Regulatory Agencies Impacting Mechanical Circulatory Support Programs

Funding AcknowledgementsType of funding sources: Public Institution(s). Main funding source(s): Instituto de Salud Carlos III in Spain (Co-funded by European Social Fund "Investing in your future").INTRODUCTIONThe Coronavirus disease 19 (COVID-19) pandemic has impacted clinical practice with important changes in the most affected areas, resulting in increased mortality from heart disease (myocardial infarction). The feasibility of continuing a temporary mechanical circulatory support (MCS) program is unknown.PURPOSEOur objective was to analyze the survival of patients requiring short-term MCS with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or Impella CP® during the COVID-19 pandemic.METHODSRetrospective study including all VA-ECMO and Impella CP® implants in a referral hospital since March 2020 compared to previous implants results.RESULTSOut of 167 short-term MCS implanted from 2013, 25 (15%) were conducted during the time of COVID-19 pandemic: 19 VA-ECMO and 6 Impella CP® (Table).Compared to preCOVID-19 implants, patients requiring MCS in the COVID era presented more frequently right ventricular dysfunction (p = 0.005) and showed a trend towards older age (p = 0.069) and lower left ventricular ejection fraction (p = 0.063), without other significant differences regarding the baseline situation and implant technique (Table). Encephalopathy was more frequent in the COVID-19 era, with no differences in other complications (Table).Survival at discharge was 43.7% in the pre-COVID era vs 36% during COVID-19 pandemic, without finding statistically significant differences (p = 0.313).CONCLUSIONSurvival after temporary MCS did not get worse significantly during the COVID-19 pandemic. The possibility of short-term MCS should be maintained for cardiogenic shock and other cases of hemodynamic instability. Comparison MCS before and during COVIDTime of implantP valueTime of implantP valuePre-COVID-192013-Feb 2020 (n = 142)COVID-19 timeMarch 2020-Nov 2020 (n = 25)Pre-COVID-192013-Feb 2020 (n = 142)COVID-19 timeMarch 2020-Nov 2020 (n = 25)Age (years) (mean+ SD)Male (n, %)62 ± 10 108 (76%)66 ± 10 15 (60%)0.069 0.079Support type VA-ECMO (n = 137) Impella CP® (n = 30) Percutaneous implant 118 (83.1%)24 (16.9%) 100 (70.4% 19 (76%) 6 (24%) 20 (80%)0.566 0.536Indication (n,%) Cardiogenic shock Refractory cardiac arrest Electrical storm0.63763 (44.4%)16 (11.3%)9 (6.3%)12 (48%) 4 (16%)2 (8%)Drugs at the implant Noradrenaline Dobutamine Adrenaline 115 (81%)114 (80.3%)51 (35.9%) 21 (84%) 21 (84%) 5 (20%) 0.370 0.312 0.108High-risk PCI Postcardiotomy shock Others17 (12%)36 (25.4%)1 (0.7%)3 (12%)4 (16%) 0 (0%)Time MCS (days)4.8 ± 53.9 ± 40.284 7.23 ± 0.16.8 ± 5 0.2920.495Complications (n,%) Vascular (bleeding, ischemia) Bleeding (minor or major) Critical care infections 35 (24.6%)59 (41.5%)67 (47.2%) 7 (28%) 9 (36%) 9 (36%) 0.096 0.117 0.096pH (mean + SD)lactate (mmol/L) (mean + SD)7.13 ± 16.03 ± 5LVEF (%) (mean + SD)Right ventricle dysfunction (n,%)28.7 ± 16 68 (47.9%)21.9 ± 15 20 (80%)0.063 0.005Ischemic/hemorragic stroke Renal replacement therapy Tracheostomy Encephalopathy9 (6.3%) 36 (25.4%) 23 (16.2%)14 (9.8%)2 (8%) 4 (16%) 5 (20%) 6 (24%)0.220 0.136 0.547 0.023Preimplant cardiac arrest (n,%)Cardiac arrest duration (min) (n,%)68 (47.9%) 28.7 ± 2312 (48%) 29.8 ± 230.364 0.880Survival at discharge (n,%)62 (43.7%)9 (36%)0.313

Evolution and Impact of Ventricular Assist Device Program on Children Awaiting Heart Transplantation

Innovative Roles To Support Advanced Heart Failure & Transplant Program Growth

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.

Mechanical circulatory support is used to augment circulatory flow in cardiogenic shock and end-stage heart failure. Support can last from hours for temporary mechanical circulatory support to years for durable mechanical circulatory support. The physiologic relationship of heart and kidney function and the epidemic of cardio-kidney-metabolic disease lead to frequent use of simultaneous mechanical circulatory support and extracorporeal KRT (dialysis). The need for dialysis can range from short periods of AKI in cardiogenic shock to long-term dialysis for individuals who receive left ventricular assist devices (LVADs) for destination therapy in advanced heart failure and progress to CKD G5 with replacement therapy. Changes in technology, clinical evidence, and organ transplantation have led to major changes in mechanical circulatory support use. With temporary mechanical circulatory support, devices and clinical situations vary widely, with intra-aortic balloon pumps, microaxial flow pumps, and venoarterial extracorporeal membrane oxygenation providing different levels of circulatory support. Considerations for dialysis, whether for AKI or CKD G5, are discussed. In durable mechanical circulatory support, LVADs are now used primarily for permanent therapy, and most LVAD recipients survive for more than 5 years, time in which kidney dysfunction can develop or progress. Outpatient dialysis with LVADs is performed for both AKI and for CKD G5, with in-center intermittent hemodialysis, peritoneal dialysis, or home hemodialysis. This article discusses considerations specific to dialysis in temporary and durable circulatory support, including the challenging aspects of volume management and complication risks. Concurrent mechanical circulatory support and dialysis present diverse clinical challenges in patients with complex medical needs. Meeting this challenge requires close cooperation and shared decision making incorporating cardiologists, nephrologists, other medical professionals, patients, and their caregivers.

The Registry of the International Society for Heart and Lung Transplantation: Twenty-seventh official adult heart transplant report—2010

Veronese, Giacomo; Cipriani, Manlio; Bottiroli, Maurizio; Garascia, Andrea; Mondino, Michele; Pedrotti, Patrizia; Pini, Daniela; Cozzi, Ottavia; Messina, Antonio; Droandi, Ginevra; Petrella, Duccio; Frigerio, Maria; Ammirati, Enrico Author Information

Background: The number of waitlisted patients requiring mechanical circulatory support (MCS) as a bridge to heart transplantation is increasing. The data concerning the results of the double-bridge strategy are limited. We sought to investigate the post-transplant outcomes across the different bridge strategies. Methods: We retrospectively reviewed a heart transplantation database from Jan 2009 to Jan 2019. Intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), and ventricular assist devices (VAD) were the MCS that we investigated. The pre- and post-transplant characteristics and variables of patients bridged with the different types of MCS were collected. The post-transplant survival was compared using Kaplan–Meier survival analysis. Results: A total of 251 heart transplants were reviewed; 115 without MCS and 136 with MCS. The patients were divided to five groups: Group 1 (no MCS): n = 115; Group 2 (IABP): n = 15; Group 3 (ECMO): n = 33; Group 4 (ECMO-VAD): double-bridge (n = 59); Group 5 (VAD): n = 29. Survival analysis demonstrated that the 3-year post-transplant survival rates were significantly different among the groups (Log-rank p < 0.001). There was no difference in survival between group 4(ECMO-VAD) and group 1(no MCS)1 (p = 0.136), or between group 4(ECMO-VAD) and group 5(VAD) (p = 0.994). Group 3(ECMO) had significantly inferior 3-year survival than group 4(ECMO-VAD) and group 5(VAD). Conclusion: Double bridge may not lead to worse mid-term results in patients who could receive a transplantation. Initial stabilization with ECMO for critical patients before implantation of VAD might be considered as a strategy for obtaining an optimal post-transplant outcome.

Up to 10% of acute coronary syndromes are complicated by cardiogenic shock (CS) with contemporary mortality rates of 40-50%. The extent of ischemic myocardium has a profound impact on the initial, in-hospital, and post-discharge management and prognosis in this patient population. Individualized patient risk assessment plays an important role in determining appropriate revascularization, drug treatment with inotropes and vasopressors, mechanical circulatory support, intensive care support of other organ systems, hospital level of care triage, and allocation of clinical resources. This review will outline the underlying causes and diagnostic criteria, pathophysiology, and treatment of CS complicating acute coronary syndromes with a focus on (a) potential therapeutic issues from the perspective an interventional cardiologist, an emergency physician, and an intensive care physician, (b) the type of revascularization, and (c) new therapeutic advancements in pharmacologic and mechanical percutaneous circulatory support.

Rationale and design of DanGer shock: Danish-German cardiogenic shock trial

Received March 26, 2008; accepted June 5, 2008. The development of durable mechanical circulatory support systems paralleled the expansion of cardiac transplantation. The National Institutes of Health sponsored grants in the 1980s to develop implantable left heart assist systems; 20 years later, they contracted for a national registry, the Interagency Registry for Mechanical Assisted Circulatory Support, to track the clinical evolution of this new technology. The Interagency Registry for Mechanical Assisted Circulatory Support has refined the classification of New York Heart Association class IV heart failure, standardized adverse event definitions, and explored outcomes of device type, location, and strategy. The majority of mechanical circulatory support patients are between the ages of 50 and 70 years, and ≈90% of patients are in the highest levels of clinical instability before implantation. Six-month survival after device implant is 75%, but it increases to 80% among those not in shock at implantation. Patients who require biventricular support have decreased survival. As longer-term outcomes are analyzed, improved outcomes may justify triage of high-risk patients awaiting heart transplantation to chronic mechanical circulatory support. The application of mechanical circulatory support in animal experiments can be traced back to the work of Carrel and Lindberg in the 1930s.1,2 With the initial foray into open-heart surgery in the 1950s,3,4 the stage was set for application of more prolonged mechanical support for myocardial recovery in situations of failure to wean from cardiopulmonary bypass. Although initial reports of successful recovery used roller-pump technology,5 their applicability was limited by issues of blood trauma and difficulties in modulation of pump speed in response to changes in left atrial and left ventricular pressure. The first clinical application of a pneumatically driven ventricular assist device (VAD) is attributed to DeBakey in 1966, in which a 37-year-old woman was successfully supported for 10 …

ECMO Assistance during Mechanical Ventilation: Effects Induced on Energetic and Haemodynamic Variables

Background Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a critical form of mechanical circulatory support (MCS) for patients with refractory cardiogenic shock (CS). The combination therapy of VA-ECMO and Impella, known as ECPELLA, provides both systemic circulatory support and left ventricular (LV) unloading. However, whether the LV unloading effect of ECPELLA further reduces myocardial damage and mortality in Society for Cardiovascular Angiography and Interventions (SCAI) Stage E patients remains unclear. Objective To evaluate whether ECPELLA reduces myocardial damage and improves short-term survival in refractory CS patients with ST-elevation myocardial infarction (STEMI) requiring VA-ECMO before reperfusion. Methods Between January 2012 and January 2025, we retrospectively screened 239 acute coronary syndrome patients who required advanced mechanical circulatory support (MCS).Patients with non-STEMI, those who did not receive VA-ECMO during percutaneous coronary intervention (PCI) (n=81), and those with mechanical complications, such as left ventricular free wall rupture (n=8) or ventricular septal perforation (n=1), were excluded. Additionally, patients who had absent vital signs after MCS implantation and were deemed for withdrawal of care (n=7) were also excluded from the study. Ultimately, 77 consecutive STEMI patients who received VA-ECMO before reperfusion were included. Patients were divided into two groups: ECPELLA (n=48) and ECMO with IABP (n=28). Serum CK-MB levels and 30-day all-cause mortality were assessed. Results There were no significant differences between the groups in age, sex, coronary risk factors, left main trunk (LMT) lesion, or the rate of extracorporeal cardiopulmonary resuscitation (E-CPR). However, renal impairment (eGFR &amp;lt;60 mL/min/1.73 m²) was significantly more prevalent in the ECMO with IABP group. Additionally, the IABP-SHOCK II score, a prognostic score for CS, was significantly higher in the ECMO with IABP group than in the ECPELLA group (3 [3–4] vs. 4 [3–6]; p=0.015). The ECPELLA group had significantly higher MCS support flow per unit of body surface area during PCI and the first three days, received a significantly lower catecholamine dose, and demonstrated better lactate clearance. ECPELLA also resulted in significantly lower peak CK-MB levels (330 [115–562] IU/L vs. 500 IU/L; p=0.026). Kaplan-Meier analysis demonstrated a significantly higher 30-day survival rate in the ECPELLA group (p=0.003 by log-rank test). Multivariable Cox proportional hazard analysis, adjusting for age, E-CPR, LMT lesion, renal impairment, IABP-SHOCK II score, and ECPELLA, identified ECPELLA as the only independent factor associated with 30-day all-cause mortality (hazard ratio: 0.52, 95% confidence interval: 0.27–0.98; p=0.044). Conclusion ECPELLA treatment provides greater circulatory support and lower CK-MB levels, which may be associated with improved short-term survival compared to ECMO with IABP support.Figure1 Figure2

A change of heart: Preliminary results of the US 2018 adult heart allocation revision.

Effect of Mechanical Circulatory Support on Outcomes After Heart Transplantation