Venoarterial extracorporeal membrane oxygenation is a viable option as a bridge to heart transplant.

OBJECTIVE: Venoarterial extracorporeal membrane oxygenation is a rescue therapy for patients in cardiogenic shock. We hypothesize that patients bridged to heart transplant with extracorporeal membrane oxygenation have decreased survival. METHODS: The United Network of Organ Sharing database was retrospectively reviewed from January 1, 1999, to March 31, 2018, for heart transplant recipients. Recipients bridged with any form of mechanical support and those without support were compared with recipients bridged with extracorporeal membrane oxygenation. The primary end point was restricted mean survival time through 16.7 years. RESULTS: Of 26,918 recipients, 15,076 required no pretransplant mechanical support (56.0%). Support patients included 9321 with left ventricular assist devices (34.6%), 53 with right ventricular assist devices (0.2%), 258 with total artificial hearts (1.0%), 686 with biventricular assist devices (2.6%), 1378 with intra-aortic balloon pumps (5.1%), and 146 who required extracorporeal membrane oxygenation (0.5%). In the first 16.7 years post-transplant, compared with recipients bridged with extracorporeal membrane oxygenation, estimated adjusted restricted mean survival time was higher in patients who required no mechanical support (16.6 months [14.0-19.4]) and patients with a left ventricular assist device (16.5 months [99% confidence interval, 13.9-19.2]), an intra-aortic balloon pump (11.2 months [8.3-14.7]), or a biventricular assist device (6.6 months [3.6-10.3]). Restricted mean survival time in patients with a right ventricular assist device or a total artificial heart was similar to patients with extracorporeal membrane oxygenation. CONCLUSIONS: Recipients bridged with extracorporeal membrane oxygenation were estimated to survive 16.6 months less than nonmechanical circulatory support recipients. Bridge to heart transplant with extracorporeal membrane oxygenation is a viable option, and these patients should be considered transplant candidates.

First Use of HeartMate 3 in a Failing Fontan Circulation.

The failing Fontan circulation can be challenging to support with ventricular assist devices, mostly because of the variety of causes of failure, some of which cannot be addressed by VAD therapy alone. A new ventricular assist device, the HeartMate 3 (Abbott, Chicago, IL), was recently approved for use in adults in the United States and is now widely available, with excellent survival results in two-ventricle patients. This case report describes the first successful implantation of the HeartMate 3 in a 22-year-old man with a failing Fontan circulation and the possible benefits this device may have in supporting this ever-growing population of young adults with single ventricles.

Biventricular Berlin Heart EXCOR pediatric use across the united states.

BACKGROUND: Biventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival. METHODS: All EXCOR Pediatric devices (Berlin Heart, Inc, The Woodlands, TX) placed in North America between May 2007 and December 2010 comprised the study cohort of 204 patients (128 [63%] LVADs and 76 [37%] BiVADs). The following patient cohorts were analyzed to determine the effect of BiVAD use on survival: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 patients, patients with abnormal bilirubin levels, patients who received previous extracorporeal membrane oxygenation (ECMO), and patients with a 10-mL pump size. RESULTS: There were more patients with BiVADs in INTERMACS profile 1 (63% compared with 46%; p = 0.018). The incidence of major bleeding, neurologic and renal dysfunction, and infection was similar between BiVAD and LVAD groups. White race, abnormal glomerular filtration rate (GFR), sites with experience of less than 5 implantations, and use of 10-mL pumps were predictors of mortality in patients who received BiVADs. BiVADs were not associated with improved survival in any patient cohort; however, they were associated with increased mortality in patients who had undergone ECMO before receiving a VAD. CONCLUSIONS: BiVAD support was not associated with improved survival in any identified subset of patients. Although not randomized, these results (which were corrected for multiple possible risk factors) suggest that some children supported with BiVADs might have done better with LVADs alone. Further prospective studies will be needed to identify patient cohorts that will be better served with BIVAD support.

Perioperative blood product use: a comparison between HeartWare and HeartMate II devices.

BACKGROUND: The HeartWare (HW) (Framingham, MA) and the HeartMate II (HM II) (Thoratec Inc, Pleasanton, CA) continuous-flow left ventricular assist devices (CF-LVADs) are commonly used to bridge patients to transplantation. We hypothesized that there are differences in perioperative blood product (BP) use and chest tube (CT) output between CF-LVAD types. METHODS: We retrospectively evaluated BP use in 71 patients who were implanted with a CF-LVAD (HM II = 38; HW = 33) by median sternotomy for bridge to transplantation (BTT) indications from 2009 to 2013. Detailed BP use data were collected during the intraoperative and postoperative periods and included packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate. RESULTS: Preoperative characteristics (age, left ventricular ejection fraction, previous sternotomy, ischemic cause), and risk stratification scores (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS]) profile, Leitz-Miller score, Kormos score) were comparable between groups (all p > 0.05). Total average intraoperative and postoperative BP use was different between device types: HW = 8.3 ± 13 versus HM II = 12.6 ± 14.0 units (p = 0.002) and HW = 6.1 ± 12.0 units compared with HM II = 13.5 ± 24.1 units (p = 0.022), respectively. Average postoperative CT output for HW (3,231 ± 3,648 mL) and HM II (3,463 ± 3,050) (p < 0.008) were different between device types. Multivariate analysis revealed that a higher preoperative Leitz-Miller score, implantation of an HM II CF-LVAD, previous sternotomy, and a longer duration of cardiopulmonary bypass (CPB) time were independently associated with increased need for BP use, whereas only use of the HM II device and a longer bypass time predicted a greater CT output. CONCLUSIONS: Compared with HM II, implantation of the HW CF-LVAD was associated with reduced intraoperative and postoperative BP use and decreased CT output. Increased awareness of device-related differences in bleeding and BP use may improve CF-LVAD patient outcomes.

[Implantable ventricular assist device].

Implantable ventricular assist device( VAD) is the only evidence-based option to treat stage D heart failure patients with significant symptoms at rest in spite of maximum medical therapy, other than heart transplant. Implantable VADs available in Japan include Evaheart, DuraHeart both from Japan, Jarvik 2000 and HeartMate II both from United States. In Japanese settings, implantable VAD is indicated and insured only for patients who are supposed to have an indication for receiving heart transplant, which means "bridge to transplantation" use. And in Japan, implantable VAD can be implanted for patients less than 65 years old if it needs to be insured. In the University of Tokyo Hospital, the mid-term outcomes of 41 implantable VAD patients were acceptable with 2 hospital deaths, 2 remote deaths and one year survival rate at 88%.Considering the present Japanese situation with extreme shortage of organ donation, the extended application of implantable VADs as "Destination Therapy" is awaited, but quality of life of care-givers as well as patients themselves and sustainable follow-up system provided by healthcare professionals need to be warranted.

Insertion of Impella 5.0 to improve candidacy for HeartMate II left ventricular assist device placement.

The Impella 5.0 is a minimally invasive heart assist device that can be used to stabilize patients with cardiogenic shock. We present the case of a 49-year-old female in cardiogenic shock who required left ventricular assist device placement, but was not an optimal candidate for surgery due to severe deconditioning and malnutrition. An Impella 5.0 pump was surgically implanted via right axillary artery approach, which allowed the patient time to improve nutritional and functional status before subsequent placement of HeartMate II left ventricular assist device.

Overview of the 2012 Food and Drug Administration circulatory system devices panel meeting on the reclassification of external counterpulsation, intra-aortic balloon pump, and non-roller-type cardiopulmonary bypass blood pump devices.

The Food and Drug Administration held a Circulatory System Devices Advisory Panel meeting, December 5 and 6, 2012, to review the classification or potential reclassification of the following device types: external counterpulsation, intra-aortic balloon pump (IABP), and non-roller-type cardiopulmonary bypass blood pumps. These 3 devices are preamendment (Medical Device Amendments of 1976) class III devices. The advisory panel discussed the data and provided recommendations for reclassification of these devices. The panel recommended reclassification of ECP to class II for stable angina pectoris and to retain a class III for all other indications. For IABP, the recommendation was to reclassify IABP to class II for several indications (acute coronary syndrome, cardiac and noncardiac surgery, and heart failure complications) and remain class III for all other indications. As for non-roller type, the panel recommended that for cardiopulmonary bypass and temporary circulatory bypass, these devices should be reclassified to class II while retaining a class III device status for all other indications, including ventricular support both for hemodynamically unstable patients and for prophylactic support in high-risk percutaneous interventions.

Arterial wall histology in chronic pulsatile-flow and continuous-flow device circulatory support.

BACKGROUND: Continuous-flow (CF) ventricular assist devices (VAD) are an established option for treatment of end-stage heart failure. However, the effect of long-term CF with lack of peripheral arterial wall motions on blood pressure regulation and end-organ arterial wall sclerosis, especially in the case of long-term support (> 3 years), remains unclear. METHODS: Tissue samples obtained at autopsy from liver, kidney, coronary arteries, and brain from 27 VAD recipients supported for > 180 days between 2000 and 2010 were histologically examined to assess vascular alterations, including perivascular infiltrate, intravascular infiltrate, wall thickness, thrombosis, endothelial cell swelling, vessel wall necrosis, and peri-vascular fibrosis. Pulsatile-flow (PF) devices had been inserted in 9 patients and CF devices had been inserted in 16. The pathologist was blinded to the group distribution. Demographic, pharmacologic, and clinical data were retrospectively analyzed before surgery and during the follow-up period of up to 24 months. RESULTS: Median duration of support was 467 days (range, 235-1,588 days) in the PF group and 263 days (range, 182-942 days) in the CF group. Demographic and clinical data before and after surgery were similar. Amiodarone was more often used during follow-up in CF group than in the PF group (61% vs 10%, p = 0.009). Throughout the follow-up period, mean arterial pressure did not differ between recipients of the 2 pump types, nor did systolic and diastolic pressure, except at 2 weeks after VAD implantation, when systolic blood pressure was higher (p = 0.05) and diastolic lower (p = 0.03) in the PF group. Histologic studies did not identify any relevant differences in arterial wall characteristics between the 2 groups. CONCLUSION: Long-term mechanical circulatory support with CF devices does not adversely influence arterial wall properties of the end-organ vasculature.

Does the type of ventricular assisted device influence survival, infection, and rejection rates following heart transplantation?

OBJECTIVE: To determine the influence of the type of left ventricular assisted device (LVAD) as predictor of survival, hospitalizations due to infection, and rejection following heart transplantation and to delineate any further predictors of such outcomes. METHODS: Patients who received a left ventricular assist device (HeartMate [Thoratec Corp., Pleasanton, CA, USA] or Novacor [World Heart Corporation, Ottawa, Canada]) as a bridge to heart transplantation between October 1991 and June 2004 using the United Network for Organ Sharing (UNOS) Thoracic Registry database were evaluated. Comparison of survival curves between HeartMate and Novacor was performed using Kaplan-Meier survival method and Cox proportional hazard model adjusting for patient demographics and co-morbidities. Infection and rejection rates between the two devices were analyzed using multivariable logistic regression model. RESULTS: The UNOS database provided 1255 patients with HeartMate and 154 patients with Novacor between 1991 and 2004. Unadjusted one- and five-year survivals for HeartMate and Novacor were 0.84 and 0.80 and 0.72 and 0.56, respectively, following heart transplantation. Adjusting for patient demographics and co-morbidities, no statistical significant difference in one-year survival was observed between those who received HeartMate and Novacor (HR = 1.49, p = 0.127). At five years, however, the HeartMate group had higher survival than Novacor (HR = 1.53, p = 0.043). All-time posttransplant hospitalizations due to infection and rejection were similar between HeartMate and Novacor recipients after adjusting for patient case mix. CONCLUSION: Controlling for patient case mix, there was no survival difference at one year between those who received Novacor versus HeartMate LVAD. At five years, a Novacor bridge to transplant patient on average had statistically significantly lower survival than HeartMate recipients. No difference in infection and rejection were observed.

Successful conversion of TandemHeart left ventricular assist device to right ventricular assist device after implantation of a HeartMate XVE.

A 60-year-old man with end-stage ischemic cardiomyopathy (ejection fraction, 10%) was admitted in cardiogenic shock, which was unresponsive to maximum inotropes and an intraaortic balloon pump. The TandemHeart (TH) left ventricular assist device (Cardiac Assist Inc, Pittsburgh, PA) was placed in the standard percutaneous transseptal configuration with improved hemodynamics. The HeartMate XVE (Thoratec Corp, Pleasanton, CA) implantation was performed as a bridge to transplant 5 days after TandemHeart insertion. The TandemHeart was converted to a temporary right ventricular assist device during the HeartMate XVE (Thoratec Corp) implantation due to right ventricular failure. The right ventricular assist device was weaned 3 days later. This strategy was useful, technically easy, and cost effective.

Tricuspid incompetence and geometry of the right ventricle as predictors of right ventricular function after implantation of a left ventricular assist device.

BACKGROUND: Implantation of a left ventricular assist device (LVAD) is an established treatment for end-stage heart failure. Right ventricular (RV) dysfunction develops in 20% to 50% of patients after LVAD implantation, leading to prolonged ICU stay and elevated mortality. However, the prediction of RV failure remains difficult. METHODS: The pre-operative echocardiographic parameters, tricuspid incompetence (TI), RV end-diastolic diameter (cut-off >35 mm), RV ejection fraction (cut-off <30%), right atrial dimension (cut-off >50 mm) and short/long axis ratio (cut-off >0.6), were analyzed retrospectively in 54 patients. Patients were divided into two groups. One group consisted of patients with RV failure (n = 9), as defined by the presence of two of the following criteria in the first 48 hours after surgery: mean arterial pressure < or =55 mm Hg; central venous pressure > or =16 mm Hg; mixed venous saturation < or =55%; cardiac index 20 units; or need for an RVAD. The other patients comprised the non-RV-failure group (n = 45). RESULTS: The RV failure group had a significantly higher short/long axis ratio of the RV (0.63 vs 0.52, p = 0.03; odds ratio 4.4, p = 0.011). For patients with a short/long axis ratio of the RV of <0.6, RV failure occurred in 7% of patients, as compared with 50% for patients with a ratio > or =0.6 (p = 0.013). Among patients with TI Grade III or IV, 75% developed RV failure as compared with 12% in patients with TI Grade I or II (p = 0.054). The odds ratio for RV failure after LVAD implantation for TI Grade III or IV was 4.7 (p = 0.012). CONCLUSIONS: Pre-operative evaluation of tricuspid incompetence and RV geometry may help to select patients who would benefit from biventricular support.

Alternatives to heart transplantation. Symposium of the "Treatment of End-stage Heart and Lung Failure" working group on October 22, 2005 in Munich.

Heart transplantation is currently the treatment of first choice in patients with end-stage refractory heart failure. But already the demand for donor organs cannot be met, and patients face long waiting times for transplantation. In the future waiting times will become even longer as life expectancy increases and the number of heart-failure patients requiring transplantation grows. Consequently, in view of the poor prognosis of the disease in its advanced stages, alternatives to heart transplantation are increasingly gaining importance. In recent years new innovative treatment methods and techniques have been developed which have already proved clinically successful in patients with end-stage heart failure, especially as bridging measures. Some of these techniques appear suitable for long-term use and could therefore serve as an alternative to heart transplantation in some patients. Interesting new avenues of research may even lead to cardiac cell replacement therapies in the future. These approaches are currently undergoing initial clinical trials. This report presents surgical and cardiologic treatments for end-stage heart failure that have already been clinically investigated as well as techniques that are still in the preclinical stage and discusses their potential as alternatives to heart transplantation.

Cerebrovascular accidents in patients with a ventricular assist device.

OBJECTIVE: A cerebrovascular accident is a devastating adverse event in a patient with a ventricular assist device. The goal was to clarify the risk factors for cerebrovascular accident. METHODS: Prospectively collected data, including medical history, ventricular assist device type, white blood cell count, thrombelastogram, and infection, were reviewed retrospectively in 124 patients. RESULTS: Thirty-one patients (25%) had 48 cerebrovascular accidents. The mean ventricular assist device support period was 228 and 89 days in patients with and without cerebrovascular accidents, respectively (P < .0001). Sixty-six percent of cerebrovascular accidents occurred within 4 months after implantation. Actuarial freedom from cerebrovascular accident at 6 months was 75%, 64%, 63%, and 33% with the HeartMate device (Thoratec Corp, Pleasanton, Calif), Thoratec biventricular ventricular assist device (Thoratec Corp), Thoratec left ventricular assist device (Thoratec), and Novacor device (WorldHeart, Oakland, Calif), respectively. Twenty cerebrovascular accidents (42%) occurred in patients with infections. The mean white blood cell count at the cerebrovascular accident was greater than the normal range in patients with infection (12,900/mm3) and without infection (9500/mm3). The mean maximum amplitude of the thrombelastogram in the presence of infection (63.6 mm) was higher than that in the absence of infection (60.7 mm) (P = .0309). CONCLUSIONS: The risk of cerebrovascular accident increases with a longer ventricular assist device support period. Infection may activate platelet function and predispose the patient to a cerebrovascular accident. An elevation of the white blood cell count may also exacerbate the risk of cerebrovascular accident even in patients without infection. Selection of device type, prevention of infection, and meticulous control of anticoagulation are key to preventing cerebrovascular accident.

Bomba sangüínea espiral: concepção, desenvolvimento e aplicação clínica de projeto original / Spiral blood pump: conception, development and clinical application of the original project

INTRODUÇÃO: O trabalho aborda projeto original relativo à concepção, ao desenvolvimento e à aplicação clínica de bomba sangüínea que associa forças centrífuga e axial de propulsão hidráulica, baseada no princípio de Arquimedes, denominada Bomba Espiral (BE), tendo recebido Patente Nacional e Relatório Preliminar Internacional categorizando-a como invento. MÉTODO: Visa avaliar sua capacidade hidrodinâmica e seu impacto aos elementos figurados do sangue por meio de testes "in vitro", como Eficiência Hidrodinâmica, Hemólise Normalizada e Visibilização de Escoamento, e, nos testes "in vivo" experimentais, feitos em carneiros submetidos a Circulação Extracorpórea (CEC), e clínico, em 43 pacientes submetidos a operações cardíacas com CEC, nas quais o elemento propulsor foi a BE. RESULTADOS: Na dependência da distância entre o rotor e a carcaça (fenda) da bomba pôde-se observar que com 1,5 mm gerou escoamento ao redor de 9 L/min, pressão acima de 400mmHg com 1500 rotações por minuto (rpm), índices de Hemólise Normalizada não superiores a 0,0375 g/100l em condições de alto fluxo e pressão, e pelo estudo de Visibilização do Escoamento no interior da bomba não se detectou áreas de estagnação ou turbulência na entrada, saída e junto à extremidade dos fusos. Nas pesquisas "in vivo" experimentais em ovinos em CEC por 6 horas a BE foi capaz de manter parâmetros pressóricos adequados e Hemoglobina Livre entre 16,36 mg por cento e 44,90 mg por cento. Durante sua aplicação em cirurgias cardíacas com CEC, num grupo de 43 pacientes, pôde-se constatar variações pré e pós-CEC, na Hemoglobina Livre de 9,34 a 44,16 mg por cento, no Fibrinogênio, de 236,65 a 547,26 mg por cento, na contagem do número de Plaquetas de 152,465 a 98,139, Desidrogenase Láctica, de 238,12 a 547,26 mg por cento, com tempo de coagulação ativada ao redor de 800 seg. quando em CEC. CONCLUSÕES: A BE mostrou resolutividade por gerar escoamento e pressão adequados, sem causar danos excessivos...

INTRODUCTION: This paper addresses an original project that encompasses the conception, development and clinical application of a helical bypass pump called the Spiral Pump, that uses the association of centrifugal and axial propulsion forces based de the Archimedes principle. This project has obtained a Brazilian Patent and an International Preliminary Report, defining it as an invention. METHODS: The aim of this work was to evaluate the hemodynamic capacity and the impact of its application on blood cells by means of experimental in vitro tests, including hydrodynamic efficiency, effect on hemolysis and flow visualization. Moreover, in vivo experimental tests were carried out on lambs that were submitted to cardiopulmonary bypass for six hours and in 43 patients submitted to heart bypass surgery using the Spiral Pump. RESULTS: When the rotor-plastic casing gap was 1.5mm, the flow generated was nearly 9 L/min, the pressure was greater than 400 mmHg at 1500 rpm, and the normalized hemolytic indexes were not greater than 0.0375 g/100L in high-flow and pressure conditions. Additionally, by the flow visualization techniques, stagnation was not seen inside the pump nor was turbulence identified at the entrance or exit of the pump, or at the ends of the spindles. In the in vivo tests using cardiopulmonary bypasses for 6 hours in lambs, the pump maintained adequate pressure rates and the free hemoglobin levels ranged between 16.36 mg percent and 44.90 mg percent. Evaluating the results of the 43 patients who used this pump in heart bypass operations we observed that the free hemoglobin ranged from 9.34 mg percent before to 44.16 mg percent after surgery, the serum fibrinogen was from 236.65 mg percent to 547.26mg percent, platelet blood count from 152,465 to 98,139 and the lactic dehydrogenase from 238.12mg percent to 547.26mg percent. The Activated Coagulation Time was close to 800 seconds during the bypass. CONCLUSION: The Spiral Pump was...

Bomba sagüínea espiral: concepção, desenvolvimento e aplicação clínica de projeto original / Spiral blood pump: conception, development and clinical application of an original project

Este trabalho aborda projeto original relativo à concepção, desenvolvimento e aplicação clínica de omba sangüínea de propulsão centrífuga a partir do princípio do parafuso sem fim, inicialmente com o rotor cilíndrico, seguido de sua modificação para a forma cônica de modo a permitir a asociação das foças centrífuga e axial de propulsão hidráulica, denominada bomba espiral, tendo recebido patente nacional e relatório preliminar internacional categorizando-a como invento. Métodos: buscam avaliar capacidade hidrodinâmica e o impacto de sua aplicação aos elementos figurados do sangue por meio de testes "in vitro", com eficiêcia hidrodinâmica, hemólise normalizada e visualização de fluxo. Os testes "in vivo" experimentais feitos em carneiros submetidos a CEC por período de 6 horas, e clínico em 43 pacientes submetidos a operações cardíacas com CEC nas quais a bomba propulsora foi a BE...