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1.
JACC Clin Electrophysiol ; 5(8): 944-954, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31439296

RESUMO

OBJECTIVES: This study aimed to evaluate incidence, clinical significance, and predictors of early ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients. BACKGROUND: LVAD implantation is increasingly used in patients with end-stage heart failure. Early VAs may occur during the 30-day post-operative period, but many questions remain unanswered regarding their incidence and clinical impact. METHODS: This observational study was conducted in 19 centers between 2006 and 2016. Early VAs were defined as sustained ventricular tachycardia and/or ventricular fibrillation occurring <30 days post-LVAD implantation and requiring appropriate implantable cardioverter-defibrillator therapy, external electrical shock, or medical therapy. RESULTS: A total of 652 patients (median age: 59.8 years; left ventricular ejection fraction: 20.7 ± 7.4%; HeartMate 2: 72.8%; HeartWare: 19.5%; Jarvik 2000: 7.7%) were included in the analysis. Early VAs occurred in 162 patients (24.8%), most frequently during the first week after LVAD implantation. Multivariable analysis identified history of VAs prior to LVAD and any combined surgery with LVAD as 2 predictors of early VAs. The occurrence of early VAs with electrical storm was the strongest predictor of 30-day post-operative mortality, associated with a 7-fold increase of 30-day mortality. However, in patients discharged alive from hospital, occurrence of early VAs did not influence long-term survival. CONCLUSIONS: Early VAs are common after LVAD implantation and increase 30-day post-operative mortality, without affecting long-term survival. Further studies will be needed to analyze whether pre- or pre-operative ablation of VAs may improve post-operative outcomes. (Determination of Risk Factors of Ventricular Arrhythmias After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device [ASSIST-ICD]; NCT02873169).

2.
Perfusion ; : 267659119864814, 2019 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-31359829

RESUMO

BACKGROUND: Thrombocytopenia is a common disorder after heart or lung transplantation. Platelet transfusion is often required to maintain haemostasis but represents a specific cause of morbidity and mortality in this setting including alloimmunisation and graft rejection. STUDY DESIGN AND METHODS: As part of a health-care quality improvement project, in a single-centre before-after pilot study, the relevance of a platelet transfusion saving strategy based on romiplostim administration after transplantation was assessed in patients with platelet count <100 × 109/L. Transfusions on days 28 and 90 were compared using propensity matched score for adjustment of demographic characteristics at baseline. The primary outcome was platelet transfusion until day 28 after transplantation. RESULTS: Ninety-three patients were analysed (73 before vs. 20 after). The median [interquartile range] number of platelet concentrate was 1 [0;4.0] before versus 0.5 [0;2.0] in the after period, mean difference 0.5 confidence interval 95% [-0.7 to 1.7], p = 0.39. On day 28, median [interquartile range] red blood cell transfusion was significantly higher in the before versus the after period, 7 [2.0;13.5] versus 6 [1.5;8.5], mean difference 3.2 CI 95% [0.4-6.0], p = 0.02. At 6 months, the rate of patients with de novo anti-human leukocyte antigen alloimmunisation was 45% before versus 53% in the after period (p = 0.56). Deep venous thrombosis was detected in nine patients (12%) before versus seven patients (35%) in the after period (p = 0.04). CONCLUSION: Romiplostim did not significantly reduce platelet transfusion after heart or lung transplantation. Its relevance and safety in a global transfusion strategy remains to be studied in this setting in a large randomised study.

3.
Xenotransplantation ; : e12535, 2019 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-31293002

RESUMO

Humans cannot synthesize N-glycolylneuraminic acid (Neu5Gc) but dietary Neu5Gc can be absorbed and deposited on endothelial cells (ECs) and diet-induced anti-Neu5Gc antibodies (Abs) develop early in human life. While the interaction of Neu5Gc and diet-induced anti-Neu5Gc Abs occurs in all normal individuals, endothelium activation by elicited anti-Neu5Gc Abs following a challenge with animal-derived materials, such as following xenotransplantation, had been postulated. Ten primary human EC preparations were cultured with affinity-purified anti-Neu5Gc Abs from human sera obtained before or after exposure to Neu5Gc-glycosylated rabbit IgGs (elicited Abs). RNAs of each EC preparation stimulated in various conditions by purified Abs were exhaustively sequenced. EC transcriptomic patterns induced by elicited anti-Neu5Gc Abs, compared with pre-existing ones, were analyzed. qPCR, cytokines/chemokines release, and apoptosis were tested on some EC preparations. The data showed that anti-Neu5Gc Abs induced 967 differentially expressed (DE) genes. Most DE genes are shared following EC activation by pre-existing or anti-human T-cell globulin (ATG)-elicited anti-Neu5Gc Abs. Compared with pre-existing anti-Neu5Gc Abs, which are normal component of ECs environment, elicited anti-Neu5Gc Abs down-regulated 66 genes, including master genes of EC function. Furthermore, elicited anti-Neu5Gc Abs combined with complement-containing serum down-regulated most transcripts mobilized by serum alone. Both types of anti-Neu5Gc Abs-induced a dose- and complement-dependent release of selected cytokines and chemokines. Altogether, these data show that, compared with pre-existing anti-Neu5Gc Abs, ATG-elicited anti-Neu5Gc Abs specifically modulate genes related to cytokine responses, MAPkinase cascades, chemotaxis, and integrins and do not skew the EC transcriptome toward a pro-inflammatory profile in vitro.

4.
Artigo em Inglês | MEDLINE | ID: mdl-31230964

RESUMO

OBJECTIVE: To determine whether high-flow oxygen therapy by nasal cannulae (HFNC) is more effective than a high-flow face mask (HFFM) in severe hypoxemia. DESIGN: Randomized, single-center, open-labeled, controlled trial. SETTING: University Hospital of Nantes, France. PARTICIPANTS: Cardiac surgery patients presenting oxygen saturation <96% with Venturi mask 50%. INTERVENTION: Oxygenation by HFNC (45 L/min, FIO2 100%) or Hudson RCI non-rebreather face mask with a reservoir bag (15 L/min). MEASUREMENTS AND MAIN RESULTS: The co-primary outcomes were the PaO2/FIO2 ratio at 1 and 24 hours. In the intent-to-treat analysis (90 patients), the mean (standard deviation) PaO2/FIO2 ratios were: after 1 hour, 113.4 (50.2) in HFFM versus 137.8 (57.0) in HFNC (mean difference 24.4, CI 97.5% [2.9-45.9], p = 0.03), and after 24 hours, 106.9 (62.6) in HFFM versus 129.9 (54.0) in HFNC (mean difference 23.0, CI 97.5% [1.5-44.6], p = 0.04). After adjustment on baseline PaO2/FIO2, this difference persisted at 24 hours (p = 0.04). For secondary outcomes, the PaO2/FIO2 ratio after 6 hours was 108.7 (47.9) in HFFM versus 136.0 (45.2) in HFNC (p = 0.01), without difference after 48 hours (p = 0.95). Refractory hypoxemia requiring noninvasive ventilation occurred in 13 (28%) patients in HFNC versus 24 (56%) patients in HFFM (p = 0.007). The HFNC improved satisfaction (p = 0.0002) and reduced mucus dryness (p = 0.003) compared with HFFM. CONCLUSION: In patients with severe hypoxemia after cardiac surgery, PaO2/FIO2 at 1 and 24 hours were higher and the use of noninvasive ventilation was reduced in HFNC compared with HFFM.

5.
Am Heart J ; 214: 69-76, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31174053

RESUMO

BACKGROUND: Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections. METHODS: Patients included in the ASSIST-ICD study (19 centers) were enrolled. The main outcome was the occurrence of LVAD-associated infection (driveline infection, pocket infection, or pump/cannula infection) during follow-up. RESULTS: Of the 652 patients enrolled, 201 (30.1%) presented a total of 248 LVAD infections diagnosed 6.5 months after implantation, including 171 (26.2%), 51 (7.8%), and 26 (4.0%) percutaneous driveline infection, pocket infection, or pump/cannula infection, respectively. Patients with infections were aged 58.7 years, and most received HeartMate II (82.1%) or HeartWare (13.4%). Most patients (62%) had implantable cardioverter-defibrillators (ICDs) before LVAD, and 104 (16.0%) had ICD implantation, extraction, or replacement after the LVAD surgery. Main pathogens found among the 248 infections were Staphylococcus aureus (n = 113' 45.4%), Enterobacteriaceae (n = 61; 24.6%), Pseudomonas aeruginosa (n = 34; 13.7%), coagulase-negative staphylococci (n = 13; 5.2%), and Candida species (n = 13; 5.2%). In multivariable analysis, HeartMate II (subhazard ratio, 1.56; 95% CI, 1.03 to 2.36; P = .031) and ICD-related procedures post-LVAD (subhazard ratio, 1.43; 95% CI, 1.03-1.98; P = .031) were significantly associated with LVAD infections. Infections had no detrimental impact on survival. CONCLUSIONS: Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation.

6.
EuroIntervention ; 15(4): e329-e335, 2019 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-30987963

RESUMO

AIMS: Percutaneous mitral valve repair has become an alternative to conventional surgery in patients suffering primary mitral regurgitation (MR) with a contraindication to surgery and could benefit patients at high surgical risk. The aim of the MITRA-HR study is to raise the level of evidence supporting the use of the MitraClip device in primary MR patients with a predefined high risk for surgery. METHODS AND RESULTS: MITRA-HR is a prospective, multicentre, randomised study designed to compare mitral valve repair using the MitraClip with conventional surgery in patients with severe primary mitral regurgitation at high risk for surgery. The surgical risk is defined by age, Society of Thoracic Surgeons (STS) risk estimate score, frailty, major organ system dysfunction, and procedure-specific impediments. The study will enrol 330 patients randomised between conventional surgery and MitraClip with a 1:1 ratio. The composite primary endpoint includes all-cause mortality, unplanned rehospitalisation for cardiovascular reasons, and mitral valve reintervention at 12 months. The main secondary safety endpoint is a major adverse event composite assessment evaluated 30 days after the procedure. CONCLUSIONS: The randomised MITRA-HR study is designed to provide additional supportive evidence of non-inferiority in efficacy and superiority in safety for percutaneous mitral valve repair using the MitraClip compared to conventional surgery in high surgical risk patients.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Valva Mitral , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do Tratamento
7.
Artigo em Inglês | MEDLINE | ID: mdl-30415900

RESUMO

OBJECTIVES: Structural valve deterioration (SVD) remains a major bioprosthesis-related complication, as recently described for the Mitroflow valve (models LX and 12A) (LivaNova, London, United Kingdom). The real incidence of the SVD risk remains unclear, often due to methodologic pitfalls by systematically using the Kaplan-Meier estimator and/or the Cox model. In this report, we propose for the first time a precise statistical modeling of this issue. METHODS: Five hundred sixty-one patients who underwent aortic valve replacement with the aortic Mitroflow valve between 2002 and 2007 were included. We used an illness-death model for interval-censored data. Median follow-up was 6.6 years; 103 cases of SVD were diagnosed. RESULTS: The 4-year and 7-year SVD cumulative incidences after the first anniversary of surgery were 15.2% (95% confidence interval, 11.9-19.1) and 31.0% (95% confidence interval, 25.8-37.2), respectively. Female gender, dyslipidemia, chronic obstructive pulmonary disease, and severe patient-prosthesis mismatch were significant risk factors of SVD. The occurrence of SVD was associated with a 2-fold increase in the risk of death. CONCLUSIONS: Appropriate statistical models should be used to avoid underestimating the SVD complication associated with worse long-term survival.

8.
Stat Med ; 37(8): 1245-1258, 2018 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-29205409

RESUMO

Multistate models with interval-censored data, such as the illness-death model, are still not used to any considerable extent in medical research regardless of the significant literature demonstrating their advantages compared to usual survival models. Possible explanations are their uncommon availability in classical statistical software or, when they are available, by the limitations related to multivariable modelling to take confounding into consideration. In this paper, we propose a strategy based on propensity scores that allows population causal effects to be estimated: the inverse probability weighting in the illness semi-Markov model with interval-censored data. Using simulated data, we validated the performances of the proposed approach. We also illustrated the usefulness of the method by an application aiming to evaluate the relationship between the inadequate size of an aortic bioprosthesis and its degeneration or/and patient death. We have updated the R package multistate to facilitate the future use of this method.

9.
Soins ; 62(820): 26-28, 2017 Nov.
Artigo em Francês | MEDLINE | ID: mdl-29153213

RESUMO

Circulatory assistance is developing as a treatment for patients with end-stage heart failure. There are two alternative devices: a univentricular circulatory assist pump, or a total artificial heart. It is used to bridge the time to transplantation and, increasingly, as a definitive alternative to a heart transplant.


Assuntos
Circulação Assistida , Insuficiência Cardíaca/cirurgia , Transplante de Coração , Humanos
10.
Circulation ; 130(23): 2012-20, 2014 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-25355912

RESUMO

BACKGROUND: Structural valve deterioration (SVD) is a major flaw of bioprostheses. Early SVD has been suspected in the last models of Mitroflow bioprosthesis. We sought to assess the incidence, mode, and impact of SVD on outcome in a large series of Mitroflow aortic valve replacement. METHODS AND RESULTS: Six hundred seventeen consecutive patients (aged 76.1±6.3 years) underwent aortic valve replacement with a Mitroflow prosthesis (models 12A/LX) between 2002 and 2007. By echocardiography, 39 patients developed early SVD (1.66% per patient-year), with stenosis as the main mode (n=36). Mean delay to SVD was only 3.8±1.4 years, and 5-year SVD-free survival was 91.6% (95% confidence interval [CI], 88.7-94.7) for the whole cohort and 79.8% (95% CI, 71.2-89.4) and 94.0% (95% CI, 90.3-97.8) for 19- and 21-mm sizes, respectively. Among the 39 patients with SVD, 13 patients (33%) had an accelerated SVD once the mean gradient exceeded 30 mm Hg. Valve-related death was 46.2% in this SVD subgroup. Five-year overall survival was 69.6% (95% CI, 65.7-73.9). In multivariable analysis, SVD was the strongest correlate of overall mortality (hazard ratio=7.7; 95% CI, 4.4-13.6). CONCLUSIONS: Early SVD is frequent in Mitroflow bioprosthesis (models 12A/LX), especially for small sizes (19 and 21 mm), and reduces overall survival. An unpredictable accelerated pattern of SVD constitutes a life-threatening condition. In view of the large number of Mitroflow valves implanted worldwide, one can expect an epidemic of SVD and valve-related deaths, which represents a major public health issue, especially in the elderly. Hence, a close follow-up with yearly echocardiography after Mitroflow implantation is advisable. An urgent reoperation should be discussed in patients with severe SVD even though they are still asymptomatic.


Assuntos
Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Bioprótese/estatística & dados numéricos , Implante de Prótese de Valva Cardíaca/mortalidade , Implante de Prótese de Valva Cardíaca/métodos , Idoso , Idoso de 80 Anos ou mais , Animais , Bioprótese/efeitos adversos , Bovinos , Feminino , Seguimentos , Insuficiência Cardíaca/mortalidade , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Incidência , Unidades de Terapia Intensiva/estatística & dados numéricos , Estimativa de Kaplan-Meier , Tempo de Internação/estatística & dados numéricos , Masculino , Neoplasias/mortalidade , Modelos de Riscos Proporcionais , Reoperação/mortalidade , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade
11.
ASAIO J ; 60(2): 140-7, 2014 Mar-Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24577368

RESUMO

Hemodynamic performances comparisons between different types of left ventricular assist devices (LVADs) remain difficult in a clinical context. The aim of this study was to create an experimental model to assess and compare two types of LVAD under hemodynamic conditions that simulated physical effort and pulmonary hypertension. An experimental mock circulatory system was created to simulate the systemic and pulmonary circulations and consisted of pulsatile left and right cardiac simulators (cardiowest pump), air/water tanks to model compliances, and tubes to model the venous and arterial resistances. Two types of continuous-flow ventricular assist devices were connected to this pulsated model: an axial flow pump, Heartmate II (HTM II), and a centrifugal pump, VentrAssist (VTA). The hemodynamic conditions at rest and during exercise were replicated. Mean aortic pressures were not significantly different at rest and during effort but mean flow under maximum pump speed was higher with HTM II (13 L vs. 10 L, p = 0.02). Left atrial pressure was lower at rest and during effort for the HTM II (11 mm Hg vs. 3 mm Hg, p = 0.02 and 9 mm Hg vs. 2 mm Hg, p = 0.008) than with the VTA, but with greater risk of left-ventricle suck-down for the axial flow. Power consumption for a similar flow was lower with the VTA during rest (4.7 W vs. 6.9 W, p = 0.002) and during effort (4.3 W vs. 6.6 W, p = 0.008). In case of high pulmonary vascular resistance with preserved right ventricular function, lower right ventricular pressure was obtained with HTM II (21 mm Hg vs. 28 mm Hg, p = 0.03). Observed results are in favor of a better discharge of the left and right cavities with the HTM II compared to the VTA yet with a higher risk of left cavity collapse occurrence.


Assuntos
Coração Auxiliar , Hemodinâmica/fisiologia , Modelos Cardiovasculares , Desenho de Prótese , Fluxo Pulsátil/fisiologia , Humanos
12.
J Cardiothorac Surg ; 8: 140, 2013 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-23725512

RESUMO

BACKGROUND: To set up an experimental model of cadaveric heart in order to evaluate and compare histologic transmurality of lesions immediately caused by different energy sources of anti-arrhythmic epicardial devices. METHODS: Procedures were performed on a cadaveric human heart in orthotopic position with an ischemic time of 48 h at 37° and supported through the use of cardiopulmonary bypass. Three anti-arrhythmic epicardial devices were studied: the bipolar forceps Cardioblate BP (Medtronic) for the radiofrequency, the Epicor Ultracinch LP Ablation device (St. Jude) for ultrasound and the Cardioblate CryoFlex (Medtronic) device for cryoablation. Histological features of lesions made at the pulmonary venous confluence assessed the effectiveness of different energy sources. RESULTS: Over 45 experimentations performed, only 28 were considered correct and retained for histological analysis. Three distinct groups were studied according to the type of procedure performed: group 1 (Radiofrequency, n = 12), group 2 (ultrasound, n = 4), group 3 (cryoablation, n = 10) and controls (n = 2). All analysed samples showed histological changes with a success rates of transmurality of 33% for radiofrequency, 25% for ultrasound and 90% for cryotherapy (p <0.001). The average length of transmurality, when it was reached and the proportion of transmurality over the total length of the lesion were respectively 12 ± 6 mm and 37 ± 18% for group 1, 10 mm and 33% for group 2 and 11.1 ± 1.1 mm and 35 ± 5% for group 3. CONCLUSION: Immediate detectable histological transmural lesions after epicardial procedure are discontinuous whatever the kind of energy source tested in this work and it strongly encourages the repetition of radiofrequency procedures. Nevertheless, our experimental model seems inadequate to assess ultrasound energy efficacy.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Criocirurgia/métodos , Sistema de Condução Cardíaco/cirurgia , Pericárdio/cirurgia , Idoso , Idoso de 80 Anos ou mais , Cadáver , Feminino , Humanos , Masculino , Veias Pulmonares/cirurgia
13.
Ann Thorac Surg ; 87(1): 124-9; discussion 130, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19101284

RESUMO

BACKGROUND: When implanted in patients with biventricular failure, the CardioWest total artificial heart has asserted itself over time as a reliable bridge-to-transplant device that as yet is used by only a few international teams. The aim of this single-center retrospective study is to assess both the comorbidity and survival of patients awaiting heart transplants while receiving circulatory support with a CardioWest total artificial heart. METHODS: From 1990 to December 2006, 42 patients received a CardioWest total artificial heart at our center. Mean age at the time of implantation was 45.7 +/- 9.5 years, and 40 patients (95%) were men. Idiopathic or dilated cardiomyopathy was diagnosed in 45.2% (n = 19) of the patients and ischemic cardiomyopathy in 42.8% (n = 18). Average body surface area was 1.9 +/- 0.22 m(2). RESULTS: Duration of support was 1 to 292 days (mean, 101 +/- 86 days). Twelve patients died (28.5%) while receiving device support, and 30 patients (71.5%) underwent transplantation. Actuarial survival rates for the transplanted patients were 90% (n = 25), 81% (n = 14), and 76% (n = 10) at 1, 5, and 10 years, respectively. Causes of death during device support included multiorgan failure in 6 (50%), sepsis in 2, acute respiratory distress syndrome in 2, alveolar hemorrhage in 1, and other cause in 1. There were no device malfunctions that led to patient death. Adverse events included stroke in 3 patients (7%) and infections in 35 patients (85%) during support. CONCLUSIONS: The CardioWest total artificial heart is an excellent bridge-to-transplant device for patients with biventricular failure. Our study demonstrates excellent safety, reliability, and efficiency. Exceptional outcome after transplantation underlines its capacity to aid in end-organ recovery.


Assuntos
Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/cirurgia , Transplante de Coração , Coração Artificial , Volume Sistólico , Adulto , Análise de Variância , Débito Cardíaco/fisiologia , Estudos de Coortes , Feminino , Seguimentos , Hemodinâmica/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Probabilidade , Desenho de Prótese , Falha de Prótese , Estudos Retrospectivos , Medição de Risco , Sensibilidade e Especificidade , Estatísticas não Paramétricas , Taxa de Sobrevida , Fatores de Tempo , Obtenção de Tecidos e Órgãos , Listas de Espera
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