Automatic Control Systems for the Artificial Heart and Ventricular Assist Device

Automatic control systems for the artificial heart (AH) and ventricular assist device were developed using selected criteria of effectiveness, a mathematical model of regulation, and noninvasive measures of the hemodynamic parameters. The Sinus IS2 system was developed for control of the AH; its main component is a high-speed servomechanism that provides for the generation of pneumatic pulses. The servomechanism is controlled by automatic regulation with pressure feedback. Mean aortic pressure was used as the primary regulated hemodynamic parameter. The systems were tested using both a physical model and a physiologic experiment. Contractile insufficiency of the left ventricle was simulated in testing the control system for circulatory assistance. The studies demonstrate that automatic control systems function effectively by providing normal blood circulation in both the resting state and in certain transient processes occurring in a real, dynamic circulatory system.     

Management of single-ventricle patients with Berlin Heart EXCOR Ventricular Assist Device: single-center experience

There are minimal data regarding chronic management of single‐ventricle ventricular assist device (VAD) patients. This study aims to describe our center's multidisciplinary team management of single‐ventricle patients supported long term with the Berlin Heart EXCOR Pediatric VAD. Patient #1 was a 4‐year‐old with double‐outlet right ventricle with aortic atresia, L‐looped ventricles, and heart block who developed heart failure 1 year after Fontan. She initially required extracorporeal membrane oxygenation support and was transitioned to Berlin Heart systemic VAD. She was supported for 363 days (cardiac intensive care unit [CICU] 335 days, floor 28 days). The postoperative course was complicated by intermittent infection including methicillin‐resistant Staphylococcus aureus, intermittent hepatic and renal insufficiencies, and transient antithrombin, protein C, and protein S deficiencies resulting in multiple thrombi. She had a total of five pump changes over 10 months. Long‐term medical management included anticoagulation with enoxaparin, platelet inhibition with aspirin and dipyridamole, and antibiotic prophylaxis using trimethoprim/sulfamethoxazole. She developed sepsis of unknown etiology and subsequently died from multiorgan failure. Patient #2 was a 4‐year‐old with hypoplastic left heart syndrome who developed heart failure 2 years after bidirectional Glenn shunt. At systemic VAD implantation, he was intubated with renal insufficiency. Post‐VAD implantation, his renal insufficiency resolved, and he was successfully extubated to daytime nasal cannula and biphasic positive airway pressure at night. He was supported for 270 days (CICU 143 days, floor 127 days). The pump was upsized to a 50‐mL pump in May 2011 for increased central venous pressures (29 mm Hg). Long‐term medical management included anticoagulation with warfarin and single‐agent platelet inhibition using dipyridamole due to aspirin resistance. He developed increased work of breathing requiring intubation, significant anasarca, and bleeding from the endotracheal tube. The family elected to withdraw support. Although both patients died prior to heart transplantation, a consistent specialized multidisciplinary team approach to the medical care of our VAD patients, consisting of cardiothoracic surgeons, heart transplant team, hematologists, pharmacists, infectious disease physicians, psychiatrists, specialty trained bedside nursing, and nurse practitioners, allowed us to manage these patients long term while awaiting heart transplantation.     

Development of a Direct Mechanical Left Ventricular Assist Device for Left Ventricular Failure

Abstract: We have developed a direct mechanical left ventricular assist device (DMLVAD) for severe left ventricular failure. The DMLVAD was attached to the left ventricle and compressed the heart by a pneumatic driving unit. In a mock circulation model with an extracted non-beating heart, a cardiac output (CO) of 1.93 L/min was obtained at a driving pressure of 200 mm Hg. In a canine left ventricular failure model induced by injection of sodium hydroxide into the myocardium, the systolic arterial pressure, systolic left ventricular pressure, maximum LV dP/dt, peak flow, and CO increased by 21, 24, 58, 144, and 37%, respectively. The mean left atrial pressure also decreased by 15% when the DMLVAD was driven. These effects were most prominent when the mean left atrial pressure was over 15 mm Hg, and the driving pressure was over 100 mm Hg. Compression at late systole was more effective in obtaining greater CO. We suggest that the DMLVAD could be an optional circulatory assist device for patients with left ventricular failure awaiting heart transplantation.     

Human Clinical Fitting Study of the DexAide Right Ventricular Assist Device

The DexAide right ventricular assist device (RVAD) has been developed as an implantable RVAD. The purpose of this study was to determine the final design and optimal anatomical placement of the DexAide RVAD when implanted simultaneously with either of two commercially available left ventricular assist devices (LVADs) in patients. A mock-up DexAide RVAD was used to assess configuration with each of two types of commercially available LVADs at the time of LVAD implantation in three human clinical cases. The pump body of the DexAide RVAD was placed either in the preperitoneal space or in the right thoracic cavity. The DexAide RVAD placed into the right thoracic cavity is suitable for use with the Novacor or HeartMate II LVADs. The results of this study will guide the finalization of the inflow cannula and optimal placement of the DexAide RVAD for human clinical trials.     

Temporary Right Ventricular Mechanical Support in High‐Risk Left Ventricular Assist Device Recipients Versus Permanent Biventricular or Total Artificial Heart Support

Early planned institution of temporary right ventricular assist device (RVAD) support with the CentriMag (Levitronix LLC, Waltham, MA, USA) in left ventricular assist device (LVAD) recipients was compared with permanent biventricular assist device (BVAD) or total artificial heart (TAH) support. Between 2007 and 2011, 77 patients (age range: 25–70 years) with preoperative evidence of biventricular dysfunction (University of Pennsylvania score >50; University of Michigan score >5) were included. Forty‐six patients (38 men; median age 54.5 years, range: 25–70 years) underwent LVAD placement combined with temporary RVAD support (group A); in 31 patients (25 men; median age 56.7 years, range: 28–68 years), a permanent BVAD or TAH implantation (group B) was performed. Within 30 days, 12 patients from group A (26.08%) and 14 patients from group B (45.1%) died on mechanical support (P = 0.02). Thirty patients (65.2%) in group A were weaned from temporary RVAD support and three (6.5%) underwent permanent RVAD (HeartWare, Inc., Framingham, MA, USA) placement. A total of 26 patients (56.5%) were discharged home in group A versus 17 (54.8%) in group B (P = 0.56). Three patients (8.5%) received heart transplantation in group A and six (19.3%) in group B (P = 0.04). In group A, 90‐day and 6‐month survival was 54.3% (n = 25) versus 51.6% (n = 16) in group B (P = 0.66). In group A, 1‐year survival was 45.6% (n = 21) versus 45.1% (n = 14) in group B (P = 0.81). The strategy of planned temporary RVAD support in LVAD recipients showed encouraging results if compared with those of a similar permanent BVAD/TAH population. Weaning from and removal of the temporary RVAD support may allow patients to be on LVAD support only despite preoperative biventricular dysfunction.     

Implantable Ventricular Assist Systems

A major goal of the Circulatory Support Program of the National Heart, Lung, and Blood Institute (NHLBI) is the development of a tether-free implantable ventricular assist system (VAS) to rehabilitate patients with advanced heart disease. In 1980, the NHLBI initiated a targeted program to develop and integrate implantable electromechanically powered VASs capable of operating for at least 2 years. The objectives of the program are to complete the development of the VAS and perform in vitro and in vivo evaluation studies. This article summarizes the research status of this NHLBI-sponsored program. It defines the VAS system requirements, describes the systems under development, identifies progress achieved to date, and identifies research challenges.     

Anesthesia for noncardiac procedures for children with a Berlin Heart EXCOR® Pediatric Ventricular Assist Device: a case series

Objectives: To report our experience of providing anesthesia for noncardiac procedures in children with in situ Berlin Heart EXCOR Pediatric^® ventricular assist devices and to suggest principles of anesthetic management. Background: With the initiation of the first North American training and support center for Berlin Heart at our institution in 2006, we have been asked to provide anesthesia for noncardiac procedures to these children. No current anesthetic approach to these children has been reported. Methods/Materials: Anesthetic records for all noncardiac procedures for children with Berlin Heart between August 2006 and February 2009 in a tertiary care pediatric hospital were retrospectively reviewed. Charts were reviewed for demographic and clinical data, perioperative management, and occurrence of hypotension. Results: Twenty‐nine procedures were performed on 11 patients. Hypotension was a common occurrence with all anesthetic induction and maintenance agents even at low doses. Ketamine induction, however, was less likely to produce hypotension, odds ratio for hypotension 0.1333 (95% confidence range 0.021–0.856). Hypotension was responsive to fluid bolus (60%) and alpha‐receptor agonists (100%). Preoperative stability and presence of biventricular ventricular assist device (BiVAD) did not predict intraoperative hemodynamic course. Conclusions: Unlike patients with other ventricular assist devices, these children do not tolerate reductions in systemic vascular resistance (SVR) because of the relatively fixed cardiac output of this device. Agents that reduce SVR should be avoided where possible. Preoperative stability is not predictive. Fluids and alpha‐agonists should be first‐line response to hypotension in this population. Further study of this unusual population is warranted to further delineate best anesthetic practice.     

In Vivo Preclinical Anticoagulation Regimens After Implantation of Ventricular Assist Devices

Ventricular assist devices (VADs) have demonstrated successfully their ability to treat failing circulation of patients with end-stage heart failure. Among the main obstacles with these VADs is thromboembolic events that increase device-related morbidity and mortality. Prior to the clinical application of any newly developed VAD, the feasibility of the device is tested on animal models. Animal species have different hemostatic properties than human patients, and this factor creates a margin of error when comparing the occurrence of VAD-induced thrombosis in an animal versus a human. This detailed literature review provides a thorough documentation of various preclinical anticoagulation protocols used to date, including their outcomes and recommendations for future anticoagulation management strategies. In summary, the outcomes favor a sheep or pig model over other animal models, and discourage the application of a single anticoagulative agent to improve outcomes with any of the currently available devices.     

Clinical Application of the Ellipsoid Left Heart Assist Device

The ellipsoid left heart assist device (E-LVAD) was implanted in eight patients suffering from intra-operative heart failure. It was not possible to remove these patients from extracorporeal circulation following an intracardiac procedure; therefore, implantation of the E-LVAD was performed during extracorporeal circulation. The inflow connector was pushed forward from a purse-string suture on the right superior pulmonary vein, across the mitral valve and into the left ventricle. The outflow connector was joined to the ascending aorta. In two patients, the artificial heart chamber was removed after complete recovery of the circulation; these patients, however, later died. In six other patients, untreatable right heart failure developed and these patients died with the pump in place. It is concluded, therefore, that the right heart must also be mechanically supported during postoperative heart failure.     

Status of Implantable Energy Systems to Actuate and Control Ventricular Assist Devices

Summary: A major goal of the Devices and Technology Branch of the National Heart, Lung, and Blood Institute (NHLBI) is the development of a family of devices that can be effectively used in the rehabilitation of patients with advanced heart disease. The development of implantable circulatory assist and total heart replacement devices forms a major portion of this goal. A miniature, implantable energy converter is a key to the development of a tether-free, implantable ventricular assist system. This paper defines the energy system design requirements, identifies key subsystems, briefly reviews NHLBI-sponsored research activities, defines the current research status, and identifies current problem areas and research issues.     

Current Strategy for Severe Heart Failure with Mechanical Circulatory Support

Abstract: In the last 10 years, 37 patients received assisted circulation or a ventricular assist device after open-heart operations at the Heart Institute of Japan. After cardiovascular surgery, 12 patients underwent venoarte-rial bypass (VAB), 13 had biventricular bypass (BVB), 8 had left ventricular bypass (LVB), and the remaining 4 received a left ventricular assist device (LVAD). Weaning and discharge rates of the patients by type of circulatory supports were 41.7 and 25.0% with VAB, 69.3 and 46.2% with BVB, 87.5 and 37.5% with LVB, 75.0 and 50.0% with LVAD, and 44.4 and 11.1% with PCPS, respectively. Concerning complications of postcardiotomy circulatory support, hemorrhage and ventricular arrhythmia postcardiotomy circulatory support, hemorrhage, and ventricular arrhythmia (immature weaning) decreased with low-heparinized isolated left ventricular supports (i.e., LVB, LVAD). However, profound biventricular failure, infection, and multiple organ failure remain as possible complications with any type of assisted circulation. These results suggest that early application of circulatory support and appropriate selection of the mode of support and devices used are important for successful circulatory support.     

Prevention of Right Heart Failure After Left Ventricular Assist Device Implantation by Phosphodiesterase 5 Inhibitor

Right ventricular (RV) function immediately after left ventricular assist device (LVAD) implantation is a crucial prognostic factor. RV failure is linked to increased mortality and worse outcome. A phosphodiesterase 5 inhibitor, sildenafil, was shown to decrease pulmonary vascular resistance and pulmonary artery pressure post‐LVAD. We report on a series of heart failure patients, and the effect of sildenafil on the incidence of RV failure after LVAD implantation. We retrospectively analyzed the data of end‐stage heart failure patients who underwent LVAD implantation with pulmonary hypertension and RV dysfunction prior to surgery. Patients were divided into two groups; group 1: patients who received sildenafil perioperatively, and group 2: patients who did not receive sildenafil. Hemodynamic and echographic data were collected before and after surgery. Fourteen patients were included, 8 patients in group 1 and 6 in group 2. Sildenafil was administered with a mean dose of 56.2 ± 9.4 mg in group 1 and was able to significantly reduce right heart failure incidence, and to demonstrate a significant reduction in pulmonary vascular resistance, pulmonary artery pressure, transpulmonary gradient, and a significant increase in cardiac output. In conclusion, sildenafil seems to have a promising role perioperatively in preventing acute RV failure postsurgery in patients with RV dysfunction and pulmonary hypertension, requiring LVAD therapy.     

Artificial Heart and Assist Devices: Directions, Needs, Costs, Societal and Ethical Issues

A Working Group appointed by the Director of the National Heart, Lung, and Blood Institute (NHBLI) has reviewed the current status of mechanical circulatory support systems (MCSS), and has examined the potential need for such devices, their cost, and certain societal and ethical issues related to their use. The media have reported the limited clinical investigative use of pneumatically energized total artificial hearts (which actually replace the patient's heart) and left ventricular assist devices (which support or replace the function of the left ventricle by pumping blood from the left heart to the aorta with the patient's heart in place). However, electrically energized systems, which will allow full implantation, permit relatively normal everyday activity, and involve battery exchange or recharge two or three times a day, are currently approaching long-term validation in animals prior to clinical testing. Such long-term left ventricular assist devices have been the primary goal of the NHLBI targeted artificial heart program. Although the ventricular assist device is regarded as an important step in the sequence of MCSS development, the Working Group believes that a fully implantable, long-term, total artificial heart will be a clinical necessity and recommends that the mission of the targeted program include the development of such systems. Past estimates of the potential usage of artificial hearts have been reviewed in the context of advances in medical care and in the prevention of cardiovascular disease. In addition, a retrospective analysis of needs was carried out within a defined population. The resulting projection of 17,000-35,000 cases annually, in patients below age 70, falls within the general range of earlier estimates, but is highly sensitive to many variables. In the absence of an actual base of data and experience with MCSS, projection of costs and prognoses was carried out using explicit sets of assumptions. The total cost of a left ventricular assist device, its implantation and maintenance for a projected average of 4 1/2 years of survival might be approximately $150,000 (in 1983 dollars). The gross annual cost to society could fall in the range of $2.5-$5 billion. Ethical issues associated with use of the artificial heart are not unique. For individual patients these relate primarily to risk-benefit, informed consent, patient selection, and privacy. However, for society as a whole, the larger concern relates to the distribution of national resources.(ABSTRACT TRUNCATED AT 400 WORDS)     

Implantation of the Left Ventricular Assist Device

Development of mechanical devices for support of the failing heart is a major goal in cardiac surgery. The application of left ventricular assist device (LVAD) is a promising approach in the case of severe and otherwise untreatable cardiac failure. In our experience we have used two external centrifugal pumps for the extracorporeal biventricular cardiac support in a post-transplantation patient who experienced severe rejection six months after heart transplantation. Our own series includes a total of ten implantations of LVAD's with six patients who could be weaned from the device but only one long-term survivor. The clinical results are not encouraging which suggests that the heart of the patient who needs an LVAD has been damaged beyond any chance for later recovery. Obviously timing is the most crucial aspect of the decision to implant the device. It would appear that orthotopic implantation of the transplanted heart remains the method of definitive treatment.