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1.
Artigo em Inglês | MEDLINE | ID: mdl-34787966

RESUMO

Replacements for diseased aortic valves are limited. Repair of the aortic valve is performed by only a few surgeons. A novel technique of aortic valve reconstruction using autologous pericardium shows promising results. In this video tutorial, we demonstrate the Ozaki procedure using an ex vivo low fidelity simulation.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Valva Aórtica/cirurgia , Humanos , Pericárdio/transplante , Reimplante
2.
ESC Heart Fail ; 2021 Nov 22.
Artigo em Inglês | MEDLINE | ID: mdl-34811959

RESUMO

Aims Worldwide applications of extracorporeal circulation for mechanical support in cardiac and circulatory failure, which are referred to as extracorporeal life support (ECLS) or veno-arterial extracorporeal membrane oxygenation (va-ECMO), have dramatically increased over the past decade. In spite of the expanding use and the immense medical as well as socio-economic impact of this therapeutic approach, there has been a lack of interdisciplinary recommendations considering the best available evidence for ECLS treatment. Methods and Results In a multiprofessional, interdisciplinary scientific effort of all scientific societies involved in the treatment of patients with acute cardiac and circulatory failure, the first evidence- and expert consensus-based guideline (level S3) on ECLS/ECMO therapy was developed in a structured approach under regulations of the AWMF (Association of the Scientific Medical Societies in Germany) and under use of GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. This article presents all recommendations created by the expert panel, addressing a multitude of aspects for ECLS initiation, continuation, weaning and aftercare as well as structural and personnel requirements. Conclusions This first evidence- and expert consensus-based guideline (level S3) on ECLS/ECMO therapy should be used to apply the best available care nationwide. Beyond clinical practice advice, remaining important research aspects for future scientific efforts are formulated.

3.
Artigo em Inglês | MEDLINE | ID: mdl-34788423

RESUMO

OBJECTIVES: Implanting a durable left ventricular assist device (LVAD) in a patient on extracorporeal life support (ECLS) is challenging. The goal of this study was to compare the results of patients from a European registry who had a durable LVAD implanted with or without transition from ECLS to cardiopulmonary bypass (CPB). METHODS: A total of 531 patients on ECLS support who had an LVAD implant between January 2010 and August 2018 were analysed; after 1:1 propensity score matching, we identified and compared 175 patients in each group. RESULTS: The duration of preoperative ECLS was 7 [standard deviation (SD) 6] vs 7 (SD 6) days in patients with or without CPB (P = 0.984). The surgical time was longer in the CPB group [285 (SD 72) vs 209 [SD 75] min; P ≤ 0.001). The postoperative chest tube output was comparable [1513 (SD 1311) vs 1390 (SD 1121) ml; P = 0.3]. However, re-exploration for bleeding was necessary in 41% vs 29% of patients with or without CPB (P = 0.01) and a significantly higher number of packed red blood cells and fresh frozen plasma [8 (SD 8) vs 6 (SD 4) units; P = 0.001 and 6 (SD 7) vs 5 (SD 5) units; P = 0.03] were administered to patients operated on with CPB. A postoperative mechanical right ventricular support device was necessary in 50% vs 41% of patients (P = 0.08). The stroke rate was not significantly different (P 0.99). No difference in survival was observed. CONCLUSIONS: Omitting CPB for an LVAD implant in patients on ECLS is safe and results in shorter operating time, less re-exploration for bleeding and fewer blood products. However, no survival benefit is observed.

4.
Int J Artif Organs ; : 3913988211056018, 2021 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-34715752

RESUMO

Simulations of the ventricular flow patterns during left ventricular assist device (LVAD) support are mainly performed with idealized cylindrical inflow, neglecting the influence of the atrial vortex. In this study, the influence of the left atrium (LA) on the intra-ventricular flow was investigated via Computational Fluid Dynamics (CFD) simulations. Ventricular flow was simulated by a combined Eulerian (carrier flow)/Lagrangian (particles) approach taking into account either the LA or a cylindrical inflow section to mimic a fully support condition. The flow deviation at the mitral valve, the blood low-velocity volume as well as the residence time and shear stress history of the particles were calculated. Inclusion of the LA deflects the flow at the mitral valve by 25°, resulting in an asymmetric flow jet entering the left ventricle. This reduced the ventricular low-velocity volume by 40% (from 6.4 to 3.9 cm3), increased (40%) the shear stress experienced by particles and correspondingly increased (27%) their residence time. Under the studied conditions, the atrial geometry plays a major role in the development of intraventricular flow patterns. A reliable prediction of blood flow dynamics and consequently thrombosis risk analysis within the ventricle requires the consideration of the LA in computational simulations.

6.
Anaesthesist ; 70(11): 942-950, 2021 11.
Artigo em Alemão | MEDLINE | ID: mdl-34665266

RESUMO

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.


Assuntos
Oxigenação por Membrana Extracorpórea , Choque , Circulação Extracorpórea , Alemanha , Humanos , Sistemas de Manutenção da Vida
7.
Med Klin Intensivmed Notfmed ; 116(8): 678-686, 2021 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-34665281

RESUMO

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.


Assuntos
Oxigenação por Membrana Extracorpórea , Choque , Circulação Extracorpórea , Alemanha , Humanos , Sistemas de Manutenção da Vida
8.
Artigo em Inglês | MEDLINE | ID: mdl-34687545

RESUMO

OBJECTIVES: The aim of this retrospective study was to determine if Cormatrix® (CM) represents a safe alternative to conventional patch materials used in congenital heart surgery. METHODS: A total of 57 paediatric patients who underwent cardiac surgery using an Extracellular Matrix Bioscaffold (CM) were categorized into 4 groups according to the patch implant location. Patch-related complications and reintervention rates were analysed. A subgroup of 18 patients was subsequently compared to a matched group of 36 patients who underwent similar surgical procedures with autologous pericardium as patch material. RESULTS: No patient died during hospitalization. There were 2 late deaths, not related to the implanted CM patch. Fourteen (66.7%) out of 21 patients with arterial patch plasty developed progressive vessel/right ventricular outflow tract stenosis or aneurysm. All 3 patients with a valved CM conduit developed haemodynamically relevant valve stenosis or regurgitation. A total of 18 (31.5%) patients needed reintervention and 12 (21.1%) related to CM. Four (7%) patients needed surgical treatment with operative removal of the stenosis. Redo valve replacement was performed on 2 (3.5%) patients. Six (10.5%) patients required an interventional cardiology procedure at a median interval of 5 months from surgery. The subgroup analysis revealed a significantly lower patch-related reintervention rate in patients treated with autologous pericardium when compared to CM (P = 0.006). CONCLUSIONS: CM is safe for atrial and ventricular defect closure. The use of CM for arterial vessel reconstruction is associated with higher reintervention rates when compared to autologous pericardium.

9.
Front Cardiovasc Med ; 8: 736503, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34692789

RESUMO

The radial artery (RA) is a frequently used conduit in coronary artery bypass grafting (CABG). Endothelial injury incurred during graft harvesting promotes oxidative damage, which leads to graft disease and graft failure. We evaluated the protective effect of DuraGraft®, an endothelial damage inhibitor (EDI), on RA grafts. We further compared the protective effect of the EDI between RA grafts and saphenous vein grafts (SVG). Samples of RA (n = 10) and SVG (n = 13) from 23 patients undergoing CABG were flushed and preserved with either EDI or heparinized Ringer's lactate solution (RL). The effect of EDI vs. RL on endothelial damage was evaluated ex vivo and in vitro using histological analysis, immunofluorescence staining, Western blot, and scanning electron microscopy. EDI-treated RA grafts showed a significant reduction of endothelial and sub-endothelial damage. Lower level of reactive oxygen species (ROS) after EDI treatment was correlated with a reduction of hypoxic damage (eNOS and Caveolin-1) and significant increase of oxidation-reduction potential. Additionally, an increased expression of TGFß, PDGFα/ß, and HO-1 which are indicative for vascular protective function were observed after EDI exposure. EDI treatment preserves functionality and integrity of endothelial and intimal cells. Therefore, EDI may have the potential to reduce the occurrence of graft disease and failure in RA grafts in patients undergoing CABG.

10.
ASAIO J ; 67(10): 1148-1158, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34582408

RESUMO

Computational fluid dynamics find widespread application in the development of rotary blood pumps (RBPs). Yet, corresponding simulations rely on shear stress computations that are afflicted with limited resolution while lacking validation. This study aimed at the experimental validation of integral hydraulic properties to analyze global shear stress resolution across the operational range of a novel RBP. Pressure head and impeller torque were numerically predicted based on Unsteady Reynolds-averaged Navier-Stokes (URANS) simulations and validated on a testbench with integrated sensor modalities (flow, pressure, and torque). Validation was performed by linear regression and Bland-Altman analysis across nine operating conditions. In power loss analysis (PLA), in silico hydraulic power losses were derived based on the validated hydraulic quantities and balanced with in silico shear-dependent dissipative power losses. Discrepancies among both terms provided a measure of in silico shear stress resolution. In silico and in vitro data correlated with low discordance in pressure (r = 0.992, RMSE = 1.02 mmHg), torque (r = 0.999, RMSE = 0.034 mNm), and hydraulic power losses (r = 0.990, RMSE = 0.015W). PLA revealed numerically predicted dissipative losses to be up to 34.4% smaller than validated computations of hydraulic losses. This study confirmed the suitability of URANS settings to predict integral hydraulic properties. However, numerical credibility was hampered by lacking resolution of shear-dependent dissipative losses.


Assuntos
Coração Auxiliar , Simulação por Computador , Hidrodinâmica , Modelos Cardiovasculares , Estresse Mecânico
11.
Life (Basel) ; 11(9)2021 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-34575071

RESUMO

Several risk scores and classifications are available to predict peri- and post-operative mortality of patients with end stage heart failure receiving Left Ventricular Assist Device (LVAD) therapy. Sarcopenia has been suggested as a sensitive predictor for post-operative mortality. We evaluated whether the psoas muscle area can predict mortality in patients undergoing LVAD implantation. The indexed psoas mean area (PMAi) was obtained by measuring the psoas muscle area at the superior endplate of the third lumbar vertebra correlated to body surface area of 106 adult patients undergoing LVAD implantation (Medtronic HVAD n = 41, Abbott HeartMate II n = 4, Abbott HeartMate 3 n = 61; mean age 65, IQR 12, 90.6% male; INTERMACS Level 1 24.5%; ischemic CMP 64.2%). Patients were divided in two groups: high/moderate and low muscle mass. The primary endpoint was 30-day mortality, assessed using a multivariate Cox proportional hazards model. Baseline characteristics did not differ between patients with high or moderate and low PMAi. Estimated survival calculated a significant higher 30-day mortality in patients with low PMAi (p = 0.04). Multivariable Cox proportional hazards regression analysis indicated low PMAi, history of previous cardiac surgery and levels of bilirubin as independent predictors of mortality in the first 30 days. In conclusion, indexed psoas muscle area predicts mortality after LVAD implantation and can be used as an additional tool for risk stratification.

12.
J Cardiothorac Surg ; 16(1): 259, 2021 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-34496905

RESUMO

BACKGROUND: The choice of aortic valve replacement needs to be decided in an interdisciplinary approach and together with the patients and their families regarding the need for re-operation and risks accompanying anticoagulation. We report long-term outcomes after different AVR options. METHODS: A chart review of patients aged < 18 years at time of surgery, who had undergone AVR from May 1985 until April 2020 was conducted. Contraindications for Ross procedure, which is performed since 1991 at the center were reviewed in the observed non-Ross AVR cohort. The study endpoints were compared between the mechanical AVR and the biological AVR cohort. RESULTS: From May 1985 to April 2020 fifty-five patients received sixty AVRs: 33 mechanical AVRs and 27 biological AVRs. In over half of the fifty-three AVRs performed after 1991 (58.5%; 31/53) a contraindication for Ross procedure was present. Early mortality was 5% (3/60). All early deaths occurred in patients aged < 1 year at time of surgery. Two late deaths occurred and survival was 94.5% ± 3.1% at 10 years and 86.4% ± 6.2% at 30 years. Freedom from aortic valve re-operation was higher (p < 0.001) in the mechanical AVR than in the biological AVR cohort with 95.2% ± 4.6% and 33.6% ± 13.4% freedom from re-operation at 10 years respectively. CONCLUSIONS: Re-operation was less frequent in the mechanical AVR cohort than in the biological AVR cohort. For mechanical AVR, the risk for thromboembolic and bleeding events was considerable with a composite linearized event rate per valve-year of 3.2%.


Assuntos
Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Idoso , Valva Aórtica/cirurgia , Criança , Humanos , Reoperação , Estudos Retrospectivos , Resultado do Tratamento
14.
Artigo em Inglês | MEDLINE | ID: mdl-34468714

RESUMO

OBJECTIVES: We reviewed our institutional experience with outflow graft stenosis (OGS) in 3 contemporary left ventricular assist devices (LVAD). METHODS: Data from 347 consecutive adult recipients of LVAD [Medtronic HVAD (n = 184, 53.0%), Abbott HeartMate II (n = 62, 17.9%) and Abbott HeartMate 3 (n = 101, 29.1%)] implanted between March 2006 and October 2019 were analysed retrospectively. Primary study end points were the incidence of OGS necessitating treatment and survival on LVAD support. RESULTS: During the study period, 17 patients (4.9%) developed OGS requiring treatment with a probability of 0.6% at 1 year, 1.9% at 2 years, 3.8% at 3 years, 4.7% at 4 years and 5.9% at 5 years of LVAD support. Notably, in 13.8% of patients, a compression-related narrowing of the outflow graft with a probability of 1.5% at 6 months, 1.8% 1 year, 6.0% at 2 years, 12.3% at 3 years, 15.4% at 4 years and 16.6% at 5 years of LVAD support with no difference between devices (P = 0.26) was observed. There was a trend towards increased risk of mortality with OGS (hazard ratio 2.21, 95% confidence interval 0.87-5.51; P = 0.09). OGS preferentially occurred in segments of the outflow graft covered by a protective coating. CONCLUSIONS: OGS is a rare but potentially lethal complication during LVAD support. Modifications of pump design and implant techniques may be needed because OGS preferentially occurs within covered portions of the outflow graft. Systematic screening may be warranted.

15.
BMC Pediatr ; 21(1): 341, 2021 08 13.
Artigo em Inglês | MEDLINE | ID: mdl-34389009

RESUMO

BACKGROUND: Neonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing paediatric anaesthesia and perioperative medicine. AIMS: We here aimed to investigate the success rates in performing ultrasound (US) guided central venous catheter insertion (CVC) in neonates and small infants undergoing cardiac surgery, and to evaluate the practicability and feasibility of thereby using a novel wireless US transducer (WUST). METHODS: Thirty neonates and small infants with a maximum body weight of 10 kg and need for CVC before cardiac surgery were included in this observational trial and were subdivided into two groups according to their weight: < 5 kg and ≥ 5 kg. Cannulation success, failure rate, essential procedure related time periods, and complications were recorded and the clinical utility of the WUST was assessed by a 5-point Likert scale. RESULTS: In total, CVC-insertion was successful in 27 (90%) of the patients and the first attempt was successful in 24 (78%) of patients. Success rates of CVC were 80% < 5 kg and 100% ≥5 kg. Comparing the two groups we found a clear trend towards longer needle insertion time in patients weighing < 5 kg (33 [28-69] vs. 24 [15-37]s, P = .07), whereas, the total time for catheter insertion and the duration of the whole procedure were similar in both groups (199 [167-228] vs. 178 [138-234] and 720[538-818] vs. 660 [562-833]s. In total, we report 3 (10%) cases of local hematoma as procedure-related complications. Assessments of the WUST revealed very good survey results for all parameters of practicability and handling (all ratings between 4.5 and 5.0). CONCLUSION: Although difficulties in CVC-placement seem to relate to vessel size and patient's weight, US guided CVC-insertion represents a valuable, fast, and safe intervention in neonates and small children undergoing cardiac surgery. Using the WUST is feasible for this clinical application and may aid in efforts aiming to optimize perioperative care. TRIAL REGISTRATION: Wireless US-guided CVC placement in infants; Clinicaltrials.gov: NCT04597021 ; Date of Registration: 21October, 2020; retrospectively registered.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Cateteres Venosos Centrais , Criança , Humanos , Lactente , Recém-Nascido , Projetos Piloto , Estudos Prospectivos , Transdutores , Ultrassonografia de Intervenção
17.
Int J Artif Organs ; 44(12): 956-964, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34088235

RESUMO

Malpositioning of left ventricular assist devices (LVAD) is a risk factor for thrombosis, but its identification from clinical imaging remains challenging. X-rays and CT scans were analyzed and parameters identified that correlated to pump thrombosis. Retrospective imaging data of patients (n = 115) with HeartmateII (HMII) or HVAD were analyzed in two groups (pump-thrombosis PT, n = 15 vs matched control group NT, n = 15) using routine X-rays and CT scans. In CT, directional deviations of the inflow cannula in three-chamber and two-chamber view (α and ß angles) were identified. In HVAD PT frontal radiographs showed reduced pump body area and smaller minor axis (PT 41.3 ± 4.8 mm vs NT 34.9 ± 6.0 mm, p = 0.026), and in the lateral radiographs the visibility of the inflow cannula served as a predictive parameter for PT. In HMII patients, no parameters were associated with PT. The angle α differed significantly (NT -1.2 ± 7.5°, PT -22.0 ± 4.7°, p = 0.006) in HVAD patients. Further, correlations of x-ray parameters with CT angles α and ß showed that radiographs can be used to identify malpositioned pumps. Well-aligned inflow cannula positions are essential. HVAD patients with a posterior rotation of the inflow cannula have a higher risk of pump thrombosis. This risk can reliably be identified from routine radiographs.


Assuntos
Insuficiência Cardíaca , Coração Auxiliar , Trombose , Ventrículos do Coração , Coração Auxiliar/efeitos adversos , Humanos , Estudos Retrospectivos , Trombose/diagnóstico por imagem , Trombose/etiologia , Tomografia Computadorizada por Raios X
19.
Interact Cardiovasc Thorac Surg ; 33(3): 455-461, 2021 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-34128047

RESUMO

OBJECTIVES: The Ross procedure is an attractive option for the management of aortic valve disease in paediatric patients. We reviewed our experience with the paediatric Ross procedure to determine survival and freedom from reoperation in the third decade after surgery. METHODS: We reviewed the data of 124 paediatric patients [71% male, median age at time of surgery 11.1 years (interquartile range 6-14.8 years); 63.7% bicuspid aortic valve], who underwent the Ross procedure at 2 tertiary centres from April 1991 to April 2020. The Ross-Konno procedures were performed on 14 (11.3%) patients. Deaths were cross-checked with the national health insurance database, and survival status was available for 96.8% of the patients. The median follow-up time was 12.1 years (interquartile range 3-18 years). RESULTS: There were 3 early and 6 late deaths. All early deaths occurred in patients aged <1 year at the time of surgery. The 25-year survival was 90.3%. Actuarial freedom from reoperation (linearized rates in parentheses) was as follows: Autograft reoperation was 90.8% (0.48%/patient-year) and right ventricular outflow tract (RVOT) reoperation was 67% (2.07%/patient year) at 25 years. The univariable Cox-proportional hazard analysis revealed younger age at time of surgery (P < 0.001), smaller implanted valve size (P < 0.001) and the use of a xenograft rather than a homograft (P < 0.001) as predictors of RVOT reoperation. At multivariable Cox-proportional hazard analysis, only age was an independent risk factor for RVOT reoperation (P = 0.041). CONCLUSIONS: The Ross and the Ross-Konno procedures are associated with good outcomes in paediatric patients. Reoperation of the RVOT is frequent and associated with younger age.


Assuntos
Estenose da Valva Aórtica , Procedimentos Cirúrgicos Cardíacos , Valva Pulmonar , Obstrução do Fluxo Ventricular Externo , Adolescente , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Criança , Feminino , Humanos , Lactente , Masculino , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/cirurgia , Reoperação , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/cirurgia
20.
Artigo em Inglês | MEDLINE | ID: mdl-34166811

RESUMO

Treatment of univentricular hearts remains restricted to palliative surgical corrections (Fontan pathway). The established Fontan circulation lacks a subpulmonary pressure source and is commonly accompanied by progressively declining hemodynamics. A novel cavopulmonary assist device (CPAD) may hold the potential for improved therapeutic management of Fontan patients by chronic restoration of biventricular equivalency. This study aimed at translating clinical objectives toward a functional CPAD with preclinical proof regarding hydraulic performance, hemocompatibility and electric power consumption. A prototype composed of hemocompatible titanium components, ceramic bearings, electric motors, and corresponding drive unit was manufactured for preclinical benchtop analysis: hydraulic performance in general and hemocompatibility characteristics in particular were analyzed in-silico (computational fluid dynamics) and validated in-vitro. The CPAD's power consumption was recorded across the entire operational range. The CPAD delivered pressure step-ups across a comprehensive operational range (0-10 L/min, 0-50 mm Hg) with electric power consumption below 1.5 W within the main operating range. In-vitro hemolysis experiments (N = 3) indicated a normalized index of hemolysis of 3.8 ± 1.6 mg/100 L during design point operation (2500 rpm, 4 L/min). Preclinical investigations revealed the CPAD's potential for low traumatic and thrombogenic support of a heterogeneous Fontan population (pediatric and adult) with potentially accompanying secondary disorders (e.g., elevated pulmonary vascular resistance or systemic ventricular insufficiency) at distinct physical activities. The low power consumption implied adequate settings for a small, fully implantable system with transcutaneous energy transfer. The successful preclinical proof provides the rationale for acute and chronic in-vivo trials aiming at the confirmation of laboratory findings and verification of hemodynamic benefit.

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