Single-Center Experience With Protocolized Treatment of Left Ventricular Assist Device Infections.

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.

Rate of thromboembolic and bleeding events in patients undergoing concomitant aortic valve surgery with left ventricular assist device implantation.

BACKGROUND: Significant aortic regurgitation at the time of left ventricular assist device (LVAD) implantation, requires concomitant aortic valve (AoV) replacement or repair. However, the impact of concomitant AoV surgery on morbidity remains unknown. Therefore, our aim is to determine the impact of concomitant AoV surgery on thromboembolic and bleeding events. METHODS: A retrospective IMACS registry study, including patients implanted from 2013 until September 2017. Differences between different concomitant AoV surgery modalities were analyzed. RESULTS: In total, 785 (5.1%) out of 15.267 patients (median age 58 IQR 49-66 years, 79% male) underwent concomitant AoV surgery (median age 63 IQR 54-69 years, 84% male); 386 (49%) patients received biological prostheses, 71 (9%) mechanical prostheses and 328 (42%) AoV repairs. In total, 54 (8%) patients with AoV surgery experienced a thromboembolic event and 1016 (9%) patients with no AoV surgery. Furthermore, concomitant AoV surgery was associated with an increased rate of all and nonsurgical bleedings. Following a multivariable Cox regression, concomitant AoV surgery remained an independent predictor for bleeding events. CONCLUSIONS: In LVAD patients undergoing concomitant AoV surgery, thromboembolic event rates were not higher, however both all and nonsurgical bleeding event rates were higher.

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.

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 < 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.

Right ventricular functional assessment by 2D multi-plane echocardiography prior to left ventricular assist device implantation.

OBJECTIVES: Right ventricular (RV) failure post left ventricular assist device (LVAD) implantation is associated with increased morbidity and mortality. A novel RV multi-plane imaging method using two-dimensional echocardiography and electronic plane rotation (MPE) was used to quantify RV function prior to LVAD implantation and to identify potential added value in this patient population. METHODS: In twenty-five end-stage heart failure patients (age 58.9 ± 6.8 years, 76% male), systolic function of four different RV walls (lateral, anterior, inferior and inferior coronal) were evaluated from one focussed apical view using MPE. RESULTS: Feasibility of tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular peak systolic velocity (RV-S') measurements were high (84-100%), with lower TAPSE values measured in the inferior (14.2 ± 4.6 mm) and inferior coronal (12.3 ± 5.0 mm) walls compared to the lateral (16.3 ± 4.5 mm) and anterior walls (16.0 ± 4.5 mm). RV wall longitudinal strain (RV-LS) measurement was most feasible in the lateral wall (80%; mean: -12.1 ± 4.2%). TAPSE and RV-LS values were significantly reduced in patients compared to matched healthy individuals (p = <0.001). Seven (28%) patients who developed moderate to severe RV failure (RVF) early post-implant (≤30 days) had lower pre-implant values across all multi-plane parameters compared to those without significant post-implant RVF, notably four-wall averaged TAPSE (11.1 ± 3.4 mm vs 15.9 ± 4.0 mm; p = 0.02). CONCLUSION: 2D MPE was highly feasible for RV wall quantification pre-LVAD surgery, detecting differences in regional wall function. This novel method comprehensively quantifies RV wall function and could complement current pre-LVAD screening protocols.

Driveline exit-site care protocols in patients with left ventricular assist devices: a systematic review.

OBJECTIVES: Driveline infections continue to be a significant complication following left ventricular assist device (LVAD) implantation. Driveline exit-site care is crucial for the prevention of infections; however, there are no uniform guidelines. The goal of this study was to provide an overview of the currently published driveline exit-site care protocols in patients with LVAD. METHODS: A systematic literature review was performed. Studies before 15 December 2020 were included if the number of driveline infections was a primary outcome and the driveline exit-site care protocol was explained. RESULTS: Eleven articles were included in the systematic review, including 1602 patients with LVADs. The median of the frequency of driveline infections in the articles was 13.8% with a range of 0-52.6%. There was a marked variability in the methods of care of driveline exit sites, without a standardized driveline dressing technique in patients with LVADs. The frequency of driveline infections was 6-7.5% in studies using a dressing kit that included chlorhexidine, a silver-based dressing and an anchoring device. Furthermore, there was variability in the anchoring devices and the frequency of dressing changes, which varied from daily to weekly. No specific anchoring device or change frequency was found to be superior. CONCLUSIONS: Based on this systematic review, driveline exit care protocols that included chlorhexidine, a silver-based dressing, the use of an anchoring device and dressing kits might be best in reducing driveline infection rates. However, prospective studies with larger cohorts are needed to establish the optimal protocol for driveline exit-site care.

Survival following a concomitant aortic valve procedure during left ventricular assist device surgery: an ISHLT Mechanically Assisted Circulatory Support (IMACS) Registry analysis.

AIMS: The aim of this study was to compare early- and late-term survival and causes of death between patients with and without a concomitant aortic valve (AoV) procedure during continuous-flow left ventricular assist device (LVAD) surgery. METHODS AND RESULTS: All adult primary continuous-flow LVAD patients on the International Society of Heart and Lung Transplantation (ISHLT) Mechanically Assisted Circulatory Support (IMACS) Registry (n = 15 267) were included in this analysis and stratified into patients submitted to a concomitant AoV procedure (AoV replacement or AoV repair) and patients without an AoV procedure. The primary outcome was early (≤90 days) survival post-LVAD surgery. Secondary outcomes were late survival (survival during the entire follow-up period) and conditional survival (in patients who survived the first 90 days post-LVAD surgery), and determinants. Patients who underwent concomitant AoV replacement (n = 457) had significantly reduced late survival compared with patients with AoV repair (n = 328) or without an AoV procedure (n = 14 482) (56% vs. 61% and 62%, respectively; P = 0.001). After adjustment for other significant predictors, concomitant AoV replacement remained an independent predictor for early [hazard ratio (HR) 1.226, 95% confidence interval (CI) 1.037-1.449] and late (HR 1.477, 95% CI 1.154-1.890) mortality. However, patients undergoing AoV replacement or repair, in whom the presence of moderate-to-severe AoV regurgitation was diagnosed prior to LVAD implantation, had survival similar to patients not undergoing AoV interventions. CONCLUSIONS: Concomitant AoV surgery in patients undergoing LVAD implantation is an independent predictor of mortality. Additional research is needed to determine the best AoV surgical strategy at the time of LVAD surgery.

Aortic root thrombus after left ventricular assist device implantation and aortic valve replacement.

Data on the risk of aortic root thrombosis in patients with aortic valve replacement (AVR) and left ventricular assist device (LVAD) surgery are scarce. Two out of nine patients receiving AVR concomitant with LVAD surgery and two out of two patients receiving AVR on LVAD support, at our centre, developed an aortic root thrombus, all diagnosed with computed tomography (CT) angiography. These results demonstrate that patients with concomitant AVR and LVAD surgery, or AVR on LVAD support, have an increased risk of aortic root thrombosis. Therefore, early anti-thrombotic therapy and vigilant diagnostic follow-up, using CT scans, are warranted to prevent thromboembolic events.

Impact of preoperative liver dysfunction on outcomes in patients with left ventricular assist devices.

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.