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1.
Artif Organs ; 47(11): 1786-1793, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37649286

RESUMEN

BACKGROUND: As the incidence of heart failure in developed countries is on the rise, mechanical circulatory support (MCS) often remains the only treatment option for patients with end-stage heart failure and is well established worldwide. Even though VAD coordinators play a key role in VAD programs, their responsibilities and daily duties are not clearly defined and characterized. Recently published data from the first 5-year multicenter clinical trial assessing experience with the HeartMate 3 left ventricular system (Abbott, Abbott Park, IL) show an overall survival of 61% at 5 years. When it comes to possible improvements to these systems, it is necessary for developers not only to know the status quo but also to determine and consider the visions and wishes of those individuals who take care of patients, provide education and deal with possible complications. This would be helpful a meaningful effort towards implementing a standard of care. METHODS: To fill this knowledge gap, we conducted an online survey using the SurveyMonkey tool, addressing representatives of programs implanting VADs worldwide. Representatives answered a standardized block of 14 questions and were asked to provide responses within 3 months. RESULTS: A total of 91 VAD coordinators from centers of various regions of the world completed the survey. The majority came from European countries. The numbers of patients followed up by the centers ranged from <20 to 390 patients. The majority of VAD coordinators had a nursing background (68%). Seventy-seven percent of the centers operate a 24-h hotline and 3-monthly visits to the outpatient department are most common. Fifty-nine percent of the centers do not use an infection scoring system for driveline wound care. The majority of the centers indicated that an optimized follow-up concept including wound care, medication, and social care is crucial and the key issue for an improved outcome. Smaller components and intensified psychosocial support ranked highest in questions about how to improve quality of life. Surprisingly, the future prospects of telemetric monitoring were not rated high in significance. CONCLUSIONS: There is a wide variability in the composition and tasks of VAD programs worldwide. Implementing a standard of care and improving psychosocial care as well as equipment is regarded most important to improve outcomes and quality of life. From the point of view of those responsible, the significance of telemetric monitoring seemed overrated.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Corazón Auxiliar/efectos adversos , Calidad de Vida , Insuficiencia Cardíaca/cirugía , Encuestas y Cuestionarios , Europa (Continente) , Resultado del Tratamiento
2.
Artif Organs ; 46(8): 1573-1584, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35230721

RESUMEN

BACKGROUND: Despite numerous design iterations, thrombus formation at the inflow cannula of continuous-flow left ventricular assist devices remains an unsolved problem. We systematically investigated the impact of cannula surface on thrombus formation. METHODS: Thrombus appearance was photographically documented in 177 explanted hearts with the polished (N = 46) or sintered (N = 131) inflow cannula of the Medtronic HeartWare™ HVAD™ System. Thrombus load was compared for both inflow cannula types. Mean thrombus length was correlated with protruding cannula length. Support duration and the extent of thrombus growth were examined. The prevalence of thrombi at the left ventricular entry site and at the sintered-to-polished transition zone was correlated with left ventricular geometry and hemodynamic parameters. RESULTS: Polished inflow cannulas showed a greater percentage and also a greater mean length of thrombus formation at the entry site than sintered cannulas (91.3% [Pol] vs. 36.7% [sTi]; p < 0.0001; mean 7.6 mm vs. 1.9 mm; p < 0.0001). A comparison of the early postoperative period (POD1-90) with long-term support (POD>90) showed an increase in thrombus length originating from the transition zone (1.96 ± 3.41 mm vs. 3.03 ± 2.91 mm; p = 0.013). CONCLUSIONS: A sintered titanium surface at the entry site is crucial to enable anchoring of myocardial tissue to the cannula. As thrombus growth progresses on polished surfaces, a greater sintered length seems to be beneficial. After an initial three-month healing period, thrombus load appears to decline during prolonged support duration at the sintered entry site but not at the transition zone.


Asunto(s)
Corazón Auxiliar , Trombosis , Cánula/efectos adversos , Ventrículos Cardíacos/cirugía , Corazón Auxiliar/efectos adversos , Hemodinámica , Humanos , Trombosis/etiología
3.
Emerg Med J ; 34(12): 831-841, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27852651

RESUMEN

The number of ventricular assist devices (VADs) being implanted for terminal heart failure is rising at an exponential rate. These implanted patients have a decreased mortality, but still have significant morbidities, as the prevalence of these patients increases in the community. When VAD patients are discharged to home, they will very likely require emergency medical services (EMSs) and emergency medical doctors (EDs) with their future care. The interface of these patients with the community would suggest an increasing prevalence of encounters requiring the need for acute medical care. This will place the initial responsibility of these patients in the hands of EMS first responders and emergency room providers. To date, there is very little literature published on out-of-hospital or ED care for VAD patients. Most EMS personnel and ED feel uncomfortable treating a patient with a VAD because they have not had sufficient exposure. The cardiovascular treatment of VAD patients in the field can pose different challenges typically encountered including difficulties measuring a pulse and sometimes undetectable BP. Despite these unique challenges, official guidelines or even standard operating procedures regarding the emergency treatment of VAD patients are still lacking. We present a basic overview of the most commonly used left VAD systems and propose guidelines that should be followed in the event of an emergency with a VAD patient out of hospital.


Asunto(s)
Servicios Médicos de Urgencia , Tratamiento de Urgencia , Insuficiencia Cardíaca/terapia , Corazón Auxiliar , Diseño de Equipo , Humanos , Guías de Práctica Clínica como Asunto
4.
J Card Surg ; 31(12): 765-771, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27766677

RESUMEN

BACKGROUND AND AIM OF THE STUDY: Driveline infections in patients with implantable left ventricular assist devices (VAD) carry increasing risk for pump infection, thromboembolic events, decreased quality of life, and increased hospitalization. We report our experience with a surgical technique for refractory driveline infections without mediastinitis consisting of translocation and wrapping of the driveline with greater omentum tissue. METHODS: We retrospectively reviewed data of VAD patients who underwent surgical treatment by translocation and wrapping with omentum for severe chronic driveline infection. RESULTS: Thirteen patients were treated between January 2010 and October 2015; 12 (92%) were male, and the mean age was 56 ± 14 years. Ten patients (77%) were managed with driveline sheathing with omentum and repositioning with a new exit site, and three (23%), suffering from driveline fistula, with driveline covering with omentum maintaining the previous exit site. Three episodes of postoperative bleeding (23%) required surgical revision. Twelve patients (92%) were discharged from the hospital and one (8%) died. Nine patients (69%) were free from infection at the time of discharge, and three (23%) had recurrence of infection within the first postoperative year. Only four patients (31%) required admission to the intensive care unit; overall median hospital stay was 23 days (range 7-205 days). CONCLUSIONS: Driveline relocation with use of omentum is a feasible and effective procedure in selected cases of chronic severe driveline infection. The risk for perioperative bleeding should be taken into consideration and carefully monitored.


Asunto(s)
Corazón Auxiliar/efectos adversos , Falla de Prótesis/efectos adversos , Infecciones Relacionadas con Prótesis/etiología , Infecciones Relacionadas con Prótesis/cirugía , Adulto , Anciano , Procedimientos Quirúrgicos Cardíacos/métodos , Enfermedad Crónica , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Epiplón , Estudios Retrospectivos , Resultado del Tratamiento
5.
J Heart Lung Transplant ; 43(2): 251-260, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37769887

RESUMEN

PURPOSE: The HeartMate 3 (HM3) left ventricular assist device (LVAD) has demonstrated excellent clinical outcomes; however, pump speed optimization is challenging with the available HM3 monitoring. Therefore, this study reports on clinical HM3 parameters collected with a noninvasive HM3 monitoring system (HM3 Snoopy) during echocardiographic speed ramp tests and Valsalva maneuvers. METHODS: In this prospective, single-center study, the HM3 data communication between the controller and pump was recorded with a novel data acquisition system. Twelve pump parameters sampled every second (1 Hz) and clinical assessments (echocardiography, electrocardiogram (ECG), and blood pressure measurement) during speed ramp tests were analyzed using Pearson's correlation (r, median [IQR]). The cause for the occurrence of pulsatility index (PI)-events during ramp speed tests and valsalva maneuvers was investigated. RESULTS: In 24 patients (age: 58.9 ± 8.8 years, body mass index: 28.1 ± 5.1 kg/m2, female: 20.8%), 35 speed ramp tests were performed with speed changes in the range of ±1000 rpm from a baseline speed of 5443 ± 244 rpm. Eight HM3 pump parameters from estimated flow, motor current, and LVAD speed together with blood pressure showed positive collinearities (r = 0.9 [0.1]). Negative collinearities were observed for pump flow pulsatility, pulsatility index, rotor noise, and left ventricular diameters (r = -0.8 [0.1]), whereas rotor displacement and heartrate showed absence of collinearities (r = -0.1 [0.08]). CONCLUSIONS: In this study, the HM3 Snoopy was successfully used to acquire more parameters from the HM3 at a higher sampling rate. Analysis of HM3 per-second data provide additional clinical diagnostic information on heart-pump interactions and cause of PI-events.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Femenino , Persona de Mediana Edad , Anciano , Estudios Prospectivos , Maniobra de Valsalva , Ecocardiografía , Corazón Auxiliar/efectos adversos
6.
J Thorac Cardiovasc Surg ; 164(6): 1922-1930.e2, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-33581897

RESUMEN

OBJECTIVE: Patients with a continuous-flow left ventricular assist device may show recovery of myocardial function with unloading. Identifying candidates for and predicting clinical and hemodynamic stability after left ventricular assist device explantation remain challenging. METHODS: Retrospective analysis of patients who underwent evaluation for left ventricular assist device explantation following a standardized protocol from January 2016 to March 2020. Patients who met screening criteria underwent echocardiography under "baseline," "minimal net flow," and "pump stop" conditions. If the protocol criteria were met, right heart catheterization with left ventricular assist device stoppage and occlusion of the outflow graft with a balloon catheter were performed. In patients with pulmonary capillary wedge pressure less than 16 mm Hg, explantation was performed under "pump stop" conditions. RESULTS: A total of 544 patients were screened. Of these, 57 (10.5%) underwent a total of 73 echocardiography under "baseline" "minimal net flow" and "pump stop" conditions and 46 underwent left ventricular assist device stoppage and occlusion of the outflow graft with balloon catheter maneuvers. Complications during the procedure were rare. Ultimately, 21 patients (3.9%) underwent explantation. The left ventricular ejection fraction at baseline was 55.5% ± 6.5%. The mean pulmonary capillary wedge pressure was 8.1 ± 2.6 mm Hg and increased to 10.7 ± 2.9 mm Hg under left ventricular assist device stoppage and occlusion of the outflow graft with a balloon catheter. A nonischemic cause of cardiomyopathy was more likely to be found in patients who underwent explantation (20/21 patients [95%], P = .020). The survival 1 year after explantation was 95.2%, with 1 death occurring 222 days after left ventricular assist device explantation. At follow-up (median 24.9 months [interquartile range, 16.4-43.1 months]), patients were in New York Heart Association class 1 (61.9%), 2 (28.6%), and 3 (9.5%). CONCLUSIONS: Our 4-year experience with a standardized protocol for left ventricular assist device explantation showed a low rate of adverse events. If all criteria are met, explantation can be performed safely and with an excellent survival and functional class.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Corazón Auxiliar/efectos adversos , Volumen Sistólico , Función Ventricular Izquierda , Estudios Retrospectivos , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/diagnóstico
7.
ASAIO J ; 68(11): 1332-1338, 2022 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-35184090

RESUMEN

As patients on long-term left ventricular assist device (LVAD) face a substantial risk for open cardiac reoperation, interventional treatment approaches are becoming increasingly important in this population. We evaluated data of 871 patients who were on LVAD support between January 1, 2016 and December 1, 2020. Interventional treatments for LVAD-associated complications were performed in 76 patients. Seventeen patients underwent transcatheter aortic valve replacements (TAVR) and 61 patients underwent outflow graft interventions (OGI). TAVR improved symptoms in patients with severe symptomatic aortic regurgitation. Postinterventional complications included aggravation of preexisting right heart failure (RHF), third-degree atrioventricular block, and intrapump thrombosis (in 3 [16.7%], 2 [11.1%], and 1 [5.6%] patients, respectively). In outflow graft obstructions, OGI led to recovery of LVAD flow ( p < 0.001), unloading of the left ventricle ( p = 0.004), decrease of aortic valve opening time ( p = 0.010), and improvement of right heart function ( p < 0.001). Complications included bleeding, RHF, and others (in 9 [10.8%], 5 [6.0%], and 5 [6.0%] patients, respectively). Eight (9.6%) patients died within the hospital stay after OGI, including mortality secondary to prolonged cardiogenic shock. In conclusion, interventional procedures are a feasible and safe treatment modality for LVAD-associated complications.


Asunto(s)
Insuficiencia de la Válvula Aórtica , Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Corazón Auxiliar/efectos adversos , Resultado del Tratamiento , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/cirugía , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/diagnóstico , Válvula Aórtica , Estudios Retrospectivos
8.
Front Cardiovasc Med ; 9: 953582, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36277782

RESUMEN

Thrombogenicity remains a major issue in cardiovascular implants (CVIs). Complete surficial coverage of CVIs by a monolayer of endothelial cells (ECs) prior to implantation represents a promising strategy but is hampered by the overall logistical complexity and the high number of cells required. Consequently, extensive cell expansion is necessary, which may eventually lead to replicative senescence. Considering that micro-structured surfaces with anisotropic topography may promote endothelialization, we investigated the impact of gratings on the biomechanical properties and the replicative capacity of senescent ECs. After cultivation on gridded surfaces, the cells showed significant improvements in terms of adherens junction integrity, cell elongation, and orientation of the actin filaments, as well as enhanced yes-associated protein nuclear translocation and cell proliferation. Our data therefore suggest that micro-structured surfaces with anisotropic topographies may improve long-term endothelialization of CVIs.

10.
ASAIO J ; 67(1): e52-e54, 2021 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-32657826

RESUMEN

Outflow graft obstruction in left ventricular assist devices (LVADs) is a rare complication whose clinical presentation may be subtle. We present six cases of outflow graft obstruction in patients on HeartMate 3 LVAD detected between 648 and 1,222 days on support. Detection principles are described and treatment strategies discussed. Three patients were successfully managed with stents, one underwent surgical revision, one patient died despite emergency treatment, and the last patient without symptoms was listed for heart transplantation.


Asunto(s)
Corazón Auxiliar/efectos adversos , Falla de Prótesis , Trombosis/diagnóstico , Trombosis/etiología , Trombosis/terapia , Adulto , Anciano , Femenino , Insuficiencia Cardíaca/cirugía , Humanos , Persona de Mediana Edad , Reoperación
11.
ASAIO J ; 67(5): 536-545, 2021 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-33417312

RESUMEN

The development of driveline infections following left ventricular assist device (LVAD) implantation remains a major problem. We investigated the impact of fluorescence in situ hybridization (FISH) combined with 16S rRNA gene sequencing on the diagnosis of driveline infections. LVAD drivelines (n = 61) from 60 consecutive patients were obtained during LVAD explantation and subjected to FISH analysis. 16S rRNA gene polymerase chain reaction (PCR) and sequencing to identify the microorganisms were performed. Results were compared with those of a standard microbiological culture. The reasons for pump removal were heart transplantation (n = 22), weaning (n = 14), pump exchange due to pump thrombosis (n = 12), technical problems (n = 7), or death (n = 5). Of the 60 patients, 26 exhibited clinical signs of a VAD-specific infection, while 34 (with 35 drivelines) showed no clinical signs of infection before explantation. The spectrum of identified pathogens differed between FISH/PCR and conventional microbiological diagnostics. In general, the bacterial spectrum was more diverse in FISH/PCR as compared with conventional microbiology, which more often showed only typical skin flora (coagulase-negative staphylococci and Corynebacteriaceae). In addition to identifying the species, FISH/PCR provided information about the spatial distribution and invasiveness of the microorganisms. Cultures usually represent the only source of microbiological information for clinicians and often prove to be unsatisfactory in complex LVAD cases. FISH/PCR not only identified a greater number and variety of microorganisms than standard culture did, but it also provided information about the number, localization, and biofilm state of the pathogens, making it a useful tool for diagnosing the specific cause of LVAD driveline infections.


Asunto(s)
Corazón Auxiliar/efectos adversos , Hibridación Fluorescente in Situ/métodos , Reacción en Cadena de la Polimerasa/métodos , Infecciones Relacionadas con Prótesis/diagnóstico , Femenino , Humanos , Masculino , Persona de Mediana Edad
12.
ASAIO J ; 66(9): e121-e122, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32101886

RESUMEN

Implantation of a left ventricular assist device (LVAD) is an established treatment in end-stage heart failure. The longevity of LVAD support systems remains uncertain to a great extent because patients usually undergo transplantation, are weaned or die while on support before the maximum service life of these pumps is reached. We report about the hitherto longest published and still ongoing LVAD support of a 65 year old patient who received an Incor LVAD (Berlin Heart, Berlin, Germany, produced 2002-2018) 13 years ago. After pump exchange due to driveline damage, the patients were discharged home.


Asunto(s)
Insuficiencia Cardíaca/terapia , Corazón Auxiliar , Anciano , Humanos , Masculino , Reoperación , Tiempo , Resultado del Tratamiento
13.
ASAIO J ; 64(6): e161-e165, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30199385

RESUMEN

International normalized ratio (INR) measurements manage risks of bleeding and clotting sequelae in the population with left ventricular assist device (LVAD). Studies suggest that point-of-care (POC) INR does not significantly differ from plasma INR (P-INR) values in other patient populations, although this has not been validated in a multicenter LVAD study. We sought to determine whether POC-INR and P-INR values differ significantly in the LVAD population and reviewed patients with permanent LVAD implantation at seven institutions internationally. Our cohort comprised of 279 paired POC-INR and P-INR checks in patients supported on average 630 ± 598 days postimplant with predominately HeartWare, HeartMate II, and HeartMate III devices. The population averaged 57.9 years of age, and there were 86.7% male. We found no statistically significant difference between POC-INR and P-INR values. International normalized ratio accuracy correlated weakly with the time between INR measurements (p < 0.001). When the time difference was less than 4 hours, the difference between INR pairs was significantly lower than measurements greater than 8 hours (p = 0.006). There was no statistically significant difference when comparing paired INR values and time after implant to INR check (p = 0.43), age (p = 0.12), known coagulopathy (p = 0.12), bleeding history (p = 0.22), or thrombosis history (p = 0.34). This is the first large multicenter international study comparing POC-INR and P-INR measurements in patients with LVAD and found no statistically significant difference between either methods, particularly when measured within less than 4 hours of each other.


Asunto(s)
Corazón Auxiliar/efectos adversos , Relación Normalizada Internacional/métodos , Sistemas de Atención de Punto , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Trombosis/prevención & control
14.
Interact Cardiovasc Thorac Surg ; 27(6): 938-942, 2018 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-30113626

RESUMEN

OBJECTIVES: No continuous-flow right ventricular assist device for long-term support is available at the moment. Two continuous-flow ventricular assist devices used in a continuous-flow biventricular assist device configuration is an emerging option which has proven its feasibility but still is not approved for routine use. We present our technique and results of modifying the left ventricular assist device and making it suitable for right ventricular support. METHODS: Between September 2009 and October 2017, 39 patients received implantation of a continuous-flow ventricular assist device for right ventricular support in a continuous-flow biventricular assist device configuration. For implantation of the HeartWare® manufacturers name of the pump HeartWare HVAD pump (HVAD)® centrifugal ventricular assist device, we performed 2 major modifications: banding of the outflow graft and reducing the intracaval length of the inflow cannula. The HVAD® could be safely implanted into the right atrium or ventricle. The HeartMate 3® left ventricular assist device needed no banding, but we increased the extraventricular part of the inflow cannula. RESULTS: The overall 30-day survival for the group receiving primarily a continuous-flow biventricular assist device was 72.7% (9.5% standard error of the mean (SEM)), and the 1-year survival was 45.0% (10.7% SEM). The overall 30-day survival for the group receiving a subsequent pump for right ventricular support in a continuous-flow biventricular assist device configuration after temporary right ventricular support was 71.4% (12.1% SEM), and 1-year survival was 40.8% (13.6% SEM). CONCLUSIONS: At the moment, there is a lack of a continuous-flow right ventricular assist device especially designed and approved for right ventricular support. Therefore, modifications in continuous-flow ventricular assist devices designed for the left ventricle are done to make them suitable for right ventricular support. However, more information is needed regarding the optimal surgical technique, patient selection and the optimal time point of implantation.


Asunto(s)
Insuficiencia Cardíaca/cirugía , Ventrículos Cardíacos/fisiopatología , Corazón Auxiliar , Volumen Sistólico/fisiología , Función Ventricular/fisiología , Adulto , Anciano , Diseño de Equipo , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Ventrículos Cardíacos/diagnóstico por imagen , Ventrículos Cardíacos/cirugía , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven
15.
Int J Artif Organs ; 39(11): 553-557, 2017 Jan 13.
Artículo en Inglés | MEDLINE | ID: mdl-28058699

RESUMEN

PURPOSE: While the HeartWare® Ventricular Assist System (HVAS) is a successful therapy for end-stage heart failure, outpatient management methods can vary significantly and require further investigation. METHODS: A survey to assess the long-term HVAS patient management and monitoring strategies was completed by 36 international heart centers that currently have over 1,450 patients on VAD support either at home or in the hospital. Multiple choice questions examined VAD program characteristics, anticoagulation management, driveline exit-site dressing and showering recommendations, blood pressure and pump parameter monitoring, and patient discharge protocols. RESULTS: Outpatient international normalized ratio (INR) was most frequently measured every 3-4 days (28.6%), and the most frequent schedule for changing driveline exit site dressings was 3 times per week (30.6%). Only 25.7% of centers required their patients to measure blood pressure at home. A subgroup analysis was performed to assess the influence of center experience and larger centers generally had more frequent monitoring compared to smaller centers. CONCLUSIONS: This survey showed specific differences in outpatient management strategies that were previously unreported. However, further studies with correlations to patient outcomes are necessary to determine optimal patient management recommendations.


Asunto(s)
Atención Ambulatoria/estadística & datos numéricos , Corazón Auxiliar , Monitoreo Ambulatorio de la Presión Arterial/estadística & datos numéricos , Instituciones Cardiológicas , Insuficiencia Cardíaca/terapia , Humanos , Relación Normalizada Internacional , Encuestas y Cuestionarios , Telemetría/estadística & datos numéricos
16.
Ann Biomed Eng ; 45(8): 1836-1851, 2017 08.
Artículo en Inglés | MEDLINE | ID: mdl-28567658

RESUMEN

Over the last few decades, the left ventricular assist device (LVAD) technology has been tremendously improved transitioning from large and noisy paracorporeal volume displacement pumps to small implantable turbodynamic devices with only a single transcutaneous element, the driveline. Nevertheless, there remains a great demand for further improvements to meet the challenge of having a robust and safe device for long-term therapy. Here, we review the state of the art and highlight four key areas of needed improvement targeting long-term, sustainable LVAD function: (1) LVADs available today still have a high risk of thromboembolic and bleeding events that could be addressed by the rational fabrication of novel surface structures and endothelialization approaches aiming at improving the device hemocompatibility. (2) Novel, fluid dynamically optimized pump designs will further reduce blood damage. (3) Infection due to the paracorporeal driveline can be avoided with a transcutaneous energy transmission system that additionally allows for increased freedom of movement. (4) Finally, the lack of pump flow adaptation needs to be encountered with physiological control systems, working collaboratively with biocompatible sensor devices, targeting the adaptation of the LVAD flow to the perfusion requirements of the patient. The interdisciplinary Zurich Heart project investigates these technology gaps paving the way toward LVADs for long-term, sustainable therapy.


Asunto(s)
Predicción , Insuficiencia Cardíaca/prevención & control , Corazón Auxiliar/efectos adversos , Corazón Auxiliar/tendencias , Hemorragia/prevención & control , Modelos Cardiovasculares , Tromboembolia/prevención & control , Simulación por Computador , Diseño Asistido por Computadora/tendencias , Diseño de Equipo/tendencias , Análisis de Falla de Equipo , Medicina Basada en la Evidencia , Hemorragia/etiología , Humanos , Cuidados a Largo Plazo/tendencias , Tromboembolia/etiología , Resultado del Tratamiento
17.
Artículo en Inglés | MEDLINE | ID: mdl-16638554

RESUMEN

The pediatric-size pneumatically driven pulsatile extracorporeal ventricular assist device (VAD) Berlin Heart EXCOR (Berlin Heart Mediprodukt GmbH, Berlin, Germany) was introduced into clinical practice by the German Heart Institute Berlin in 1992. Until July 1, 2005, Berlin Heart EXCOR systems have been used for circulatory support in 68 children up to 18 years of age with severe circulatory failure resistant to pharmacologic therapy. These were patients suffering from cardiomyopathy, fulminant myocarditis, end-stage congenital cardiac defects, and acute heart failure following congenital heart surgery. Mean VAD support time was 35 days (range, 0 to 420 days). Forty-two patients (62%) survived to transplantation or after weaning; 37 patients (54%), including eight infants, were discharged home. These results in patients with very advanced disease have improved significantly in recent years because of technical developments and growing experience in the treatment of patients on the device, in postoperative care and optimal timing for VAD implantation. Timely implantation of the Berlin Heart EXCOR in the course of progressive heart failure now appears to be justified because the system has undergone the necessary modifications and the accumulation of clinical knowledge has made its use highly reliable and safe.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos/efectos adversos , Cardiopatías/complicaciones , Insuficiencia Cardíaca/cirugía , Corazón Auxiliar , Choque Cardiogénico/cirugía , Adolescente , Anticoagulantes/uso terapéutico , Cardiomiopatías/complicaciones , Niño , Preescolar , Remoción de Dispositivos , Femenino , Cardiopatías Congénitas/complicaciones , Insuficiencia Cardíaca/etiología , Trasplante de Corazón , Humanos , Lactante , Recién Nacido , Masculino , Miocarditis/complicaciones , Cuidados Posoperatorios , Complicaciones Posoperatorias , Flujo Pulsátil , Choque Cardiogénico/etiología
18.
Expert Rev Med Devices ; 13(5): 463-74, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-26972560

RESUMEN

Ventricular assist devices (VAD) are used for mechanical support of the terminally failing heart. Failure of these life supporting systems can be fatal. Early and reliable detection of any upcoming problems is mandatory and is crucial for the outcome. Medical imaging methods are described within this review, which are not only essential for diagnosis of typically VAD-related complications but also for the detection or verification of technical issues. Within this review the utilization of medical imaging equipment for the diagnosis of technical malfunctions or damages of implanted system components is discussed. A newly developed specialized acoustic imaging method for pump thrombosis detection will also be described along with the most common VAD-related medical complications and their respective imaging methods and the limitations induced by the use of the VAD-system.


Asunto(s)
Diagnóstico por Imagen/métodos , Insuficiencia Cardíaca/diagnóstico , Corazón Auxiliar/efectos adversos , Adulto , Insuficiencia Cardíaca/diagnóstico por imagen , Humanos
19.
Eur J Cardiothorac Surg ; 50(2): 203-10, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-26905181

RESUMEN

This paper reviews the development and establishment of the Berlin Heart EXCOR® (BHE®) as a paediatric mechanical circulatory support and reports our entire experience with regard to indications, timing of implantation and explantation and outcome. The Berlin group reported the first successful paediatric bridge to transplantation using a pulsatile pneumatic paracorporeal biventricular assist device, the BHE®, in 1990 in an 8-year-old boy with end-stage heart failure and coarctation of the aorta. This experience prompted them to develop miniaturized pump systems for children through the company Berlin Heart Mediproduct GmbH. The development and production of BHE® to support paediatric patients with heart failure then began. Between 1990 and 2013, the BHE® has been implanted in 122 patients (median age 8.64 years, range 3 days to 17 years) with heart failure, who were inotrope-dependent or switched from extracorporeal membrane oxygenation support or had postcardiotomy low-output syndrome. Thirty-five patients were <1 year old (median 125 days). The aetiology of heart failure included cardiomyopathy in 56 (median age 9.14 years), fulminant myocarditis in 17 (median age 8.2 years), end-stage congenital heart disease in 18 (median age 6.4 years), postcardiotomy heart failure (after correction of congenital heart disease) in 28 (median age 9.6 years) and transplant graft failure in 3 (median age 12.5 years). The overall median duration of implantation was 63.6 (range 1-841) days. Fifty-six children eventually underwent orthotopic heart transplantation. Eighteen patients had myocardial recovery and were weaned successfully. They had entirely normal cardiac function after a range of 4-10 years after surgery. At the time of this report, five patients were still on support, with a duration of 354-369 days. Forty-three patients died on the system from loss of peripheral circulatory resistance, multiorgan damage, sepsis or haemorrhagic or thrombotic complications. Re-exploration because of bleeding was necessary in 22 patients. Pump exchange because of thrombus formation in the valves was necessary 35 times. With the introduction of a modified anticoagulation regimen in 2000, the pump exchange rate has decreased. The BHE® can reliably support the circulation at any age for long periods with good results. It is now an established treatment for children with heart failure of any aetiology.


Asunto(s)
Oxigenación por Membrana Extracorpórea/tendencias , Insuficiencia Cardíaca/cirugía , Corazón Auxiliar/tendencias , Berlin , Niño , Diseño de Equipo , Humanos
20.
ASAIO J ; 62(4): 438-41, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27014790

RESUMEN

Risk stratification of patients are claimed to be useful before left ventricular assist device (LVAD) implantation and different scoring systems are available. The aim of the study was to validate the Cardiac Health Risk Stratification System (CHRiSS), based on Bayesian network analysis, and the HeartMate II score in our patient population. We retrospectively calculated the CHRiSS using a web-based application and the HeartMate II score of 105 adult patients who underwent consecutive HVAD (HeartWare International, Inc.) implantation as primary LVAD at our institution in a 12-month period (May 2014-April 2015). Survival was 83.8 % (3.6%) at 30 days, 77.8% (4.0%) at 90 days, and 72.8% (4.8%) at 6 months and 1 year. The area under the curve (AUC) of the receiver operating characteristics (ROC) curve for CHRiSS was 0.75 at 30 days, 0.66 at 90 days, and 0.65 at 6 months. The HeartMate II score had an AUC of 0.73 at 90 days. Comparison between the ROC curves of the two models calculated at 90 days showed no statistically significant difference (p = 0.48): CHRiSS presents a high positive predictive value (85 [80-91]), the opposite to the HeartMate II score, which has a high negative predictive value (91 [83.4-96.6]). In our population, application of the CHRiSS was valuable at 30 days, but the overall predictive value of both scores is not satisfactory. The CHRiSS model proved to be a promising tool, suggesting that, with greater sample size and a longer data collection period, it might potentially outperform the HeartMate II scoring system.


Asunto(s)
Corazón Auxiliar/efectos adversos , Adulto , Anciano , Teorema de Bayes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Curva ROC , Estudios Retrospectivos , Riesgo
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