Mechanical circulatory support in patients with cardiogenic shock in intensive care units: A position paper of the "Unité de Soins Intensifs de Cardiologie" group of the French Society of Cardiology, endorsed by the "Groupe Athérome et Cardiologie Interventionnelle" of the French Society of Cardiology.

Cardiogenic shock (CS) is a major challenge in contemporary cardiology. Despite a better understanding of the pathophysiology of CS, its management has only improved slightly. The prevalence of CS has remained stable over the past decade, but its outcome has seen few improvements, with the 1-month mortality rate still in the range of 40-60%. Inotropes and vasopressors are the first-line therapies for CS, but they are associated with significant hazards, and have well-known deleterious effects. Furthermore, a significant number of patients develop refractory CS with haemodynamic instability, causing critical organ hypoperfusion and/or pulmonary congestion, despite increasing doses of catecholamines. A major change has resulted from the recent advent and availability of potent mechanical circulatory support (MCS) devices. These devices, which ensure sustained blood flow, provide a great and long-awaited opportunity to improve the prognosis of CS. Several efficient MCS devices are now available, including left ventricle-to-aorta circulatory support devices and full pulmonary and circulatory support with venoarterial extracorporeal membrane oxygenation. However, evidence to support their indications, the timing of implantation and the selection of patients and devices is scarce. Because these devices are gaining momentum and are becoming readily available, the "Unité de Soins Intensifs de Cardiologie" group of the French Society of Cardiology aims to propose practical algorithms for the use of these devices, to help intensive care unit and cardiac care unit physicians in this complex area, where evidence is limited.

[Cardiac Rehabilitation in Patients with Mechanical Circulatory Support]. / Mechanische Herzunterstützungssysteme in der kardiologischen Rehabilitation.

Background Heart failure in a terminal stage is usually treated with a heart transplant or with implantation of ventricular assist devices (VAD). VAD treatment is increasingly chosen as a permanent therapy. Problem The growing number of VAD implants leads to an increased need for rehabilitation programs. The development of standards is essential. So far only a few single center reports with a limited number of patients have been published. Guidelines on this subject are not available. Results A working group of German rehabilitation physicians was installed in order to analyze the problems and to develop strategies for the process of rehabilitation of VAD-patients, ending in a consensus statement 1.The most important aspects of rehabilitation aiming at the safest possible participation in everyday life with a VAD are summarized here.

Mechanical circulatory devices in acute heart failure.

Cardiogenic shock remains a leading cause of mortality despite advances in the treatment of myocardial infarction and advanced heart failure. Medical therapy can be inadequate, and patients may need mechanical circulatory support (MCS). The proper application of MCS requires knowledge of the underlying cause of acute heart failure, familiarity with the circulatory support devices, and the potential benefits and limitations of device therapy. This article describes the most commonly used temporary ventricular assist devices and their use in the various causes of cardiogenic shock.

Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

OBJECTIVES: The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. BACKGROUND: After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. METHODS: The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. RESULTS: Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. CONCLUSIONS: The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.

Development of standard tests to examine viscoelastic properties of blood of experimental animals for pediatric mechanical support device evaluation.

We investigated the applicability of measuring the viscoelasticity of bovine, ovine, and porcine whole blood for the evaluation of sublethal damage to red blood cells (RBCs). An increase in blood viscosity and elasticity without changes in hematocrit and plasma viscosity would signify a decrease in RBC deformability. Blood viscoelasticity was assessed using a Vilastic Scientific viscoelastometer. Due to the natural absence of RBC aggregation and small RBC size in normal bovine and ovine blood, viscoelastic properties are less readily detected. However, we found that adjustment of blood hematocrit to a standard level of 40-50% allows for sensitive assessment of viscoelasticity in these blood types demonstrating a marked non-Newtonian behavior mostly related to RBC deformability. Porcine blood showed a pronounced non-Newtonian behavior at all tested hematocrit values, which makes it rheologically comparable to human blood. Both viscosity and elasticity were elevated after blood exposure to a uniform mechanical stress. RBCs rigidified by heat exposure demonstrated a loss of viscoelasticity dependence on shear rate. Measurements of blood viscoelasticity can be meaningful in bovine, ovine, and, especially, porcine blood, and can be used for evaluation of sublethal blood damage during in vitro and animal trials of heart-assist devices.

Study on mechanical circulatory support and currently available supporting parts in China.

The research and development on extracorporeal and assisted circulation in China have been painstaking. On one hand, China has the largest population of 1.3 [corrected] billion in the world, and the demands for supporting equipment are huge. On the other hand, as a developing country, China is not wealthy. It is urgent to design and fabricate affordable circulatory support parts, machines, and artificial hearts for Chinese market. In this regard, we have made our own heart-lung machine, mechanical and tissue valves, oxygenators, and artificial hearts and their improved versions. The cost of these parts is much lower as compared with those in the Western market. Although the results of clinical application are good so far, the quality of these lifesaving parts needs to be continuously improved.

Percutaneous cardiopulmonary support as a bridge to emergency operation--two surviving cases.

Two patients had percutaneous cardiopulmonary support (PCPS) used as a bridge to emergency surgery. A 66-year-old man admitted with profound cardiogenic shock underwent direct stenting under PCPS with the diagnosis of acute myocardial infarction of the left main trunk, with the intention of performing revascularization as soon as possible. Subsequently, double coronary artery bypass grafting was successfully accomplished. A 69-year-old woman, admitted with acute heart failure due to critical aortic stenosis, manifested cardiogenic shock while undergoing catheterization. PCPS was immediately instituted until the acute deterioration of her hemodynamic state could be reversed, and was continued uneventfully till aortic valve replacement was performed. These results suggest that the current PCPS system is an effective response to acute circulatory collapse and will contributed to the improved survival of patients.

Hydraulic assessment of the floating impeller phenomena in a centrifugal pump.

A compact eccentric inlet port centrifugal blood pump (C1E3) has been perfected for a long-term centrifugal ventricular assist device as well as a cardiopulmonary bypass pump. The C1E3 pump incorporates a sealless design and a blood stagnation free structure. The pump's impeller is magnetically coupled to the driver magnet in a sealless manner. The latest hemolysis study reveals that hemolysis is affected by the magnetic coupling distance between the driver and impeller magnet. Furthermore, a floating phenomenon can be observed in a pivot bearing supported pump. Attention was focused on the relationship between the floating phenomenon's characteristics and the magnetic coupling design in the C1E3 pump. Studies were conducted to evaluate the hydromechanical performance in the floating phenomenon. In this study, the relationship between the magnetic coupling design and the floating phenomenon was verified with a smooth spinning condition. The optimized magnetic coupling distance for the floating mode was estimated to be 12 mm for left ventricular assist device and 9 mm for cardiopulmonary bypass pump. Obtaining an optimal spinning condition is required for regulating the magnetic coupling force. To develop a double pivot bearing pump, it is necessary to establish an optimal spinning and/or floating condition and to determine the proper magnetic coupling and magnetic force between the impeller and driver.

Technical standards for medical devices. Assisted circulation devices.

The steep rise in the clinical use of high technology biomedical devices and materials, involving multidisciplinary competencies, points out the problem of mutual standards defining, first of all, functional characteristic and tests able to characterise and qualify devices, materials and minimal safety requirements both for patients and operators. Standards defined by consent of the parties or by law are used to this aim. Fast technical development in specific sectors produces besides lack of rules, which must be quickly filled up. The aim of this paper is both the presentation of the approach to problems related to technical standards for biomedical devices and the presentation of the set up of a technical standard for mechanical heart assist devices.

Skeletal muscle ventricles: frontiers in 1995.

Skeletal muscle ventricles (SMVs) constructed from electrically conditioned latissimus dorsi muscle (LDM) may become an alternative for assisting the failing heart. Left and right heart circulatory assist using SMVs has been performed successfully in both acute and chronic animal models. The configurations used to connect SMVs to the circulation have included a left atrium to aorta bypass, a left ventricle apex to aorta bypass, aortic counterpulsators, a cavopulmonary bypass, and a right ventricle to pulmonary artery bypass. One SMV used as an aortic counterpulsator functioned effectively in the circulation for more than 27 months. Recent application of the pericardium to the SMV as an inner layer and design changes in the connection of the SMV to the circulation have reduced the risk of thrombus formation and SMV rupture. Although several problems have yet to be solved, the goal of the SMV as a permanent circulatory assist device without the limitation of an external power source seems within reach.

Seal-less centrifugal blood pump with magnetically suspended rotor: rot-a-flot.

Limitations of current centrifugal blood pumps are related to heat generation of bearings and leakage of seals, to dead water zones, and to poor efficiency. A new concept is proposed in this paper to ameliorate these problems based on a miniaturized magnetic drive, and a prototype is introduced. The pump rotor is suspended and driven by a radial permanent magnetic field that stabilizes the impeller in 4 of the 6 spatial degrees of freedom and allows it to be top-spun on a single blood-flushed pivot bearing with minimal load and friction. A shrouded impeller with an open center and 4 logarithmically curved channels is run inside a cone-and-plate-type housing with a spiral volute chamber. In vitro testing was performed comparing this design with the BioMedicus, St. Jude, and Sarns pumps. The prototype is demonstrated to have the smallest internal volume (35 ml), surface (190 qcm), and passage time (0.5 s at 4 L/min), as well as the highest hydraulic efficiency (up to 0.4) of all devices studied.

The need for standardizing the index of hemolysis.

Hemolysis is one of the most important performance parameters of blood pumps. However, comparative in vitro evaluation of the reported hemolysis effect is difficult owing to the lack of uniformity in the test methods used. Currently, three types of formulas are generally accepted and widely used for the index of hemolysis: the traditionally used index of hemolysis (defined as grams of plasma free hemoglobin released per 100 L of blood pumped); the normalized index of hemolysis (normalized by hematocrit); and the modified index of hemolysis (taking into account not only hematocrit but also hemoglobin). In addition, the tested blood conditions are often not indicated in the reports. To address this confusing situation, all three indices of hemolysis were routinely derived in our laboratory. To avoid further confusion, the tested blood conditions and test loop were defined in each study in our laboratory. If we limit the acceptable range of hemoglobin in human blood, the normalized index of hemolysis is sufficient. Furthermore, using milligrams as the unit of expression would be easier and reasonable for comparing the less hemolytic blood pumps, such as the centrifugal pumps that are currently available clinically. We would like to propose this value of a normalized index of hemolysis in milligrams as the most useful formula for the index of hemolysis in the assessment of various types of rotary blood pumps.