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Aims: This retrospective study investigated the association between anatomical variations in the aortic arch branching and adverse events, including the risk of cerebrovascular accidents (CVAs), in patients with a left ventricular assist device (LVAD)., Methods: Medical charts were reviewed for all patients with HeartMate 3 LVAD support at our center from 2016 to 2021. Computed tomography scans were evaluated to categorize the variations in the aortic arch branching based on seven different types, as described in the literature., Results: In total, 101 patients were included: 86 (85.1%) with a normal branching pattern and 15 (14.9%) with an anatomical variation. The following variations were observed: eight (7.9%) with a bovine arch and seven (6.9%) with a left vertebral arch. The median age was 57 years, 77.2% were men, and the median follow-up was 25 months. No difference was found in the rate of early (< 30 days) re-exploration due to bleeding after LVAD implantation. The rate of CVA and mortality did not differ significantly between patients with a normal arch or an anatomical variation during follow-up, with hazard ratios of 1.47 [95% confidence interval (CI): 0.48-4.48; P = 0.495] and 0.69 (95% CI: 0.24-1.98; P = 0.489), respectively., Conclusion: This preliminary study showed no differences in early and long-term adverse events, including CVA, when comparing patients with a variation in the aortic arch branching to patients with a normal aortic arch. However, knowledge of the variations in aortic arch branching could be meaningful during cardiac surgery for potential differences in surgical events in the perioperative period., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Italian Federation of Cardiology.)

Background: Right ventricular failure (RVF) is a significant cause of morbidity and mortality in patients with a left ventricular assist device (LVAD). This study is aimed to investigate the influence of a pectus excavatum on early and late outcomes, specifically RVF, following LVAD implantation., Methods: A retrospective study was performed, that included patients with a HeartMate 3 LVAD at our tertiary referral center. The Haller index (HI) was calculated using computed tomography (CT) scan to evaluate the chest-wall dimensions., Results: In total, 80 patients (median age 57 years) were included. Two cohorts were identified: 28 patients (35%) with a normal chest wall (HI < 2.0) and 52 patients (65%) with pectus excavatum (HI 2.0-3.2), with a mean follow-up time of 28 months. Early ( ≤ 30 days) RVF and early acute kidney injury events did not differ between cohorts. Overall survival did not differ between cohorts with a hazard ratio (HR) of 0.47 (95% confidence interval (CI): 0.19-1.19, p = 0.113). Late ( > 30 days) recurrent readmission for RVF occurred more often in patients with pectus excavatum ( p = 0.008). The onset of late RVF started around 18 months after implantation and increased thereafter in the overall study cohort., Conclusions: Pectus excavatum is observed frequently in patients with a LVAD implantation. These patients have an increased rate of readmissions and late RVF. Further investigation is required to explore the extent and severity of chest-wall abnormalities on the risk of RVF., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 The Author(s). Published by IMR Press.)

Background: Left ventricular assist device (LVAD) therapy is an established treatment for advanced heart failure with reduced ejection fraction. We evaluated the characteristics and clinical outcomes of patients implanted with an LVAD in the Netherlands., Methods: Patients implanted with an LVAD in the Netherlands between 2016 and 2020 were included in the analysis. Baseline characteristics entered into this registry, as well as clinical outcomes (death on device, heart transplantation) and major adverse events (device dysfunction, major bleeding, major infection and cerebrovascular event), were evaluated., Results: A total of 430 patients were implanted with an LVAD; mean age was 55 ± 13 years and 27% were female. The initial device strategy was bridge to transplant (BTT) in 50%, destination therapy (DT) in 29% and bridge to decision (BTD) in the remaining 21%. After a follow-up of 17 months, 97 (23%) patients had died during active LVAD support. Survival was 83% at 1 year, 76% at 2 years and 54% at 5 years. Patients implanted with an LVAD as a BTT had better outcomes compared with DT at all time points (1 year 86% vs 72%, 2 years 83% vs 59% and 5 years 58% vs 33%). Major adverse events were frequently observed, most often major infection, major bleeding and cerebrovascular events (0.84, 0.33 and 0.09 per patient-year at risk, respectively) and were similar across device strategies. Patients supported with HeartMate 3 had a lower incidence of major adverse events., Conclusions: Long-term survival on durable LVAD support in the Netherlands is over 50% after 5 years. Major adverse events, especially infection and bleeding, are still frequently observed, but decreasing with the contemporary use of HeartMate 3 LVAD., (© 2023. The Author(s).)

Mechanical device malfunction remains a known issue in left ventricular assist devices (LVADs). We investigated the incidence of mechanical device malfunction in the HeartMate II and HeartMate 3 LVADs. We conducted a retrospective study of all HeartMate II and HeartMate 3 LVADs implanted in our center. We evaluated major malfunction, potential major malfunction, minor malfunction, and need of device exchange. In total, 163 patients received an LVAD; in 63 (39%) a HeartMate II, and in 100 (61%) a HeartMate 3, median support time of respectively 24.6 months (interquartile range [IQR]: 32.4) and 21.1 months [IQR: 27.2]. Mechanical device malfunction, consisting of both major and potential major malfunction, occurred significantly less in the HeartMate 3 patients with a hazard ratio (HR) of 0.37 (95% confidence interval [CI]: 0.15-0.87, p = 0.022). Major malfunction alone occurred significantly less in HeartMate 3 patients with a HR of 0.18 (95% CI: 0.05-0.66, p = 0.009). HeartMate 3 patients had a significantly decreased hazard of a pump or outflow graft exchange (HR 0.13, 95% CI: 0.08-0.81, p = 0.008). System controller defects occurred significantly less in HM 3 patients ( p = 0.007), but battery-clips defects occurred significantly more in HM 3 patients ( p = 0.039). Major device malfunction including pump or outflow graft exchange occurred significantly less in HeartMate 3 compared to HeartMate II, while minor malfunctions were similar. Periodical assessment of the technical integrity of the device remains necessary during long-term LVAD support., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Objectives: This retrospective study investigated the correlation between the angular position of the left ventricular assist device (LVAD) inflow cannula and relapsing low-flow alarms., Methods: Medical charts were reviewed of all patients with HeartMate 3 LVAD support for relapsing low-flow alarms. A standardized protocol was created to measure the angular position with a contrast-enhanced computed tomography scan. Statistics were done using a gamma frailty model with a constant rate function., Results: For this analysis, 48 LVAD-supported patients were included. The majority of the patients were male (79%) with a median age of 57 years and a median follow-up of 30 months (interquartile range: 19-41). Low-flow alarm(s) were experienced in 30 (63%) patients. Angulation towards the septal-lateral plane showed a significant increase in low-flow alarms over time with a constant rate function of 0.031 increase in low-flow alarms per month of follow-up per increasing degree of angulation (P = 0.048). When dividing this group using an optimal cut-off point, a significant increase in low-flow alarms was observed when the septal-lateral angulation was 28° or more (P = 0.001). Anterior-posterior and maximal inflow cannula angulation did not show a significant difference., Conclusions: This study showed an increasing number of low-flow alarms when the degrees of LVAD inflow cannula expand towards the septal-lateral plane. This emphasizes the importance of the LVAD inflow cannula angular position to prevent relapsing low-flow alarms with the risk of diminished quality of life and morbidity., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Purpose: Because of the current lack of evidence-based antimicrobial treatment guidelines, Left Ventricular Assist Device (LVAD) infections are often treated according to local insights. Here, we propose a flowchart for protocolized treatment, in order to improve outcome., Methods: The flowchart was composed based on literature, consensus and expert opinion statements. It includes choice, dosage and duration of antibiotics, and indications for suppressive therapy, with particular focus on Staphylococcus aureus (SA) (Figure 1). The preliminary treatment results of 28 patients (2 from start cephalexin suppressive therapy) after implementation in July 2018 are described., Results: Cumulative incidence for first episode of infection in a 3-year time period was 27% (26 of 96 patients with an LVAD). Twenty-one of 23 (91%) first episodes of driveline infection (10 superficial and 13 deep; nine of 13 caused by SA) were successfully treated with antibiotics according to flowchart with complete resolution of clinical signs and symptoms. For two patients with deep driveline infections, surgery was needed in addition. There were no relapses of deep driveline infections, and only 2 SA deep driveline re-infections after 6 months. Nine patients received cephalexin of whom four patients (44%) developed a breakthrough infection with cephalexin-resistant gram-negative bacteria., Conclusions: The first results of this protocolized treatment approach of LVAD infections are promising. Yet, initiation of cephalexin suppressive therapy should be carefully considered given the occurrence of infections with resistant micro-organisms. The long-term outcome of this approach needs to be established in a larger number of patients, preferably in a multi-center setting., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Verkaik, Yalcin, Bax, Constantinescu, Brugts, Manintveld, Birim, Croughs, Bogers and Caliskan.)

Aims: The need for permanent pacemakers (PMs) after heart transplantation (HT) is increasing. The aim was to determine the influence of cardiac allograft vasculopathy (CAV), donor age, and other risk factors on PM implantations early and late after HT and its effect on survival., Methods and Results: A retrospective, single-centre study was performed including HTs from 1984 to July 2018. Early PM was defined as PM implantation ≤90 days and late PM as PM > 90 days. Risk factors for PM and survival after PM were determined with (time-dependent) multivariable Cox regression. Out of 720 HTs performed, 62 were excluded (55 mortalities ≤30 days and 7 retransplantations). Of the remaining 658 patients, 95 (14%) needed a PM: 38 (6%) early and 57 (9%) late during follow-up (median 9.3 years). Early PM risk factors were donor age [hazard ratio (HR) 1.06, P < 0.001], ischaemic time (HR 1.01, P < 0.001), and in adults amiodarone use before HT (HR 2.02, P = 0.045). Late PM risk factors were donor age (HR 1.03, P = 0.024) and CAV (HR 3.59, P < 0.001). Late PM compromised survival (HR 2.05, P < 0.001), while early PM did not (HR 0.77, P = 0.41)., Conclusions: Risk factors for early PM implantation were donor age, ischaemic time, and in adults amiodarone use before HT. Late PM implantation risk factors were donor age and CAV. Late PM diminished survival, which is probably a surrogate marker for underlying progressive cardiac disease., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aim: We aimed to assess the safety and feasibility of using CardioMEMS monitoring in patients before and after left ventricular assist device (LVAD) surgery. Patients & methods: Ten patients accepted for elective LVAD surgery were included, received a CardioMEMS at baseline and were categorized based on mean pulmonary artery pressure (mPAP) ≤25 mmHg (n = 4) or mPAP >25 mmHg [n = 6]) before LVAD surgery. Results: The combined end point of all-cause mortality, acute kidney injury and/or renal replacement therapy, and right ventricular failure occurred more often in patients with an mPAP >25 mmHg (83 vs 0%, p = 0.017). Conclusion: This pilot study demonstrates that combining CardioMEMS monitoring with LVAD therapy is safe and generates the hypothesis that patients with an mPAP >25 mmHg before LVAD surgery identify a very high-risk group for adverse clinical outcomes.

Objectives: We evaluated the impact of preoperative liver function on early and 1-year postoperative outcomes in patients supported with a left ventricular assist device (LVAD) and subsequent evolution of liver function markers., Methods: A retrospective multicentre cohort study was conducted, including all patients undergoing continuous-flow LVAD implantation. The Model for End-stage Liver Disease (MELD) score was used to define liver dysfunction., Results: Overall, 290 patients with an LVAD [78% HeartMate II, 15% HVAD and 7% HeartMate 3, mean age 55 (18), 76% men] were included. Over 40 000 measurements of liver function markers were collected over a 1-year period. A receiver operating characteristic curve analysis for the 1-year mortality rate identified the optimal cut-off value of 12.6 for the MELD score. Therefore, the cohort was dichotomized into patients with an MELD score of less than or greater than 12.6. The early (90-day) survival rates in patients with and without liver dysfunction were 76% and 91% (P = 0.002) and 65% and 90% at 1 year, respectively (P < 0.001). Furthermore, patients with preoperative liver dysfunction had more embolic events and more re-explorations. At the 1-year follow-up, liver function markers showed an overall improvement in the majority of patients, with or without pre-LVAD liver dysfunction., Conclusions: Preoperative liver dysfunction is associated with higher early 90-day and 1-year mortality rates after LVAD implantation. Furthermore, liver function improved in both patient groups. It has become imperative to optimize the selection criteria for possible LVAD candidates, since those who survive the first year show excellent recovery of their liver markers., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

We present a case to demonstrate the feasibility of pulmonary artery monitoring with the CardioMEMS sensor for the preoperative optimization of patients with end-stage heart failure undergoing LVAD surgery. Additionally, we demonstrate the feasibility of combining two state-of-the-art techniques by integrating haemodynamic feedback from CardioMEMS and static pump settings of an LVAD. CardioMEMS aids in the remote monitoring of LVAD patients with the potential of identifying complications, pump dysfunction or filling status alterations., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Aims: We aim to study the feasibility and clinical value of pulmonary artery pressure monitoring with the CardioMEMS™ device in order to optimize and guide treatment in patients with a HeartMate 3 left ventricular assist device (LVAD)., Methods and Results: In this single-centre, prospective pilot study, we will include 10 consecutive patients with New York Heart Association Class IIIb or IV with Interagency Registry for Mechanically Assisted Circulatory Support Classes 2-5 scheduled for implantation of a HeartMate 3 LVAD. Prior to LVAD implantation, patients will receive a CardioMEMS sensor, for daily pulmonary pressure readings. The haemodynamic information provided by the CardioMEMS will be used to improve haemodynamic status prior to LVAD surgery and optimize the timing of LVAD implantation. Post-LVAD implantation, the haemodynamic changes will be assessed for additive value in detecting potential complications in an earlier stage (bleeding and tamponade). During the outpatient clinic phase, we will assess whether the haemodynamic feedback can optimize pump settings, detect potential complications, and further tailor the clinical management of these patients., Conclusions: The HEMO-VAD study is the first prospective pilot study to explore the safety and feasibility of using CardioMEMS for optimization of LVAD therapy with additional (remote) haemodynamic information., (© 2019 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

Objectives: Moderate-to-severe tricuspid regurgitation is common in end-stage heart disease and is associated with an impaired survival after left ventricular assist device (LVAD) surgery. Controversy remains whether concomitant tricuspid valve surgery (TVS) during LVAD implantation is beneficial. We aimed to provide a contemporary overview of outcomes in patients who underwent LVAD surgery with or without concomitant TVS., Methods: A systematic literature search was performed for articles published between January 2005 and March 2017. Studies comparing patients undergoing isolated LVAD implantation and LVAD + TVS were included. Early outcomes were pooled in risk ratios using random effects models, and late survival was visualized by a pooled Kaplan-Meier curve., Results: Eight publications were included in the meta-analysis, including 562 undergoing isolated LVAD implantation and 303 patients with LVAD + TVS. Patients undergoing LVAD + TVS had a higher tricuspid regurgitation grade, central venous pressure and bilirubin levels at baseline and were more often female. We found no significant differences in early mortality and late mortality, early right ventricular failure and late right ventricular failure, acute kidney failure, early right ventricular assist device implantation or length of hospital stay. Cardiopulmonary bypass time was longer in patients undergoing additional TVS [mean difference +35 min 95% confidence interval (16-55), P = 0.001]., Conclusions: Adding TVS during LVAD implantation is not associated with worse outcome. Adding TVS, nevertheless, may be beneficial, as baseline characteristics of patients undergoing LVAD + TVS were suggestive of a more progressive underlying disease, but with comparable short-term outcome and long-term outcome with patients undergoing isolated LVAD.

Long-term durability and incidence of potential mechanical device failure (MDF) are largely unknown. In this study, we investigated the incidence and potential predictors of MDF in continuous flow left ventricular assist device (CF-LVAD) patients. We conducted a retrospective study of all CF-LVADs (type HeartMate II) implanted in our center. MDF was defined as a failure of driveline, inflow-outflow graft, electrical power, drive unit, or motor failure, excluding device failure because of a biologic complication (e.g., device thrombosis, hemolysis, or infections). A total of 69 CF-LVADs were implanted in 59 patients (median support time 344 days [interquartile range {IQR}, 149-712 days], mean age 50.1 ± 10.7 years, 75% male). MDF occurred in 9 (13%) CF-LVAD patients at a median follow-up time of 846 (IQR, 708-1337) days after implantation. Freedom of MDF through the first, second, and third year after LVAD implantation was 100%, 85%, and 64%, respectively. Patients who experienced MDF were significantly longer supported by their LVAD (median 846 [IQR, 708-1337] vs 268 [IQR, 103-481] days; p = 0.001) and were more frequently readmitted because of LVAD-related technical problems (p = 0.002), including a higher rate of LVAD controllers exchange (44% vs 12%, respectively; p = 0.03). The main reason for MDF was a damaged or fractured driveline (n=8, 89%). In 2 patients, sudden death was related to MDF. Patients needing extended CF-LVAD support are at increasing risk for MDF. Various technical problems precede the onset of MDF. Periodical extensive assessment of the technical integrity of the device is urgently needed during long-term LVAD support.

Objectives: Bleeding is a common complication following left ventricular assist device (LVAD) implantation. The goal of this study was to investigate the incidence, predictors and clinical outcome of early bleeding events in patients after LVAD implantation., Methods: A total of 83 patients (age 50 ± 13 years, 76% men) had an LVAD implanted [77% HeartMate II, 19% HeartMate 3 (Abbott, Chicago, IL, USA)] over a period of 11 years. Patients were included consecutively. An early bleeding event was defined as the need for thoracic surgical re-exploration or transfusion with >4 units of packed red blood cells before discharge., Results: Overall, 39 (47%) patients (age 50 ± 14 years, 77% men) experienced an early bleeding event [median time 6 days (interquartile range 1-9 days)]. Furthermore, 10 (26%) of these patients had ≥2 bleeding events. Twelve of the 14 (92%) patients with venoarterial extracorporeal membrane oxygenation (ECMO) support before LVAD implantation experienced an early bleeding event versus 27 of the 69 (39%) patients without ECMO support (P < 0.001). No difference was found in early bleeding rates between HeartMate II and HeartMate 3. Predictors for early bleeding events were lower pre- and postimplant platelet counts and ECMO support preimplantation. After multivariable adjustment, early bleeding events were associated with ECMO support preimplantation (odds ratio 6.3, 95% confidence interval 1.2-32.4; P = 0.03) and thrombocytopenia (<150 × 109/l) postimplant (odds ratio 5.9, 95% confidence interval 1.9-18.7; P = 0.002). Patients who experienced an early bleeding event had a significantly worse 90-day survival rate compared to patients who did not (79% vs 96%, P = 0.03)., Conclusions: An early bleeding event needing surgical exploration is highly prevalent after LVAD implantation, especially in patients bridged with ECMO and with pre- and postimplant thrombocytopenia.

Purpose: Acute kidney injury (AKI) frequently occurs after heart transplantation (HTx), but its relation to preoperative right heart hemodynamic (RHH) parameters remains unknown. Therefore, we aimed to determine their predictive properties for postoperative AKI severity within 30 days after HTx., Methods: From 1984 to 2016, all consecutive HTx recipients (n = 595) in our tertiary referral center were included and analyzed for the occurrence of postoperative AKI staged by the kidney disease improving global outcome criteria. The effects of preoperative RHH parameters on postoperative AKI were calculated using logistic regression, and predictive accuracy was assessed using integrated discrimination improvement (IDI), net reclassification improvement (NRI), and area under the receiver operating characteristic curves (AUC)., Results: Postoperative AKI occurred in 430 (72%) patients including 278 (47%) stage 1, 66 (11%) stage 2, and 86 (14%) stage 3 cases. Renal replacement therapy (RRT) was administered in 41 (7%) patients. Patients with higher AKI stages had also higher baseline right atrial pressure (RAP; median 7, 7, 8, and in RRT 11 mmHg, p trend = 0.021), RAP-to-pulmonary capillary wedge pressure ratio (median 0.37, 0.36, 0.40, 0.47, p trend = 0.009), and lower pulmonary artery pulsatility index (PAPi) values (median 2.83, 3.17, 2.54, 2.31, p trend = 0.012). Higher RAP and lower PAPi values independently predicted AKI severity [adjusted odds ratio (OR) per doubling of RAP 1.16 (1.02-1.32), p = 0.029; of PAPi 0.85 (0.75-0.96), p = 0.008]. Based on IDI, NRI, and delta AUC, inclusion of these parameters improved the models' predictive accuracy., Conclusions: Preoperative PAPi and RAP strongly predict the development of AKI early after HTx and can be used as early AKI predictors.