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1.
Artigo em Inglês | MEDLINE | ID: mdl-31317177

RESUMO

OBJECTIVES: Pump thrombosis (PT) and thromboembolic events (TEs) remain major adverse events in left ventricular assist device (LVAD) therapy at an annual rate of 6-8% supported with the HeartWare HVAD and HeartMate II. PT and TEs are multifactorial events. Understanding the predisposing risk factors for PT and TE is paramount to define preventive strategies. Preoperative atrial fibrillation (AF) is considered a significant and potentially modifiable risk factor. This study investigates whether LVAD patients with AF exhibit a higher rate of PT and TE than those in sinus rhythm (SR). METHODS: We evaluated medical records of consecutive patients who underwent implantation of the HeartMate II (n = 195; 25.4%) and HeartWare HVAD (n = 574; 74.6%) at our institution between 2006 and 2015. Only visually confirmed PT was included in the study. TE was defined as any peripheral embolism or cerebral embolism according to the INTERMACS definitions. RESULTS: SR was documented preoperatively in 211 patients (SR group) and AF in 558 patients (AF group). The median duration of support was 0.78 years in the AF group and 1.03 years in the SR group. The mean age was 60.27 years in the AF group and 52.04 years in the SR group. In the AF group, 83.0% of the patients were male, compared to 77.3% in the SR group. The cumulative incidence of PT in the SR group was 2.5% [95% confidence interval (CI) 0.3-4.7%] after 1 year and 5.7% (95% CI 2.2-9.2%) after 2 years, and in the AF group 4.9% (95% CI 3.0-6.7%) and 7.8% (95% CI 5.4-10.2%), respectively (P = 0.129). TEs were recorded in the SR group in 4.4% (95% CI 1.6-7.2%) after 1 year and in 6.3% (95% CI 2.8-9.8%) after 2 years, and occurred after a median support time of 214 days (range 120-768). In the AF group, the cumulative incidence was 8.4% (95% CI 6.0-10.7%) and 10.7% (95% CI 8.0-13.4%), respectively, after a median support time of 116 days (range 37-375), P-value = 0.163. In the multivariate analysis, event-free survival was not influenced by the preoperative SR [hazard ratio (HR) 0.86, 95% CI 0.68-1.1; P = 0.19]. CONCLUSIONS: Our study showed that the preoperative rhythm has no impact on survival, PT and TEs despite different preoperative risk factor profiles in the AF and SR group. Thus, the effect of a maze procedure, catheter ablation or left atrial appendage closure on PT and TE's for AF patients during LVAD implantation is questionable. However, to obtain a definitive answer, a prospective study would be of value.

2.
Eur J Cardiothorac Surg ; 56(2): 230-270, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31100109

RESUMO

Long-term mechanical circulatory support (LT-MCS) is an important treatment modality for patients with severe heart failure. Different devices are available, and many-sometimes contradictory-observations regarding patient selection, surgical techniques, perioperative management and follow-up have been published. With the growing expertise in this field, the European Association for Cardio-Thoracic Surgery (EACTS) recognized a need for a structured multidisciplinary consensus about the approach to patients with LT-MCS. However, the evidence published so far is insufficient to allow for generation of meaningful guidelines complying with EACTS requirements. Instead, the EACTS presents an expert opinion in the LT-MCS field. This expert opinion addresses patient evaluation and preoperative optimization as well as management of cardiac and non-cardiac comorbidities. Further, extensive operative implantation techniques are summarized and evaluated by leading experts, depending on both patient characteristics and device selection. The faculty recognized that postoperative management is multidisciplinary and includes aspects of intensive care unit stay, rehabilitation, ambulatory care, myocardial recovery and end-of-life care and mirrored this fact in this paper. Additionally, the opinions of experts on diagnosis and management of adverse events including bleeding, cerebrovascular accidents and device malfunction are presented. In this expert consensus, the evidence for the complete management from patient selection to end-of-life care is carefully reviewed with the aim of guiding clinicians in optimizing management of patients considered for or supported by an LT-MCS device.

3.
Eur Heart J ; 40(26): 2164-2169, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30891599

RESUMO

AIMS: Haemodynamic load induces cardiac remodelling via mechano-transduction pathways, which can further trigger inflammatory responses. We hypothesized that particularly in an inflammatory disorder such as myocarditis, a therapeutic strategy is required which, in addition to providing adequate circulatory support, unloads the left ventricle, decreases cardiac wall stress, and mitigates inflammatory responses. METHODS AND RESULTS: Axial flow pumps such as the Impella systems comply with these requirements. Here, we report a potential mode-of-action of prolonged Impella support (PROPELLA concept) in fulminant myocarditis, including a decrease in cardiac immune cell presence, and integrin α1, α5, α6, α10 and ß6 expression during unloading. CONCLUSION: PROPELLA may provide benefits beyond its primary function of mechanical circulatory support in the form of additional disease-altering effects, which may contribute to enhanced myocardial recovery/remission in patients with chronic fulminant myocarditis.

4.
J Heart Lung Transplant ; 37(12): 1399-1402, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30241889

RESUMO

Significant right ventricular failure accompanying left ventricular failure was treated by implantation of the fully magnetically levitated centrifugal HeartMate 3 ventricular assist device as biventricular (BiVAD) support in 14 patients at 6 medical centers worldwide. The clinical details of this first multicenter experience are presented. Nine of these patients (64%) were alive as of January 1, 2018. Eight of the 9 have continued on BiVAD support for 95 to 636 (mean 266) days: 7 at home, and 1 successfully transplanted after 98 days of support.

6.
Artigo em Inglês | MEDLINE | ID: mdl-30084076

RESUMO

Mechanical circulatory support (MCS) is often required to stabilize patients with acute fulminant myocarditis with cardiogenic shock. This review gives an overview of the successful use of left-sided Impella in the setting of fulminant myocarditis and cardiogenic shock as the sole means of MCS as well as in combination with right ventricular (RV) support devices including extracorporeal life support (ECLS) (ECMELLA) or an Impella RP (BI-PELLA). It further provides evidence from endomyocardial biopsies that in addition to giving adequate support, LV unloading by Impella exhibits disease-modifying effects important for myocardial recovery (i.e., bridge-to-recovery) achieved by this newly termed "prolonged Impella" (PROPELLA) concept in which LV-IMPELLA 5.0, implanted via an axillary approach, provides support in awake, mobilized patients for several weeks. Finally, this review addresses the question of how to define the appropriate time point for weaning strategies and for changing or discontinuing unloading in fulminant myocarditis.

11.
J Am Coll Cardiol ; 67(23): 2758-2768, 2016 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-27282897

RESUMO

BACKGROUND: Thrombosis is an uncommon, but severe complication of left ventricular assist devices (LVADs). OBJECTIVES: This study analyzed experience with obstruction of blood flow through the LVAD with the purpose of developing optimal diagnosis and treatment of LVAD-related thrombosis. METHODS: Between October 2009 and July 2015, a total of 652 LVAD were implanted in 557 patients. Blood flow abnormalities in patients with LVAD (n = 524) were identified and classified as "high-power" and "low-flow" events. RESULTS: Three types of late blood flow obstructions were identified: 1) pre-pump via thrombus obstructing the inflow cannula (26 events; 0.037 events per patient-year); 2) intra-pump (70 events; 0.1 events per patient-year); and 3) post-pump via thrombosis of the outflow graft or stenosis of the anastomosis to the aorta (4 events; 0.006 events per patient-year). Pre-pump obstruction was treated by washout maneuver in 9 cases (success rate, 100%), thrombolysis in 9 patients (success rate, 56%), and pump exchange in 9 cases (success rate, 100%); 1 patient died without treatment and 2 were weaned from LVAD. Intra-pump obstruction was treated by thrombolysis (n = 9; success rate, 33%), pump exchange (n = 53; success rate, 94%), and removal due to myocardial recovery (n = 3; success rate, 100%); 7 patients died without treatment and parameters spontaneously normalized in 2 cases. Post-pump obstruction was treated in 2 patients by stenting (success rate, 100%), and was left untreated in 2 cases. CONCLUSIONS: We identified 3 types of LVAD-related blood flow obstruction, and developed an algorithm for optimal diagnosis and treatment.


Assuntos
Algoritmos , Coração Auxiliar/efeitos adversos , Trombose/etiologia , Desenho de Equipamento , Falha de Equipamento , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Trombectomia/instrumentação , Trombose/mortalidade , Trombose/terapia , Tirofibana , Tirosina/análogos & derivados , Tirosina/uso terapêutico
12.
Dtsch Arztebl Int ; 113(3): 39-40, 2016 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-26857514
14.
J Thorac Cardiovasc Surg ; 149(6): e115-6, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25749142

Assuntos
Estimulação Cardíaca Artificial , Procedimentos Cirúrgicos Cardíacos , Cardiomiopatia Dilatada/cirurgia , Cardiopatias Congênitas/cirurgia , Insuficiência Cardíaca/cirurgia , Coração Auxiliar , Insuficiência da Valva Mitral/cirurgia , Implantação de Prótese/instrumentação , Insuficiência da Valva Tricúspide/cirurgia , Disfunção Ventricular Direita/cirurgia , Adolescente , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Cardiomiopatia Dilatada/complicações , Cardiomiopatia Dilatada/diagnóstico , Cardiomiopatia Dilatada/fisiopatologia , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Cardiopatias Congênitas/complicações , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/fisiopatologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/fisiopatologia , Transplante de Coração , Hemodinâmica , Humanos , Masculino , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/fisiopatologia , Marca-Passo Artificial , Desenho de Prótese , Reoperação , Esternotomia , Fatores de Tempo , Resultado do Tratamento , Insuficiência da Valva Tricúspide/diagnóstico , Insuficiência da Valva Tricúspide/etiologia , Insuficiência da Valva Tricúspide/fisiopatologia , Disfunção Ventricular Direita/diagnóstico , Disfunção Ventricular Direita/etiologia , Disfunção Ventricular Direita/fisiopatologia , Listas de Espera
15.
Eur J Cardiothorac Surg ; 47(1): e29-33, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25349161

RESUMO

OBJECTIVES: Mechanical circulatory support (MCS) creates improvement of cardiac function in a small portion of patients with idiopathic dilated cardiomyopathy (iDCM). Among other factors, cardiomyocyte hypertrophy seems to represent an important prerequisite for MCS-related cardiac recovery. We have previously shown that connective tissue growth factor (CTGF) leads to adaptive cardiomyocyte hypertrophy associated with a protective cardiac function in transgenic mice. To test whether a functional genetic variant in the CTGF promoter impacts MCS-related cardiac recovery, three groups of iDCM patients with and without cardiac recovery on MCS were genotyped. METHODS: The CTGF promoter variant (c.-945C>G) was analysed in 314 patients with iDCM receiving medical treatment only (Group I). Forty-nine iDCM patients who were either weaned from MCS for more than 6 months (Group II; n=20) or bridged to cardiac transplantation (Group III: n=29) were also genotyped. Patients on MCS were followed up for at least 12 months. Clinical characteristics and outcome on MCS were correlated with the respective genotypes. RESULTS: The c.-945C>G allele frequencies in 314 iDCM patients (Group I) were similar to controls deposited in the HapMap database or those published in a recent study. There were no differences in allele prevalence between patients with mild to moderate iDCM (Group I) compared with patients with severe iDCM requiring MCS (Groups II and III). Intriguingly, 50% of patients who were weaned from MCS (Group II) were homozygous for the G allele compared with only 17.2% of patients included in Group III, which is a significant difference (P=0.03). CONCLUSIONS: Homozygosity of the promoter-activating G allele in the CTGF_c.-945C>G variant is overrepresented in patients with cardiac recovery on MCS when compared with iDCM patients without cardiac recovery. Further studies are needed to evaluate c.-945C>G as a genetic predictor for clinical outcome on MCS.


Assuntos
Cardiomiopatia Dilatada/genética , Fator de Crescimento do Tecido Conjuntivo/genética , Coração Auxiliar , Polimorfismo de Nucleotídeo Único/genética , Regiões Promotoras Genéticas/genética , Adulto , Cardiomiopatia Dilatada/cirurgia , Feminino , Frequência do Gene/genética , Marcadores Genéticos/genética , Genótipo , Homozigoto , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
16.
Eur J Cardiothorac Surg ; 47(6): 984-9, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25209626

RESUMO

OBJECTIVES: The implantable continuous-flow left ventricular assist devices (LVADs) HeartMate II (HM II) and HeartWare HVAD (HW) underwent design modifications. The impact of these changes on life-threatening pump malfunctions was evaluated. METHODS: We retrospectively analysed pump malfunctions due to thrombosis or cable damage in patients supported with primarily implanted HM II (n = 191) and HW (n = 347), separated into patients supported with the old and new pump designs. In 2010, the cable strain relief of the HM II device was improved (132 patients with old and 79 with new) and sealed grafts were introduced (68 patients with sealed inflow connector and outflow graft and 125 without). In 2011, titanium sintering of the inflow cannula of HW pumps was introduced (137 patients with a non-sintered and 210 with a sintered inflow cannula). RESULTS: The median support time was 1.12 (0-6.1) years for all HM II and 0.59 (0-4.2) years for all HW patients. The cumulative rate of events per patient-year (EPPY) was 0.11 in HM II patients, compared with 0.09 EPPY in HW patients (P = 0.32). After introduction of the new cable design, incidence of cable damage in HM II patients dropped from 0.06 to 0 EPPY (P = 0.03), whereas pump thrombosis increased from 0.02 to 0.14 EPPY (P < 0.001) after the sealed graft was introduced. Pump thrombosis occurred in 4% of patients supported with HW with a sintered inflow cannula vs 15% with a non-sintered pump; the incidence changed from 0.10 to 0.07 EPPY in sintered pumps (P = 0.45). Kaplan-Meier analysis showed no differences over a period of 2.5 years for events when the HM II cohort with sealed graft and new cable design (n = 68) was compared with the HW group with a sintered cannula (P = 0.14). CONCLUSIONS: The modified cable strain relief of the HM II pump and the sintering of the inflow cannula of the HW pump demonstrated a significant reduction in the incidence of life-threatening pump-related complications, whereas the sealed inflow connector and outflow graft seem to be associated with a higher incidence of pump thrombosis. However, the overall incidence of pump-related complications after the latest design changes was similar for both pumps over a 2.5-year period.


Assuntos
Procedimentos Cirúrgicos Cardíacos/instrumentação , Procedimentos Cirúrgicos Cardíacos/mortalidade , Coração Auxiliar/efeitos adversos , Coração Auxiliar/estatística & dados numéricos , Desenho de Prótese/mortalidade , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Análise de Falha de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Trombose , Adulto Jovem
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