The Berlin Heart EXCOR Pediatrics—The SickKids Experience 2004–2008

The ventricular assist device (VAD) Berlin Heart EXCOR Pediatrics was utilized at our institution since 2004 for bridging pediatric patients to cardiac transplantation or myocardial recovery. The present study reviewed our results following VAD implantation. We retrospectively reviewed patients that underwent implantation of a VAD between October 2004 and October 2008. Data collected included age at implantation, gender, weight, underlying disease, pre‐ and postdevice clinical status, complications, and outcome. Fifteen patients were identified (9 female and 6 male, average age: 8.8 years, range 0.3–14.8; average weight 31.1 kg, range 5.2–86.4). Indications for VAD support were dilated cardiomyopathy in 14 patients and progressing heart failure with a single ventricle physiology (bidirectional Glenn shunt) in one patient. Three patients (20%) were bridged from extracorporeal membrane oxygenation to VAD. Average support was 29 (1–108) days. Fourteen patients were on a bi‐VAD, one patient (single ventricle) had single VAD support. Three patients developed mediastinal/pericardial fluid collections, requiring surgical exploration in two, and drain insertion in one. Three patients presented with neurological symptoms. In two patients, a total of three blood pumps were exchanged due to thrombus formation. No patient was weaned off the VAD; two patients (13%) died on the VAD. All surviving patients are neurologically intact at follow‐up. In our experience, VAD support provides an effective means of bridging children with advanced dilated cardiomyopathy or heart failure to transplantation with a relatively small number of complications and deaths given the complexity of the patient population.     

Complication Profile of the Berlin Heart EXCOR Biventricular Support in Children

In chronic cardiomyopathy, mechanical circulatory support (MCS) plays an increasingly important role for children as the shortage of suitable donor hearts increases waiting time on the transplant list. We report our experience with the paracorporal Berlin Heart EXCOR System (Berlin Heart AG, Berlin, Germany) used as a biventricuclar assist device (BVAD). Nine patients with a BVAD EXCOR system were treated between 2006 and 2012; out of these patients, four were less than 18 years old (6, 14, 14, and 17 years old). Their diagnoses were postcardotomy failure (n = 1), dilatative cardiomyopathy (n = 2), and terminal heart failure (n = 1). Overall survival, waiting time for heart transplantation (HTx) and complication profile for the BVAD were analyzed retrospectively. Thirty days' mortality was 25% (n = 1). One child died after 84 days on support due to cerebral bleeding. Mean support time was 218.75 days (4, 84, 262, and 525 days). Pump chamber exchange was necessary three times due to pump chamber thrombosis (n = 2) and partial pump chamber membrane rupture (n = 1). Complications included: sepsis (n = 1), drive line infection requiring intravenous antibiotics (n = 2), and recurrent epistaxis (n = 3). Two children were successfully transplanted after 262/525 days on BVAD; they are currently at home (follow‐up: 1.9 and 2.3 years). The EXCOR is a life‐saving MCS system suitable for long‐term paracorporeal biventricular assistance.     

Mechanical Circulatory Assistance in Children: Clinical Outcome

BackgroundIn countries where organ donation is scarce, mortality in the pediatric heart transplant waiting list is high, and ventricular assist devices (VADs) are therapeutic alternatives in these situations. Berlin Heart EXCOR is currently 1 of the few VADs specific for children.MethodsThis retrospective study includes pediatric patients who underwent Berlin Heart EXCOR placement in a Brazilian hospital between 2012 and 2021. Clinical and laboratory data at the time of VAD implantation and the occurrence of complications and outcomes (success as a bridge to transplant or death) were analyzed.ResultsEight patients, from 8 months to 15 years, were included: 6 with cardiomyopathy and 2 with congenital heart disease. Six were on Intermacs 1 and 2 on Intermacs 2. The most common complications observed were stroke and right ventricular dysfunction. Six were transplanted, and 2 died. Those submitted to transplant had a higher mean weight than those who died, with no statistically significant difference. The underlying disease had no impact on the outcome. The group undergoing transplant had lower brain natriuretic peptide and lactate values, but no laboratory variable showed a statistically significant difference in the outcome.ConclusionA VAD is an invasive treatment with potentially serious adverse effects and is still poorly available in Brazil. However, as a bridge to transplant, it is a useful treatment for children in progressive clinical decline. In this study, we did not observe any clinical or laboratory factor at the time of VAD implantation that implied better outcomes.     

Ventricular assist device as a bridge to heart transplantation in adults

Background

Because of the shortage of donor hearts, various ventricular asist devices (VAD) have been used in decompensated patients to prolong patient survival until a suitable heart becomes available. In this paper, we present our single-center report of adult patients in whom bridging was used with VAD.

Methods

We performed a retrospective review of 14 adult patients who underwent heart transplantation after insertion of a long-term VAD. The study spans from February 2006 until September 2010. The mean patient age was 44.28 ± 11.06 years. We used the Berlin Heart EXCOR VADs (n = 11; Berlin Heart AG Berlin, Germany), or the Berlin Heart Incor (n = 2), or the Abiomed AB500 (n = 1). Preimplantation status of the subjects were critical cardiogenic shock (n = 6), deterioration on inotropes (n = 3), or stable but inotrope-dependent (n = 5).

Results

Mean VAD support time was 153.71 days (range, 25-517). Major adverse events during VAD support included reexploration for bleeding (n = 3; 21.4%), neurologic events (n = 2; 14.3%), left VAD-related infection (n = 2; 14.3%), pneumonia (n = 1; 14.3%), or primary device failure (n = 1; 7.1%). One (7.1%) patient showed evidence of human leukocyte antigen sensitization. There were 2 deaths (14.3%) over a mean of 324 days follow-up after heart transplantation: One due to biventricular failure in the early postoperative period and the other, at 69 days from pneumonia. Rejection was observed in 2 patients who had International Society for Heart and Lung Transplantation grade 2R without hemodynamic deterioration. In our series, the 1-year mortality was 14.4% among heart transplantations without VAD implantation and 14.2% among the bridge-to-transplantation group.

Conclusion

We conclude that VAD implantation improved end-organ function before heart transplantation in critically ill patients.     

Fundus Fluorescein Angiographic Findings in Patients Who Underwent Ventricular Assist Device Implantation

Disruption of microcirculation in various tissues as a result of deformed blood rheology due to ventricular assist device (VAD) implantation causes novel arteriovenous malformations. Capillary disturbances and related vascular leakage in the retina and choroidea may also be seen in patients supported by VADs. We aimed to evaluate retinal vasculature deteriorations after VAD implantation. The charts of 17 patients who underwent VAD implantation surgery for the treatment of end‐stage heart failure were retrospectively reviewed. Eight cases (47.1%) underwent pulsatile pump implantation (Berlin Heart EXCOR, Berlin Heart Mediprodukt GmbH, Berlin, Germany); however, nine cases (52.9%) had continuous‐flow pump using centrifugal design (HeartWare, HeartWare Inc., Miramar, FL, USA). Study participants were selected among the patients who had survived with a VAD for at least 6 months, and results of detailed ophthalmologic examinations including optic coherence tomography (OCT) and fundus fluorescein angiography (FA) were documented. All of the 17 patients were male, with a mean age of 48.5 ± 14.8 years (15–67 years). Detailed ophthalmologic examinations including the evaluation of retinal vascular deteriorations via FA were performed at a mean of 11.8 ± 3.7 months of follow‐up (6–18 months). Mean best‐corrected visual acuity and intraocular pressure were found as logMAR 0.02 ± 0.08 and 14.6 ± 1.9 mm Hg, respectively in the study population. Dilated fundoscopy revealed severe focal arteriolar narrowing in two patients (11.8%), and arteriovenous crossing changes in four patients (23.5%); however, no pathological alteration was present in macular OCT scans. In patients with continuous‐flow blood pumps, mean arm‐retina circulation time (ARCT) and arteriovenous transit time (AVTT) were found to be 16.8 ± 3.0 and 12.4 ± 6.2 s, respectively; whereas those with pulsatile‐flow blood pumps were found to be 17.4 ± 3.6 and 14.0 ± 2.1 s in patients (P = 0.526 and P = 0.356, respectively). FA also revealed a tendency for increased frequency of dye leakage from the optic disc in our study population. Except for remarkable delays in both ARCT and AVTT as well as a tendency for increased frequency of dye leakage from the optic disc, ophthalmologic evaluations revealed no other significant pathology or vascular deterioration in the retina that could be attributed to artificial heart systems.     

The profile of the systemic inflammatory response in children undergoing ventricular assist device support

OBJECTIVES Serum C-reactive protein (CRP) has been used as a systemic inflammatory response (SIR) marker in the critical ill, including children after cardiopulmonary bypass surgery. Ventricular assist devices (VAD) have been increasingly used as a bridge support to heart transplantation in children. We aimed to examine the profiles of CRP in children receiving VAD support. METHODS Charts of 13 children receiving Berlin Heart EXCOR(?) from 2005 to 2009 were reviewed. The data obtained prior to and during VAD support included: CRP, white blood cells, inotropes and steroid use, VAD mode and duration of VAD support. Ten patients received left VAD (LVAD) and 3 biventricular VAD (BiVAD). RESULTS The median duration of VAD support was 59 days (ranged 3-678 days). Pre-VAD CRP was 35?±?51?mg/l and increased to 109?±?59?mg/l on days 1-3 after the VAD implantation (P?=?0.01), then gradually decreased to 28?±?28?mg/l by 4 months and normalized by 5 months (P?相似文献   

Management of Deep Wound Complications With Vacuum‐Assisted Therapy After Berlin Heart EXCOR Ventricular Assist Device Placement in the Pediatric Population

Wound complications after ventricular assist device (VAD) placement remain a formidable challenge to surgeons. The Berlin Heart EXCOR VAD is a versatile pulsatile system that has been successful in pediatric patients of all ages and sizes. Prevention of device‐related complications such as infection, particularly in pediatric patients, remains an essential issue in minimizing patient morbidity and mortality. The introduction of vacuum‐assisted wound closure (VAC) therapy and its application in VAD‐related wound complications provide an efficient and effective method for wound healing. We report our experience in the management of deep wound complications in two pediatric patients after placement of the Berlin Heart EXCOR VAD. The wound VAC system proved to achieve complete wound healing without any infectious complications.     

HeartWare Ventricular Assist Device Implantation for Pediatric Heart Failure—A Single Center Approach

While pediatric HeartWare HVAD application has increased, determining candidacy and timing for initiation of pediatric VAD support has remained a challenge. We present our experience with a systematic approach to HVAD implantation as a bridge to pediatric heart transplantation. We performed a retrospective, single center review of pediatric patients (n = 11) who underwent HVAD implantation between September 2014 and January 2018. Primary endpoints evaluated were survival to heart transplantation, need for right ventricular assist device (RVAD) at any point, ongoing HVAD support, or death. Median patient age was 11 years (range: 3–16). Median BSA was 1.25 m² (range: 0.56–2.1). Heart failure etiologies requiring support were dilated cardiomyopathy (n = 8), myocarditis (n = 1), congenital mitral valve disease (n = 1), and single ventricle heart failure (n = 1). Median time from cardiac ICU admission for heart failure to HVAD placement was 15 days (range 3–55), based on standardized VAD implantation criteria involving imaging assessment and noncardiac organ evaluation. The majority of patients (91%) were INTERMACS Level 2 at time of implant. Three patients (27%) had CentriMag RVAD placement at time of HVAD implantation. Two of these three patients had successful RVAD explanation within 2 weeks. Median length of HVAD support was 60 days (range 6–405 days). Among the 11 patients, survival during HVAD therapy to date is 91% (10/11) with 9 (82%) bridged to heart transplantation and one (9%) continuing to receive support. Posttransplant survival has been 100%, with median follow‐up of 573 days (range 152–1126). A systematic approach to HVAD implantation can provide excellent results in pediatric heart failure management for a variety of etiologies and broad BSA range.     

Outcomes With Ventricular Assist Device Versus Extracorporeal Membrane Oxygenation as a Bridge to Pediatric Heart Transplantation

Extracorporeal membrane oxygenation (ECMO) has long been the sole means of mechanical support for pediatric patients with end‐stage cardiac failure, but has a high waitlist mortality and a reported survival to hospital discharge of less than 50%. The purpose of this study was to compare waitlist mortality and survival for ECMO versus ventricular assist device (VAD) support. A review was conducted of all patients listed for heart transplantation (HTx) since 2002 and requiring mechanical support. VAD support has been available from 2004 (Berlin Heart Excor Pediatrics). Competing risks analysis was used to model survival to one of four outcomes (HTx, death on waitlist, delisting, improvement). Thirty‐six patients were on mechanical support while awaiting HTx (21 ECMO, 12 VAD, three both). Median age at listing was 1.2 years (birth–16.6 years) for ECMO and 11.3 years (0.3–14.6 years) for VAD. Diagnosis was cardiomyopathy in 33% for ECMO and 93% for VAD. Median time to HTx was 37 days (1–930) overall, 20 days (1–85) for ECMO, and 39 days (5–108) for VAD. Mechanical support was associated with increased odds of HTx (hazard ratio [HR] 2.4 [1.7–3.3], P < 0.0001) but also delisting or death waiting (HR 3.0 [1.1–7.8], P = 0.03). Waitlist mortality of 38% on ECMO was reduced to 13% with VAD use. Survival post‐HTx to hospital discharge was better in the group on VAD support (92 vs. 80%). Pediatric patients requiring mechanical support as a bridge to HTx have short wait times but high waitlist mortality. Those patients who survived to be put on the Berlin Heart Excor Pediatric device based on individualized clinical decision making then had a lower waitlist mortality, a longer duration of support, and a higher survival to transplantation and hospital discharge.     

Survival Results After Implantation of Intrapericardial Third‐Generation Centrifugal Assist Device: An INTERMACS‐Matched Comparison Analysis

Reports on third‐generation centrifugal intrapericardial pumps (HeartWare International, Inc., Framingham, MA, USA) have shown better survival results than the previous‐generation devices. However, outcomes depending on the preoperative level of stability can substantially differ, resulting in a limited analysis of potentialities and drawbacks of a given device. In the present study we sought to compare in our single‐center experience the survival results of this third‐generation device with previous left ventricular systems taking into account the different preoperative Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels. Between February 1993 and March 2012, 287 patients underwent assist device implantation in our university hospital (INTERMACS Level 1‐2 = 158 patients; INTERMACS Level 3‐4‐5 = 129 patients). Assist devices implanted were: Group A (HVAD HeartWare, n = 52), group B (previous continuous‐flow ventricular assist device [VAD], InCor [Berlin Heart, Berlin, Germany], n = 37; VentrAssist [VentraCor, Inc., Chatswood, NSW, Australia], n = 7; DeBakey [MicroMed Cardiovascular, Inc., Houston, TX, USA], n = 32), and group C (pulsatile systems, n = 159). After cumulative support duration of 54 436 days and a mean follow‐up of 6.21 ± 7.46 months (range 0–45.21 months), log‐rank analysis revealed a survival for group A of 82.0%, 70.4%, and 70.4%; for group B of 84.0%, 48.2%, 33.7%; and for group C of 71.6%, 46.1%, 33.8%, at 1, 12, and 24 months respectively, with a significantly (P = 0.013) better outcome for group A. When stratifying the survival on the basis of INTERMACS level, no significant survival improvement was observed among all patients who underwent VAD implantation in INTERMACS 1‐2 (P = 0.47). However, among patients who underwent elective VAD implantation (INTERMACS 3‐4‐5), group A had a significantly better outcome (P = 0.005) compared with the other INTERMACS‐matched groups (B,C) with a survival rate of 88.8% in group A versus 34.2% in group B and 45.6% in group C at 24 months, respectively. Elective HVAD system implantation shows improved survival benefit over the other INTERMACS‐matched devices. Moreover, preoperative unstable hemodynamics resulted in a poor prognosis independently from the pump generation.     

Anesthetic management of children with in situ Berlin Heart EXCOR™

Modern mechanical devices can support children with severely impaired cardiac function until a donor heart is found for transplantation or native function recovers. Pediatric heart transplantation offers a good chance of survival with a high quality of life to individuals with limited life expectancy and/or severe limitation to daily activities, but many die on the transplant list or are not listed because of a shortage of donor organs. In recent cohorts, there is better outcome when ventricular assist devices (VADs) rather than extracorporeal membrane oxygenation are used as a ‘bridge’ to transplantation. Anesthesiologists working in centers where VADs are available may increasingly be asked to provide anesthesia to children with such devices in situ, including procedures outside the cardiac surgical operating room. The Berlin Heart EXCOR? device is a VAD system with increasing popularity in pediatric practice and has system components available in sizes suitable even for neonates. Postimplantation considerations include hemodynamics, thromboembolic complications and their prevention by anticoagulation, antimicrobial therapy, and the rehabilitation and mobilization of recipients. VAD‐specific emergencies must be recognized and managed appropriately by anesthesiologists looking after Berlin Heart recipients. These include malignant dysrhythmias, sudden loss of VAD output, air or clot embolism, and sudden cyanosis. Provision of anesthesia for patients with an in situ Berlin Heart requires attention to particular considerations in preoperative assessment, induction, maintenance, and postoperative care.     

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.     

Ventricular assist device support in children and adolescents with heart failure: the Children's Medical Center of Dallas experience

Children with heart failure unresponsive to medical therapy are left with few options for survival. Ventricular assist devices (VADs) are life-saving options for such patients, allowing for bridge to transplantation or cardiac recovery. Retrospective review of cases from May 2006 to October 2010 was undertaken. Fourteen patients underwent implantation of VADs for refractory heart failure. Mean age was 9 years (range 1-17 years), and weight was 41 kg (range 9.7-71 kg). Indications for support: end-stage cardiomyopathy (n = 8), myocarditis (n = 3), univentricular failure (n = 2), and congenital heart disease/postcardiotomy (n = 1). Level of limitation at time of implant included critical cardiogenic shock in six (43%) and progressive decline in eight (57%). Extracorporeal membrane oxygenation was used as a bridge to VAD in five (36%) patients. Preimplant variables: 86% of patients requiring mechanical ventilation (mean 10.3 days), hyperbilirubinemia in 75%, and acute renal insufficiency in 79%. Device selection was systemic VAD in 11 (79%) and biventricular assist device in three (21%). Berlin Heart EXCOR was used in eight patients, while six patients received a Thoratec implantable VAD or paracorporeal VAD. Mean duration of support was 68 days (range 8-363 days). Overall survival was 79%. Ten patients (71%) were successfully bridged to transplantation, three (21%) died while on a device, one remains on support, and no patients were weaned from VAD. Children supported for single ventricle heart failure had a 50% survival with none currently bridged to transplantation. Complications included bleeding requiring reoperation in 21% (n = 3), stroke in 29% (n = 4), and driveline infections in 7% (n = 1). In two patients, a total of six pump exchanges were performed for thrombus formation. Survival for pediatric patients of all ages is excellent using current device technology with a majority of patients being successfully bridged to transplantation. Morbidity is acceptably low considering the severity of illness. Significant challenges exist with long-term extracorporeal support due to lack of donor availability and the high incidence of preformed alloantibodies especially in the failing single ventricle.     

The Impact of Pretransplantation Urgency Status and the Presence of a Ventricular Assist Device on Outcome After Heart Transplantation

Introduction

There are conflicting reports on the posttransplantation morbidity and mortality of patients listed urgently and/or supported by a ventricular assist device (VAD). The aim of this study was to analyze the outcomes with regard to pretransplantation condition (elective, urgent, VAD).

Methods

All adult recipients between January 1, 2005, and October 31, 2012, were included. Demographics; preoperative, operative, and postoperative data; outpatient follow-up; and donor characteristics were collected and analyzed.

Results

Of a total of 74 patients, 19 were listed urgently, 20 had a Berlin Heart EXCOR BVAD (biventricular assist device) (Berlin Heart, Berlin, Germany) (8 urgent), 7 had a Berlin Heart INCOR left VAD (Berlin Heart, Berlin, Germany) (2 urgent), and 2 had a HeartWare left VAD (HeartWare International, Framingham, Mass, USA) (none urgent). Mean age was 52 ± 12years. The overall 30-day, 1-year, and 3-year survival was 90% ± 3%, 79% ± 5%, and 66% ± 7%. There was no difference in survival when comparing urgently listed (95% ± 5%, 84% ± 8%, 74% ± 12%) and elective patients (89% ± 4%, 77% ± 6%, 63% ± 8%; P = .4), and VAD patients (86% ± 6%, 76% ± 8%, 63% ± 11%) and those without mechanical support (93% ± 4%, 81% ± 6%, 69% ± 9%; P = .6). In-hospital outcomes and long-term complications were also comparable.

Conclusions

Our series suggests that urgent patients and patients on a VAD have a posttransplantation outcome comparable to elective patients and patients without a VAD. These data support the effectiveness of the current practice of listing for heart transplantation.     

Surgical therapy of end-stage heart failure in pediatric patients

Objective

We herein review our experience with ventricular assist device (VAD) implantation and heart transplantation in children with end-stage heart failure.

Methods

We performed a retrospective nonrandomized review of all patients who underwent insertion of a Berlin Heart Excor VAD or heart transplantation in our clinic. The study spans from July 2005 to July 2010. We transplanted 11 patients of mean age 11.8 ± 4.49 years, 3 of whom with critical hemodynamic situations were bridged to heart transplantation by VAD implantation. Despite the poor right ventricular systolic functions, they did not require right rVAD. In addition, 2 patients who underwent VAD implantation are still awaiting a donor heart. The mean follow-up was 825.27 ± 630.23 days (range, 21-1,888 days).

Results

There was no serious complication during VAD support. The overall heart transplantation mortality rate was 9.1% (1/11). In all patients, impaired end-organ functions were improved by VAD implantation before the heart transplantation. Cardiac biopsies revealed 4 grade 2R rejection episodes, which were successfully controlled in 3 patients.

Conclusion

Heart transplantation is highly effective therapy for pediatric patients with end-stage heart failure. Pediatric VAD implantation provided satisfactory safe circulatory support for small children in poor condition on the waiting list. This option should be considered for all pediatric candidates who show a poor hemodynamic status.     

Mechanical heart support at the Deutsches Herzzentrum Berlin: Recent developments (2011)

Since the inception of the mechanical circulatory support (MCS) program at the Deutsches Herzzentrum Berlin (DHZB) in 1987, more than 1600 patients have received support with 18 different designs of technical blood pump systems, in accordance with the respective state of the art. At the beginning, pulsatile pneumatic extracorporeal ventricular assist devices (VAD) and implantable pneumatic total artificial hearts (TAH) were available, followed by pulsatile electromechanical implantable devices. At this time the assist program was based on three objectives: bridging to recovery, bridging to heart transplantation (HTx) and for permanent support. Very soon (in 1995) patients of advanced age – over 65 years – were included in the program. In 1998 rotary blood pumps with continuous flow entered the program, from 2006 edging out step by step the pulsatile systems. Today the implantable pulsatile systems have disappeared from the DHZB program, with the exception of the extracorporeal uni‐ or biventricular pneumatic EXCOR systems (Berlin Heart GmbH), which are the only systems available for newborns and children. The only approved total artificial heart is the CardioWest device, implanted in rare cases after explantation of the natural heart. Miniaturized rotary blood pumps, axial flow turbines or centrifugal radial flow pumps are leading today's market. The size and configuration of one of these pumps, the hydrodynamically and magnetically levitated HeartWare HVAD, allowed its application as a biventricular implantable assist device. The worldwide first clinical implantation of this system was performed at the DHZB in 2009. With the increasing number of patients needing immediate circulatory support and the stagnating or even decreasing number of donor hearts available for HTx, the extreme discrepancy means that other therapies are gaining increasing importance. The objectives of the MCS program therefore had to focus on permanent VADs, thus creating a growing population of long‐term outpatients with implanted systems, living with their families a near‐normal life. Within a quarter century VAD implantation has grown from an experimental procedure into an established and generally accepted therapy. Facing the rapidly increasing population of patients with end‐stage heart failure and the stagnating number of heart transplants, the use of VAD technology may represent the most advanced progress in cardiac care in the coming years. Further minaturization of the devices will allow the treatment of patients with a wide age spectrum, from newborn children to the elderly, even with biventricular support. The ultimate goal will be the development of a durable total artificial heart, based on the rotary blood pump technology, with transcutaneous energy transfer through the intact skin, guaranteeing the patients optimal quality of life for many years of support.     

Pulsatile mechanical cardiac assistance in pediatric patients with the Berlin heart ventricular assist device

Mechanical cardiac assistance for neonates, infants, children and adolescents may be accomplished with pulsatile ventricular assist devices (VAD) instead of extracorporeal membrane oxygenation or centrifugal pumps. The Berlin Heart VAD consists of extracorporeal, pneumatically driven blood pumps for pulsatile univentricular or biventricular assistance for patients of all age groups. The blood pumps are heparin-coated. The stationary driving unit (IKUS) has the required enhanced compressor performance for pediatric pump sizes. The Berlin Heart VAD was used in a total number of 424 patients from 1987 to November 2001 at our institution. In 45 pediatric patients aged 2 days-17 years the Berlin Heart VAD was applied for long-term support (1-111 days, mean 20 days). There were three patient groups: Group I: "Bridge to transplantation" with various forms of cardiomyopathy (N = 21) or chronic stages of congenital heart disease (N = 9); Group II: "Rescue" in intractable heart failure after corrective surgery for congenital disease (N = 7) or in early graft failure after heart transplantation (N = 1); and Group III: "Acute myocarditis" (N = 7) as either bridge to transplantation or bridge to recovery. Seventeen patients were transplanted after support periods of between 4 and 111 days with 12 long-term survivors, having now survived for up to 10 years. Five patients (Groups I and III) were weaned from the system with four long-term survivors. In Group II only one patient survived after successful transplantation. Prolonged circulatory support with the Berlin Heart VAD is an effective method for bridging until cardiac recovery or transplantation in the pediatric age group. Extubation, mobilization, and enteral nutrition are possible. For long-term use, the Berlin Heart VAD offers advantages over centrifugal pumps and ECMO in respect to patient mobility and safety.     

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.     

Ventricular Assist Device in Single‐Ventricle Heart Disease and a Superior Cavopulmonary Anastomosis

Our objective is to describe the use of a ventricular assist device (VAD) in single‐ventricle patients with circulatory failure following superior cavopulmonary anastomosis (SCPA). We performed a retrospective chart review of all single‐ventricle patients supported with a VAD following SCPA. Implantation techniques, physiologic parameters while supported, medical and surgical interventions postimplant, and outcomes were reviewed. Four patients were supported with an EXCOR Pediatric (Berlin Heart Inc., The Woodlands, TX, USA) following SCPA for a median duration of 10.5 days (range 9–312 days). Selective excision of trabeculae and chords facilitated apical cannulation in all patients without inflow obstruction. There were two pump exchanges in the one patient supported for 312 days. Two patients were evaluated by cardiac catheterization while supported. Three of four patients were successfully bridged to transplantation. One patient died while supported. All patients had significant bleeding at the time of transplantation, and one required posttransplant extracorporeal membrane oxygenation with subsequent full recovery. VAD support can provide a successful bridge to transplantation in patients with single‐ventricle circulation following SCPA. A thorough understanding of the challenges encountered during this support is necessary for successful outcomes.     

Ventricular assist device in patients with prosthetic heart valves

Ventricular assist device (VAD) support inpatients with a prosthetic heart valve had previously been considered a relative contraindication due to an increased risk of thromboembolic complications. We report our clinical experience of VAD implantation in patients with prosthetic heart valves, including both mechanical and bioprosthetic valves. The clinical records of 133 consecutive patients who underwent VAD implantation at a single institution from January 2002 through June 2009 were retrospectively reviewed. Six of these patients had a prosthetic valve in place at the time of device implantation. Patient demographics,operative characteristics, and postoperative complications were reviewed.Of the six patients,four were male.The mean age was 57.8 years (range 35–66 years). The various prosthetic cardiac valves included a mechanical aortic valve (n = 2), a bioprosthetic aortic valve (n = 3), and a mechanical mitral valve (n = 1).The indications for VAD support included bridge to transplantation (n = 2), bridge to recovery (n = 1), and postcardiotomy ventricular failure(n = 3). Three patients underwent left ventricular assist device placement and three received a right ventricular assist device. Postoperatively, standard anticoagulation management began with a heparin infusion (if possible)followed by oral anticoagulation.The 30-day mortality was50% (3/6). The mean duration of support among survivors was 194.3 days (range 7–369 days) compared with 16.0 days(range 4–29 days) for nonsurvivors. Of the three survivors,two were successfully bridged to heart transplantation and one recovered native ventricular function.Among the three nonsurvivors,acute renal failure developed in each case, and two developed heparin-induced thrombocytopenia. This study suggests that VAD placement in patients with a prosthethic heart valve, either mechanical or bioprosthetic,appears to be a reasonable option.