Search Results (33)

Background/Objectives: Impella support is increasingly utilized as a crucial bridge to durable left ventricular assist device (LVAD) in patients with refractory cardiogenic shock. However, the transvalvular path of the Impella catheter raises concerns regarding mechanical trauma, potentially precipitating or accelerating aortic regurgitation (AR). We aimed to characterize the complete longitudinal trajectory of AR following Impella bridge-to-LVAD and to determine its association with clinical and hemodynamic sequelae. Methods: We conducted a single-center retrospective cohort study including all patients bridged from Impella to durable LVAD between 2013 and 2024 (n = 19). At Impella initiation, all patients met the retrospective SCAI shock stage D or worse criteria. At LVAD implantation, all patients were classified as INTERMACS 1–2 (INTERMACS 2, n = 13). The Impella models were 5.0 in 11 (axillary access), 2.5 in 5 (femoral access), and CP in 3 (femoral access); no periprocedural Impella complications were recorded. The implanted LVAD systems were HeartMate II (n = 7), HVAD (n = 3), and HeartMate III (n = 9). Patients undergoing concomitant aortic valve intervention were excluded. Transthoracic/TEE echocardiography was performed at prespecified time points (pre-Impella, pre-LVAD, post-LVAD discharge, 12 months, and 24 months) with standardized aortic regurgitation (AR) grading. Right ventricular (RV) function was assessed qualitatively when quantitative indices (TAPSE) were unavailable. Primary endpoints were new or progressive AR and AR severity at LVAD implantation. Secondary endpoints included survival, renal dysfunction, biomarkers, and rehospitalization. Univariate analyses were used to compare outcomes according to AR severity. Results: Nineteen patients (68% male, median age 57 years, IQR 47–60) underwent Impella support for 13.3 ± 9.9 days before HeartMate 3 (84%) or HVAD (16%) implantation. All patients had competent aortic valves (grade 0 AR) at the time of LVAD implantation. AR ≥ mild developed in 9/18 (50%) at discharge, 12/15 (80%) at 12 months, and 13/15 (87%) at 24 months, and 8/15 (53%) progressed to ≥ moderate AR by 24 months. Patients with moderate-to-severe AR had higher NT-proBNP levels at 12 months (median 6318 vs. 2336 pg/mL, p = 0.137). Thirty-day and 24-month survival rates were 95% and 79%, respectively. Conclusions: Aortic regurgitation frequently develops or progresses from the pre-LVAD period to follow-up in patients bridged from Impella to durable LVAD. Although limited by a small sample size and incomplete quantitative RV metrics, these observations support structured echocardiographic surveillance after Impella use and management strategies—routine valve inspection at LVAD implantation and post-LVAD speed/blood pressure targets that encourage aortic valve opening—to mitigate the risk and clinical impact of aortic regurgitation. Full article

Background and Objectives: The use of the HeartMate 3 (HM3) ventricular assist device (VAD) as a bridge to transplant is rising notably in pediatric patients with end-stage heart disease. This study reports a single-centre experience with the HM3 device in pediatric patients. Materials and Methods: We conducted a retrospective clinical data review (including procedural, perioperative and follow-up parameters) of pediatric patients (n = 5, aged 10–16 years) supported with HM3 VAD at our institution between January 2022 and October 2025. Results: During this period, five pediatric patients (median age of 13 years [range 10–16, IQR 10–14.5]; median weight of 41.5 kg [24–75 IQR 32–62]) underwent HM 3 implantation. The Pedimacs profiles ranged from 1 to 2. Two patients with Pedimacs profile 1 received a temporary left ventricular assist device preoperatively for hemodynamic stabilization. The median intensive care unit stay was 47 days (range 21–54, IQR 28–50.5). Right ventricular dysfunction occurred in four patients and was managed conservatively in three, while one required intraoperative implantation of a temporary CentriMag right ventricular assist device. Two patients remain on device support, while three patients were successfully bridged to heart transplantation. No mortality was observed, and none of the patients experienced pump-related complications. Conclusions: The use of the HeartMate 3 is a safe and effective treatment strategy for successful bridging to heart transplantation. Right ventricular dysfunction is a common and clinically significant complication, but it can be effectively managed with appropriate measures. Full article

Background/Objectives: Mechanical circulatory support (MCS) is increasingly utilized for the management of acute decompensated heart failure (HF) and cardiogenic shock (CS). The primary goals of MCS are to restore systemic perfusion, reduce cardiac workload, and support end-organ function. A thorough understanding of cardiovascular physiology in patients supported by MCS is essential for clinical decision-making. This review summarizes current evidence on the physiological effects of various MCS devices, key monitoring techniques, patient management, and explores the emerging role of artificial intelligence (AI) in this field. Main Text: Short-term MCS devices include intra-aortic balloon pumps (IABP), percutaneous left-sided devices such as Impella (Abiomed, Danvers, MA, USA) and TandemHeart (LivaNova, London, UK), percutaneous right-sided support devices like Protek Duo (LivaNova, London, UK) and Impella RP Flex (Abiomed, Danvers, MA, USA), and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Long-term support is mainly provided by left ventricular assist devices (LVADs), including the HeartMate 3 (Abbott Laboratories, Chicago, IL, USA). Optimal MCS application requires an understanding of device-specific cardiovascular interactions and expertise in appropriate monitoring tools to assess device performance and patient response. The choice of device, timing of initiation, and patient selection must be individualized, with careful consideration of ethical implications. The integration of AI offers significant potential to advance clinical care by improving complication prediction, enabling real-time optimization of device settings, and refining patient selection criteria. Conclusions: MCS is a rapidly evolving field that requires a comprehensive understanding of cardiovascular interactions, careful selection of monitoring strategies, and individualized clinical management. Future research should address current device limitations, clarify device-specific clinical applications, and assess the validity of AI-driven technologies. Full article

Background/Objectives: Preoperative hypoalbuminemia is a known risk factor for adverse outcomes in cardiac surgery, but its role in patients undergoing HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation is unclear. This study evaluated the association between albumin levels and postoperative outcomes, aiming to define a clinically meaningful cut-off for risk stratification. Methods: We retrospectively analyzed 205 adult patients who underwent HM3 implantation at a single center from June 2014 to December 2023. Receiver operating characteristic (ROC) analysis identified an optimal pre-implant albumin cut-off of <32 g/L. This threshold, derived using the maximal Youden Index, provided a sensitivity of 52.1%, specificity of 71.6%, and an AUC of 0.64 (95% CI 0.56–0.71), with internal bootstrapping validation confirming model stability, and calibration demonstrating good agreement between predicted and observed outcomes. Kaplan–Meier analysis assessed freedom from hemocompatibility-related adverse events (HRAEs) and survival. Cox proportional hazards models evaluated albumin and other variables as independent risk factors for HRAEs. Results: Patients with pre-implant albumin <32 g/L had higher rates of HRAEs, including stroke (24.9% vs. 8.4%, p = 0.004) and bleeding (38.1% vs. 23.2%, p = 0.012). Freedom from HRAEs was significantly lower in the hypoalbuminemia group (45.2% vs. 69.8%, p < 0.001) and competing risk-adjusted cumulative incidence for HRAE was higher, but did not reach statistical significance (p = 0.11), one-year HRAE-free survival was also reduced (68.5% vs. 85.7%, p = 0.03). In multivariable analysis, low albumin (HR 0.56, 95% CI 0.33–0.93, p = 0.026) and temporary right ventricular assist device (RVAD) support (HR 3.32, 95% CI 2.05–5.39, p < 0.001) were independent predictors of HRAEs. Conclusions: Low preoperative albumin is independently associated with increased HRAEs and reduced one-year survival after HM3 implantation. Compared with the traditional 35 g/L threshold, the ROC-derived 32 g/L cut-off offered superior balance between sensitivity and specificity, underscoring its clinical utility. Albumin may serve as a simple, pragmatic, and cost-effective biomarker for preoperative risk assessment and optimization. Full article

Background: Multi-organ failure (MOF) is a common complication of advanced heart failure (HF), significantly influencing patient prognosis. This study aimed to assess and compare the impact of orthotopic heart transplantation (HTx) and left ventricular assist device (LVAD) implantation on the severity of MOF, as measured by the model for end-stage liver disease excluding INR (MELD-XI) score. Methods: Data from 1 month before to 1 year after HTx or LVAD implantation were analysed. The MELD-XI score was calculated using average bilirubin and creatinine values. Comparative assessments of MELD-XI scores were performed within the HTx and LVAD groups at various time points pre- and post-procedure. Results: The analysis included 107 HTx patients and 30 LVAD patients. The median MELD-XI score 1 month pre-procedure was 11.7 (9.4–16.7) in all patients. There were no significant differences in MELD-XI scores between the groups at 3-, 6-, and 12-month follow-ups. However, a significant difference was observed 1 month post-procedure [HTx: 14.8 (9.4–17.7) vs. LVAD: 11.2 (7.3–14.9), p = 0.02]. In the LVAD group, a significant decrease in MELD-XI score was noted for 3 months post-procedure compared to 1 month pre-procedure (p < 0.001), whereas at 6- and 12-month follow-ups the score did not differ from pre-procedural scores. In the HTx group, significant decreases in MELD-XI scores were observed from 3 months, 6 months, and 1 year post-procedure compared to 1 month pre-procedure (p < 0.002). Conclusions: The MELD-XI scale reveals different MOF trajectories between HTx and LVAD recipients. Both interventions lead to early improvements in liver and kidney function, with sustained benefits in HTx patients, highlighting the distinct impacts on organ function. Full article

Heart failure (HF) and left ventricular hypertrophy (LVH) are linked to fibroblast growth factor 23 (FGF23). This study aims to analyze whether FGF23 can predict postoperative outcomes in unselected left ventricular assist device (LVAD) candidates. Methods: We conducted a prospective observational study that included 27 patients (25 HeartMate3 and 2 HeartMateII) with a median follow-up of 30 months. We measured preoperative FGF23 plasma levels and computed the HeartMateII risk score (HMRS), the HeartMate3 risk score (HM3RS) and the EuroSCOREII with respect to postoperative mortality, as well as the Michigan right heart failure risk score (MRHFS), the Euromacs RHF risk score (EURORHFS), the CRITT score with respect to RHF prediction and the kidney failure risk equation (KFRE) with respect to kidney failure. Multivariate logistic regression and receiver operating characteristic (ROC) analyses were performed. Results: In the multivariate logistic regression, preoperative FGF23 level was found to be a predictor of postoperative RHF (OR: 1.37, 95-CI: 0.78–2.38; p = 0.031), mortality (OR: 1.10, 95%-CI: 0.90–1.60; p = 0.025) and the need for postoperative dialysis (OR: 1.09, 95%-CI: 0.91–1.44; p = 0.032). In the ROC analysis, FGF23 as a predictor of post-LVAD RHF had an area under the curve (AUC) of 0.81. Conclusions: FGF23 improves the prediction of clinically significant patient outcomes—such as need for dialysis, RHF and mortality—after HM3 and HMII implantation, as adding FGF23 to established risk scores increased their predictive value. Full article

Background: In advanced heart failure patients implanted with a fully magnetically levitated HeartMate 3 (HM3) Abbott left ventricular assist device (LVAD), it is unknown how the role of the LVAD outpatient clinic may affect the long-term survival after hospital discharge. Our objective is to share our standardized protocol for outpatient care, to describe the role of the LVAD outpatient clinic in postoperative long-term care after LVAD implantation, and to report survival. Methods: We retrospectively reviewed all patients implanted with HM3 LVAD in our institute between September 2015 and January 2025. Patients who received HeartWare Ventricular Assist Device (HVAD) and HeartMate 2 LVAD devices were excluded from our study, to ensure a homogenous cohort focusing on the latest and the only currently used LVAD device generation. We included a total of 48 patients. After LVAD patients are discharged from our center, they are followed in our outpatient clinic in 3-month intervals. During visits, bloodwork, EKG, wound inspection, and echocardiography are performed in addition to LVAD analysis. The role of the outpatient clinic is to detect early signs of deterioration or problems and act accordingly to prevent serious complications. Results: Thirty-three patients (68.7%) are still alive in 2025; two patients (4.2%) had a successful heart transplantation; and thirty-one patients (64.5%) are still on LVAD support. There were 210 total patient years of support. The mean time on device is 4.4 years. During the follow-up period we noticed 15 deaths (31.3%). Notably, there was no technical device-related death. Kaplan–Meier analysis estimated an overall survival rate of 97.9%, 92.8%, 83.7%, and 51.1% at 1, 2, 4, and 8 years, respectively. Conclusion: Strict control of patients after discharge in an outpatient clinic is essential for the long-term survival of these patients. A well-structured outpatient program is of utter importance to avoid LVAD-related complications and should be a cornerstone for the treatment, especially in non-transplant centers. Full article

Background: The yearly number of left ventricular assist device (LVAD) implantations is approximately twice the number of heart transplantations (HTX) in Germany. As the number of patients with an LVAD installed grows, so does the likelihood of their presentation to the emergency room (ER). Due to uneasiness in identifying their primary complaint, ER personnel are often likely to overlook important clues in the treatment of patients with an LVAD. Methods: To assess the urgency of patients’ conditions and their relationship with LVADs, we retrospectively examined the ER admissions of patients with HeartMate 3^TM (HM 3) LVADs installed between 2014 and 2024 at our university medical center. We counted referrals to the peripheral ward (minor) and to the intensive care unit (ICU, major). Relation to LVAD relation was also recorded. The survival was analyzed with respect to the severity of the cause of admission (minor/major) and the relationship to the LVAD therapy. Results: We observed 100 presentations to the emergency department. Of these, 77 were minor and 23 were major. The majority (92) was not related to the LVAD. Of the eight admissions related to the LVAD, two were major adverse events, accounting only for 2% of the total cases. Conclusions: An ER presentation of a patient with an HM 3 is very likely to have a medical cause not related to the LVAD. LVAD-related causes were mostly minor and could be treated on the ward. Full article

Background: The HeartMate 3 (HM3) left ventricular assist device (LVAD) has demonstrated improved clinical outcomes in patients with advanced heart failure (HF). However, the influence of underlying HF etiology—ischemic cardiomyopathy (ICM) versus dilated cardiomyopathy (DCM)—on post-implantation outcomes remains insufficiently characterized. Objectives: This paper aims to evaluate early postoperative outcomes following HM3 LVAD implantation in patients with ICM versus DCM and to identify the preoperative hemodynamic and clinical predictors of early mortality and hemodynamic instability. Methods: We conducted a retrospective single-center cohort study of 30 patients who underwent HM3 LVAD implantation between 2017 and 2024. Patients were stratified by HF etiology (ICM, n = 17; DCM, n = 13), and preoperative clinical, echocardiographic, and right heart catheterization data were analyzed. The primary endpoint was 30-day postoperative survival. Secondary endpoints included postoperative hemodynamic stability and the need for vasopressor support. Results: Non-survivors (n = 13) demonstrated elevated central venous pressure (>16.5 mmHg), mean right ventricular pressure (>31.5 mmHg), and pulmonary vascular resistance (>7.5 Wood units), in addition to higher preoperative creatinine levels and longer cardiopulmonary bypass times. Vasopressor requirement postoperatively was associated with elevated pre-implant systolic pulmonary artery pressure. Conclusions: Preoperative right-sided pressures and renal dysfunction are strong predictors of early mortality following HM3 LVAD implantation. Patients with ICM exhibit greater early left ventricular recovery compared to those with DCM. These findings underscore the importance of comprehensive and personalized preoperative risk stratification—particularly in patients with DCM and pulmonary hypertension—to optimize postoperative outcomes and guide patient selection for durable LVAD support. Full article

This review provides an in-depth analysis of argatroban as an alternative anticoagulant in cardiac surgery, with a focus on its use in patients with heparin-induced thrombocytopenia (HIT). We examine argatroban’s pharmacokinetics and dosing regimens and the challenges associated with cosnventional monitoring methods—such as activated clotting time (ACT) and activated partial thromboplastin time (aPTT)—to evaluate its safety and effectiveness in high-risk surgical settings. Drawing on data from multiple case reports and series, our review highlights both the potential benefits and limitations of argatroban, including complications such as clot formation in extracorporeal circulation systems and prolonged postoperative coagulopathy. In addition to the literature review, we present a detailed clinical case of urgent HeartMate 3 left ventricular assist device implantation in a patient with advanced heart failure and active HIT. In this case, despite targeting an ACT above 400 s, intraoperative complications such as clot formation in the heart–lung machine and difficulty achieving hemostasis highlight the need for improved monitoring and dosing protocols. Our findings call for refined anticoagulation strategies and advanced monitoring techniques to optimize argatroban use in cardiac surgery, offering valuable insights for clinicians managing complex scenarios where conventional heparin therapy is contraindicated. Full article

Background: Durable mechanical circulatory support (DMCS) infections remain a serious challenge. Ventricular assist device (VAD)-specific driveline infections (DLIs) are the most common type; however, no consensus exists on their surgical management. We aimed to define the incidence, risk factors, and microbiology of DLIs and discuss the surgical treatment modalities. Methods: We retrospectively reviewed 90 patients who underwent a left or biventricular ventricular assist device (LVAD or BiVAD) implantation with either a HeartMate 2 (Abbott), HeartWare HVAD (Medtronic), or HeartMate 3 (Abbott) in a single center between 1 March 2011 and 30 May 2023. Results: DLIs were detected in 20 (21.5%) patients during the follow-up. The mean duration of VAD support was 561.1 ± 833.2 days (1–4124 days), while it was 1277.9 ± 621.6 days in the DLI group. An extended duration of VAD support was associated with higher incidence rates of late-onset DLIs (p < 0.05). A younger age and lower plasma albumin levels were independent predictive factors for the risk of a DLI, with a hazard ratio of 9.77 (95%CI: 1.3–74.5) and 10.55 (95%CI: 1.40–79.35), respectively. The removal of the biofilm with velour and DL relocation through the rectus muscle combined with vacuum-assisted strategies (VAC) were performed in nine patients. One patient developed a recurrent infection, and another patient with a deep DLI subsequently received a heart transplant. No patient underwent a device exchange for an intractable DLI. Conclusions: Our results suggest that DLIs are common infectious complications after VAD implantation, which endanger patient autonomy, and impair their quality of life and overall survival. A DL relocation through the rectus muscles and VAC strategies have a role in controlling DLIs. Full article

(1) Left ventricular assist device (LVAD) implantation is increasingly used as a treatment option for patients with advanced heart failure (HF). There is a need to provide patients with LVAD with long-term care, preferably at home. The implementation of home-based telerehabilitation (HTR) and telecare offers new opportunities in this field. Purpose: The purpose of this study was to assess the feasibility and safety of HTR and telecare in HF patients with implanted LVAD and evaluate patients’ acceptance of and adherence to HTR. (2) The study enrolled 30 HF patients with recently implanted LVAD (21 Heart Mate III, 9 Heart Ware) (29 males, mean 59 years) who underwent a 12-week telecare and HTR program based on walking, respiratory, and resistance training, five times weekly. HTR was telemonitored with a device adjusted to register electrocardiogram (ECG) recordings and to transmit data via a mobile phone network to the monitoring center. The moments of automatic ECG registration were pre-set and coordinated with exercise. The influence on physical capacity was assessed by comparing changes in peak oxygen consumption (pVO₂; [mL/kg/min]) and workload duration (t; [s]) during the cardiopulmonary exercise test. (3) HTR resulted in a significant physical capacity improvement in pVO₂ 12.5 ± 2.9 vs. 15.1 ± 3.0 (p < 0.001), and workload duration t 628 ± 204 vs. 728 ± 222 (p < 0.001) during the cardiopulmonary exercise test. There were neither deaths nor adverse events during HTR. Patients accepted HTR, including the need for interactive everyday collaboration with the medical team. All patients completed HTR. (4) HTR is a feasible and safe form of rehabilitation that is well-accepted by patients. The adherence to HTCR was high. Full article

Background: The HeartMate 3 (HM3, Abbott) left ventricular assist device (LVAD) is the only commercially available option considered suitable for long-term circulatory support. External compression of the outflow graft causing obstruction (eOGO) is a serious adverse event affecting patients on long-term support. The obstruction occurs due to the accumulation of gelatinous substance between the bend relief and outflow graft. This systematic review evaluated all available studies with regard to the diagnosis and therapy of eOGOs. Methods: A systematic literature review and analysis of individual patient data was performed using MEDLINE/PubMed following PRISMA guidelines. Original works dating up to 31 October 2024 were considered. Results: Twenty-four publications that met the inclusion criteria were identified, providing individual data from 113 patients with a median support time to eOGO diagnosis of 809 days [588, 1095] and follow-up after treatment of 365 days [33, 605]. eOGO severity classification was performed on 108 patients according to our grading system. For treatment, most patients underwent surgery (n = 38) or stenting (n = 29). A hazard ratio of 0.75 [0.28, 2.03] was calculated for the surgical group versus the stenting group (p = 0.570). Conclusions: Concerning 30-day mortality, we did not find a significant difference between the eOGO severity of survivors and non-survivors. We found no significant differences in outcome between patients with differing eOGO severity and treatment strategy, namely stenting and surgery. Due to an increase in eOGO incidence after one year of support, we propose that clinicians monitor their patients for this complication when support time surpasses one year. Full article

Background: Patients with a HeartMate 3 (HM3) left ventricular assist device (LVAD) typically receive anticoagulation and antiplatelet therapy. The HM3 has shown a marked reduction in hemocompatibility-related adverse events (HRAEs) like stroke, bleeding, and pump thrombosis. This study evaluated whether aspirin (ASA) response influences HRAE incidence and if ASA sensitivity changes over time in HM3 recipients. Methods: This single-center, cross-sectional study included 32 HM3 patients (age: 59.0 ± 10.0 years, 15.6% female). ASA sensitivity was assessed twice using the VerifyNow assay, with ASA resistance defined by ASA reactivity units (ARU) > 550. The primary endpoint was HRAE incidence in ASA responders vs. non-responders over two consecutive follow-ups; the secondary endpoint was temporal changes in ASA resistance. Results: At the first follow-up, 13 (40.6%) patients were ASA-resistant, and 8 (28.6%) were resistant at the second follow-up, without significant change (p = 0.22). ASA non-responders and responders had similar ASA doses and baseline characteristics. No significant difference in HRAE incidence was found between ASA non-responders and responders (0.0% vs. 15.8%, p = 0.14), and no additional HRAEs occurred during follow-up. Conclusions: ASA resistance varied considerably among HM3 patients without significant temporal changes, and the demonstrated excellent hemocompatibility supports recent evidence that ASA may have a limited role in the antithrombotic regimen for HM3 recipients. Full article

Background: Pulmonary arterial elastance (Ea) is a helpful parameter to predict the risk of acute postoperative right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation. A new method for calculating Ea, obtained by the ratio between transpulmonary gradient and stroke volume (Ea^B), has been proposed as a more accurate measure than the Ea obtained as the ratio between pulmonary artery systolic pressure and stroke volume (Ea^C). However, the role of Ea^B in predicting acute RVF post-LVAD implantation remains unclear. Methods and Results: A total of 35 patients who underwent LVAD implantation from 2018 to 2021 were reviewed in this retrospective analysis. Acute RVF after LVAD implantation occurred in 12 patients (34%): 5 patients with moderate RVF (14% of total) and 7 patients with severe RVF. The Ea^B was not significantly different between the “severe RVF” vs. “not-severe RVF” groups (0.27 ± 0.04 vs 0.23 ± 0.1, p < 0.403). However, the combination of arterial elastance and central venous pressure was significantly different between the “not-severe RVF” group (central venous pressure < 14 mmHg and Ea^C < 0.88 mmHg/mL or Ea^B < 0.24 mmHg/mL; p < 0.005) and the “severe RVF” group (central venous pressure > 14 mmHg and Ea^C > 0.88 mmHg/mL or Ea^B > 0.24 mmHg/mL; p < 0.005). Conclusions: Ea is a reliable parameter of right ventricular afterload and helps discriminate the risk of acute RVF after LVAD implantation. The combined analysis of Ea and central venous pressure can also risk stratify patients undergoing LVAD implantation for the development of RVF. Full article