nature of the Challenge or the Lack of Nurture? The Value of FDA Support and Public-Private Partnerships in Mechanical Circulatory Support.

The 2023 International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support: A 10- Year Update

Primary graft dysfunction in heart transplantation: How to recognize it, when to institute extracorporeal membrane oxygenation, and outcomes

The Cusp of a New Era in Long-term Mechanical Circulatory Support

Univentricular palliation is performed in patients with congenital heart defects, such as single functional ventricle, hypoplasia, septal defects, valve defects, obstructive defects, etc. After the palliation, the single ventricle becomes systemic, and venae cavae are directly or indirectly connected to pulmonary arteries. Palliated patients may temporary lead a full life yet eventually need heart transplantation. Mechanical circulatory support (MCS) may be an alternative treatment for heart transplantation in patients having univentricular circulation. Personalized modeling of a biotechnical MCS system allows to forecast current and optimal system states and assess support advisability and efficacy before implanting a circulatory assist device. In this study, a mathematical model of univentricular circulation with possibility to connect a circulatory assist device is presented. An algorithm for efficacy forecast and assessment of personalized mechanical univenricular circulatory support was developed. The algorithm automatically determines circulatory model parameters based on patient’s hemodynamic data and a set of parameter templates for corresponding age groups and circulatory states. This first stage is based on genetic algorithm with model parameters used as a genotype. Criterion of obtaining personalized model parameters is a zero sum of relative deviations of patient’s hemodynamic data and simulated data after personalization given the acceptable ranges of deviations determined based on accuracy of clinical diagnostic devices. At the second stage, the developed algorithm simulates a personalized biotechnical system of mechanical univentricular circulatory support using personalized circulatory model and pressure head–flow rate characteristics of circulatory assist device. At the third stage, the algorithm assesses advisability of chosen control strategy with negative recommendation for inadvisable strategy. At the last stage, the algorithm forecasts optimal states of biotechnical system determined as sufficiently approximate to normal circulation. Verification of the developed algorithm was performed with patients’ hemodynamic data from literature. Distributions of hemodynamic parameters in simulated biotechnical systems for three patients are described along with forecast optimal states and corresponding values of control parameter for chosen methods of support. In these cases, pediatric rotary blood pump previously developed by our research group was used as circulatory assist device. Assessment of changes in biotechnical system after implantation of circulatory assist device revealed inefficacy of MCS in one of three considered patients.

Severe early graft dysfunction post-heart transplantation: Two clinical trajectories and diastolic perfusion pressure as a predictor of mechanical circulatory support

HFSA/SAEM/ISHLT clinical expert consensus document on the emergency management of patients with ventricular assist devices.

The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a North American national registry for mechanical circulatory support devices (MCSDs) that are used to treat advanced heart failure. Durable MCSDs that have been approved by the US Food and Drug Administration (FDA) are included in this registry; however, MCSDs that remain in FDA trials pending initial approval (ie, investigational device exemption [IDE] trials) and devices intended for short-term use (eg, Abiomed BVS 5000 ventricular assist device [Abiomed, Danvers, MA]) are not included. The purposes of this article are to present a developmental history of INTERMACS, to outline the collaboration of INTERMACS with various constituencies (eg, FDA, National Institutes of Health, Center for Medicare & Medicaid Services, industry, and physicians), to present a summary of information generated to date by INTERMACS, and to describe the future directions of INTERMACS. The concept of using mechanical circulatory assistance for more than a brief time after a cardiac operation dates to the early 1960s with the development of MCSDs that fit the definitions of counterpulsation devices (eg, the intra-aortic balloon pump), ventricular assist devices (VADs), and total artificial hearts.1–5 The development and initial clinical evaluation of these devices were regulated by individual academic medical center review groups that evolved into institutional review boards. The FDA entered this arena in 1976 with the advent of the FDA section for device regulation based on passage of the 1976 Medical Device Amendments.6 By 1991, groups including the Institute of Medicine foresaw the need for a detailed longitudinal database for patients receiving MCSDs, stating in an Institute of Medicine report that “patients should be followed through a registry for the remainder of their lives….”7 The committee further recommended that the National Heart, Lung, and Blood Institute support long-term follow-up studies. Eventually, a …

Comparative Analysis of von Willebrand Disease in Patients with Mechanical Circulatory Pulsatile and Non-Pulsatile Support

Mechanical cardiac support 2000: current applications and future trial design: June 15-16, 2000 Bethesda, Maryland.

Mechanical Circulatory Support: a Companion to Braunwald's Heart Disease

Mechanical circulatory support (MCS) offers a surgical option for advanced heart failure when optimal medical therapy is inadequate. MCS therapy improves prognosis, functional status, and quality of life.1,2 The INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) tracks patient selection and outcomes for all implanted US Food and Drug Administration–approved MCS devices. From June 2006 until December 2014, >15 000 patients received MCS, and >2000 implantations are performed annually. One-year survival with current continuous-flow devices is reported to be 80%, and 2-year survival, 70%.3 In patients awaiting heart transplantation, MCS provides a bridge to transplantation, and for others who are ineligible for heart transplantation, MCS provides permanent support or destination therapy. Indications and absolute and relative contraindications to durable MCS are listed in Table 1. View this table: Table 1. Indications and Contraindications to Durable Mechanical Support As of July 2014, 158 centers in the United States offer long-term MCS.3 Patients often live a substantial distance from the implanting center, necessitating active involvement of local first responders (emergency medical technicians, police, and fire department personnel), emergency department staff, primary care, and referring cardiologists. Because patients with MCS are becoming increasingly mobile, basic knowledge of equipment is necessary for personnel in public areas such as schools, public transportation, and airplanes/airports. Ambulatory patients with MCS can span the entire age spectrum from pediatrics to geriatrics. The aim of this document is to provide guidance for nonexperts in MCS and to facilitate the informed assessment, stabilization, and transport of the patient with MCS back to the MCS center for definitive therapy. In addition, the principles herein provide a foundation for emergency management and a framework to address the management of known MCS-associated complications and expected comorbid medical problems. Currently in the United States, the most frequently used durable devices are continuous-flow devices with …

Second INTERMACS annual report: More than 1,000 primary left ventricular assist device implants

Support measures currently represent the mainstay of treatment for fulminant myocarditis, while effective and safe anti-inflammatory therapies remain an unmet clinical need. However, clinical and experimental evidence indicates that inhibition of the pro-inflammatory cytokine interleukin 1 (IL-1) is effective against both myocardial inflammation and contractile dysfunction. We thus evaluated treatment with the IL-1 receptor antagonist anakinra in a case of heart failure secondary to fulminant myocarditis. A 65-year-old man with T cell lymphoma developed fulminant myocarditis presenting with severe biventricular failure and cardiogenic shock requiring admittance to the intensive care unit and mechanical circulatory and respiratory support. Specifically, acute heart failure and cardiogenic shock were initially treated with non-invasive ventilation and mechanical circulatory support with an intra-aortic balloon pump. Nevertheless, cardiac function deteriorated further, and there were no signs of improvement. Treatment with anakinra, the recombinant form of the naturally occurring IL-1 receptor antagonist, was started at a standard subcutaneous dose of 100 mg/day. We observed a dramatic clinical improvement within 24 h of initiating anakinra. Prompt, progressive amelioration of cardiac function allowed weaning from mechanical circulatory and respiratory support within 72 h of anakinra administration. Recent studies point at inhibition of IL-1 activity as an attractive treatment option for both myocardial inflammation and contractile dysfunction. Furthermore, IL-1 receptor blockade with anakinra is characterized by an extremely rapid onset of action and remarkable safety and may thus be suitable for the treatment of patients critically ill with myocarditis.

Introduction: Without timely reperfusion therapy, acute myocardial infarction (AMI) can lead to mechanical complications (MC) such as papillary muscle rupture (PMR), ventricular septal rupture (VSR), free wall rupture (FWR). Mechanical circulatory support (MCS) devices such as intra-aortic balloon pump (IABP), Impella and extracorporeal membrane oxygenation (ECMO) are used in cardiogenic shock associated with AMI-MC. Hypothesis: As per the SHOCK-II trial use of MCS in MI complicated cardiogenic shock showed no difference in mortality. We sought to determine the rates of AMI-MC, MCS device placements and outcomes associated with them. Methods: The Nationwide Inpatient Sample was queried from 2010 to 2014 using ICD-9 codes with a primary diagnosis of AMI. We also used diagnosis and procedure codes for MC and MCS devices. We excluded patients with NSTEMI. Results: From 2010 to 2014, we identified 3158 hospitalizations related to AMI-MC with a mean age of 64±13.4 years. Majority were men 69% with 75% Caucasian with an in-hospital mortality rate of 37%. Use of MCS was most common in males (67%), Caucasians (77%), and with an age group of 50-70 years (54%). Of these patients, PMR was noted in 13%, VSR in 31% and FWR in 56%. Rates of MCS devices were 38% (IABP 35%, Impella 3% and ECMO 4%). Overall use of MCS for FWR, VSR, PMR were 15%, 61%, 80%. Percentage of MC requiring IABP, Impella, ECMO were as follows; FWR (15%, 0.6%, 0.3%), VSR (58%, 7%, 6%), PMR (70%, 5%, 12%). Patients that received cardiac transplant was 0.2%. In-hospital mortality among patients who received MCS to those who did not receive MCS were 59% vs 24%; p<0.001, among patients who received IABP to those who did not receive any MCS were 54% vs 24%; p<0.001 and among patients who received Impella to no MCS were 86% vs 24%; p<0.001. Conclusions: Based on the results, FWR was the most common MC. MCS were most commonly used in PMR followed by VSR, with IABP being the most common type. Patients on MCS had increased in-hospital mortality compared to those without MCS. Large randomized trials are needed to determine the effectiveness of these devices in predicting outcomes associated with AMI-MC

Introduction: The use of mechanical circulatory support (MCS) in complex percutaneous coronary intervention (PCI) is the subject of ongoing investigation, but the role of MCS in chronic total occlusion (CTO) PCI is not well studied. Methods: We analyzed the patient and angiographic characteristics and procedural outcomes of 7,171 CTO PCIs performed between 2012 and June 2021 at 35 international centers. Results: Mean patient age was 64.5±10 years, mean left ventricular ejection fraction was 50 ± 13 % and 82% were men. MCS was used in 4.5% of the overall cases, MCS use was elective in 78.7% and urgent in 21.3%. The most common type of MCS was Impella CP (55.5%) followed by intra-aortic balloon pump (14.8%), Tandem Heart (10.0%) and Impella 2.5 (8.7%). Diabetes mellitus (51.0% vs. 42.4%, p=0.003), prior congestive heart failure (60.6% vs. 27.9%, p<0.001) and prior myocardial infarction (52.3% vs. 45.3%, p=0.020) were more common in MCS patients. Left ventricular ejection fraction was lower in the patients with MCS use compared to patients without (Mean±standard deviation, 51.0 ± 12 vs. 34.0 ± 15 %, p<0.001). Cases in which MCS was used were more complex with higher J-CTO score compared with cases without MCS (2.94 ± 1.19 vs. 2.39 ± 1.27, p<0.001). Cases performed with MCS had lower technical (81.6% vs. 86.7%, p=0.011) and procedural (71.3% vs. 85.6%, p<0.001) success rates with higher rates of periprocedural major cardiac adverse events compared to no MCS use (12.6% vs. 1.68%, p<0.001). Conclusions: In a contemporary, multicenter registry MCS was used in 4.5% of CTO PCI. Cases where MCS was used were associated with lower technical and procedural success with higher periprocedural major complication rates. Further investigation is required to see if elective use of MCS can improve outcomes in patients with increased comorbidities and higher lesion complexity.