BACKGROUND: The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study. METHODS: A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases. RESULTS: Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%). CONCLUSIONS: Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant.

• Klíčová slova
• HeartMate 3, left ventricular assist device, outflow graft obstruction,
• MeSH
• lidé MeSH
• počítačová rentgenová tomografie MeSH
• podpůrné srdeční systémy * škodlivé účinky   MeSH
• retrospektivní studie MeSH
• srdeční selhání * MeSH
• transplantace srdce * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH

OBJECTIVES: The HeartMate 3 left ventricular assist device was first implanted in 2014 and received the Conformité Européenne mark in 2015. Since then, several trials demonstrated its high haemocompatibility associated with good survival and low adverse events rates. Herein, we report our institutional experience with patients supported with HeartMate 3 for 5 years. METHODS: This prospective cohort study included patients receiving a HeartMate 3 implantation in 2014 as part of the HeartMate 3 Conformité Européenne Mark clinical trial. Patients had follow-up visits every 3 months while on left ventricular assist device support, and all patients completed the 5-year follow-up. The primary end point was survival at 5 years. Secondary end points included adverse events, health status and quality of life. RESULTS: Eight patients (men: 75%) aged 59 years (min-max: 52-66 years) were enrolled. At 5 years, survival was 100%. Patients remained on support for a median time of 1825 days (min-max: 101-1825 days); 2 patients successfully received cardiac transplants. No right heart failure, haemolysis, pump thrombosis, pump malfunction or neurological events occurred in any patients. A driveline infection was observed in 6 patients (0.25 events/patient-year). Compared to baseline, a significant improvement in quality of life and in New York Heart Association functional class was noted after the implant and for the whole follow-up time. A slight decline in kidney function and in the 6-min walk test results occurred after 3 years. CONCLUSIONS: This study reports the longest single-centre follow-up of the HeartMate 3, showing excellent haemocompatibility over time with high survival and low complication rates at 5 years.

• Klíčová slova
• Heart failure, HeartMate 3, Left ventricular assist device, Mechanical circulatory support,
• MeSH
• kvalita života MeSH
• lidé MeSH
• podpůrné srdeční systémy * MeSH
• prospektivní studie MeSH
• srdeční selhání * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

• MeSH
• časové faktory MeSH
• celosvětové zdraví MeSH
• dospělí MeSH
• lidé MeSH
• míra přežití trendy   MeSH
• následné studie MeSH
• podpůrné srdeční systémy * MeSH
• předoperační období MeSH
• prospektivní studie MeSH
• srdeční selhání mortalita   terapie   MeSH
• transplantace srdce MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH

BACKGROUND: Cardiogenic shock occurs in 10%-15% of patients with Takotsubo syndrome (TS). For several reasons catecholamines, and especially inotropes, should be avoided in TS. Temporary mechanical circulatory support (MCS) appears attractive as bridge-to-recovery, but prospective studies are lacking. Here we analyze the available literature on MCS use in patients with TS. METHODS AND RESULTS: PubMed/Medline was systematically screened until December 2019. 18 studies reporting pooled data of 5629 TS patients, of whom 227 had received MCS, were considered for a qualitative synthesis. 81 articles from 2003 through 2019 reporting individual data of 93 MCS cases were included in a meta-analysis. Median age was 57 (IQR: 43-68) years, 83.9% were women, and a physical trigger could be identified in 74.1% of cases. Median left ventricular ejection fraction (LVEF) before MCS was 20% (IQR: 15-25) and comparable between groups defined by MCS device. An apical TS type was present in 76.1% of cases. The overall number of publications on MCS for TS increased over time, as did those using veno-arterial extracorporeal membrane oxygenation (V-A ECMO) and Impella, while those using intra-aortic balloon pump declined. MCS-related complications were not regularly reported. Median time on MCS was 3 (IQR: 2-7) days, with an overall survival of 94.6%. CONCLUSIONS: MCS for TS-related shock is increasingly reported, with a growing use of V-A ECMO and Impella. Currently available clinical data support this approach. Prospective studies are needed to evaluate safety and efficacy of different devices as well as timing of MCS in this special patient population.

• Klíčová slova
• Cardiac arrest, Cardiogenic shock, ECLS, ECMO, Extracorporeal membrane oxygenation, Heart failure, Impella, Mechanical circulatory support, Takotsubo syndrome,
• MeSH
• funkce levé komory srdeční MeSH
• kardiogenní šok diagnóza   terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• podpůrné srdeční systémy * MeSH
• prospektivní studie MeSH
• takotsubo kardiomyopatie * diagnóza   epidemiologie   terapie   MeSH
• tepový objem MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• metaanalýza MeSH
• systematický přehled MeSH

BACKGROUND: In patients with a continuous-flow left ventricular assist device, preimplant predictors of poor physical performance are not well-described. We aimed to identify predictors of inability to walk more than 300 m on 6-minute walk test (6MWT) 6 months after HeartMate 3 implantation. METHODS AND RESULTS: Using data from the European Registry of Patients Implanted With a Full Magnetically Levitated LVAD, patients with available 6MWT at 6 months after implantation were included (N = 194) and grouped according to 6MWT distance (6MWD) of >300 m (n = 150) or 6MWD of <300 m (n = 44). Patients walking <300 m were older (60 ± 10 vs 52 ± 12 years; P < .001), more often New York Heart Association functional class IV (63% vs 42%; P = .03), and more often had type 2 diabetes (43% vs 17%; P < .001) at implantation. Atrial fibrillation was seen in 57% in those with a 6MWT of <300 m vs 31% in those walking longer (P < .002). Further, hemoglobin and estimated glomerular filtration rate was lower in those walking <300 m (both P < .01). In multivariable regression analysis, independent predictors of a 6MWD of <300 m were: atrial fibrillation (odds ratio [OR], 3.22; 95% confidence interval [CI], 1.12-8.67), older age (OR for 10-year increment, 2.81; 95% CI, 1.55-5.07), New York Heart Association functional class IV (OR, 3.37; 95% CI, 1.27-8.98), and Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (OR, 6.53; 95% CI, 1.92-22.19). CONCLUSIONS: Six months after HeartMate 3 implantation, 77% of patients walked >300 meters in 6 minutes. Apart from age and measures of heart failure severity, atrial fibrillation at implantation is an independent predictor of low 6MWD at 6 months after implantation.

• Klíčová slova
• 6-minute walk test, Continuous-flow left ventricular assist device, Exercise, Work intolerance,
• MeSH
• diabetes mellitus 2. typu * MeSH
• lidé MeSH
• podpůrné srdeční systémy * MeSH
• registrace MeSH
• senioři MeSH
• srdeční selhání * epidemiologie   terapie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH

AIM: This study aimed to assess safety and outcomes of patients, 2 years after implantation with the HeartMate 3 Left Ventricular Assist System. METHODS AND RESULTS: This study included 50 adults with New York Heart Association (NYHA) class IIIB or IV symptoms or American College of Cardiology/American Heart Association stage D heart failure with an ejection fraction ≤25% and a cardiac index ≤2.2 L/min/m2 without inotropes, or inotrope-dependent with optimal medical management, or listed for heart transplant. The median duration of left ventricular assist device support was 694 days (range: 19-833 days). At baseline, cardiac index was 1.8 ±0.5 L/min/m2 , 58% of patients were receiving inotropes, and 92% were INTERMACS profiles 2-4. At 2 years, Kaplan-Meier survival was 74 ±6%, 5 (10%) patients were transplanted, and 32 patients (64%) remain with support. Adverse event rates include bleeding requiring surgery (16%), gastrointestinal bleeding (20%), driveline infection (24%), ischaemic stroke (16%), haemorrhagic stroke (8%), right heart failure (14%), and outflow graft thrombosis (2%). Notably, no haemolysis, pump thrombosis, or pump malfunction events occurred. At 2 years, 47% of patients remained in NYHA class I and 41% in NYHA class II (P <0.0001). From baseline to 2 years, the mean six-minute walk distance increased from 239 m to 347 m (P <0.0001), and the mean EQ-5D quality of life score improved from 48.2 to 70.6 (P < 0.0001). CONCLUSIONS: Two years post-HeartMate 3 implantation, results show expected and acceptable survival, enhanced haemocompatibility, improved patient functional status and quality of life. This corroborates the success of HeartMate 3 since its first-in-man implantation case in Germany. ClinicalTrials.gov: NCT02170363.

• Klíčová slova
• Heart failure, HeartMate 3, Left ventricular assist system, Magnetic levitation,
• MeSH
• časové faktory MeSH
• design vybavení MeSH
• lidé středního věku MeSH
• lidé MeSH
• míra přežití trendy   MeSH
• následné studie MeSH
• podpůrné srdeční systémy * MeSH
• prospektivní studie MeSH
• srdeční komory patofyziologie   MeSH
• srdeční selhání mortalita   patofyziologie   terapie   MeSH
• tepový objem fyziologie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Austrálie epidemiologie   MeSH
• Evropa epidemiologie   MeSH
• Kanada epidemiologie   MeSH
• Kazachstán epidemiologie   MeSH
• Spojené státy americké epidemiologie   MeSH

BACKGROUND: The Heartmate 3 (HM3) is a Conformiteé Européenne mark-approved left ventricular (LV) assist device (LVAD) with fully magnetically levitated rotor and features consisting of a wide range operational speeds, wide flow paths, and artificial pulse. We performed a hemodynamic-echocardiographic speed optimization evaluation in HM3-implanted patients to achieve optimal LV- and right ventricular (RV) shape. METHODS AND RESULTS: Sixteen HM3 patients underwent pump speed ramp tests with right heart catheterization. Three-dimensional echocardiographic (3DE) LV and RV datasets (Philips) were acquired, and volumetric (Tomtec) and shape (custom software) analyses were performed (LV: sphericity, conicity; RV: septal and free-wall curvatures). Data were recorded at up to 13 speed settings. Speed changes were in 100-rpm steps, starting at 4600 rpm and ramping up to 6200 rpm. 3DE was feasible in 50% of the patients. Mean original speed was 5306 ± 148 rpm. LV end-diastolic (ED) diameter (-0.15 ± 0.09 cm/100 rpm) and volumes (ED: 269 ± 109 mL to 175 ± 90 mL; end-systolic [ES]: 234 ± 111 mL to 146 ± 81 mL) progressively decreased as the shape became less spherical and more conical; RV volumes initially remained stable, but at higher speeds increased (ED: from 148 ± 64 mL to 181 ± 92 mL; ES: 113 ± 63 mL to 130 ± 69 mL). On average, the RV septum became less convex (bulging toward the LV) at the highest speeds. CONCLUSIONS: LV and RV shape changes were noted in HM3-supported patients. Although a LV volumetric decrease and shape improvement was consistently noted, RV volumes grew in response to increase in speed above a certain point. A next concern would be whether understanding of morphologic and function changes in LV and RV during LVAD speed change assessed with the use of 3DE helps to optimize LVAD speed settings and improve clinical outcomes.

• Klíčová slova
• HVAD, Heartmate 3, conicity, echocardiography, ramp test, sphericity,
• MeSH
• echokardiografie trojrozměrná trendy   MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetoterapie metody   trendy   MeSH
• podpůrné srdeční systémy trendy   MeSH
• prospektivní studie MeSH
• senioři MeSH
• srdeční katetrizace metody   trendy   MeSH
• srdeční komory diagnostické zobrazování   chirurgie   MeSH
• srdeční selhání diagnostické zobrazování   terapie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH

BACKGROUND: The novel HeartMate 3 (Abbott, Chicago, IL, USA) left ventricular assist device (LVAD) was worldwide first implanted by Prof. Schmitto and his team in 2014 at the Hannover Medical School, Germany and received CE Mark approval in October, 2015 following completion of a clinical trial. METHODS: Although HeartMate 3 implantation in the clinical trial was restricted to conventional sternotomy, the small size of the pump allows for less-invasive implantation, generally associated with less trauma and reduced perioperative complication rates. Herein we describe our first experiences with a less-invasive implantation of the HeartMate 3 using an upper hemi-sternotomy combined with anterior lateral thoracotomy approach. RESULTS: Results demonstrate the feasibility of this novel, less invasive technique for HeartMate 3 LVAD implantation with diminished surgical trauma, less postoperative bleeding, maintenance of the chest stability, reduced need of blood product transfusion and earlier recovery. CONCLUSIONS: The results of our study indicate that less-invasive implantation of the HeartMate 3 is technically feasible and offers several benefits for surgical outcome and may become the standard of care for LVAD implantation techniques.

• Klíčová slova
• HeartMate 3, Less-invasive, implantation, left ventricular assist device (LVAD),
• Publikační typ
• časopisecké články MeSH

BACKGROUND: The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein. METHODS: A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days. RESULTS: Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 + 0.5 L/min/m2 and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006). CONCLUSIONS: The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient's functional status and quality of life significantly improved over time. TRIAL REGISTRATION: Clinicaltrials.gov registration number: NCT02170363 . Registered June 19, 2014.

• Klíčová slova
• Heart failure, HeartMate 3, LVAS, Magnetic levitation,
• MeSH
• časové faktory MeSH
• design vybavení MeSH
• hemodynamika fyziologie   MeSH
• kvalita života MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnety MeSH
• následné studie MeSH
• podpůrné srdeční systémy * MeSH
• prospektivní studie MeSH
• srdeční selhání patofyziologie   terapie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH

BACKGROUND: Current recommendations of antithrombotic therapy for HeartMate II (HMII) patients include the use of both an anticoagulant and an antiplatelet agent. Because bleeding is still the most frequent adverse event, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelet Therapy in Patients with the HeartMatE II) study was initiated to evaluate the incidence of adverse events in HMII patients on reduced antithrombotic (RT) therapy. METHODS: HMII patients (n = 101) from nine centers were enrolled in the European arm of TRACE and were managed on a single anticoagulant (vitamin K antagonist) with no antiplatelet agents. An analysis of bleeding and thrombotic adverse events from all 101 patients with 2-year follow-up after initiation of RT therapy is reported here. RESULTS: Median age was 56 years (range, 18 to 72 years), 93% were men, 70% had an Interagency Registry for Mechanically Assisted Circulatory Support profile 1 to 3, and 82% received the HMII as a bridge to transplantation. Ninety-two percent were placed on RT therapy as a center standard of care or due to physician preference and 6% as a response to bleeding. Median HMII support duration on RT therapy was 25 months (range, 1 to 93 months). Median international normalized ratio was 2.31 [quartile 1 to quartile 3: 2.07 to 2.60]. At 2 years, freedom from bleeding, ischemic stroke, hemorrhagic stroke, and pump thrombosis after initiation of RT therapy was 81% ± 6%, 96% ± 2%, 94% ± 3%, and 94% ± 3%, respectively. CONCLUSIONS: The 2-year analysis of the observational European TRACE study suggests that managing HMII patients with a vitamin K antagonist with a target international normalized ratio of 2.3 without antiplatelet therapy may help to reduce the incidence of major bleeding without increasing the risk of thromboembolic events, including ischemic stroke and pump thrombosis.

• MeSH
• antikoagulancia terapeutické užití   MeSH
• časové faktory MeSH
• dospělí MeSH
• incidence MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• kohortové studie MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• podpůrné srdeční systémy * MeSH
• pooperační krvácení epidemiologie   MeSH
• senioři MeSH
• srdeční selhání mortalita   terapie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH
• Geografické názvy
• Evropa MeSH
• Názvy látek
• antikoagulancia MeSH
• inhibitory agregace trombocytů MeSH