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  • 1
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    Outcomes after tricuspid valve surgery concomitant with left ventricular assist device implantation in the EUROMACS registry: a propensity score matched analysis
    Oxford University Press (OUP) ; 2019
    In:  European Journal of Cardio-Thoracic Surgery Vol. 56, No. 6 ( 2019-12-01), p. 1081-1089
    Details
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 56, No. 6 ( 2019-12-01), p. 1081-1089
    Abstract: OBJECTIVES Tricuspid regurgitation (TR) is common in patients receiving a left ventricular assist device (LVAD). Controversy exists as to whether concomitant tricuspid valve surgery (TVS) is beneficial in currently treated patients. Therefore, our goal was to investigate the effect of TVS concomitant with a LVAD implant. METHODS The European Registry for Patients with Mechanical Circulatory Support was used to identify adult patients. Matched patients with and without concomitant TVS were compared using a propensity score matching strategy. RESULTS In total, 3323 patients underwent LVAD implantation of which 299 (9%) had TVS. After matching, 258 patients without TVS were matched to 258 patients with TVS. In the matched population, hospital deaths, days on inotropic support, temporary right ventricular assist device implants and hospital stay were comparable, whereas stay in the intensive care unit was higher in the TVS cohort (11 vs 15 days; P = 0.026). Late deaths (P = 0.17), cumulative incidence of unexpected hospital readmission (P = 0.15) and right heart failure (P = 0.55) were comparable between patients with and without concomitant TVS. In the matched population, probability of moderate-to-severe TR immediately after surgery was lower in patients with concomitant TVS compared to patients without TVS (33% vs 70%; P = 0.001). Nevertheless, the probability of moderate-to-severe TR decreased more quickly in patients without TVS (P = 0.030), resulting in comparable probabilities of moderate-to-severe TR within 1.5 years of follow-up. CONCLUSIONS In matched patients, TVS concomitant with LVAD implant does not seem to be associated with better clinical outcomes. Concomitant TVS reduced TR significantly early after LVAD implant; however, differences in probability of TR disappeared during the follow-up period.
    Type of Medium: Online Resource
    ISSN: 1010-7940 , 1873-734X
    URL: Article
    DOI: 10.1093/ejcts/ezz208
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 2
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    The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report
    Oxford University Press (OUP) ; 2022
    In:  European Journal of Cardio-Thoracic Surgery Vol. 62, No. 1 ( 2022-06-15)
    Details
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 62, No. 1 ( 2022-06-15)
    Abstract: In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era. METHODS Procedures in adult patients (January 2011–June 2020) were included. Patients from centres with & lt;60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011–2013, 2014–2017 and 2018–2020). Adverse event rates (AERs) were calculated and stratified into early phase ( & lt;3 months) and late phase ( & gt;3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio ( & lt;3 vs & gt;3 months). RESULTS In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3–2.6) years. The annual number of implants (range: 346–600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4–7: 23, 25 and 33%; P & lt; 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P & lt; 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER & lt;3 months: 1.44 vs AER & gt;3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant. CONCLUSIONS In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent.
    Type of Medium: Online Resource
    ISSN: 1010-7940 , 1873-734X
    URL: Article
    DOI: 10.1093/ejcts/ezac032
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 3
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    Left ventricular assist device-related infections and the risk of cerebrovascular accidents: a EUROMACS study
    Oxford University Press (OUP) ; 2022
    In:  European Journal of Cardio-Thoracic Surgery Vol. 62, No. 5 ( 2022-10-04)
    Details
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 62, No. 5 ( 2022-10-04)
    Abstract: In patients supported by a durable left ventricular assist device (LVAD), infections are a frequently reported adverse event with increased morbidity and mortality. The purpose of this study was to investigate the possible association between infections and thromboembolic events, most notable cerebrovascular accidents (CVAs), in LVAD patients. METHODS An analysis of the multicentre European Registry for Patients Assisted with Mechanical Circulatory Support was performed. Infections were categorized as VAD-specific infections, VAD-related infections and non-VAD-related infections. An extended Kaplan–Meier analysis for the risk of CVA with infection as a time-dependent covariate and a multivariable Cox proportional hazard model were performed. RESULTS For this analysis, 3282 patients with an LVAD were included with the majority of patients being male (83.1%). During follow-up, 1262 patients suffered from infection, and 457 patients had a CVA. Cox regression analysis with first infection as time-dependent covariate revealed a hazard ratio (HR) for CVA of 1.90 [95% confidence interval (CI): 1.55–2.33; P  & lt; 0.001]. Multivariable analysis confirmed the association for infection and CVAs with an HR of 1.99 (95% CI: 1.62–2.45; P  & lt; 0.001). With infections subcategorized, VAD-specific HR was 1.56 (95% CI: 1.18–2.08; P 0.002) and VAD-related infections [HR: 1.99 (95% CI: 1.41–2.82; P  & lt; 0.001)] remained associated with CVAs, while non-VAD-related infections (P = 0.102) were not. CONCLUSIONS Infection during LVAD support is associated with an increased risk of developing an ischaemic or haemorrhagic CVA, particularly in the setting of VAD-related or VAD-specific infections. This suggests the need of a stringent anticoagulation management and adequate antibiotic treatment during an infection in LVAD-supported patients.
    Type of Medium: Online Resource
    ISSN: 1873-734X
    URL: Article
    DOI: 10.1093/ejcts/ezac421
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 4
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    Survival and adverse events in patients with atrial fibrillation at left ventricular assist device implantation: an analysis of the European Registry for Patients with Mechanical Circulatory Support
    Oxford University Press (OUP) ; 2022
    In:  European Journal of Cardio-Thoracic Surgery Vol. 61, No. 5 ( 2022-05-02), p. 1164-1175
    Details
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 61, No. 5 ( 2022-05-02), p. 1164-1175
    Abstract: OBJECTIVES Atrial fibrillation (AF) is a risk factor for mortality and cerebrovascular accidents (CVAs) and is common in patients with heart failure. This study evaluated survival and adverse events in patients with a left ventricular assist device (LVAD) and a history of AF in the European Registry for Patients with Mechanical Circulatory Support. METHODS Patients with a continuous-flow LVAD, AF or sinus rhythm (SR) and a follow-up were included. Kaplan–Meier analyses for survival (including a propensity-scored matched analysis), freedom from CVA, pump thrombosis, bleeding and a composite of pump thrombosis/CVA were performed. To correct for covariate imbalance, a Kaplan-Meier (KM) analysis was performed after propensity score (PS) matching the groups. Finally, a Cox regression was performed for predictors of lower survival. RESULTS Overall, 1821 patients (83% male) were included, with a median age of 57 years and a median follow-up of 13.1 months (interquartile range: 4.3–27.7). Preoperative Electrocardiogram (ECG) rhythm was AF in 421 (23.1%) and SR in 1400 (76.9%) patients. Patients with pre-LVAD AF had a lower ≤90-day (81.9% vs 87.1%, P = 0.0047) and 4-year (35.4% vs 44.2%, P = 0.0083) survival compared to SR. KM analysis with PS matching groups revealed a trend (P = 0.087) towards decreased survival. Univariable analyses confirmed pre-LVAD AF as a predictor for mortality, but the multivariable analysis did not. No difference in the rate of adverse events was found. An analysis of patients at 24 months revealed a higher rate of CVAs for pre-LVAD AF patients (77% vs 94.3%, P  & lt; 0.0001). CONCLUSIONS Patients with pre-LVAD AF undergoing LVAD implantation had a worse survival. However, after performing a multivariate analysis, and PS matching analysis, AF was no longer significant, indicating a worser preoperative condition in these patients. Concerning thrombo-embolic events, only patients with pre-LVAD AF alive beyond 24 months have a higher risk of CVAs.
    Type of Medium: Online Resource
    ISSN: 1010-7940 , 1873-734X
    URL: Article
    DOI: 10.1093/ejcts/ezac023
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 5
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    Use of Intracorporeal Durable LVAD Support in Children Using HVAD or HeartMate 3—A EUROMACS Analysis
    MDPI AG ; 2023
    In:  Journal of Cardiovascular Development and Disease Vol. 10, No. 8 ( 2023-08-17), p. 351-
    Details
    In: Journal of Cardiovascular Development and Disease, MDPI AG, Vol. 10, No. 8 ( 2023-08-17), p. 351-
    Abstract: Purpose: The withdrawal of HVAD in 2021 created a concern for the pediatric population. The alternative implantable centrifugal blood pump HeartMate 3 has since been used more frequently in children. This paper analyses the outcome of children on LVAD support provided with an HVAD or HM3. Methods: A retrospective analysis of the EUROMACS database on children supported with VAD 〈 19 years of age from 1 January 2009 to 1 December 2021 was conducted. All patients with an LVAD and either an HVAD or HM3 were included. Patients with missing data on VAD status and/or missing baseline and/or follow up information were excluded. Kaplan–Meier survival analysis was performed to evaluate survival differences. Analyses were performed using Fisher’s exact test. Results: The study included 150 implantations in 142 patients with 128 implants using an HVAD compared to 28 implants using an HM3. Nine patients (6%) needed temporary right ventricular mechanical support, which was significantly higher in the HM3 group, with 25% (p: 0.01). Patients in the HVAD group were significantly younger (12.7 vs. 14.5 years, p: 0.01), weighed less (45.7 vs. 60 kg, p: 〈 0.000) and had lower BSA values (1.3 vs. 1.6 m2, p: 〈 0.000). Median support time was 204 days. Overall, 98 patients (69%) were discharged and sent home, while 87% were discharged in group HM3 (p: ns). A total of 123 children (86%) survived to transplantation, recovery or are ongoing, without differences between groups. In the HVAD group, 10 patients (8%) died while on support, whereas in 12% of HM3 patients died (p: 0.7). Conclusions: Survival in children implanted with an HM3 was excellent. Almost 90% were discharged and sent home on the device.
    Type of Medium: Online Resource
    ISSN: 2308-3425
    URL: Article
    DOI: 10.3390/jcdd10080351
    Language: English
    Publisher: MDPI AG
    Publication Date: 2023
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  • 6
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    Impact of concomitant cardiac valvular surgery during implantation of continuous‐flow left ventricular assist devices: A European registry for patients with mechanical circulatory support (EUROMACS) analysis
    Wiley ; 2022
    In:  Artificial Organs Vol. 46, No. 5 ( 2022-05), p. 813-826
    Details
    In: Artificial Organs, Wiley, Vol. 46, No. 5 ( 2022-05), p. 813-826
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0160-564X , 1525-1594
    URL: Issue
    URL: Article
    DOI: 10.1111/aor.v46.5
    DOI: 10.1111/aor.14143
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2003825-2
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  • 7
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    Validation of microbiological testing in cardiovascular tissue banks: results of a quality round trial
    Oxford University Press (OUP) ; 2017
    In:  European Journal of Cardio-Thoracic Surgery Vol. 52, No. 5 ( 2017-11-01), p. 895-900
    Details
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 52, No. 5 ( 2017-11-01), p. 895-900
    Type of Medium: Online Resource
    ISSN: 1010-7940 , 1873-734X
    URL: Article
    DOI: 10.1093/ejcts/ezx178
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2017
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  • 8
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    Validation of microbiological testing in cardiovascular tissue establishments: results of a second international quality-round trial
    Springer Science and Business Media LLC ; 2019
    In:  European Journal of Clinical Microbiology & Infectious Diseases Vol. 38, No. 8 ( 2019-8), p. 1481-1490
    Details
    In: European Journal of Clinical Microbiology & Infectious Diseases, Springer Science and Business Media LLC, Vol. 38, No. 8 ( 2019-8), p. 1481-1490
    Type of Medium: Online Resource
    ISSN: 0934-9723 , 1435-4373
    URL: Article
    DOI: 10.1007/s10096-019-03576-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2019
    detail.hit.zdb_id: 1459049-9
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  • 9
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    Durable left ventricular assist device explantation following recovery in paediatric patients: Determinants and outcome after explantation
    Oxford University Press (OUP) ; 2024
    In:  European Journal of Cardio-Thoracic Surgery Vol. 65, No. 4 ( 2024-03-29)
    Details
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 65, No. 4 ( 2024-03-29)
    Abstract: OBJECTIVES Myocardial recovery in children supported by a durable left ventricular assist device is a rare, but highly desirable outcome because it could potentially eliminate the need for a cardiac transplant and the lifelong need for immunosuppressant therapy and the risk of complications. However, experience with this specific outcome is extremely limited. METHODS All patients & lt; 19 years old supported by a durable left ventricular assist device from the European Registry for Patients with Mechanical Circulatory Support database were included. Participating centres were approached for additional follow-up data after explantation. Associated factors for explantation due to myocardial recovery were explored using Cox proportional hazard models. RESULTS The incidence of recovery in children supported by a durable left ventricular assist device was 11.7% (52/445; median duration of support, 122.0 days). Multivariable analyses showed body surface area (hazard ratio 0.229; confidence interval 0.093–0.565; P = 0.001) and a primary diagnosis of myocarditis (hazard ratio 4.597; confidence interval 2.545–8.303; P & lt; 0.001) to be associated with recovery. Left ventricular end-diastolic diameter in children with myocarditis was not associated with recovery. Follow-up after recovery was obtained for 46 patients (88.5%). Sustained myocardial recovery was reported in 33/46 (71.7%) at the end of the follow-up period (28/33; & gt;2 year). Transplants were performed in 6/46 (11.4%) (in 5 after a ventricular assist device was reimplanted). Death occurred in 7/46 (15.2%). CONCLUSIONS Myocardial recovery occurs in a substantial portion of paediatric patients supported with durable left ventricular assist devices, and sustainable recovery is seen in around three-quarters of them. Even children with severely dilated ventricles due to myocarditis can show recovery. Clinicians should be attentive to (developing) myocardial recovery. These results can be used to develop internationally approved paediatric weaning guidelines.
    Type of Medium: Online Resource
    ISSN: 1873-734X
    URL: Article
    DOI: 10.1093/ejcts/ezae126
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2024
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  • 10
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    The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report
    Oxford University Press (OUP) ; 2018
    In:  European Journal of Cardio-Thoracic Surgery Vol. 54, No. 5 ( 2018-11-01), p. 800-808
    Details
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 54, No. 5 ( 2018-11-01), p. 800-808
    Abstract: EUROMACS is a registry of the European Association for Cardio-Thoracic Surgery (EACTS) whose purpose is to gather clinical data related to durable mechanical circulatory support for scientific purposes and to publish annual reports. Because the treatment of children with end-stage heart failure has several significantly different characteristics than the treatment of adults, data and outcomes of interventions are analysed in this dedicated paediatric report. METHODS: Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 31 December 2017 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events. RESULTS: Twenty-five hospitals contributed 237 registered implants in 210 patients (81 ♀, 129 ♂) to the registry. The most frequent diagnosis was any form of cardiomyopathy (71.4%) followed by congenital heart disease (18.6%). Overall mean support time on a device was 11.6 months (±16.5 standard deviation). A total of 173 children (82.4%) survived to transplant, recovery or are ongoing; 37 patients (17.6%) died while on support within the observed follow-up time. At 12 months 38% of patients received transplants, 7% were weaned from their device and 15% died. At 24 months, 51% of patients received transplants, 17% died while on support, 22% were on a device and 9% were explanted due to myocardial recovery. The adverse events rate per 100 patient-months was 11.97 for device malfunction, 2.83 for major bleeding, 2.83 for major infection and 1.52 for neurological events within the first 3 months after implantation. CONCLUSIONS: The first paediatric EUROMACS report reveals a low transplant rate in European countries within the first 2 years of implantation compared to US data. The 1-year survival rate seems to be satisfactory. Device malfunction including pump chamber changes due to thrombosis was the most frequent adverse event.
    Type of Medium: Online Resource
    ISSN: 1010-7940 , 1873-734X
    URL: Article
    DOI: 10.1093/ejcts/ezy298
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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