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1.
Sci Rep ; 14(1): 10291, 2024 05 04.
Artículo en Inglés | MEDLINE | ID: mdl-38704426

RESUMEN

Kazakhstan has one of the lowest heart transplantation (HTx) rates globally, but there are no studies evaluating the outcomes of HTx. This study aimed to provide a comprehensive analysis of the national HTx program over a 12-year period (2012-2023). Survival analysis of the national HTx cohort was conducted using life tables, Kaplan‒Meier curves, and Cox regression methods. Time series analysis was applied to analyze historical trends in HTx per million population (pmp) and to make future projections until 2030. The number of patients awaiting HTx in Kazakhstan was evaluated with a regional breakdown. The pmp rates of HTx ranged from 0.06 to 1.08, with no discernible increasing trend. Survival analysis revealed a rapid decrease in the first year after HTx, reaching 77.0% at 379 days, with an overall survival rate of 58.1% at the end of the follow-up period. Among the various factors analyzed, recipient blood levels of creatinine and total bilirubin before surgery, as well as the presence of infection or sepsis and the use of ECMO after surgery, were found to be significant contributors to the survival of HTx patients. There is a need for public health action to improve the HTx programme.


Asunto(s)
Trasplante de Corazón , Kazajstán/epidemiología , Trasplante de Corazón/mortalidad , Humanos , Masculino , Femenino , Persona de Mediana Edad , Adulto , Adulto Joven , Adolescente , Tasa de Supervivencia , Estimación de Kaplan-Meier , Anciano
2.
Sci Rep ; 14(1): 9304, 2024 04 23.
Artículo en Inglés | MEDLINE | ID: mdl-38654041

RESUMEN

There is a scarcity of publications evaluating the performance of the national liver transplantation (LTx) program in Kazakhstan. Spanning from 2012 to 2023, it delves into historical trends in LTx surgeries, liver transplant centers, and the national cohort of patients awaiting LTx. Survival analysis for those awaiting LTx, using life tables and Kaplan-Meier, is complemented by time series analysis projecting developments until 2030. The overall per million population (pmp) LTx rate varied from 0.35 to 3.77, predominantly favoring living donor LTx. Liver transplant center rates ranged from 0.06 to 0.40. Of 474 LTx patients, 364 on the waiting list did not receive transplantation. The 30-day and 1-year survival rates on the waiting list were 87.0% and 68.0%, respectively. Viral hepatitis and cirrhosis prevalence steadily rose from 2015 to 2023, with projections indicating a persistent trend until 2030. Absent targeted interventions, stable pmp rates of LTx and liver transplant centers may exacerbate the backlog of unoperated patients. This study sheds light on critical aspects of the LTx landscape in Kazakhstan, emphasizing the urgency of strategic interventions to alleviate the burden on patients awaiting transplantation.


Asunto(s)
Trasplante de Hígado , Listas de Espera , Trasplante de Hígado/estadística & datos numéricos , Trasplante de Hígado/tendencias , Kazajstán/epidemiología , Humanos , Masculino , Femenino , Persona de Mediana Edad , Adulto , Adolescente , Anciano , Tasa de Supervivencia , Adulto Joven , Donadores Vivos/estadística & datos numéricos
3.
J Extra Corpor Technol ; 56(1): 10-15, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38488713

RESUMEN

BACKGROUND: Left ventricular assist device (LVAD) candidates are at increased risk of immune dysregulation and infectious complications. To attenuate the elevated proinflammatory cytokine levels and associated adverse clinical outcomes, it has been postulated that extracorporeal blood purification could improve the overall survival rate and morbidity of patients undergoing LVAD implantation. METHODS: We retrospectively reviewed prospectively collected data of 15 patients who underwent LVAD implantation at our center between January 2021 and March 2022. Of these, 15 (100%) who received HeartMate 3™ (St. Jude Medical, Abbott, MN, USA) device were eligible. Intraoperatively, patients were single randomized 1:1:1 to three groups: group 1, patients who received Cytosorb therapy (n = 5; installed in the CPB circuit); group 2, patients who received Jafron HA330 (n = 5; installed in the CPB circuit); and control group 3, patients who did not receive filter (n = 5; usual care, neither Cytosorb nor Jafron during CPB). Baseline patient characteristics and intraoperative data were compared between the groups. Blood sample analyses were performed to assess the levels of inflammatory markers (IL-1, 6, 8; CRP, Leukocyte, Lactate, PCT, NT-proBNP, TNF-α) in both preoperative and postoperative data. RESULTS: Baseline patient characteristics were similar in all three groups. We found that IL1α; IL 6; IL8; Lactatedehydrogenase, PCT, pro-BNP, CRP; Leukocyte, and TNFα levels significantly increased with LVAD implantation and that neither Cytosorb nor Jafron influenced this response. In-hospital mortality and overall survival during follow-up were similar among the groups. CONCLUSION: Our preliminary results showed that hemoadsorption therapy using Cytosorb or Jafron hemoadsorption (HA) 330 may not be clinically beneficial for patients with advanced heart failure undergoing LVAD implantation. Large prospective studies are needed to evaluate the potential role of HA therapy in improving outcomes in patients undergoing LVAD implantation.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Estudios Retrospectivos , Corazón Auxiliar/efectos adversos , Estudios Prospectivos , Resultado del Tratamiento
4.
Eur Heart J ; 45(8): 613-625, 2024 Feb 21.
Artículo en Inglés | MEDLINE | ID: mdl-38036414

RESUMEN

BACKGROUND AND AIMS: HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval. METHODS: A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival. RESULTS: Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1-3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively). CONCLUSIONS: Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Masculino , Persona de Mediana Edad , Femenino , Corazón Auxiliar/efectos adversos , Calidad de Vida , Resultado del Tratamiento , Estudios Prospectivos , Sistema de Registros
5.
JAMA ; 330(22): 2171-2181, 2023 12 12.
Artículo en Inglés | MEDLINE | ID: mdl-37950897

RESUMEN

IMPORTANCE: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety. OBJECTIVE: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. DESIGN, SETTING, and PARTICIPANTS: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. MAIN OUTCOMES AND MEASURES: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events. RESULTS: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics. CONCLUSIONS AND RELEVANCE: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Accidente Cerebrovascular , Tromboembolia , Masculino , Humanos , Femenino , Aspirina/efectos adversos , Corazón Auxiliar/efectos adversos , Fibrinolíticos/efectos adversos , Método Doble Ciego , Insuficiencia Cardíaca/fisiopatología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/efectos adversos , Hemorragia/etiología , Tromboembolia/etiología , Tromboembolia/prevención & control
6.
Front Cardiovasc Med ; 10: 1152280, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37485262

RESUMEN

Generally, the dysfunction or failure of bioprosthetic heart valves (BHVs) is managed by replacement surgery. In the case of tricuspid valve dysfunction, re-do surgery is rarely attempted because of the critically high risk of developing pulmonary hypertension, pulmonary embolism, and intraoperative mortality. Hence, transcatheter tricuspid repair and replacement procedures are preferred. More recently, transcatheter valve-in-valve (ViV) treatments have gained importance because of their less invasiveness, especially for patients with prior surgeries. Encouraging evidence of the safety and effectiveness of a novel balloon-expandable (BE) transcatheter heart valve (THV)-the Myval THV-has been reported for ViV procedures. Here, we present a case-series of 5 patients, in whom tricuspid ViV procedure was performed using BE Myval THV, implanted supra-annularly by anchoring onto the deteriorated BHV. This case-series details the procedural steps to prevent in-hospital adverse events and early (30-day) mortality and the challenges during tricuspid ViV interventions.

7.
Front Cardiovasc Med ; 10: 1091420, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37089890

RESUMEN

The implantation of a left ventricular assist device (LVAD) has become an essential requirement for managing patients with end-stage heart failure. However, aortic valve insufficiency is a contraindication for LVAD implantation in patients with end-stage heart failure, partly because of the decreasing efficiency of mechanical circulatory support and the eventual development of right ventricular failure. Herein, we present the first case of performing transcatheter aortic valve replacement in valve-in-ring along with LVAD implantation for the treatment of a 60-year-old male suffering from refractory heart failure due to dilated cardiomyopathy and pure aortic insufficiency in need of a new aortic bioprosthesis. A balloon-expandable bioprosthetic transcatheter heart valve was implanted into a previously sewn annulus ring into the aortic root via transaortic access. Subsequently, a centrifugal-flow LVAD was implanted. Postoperatively, the patient was in New York Heart Association Functional Class (NYHA) II with 6-min walk test of 310 m. The patient has completed 6 months of follow-up with no events. This novel and feasible surgical technique reduced the cardiopulmonary bypass time and duration of surgery. Furthermore, it avoids the risk of redo sternotomy and decreases the chances of paravalvular leakage and worsening of aortic regurgitation.

8.
Bratisl Lek Listy ; 124(3): 212-220, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36598313

RESUMEN

BACKGROUND: Choosing the method of revascularization - coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) - remains debatable. METHODS: We selected 406 patients with multivessel disease who underwent PCI with a drug-eluting stent (DES) (n = 200, 100 with a SYNTAX score (SS) ≤ 22 and 100 with a SS 23-32); and CABG (n = 206, 100 with a SS ≤ 22 and 106 with a SS 23-32). The mean follow-up period was 9±1.9 years. The endpoints of the study were as follows: major adverse cardiac and cerebrovascular events (МАССЕ), a repeat revascularization (RR), diminished left ventricular ejection fraction (LVEF), and high SS in dynamics. RESULTS: Patients with an intermediate SS needed RR more often with PCI than after CABG (64 % vs 22.6 %; HR: 3.52; CI: 2.19-5.66; р < 0.001). We found no significant differences for other MACCE between the groups. The decrease in LVEF was greater in the low SS subgroup in operated patients than after PCI (39.5 % vs 27.7 %; HR: 0.57; CI: 0.34-0.98; p = 0.04). The difference between the initial and final SS, was greater after the CABG than after PCI (43.5 % vs 10.9 %; HR: 0.26; CI: 0.14-0.47; р < 0.001). CONCLUSIONS: After 9 ± 1.9 years in intermediate SS group CABG exhibited an advantage over PCI with DES in terms of the MACCE indicators due to a smaller number of RR in the CABG group. The CABG group showed a more significant progression of atherosclerosis, and more heart failure cases (Tab. 2, Fig. 4, Ref. 29). Text in PDF www.elis.sk Keywords: coronary artery disease, coronary artery bypass grafting, percutaneous coronary intervention, SYNTAX score.


Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Stents Liberadores de Fármacos/efectos adversos , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular Izquierda , Revascularización Miocárdica/métodos , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/etiología
9.
Artif Organs ; 47(4): 721-730, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36398369

RESUMEN

BACKGROUND: ECMO support is associated with the development of a systemic hyper-inflammatory response, which may become quite significant and extreme in some cases. We hypothesize that Cytosorb or Jafron therapy may benefit patients on V-A ECMO in terms of levels of inflammatory markers such as IL-6, complications, and overall outcomes. METHODS: We conducted a retrospective study of prospectively collected data in a single tertiary care center between January 2021 and April 2022. At the time of the analysis of this article, 20 patients on V-A ECMO had cytokine adsorption while on ECMO support: Cytosorb group (n = 10), Jafron group (n = 10). In 10 ECMO-supported patients cytokine adsorption was not used, this group served as a control group, which may be quite significant in some cases. Evaluation of the level of inflammatory markers (IL-1, 6, 8; CRP, Leukocyte, Lactate, PCT, NT-proBNP, TNF-α) was performed. RESULTS: There was statistically significant longer CPB time, aortic cross-clamp time and ICU stay in cytokine adsorption groups than in the control group, but there were no differences between subgroups with different types of haemoadsorption used. Moreover, in the control group mortality rate was higher than in the cytokine adsorption groups (60% vs. 20%, p = 0.02). All patients had an elevation of inflammatory markers in the perioperative and immediate postoperative periods. After 72 h of intensive care, blood inflammation markers had a tendency to decline. CONCLUSION: At the time of writing, hemadsorption in patients requiring V-A ECMO support represents a good therapeutic effect. This effect is permanent for the whole period of extracorporeal cytokine hemadsorption application for both CytoSorb and Jafron HA330 devices.


Asunto(s)
Oxigenación por Membrana Extracorpórea , Hemabsorción , Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Estudios Retrospectivos
11.
J Pers Med ; 12(5)2022 May 04.
Artículo en Inglés | MEDLINE | ID: mdl-35629166

RESUMEN

The left ventricular assist device (LVAD) is one of the alternative treatments for heart failure (HF) patients. However, LVAD support is followed by thrombosis, and bleeding complications which are caused by high non-physiologic shear stress and antithrombotic/anticoagulant therapy. A high risk of complications occurs in the presence of the genotype polymorphisms which are involved in the coagulation system, hemostasis function and in the metabolism of the therapy. The aim of the study was to investigate the influence of single-nucleotide polymorphisms (SNP) in HF patients with LVAD complications. We analyzed 21 SNPs in HF patients (n = 98) with/without complications, and healthy controls (n = 95). SNPs rs9934438; rs9923231 in VKORC1, rs5918 in ITGB3 and rs2070959 in UGT1A6 demonstrated significant association with HF patients' complications (OR (95% CI): 3.96 (1.42-11.02), p = 0.0057), (OR (95% CI): 3.55 (1.28-9.86), p = 0.011), (OR (95% CI): 5.37 (1.79-16.16), p = 0.0056) and OR (95% CI): 4.40 (1.06-18.20), p = 0.044]. Genotype polymorphisms could help to predict complications at pre- and post-LVAD implantation period, which will reduce mortality rate. Our research showed that patients can receive treatment with warfarin and aspirin with a personalized dosage and LVAD complications can be predicted by reference to their genotype polymorphisms in VKORC1, ITGB3 and UGT1A6 genes.

12.
Artif Organs ; 46(5): 813-826, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-34904255

RESUMEN

BACKGROUND: We investigated the clinical outcomes after cardiac valvular surgery procedures concomitant (CCPs) with left ventricular assist device (LVAD) implantation compared to propensity score (PS) matched controls using the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data. METHODS: Between 2006 and 2018, 2760 continuous-flow LVAD patients were identified. Of these, 533 underwent a CCP during the LVAD implant. RESULTS: Cardiopulmonary bypass time (p < 0.001) and time for implant (p < 0.001) were both significantly longer in the LVAD+CCP group. Hospital mortality was comparable between the two groups from the unmatched population (15.7% vs. 14.1%, p = 0.073). Similarly, short-to-mid-term survival was similar in both groups, with 1-year, 3-year, and 5-year survival rates of 67.9%, 48.2%, and 27.7% versus 66.4%, 46.1%, and 26%, respectively (log-rank, p = 0.25). The results were similar in the PS-matched population. Hospital mortality was comparable between the two groups (18.9% vs. 17.4%, p = 0.074). The short-to-mid-term Kaplan-Meier survival analysis was similar for both groups, with 1-year, 3-year, and 5-year survival rates of 63.4%, 49.2%, and 24.7% versus 66.5%, 46%, and 25.1%, respectively (log-rank, p = 0.81). In the unmatched population, LVAD+CCP patients had longer intensive care unit (ICU) stays (p < 0.0001), longer mechanical ventilation time (p = 0.001), a higher rate of temporary right ventricular assist device (RVAD) support (p = 0.033), and a higher rate of renal replacement therapy (n = 35, 6.6% vs. n = 89, 4.0%, p = 0.014). In the PS-matched population, the LVAD+CCP patients had longer ICU stays (p = 0.019) and longer mechanical ventilation time (p = 0.002). CONCLUSIONS: The effect of additive valvular procedures (CCPs) does not seem to affect short-term survival, significantly, based on our registry data analysis. However, the decision to perform CCPs should be balanced with the projected type of surgery and preoperative characteristics. LVAD+CCP patients remain a delicate population and adverse device-related events should be strictly monitored and managed.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/cirugía , Corazón Auxiliar/efectos adversos , Humanos , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento
13.
PLoS One ; 16(12): e0261272, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34936681

RESUMEN

BACKGROUND: First reported case of Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in Kazakhstan was identified in March 2020. Many specialized tertiary hospitals in Kazakhstan including National Research Cardiac Surgery Center (NRCSC) were re-organized to accept coronavirus disease 2019 (COVID-19) infected patients during summer months of 2020. Although many studies from worldwide reported their experience in treating patients with COVID-19, there are limited data available from the Central Asia countries. The aim of this study is to identify predictors of mortality associated with COVID-19 in NRCSC tertiary hospital in Nur-Sultan, Kazakhstan. METHODS: This is a retrospective cohort study of patients admitted to the NRCSC between June 1st-August 31st 2020 with COVID-19. Demographic, clinical and laboratory data were collected from electronic records. In-hospital mortality was assessed as an outcome. Patients were followed-up until in-hospital death or discharge from the hospital. Descriptive statistics and factors associated with mortality were assessed using univariate and multivariate logistic regression models. RESULTS: Two hundred thirty-nine admissions were recorded during the follow-up period. Mean age was 57 years and 61% were males. Median duration of stay at the hospital was 8 days and 34 (14%) patients died during the hospitalization. Non-survivors were more likely to be admitted later from the disease onset, with higher fever, lower oxygen saturation and increased respiratory rate compared to survivors. Leukocytosis, lymphopenia, anemia, elevated liver and kidney function tests, hypoproteinemia, elevated inflammatory markers (C-reactive protein (CRP), ferritin, and lactate dehydrogenase (LDH)) and coagulation tests (fibrinogen, D-dimer, international normalized ratio (INR), and activated partial thromboplastin time (aPTT)) at admission were associated with mortality. Age (OR 1.2, CI:1.01-1.43), respiratory rate (OR 1.38, CI: 1.07-1.77), and CRP (OR 1.39, CI: 1.04-1.87) were determined to be independent predictors of mortality. CONCLUSION: This study describes 14% mortality rate from COVID-19 in the tertiary hospital. Many abnormal clinical and laboratory variables at admission were associated with poor outcome. Age, respiratory rate and CRP were found to be independent predictors of mortality. Our finding would help healthcare providers to predict the risk factors associated with high risk of mortality. Further investigations involving large cohorts should be provided to support our findings.


Asunto(s)
COVID-19/mortalidad , Mortalidad Hospitalaria/tendencias , Adulto , Factores de Edad , Anciano , Biomarcadores , COVID-19/epidemiología , Estudios de Cohortes , Femenino , Hospitalización/estadística & datos numéricos , Hospitalización/tendencias , Humanos , Kazajstán/epidemiología , Masculino , Persona de Mediana Edad , Pronóstico , Frecuencia Respiratoria , Estudios Retrospectivos , Factores de Riesgo , SARS-CoV-2/patogenicidad
15.
16.
ASAIO J ; 67(10): 1100-1108, 2021 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-34138778

RESUMEN

The CARMAT-Total Artificial Heart (C-TAH) is designed to provide heart replacement therapy for patients with end-stage biventricular failure. This report details the reliability and efficacy of the autoregulation device control mechanism (auto-mode), designed to mimic normal physiologic responses to changing patient needs. Hemodynamic data from a continuous cohort of 10 patients implanted with the device, recorded over 1,842 support days in auto-mode, were analyzed with respect to daily changing physiologic needs. The C-TAH uses embedded pressure sensors to regulate the pump output. Right and left ventricular outputs are automatically balanced. The operator sets target values and the inbuilt algorithm adjusts the stroke volume and beat rate, and hence cardiac output, automatically. Auto-mode is set perioperatively after initial postcardiopulmonary bypass hemodynamic stabilization. All patients showed a range of average inflow pressures of between 5 and 20 mm Hg during their daily activities, resulting in cardiac output responses of between 4.3 and 7.3 L/min. Operator adjustments were cumulatively only required on 20 occasions. This report demonstrates that the C-TAH auto-mode effectively produces appropriate physiologic responses reflective of changing patients' daily needs and represents one of the unique characteristics of this device in providing almost physiologic heart replacement therapy.


Asunto(s)
Insuficiencia Cardíaca , Corazón Artificial , Presión Sanguínea , Insuficiencia Cardíaca/cirugía , Hemodinámica , Homeostasis , Humanos , Reproducibilidad de los Resultados
17.
J Card Surg ; 36(7): 2592-2595, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-33783046

RESUMEN

Cold storage preservation is the standard approach for heart transplantation but is a time-limited method of care. Ex vivo heart perfusion expands the donor pool due by mitigating time and distance barriers and allows the possibility to improve graft function. We report long term follow up of a successful heart transplantation following an ex vivo time of 17 h using the Organ Care System in a patient with a left ventricular assist device.


Asunto(s)
Trasplante de Corazón , Corazón Auxiliar , Estudios de Seguimiento , Humanos , Preservación de Órganos , Perfusión , Donantes de Tejidos
18.
Eur J Cardiothorac Surg ; 59(6): 1155-1163, 2021 06 14.
Artículo en Inglés | MEDLINE | ID: mdl-33585913

RESUMEN

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.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Masculino , Estudios Prospectivos , Calidad de Vida , Resultado del Tratamiento
20.
J Cardiothorac Surg ; 15(1): 323, 2020 Oct 27.
Artículo en Inglés | MEDLINE | ID: mdl-33109229

RESUMEN

BACKGROUND: Organ Care System (OCS) minimizes the cold ischemic time and allows for optimization of logistics and meticulous recipient preparation. Impact of normothermic ex-vivo preservation using OCS compared with cold storage (CS) for prolonged heart preservation especially beneficial for high-risk recipients bridged to transplantation with Mechanical Circulatory Support (MCS). METHODS: Between 2012 and 2018, we performed a retrospective single-center review of prospectively collected data. All patients who underwent heart transplantation with MCS using the OCS Heart (n = 25) versus standard cold storage (n = 10) were included in this study. RESULTS: During this period, 353 patients were implanted with left ventricular assisted device (LVAD) and 35 (10%) were bridged to heart transplantation. There was no significant difference in donor and recipient characteristics and risk factors. The Index for Mortality Prediction after Cardiac Transplantation (IMPACT) score was a trend towards higher estimated risk of death at 1y in the OCS group (14.2 vs. 10.8% p = 0.083). Mean total ischemic time during preservation was statistically significantly longer in CS vs OCS group (210 (23) Vs 74.6 (13) min p = 0.001). Median ex vivo normothermic heart perfusion time in OCS was 348.4(132; 955) min. There was significant difference in total out of body time between OCS group 423(67) Vs CS group 210(23) min p = 0.002). All patients were alive on the 30th days post implant in CS groups and 96% in OCS group (p = 0.5). CONCLUSION: Normothermic ex-vivo preservation of the allograft during transportation with the organ care system might be beneficial for long-time out of body organ preservation in comparison of cold storage especially for recipients on mechanical circulatory support.


Asunto(s)
Circulación Extracorporea/métodos , Cardiopatías/cirugía , Trasplante de Corazón/métodos , Corazón Auxiliar , Preservación de Órganos/métodos , Donantes de Tejidos , Adulto , Criopreservación/métodos , Femenino , Humanos , Masculino , Estudios Retrospectivos , Factores de Riesgo
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