HeartMate 3 biventricular support exceeding 4.5 years.

A 47-year old male with ischaemic cardiomyopathy was referred to us for durable left ventricular assist device placement. He was found to have prohibitively elevated pulmonary vascular resistance for heart transplantation. He underwent HeartMate 3 left ventricular assist device implantation, with additional temporary right ventricular assist device (RVAD) placement. Following a 2-week period of unweanable temporary right ventricular support, the patient was switched to durable biventricular support with two Heartmate 3 pumps. The patient was placed on a transplant waiting list but was not offered a heart for over 4 years. While on Heartmate 3 biventricular support (BiVAD), he returned to full activity and enjoyed an excellent quality of life. He underwent laparoscopic cholecystectomy 7 months after the BIVAD implant. After 52 months of uneventful BiVAD support, he presented with a combination of adverse events that occurred over a short period. These included subarachnoidal haemorrhage and a new motor deficit, followed by RVAD infection and RVAD low-flow alarms. After over 4 years of unimpeded RVAD flows, new imaging revealed an outflow graft twist with subsequent flow reduction. The patient underwent heart transplantation after a total of 1655 days of Heartmate 3 BiVAD support and continues to do well on latest follow-up.

A novel intrapericardial pulsatile device for individualized, biventricular circulatory support without direct blood contact.

OBJECTIVE: Due to severely limited donor heart availability, durable mechanical circulatory support remains the only treatment option for many patients with end-stage heart failure. However, treatment complexity persists due to its univentricular support modality and continuous contact with blood. We investigated the function and safety of reBEAT (AdjuCor GmbH), a novel, minimal invasive mechanical circulatory support device that completely avoids blood contact and provides pulsatile, biventricular support. METHODS: For each animal tested, an accurately sized cardiac implant was manufactured from computed tomography scan analyses. The implant consists of a cardiac sleeve with three inflatable cushions, 6 epicardial electrodes and driveline connecting to an electro-pneumatic, extracorporeal portable driver. Continuous epicardial electrocardiogram signal analysis allows for systolic and diastolic synchronization of biventricular mechanical support. In 7 pigs (weight, 50-80 kg), data were analyzed acutely (under beta-blockade, n = 5) and in a 30-day long-term survival model (n = 2). Acquisition of intracardiac pressures and aortic and pulmonary flow data were used to determine left ventricle and right ventricle stroke work and stroke volume, respectively. RESULTS: Each implant was successfully positioned around the ventricles. Automatic algorithm electrocardiogram signal annotations resulted in precise, real-time mechanical support synchronization with each cardiac cycle. Consequently, progressive improvements in cardiac hemodynamic parameters in acute animals were achieved. Long-term survival demonstrated safe device integration, and clear and stable electrocardiogram signal detection over time. CONCLUSIONS: The present study demonstrates biventricular cardiac support with reBEAT. Various demonstrated features are essential for realistic translation into the clinical setting, including safe implantation, anatomical fit, safe device-tissue integration, and real-time electrocardiogram synchronized mechanical support, result in effective device function and long-term safety.

Temporary biventricular support as a bridge to recovery: A justifiable strategy for small children with fulminant myocarditis.

Short-term mechanical circulatory support can be life-saving in the pediatric population with acute cardiogenic shock (ACS). However, recovery from MCS is a rare entity. MCS options are limited for low-body-weight children in Turkey. Over the last decade, extracorporeal membrane oxygenation (ECMO) has been the primary bridging modality for children with end-stage heart failure in our country. However, VA-ECMO may cause increased wall stress and oxygen demand, which may alter myocardial recovery. Here, we describe using a Levitronix CentriMag Systems for biventricular support as a bridge to recovery in a 16-month-old boy (weight, 11 kg; BSA, 0.5 m2) with type A influenza related-fulminant myocarditis (FM). Levitronix CentriMag System provides a safe and efficient short-term, biventricular, paracorporeal support for infants, and small children with ACS.

Biventricular Impella use in pediatric patients with severe graft dysfunction from acute rejection after heart transplantation.

Rejection with severe hemodynamic compromise is a significant source of morbidity and mortality for pediatric heart transplant patients. Traditionally, treatment for these patients includes inotropes and escalation to extracorporeal membrane oxygenation (ECMO) when necessary. There is increasing interest in using percutaneous ventricular assistive devices in the pediatric population as a less invasive alternative to ECMO. We report the largest case series to date of biventricular support using percutaneous Impella devices. Retrospective case series was performed by chart review. Hemodynamics, left ventricular ejection fraction (LVEF), and indices of end organ function were collected before and after Impella placement. A 14-year-old male, 18-year-old male, and 19-year-old female, all status post heart transplant, presented with severely decreased biventricular function due to presumed clinical rejection, requiring maximal inotropic support without improvement. In all the three cases, simultaneous Impella CP and RP devices were placed percutaneously. Prior to implantation, LVEFs were 40%, 23%, and 25%, respectively. Hemodynamics measured invasively prior to device placement showed elevated filling pressures. Adverse events while on support included bleeding, hemolysis, and right femoral arterial dissection during implantation. All patients were successfully weaned from the devices and survived to discharge. The average time of right-sided support and total support was 11 days and 13 days, respectively. After device removal, right-sided pressures and echocardiographic measurements showed improvement in all patients. Bilateral Impella configuration (BiPella) is a viable option for temporary mechanical circulatory support in pediatric patients with significant graft dysfunction.

Long-term continuous flow mechanical biventricular support: 9 years and counting.

We report 2 continuous flow HeartWareTM left ventricular assist devices successfully used in a patient with advanced heart failure of giant cell myocarditis origin in a biventricular configuration. Despite technical challenges of adapting a left ventricular assist device engineered for systemic pressure to function as a right ventricular assist device, the addition of dynamic banding on the right ventricular assist device outflow graft allowed successful adaptation of afterload. This patient has now been on biventricular configuration support for 9 years, and remains stable to this day.

Results of primary biventricular support: an analysis of data from the EUROMACS registry.

OBJECTIVES: The purpose of this study was to describe pre- and postoperative data from the EUROMACS registry with regard to indications, for and survival and complication rates of patients with primary continuous flow and pulsatile biventricular long-term assist devices (BiVADs) versus total artificial hearts (TAHs) or left ventricular assist devices (LVADs) + short-term right ventricular assist device (RVAD) implants. METHODS: We investigated patients who received implants between 1 January 2011 and 21 October 2017. Clinical baseline information about comorbidities, laboratory results, medical and device therapies and echocardiographic, haemodynamic and right ventricle (RV) parameters were evaluated along with the rates of deaths and complications. RESULTS: A total of 413 of 3282 patients (12.5%) needed a biventricular pump. We investigated 37 long-term BiVADs, 342 LVAD + short-term RVAD implants and 34 TAHs. Minor differences were found in the baseline characteristics of our population, which had an overall high morbidity profile. The 1-year survival rate was 55% for patients with a continuous flow BiVAD; 52% for patients with an LVAD + short-term RVAD; 37% for patients with pulsatile BiVADs; and 36% for patients with a TAH. No statistical difference was observed among the groups. Over 50% of patients with BiVAD support were classified as INTERMACS profiles 1 and 2. The percent of patients with ambulatory heart failure (INTERMACS 4‒7) undergoing BiVAD implants was modest at <15%. No patients with a pulsatile BiVAD (n = 15) or a TAH (n = 34) were implanted as destination therapy, but 27% of the patients with continuous flow BiVADs (n = 6) and 23% of the patients with LVAD + short-term RVAD (n = 342) were implanted as 'destination'. The adverse events profile remained high, with no significant difference among pump types. The right ventricular stroke work index and right heart failure scores indicated poor RV function in all groups. After 3 months of LVAD + short-term RVAD support, 46.7% still required ongoing support, and only 18.5% were weaned from RVAD support; 33.1% died. CONCLUSIONS: The mortality rate after BiVAD support was high. Survival rates and adverse events were statistically not different among the investigated groups. In the future, composite study end points examining quality of life and adverse events beyond survival may help in shared decision-making prior to general mechanical circulatory support, particularly in patients with BiVAD implants.

Biventricular unloading in patients with refractory cardiogenic shock.

BACKGROUND: Cardiogenic shock remains a clinical challenge with high mortality rate. Mechanical circulatory support (MCS) devices have become an integral component of the therapeutic armamentarium expanding the treatment options for refractory cardiogenic shock (RCS). METHODS: We included all consecutive patients with biventricular unloading with Impella-2.5 and VA-ECMO admitted for RCS between October 2013 and March 2015. Outcome data included survival to discharge, bridging to VAD and 28-day mortality. RESULTS: A total of 17 patients were included. Mean age was 63.3±10.5 and 15 (88%) patients were male. RCS resulted from acute myocardial infarction in 14 (82%), acute myocarditis in 1 (6%) dilated cardiomyopathy in 2 (12%) patients. Mean SAPS II and SOFA score on admission was 74.7±16.86 and 11.16±1.79, respectively. Vasopressor doses and lactate levels were significantly decreased within 72h on biventricular support (p=0.025 for norepinephrine and p=0.005 for lactate). Nine (53%) patients died while on support. Of the remaining 8 patients, 5 (29%) patients were weaned successfully and discharged in cardiac rehabilitation and 3 (18%) patients were successfully bridged to VAD. All 5 patients who were discharged to rehabilitation survived at day 28 after discharge, while 1 of 3 VAD patients died after VAD implantation, corresponding to an overall 28-day survival rate of 41%. CONCLUSIONS: Biventricular support with Impella-2.5 and VA-ECMO in patients with RCS is feasible and led to significant hemodynamic improvement and reduction of lactate levels. Despite high severity scores, ICU- and 28-day mortality rates were better than predicted.

Outcomes of contemporary mechanical circulatory support device configurations in patients with severe biventricular failure.

OBJECTIVES: Severe right ventricular failure often is considered a contraindication for left ventricular assist device (LVAD) therapy and necessitates use of biventricular assist devices (BiVADs). Available options for BiVADs are limited, and comparative outcomes are largely unknown. METHODS: Heart transplant candidates who were registered on the United Network for Organ Sharing waitlist and underwent long-term contemporary LVAD (n = 3195) or BiVAD (n = 408) implantation, from January 2010 through June 2014, were retrospectively analyzed. We evaluated clinical characteristics and outcomes of patients requiring a BiVAD, as well as regional differences in utilization of this technology. RESULTS: Patients requiring a BiVAD were younger (48.9 vs 53.3 years), had a higher proportion of nonischemic disease (69.1% vs 58.2%), a higher bilirubin level (0.9 vs 0.7 mg/dL), and a lower 6-month survival rate (68.1% vs 92.7%) after device implantation (all P < .05). Postimplantation and posttransplantation survival was comparable for commonly used BiVAD configurations, including total artificial heart, continuous flow BiVAD, a continuous-flow LVAD coupled with a right-sided device, and pulsatile flow. Significant variation was found in regional utilization of these devices, regardless of differences in transplantation waitlist times. A large body surface area was an independent predictor of mortality on a BiVAD (hazard ratio = 2.12, P = .017). CONCLUSIONS: Outcomes of patients requiring a BiVAD remain poor in the contemporary device era, regardless of the configuration used. Among other clinical factors, body surface area should be incorporated into decision making for device selection in these patients.

Implantation of HeartMate II as a Bridge to Bridge from Biventricular Support / 日本心臓血管外科学会雑誌

<p>A 27-year-old man who presented with worsening dyspnea was transferred to our hospital due to congestive heart failure with multiple organ dysfunction. Echocardiogram showed severe left ventricular systolic dysfunction and a huge thrombus in the left ventricle. An urgent operation was performed to remove the thrombus simultaneously with the placement of bilateral extracorporeal ventricular assist devices. After the operation, despite a rapid improvement in the liver function, renal dysfunction persisted and he remained anuric for nearly a month. We continued maximal circulatory support with biventricular assist device to optimize his end-organ function. His renal function gradually improved, allowing him to be registered as a heart transplant candidate on the 140th postoperative day. On the 146th postoperative day, the patient underwent successful removal of the right ventricular assist device, and the left extracorporeal device was replaced by an implantable device (HeartMate II). He was discharged 78 days after the implantation. We present here a case where adequate support with biventricular assist device enabled a successful bridge to transplantation even in a patient with end-stage heart failure having end-organ dysfunction.</p>

Survival on biventricular mechanical support with the Centrimag® as a bridge to decision: a single-center risk stratification.

OBJECTIVE: Temporary mechanical assist devices are increasingly being used as a lifesaving bridge to decision in patients requiring cardiopulmonary resuscitation. We report our single-center experience with biventricular Centrimag® pumps over a five-year period. METHOD: Data was retrospectively collected in consecutive patients who required biventricular support from 2008 to 2013. Patients who were supported with central cannulation using the Centrimag® system were analyzed. In addition to demographic information, data pertaining to indications, outcomes and mortality were collected. RESULTS: The cohort consisted of 48 patients (19 women and 29 men, mean age of 56 years). The median duration of support was 14 days. The median duration to patient expiration while still on the Centrimag® was 12 days. Thirty-day survival was 56% (27/48). Nine patients were explanted to recovery, while fourteen patients were converted to a durable LVAD, two of whom were then transplanted. We stratified patients into two groups. Group I comprised patients who were either explanted to recovery, converted to durable LVAD or transplanted (23/48) and Group II consisted of patients who either died on the Centrimag® or were explanted for withdrawal of care (25/48). Statistical analysis did not reveal any clinically significant differences between the two groups in terms of age, sex, etiology, hemodynamic, co-morbidities or laboratory parameters. CONCLUSION: The biventricular Centrimag® can be used as a bridge to decision in patients with thirty-day survival of >50%. Parameters to predict 30-day survival in this high-risk cohort continue to remain elusive.