Technology and technique for left ventricular assist device optimization: A Bi-Tech solution.

BACKGROUND: We investigated the synergistic effect of the new cone-bearing design of Jarvik 2000 (Jarvik Heart Inc., NY) together with a minimally-invasive approach to outcomes of LVAD patients. METHODS: We retrospectively reviewed all patients from 5 institutions involved in the Jarvik 2000 Italian Registry, from October 2008 to October 2016. Patients were divided into three groups according to pump design and implantation technique: pin-bearing design and conventional approach (Group 1); cone-bearing and conventional approach (Group 2); cone-bearing and minimally-invasive implantation (Group 3). RESULTS: A total of 150 adult patients with end-stage heart failure were enrolled: 26 subjects in Group 1, 74 in Group 2, and 50 in Group 3. Nineteen patients (73%) in Group 1, 51 (69%) in Group 2, and 36 (72%) in Group 3 were discharged. During follow-up, 22 patients underwent transplantation, while in 3 patients the LVAD was explanted. The overall 1-year survival was 58 ± 10%, 64 ± 6%, and 74% ± 7% in Groups 1, 2, and 3, respectively (p = 0.034). The competing-risks-adjusted cumulative incidence rate for adverse events was 42.1 [27-62.7] per 100 patient-years in Group 1, 35.4 [25.3-48.2] in Group 2, and 22.1 [12.4-36.4] in Group 3 (p = 0.046 for Group 1 vs. 3). CONCLUSIONS: The association of the modern cone-bearing configuration of Jarvik 2000 and minimally invasive surgery improved survival and minimized the risk for cardiovascular events, as a result of combining technology and technique.

Performance of the Jarvik 2000 left ventricular assist device on mid-term hemodynamics and exercise capacity.

The hemodynamic and exercise capacity performance of the Jarvik 2000 left ventricular assist device (LVAD), which is generally used in patients with small body size and relatively preserved cardiac function, is not well understood. We retrospectively examined 18 patients implanted with the Jarvik 2000 LVAD. Pump rotation speed was optimized by the hemodynamic ramp test one year after implantation based on the criteria of mean pulmonary capillary wedge pressure (PCWP) < 18 mmHg, mean right atrial pressure (RAP) < 12 mmHg, and cardiac index (CI) > 2.2 L/min/m2 as well as echocardiographic parameters. Exercise capacity was assessed by cardiopulmonary exercise test in an optimized setting. To investigate the impacts of larger body surface area (BSA) and extremely impaired pre-implantation cardiac function on hemodynamics and exercise capacity, two correlation analyses based on BSA and original CI were performed. At a pump speed of 9500 ± 707 rpm, the mean pulmonary artery pressure, PCWP, RAP, and CI were 17 ± 5 mmHg, 9 ± 5 mmHg, 6 ± 4 mmHg, and 2.82 ± 0.54 L/min/m2, respectively. Only one patient failed to achieve the hemodynamic criteria. The peak VO2 and VE/VCO2 slope were 12.9 ± 3.1 mL/min/kg and 37.7 ± 15.0, respectively. There was an inverse correlation between original CI and heart rate (r = -0.60, p = 0.01), and a weak correlation between BSA and PCWP (r = 0.43, p = 0.08). Based on this study, the overall performance of the Jarvik 2000 device was acceptable, and the patients' body size and original cardiac function had minimum effect on the performance of this device.

A modified surgical technique for the Jarvik 2000 using a postauricular approach.

The Jarvik 2000, with a postauricular cable, is a left ventricular assistance device with a driveline that is passed to the postauricular region subcutaneously. A titanium pedestal base that holds a 3-pin connector is fixed to the parietal bone, posterior to the auricle. Essentially, the device is fixed in the same position as a cochlear implant; however, the disadvantages include continuous mechanical stress on the cable by neck rotations, and the visibility of the apparatus. To improve such concerns, we adjusted the location of the pedestal of the lower parietal bone to just above the transverse sinus and closer to the mastoid process. To reach this point, the internal cable was passed through the retromastoid pathway commonly used in ventriculoperitoneal shunting. The thickness of the skull at this location is sufficient for safe fixation; however, preoperative evaluation by a neurosurgeon using CT is necessary.

Jarvik 2000 with postauricular cable as destination therapy: first clinical case in Japan.

Currently in Japan, a left ventricular assist device powered by an abdominal driveline is the only type of left ventricular assist device available. The driveline is vulnerable to infection secondary to inappropriate fixation and the traditional Japanese custom of bathing is prohibited in patients with an abdominal driveline. The Jarvik 2000 with postauricular cable is a left ventricular assist device in which the driveline exits the body behind the ear (postauricular) instead of exiting through an abdominal site. This case report is the first to describe the implantation of Jarvik 2000 with postauricular cable as destination therapy in a Japanese patient. This device enables patients to take a bath and may reduce the incidence of driveline infection.

Effects of high-energy photon beam radiation therapy on Jarvik 2000 LVAD: in vitro evaluation.

PURPOSE: Left ventricular assist device (LVAD) is considered a standard care for patients with advanced heart failure. The aim of this work was to study in vitro the effects of direct exposure of the Jarvik 2000 LVAD to 10-MV photon beams. METHODS: Jarvik 2000 pump was immersed in a siliconized box filled with deionized water. A 30 × 30 × 15 cm RW3 slabs were added forth and back to the box. A treatment plan consisting of a single direct 10 × 10 cm2 field size beam was used to deliver 1000 MU at the center of the pump. During irradiation, the external Flow Maker controller and the lithium battery were positioned away from the beam. Pump parameter data (included voltage, current and frequency) were measured, recorded and analyzed for changes in pump function among baseline, pre-irradiation, during irradiation, post-irradiation and after 6 months. The whole session lasted 6 months. The Mann-Whitney U test was used to compare the repeated measurements. X-ray radiation attenuation was also studied. RESULTS: The parameters investigated remained stable over the 6 months; that is, no pump stops, alarms, events, operational changes or abnormalities during the discharge rate of the connected power sources, were encountered, confirmed by the Mann-Whitney U test applied to all sessions (p > 0.1). The measured X-ray attenuation differed from the calculated one by TPS by 34%. CONCLUSION: The Jarvik 2000 resulted stable under direct X-ray beam of 10-MV energy. Its strong attenuation, however, can affect dose deposition in the pump in TPS, and it must be taken into account.

Jarvik 2000 axial flow ventricular assist device in right single ventricle after Fontan operation.

We present a case of successful ventricular assist device support in a 13-year-old female diagnosed with right single ventricle, asplenia, dextrocardia, who had undergone a Fontan operation at 4 years old in an associated children hospital. She underwent placement of Jarvik 2000 axial flow ventricular assist device to the morphologic right ventricle which worked as systemic ventricle. The postoperative course was not eventful. She was waiting for heart transplantation attending high school 3 years after implantation.

Therapeutic hypothermia after global cerebral ischemia due to left ventricular assist device malfunction.

Herein we report the case of a patient who suffered from global cerebral ischemia due to pump stoppage of Jarvik2000 Left ventricular assist device (LVAD) for unknown reason and fatal ventricular arrhythmia at home. Cardiopulmonary resuscitation was started by paramedics 6-7 min after the patient fell down. The patient was transferred to our hospital after the restoration of the LVAD function by exchanging external cables. Mild therapeutic hypothermia was induced and body temperature was kept at 33 °C for 24 h. After rewarming, the patient recovered his consciousness without any neurological deficit.

How to implant the Jarvik 2000 post-auricular driveline: evolution to a novel technique.

The post-auricular (PA) driveline positioning for percutaneous power delivery is a specific feature of the Jarvik 2000 FlowMaker LVAD. We applied several technical refinements to optimise the PA implant. Here, we present and discuss these modifications. We retrospectively reviewed all patients implanted with Jarvik 2000 at our Institution. Different PA implant techniques were described. A machine learning analysis was performed to evaluate the determinants of driveline infection. From December 2008 to December 2017, 62 patients were implanted with Jarvik 2000, at our Institution. The PA connection was managed through the "question mark-shaped" incision in 24 patients (39%) and with the "C-shaped" in 18 (29%), whereas 10 (16%) cases received the "vertical incision" and 10 (16%) the "orthogonal incision". The implant technique resulted highly predictive of driveline infection. The rate of driveline infections was numerically lower among cases managed with the last two techniques. After evolving through different implant techniques, we propose and suggest the "orthogonal incision" to maximise the advantages of the Jarvik 2000 post-auricular driveline.

A successful management of infection of the left ventricular assist device by pump exchange: conversion from DuraHeart to Jarvik 2000.

We successfully controlled infection of a left ventricular assist device by performing pump exchange. A 53-year-old man was implanted with DuraHeart for ischemic cardiomyopathy as a bridge to transplantation. Two years later, he was hospitalized with the diagnosis of driveline infection. The blood cultures detected Pseudomonas aeruginosa. During the admission, he developed brain hemorrhage perhaps due to septic emboli. The chest computed tomography scan revealed a small defect inside the outflow graft of the DuraHeart, which was highly suspected of vegetation. He underwent pump exchange, from DuraHeart to Jarvik 2000 with concomitant omentopexy. His postoperative course was uneventful, and he was discharged with no sequela of the brain hemorrhage. Four months after the pump exchange, he successfully underwent heart transplantation. No infectious tissue was observed in the pericardial space at the time of heart transplantation. Pump exchange is an effective way to manage refractory left ventricular assist device infection, and the timing of surgical intervention is of great importance.

Jarvik 2000 axial-flow ventricular assist device placement to a systemic morphologic right ventricle in congenitally corrected transposition of the great arteries.

Few descriptions of the implantation and management of an implantable ventricular assist device in patients with complex congenital heart disease exist in the literature. The Jarvik 2000 axial-flow ventricular assist device (Jarvik Heart, Inc., NYC, NY, USA) can be placed in either the left or the right ventricle. We present the case of a 60-year-old man with congenitally corrected transposition of the great arteries who underwent successful placement of a Jarvik 2000 axial-flow ventricular assist device in a systemic morphologic right ventricle.

Jarvik 2000 pump technology and miniaturization.

Blood-pump miniaturization has made amazing progress, reducing the pump diameter to one-tenth of the size of previous positive displacement pumps. In particular, axial-flow-pump technology allows tiny pumps running at high speeds to deliver from 2 to 10 L/min. A review of the background inventions of the Jarvik 2000 technology is presented, together with the reason that making pumps smaller than demanded by the particular application for which they are designed is counterproductive. Pump miniaturization is nearing its practical limit. The optimization of performance and patient outcomes should remain our primary design goal.

Pump Exchange from a Left Ventricular Assist Device to a Jarvik 2000 with a Postauricular Cable Due to Abdominal Driveline Infection.

Driveline infection in patients with implantable left ventricular assist devices (LVAD) remains common and crucial. Once a driveline exit-site infection reaches the LVAD component, radical treatment such as LVAD exchange may become necessary, although the clinical results are unsatisfactory. The Jarvik 2000 device, which utilizes a postauricular cable, allows the driveline to exit the body behind the ear (postauricular) instead of through an abdominal site. Here, we report the case of a patient who had awaited heart transplantation for more than 6 years and had a critical driveline infection that almost reached the LVAD pump. The patient underwent a pump exchange using the Jarvik 2000 with a postauricular cable, with excellent results. It is a useful replacement option for patients with abdominal driveline infections, owing to its small pump pocket and the availability of an alternative pathway for the driveline.

Dalbavancin as chronic antibiotic suppression therapy for left ventricular assist device driveline infection due to methicillin-resistant Staphylococcus aureus: a case report.

Left Ventricular Assist Devices (LVADs) represent an important therapeutic option in the management of advanced heart failure. We report a case of 74 years-old male with a Jarvik 2000® (Jarvik Heart, New York, USA) LVAD who presented with an infection of the LVAD driveline due to methicillin-resistant Staphylococcus aureus (MRSA) that was treated with dalbavancin as chronic antimicrobial suppression therapy without adverse events and maintaining a good quality of life for more than 37 weeks. Dalbavancin could represent a valid option for the treatment of LVAD infections because of its efficacy, pharmacokinetic/pharmacodynamic proprieties, safety and tolerability.

Surgical repositioning of Jarvik 2000 LVAD power supply pedestal following fall trauma.

Advanced heart failure (HF) is one of the leading causes of mortality and morbidity. With an aging population, its prevalence is expected to rise further. Although orthotopic heart transplantation (HTX) remains the gold standard in therapy, there is a significant deficiency in the ratio of donor organs to recipient patients. Left ventricular assist devices (LVAD) could relieve this problem either as a bridge-to-transplant (BTT) or as a destination therapy (DT). Despite the widespread implantation of ventricular assist devices, their efficacy may be limited by some serious adverse events, while infection is a major issue. A longer period of LVAD support significantly increases the risk of driveline infections (DLI). The Jarvik 2000® ventricular assist device (Jarvik Heart, New York, NY, USA) offers prolonged infection-free survival. In our report, we present the case of a 61-year-old female patient with a driveline pedestal that has become fully detached from the skull following a fall trauma. We describe how the traumatized pedestal was surgically replaced by removing the previous, damaged unit and inserting a repositioned new one. The surgical procedure presented in our case has not been performed before and we have not found any similar one in the literature. It requires individual surgical planning and a multidisciplinary surgeon's team to ensure the procedure is safe and feasible.

Successful Open Chest Epicardial Ablation for Refractory Ventricular Tachycardia in an LVAD Recipient.

A patient with history of dilated cardiomyopathy, a cardiac resynchronization therapy defibrillator, and endocardial ablation presented for refractory ventricular tachycardia 3 years after implantation of a Jarvik 2000 left ventricular assist device (Jarvik Heart, Inc., New York, New York). Open-chest epicardial ablation safely and effectively terminated the arrhythmia, without ventricular tachycardia recurrence at 9-month follow-up and in the absence of complications during the hospital stay. (Level of Difficulty: Advanced.).

The Jarvik 2000 left ventricular assist device as a bridge to transplantation: Japanese Registry for Mechanically Assisted Circulatory Support.

BACKGROUND: The Jarvik 2000 ventricular assist device features a miniaturized intraventricular pump and an intermittent low-speed function that facilitates aortic valve opening. Despite its long history, little is known about the Jarvik device with regard to post-implantation outcomes. METHODS: Prospectively collected data from 13 participating hospitals were extracted from the Japanese Registry for Mechanically Assisted Circulatory Support database to analyze mortality, morbidity and de-novo aortic regurgitation. Data on 83 patients who underwent implantation of the Jarvik 2000 were reviewed. Median support duration was 191 (maximum 758) days. All recipients underwent implantation as a bridge to transplantation. RESULTS: Overall survival proportions at 1 and 2 years were 85.0% and 79.3%, respectively. Nine patients were in INTERMACS Level 1, and 28 patients were on mechanical circulatory support at the time of implantation. Causes of death included stroke, infection and device malfunction. Three patients had their device removed: 2 at the time of heart transplantation and 1 after recovery of the left ventricle. Common adverse events included major bleeding (27.7%), new infection (31.3%), stroke (20.5%) and device malfunction (20.5%). De-novo aortic regurgitation was observed in 17 patients, 6 of whom developed at least moderate regurgitation during follow-up. CONCLUSIONS: Mid-term survival after Jarvik 2000 implantation was satisfactory and comparable to that reported by other national and international registries (INTERMACS and IMACS) for continuous-flow LVADs. De novo aortic regurgitation occurred despite the intermittent low-speed effect of this device, with some recipients experiencing progressive worsening of aortic regurgitation within 2 years post-implantation.

From bench to bedside: Can the improvements in left ventricular assist device design mitigate adverse events and increase survival?

OBJECTIVE: In vitro tests demonstrated that the new cone-bearing configuration of the Jarvik 2000 (Jarvik Heart Inc, New York, NY) left ventricular assist device exhibits better hydraulic efficiency than the previous pin-bearing design. We investigated the long-term outcomes of patients who received the Jarvik 2000 left ventricular assist device, depending on bearing design. METHODS: A retrospective review of prospectively collected data from 18 centers included in the Italian Registry was performed. From May 2008 to September 2013, 99 patients with end-stage heart failure were enrolled. Patients were divided into 2 groups according to their Jarvik 2000 suspending mechanism: Group pin included patients with pin bearings (May 2008 to June 2010), and group cone included patients with newer cone bearings (July 2010 to September 2013). The 2 groups did not differ significantly in terms of baseline characteristics. RESULTS: A total of 30 of 39 patients (group pin) and 46 of 60 patients (group cone) were discharged. During follow-up, 6 patients underwent transplantation, and in 1 patient the left ventricular assist device was explanted. The cumulative incidence competing risk of the entire cohort for noncardiovascular-related death was 28% (20%-40%); the cumulative incidence competing risk for cardiovascular-related death was 56% (42%-73%): 71% in group pin versus 26% in group cone (P = .034). The multivariate analyses confirmed that the pin-bearing design was a risk factor for cardiovascular death, along with Interagency Registry for Mechanically Assisted Circulatory Support class. Right ventricular failures and ischemic and hemorrhagic strokes were significantly higher in group pin. CONCLUSIONS: Patients with the new pump configuration showed a better freedom from cardiovascular death and lower incidence of fatal stroke and right ventricular failure. Further studies are needed to prove the favorable impact of pump-enhanced fluid dynamics on long-term results.

Ventricular assist devices in pediatrics.

The implantation of a mechanical circulatory device for end-stage ventricular failure is a possible therapeutic approach in adult and pediatric cardiac surgery and cardiology. The aim of this article is to present mechanical circulatory assist devices used in infants and children with special emphasis on extracorporeal membrane oxygenation, Berlin Heart assist device, centrifugal pump and Medos assist device. The success of long-term support with implantable ventricular assist devices in adults and children has led to their increasing use as a bridge to transplantation in patients with otherwise non-treatable left ventricular failure, by transforming a terminal phase heart condition into a treatable cardiopathy. Such therapy allows rehabilitation of patients before elective cardiac transplantation (by removing contraindications to transplantation mainly represented by organ impairment) or acting as a bridge to recovery of the native left ventricular function (depending on underlying cardiac disease). Treatment may also involve permanent device implantation when cardiac transplantation is contraindicated. Indications for the implantation of assisted circulation include all states of cardiac failure that are reversible within a variable period of time or that require heart transplantation. This article will address the current status of ventricular assist devices by examining historical aspects of its development, current technical issues and clinical features of pediatric ventricular assist devices, including indications and contraindications for support.