Use of the AB5000™ Ventricular Assist Device in Cardiogenic Shock After Acute Myocardial Infarction

doi:10.1016/j.athoracsur.2010.03.066

The Annals of Thoracic Surgery

Volume 90, Issue 3, September 2010, Pages 706-712

https://doi.org/10.1016/j.athoracsur.2010.03.066 Get rights and content

Background

The mortality rate of patients experiencing acute myocardial infarction (AMI) complicated by cardiogenic shock remains high. After conventional therapies have failed, ventricular assist devices (VADs) have been used to bridge patients to recovery or transplantation.

Methods

A voluntary US registry was established to track all patients implanted with the AB5000 VAD. We report the results of the first 100 patients in the registry with the indication of AMI cardiogenic shock. Data were retrospectively reviewed for demographics, preimplant condition, surgical techniques, and outcomes. Survival was assessed at 30 days after VAD explant or at discharge. Myocardial recovery (subset of survival) was defined as satisfactory unassisted native cardiac function for 30 days after VAD explant or at discharge.

Results

Forty patients (40%) survived to 30 days after VAD explant or discharge of the first 100 patients. Of the survivors, 63% (n = 25) experienced myocardial recovery. Patients who recovered required an average of 25 ± 22 days of VAD support. The estimated survival after explant for the recovery patients at 2 years after VAD explant was 78%.

Conclusions

Results from this nationwide registry suggest that VADs can restore normal hemodynamics and support recovery of native cardiac function in the majority of survivors when conventional therapies fail. However, a longer duration of support than previously recognized may be required. In the absence of clinical guidelines, early aggressive use of VAD support in AMI complicated by cardiogenic shock may improve outcomes, and recovery of native cardiac function should always be the primary goal.

Section snippets

Patients and Methods

This was a retrospective study of patients with CS after AMI supported with the AB5000™ paracorporeal VAD technology (Abiomed, Inc, Danvers, MA) and enrolled in the voluntary nationwide registry maintained by Abiomed, Inc. The registry was designed to support the postmarket study requested by the US Food and Drug Administration (FDA) as part of the Premarket Approval. The first 60 patients supported with the AB5000 VAD technology were reported to the FDA for all indications including CS after

Patient Characteristics Before Ventricular Assist Device Implant

Relevant patient demographics are shown in Table 1. Eighty-eight percent (n = 88) of patients presented with shock on admission at the implanting hospitals; the remaining 12% (n = 12) experienced CS after emergent coronary artery bypass grafting (CABG) after AMI, either failing to wean from cardiopulmonary bypass (8%) or having low cardiac output CS (4%) when weaned off cardiopulmonary bypass.

The median time from shock to VAD implant was 26.5 hours (range, 1 to 318 hours). Fifty-two percent of

Comment

Our study includes the first 100 consecutive patients enrolled in the registry who were implanted with an AB5000 VAD for AMI CS indication. Patients were implanted in 42 US institutions, each with its own protocol for VAD implantation, patient selection, and VAD management. There was no selection of patients or institutions. Thus, the reported survival and recovery rates are representative of real-world experience with maximal heterogeneity in patient selection and medical practice.

Perhaps the

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Moving Beyond SHOCK: New Paradigms in the Management of Acute Myocardial Infarction Complicated by Cardiogenic Shock
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The current management of patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with a high rate of mortality, despite widespread regional implementation of rapid transfer to percutaneous coronary intervention-capable centres for prompt infarct-related artery reperfusion. The limited clinical effectiveness of early revascularization in patients with AMI-CS might be secondary to the extent of coronary artery disease in these patients and the risk of incomplete revascularization, as well as the lower probability of achieving successful reperfusion compared with acute myocardial infarction without hemodynamic instability. Also, the severity of end-organ injury is a critical determinant of outcome. We review adjunctive therapies to early revascularization in AMI-CS, specifically with a focus on the role of short-term mechanical circulatory support. In selected patients with AMI-CS, there might be a benefit associated with early institution of mechanical circulatory support before revascularization.
La prise en charge des patients victimes d’un infarctus aigu du myocarde compliqué d’un choc cardiogénique (IAM-CG) est associée à un taux élevé de mortalité en dépit de l’instauration généralisée de modalités de transfert rapide à un centre équipé d’un laboratoire d’intervention coronarienne percutanée où l’on pourra sans délai procéder à la revascularisation de la ou des artères en cause dans l’infarctus. Le succès mitigé du processus de revascularisation précoce chez les patients susmentionnés pourrait être lié à l’importance de la maladie et au risque d’une revascularisation incomplète de même qu’à la plus faible probabilité d’obtenir une reperfusion complète chez ces patients que chez ceux qui ne présentent pas d’instabilité hémodynamique. L’importance de l’atteinte organique constitue également un élément déterminant de l’issue thérapeutique finale. Dans cet article, nous examinons les traitements d’appoint à la revascularisation précoce chez les patients atteints d’un IAM-CG, notamment l’assistance circulatoire mécanique à court terme. En effet, chez certains patients victimes d’un IAM-CG, l’instauration rapide d’une assistance circulatoire mécanique avant de procéder à la revascularisation pourrait être bénéfique.
Polymeric heart valves for surgical implantation, catheter-based technologies and heart assist devices
2015, Biomaterials
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These two systems were based on different design philosophies, the first using a non-bulbous root to improve washout, the latter using a bulbous sinus-like housing to facilitate leaflet function. The third company involved with these types of systems, Abiomed, developed two products a VAD [101,102] and a total artificial heart [103,104]. Zimmerman et al. showed no difference in the clinical efficacies of the devices from these companies and concluded that selection should be based on practical issues on a patient basis.
Efficient function and long-term durability without the need for anticoagulation, coupled with the ability to be accommodated in many different types of patient, are the principal requirements of replacement heart valves. Although the clinical use of valves appeared to have remained steady for several decades, the evolving demands for the elderly and frail patients typically encountered in the developed world, and the needs of much younger and poorer rheumatic heart disease patients in the developing world have now necessitated new paradigms for heart valve technologies and associated materials. This includes further consideration of durable elastomeric materials. The use of polymers to produce flexible leaflet valves that have the benefits of current commercial bioprosthetic and mechanical valves without any of their deficiencies has been held desirable since the mid 1950s. Much attention has been focused on thermoplastic polyurethanes in view of their generally good physico-chemical properties and versatility in processing, coupled with the improving biocompatibility and stability of recent formulations. Accelerated in vitro durability of between 600 and 1000 million cycles has been achieved using polycarbonate urethanes, and good resistance to degradation, calcification and thrombosis in vivo has been shown with some polysiloxane-based polyurethanes. Nevertheless, polymeric valves have remained relegated to use in temporary ventricular assist devices for bridging heart failure patients to transplantation. Some recent studies suggest that there is a greater degree of instability in thermoplastic materials than hitherto believed so that significant challenges remain in the search for the combination of durability and biocompatibility that would allow polymeric valves to become a clinical reality for surgical implantation. Perhaps more importantly, they could become candidates for use in situations where minimally invasive transcatheter procedures are used to replace diseased valves. Being amenable to relatively inexpensive mass production techniques, the attainment of this goal could benefit very large numbers of patients in developing and emerging countries who currently have no access to treatment for rheumatic heart disease that is so prevalent in these areas. This review discusses the evolution and current status of polymeric valves in wide-ranging circumstances.
Mechanical circulatory support for cardiogenic shock
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Pneumatically driven pulsatile devices, such as Abiomed BVS 5000 and AB5000 (Abiomed Inc., Danvers, MA, USA) and Thoratec paracorporeal VAD (Thoratec Corporation, Pleasanton, CA, USA) are used for this purpose.64 Overall survival to discharge rates up to 30–40% have been reported with the Abiomed devices.65 These VADs are implanted through median sternotomy with CPB, though off-pump implantations have been described.
Cardiogenic shock (CS) is a syndrome of progressive depression of myocardial function with systemic hypoperfusion. It occurs due to various aetiologies such as acute myocardial infarction, myocarditis, acute decompensated heart failure and postcardiotomy. Cardiogenic shock carries poor prognosis, and medical therapy alone is not effective. Mechanical circulatory support is required to unload the ventricles, decrease the myocardial demand, prevent further injury, improve the coronary perfusion, stabilise the haemodynamics and maintain the end-organ perfusion before definitive interventions such as coronary reperfusion can take place. Currently, there are several methods of mechanical circulatory support. These include extracorporeal life support, paracorporeal or extracorporeal ventricular-assist devices, percutaneous ventricular assist devices, intra-aortic balloon counterpulsation and total artificial heart. In this review, we discuss the role of each of these circulatory support devices in the management of acute cardiac failure.
Percutaneous Mechanical Support for the Failing Right Heart
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Cardiogenic shock in women
2012, Interventional Cardiology Clinics
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A voluntary US registry study (consisting of 32% female patients) showed that the AB5000 VAD can restore normal hemodynamics and support recovery of native cardiac function in most survivors when conventional therapies fail in CS following MI. In this study, the VAD was in place for an average of 25 days before a satisfactory native cardiac function was achieved.90 CS is the leading cause of death, complicating up to 10% of admissions among patients presenting with MI.
Preliminary in vivo testing of a novel pump for short-term extracorporeal life support
2012, Annals of Thoracic Surgery
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Temporary extracorporeal mechanical circulatory support can stabilize hemodynamics, restore end-organ function, and allow time to assess the likelihood of cardiac recovery or determine the patient's suitability for long-term cardiac replacement with an implantable VAD or heart transplantation [10]. This paradigm, referred to as “bridge to decision” uses a variety of available devices in a number of applications, including peripheral and central ECMO [11, 12], percutaneous transseptal left ventricular assistance [13], and surgically implanted temporary VADs [2, 4]. Different mechanical blood pumps can be used for these applications, but regardless of the mode and location of cannulation or the presence of an oxygenator, the same basic principles of an ideal pump should be applicable.
Blood pumps used for temporary circulatory support have limitations. We propose a novel device designed for short-term extracorporeal support that is intrinsically volume responsive, afterload insensitive, and incapable of cavitation or excessive hemolysis. After in vitro testing, we performed the initial in vivo implantations and assessments.
The BioVAD prototype (MC3, Inc, Ann Arbor, MI) was implanted in 6 adult male sheep (60.2 ± 2.8 kg) through the left ventricular apex and descending thoracic aorta. Arterial, left and right atrial, and pump inlet and outlet pressures and BioVAD flow were measured and recorded. The animals were volume loaded to assess volume responsiveness, and the inlet lines were abruptly clamped during maximum support to observe for cavitation. An acute heart failure model was created with rapid ventricular pacing, and the animals were supported for 4 hours.
Peak flow was 3.19 ± 0.56 L/min and increased to 3.71 ± 0.53 L/min with 20 mm Hg vacuum-assisted drainage. Without manual changes in pump settings, pump flow increased 17.5% with volume loading. During acute venous line occlusion, there was no evidence of cavitation, and inlet suction was minimal. Hemodynamics were maintained for 4 hours during acute heart failure.
The BioVAD provided adequate flow in an acute in vivo model. Its design may be superior for short-term extracorporeal support.

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Original articleAdult cardiacUse of the AB5000™ Ventricular Assist Device in Cardiogenic Shock After Acute Myocardial Infarction

Background

Methods

Results

Conclusions

Section snippets

Patients and Methods

Patient Characteristics Before Ventricular Assist Device Implant

Comment

J Am Coll Cardiol

Am Heart J

Lancet

Ann Thorac Surg

J Heart Lung Transplant

Cardiol Clin

Ann Thorac Surg

Am Heart J

J Heart Lung Transplant

J Am Coll Cardiol

J Am Coll Cardiol

Am Heart J

J Am Coll Cardiol

Original article
Adult cardiac
Use of the AB5000™ Ventricular Assist Device in Cardiogenic Shock After Acute Myocardial Infarction