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The DexAide right ventricular assist device (RVAD) is a magnetically and hydrodynamically levitated implantable centrifugal pump. Recent progress includes 1) redesign of the inflow/outflow conduits, which yielded two successful 3-month experiments, 2) development of alternative journal bearing materials, and 3) completion of an 18-month duration of in vitro endurance testing. Verification testing of the RVAD electronics has been completed, and a prototype biventricular assist device (BVAD) system has been tested. Acute DexAide/CorAide BVAD implantations via median sternotomy in two calves documented BVAD control algorithms and anatomical fit. A drug-induced chronic calf heart failure model, currently under development in our laboratory, resulted in a successful BVAD implantation in a calf with heart failure. Our future plans are to complete in vitro and in vivo validation of alternative bearing materials, perform preclinical DexAide in vivo and in vitro reliability studies, and obtain Food and Drug Administration (FDA) approval for an Investigational Device Exemption to conduct a clinical pilot study. In conclusion, two successful 3 month in vivo experiments and an 18-month in vitro endurance test were completed. After final bearing material selection, the DexAide design will be "frozen" so that preclinical systems can be manufactured. BVAD experiments using a chronic heart failure model are in progress.

Right ventricular failure can occur early or late after left ventricular assist device implantation. Support with a right ventricular assist device is needed in patients whose right ventricular failure does not respond to conservative management. The use of a temporary right ventricular assist device can enable the recovery of right ventricular function and avoid the use of a more permanent biventricular assist device, which is associated with complications and higher costs. We present our technique of instituting temporary right ventricular assist device support in patients who have undergone left ventricular assist device implantation.

In totally implantable ventricular assist device systems, measuring flow rate of the pump is necessary to ensure proper operation of the pump in response to the recipient's condition or pump malfunction. To avoid problems associated with the use of flow probes, several methods for estimating flow rate of a rotary blood pump used as a ventricular assist device have been studied. In the present study, we have performed a chronic animal experiment with two NEDO PI gyro pumps as the biventricular assist device for 63 days to evaluate our estimation method by comparing the estimated flow rate with the measured one every 2 days. Up to 15 days after identification of the parameters, our estimations were accurate. Errors increased during postoperation days 20 to 30. Meanwhile, their correlation coefficient r was higher than 0.9 in all the acquired data, and estimated flow rate could simulate the profile of the measured one.

The purpose of this program is to design, develop, and clinically evaluate a new, implantable right ventricular assist device (RVAD) that can be used as a component of an implantable biventricular assist device for patients with severe biventricular heart failure. The initial phase of this program resulted in a prototype RVAD, named DexAide, a modified version of the CorAide left ventricular assist device. In vitro testing was performed in a stand-alone circuit and in a true RVAD mode to evaluate pump performance. Pump flow and power were measured under various afterload and pump speed conditions. The pump performance requirements of 2 to 6 l/min and a pressure rise of 20 to 60 mm Hg were successfully met with pump speeds between 1,800 and 3,200 rpm. The nominal design point of 4 l/min and 40 mm Hg pressure rise was achieved at 2,450 +/- 70 rpm with a power consumption of 3.0 +/- 0.2 W. The initial in vitro testing met the design criteria for the new DexAide RVAD. Initial in vivo testing is under way, which will be followed by preclinical readiness testing and a pilot clinical trial in this 5-year program.

The New Energy and Industrial Technology Development Organization (NEDO) project was started in 1995. The goal is the development of a multipurpose, totally implantable biventricular assist device (BVAD) that can be used for any patient who suffers from severe heart failure. Our C1E3 (two-week pump) centrifugal pump, called the Gyro pump, has three design characteristics: a magnetic coupling and double pivot bearing system, an eccentric inlet port, and secondary vanes on the bottom of the impeller. The pump was miniaturized. The C1E3 evolved into the NEDO PI-601, a totally implantable centrifugal pump for BVAD. The current NEDO PI-710 pump (five-year pump) system includes a centrifugal pump with pivot bearings, a hydraulically-levitated impeller, an rpm-controlled miniaturized actuator (all-in-one actuator plus controller), an emergency clamp on the left outflow, and a Frank-Starling-type flow control. The final mass production model is now finalized, and the final animal study and two-year endurance studies are ongoing.

In 1995, a group at Baylor College of Medicine started to develop the NEDO biventricular assist device (BVAD) using two Gyro permanently implantable (PI) centrifugal pumps. This pump consists of a sealless pump housing and an impeller supported with a double pivot bearing. In May 2001, an RPM dynamic suspension system (RPM-DS) for the impeller was developed to improve durability and antithrombogenicity without a complex magnetic suspension system. From March 2000 to March 2002, eight BVAD bovine experimental studies were performed for more than 1 month. Two pumps were implanted in two cases without the RPM-DS (group A) and in six cases with the RPM-DS (group B). In group A, the survival period was 45 and 50 days. The primary reason for termination was an increase in the requiring power, which was related to deposition of white thrombus on the bottom bearing. In group B, the survival period was 37, 48, 51, 60, 80, and 90 days. The reasons for termination were not related to thrombus formation. No thrombus was observed in the pumps except for one right pump. In that experiment, the thrombus formation may have occurred when that pump had a low flow rate at a level of 1 L/min for 6 hr. These studies demonstrate the apparent antithrombogenic effect of RPM-DS. The NEDO BVAD is ready to move into a 3-month preclinical system evaluation.

Eine 37-jahrige Patientin wurde im kardiogenen Schock bei Multiorganversagen eingewiesen. Echokardiographisch war die linksventrikulare Funktion zunachst auf 35% reduziert. Klinisch bestand der V.a. eine Myokarditis. Anamnestisch bestand ein grippaler Infekt seit 1 Woche. Innerhalb von 24 h kam es zu einer weiteren dramatischen Reduktion der linksventrikularen Funktion auf 7%. Links- bzw. Rechtsherzkatheteruntersuchungen unter Entnahme von rechtsventrikularen Myokardbiopsien wurden durchgefuhrt. Die histo- und molekularpathologischen Untersuchungen ergaben die Diagnose einer Enterovirusmyokarditis. Bei Multiorganversagen blieb als einzige Therapieoption die Implantation eines biventrikularen Unterstutzungssystems („biventricular assist device“ [BVAD] – Berlin Heart). Postoperativ war die Patientin nur noch vorubergehend katecholaminpflichtig. Aufgrund der notwendigen Antikoagulation waren bei Nachblutungen drei Rethorakotomien erforderlich. Die Nieren- und Leberfunktion normalisierten sich im weiteren Verlauf. Das BVAD konnte schlieslich nach 25 Tagen bei vollstandiger Erholung der globalen Herzfunktion ohne Herz-Lungen-Maschine entfernt werden.

AnyHeart is a single-piece, implantable biventricular assist device. This electromechanical BVAD has a moving-actuator mechanism. To monitor the status of AnyHeart from anywhere at any time, a portable personal digital assistant (PDA) monitor and web-based remote monitoring system were developed. The PDA local monitoring system has replaced bulky personal computer monitoring systems. The web-based remote monitoring system has several functions such as data collecting, storing, and posting through the internet. Basically, interventricular pressure (IVP) is a parameter indicating the filling level of the blood chambers of AnyHeart. The pump output can be estimated using IVP, which is acquired noninvasively from AnyHeart. With the proposed method, we can estimate the pump output with a small margin of error.

CONCLUSIONS In cases of acute aortic dissection, the potential for a circumferential intimal tear needs to be considered because intimo-intimal intussusception, although rare, is a serious complication of aortic dissection. Coronary angiography may indicate complete coronary artery occlusion that may be due to the intussuscepting flap and will resolve once the aortic defect has been repaired. Intraoperative

OBJECTIVE: Ventricular assist devices (VADs) are associated with increased anti–human leukocyte antigen antibody production. The purpose of this study is to characterize differences in sensitization patterns in patients receiving axial flow, implantable VADs versus pulsatile, paracorporeal biventricular assist devices (BIVADs) as bridges to transplantation. METHODS: The study is a retrospective review of 68 patients who were bridged to transplantation with either a VAD or a BIVAD, as described, from January 2007 to June 2010, at a university medical center. RESULTS: Five of 15 (33.3%) VAD patients became sensitized during treatment, compared with 30 of 53 (56.6%) BIVAD patients, P = .15. Multivariable analysis comparing BIVAD with VAD, while controlling for previous cardiac surgery, pregnancy, and packed red blood cell transfusion produced an odds ratio of 2.99, P = .14. Of sensitized patients, all 5 (100%) of the VAD patients had pre-existing antibodies before VAD placement, compared with 9 of 30 (30.0%) BIVAD patients, P = .006. Maximum cumulative mean fluorescence intensities for BIVAD were 46,259 ± 66,349 versus 42,540 ± 12,840 for VAD, P = .90. Time to maximum antibody expression was shorter for the VAD group (34 ± 28 days vs 5.8 ± 9 days, P = .04). CONCLUSIONS: Device type was not a factor in patient sensitization after implantation. However, VAD patients required pre-existing sensitization before implantation to produce antibodies during their treatment interval, whereas more than two thirds of BIVAD patients developed de novo antibodies. These data suggest that the mechanism of sensitization between VAD and BIVAD patients may differ, and further mechanistic studies into the impact of device types on patient sensitization are warranted.

心臓サルコイドーシスに致死性不整脈重積を合併し,頻回の除細動により高度心機能低下をきたした患者に対して経皮的心肺補助(percutaneous cardiopulmonary support, PCPS),引き続いて両心補助人工心臓(biventricular assisted device, BiVAD)を装着し救命した。PCPS装着1週間でBiVADに移行したが,PCPSでは得られない左心系の負荷軽減により不整脈のコントロールが可能となった。本症例では心臓以外の臓器障害が軽度であり,かつ多臓器不全,下肢阻血などのPCPSの重篤な合併症を起こす前にタイミングよくBiVADへ移行できたことが救命のポイントであった。

The aim was to assess the influence of a biventricular assist device (BVAD) on ventricular energetics parameters (external work, oxygen consumption, cardiac mechanical efficiency) for both ventricles, when mechanical ventilation was applied. The experiments were performed using a computer simulator of cardiovascular system (CARDIOSIM) after modelling a pathological state of the left ventricle (E(v)Left = 0. 9 mmHg cm(-3) and increasing pulmonary resistance (Rap = 0.3 mmHg cm(-3 s). The effect of mechanical ventilation was mean intrathoracic pressure changes from 0 to +5 mmHg. This simulation showed that application of BVAD for both ventricles reduces external work and that this effect is stressed by positive intrathoracic pressure, reduces cardiac mechanical efficiency that is quite insensitive to intrathoracic pressure and increases oxygen consumption, which is reduced by positive intrathoracic pressure. The increase of potential energy at the onset of BVAD evidences a rightwards shift of ventricular work cycle (unloading of the ventricles). In general, positive intrathoracic pressure during BVAD assistance adversely affects ventricular energetics.

Dobutamine is a rare and unrecognized cause of eosinophilic myocarditis (EM). It is even more unique for it to cause significant clinical deterioration. Patients with end stage cardiomyopathy have very little cardiac reserve and dobutamine induced myocarditis may cause enough harm to require urgent mechanical circulatory support. We describe a man with dilated cardiomyopathy that developed accelerated clinical deterioration from dobutamine induced EM. He had a predominance of right heart failure, requiring an urgent biventricular assist device and acutely responded to withdrawal of dobutamine.

As waiting times for transplants have lengthened, long-term mechanical circulatory support (MCS) has become more common in patients who present with severe cardiogenic shock leading to multiorgan failure. With these patients, we used the biventricular assist device (BVAD, Berlin Heart). In this report, we will describe our 4 years of experience with 11 patients on a BVAD who were discharged home while awaiting transplantation. The 11 patients underwent BVAD implantation from 1997 to 2000. These were 2 women and 9 men. The mean support time was 382 days (range: 156 - 567). The indication for BVAD was cardiomyopathy--six dilated, one restrictive and four ischemic. These patients were monitored for infections, thromboembolic events, bleeding complications, and psychological effects during the time they spent at home. Our experience shows that all of the patients could leave hospital following sufficient training for dressings and anticoagulation after recovering completely from secondary organ dysfunction. The mean time period the patients spent at home was 48 days (range: 3 - 182) days. Seven patients (63 %) had to be readmitted to the hospital--due to transitory ischemic attacks in two cases, hemorrhoidal bleeding in one and wound infections in four cases. One patient died of a traumatic accident during sexual activity. The use of a BVAD is feasible for outpatient use as a bridge to transplantation. It ensures the survival of the patient, enables recovery from multiorgan failure and offers an acceptable quality of life.

Die Bedeutung der mechanischen Kreislaufunterstutzungssysteme hat durch die zunehmende Wartezeit auf ein Spenderorgan zugenommen. Bei Patienten, die ein terminales Herzversagen und ein sekundares Multiorganversagen aufweisen, wird ein biventrikulares Kreislaufunterstutzungssystem Typ Berlin Heart implantiert. Wir berichten uber unsere Erfahrung mit 33 Patienten, die uber einen Zeitraum von uber 150 Tagen durch ein biventrikulares Kreislaufunterstutzungsystem Typ Berlin Heart (BVAD) unterstutzt wurden. Es handelte sich hierbei um 27 Manner (82%) und 6 Frauen (18%) mit einem Durchschnittsalter von 45±10,7 Jahren (von 24–62 Jahren). Die Grunderkrankungen vor Implantation eines BVAD stellten bei 24 Patienten dilatative Kardiomyopathie, bei drei Patienten eine restriktive Kardiomyopathie und bei sechs Patienten eine ischamische Kardiomyopathie dar. Die Patienten wurden bezuglich Infektionen, thrombembolischer Ereignisse, Blutungen und psychologischer Probleme beobachtet. Es konnte festgestellt werden, dass sich 32 Patienten (97%) vom Multiorganversagen komplett erholten. Einundzwanzig Patienten (64%) konnten wahrend der Wartezeit am BVAD entlassen werden. Hautinfektionen im Bereich der Durchtrittsstellen der Kanulen traten spatestens 120 Tage nach der Kunstherzimplantation bei allen Patienten auf. Der am haufigsten nachgewiesene Erreger war ein koagulase negativer Staphylokokkus. Mit einer dem Antibiogramm angepassten Therapie stellte dieses in keinem Fall eine Kontraindikation zur Herztransplantation dar. Aufgrund der parakorporal plazierten, transparenten Blutpumpen, konnten sie taglich auf entstehende Fibrinbelage untersucht werden. Kam es zu solchen Ablagerungen, so wurden die Pumpen gewechselt oder gereinigt. Mit einem speziellen Blutgerinnungsmanagement und einer spezifischen Hemmung der Thrombozytenaggregation konnten thrombembolische Ereignisse und Blutungen erheblich reduziert werden. Elf Patienten (33%) verstarben nach einer mittleren Unterstutzungszeit von 303 Tagen (von 151–552 Tage) wahrend sie auf ein Spenderorgan warteten. Zwei Patienten verstarben aufgrund von Hirnblutungen, sieben Patienten aufgrund von Infektionen, eine an ihrer Grunderkrankung (Amyloidose) und ein Patient an einer traumatischen Kanulenverletzung bei sexueller Aktivitat. Zum jetzigen Zeitpunkt warten zwei Patienten (6%) am BVAD auf die Herztransplantation und 20 Patienten (60%) konnten nach einer mittleren Wartezeit von 286 Tagen (von 152 bis 571 Tagen) transplantiert werden. Die Resultate nach der Transplantation waren akzeptabel: bis auf drei Patienten uberlebten alle.

Recombinant activated factor VII (rFVIIa) has been approved for treatment of bleeding episodes in patients with hemophilia and in nonhemophilia patients with acquired antibodies against factor VIII or IX. The application of rFVIIa in nonapproved settings, as in cardiac surgery, has not been established. It raises concerns regarding its safety. We used rFVIIa in a patient with excessive nonsurgical bleeding on extracorporeal membrane oxygenation, which was established for early graft failure after heart transplantation and after 3 months of biventricular assist device support. After rFVIIa administration, cardiac thrombosis developed and caused the patient's death.

Sleep-disordered breathing (SDB) is common in chronic heart failure. Both obstructive sleep apnea syndrome (OSAS) and central sleep apnea with periodic Cheyne-Stokes respiration (CSA-CSR) can occur. CSA-CSR is believed to correlate with heart function. Little information exists about the impact of mechanical assist devices and heart transplantation on SDB in patients with end-stage heart failure. Here, we describe, for the first time, the effects on SDB of a biventricular external assist device and of heart transplantation used successively in the same patient. Citation: Vermes E; Fonkoua H; Kirsch M; Damy T; Margarit L; Hillion ML; Hittinger L; d'Ortho MP. Resolution of sleep-disordered breathing with a biventricular assist device and recurrence after heart transplantation. J Clin Sleep Med 2009;5(3):248–250.

Acknowledgment: The figures in this article were provided by ABIOMED Cardiovascular, Inc. Introduction Centralized tertiary care has increased the need for patient transfer from local hospitals to regional centers of excellence. Interhospital transport of critically ill patients long has been the mission of many helicopter programs, including MedSTAR Transport of Washington Hospital Center. The movement of patients with ventricular assist devices (VADs) by ambulance, fixed-wing aircraft, and helicopter is becoming more widespread.‘,2 We pre sent the first case in the literature of a rotor-wing transport of a patient with an open chest and a biventricular assist de vice, the ABIOMED BVS 5000 biventricular support system (ABIOMED Cardiovascular, Inc., Danvers, Mass.). Through preflight planning, intlight adap tation, and postflight debriefing, we have developed innovative strategies to facilitate the transport of highly complex cardiac patients. Key considerations include the equipment, helicopter, and crew composition and training. The purpose of this case report is to share our experience and provide a template for future complex transports.

We describe the case of a 39-year-old woman who received a self-made total artificial heart built of components from the Thoratec and ExCor Berlin Heart systems. The patient had a severe aortic/myocardial infection following replacement of the ascending aorta with a Shelhigh conduit due to type A aortic dissection. The surgical technique is described in detail in this article. This technique is feasible if a total artificial heart is not available and implantation of a biventricular assist device is not possible.

w d r t t m t s m t b a ENTRICULAR ASSIST DEVICES (VADs) are increasingly used for treatment of end-stage heart failure.1-3 The horatec VAD (Thoratec Corp, Pleasanton, CA) is designed to upport the pulmonary and/or systemic circulation when the atient’s heart is unable to maintain adequate perfusion with onventional therapy, often as a bridge to transplantation. An nteresting complication of right ventricular cannulation and he related anesthetic management are described.

Heart transplantation is currently the preferred treatment for patients with end stage heart failure, with a median survival rate of 11 years for all patients and 14 years for patients who survive the early post-implantation period [1]. A limited number of donor organs andmorepeople livingwith serious heart failure have increasedtheimportance for alternative options. Ventricular assist devices are being successfully used as bridge-to-transplant or as destination therapy when heart transplantation cannot be considered, for example due to inoperability or non-compliance. Implantation of a VAD has shown to improve exercise capacity, quality of life and mortality in patients with severe heart failure, although exercise capacity after VAD therapy remainsbelow that reportedfor age-matchedcontrolsafter heart transplantation [2]. Exercise and improved peak oxygen uptake (VO2peak) are related to improved quality of life and prognosis in patients with severe heart failure [3]. Therefore, improving VO2 peak is an important goal with multifaceted clinical relevance in patients on VAD therapy. The few studies investigating exercise in patients on VAD therapy

Recently, several new cell separators have become available for high platelet low WBC contamination thrombocytapheresis. In their original configuration, these apparatuses can only collect plasma along with platelets, while no concurrent red cell collection can be carried out. In this study, we present the preliminary results of plasma and/or erythrothrombocytapheresis after the adaptation of the lines of two different cell separators, namely the Fresenius AS 204 and the Baxter Health Care Amicus. In addition, the preliminary results of multicomponent collection using the Dideco Excel will be presented; in the latter a system of plasma recirculation was introduced, to increase the purity and quality of the platelet product. The results of these studies show that erythrothrombocytapheresis can be carried out with all these apparatuses, but only with Dideco-Excel and the Fresenius AS 204 the procedure is totally automated. There are marginal differences in the quality of the RBC product in terms of percent hematocrit, from 65% with the Excel and AS 204 to ∼ 75% with the Amicus and in terms total content of hemoglobin which averages 58 g per RBC concentrate when RBC collection is carried out during the processing of ∼ 420 ml of whole blood. In terms of platelet collection, the differences are presently moderate, as the platelet yield and WBC contamination are not affected by the concurrent RBC collection. The average platelet yield was 3.98-4.1, and 4.01x1011 and the total WBC contamination was 1.2-2.9, and 1.9X105 rerspectively with the Amicus, the AS 204 and the Excel. These represent a new step in the direction of total apheresis for blood and blood component procurement.

Continuous coronary perfusion with warm beta-blocker-enriched blood has been suggested as an alternative to cardioplegic arrest for myocardial protection during coronary artery surgery. The purpose of the present work was 1.) to experimentally investigate this technique using an animal model, and 2.) to clinically apply this alternative myocardial protection technique and compare it to standard crystalloid cardioplegia in a controlled study. We placed 6 dogs on CPB and 6 dogs on a biventricular assist device and created "beta-blocker-induced cardiac surgical conditions" by suppressing myocardial chronotropy and inotropy with systemic infusion of the ultra-short acting beta-blocker esmolol. For the clinical study we randomized 60 coronary artery surgery patients to receive either crystalloid cardioplegia (Bretschneider HTK) or selective continuous coronary perfusion via the aortic root with warm esmolol-enriched CPB blood. In the experimental study we found that continuous coronary perfusion with warm esmolol-enriched blood avoided myocardial ischemia and minimized myocardial edema, thus completely preserving cardiac performance. Our clinical data showed the alternative technique to be superior to standard crystalloid cardioplegia in terms of both functional and structural myocardial protection. The concept of beta-blocker-induced cardiac surgical conditions is a useful alternative for myocardial protection during coronary artery surgery and may be particularly beneficial for severely compromised hearts.

The use of mechanical circulatory support devices to keep patients alive until transplantation has become essential in the face of an increasing organ shortage. We report successful heart transplantations after 841 days of left ventricular assist device (LVAD) support in a child with hypoplastic left heart syndrome, and after 547 days of biventricular assist device (BVAD) support in another child with cardiomyopathy. To our knowledge, this report is the first on the longest-term (841 days) LVAD and the longest-term (547 days) BVAD support in children who were mobile and awake during the support, as a most effective bridge to heart transplantation.

Background . The success of heart transplantation led to the extension of the criteria for both recipients and donors. The aim of the study was to evaluate the experience with this therapeutic approach for end-stage heart failure at a single center. Methods . Between April 1986 and January 1996, 1,413 patients were accepted as candidates for heart transplantation. Ventricular assist devices were used as a bridge to transplantation in 173 patients (biventricular assist device in 141 patients and left ventricular assist device in 32 patients). The longest duration of support was 572 days (average, 46 days). Results . Of the 1,413 patients, 891 underwent heart transplantation (65 children/adolescents and 826 adults; 522 (36%) patients died awaiting a donor heart. The average time spent on the waiting list was 107 days. The average recipient age was 44 years, and the age of donors was extended up to 69 years. Eighty-three patients with ventricular assist devices (48%) subsequently underwent heart transplantation. Twenty-five patients (2.7%) underwent retransplantation. The 30-day mortality rate was 14%, and the overall actual survival at 1, 5, and 10 years was 80%, 59%, and 50%, respectively. Ninty-four percent of patients were in New York Heart Association functional class I or II at 1 year, and 44% returned to work after transplantation. Conclusions . Despite the broadening of the selection criteria for both recipients and donors, heart transplantation remains an effective treatment for end-stage heart failure. Nevertheless, this therapeutic approach is severely limited by a considerable disparity between the need and availability of donor organs.

Circulatory assist devices as bridge to heart transplantation have become more important as the number of possible recipients has increased and the number of donors remains stable. The number of patients successfully bridged and discharged home after transplantation was determined for the Novacor Left Ventricular Assist System (Baxter Healthcare Corp., Oakland, CA) (LVAS), console and wearable; the TCI Left Ventricular Assist Device (Thermo Cardio Systems Inc., Woburn, MA) (LVAD), pneumatic and electric; the Thoratec LVAD and Biventricular Assist Device (Thoratec Lab Co., Berkeley, CA) (BIVAD); and the CardioWest total artificial heart (CardioWest Tech. Inc., Tuscon, AZ) (TAH). A total of 1,286 devices (14% Novacor console, 14% Novacor wearable, 35% TCI pneumatic, 4% TCI electric, 10% thoratec LVAD, 19% Thoratec BIVAD, and 4% CardioWest TAH) were implanted worldwide since 1984. A total of 776 (60%) patients reached heart transplantation and 687 patients (88.5% of those transplanted) were discharged home. The individual success rate for each device to bridge a patient to heart transplantation and be discharged home is as follows: Novacor LVAS console, 90%; Novacor LVAS wearable, 92%; TCI LVAD pneumatic, 89%; TCI LVAD electric, 89%; Thoratec LVAD, 93%; Thoratec BIVAD, 81%; and CardioWest TAH, 92%. The success rate with all the available systems to bridge a patient to heart transplantation and be discharged home is similar for all devices. The criteria used to determine which system to be used should be individualized for each patient. Some of the factors that should be considered in making a decision on which device to use should include anticoagulation, univentricular vs biventricular failure, mobility, protocol to discharge home, and size of the patient.

S m v e b s 2 c t UCCESSFUL WEANING from biventricular mechanical support with full recovery of myocardial function in chilren with acute myocarditis has been described before.1,2 Durng the period of weaning from the assist device, the pharmaologic treatment with inotropic agents is a clinical challenge. atecholamines and phosphodiesterase-III inhibitors are well stablished in the treatment of the acute low-output syndrome. here is only limited experience with new inotropic agents in ardiac anesthesia and cardiac surgery. Levosimendan is a new notrope that is being investigated in the therapy of severe heart ailure.3,4 The authors report a case in which a 12-year-old girl required mplantation of a biventricular assist device because of acute yocarditis. The decision to explant the mechanical support as made at a point in time when left ventricular function was till reduced because a device-related infection was considered o be very likely. During and after infusion of levosimendan, eft ventricular function, as measured by transthoracic echocariography (TTE), improved dramatically and the patient made full recovery.

This report describes a patient treated for metastatic leiomyosarcoma, who acutely developed doxorubicin-induced cardiotoxicity, and consequently developed heart failure. Medical therapy was initiated; however, her condition deteriorated and a surgical alternative was proposed. A biventricular assist device was implanted, allowing her multisystem organ failure to improve. During the next 9 days while on the assist device, her heart failure resolved, her organs were well perfused, and her heart entered a recovery period. After 9 days of mechanical support with the biventricular assist device, she was explanted from the assist device, and with inotropic support and an intra-aortic balloon pump, she maintained adequate hemodynamics. Eighteen days after implantation of the assist device, she was discharged from the hospital with hospice care, where she later died. Although the patient's cardiac function did not have long-term recovery, short-term recovery after doxorubicin toxicity was achieved. The authors maintain that the use of a biventricular assist device in the treatment of acute heart failure resulting from doxorubicin-induced cardiomyopathy is an effective way to manage this patient population.

Biventricular assist device (BiVAD) support is a mechanical circulatory support using both left ventricular assist device (LVAD) and right ventricular assist device (RVAD). BiVAD support is now increasingly used as an alternative treatment for end-stage heart failure patients, such as bridge to transplantation, bridge to recovery, and permanent support. Both flow balancing and Starling response of the right and left ventricles should be concerned to prevent the suction event on both right and left ventricles. In this study, the cardiovascular system model using the rotary blood pump was implemented to study the mechanical circulatory support management during left ventricular assist device (LVAD) support alone and during BiVAD support. The pathological ventricles were generated by reducing the maximum elastance (Emax) in the model. The pressure -volume loop of difference heart conditions (normal ventricle: 100% of Emax, pathological ventricle: 50% of Emax) and the levels of pump support (non-support, partial support and full support) were simulated. From all simulations, the suction events in the right ventricle ( represented by negative values of right ventricular volume and pressure) were observed during the unbalanced flow conditions of BiVAD support. Therefore, the flow balancing or pump speed adjustment is a key for BiVAD management. .

Chronische Herzinsuffizienz ist eine der entscheidenden Ursachen für Morbidität und Mortalität in industrialsierten Ländern. Konkret erleiden in Deutschland jährlich bis zu 28000 Patienten einen kardiogenen Schock, 19.000 Menschen versterben daran. Ausgelöst wird der kardiogene Schock in 70 Prozent der Fälle durch einen Myokardinfarkt. Bei erfolgloser medikamentöser Therapie bestehen nur zwei Alternativen: eine sofortige Herztransplantation oder eine Unterstützung des schwerkranken Herzens mittels mechanischer Systeme. Da die Wartezeit auf eine Herz-Transplantation in Europa, auch in der HU (High Urgent)-Liste, mehrere Wochen beträgt, ist eine mechanische Kreislaufunterstützung die einzige Alternative in einer akuten Situation. Methode: Von Januar 1986 bis März 2006 wurden im Deutschen Herzzentrum Berlin 426 Patienten mit BVAD versorgt. Davon wurden 186 Patienten, die BVAD in kardiogenem Schockzustand bekommen hatten, in unserer Studie aufgenommen, Nach Abschluss der Patientenrekrutierung erfolgte die retrospektive Aufteilung der Patienten in zwei Gruppen. Gruppe I: Patienten, die mehr als 30 Tage gelebt haben oder innerhalb der 30 Tage transplantiert oder von VAD entwöhnt wurden (n=122). Gruppe II: Patienten, die weniger als 30 Tage am VAD gelebt haben (n=64). Wir haben alle 69 präoperativen Standardparameter, die im Deutschen Herzzentrum Berlin regelmäßig erhoben wurden, in unserer Studie unter Einbeziehung der Zwei verschiedenen Scoringsystemen ( MODS und SOFA) analysiert. Abschließend wurden diese Parameter mittels t-Test zwischen den Gruppen verglichen. Lag keine Normalverteilung vor, kam der Mann- Whitney-U-Test zum Einsatz. Als signifikant wurden Werte angenommen, für die höchstens eine Irrtumswahrscheinlichkeit von p=0,05 gefunden wurde. Weiterhin wurden die als signifikant erkannten Parameter mittels multivariater Analyse untersucht. Ergebnisse: Die statistische Auswertung aller Parameter im Vergleich zwischen beiden Gruppen ergab, dass die 30-Tage-Mortalität bei den Patienten , die einen kardiogenen Schock aufgrund eines erlittenen Myokardinfarkt hatten, 50% beträgt. Von allen verwendeten Beurteilungsparametern und Scoringsystemen erwiesen sich lediglich das Alter mit p=0,02 und der artierielle pH-Wert mit 0,004 als signifikant. Auch im Ergebnis der vorgenommenen Multivarianzanalyse waren sich das Alter und der arterielle pH-Wert als signifikant heraus. So war die Odds ratio für Alter 1,42 in 10 Jahre Steigerung und für art. pH-Wert 0,012 bei 0,01 Steigerung. Die Untersuchung der 30-Tage-Mortalität für verschiedene Alters- und pH- Wertgruppen hat ergeben, dass mit steigendem Alter die Mortalität steigt und bei steigendem arteriellem. pH-Wert die 30-Tage-Mortalität sinkt. Diskussion: Letztendlich stellt sich aus unserer Sicht als Lösung für die Gruppe von Patienten, die unter kardiogenem Schock und Multiorganversagen leiden und für die kein Spenderherz in Sicht ist, Folgendes dar: Bei bestimmten Konstellationen (hohes Alter, niedriger Blut-pH-Wert, hohe Körpertemperatur) ist es sinnvoll, zuerst ein Kurzzeitsystem (Überbrückung) bis zur endgültigen Entscheidung zu implantieren, um später, bei einem guten Verlauf der Organerholung, auf ein Langzeitsystem zu wechseln. Der retrospektive Charakter dieser Arbeit ist als Anstoß für weitere Studien zu sehen. Als Konsequenz für zukünftige Therapieentscheidungen sollte aber eine prospektive Studie die von uns gefundenen Zusammenhänge ergänzend validieren und untersetzen., Mechanical circulatory support (MCS) is a valuable tool to save patients suffering from severe cardiogenic schock. However, the reversibility of multiorgan failure (MOF) limits the survival. We investigated predictors of recovery from of MOF in patients supported with biventricular assist device (BVAD) or total artificial heart (TAH). Methods We investigated 426 patients implanted with BVAD/TAH between 1988 and 2006, except for postcardiotomy syndrome and transplant failure. In 187 patients without technical or bleeding problems requiring re-thoracotomy evaluation of 69 clinical, hemodynamic, echocardiographic and laboratory parameters was performed. The patients were divided into two groups regarding procedural success. Group I – survival >30 days or heart transplantation or weaning from device (n=123) and Group II – dead on system

One hundred and seventy-two patients at The Methodist Hospital in Houston, Texas, were placed on BioMedicus centrifugal ventricular support. One hundred thirty-nine patients were male and 33 were female with a mean age of 59.7 years. Reasons for support were post-cardiotomy cardiac failure (129 patients), cardiac allograft failure (17 patients), bridge to transplantation (10 patients), resuscitation (7 patients), postpercutaneous trans-luminal coronary angioplasty emergent (2 patients), and other (7 patients). Support was by left ventricular assist device in 108 patients, right ventricular assist device in 20 patients, and biventricular assist device in 44 patients. Eighty-four patients (48.8%) were weaned from the ventricular assist device, and 88 patients (51.2%) were not weaned. Thirty-four patients (20.0%) were discharged from the hospital. Complications included coagulopathy, renal insufficiency/failure, respiratory insufficiency/ failure, neurological deficits, sepsis, arrhythmias, and device-related complications. Overall causes of death were ventricular failure (55.1%), triage (13.0%), arrhythmias (9.4%), graft failure (5.9%), coagulopathy (4.3%), sepsis syndrome (2.9%), device-related (0.7%), and other (0.7%). BioMedicus centrifugal ventricular support can be implemented rapidly and easily. Device-related complications are few (1.2%), and it is relatively inexpensive when compared with other ventricular assist systems. This series demonstrates that a substantial number of patients may benefit from temporary centrifugal ventricular support.

Rotary ventricular assist device (VAD) support of the cardiovascular system is susceptible to suction events due to the limited preload sensitivity of these devices. This may be of particular concern with rotary biventricular support (BiVAD) where the native, flow-balancing Starling response is diminished in both ventricles. The reliability of sensor and sensor-less based control systems which aim to control VAD flow based on preload have limitations and thus an alternative solution is desired. This study introduces a compliant inflow cannula (CIC) which could improve the preload sensitivity of a rotary VAD by passively altering VAD flow depending on preload. To evaluate the design, both the CIC and a standard rigid inflow cannula were inserted into a mock circulation loop to enable biventricular heart failure support using configurations of atrial and ventricular inflow, and arterial outflow cannulation. A range of left (LVAD) and right VAD (RVAD) rotational speeds were tested as well as step changes in systemic/pulmonary vascular resistance to alter relative preloads, with resulting flow rates recorded. Simulated suction events were observed, particularly at higher VAD speeds, during support with the rigid inflow cannula, while the CIC prevented suction events under all circumstances. The compliant section passively restricted its internal diameter as preload was reduced, which increased the VAD circuit resistance and thus reduced VAD flow. Therefore, a compliant inflow cannula could potentially be used as a passive control system to prevent suction events in rotary left, right and biventricular support.

A patient with a Jarvik 2000 (Jarvik Heart, Inc., New York, NY) biventricular assist device had massive hemolysis and device insufficiency of the right ventricular assist device (RVAD) after the anticoagulation was temporarily reversed due to cerebral hemorrhage. After the patient’s condition was stabilized by bridge use of CentriMag (Levitronix LLC, Waltham, MA) for right ventricle support, the Jarvik 2000 pumps with pin-shaped bearings were exchanged with new conical bearing pumps. Examination of the removed pumps revealed tight thrombus formation around the pin-shaped bearings.

Intensive care unit nurses are often faced with challenging situations. This case study focuses on an older school-age child in an adult intensive care unit (ICU) for the placement of a biventricular assist device (BIVAD) and eventual heart transplantation. Discussion of the assist device and transplantation is included as well as a discussion of the nursing care issues. The care issues discussed include alteration in family processes, alteration in body image, and grieving related to the possibility of death.

Mechanical circulatory support has been used to treat graft failure caused by rejection after heart transplantation, but the prognosis remains bleak. Organ failure induced by the addition of or an increase in immunosuppressive medication is known to be a cause of the poor outcomes. Thus we tried a new therapeutic technique that allows complete withdrawal of immunosuppressive medication, as the donor heart is removed and circulatory support is maintained with a biventricular assist device.

The ventricular assist device (VAD) is a hemodynamic support device that augments cardiac output for patients with severe ventricular dysfunction. With improved reliability and technological advances, the use of VADs to support patients is increasing. Many VAD-dependent patients ultimately require heart transplants that are only available in specialized centers, necessitating an interhospital transfer. To date there are few reports of long-distance fixed wing aeromedical transport of patients dependent on a VAD. Here we describe the successful transfer of a patient supported by a biventricular assist device (BiVAD) from Cambridge, UK, to Durham, NC, via fixed-wing jet aircraft. During this transfer, we observed hemodynamic alterations secondary to gravitational forces, which should be anticipated and may be mitigated with simple maneuvers. With high-level logistical planning and appropriate medical oversight, patients dependant on BiVADs can be safely transported by fixed wing aircraft over long distances.

The treatment of severe biventricular (BV) contractile failure using mechanical circulatory support is challenging. We analyzed our center's results following implantation of a biventricular assist device (BVAD).We implanted 39 BVADs between September 2001 and January 2009. All patients were qualified candidates for heart transplantation, without an organ available at time of BVAD implantation. Fifteen patients without a history of chronic cardiomyopathy suffered from acute BV failure (group 1), whereas the other 24 suffered from severe chronic cardiomyopathy (group 2). The indication for BVAD implantation was determined in reference to echocardiography, the degree of end-organ damage, and whether the patient qualified for a heart transplant or was a candidate for bridge to recovery.Both groups were similar regarding their preoperative hemodynamics, intraoperative and early postoperative findings, and adverse events. Patients in group 1 were younger (mean age 37±17 years) than those in group 2 (51±12 years). Mean duration of support in group 1 was 137±109 days, and 65±61 days in group 2. In group 1, 33% (5/15) were weaned off the device and 53% (8/15) underwent heart transplantation, whereas 8/24 patients (42%) in the chronic group were transplanted. Group 1's mortality on the device was lower than that of group 2 (13% vs 67%). Furthermore, 11 patients of group 1 survived for 1 year compared with four in group 2 (73% vs 17%).Implantation of a BVAD in patients with chronic heart failure and acute decompensation is associated with a high mortality and morbidity rate. By contrast, BVAD implantation can achieve excellent results in patients with acute BV failure without a history of chronic cardiomyopathy, even if they are in cardiogenic shock upon admission.