INTRODUCTION: Left ventricular assist device (LVAD) therapy may lead to an aortic regurgitation, limiting left ventricular unloading and causing adverse events. Whether concomitant aortic valve replacement may improve outcomes in patients with preoperative mild-to-moderate aortic regurgitation remains unclear. METHODS: A retrospective propensity score-matched analysis of adult patients with preoperative mild-to-moderate aortic regurgitation undergoing durable LVAD implantation between 01/01/2011 and 30/11/2021 was performed. Patients undergoing concomitant valve surgery other than biological aortic valve replacement were excluded, resulting in 77 with concomitant biological aortic valve replacement and 385 without. RESULTS: Following 1:1 propensity score matching, two groups of 55 patients with and without biological aortic valve replacement were obtained, (mean age 59 ± 11 years, 92% male, 59.1% HeartWare). Aortic regurgitation was mild in 72.7% and 76.4% and moderate in 27.3% and 23.6% in non-replacement and replacement cohorts respectively. The 30-day survival was 89.1% vs. 85.5% (p = 0.59), 1-year survival 69.1% vs. 56.4% (p = 0.19), and 2-year survival 61.8% vs. 47.3% (p = 0.10) in the non-replacement and replacement groups, respectively. After a mean follow-up of 1.2 years, non-replacement patients had a higher incidence of pump thrombosis (11 [20%] vs. 3 [5.5%], p = 0.022) and fewer major bleedings (2 [3.6%] vs. 11 [20%], p = 0.008). CONCLUSION: Compared with those treated conservatively, patients with mild-to-moderate aortic regurgitation undergoing concomitant aortic valve replacement during LVAD implantation have a similar survival up to 2 years on support. Patients with concomitant valve replacement had a higher risk of bleeding complications but fewer pump thromboses.
- MeSH
- Aortic Valve * surgery MeSH
- Aortic Valve Insufficiency * surgery complications mortality MeSH
- Heart Valve Prosthesis Implantation * adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Heart-Assist Devices * adverse effects MeSH
- Retrospective Studies MeSH
- Aged MeSH
- Heart Failure * complications mortality surgery therapy MeSH
- Propensity Score MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
IMPORTANCE: The Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure (ARIES-HM3) study demonstrated that aspirin may be safely eliminated from the antithrombotic regimen after HeartMate 3 (HM3 [Abbott Cardiovascular]) left ventricular assist device (LVAD) implantation. This prespecified analysis explored whether conditions requiring aspirin (prior percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], stroke, or peripheral vascular disease [PVD]) would influence outcomes differentially with aspirin avoidance. OBJECTIVE: To analyze aspirin avoidance on hemocompatibility-related adverse events (HRAEs) at 1 year after implant in patients with a history of CABG, PCI, stroke, or PVD. DESIGN, SETTING, AND PARTICIPANTS: This was an international, multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial including patients implanted with a de novo HM3 LVAD across 51 centers. Data analysis was conducted from April to July 2024. INTERVENTIONS: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg per day) or placebo, in addition to a vitamin K antagonist (VKA) targeted to an international normalized ratio of 2 to 3 in both groups. MAIN OUTCOMES AND MEASURES: Primary end point (assessed for noninferiority) was a composite of survival free of any nonsurgical (>14 days after implant) HRAEs including stroke, pump thrombosis, bleeding, and arterial peripheral thromboembolism at 12 months. Secondary end points included nonsurgical bleeding, stroke, and pump thrombosis events. RESULTS: Among 589 of 628 patients (mean [SD] age, 57.1 [13.7] years; 456 male [77.4%]) who contributed to the primary end point analysis, a history of PCI, CABG, stroke, or PVD was present in 41% (240 of 589 patients). There was no interaction between the presence of an atherosclerotic vascular condition and effect of aspirin compared with placebo (P for interaction= .23). The preset 10% noninferiority margin was not crossed for the studied subgroup of patients. Thrombotic events were rare, with no differences between aspirin and placebo in patients with and without vascular disease (P for interaction = .77). Aspirin treatment was associated with a higher rate of nonsurgical major bleeding events in the group with prior vascular condition history compared with those without aspirin (rate ratio for placebo compared with aspirin, 0.52; 95% CI, 0.35-0.79). CONCLUSIONS AND RELEVANCE: Results of this prespecified analysis of the ARIES-HM3 randomized clinical trial demonstrate that in patients with advanced heart failure who have classical indications for antiplatelet therapy use at the time of LVAD implantation, aspirin avoidance was safe and not associated with increased thrombosis risk. Importantly, elimination of aspirin was associated with no increased thrombosis but a reduction in nonsurgical bleeding events in patients with a history of PCI, CABG, stroke, or PVD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156.
- MeSH
- Aspirin * therapeutic use MeSH
- Atherosclerosis MeSH
- Stroke prevention & control MeSH
- Double-Blind Method MeSH
- Fibrinolytic Agents therapeutic use MeSH
- Platelet Aggregation Inhibitors therapeutic use MeSH
- Percutaneous Coronary Intervention methods MeSH
- Hemorrhage chemically induced MeSH
- Middle Aged MeSH
- Humans MeSH
- Heart-Assist Devices * MeSH
- Prospective Studies MeSH
- Aged MeSH
- Heart Failure MeSH
- Thrombosis prevention & control MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Comment MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
OBJECTIVES: This 4th report aimed to provide insights into patient characteristics, outcomes and standardized outcome ratios of patients implanted with durable Mechanical Circulatory Support across participating centres in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) registry. METHODS: All registered patients receiving durable mechanical circulatory support up to August 2024 were included. The expected number of events was predicted using penalized logistic regression. Standardized outcome ratios (Observed/Expected events) were presented in plots to assess 30-day and 1-year mortality, ischaemic stroke and major bleeding outcomes. Expected events were estimated using penalized logistic regression using demographics and comorbidities as predictors. Centres with <90% follow-up completeness were excluded from standardized outcome ratio assessment. RESULTS: Analysis included 6962 implants in 6408 patients (457 patients underwent repeated implants) registered in EUROMACS from 17 countries (32 centres) (median age: 58 years, 83% males, 17% Interagency Registry for Mechanically Assisted Circulatory Support class 1). Thirty-day mortality, major bleeding and ischaemic stroke probabilities were 9.6, 12.6% and 2.1%, respectively. Standardized mortality ratios showed variability between centres, ranging from 0 (95% CI 0-0) to 1.4 (95% CI 1.2-1.7). Higher standardized bleeding outcome ratios correlated with higher standardized ischaemic stroke ratio's (Spearman r: 0.56, P = 0.008). CONCLUSIONS: Most included centres perform as expected given the demographics and comorbidities of patients. A positive correlation was found between standardized bleeding and ischaemic stroke ratios, reflecting the need of continuously monitoring of adverse events by quality improvement programs.
- MeSH
- Middle Aged MeSH
- Humans MeSH
- Heart-Assist Devices * statistics & numerical data MeSH
- Registries * statistics & numerical data MeSH
- Aged MeSH
- Heart Failure mortality surgery therapy epidemiology MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Geographicals
- Europe MeSH
Úvod: Falešné aneuryzma hrudní aorty je vzácnou komplikací kardiochirurgických výkonů nebo výkonů na hrudní aortě. Uvádíme výsledky systematického přehledu literatury. Naším cílem bylo stanovit nejlepší možnosti léčby a operační postupy. Metody: Provedli jsme rešerši literatury zabývající se pseudoaneuryzmatem hrudní aorty a jeho chirurgickou léčbou v angličtině, která byla vymezena daty 1. leden 1979 až 31. prosinec 2022. V databázích PubMed a EMBASE jsme vyhledávali následující medicínské termíny: falešné aneuryzma hrudní aorty, pseudoaneuryzma a chirurgická léčba. Výsledky: Naše vyhledávání prověřilo celkem 4 046 článků. Pouze devět z nich splňovalo kritéria způsobilosti. Ostatní články byly samostatné kazuistiky nebo malé série kazuistik s méně než devíti pacienty. Všechny studie byly retrospektivní. Devadesát procent případů už dříve podstoupilo operaci aorty nebo srdce. Strategie chirurgické léčby byly zvoleny podle umístění pseudoaneuryzmatu a byly celkově nejednoznačné. Závěr: Podle současné literatury neexistují jednoznačné pokyny či doporučení, operace by tedy měla být přizpůsobena individuálně danému pacientovi. Po kardiochirurgických výkonech se doporučují pravidelné kontroly, které obnášejí i vyšetření zobrazovacími metodami. I navzdory výraznému pokroku v endovaskulární léčbě není tato metoda vždy vhodná, a pak je léčbou volby otevřená operace.
Introduction: Thoracic aortic false aneurysm is a rare complication of cardiac surgery or procedures on the thoracic aorta. We present the results of a systematic review of the literature. Our aim was to determine the best treatment options and surgical techniques. Methods: We performed a literature search regarding thoracic aortic pseudoaneurysm and its surgical treatment in English, limited by the dates 1st January 1979 to 31st December 2022. We searched the PubMed and EMBASE databases for the following medical terms: thoracic aortic false aneurysm, pseudoaneurysm, and surgical treatment. Results: Our search screened 4,046 articles. Only nine articles were eligible. The other articles were single case reports or small series of case reports with fewer than nine patients. All the studies were retrospective. Ninety percent of the cases underwent prior aortic or cardiac surgery. The surgical treatment strategies were chosen according to the location of the pseudoaneurysm and were overall inconclusive. Conclusion: According to the current literature, there are no clear guidelines or recommendations; therefore, the operation should be tailored to each patient individually. Regular checkups involving imaging techniques after cardiac surgeries are recommended. Despite significant advancements in endovascular treatment, it is often not suitable, making open surgery the treatment of choice.
INTRODUCTION: Thoracic aorta false aneurysms (TAFA) are unexplored complications after cardiac surgery associated with significant morbidity and mortality. Therefore, the purpose of this study was to examine the clinical profiles, surgical techniques, and operative outcomes, of patients treated for TAFA at a single institution. METHODS: From 1996 to 2022, 112 patients were treated for aortic pseudoaneurysm (mean age 55 ± 14 years, 78 patients were male). In the majority of the patients (90%) TAFA developed after previous cardiovascular surgery, the most common diagnosis and surgical procedure preceding the TAFA development was an aortic dissection (52%) and Bentall procedure (47%). In the rest of the cohort, the leading cause was trauma. RESULTS: Sixty-one percent of patients were indicated for reintervention (surgical reoperation, endoluminal graft implantation, septal occluder implantation, coil embolization, or a combination of procedures). Overall, 52 patients had undergone cardiac reoperation. TAFA was resected and the aorta was repaired in 55% or replaced in 45%. Operative mortality was 5.7%. In postoperative follow-up, a hypoechogenic lesion encircling aortic prosthesis was present in 94%, therefore it was determined as a negative prognostic factor. The mean follow-up was 13.2 ± 19.4 years. CONCLUSION: Although there is no specific approach how to prevent TAFA development, maintaining normal blood pressure and regular follow-up should be applied. More frequent follow-ups should be performed in patients with a hypoechogenic lesion encircling and aortic prosthesis. Early detection during long-term postoperative follow-up, an individually tailored approach of a multidisciplinary team is necessary for favorable treatment outcomes.
- MeSH
- Aortic Aneurysm, Thoracic * surgery MeSH
- Aorta, Thoracic surgery diagnostic imaging MeSH
- Time Factors MeSH
- Blood Vessel Prosthesis Implantation adverse effects MeSH
- Adult MeSH
- Endovascular Procedures adverse effects MeSH
- Combined Modality Therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Aneurysm, False * surgery etiology diagnostic imaging therapy MeSH
- Postoperative Complications etiology surgery MeSH
- Reoperation MeSH
- Retrospective Studies MeSH
- Risk Factors MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: Heart transplantation (HTx) is an established therapeutic option for children with end-stage heart failure. Comprehensive pediatric nationwide HTx program was introduced in 2014 in the Czech Republic. The aim of this study was to evaluate its mid-term characteristics and outcomes and to compare them with international data. METHODS: Retrospective observational study, including all patients who underwent HTx from June 2014 till December 2022. Data from the institutional database were used for descriptive statistics and survival analyses. RESULTS: A total of 30 HTx were performed in 29 patients with congenital heart disease (CHD, N = 15, single ventricular physiology in 10 patients) and cardiomyopathy (CMP, N = 14). Ten patients were bridged to HTx by durable left ventricular assist devices (LVADs) for a mean duration of 104 (SD 89) days. There was one early and one late death during median follow-up of 3.3 (IQR 1.3-6.1) years. Survival probability at 5 years after HTx was 93%. Two patients underwent re-transplantation (one of them in an adult center). Significant rejection-free survival at 1, 3, and 6 years after HTx was 76%, 63%, and 63%, respectively. CONCLUSIONS: The introduced pediatric HTx program reflects the complexity of the treated population, with half of the patients having complex CHD and one-third being bridged to HTx by LVADs. Mid-term results are comparable to worldwide data. The data confirm the possibility of establishing a successful nationwide pediatric HTx program in a relatively small population country with well-developed pediatric cardiovascular care and other transplantation programs.
- MeSH
- Child MeSH
- Adult MeSH
- Cardiomyopathies * MeSH
- Humans MeSH
- Heart-Assist Devices * MeSH
- Retrospective Studies MeSH
- Heart Failure * surgery MeSH
- Heart Transplantation * MeSH
- Heart Defects, Congenital * MeSH
- Treatment Outcome MeSH
- Check Tag
- Child MeSH
- Adult MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Observational Study MeSH
- Geographicals
- Czech Republic MeSH
BACKGROUND: The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study. METHODS: A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases. RESULTS: Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%). CONCLUSIONS: Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant.
OBJECTIVES: The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report. METHODS: All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis. RESULTS: A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111-2.036, P = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333-0.823, P = 0.005), CHD (HR 1.641, CI 1.054-2.555, P = 0.028) and pulsatile flow support (HR 2.345, CI 1.406-3.910, P = 0.001) in multivariable analyses. CONCLUSIONS: This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes.
- MeSH
- Child MeSH
- Infant MeSH
- Humans MeSH
- Adolescent MeSH
- Infant, Newborn MeSH
- Heart-Assist Devices * statistics & numerical data adverse effects MeSH
- Child, Preschool MeSH
- Registries * statistics & numerical data MeSH
- Heart Failure mortality surgery MeSH
- Heart Defects, Congenital surgery mortality MeSH
- Check Tag
- Child MeSH
- Infant MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Infant, Newborn MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Geographicals
- Europe MeSH
BACKGROUND: Circulatory support with a catheter-based microaxial flow pump (mAFP) plays a major role in the treatment of severe cardiogenic shock. In most patients who fail to recover while on temporary mechanical circulatory support (tMCS) and who are not eligible for heart transplantation, durable left ventricular assist device (dLVAD) implantation is usually considered a reliable option. This study aimed to describe the outcome of dLVAD therapy following mAFP support and to identify predictors of mortality. METHODS: This was a retrospective analysis of data from a multicenter registry on patients who underwent dLVAD implantation following tMCS with a mAFP between January 2017 and October 2022 (n = 332) from 19 European centers. RESULTS: Patients were supported with an Impella 5.5 (n = 92), 5.0 (n = 153) or CP (n = 87) and were transitioned to a HeartWare HVAD (n = 128) or Heartmate 3 (n = 204) during the same period. One hundred and twenty-five patients (39.2%) also required extracorporeal life support before and/or during mAFP therapy. The 30-day and 1-year survival were 87.8% and 71.1%, respectively. The following risk factors for 1-year mortality were identified: age (odds ratio [OR], 1.02), specifically age over 55 years (OR, 1.09), body mass index >30 kg/m2 (OR, 2.2), female sex (OR for male sex, 0.43), elevated total bilirubin (OR, 1.12), and low platelet count (OR, 0.996). CONCLUSIONS: Based on the identified risk factors, a risk score for estimating 1-year mortality was calculated to optimize patient selection for dLVAD implantation.
- Publication type
- Journal Article MeSH
BACKGROUND: Sodium-glucose cotransporter 2 inhibitors (SGLT-2i) are glucose-lowering agents used for the treatment of type 2 diabetes mellitus, which also improve heart failure and decrease the risk of cardiovascular complications. Epicardial adipose tissue (EAT) dysfunction was suggested to contribute to the development of heart failure. We aimed to elucidate a possible role of changes in EAT metabolic and inflammatory profile in the beneficial cardioprotective effects of SGLT-2i in subjects with severe heart failure. METHODS: 26 subjects with severe heart failure, with reduced ejection fraction, treated with SGLT-2i versus 26 subjects without treatment, matched for age (54.0 ± 2.1 vs. 55.3 ± 2.1 years, n.s.), body mass index (27.8 ± 0.9 vs. 28.8 ± 1.0 kg/m2, n.s.) and left ventricular ejection fraction (20.7 ± 0.5 vs. 23.2 ± 1.7%, n.s.), who were scheduled for heart transplantation or mechanical support implantation, were included in the study. A complex metabolomic and gene expression analysis of EAT obtained during surgery was performed. RESULTS: SGLT-2i ameliorated inflammation, as evidenced by the improved gene expression profile of pro-inflammatory genes in adipose tissue and decreased infiltration of immune cells into EAT. Enrichment of ether lipids with oleic acid noted on metabolomic analysis suggests a reduced disposition to ferroptosis, potentially further contributing to decreased oxidative stress in EAT of SGLT-2i treated subjects. CONCLUSIONS: Our results show decreased inflammation in EAT of patients with severe heart failure treated by SGLT-2i, as compared to patients with heart failure without this therapy. Modulation of EAT inflammatory and metabolic status could represent a novel mechanism behind SGLT-2i-associated cardioprotective effects in patients with heart failure.
- MeSH
- Anti-Inflammatory Agents therapeutic use pharmacology MeSH
- Biomarkers blood MeSH
- Diabetes Mellitus, Type 2 drug therapy metabolism diagnosis MeSH
- Epicardial Adipose Tissue MeSH
- Ventricular Function, Left drug effects MeSH
- Sodium-Glucose Transporter 2 Inhibitors * therapeutic use pharmacology adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Inflammation Mediators * metabolism MeSH
- Metabolomics MeSH
- Pericardium * metabolism drug effects MeSH
- Heart Failure * metabolism physiopathology drug therapy MeSH
- Severity of Illness Index * MeSH
- Stroke Volume drug effects MeSH
- Adipose Tissue * drug effects metabolism MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
