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Aims Most devices for treating ambulatory Class II and III heart failure are linked to electrical pulses. However, a steady electric potential gradient is also necessary for appropriate myocardial performance and may be disturbed by structural heart diseases. We investigated whether chronic application of electrical microcurrent to the heart is feasible and safe and improves cardiac performance. The results of this study should provide guidance for the design of a two‐arm, randomized, controlled Phase II trial. Methods and results This single‐arm, non‐randomized pilot study involved 10 patients (9 men; mean age, 62 ± 12 years) at two sites with 6 month follow‐up. All patients had New York Heart Association (NYHA) Class III heart failure and non‐ischaemic dilated cardiomyopathy, with left ventricular ejection fraction (LVEF)

Background The aim of this study was to evaluate the impact of the surgical approach on the postoperative outcome in patients who underwent left ventricular assist device (LVAD) implantation after having received veno-arterial extracorporeal life support (va-ECLS) using data from a European registry (ECLS-VAD). Five hundred and thirty-one patients were included. Methods A propensity score-adjusted outcome analysis was performed, resulting in 324 patients in the full sternotomy (FS) group and 39 in the less invasive surgery (LIS) group. Results The surgery lasted in median 236 min in the FS group versus 263 min in the LIS group (p = 0.289). The median chest tube output during the first 24 h was similar in both groups. Patients who underwent implantation with an FS required more blood products during the first 24 postoperative hours (median 16 vs. 12, p = 0.033). The incidence of revision due to bleeding was also higher (35.5 vs. 15.4%, p = 0.016). A temporary postoperative right ventricular assist device was necessary in 45.1 (FS) versus 23.1% (LIS) of patients, respectively (p = 0.067). No stroke occurred in the LIS group during the first 30 days after surgery (7.4% in the FS group). The incidence of stroke and of renal, hepatic, and respiratory failure during the follow-up was similar in both groups. The 30-day and one-year survival were similar in both groups. Conclusion LIS for implantation of a durable LVAD in patients on va-ECLS implanted for cardiogenic shock is associated with less revision due to bleeding, less administration of blood products and absence of perioperative stroke, with no impact on survival.

Background The decision to implant durable mechanical circulatory systems (MCSs) in patients on extracorporeal life support (ECLS) is challenging due to expected poor outcomes in these patients. Objectives The aim of this study was to identify outcome predictors that may facilitate future patient selection and decision making. Methods The Durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent MCS implantation after ECLS between January 2010 and August 2018 in 11 high-volume European centers. Several perioperative parameters were collected. The primary endpoint was survival at 1 year after durable MCS implantation. Results A total of 531 durable MCSs after ECLS were implanted during this period. The average patient age was 53 ± 12 years old. ECLS cannulation was peripheral in 87% of patients and 33% of the patients had history of cardiopulmonary resuscitation before ECLS implantation. The 30-day, 1-year, and 3-year actuarial survival rates were 77%, 53%, and 43%, respectively. The following predictors for 1-year outcome have been observed: age, female sex, lactate value, Model of End-Stage Liver Disease XI score, history of atrial fibrillation, redo surgery, and body mass index >30 kg/m2. On the basis of this data, a risk score and an app to estimate 1-year mortality was created. Conclusions The outcome in patients receiving durable MCS after ECLS remains limited, yet preoperative factors may allow differentiating futile patients from those with significant survival benefit.

OBJECTIVES We reviewed our institutional experience with intravenous thrombolysis (TL) as first-line therapy in patients with Medtronic/HeartWare HVAD left ventricular assist device pump thrombosis (PT). METHODS From March 2006 to November 2018, 30 Medtronic/HeartWare HVAD left ventricular assist device patients had 48 PT events. We analysed outcomes with intravenous Alteplase as a first-line therapy for PT. Pump exchange or urgent heart transplantation was only considered after the failure of TL or existing contraindications to TL. RESULTS TL was used as the first-line therapy in 44 PT events in 28 patients without a contraindication to TL. TL was successful in 61.4% of PT events. More than 1 cycle of TL was necessary in 55.6% of events. The combined success of TL and heart transplantation or device exchange was 81.8%. In 15.9% of events, PT was fatal. Causes of death were severe complications (9.1%) related to TL or discontinuation of therapy for multi-organ failure (6.8%). Intracranial bleeding and arterial thromboembolism were observed in 4.5% and 11.5% of the PT events after TL. CONCLUSIONS Intravenous TL as a first-line therapy for PT in Medtronic/HeartWare HVAD patients can be a reasonable treatment option and does not preclude subsequent heart transplantation or device exchange. However, thromboembolic and bleeding complications are common. The decision to perform TL or device exchange should, therefore, be made on an individual basis after balancing the risks and benefits of different treatment approaches.

OBJECTIVES Our aim was to investigate associations between blood stream infection [≥1 positive blood culture (BC)] and outcomes in recipients of a left ventricular assist device (LVAD). METHODS We retrospectively analysed all adult recipients of a continuous-flow LVAD between 2006 and 2016 at the Division of Cardiac Surgery, Medical University of Vienna (n = 257; devices: Medtronic HeartWare® HVAD®, Abbott HeartMate II®, Abbott HeartMate 3™). The primary outcome was all-cause mortality during follow-up. Secondary outcomes included the risk of stroke and pump thrombus during follow-up as well as the probability of heart transplantation (HTx). Risk factors for the development of ≥1 positive BC were evaluated additionally. RESULTS The incidence of ≥1 positive BC during the first year of LVAD support was 32.1% [95% confidence interval (CI) 26.4–37.9]. Multivariable Cox proportional cause-specific hazards regression analysis showed that a positive BC was associated with significantly increased all-cause mortality [hazard ratio (HR) 5.51, 95% CI 3.57–8.51; P CONCLUSIONS Blood stream infection is common and associated with a significantly increased risk of all-cause mortality and stroke at any given time during LVAD support. Effective strategies of prevention and treatment are necessary.

Despite increasing popularity and multiple postulated benefits, less invasive (LIS) left ventricular assist device (LVAD) implantation has not been sufficiently compared with standard full sternotomy (FS). We report the outcomes of a propensity score analysis designed to compare LIS and FS LVAD implantation, with perioperative blood product use, adverse event rates, and mortality as primary objective. From September 2010 to August 2016, 159 consecutive patients received a Medtronic HVAD or Abbott HeartMate 3 LVAD via a FS or LIS approach. Outcomes were analyzed using proportional hazard Cox regression, with risk adjustment based on a LIS approach propensity score model computed from demographics, risk factors, and operative covariates. Seventy-five patients were matched and compared (HVAD 83% [n = 62]; LIS approach 43% [n = 32]; mean age 60 ± 12 years; 89% [n = 67] male; 48% [n = 36] ischemic cardiomyopathy [ICMP]; 37% [n = 28]). Patient groups were comparable with regard to preoperative patient characteristics. Less invasive LVAD implantation was successful in all patients with no intraoperative conversions. In-hospital mortality was 16% in both groups, despite 37% Interagency Registry for Mechanically Assisted Circulatory Support Level I patients. Overall, 28% of the LIS patients did not receive any blood products intraoperatively, whereas, in the FS group, only two patients (5%) did not require the administration of blood products (p = 0.000). This was also a significant finding in the overall perioperative phase in which seven LIS patients (22%) who not receive any blood products versus two FS patients (5%; p = 0.033). Otherwise, outcomes were comparable. Less invasive LVAD implantation is a feasible, safe, and reduces blood product use.

Left ventricular assist devices can reverse pulmonary hypertension in cardiac transplant candidates with heart failure with a reduced ejection fraction. Whether a similar approach is applicable in restrictive cardiomyopathy is uncertain. We report the successful implantation of a Medtronic HVAD left ventricular assist device in a bridge-to-candidacy concept in 2 paediatric patients with restrictive cardiomyopathy.

Significant expression of neprilysin (NEP) is found on neutrophils, which present the transmembrane integer form of the enzyme. This study aimed to investigate the relationship of neutrophil transmembrane neprilysin (mNEP) with disease severity, adverse remodeling, and outcome in HFrEF. In total, 228 HFrEF, 30 HFpEF patients, and 43 controls were enrolled. Neutrophil mNEP was measured by flow-cytometry. NEP activity in plasma and blood cells was determined for a subset of HFrEF patients using mass-spectrometry. Heart failure (HF) was characterized by reduced neutrophil mNEP compared to controls (p &lt, 0.01). NEP activity on peripheral blood cells was almost 4-fold higher compared to plasma NEP activity (p = 0.031) and correlated with neutrophil mNEP (p = 0.006). Lower neutrophil mNEP was associated with increasing disease severity and markers of adverse remodeling. Higher neutrophil mNEP was associated with reduced risk for mortality, total cardiovascular hospitalizations, and the composite endpoint of both (p &lt, 0.01 for all). This is the first report describing a significant role of neutrophil mNEP in HFrEF. The biological relevance of neutrophil mNEP and exact effects of angiotensin-converting-enzyme inhibitors (ARNi) at the neutrophil site have to be determined. However, the results may suggest early initiation of ARNi already in less severe HF disease, where effects of NEP inhibition may be more pronounced.

To assess the influence of primary arterial access in patients receiving peripheral postcardiotomy extracorporeal life support on associated complications and outcome.Of 573 consecutive patients requiring PC-ECLS between 2000 and 2019 at a single center, 436 were included in a retrospective analysis and grouped according to primary arterial extracorporeal life support access site. Survival and rate of access-site-related complications with special emphasis on fatal/disabling stroke were compared.The axillary artery was cannulated in 250 patients (57.3%), whereas the femoral artery was used as primary arterial access in 186 patients (42.6%). There was no significant difference in 30-day (axillary: 62%; femoral: 64.7%; P = .561) and 1-year survival (axillary: 42.5%; femoral: 44.8%; P = .657). Cerebral computed tomography-confirmed stroke with a modified ranking scale ≥4 was significantly more frequent in the axillary group (axillary: n = 28, 11.2%; femoral: n = 4, 2.2%; P = .0003). Stroke localization was right hemispheric (n = 20; 62.5%); left hemispheric (n = 5; 15.6%), bilateral (n = 5; 15.6%), or infratentorial (n = 2; 6.25%). Although no difference in major cannulation site bleeding was observed, cannulation site change for bleeding was more frequent in the axillary group (axillary: n = 13; 5.2%; femoral: n = 2; 1.1%; P = .03). Clinically apparent limb ischemia was significantly more frequent in the femoral group (axillary: n = 12, 4.8%; femoral: n = 31, 16.7%; P .0001).Although survival did not differ, surgeons should be aware of access-site-specific complications when choosing peripheral PC-ECLS access. Although lower rates of limb ischemia and the advantage of antegrade flow seem beneficial for axillary cannulation, the high incidence of right hemispheric strokes in axillary artery cannulation should be considered.

Several risk scores and classifications are available to predict peri- and post-operative mortality of patients with end stage heart failure receiving Left Ventricular Assist Device (LVAD) therapy. Sarcopenia has been suggested as a sensitive predictor for post-operative mortality. We evaluated whether the psoas muscle area can predict mortality in patients undergoing LVAD implantation. The indexed psoas mean area (PMAi) was obtained by measuring the psoas muscle area at the superior endplate of the third lumbar vertebra correlated to body surface area of 106 adult patients undergoing LVAD implantation (Medtronic HVAD n = 41, Abbott HeartMate II n = 4, Abbott HeartMate 3 n = 61, mean age 65, IQR 12, 90.6% male, INTERMACS Level 1 24.5%, ischemic CMP 64.2%). Patients were divided in two groups: high/moderate and low muscle mass. The primary endpoint was 30-day mortality, assessed using a multivariate Cox proportional hazards model. Baseline characteristics did not differ between patients with high or moderate and low PMAi. Estimated survival calculated a significant higher 30-day mortality in patients with low PMAi (p = 0.04). Multivariable Cox proportional hazards regression analysis indicated low PMAi, history of previous cardiac surgery and levels of bilirubin as independent predictors of mortality in the first 30 days. In conclusion, indexed psoas muscle area predicts mortality after LVAD implantation and can be used as an additional tool for risk stratification.

Fixed pulmonary hypertension (FPH) is a contraindication for heart transplantation (HTX). However, this condition might be reversed by continuous left-ventricular unloading with a left-ventricular assist device. We present a case of apical hypertrophic cardiomyopathy with extensive left-ventricular endocardial calcification and severe FPH (systolic pulmonary artery pressure, 102 mm Hg). To bridge the patient to candidacy for HTX, two Abbott HeartMate 3 ventricular assist devices were implanted in a total artificial heart (TAH) configuration ("HeartMate 6"). Before TAH implantation, an Abbott CardioMEMS pressure sensor was implanted to assess reversal of FPH before listing for HTX.

(1) Alkaline phosphatase (AP) is consumed during cardiopulmonary bypass (CPB). A high AP depletion leads to an impaired outcome after cardiac surgery. However, data is scarce on the postoperative course of AP under venoarterial ECMO (VA-ECMO) support. (2) A total of 239 patients with VA-ECMO support between 2000 and 2019 at the Department of Cardiac Surgery (Vienna General Hospital, Austria) were included in this retrospective analysis. Blood samples were collected at several timepoints (baseline, postoperative day (POD) 1–7, POD 14 and 30). Patients were categorized according to the relative AP drop (&lt, 60% vs. ≥60%) and ECMO duration (&lt, 5 days vs. ≥5 days). (3) Overall, 44.4% reached the baseline AP values within 5 days—this was only the case for 28.6% with a higher AP drop (compared to 62.7% with a lower drop, p = 0.000). A greater AP drop was associated with a significantly higher need for renal replacement therapy (40.9% vs. 61.9%, p = 0.002) and an impaired 1-year survival (51.4% vs. 66.0%, p = 0.031). (4) CPB exceeds the negative impact of VA-ECMO, still, ECMO seems to delay alkaline phosphatase recovery. A greater initial AP drop bears the risk of higher morbidity and mortality.

Purpose Neurological complications are considered as most frequent complications following left ventricular device device (VAD) implantation. The aim of this multicenter study is to investigate neurological complications in patients requiring durable VADs following extra-corporeal life support (ECLS) implantation. Methods Data of eleven high volume ECLS/VAD centers are collected and evaluated to identify patients who underwent durable mechanical circulatory support system implantation after ECLS systems between January 2010 and July 2018. Preoperative parameters and postoperative outcome are analysed. Data of patients who developed postoperative neurological complication will be analysed and compared. A total of 531 patients meets the inclusion criteria. Patients who were supported with pulsatile pumps, CardioWest TAH and DeBakey VADs will be excluded. The outcome of the remaining 501 patients (mean age 53 ±2 yo, 82% male, average ECLS support duration of 7 ± 7 days and average MELD score of 19 ± 8), who were supported with either HeartWare HVAD, HeartMate II or HeartMate III pumps will be analysed. Endpoints The primary endpoint will be freedom from stroke at 30, 180, and 360 days post implant. Association of stroke events with operative strategies (using heart lung machine vs. ECLS for VAD implantation) will be evaluated. Further, factors predicting stroke events in this patient population are analyzed. We hypothesize that postoperative (after VAD Implantation) stroke complications may be higher in this sick patient population on ECLS compared to traditional VAD candidates.

Background Mechanical circulatory support (MCS) in pediatric patients remains challenging because of small body size, limited availability of approved devices, and the variety of etiologies, including biventricular and univentricular physiologies. We report our single-center experience with MCS in pediatric patients in terms of survival and adverse events. Methods Outcome, etiologic, and demographic data of pediatric patients implanted with a long-term MCS device between 2011 and 2019 at the Medical University of Vienna were retrospectively collected and analyzed. Overall survival and freedom of treatment-related adverse events at 1 year were investigated by Kaplan–Meier analyses and stratified for circulation (biventricular vs univentricular), age group ( 6 years), and pump technology (pulsatile ventricular assist device [p-VAD] vs continuous flow pump [cf-VAD]). Results One-year survival of all 33 pediatric patients (median, 4 years; interquartile range, 0-13 years) was 73%, with a tendency toward better outcomes in patients with biventricular circulation than in those with univentricular circulation (80%; n = 25 vs 50%; n = 8; P = .063). The trends toward better survival probability in older patients and in patients with cf-VADs did not reach statistical significance (63.2% vs 85.7%; P = .165 and 82.4% vs 62.5%; P = .179, respectively). Freedom from adverse events was higher in older patients (57.1% vs 5.6%; P Conclusions MCS is a promising therapy for a broad spectrum of pediatric patients, irrespective of heart failure etiology, age, and pump type. With increasing experience, improved devices, and patient selection, MCS may become a valuable treatment option for patients with univentricular hearts.

Background: Additional cardiac pathologies including tricuspid or mitral valve regurgitation are common in left ventricular assist device (LVAD) recipients and whether to address them remains controversial. We present our institutional outcomes of concomitant cardiac procedures, other than temporary right ventricular (RV) support, at the time of LVAD implantation. Methods: From 03/2006 to 06/2020, 352 adult patients {median age 60 [interquartile range (IQR): 52–66] years; INTERMACS level 1 29%; INTERMACS level 2 17%; INTERMACS level 3 23%, INTERMACS level 4–6 31%; male 86%} underwent continuous-flow LVAD [Medtronic HVAD® (HVAD) 50%; Abbott HeartMate IITM (HMII) 17%; Abbott HeartMate 3TM (HM3) 33%] implantation. Concomitant valvular procedures were performed in 86 patients (24%) and the majority of patients received the LVAD as bridge to candidacy (BTC) for transplant (74%). Primary study endpoints were short- and mid-term mortality, as well as need for temporary RV support. Results: Tricuspid valve annuloplasty was the most frequent concomitant procedure (77%), followed by aortic valve replacements (AVRs) or Park’s stitch (33%). Temporary RV support was common in the study cohort (35%) using either extracorporeal life support (ECLS, 37%) or a temporary RV assist device (RVAD, 63%). A less invasive (LIS) implantation technique was pursued in 12%. Thirty-day mortality was comparable between those with and without concomitant surgery (4% vs. 6%, P=0.426). In-hospital mortality was significantly higher for additional interventions (22% vs. 14%, P=0.05), whereas one-year survival was similar (71% vs. 79%, P=0.106). Conclusions: Concomitant cardiac procedures, especially tricuspid and aortic valve surgery, are frequent but are associated with a higher perioperative morbidity and mortality.

OBJECTIVES Implanting a durable left ventricular assist device (LVAD) in a patient on extracorporeal life support (ECLS) is challenging. The goal of this study was to compare the results of patients from a European registry who had a durable LVAD implanted with or without transition from ECLS to cardiopulmonary bypass (CPB). METHODS A total of 531 patients on ECLS support who had an LVAD implant between January 2010 and August 2018 were analysed; after 1:1 propensity score matching, we identified and compared 175 patients in each group. RESULTS The duration of preoperative ECLS was 7 [standard deviation (SD) 6] vs 7 (SD 6) days in patients with or without CPB (P = 0.984). The surgical time was longer in the CPB group [285 (SD 72) vs 209 [SD 75] min; P ≤ 0.001). The postoperative chest tube output was comparable [1513 (SD 1311) vs 1390 (SD 1121) ml; P = 0.3]. However, re-exploration for bleeding was necessary in 41% vs 29% of patients with or without CPB (P = 0.01) and a significantly higher number of packed red blood cells and fresh frozen plasma [8 (SD 8) vs 6 (SD 4) units; P = 0.001 and 6 (SD 7) vs 5 (SD 5) units; P = 0.03] were administered to patients operated on with CPB. A postoperative mechanical right ventricular support device was necessary in 50% vs 41% of patients (P = 0.08). The stroke rate was not significantly different (P 0.99). No difference in survival was observed. CONCLUSIONS Omitting CPB for an LVAD implant in patients on ECLS is safe and results in shorter operating time, less re-exploration for bleeding and fewer blood products. However, no survival benefit is observed.

Left ventricular assist device implantation without sternotomy (LIS) may simplify heart transplantation (HTX) by avoiding adhesions and eliminating the need for a re-sternotomy. This study investigates the impact of LIS LVAD implantation on HTX outcomes. A retrospective comparison of 46 patients undergoing HTX between 07/13 and 06/19 after conventional LVAD implantation with a full sternotomy (FS) and LIS LVAD implantation (LIS: n = 27 patients, 59%; FS: n = 19 patients, 41%) was performed. Endpoints were perioperative data including blood product use, de-novo formation of donor specific antibodies (DSAs) and survival. Patient demographics (mean age FS: 60.3 ± 9.3 years vs LIS 58.0 ± 7.7 years, P = 0.313; male gender FS: 84% vs LIS: 82%, P = 1.000; urgent HTX FS: 16% vs LIS 18%, P = 1.000) were comparable between LIS and FS patients. The primary finding was a significantly higher risk to develop de novo donor specific antibodies (DSAs) after HTX in patients of the FS group (FS: 36% vs LIS: 4%; P = 0.006). LIS patients had a significant reduction of intraoperative packed red blood cells (PRBCs) use (LIS: 4 (IQR 2–7) Units vs FS: 7 (IQR 4–8) Units; P = 0.045). Other adverse events rates and in-hospital mortality (LIS: 7% vs FS 5%, P = 1.000) were comparable between both groups. LIS LVAD reduces formation of donor specific antibodies after HTX.

Background: The literature on outcomes of patients requiring durable mechanical circulatory support (MCS) after extra-corporeal life support (ECLS) is limited. The aim of this study was to investigate the impact of preoperative ECLS cannulation on postoperative outcome after durable MCS implantation. Methods: The durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent durable MCS implantation after ECLS between January 2010 and August 2018 in eleven high volume European centers. Patients who underwent the implantation of total artificial heart, pulsatile pumps, or first-generation pumps after ECLS were excluded from the analysis. The remaining patients were divided into two groups; central ECLS group (cECLS) and peripheral ECLS group (pECLS). A 1:1 propensity score analysis was performed to identify two matched groups. The outcome of these two groups was compared. Results: A total of 531 durable MCS after ECLS were implanted during this period. The ECLS cannulation site was peripheral in 87% (n=462) and central in 13% (n=69) of the patients. After excluding pulsatile pumps and total artificial heart patients, a total of 494 patients remained (pECLS =434 patients, cECLS =60 patients). A 1:1 propensity score analysis resulted in 2 matched groups (each 55 patients) with median age of 54 years (48–60 years) in cECLS group and 54 years (43–60 years) in pECLS group. HeartWare HVAD (Medtronic, Minneapolis, MN) was implanted in the majority of the patients (cECLS =71% vs. pECLS =76%, P=0.67). All postoperative morbidities were comparable between the groups. The thirty-day, one year and long-term survival was comparable between the groups (P=0.73). Conclusions: The cannulation strategy of ECLS appears to have no impact on the post-operative outcome after durable MCS implantation.

OBJECTIVESWe reviewed our institutional experience with outflow graft stenosis (OGS) in 3 contemporary left ventricular assist devices (LVAD).METHODSData from 347 consecutive adult recipients of LVAD [Medtronic HVAD (n = 184, 53.0%), Abbott HeartMate II (n = 62, 17.9%) and Abbott HeartMate 3 (n = 101, 29.1%)] implanted between March 2006 and October 2019 were analysed retrospectively. Primary study end points were the incidence of OGS necessitating treatment and survival on LVAD support.RESULTSDuring the study period, 17 patients (4.9%) developed OGS requiring treatment with a probability of 0.6% at 1 year, 1.9% at 2 years, 3.8% at 3 years, 4.7% at 4 years and 5.9% at 5 years of LVAD support. Notably, in 13.8% of patients, a compression-related narrowing of the outflow graft with a probability of 1.5% at 6 months, 1.8% 1 year, 6.0% at 2 years, 12.3% at 3 years, 15.4% at 4 years and 16.6% at 5 years of LVAD support with no difference between devices (P = 0.26) was observed. There was a trend towards increased risk of mortality with OGS (hazard ratio 2.21, 95% confidence interval 0.87–5.51; P = 0.09). OGS preferentially occurred in segments of the outflow graft covered by a protective coating.CONCLUSIONSOGS is a rare but potentially lethal complication during LVAD support. Modifications of pump design and implant techniques may be needed because OGS preferentially occurs within covered portions of the outflow graft. Systematic screening may be warranted.

Anticoagulation therapy in patients using left ventricular assist device (LVAD) is essential to reduce hemocompatibility related adverse events (HRAEs). Vitamin K-antagonist dosage must be adapted and monitored by INR point-of-care testing (POCT) in outpatients. The study aims to determine if the frequency of INR POCT in LVAD outpatients has an influence on the quality of anticoagulation therapy (ACQ), HRAEs, and outcomes. This retrospective study included n = 48 patients who received LVAD implantation (HMII, HM3, and HVAD) between 2013 and 2017. ACQ (% of INR tests in range, PTR), outcomes and HRAEs using Kaplan-Meier curves were compared in a daily (n = 36) and 3×/week (n = 12) INR POCT group. Further, based on the achieved PTR ranging from 0-60% (poor), 61-70% (acceptable), and 71-100% (well controlled), HRAEs and outcomes were compared. Daily and 3×/week groups were similar in perioperative risk factors and INR target (p = 0.28). Freedom from any HRAE (38.9% vs. 25.0%, p = 0.44), any readmission (72.2% vs. 75.0%, p = 0.97), and 1 year survival (91.7% vs. 91.7%, p = 0.98) were comparable in both groups. The PTR was significantly higher with the daily self-assessments (73.5% vs. 68.4%, p = 0.006). Well vs. poorly controlled INR POCT patients more often had (p = 0.01) a daily POCT frequency (92%) vs. poorly controlled (54%) and significantly higher freedom from neurologic events (96.0 vs. 69.2%, p = 0.024) as well as hemorrhagic strokes (100% vs. 76.9%, p = 0.011). Well-controlled anticoagulation of LVAD outpatients is associated with less neurologic events. The frequency of INR POCT could be one of the key factors in the reduction of HRAEs, so future prospective, large-scale studies should help to clarify the effects.

Suction of the left ventricle can lead to potentially life‐threatening events in left ventricular assist device (LVAD) patients. With the resolution of currently available clinical LVAD monitoring healthcare professionals are unable to evaluate patients’ suction occurrences in detail. This study investigates occurrences and durations of suction events and their associations with tachycardia in stable outpatients. Continuous high‐resolution LVAD data from HVAD patients were analyzed in the early outpatient period for 15 days. A validated suction detection from LVAD signals was used. Suction events were evaluated as suction rates, bursts of consecutive suction beats, and clusters of suction beats. The occurrence of tachycardia was analyzed before, during, and after suction clusters. Furthermore, blood work, implant strategy, LVAD speed setting, inflow cannula position, left ventricular diameters, and adverse events were evaluated in these patients. LVAD data of 10 patients was analyzed starting at 78 ± 22 postoperative days. Individuals’ highest suction rates per hour resulted in a median of 11% (range 3%‐61%). Bursts categorized as consecutive suction beats with n = 2, n = 3‐5, n = 6‐15, and n > 15 beats were homogenously distributed with 10.3 ± 0.8% among all suction beats. Larger suction bursts were followed by shorter suction‐free periods. Tachycardia during suction occurred in 12% of all suction clusters. Significant differences in clinical parameters between individuals with high and low suction rates were only observed in left ventricular end‐diastolic and end‐systolic diameters (P

Literature on driving capacities of ventricular assist device patients is rare and driving restrictions differ from center to center. Currently, no guidelines exist on whether and when left ventricular assist device (LVAD) patients are allowed to begin driving cars after device implantation. In this study, we assess the driving abilities of patients after LVAD implantation. Three hundred and ninety LVAD patients have been surveyed in a worldwide, multicenter study. The single survey followed a multi-method design, including online, phone, and face-to-face interviews. Out of 390 patients, 72% are still driving and 28% did not continue driving after LVAD implantation. Reasons for discontinuation were capability (24%), insecurity (17%), and disapproval by family members (9%) or doctors (5%). Ninety percent of the patients describe their ability to drive as perfect or adequate. Sixty-nine percent state that they are not restricted in their general driving capacity. Forty-nine percent report not to be restricted in agility to drive by the device equipment. The majority of patients have not been involved in car accidents or major complications (94%). Eight accidents were reported (3%). Out of those, all were minor collisions. No patient reported the occurrence of a fatal accident or casualties. LVAD alarms did occur in six incidents (2%) with the majority being low battery alarms. The results of this study suggest that driving with a left ventricular assist device is safe for stable patients and driving can be resumed 3 months after LVAD implantation after careful patient assessment.

Ventricular assist devices (VADs) are an established therapeutic option for patients with chronic heart failure. Continuous monitoring of VAD parameters and their adherence to guidelines are crucial to detect problems in an early stage to optimize outcomes. A telephone intervention algorithm for VAD outpatients was developed, clinically implemented and evaluated. During the phone calls, a structured inquiry of pump parameters, alarms, blood pressure, INR, body weight and temperature, exit-site status and heart failure symptoms was performed and electronically categorized by an algorithm into 5 levels of severity. VAD outpatient outcomes without (n = 71) and with bi-weekly telephone interviews in their usual care (n = 25) were conducted using proportional hazard Cox regression, with risk adjustment based on a propensity score model computed from demographics and risk factors. From February 2015 through October 2017, 25 patients (n = 3 HeartMate II, n = 4 HeartMate 3 and n = 18 HeartWare HVAD) underwent 637 telephone interventions. In 57.5% of the calls no problems were identified, 3.9% were recalled on the next day because of alarms. In 26.5% (n = 169), the VAD Coordinator had to refer to the physician due to elevated blood pressure (n = 125, >85 mm Hg), INR 4.0 (n = 24) or edema (n = 10), 11.9% of the calls led to a follow-up because of equipment or exit-site problems. Propensity-adjusted 2-year survival (89% vs. 57%, P = 0.027) was significantly higher for the telephone intervention group. Continuous, standardized communication with VAD outpatients is important for early detection of upcoming problems and leads to significantly improved survival.

Left ventricular assist device outflow graft stenosis is a rare but life-threatening complication of mechanical cirulatory support therapy. Current treatment modalities (pump exchange or systemic thrombolytic therapy) are associated with significant mortality and morbidity. Implantation of bare metal stents within the stenosed outflow graft is an alternative. Herein, we describe a series of three cases with successful stent placement. This seems to be safe and successful; however, correct and early diagnosis of outflow stenosis can be challenging. Information provided by the HeartWare ventricular assist device (HVAD) logfiles is extremely helpful for diagnosis.

Purpose Right heart failure (RHF) is a crucial risk factor in the development of acute kidney injury. By decreasing the right-ventricular filling pressures and increasing cardiac output, right ventricular assist devices (RVAD) may prevent the development of cardiorenal syndrome. We report our institutional experience on the development of renal function and outcome after left ventricular assist device (LVAD) and temporary RVAD implantation in congestive heart failure patients. Methods We retrospectively reviewed the data of 72 consecutive patients who received a continuous-flow LVAD and temporary RVAD due to terminal heart failure at our center from 12/ 2001 and 12/ 2019. Mean age of patient population was 58 ± 12 years, with 86.1% of the patients being male. Sixty-three patients (87.5%) were able to be successfully weaned from temporary RVAD support. However, two patients (2.8%) required an RVAD to be re-implanted due to progressive RHF. Median time of temporary RVAD support was 13 days (4 - 90 days). Renal function was determined by the Modification of Diet in Renal Disease (MDRD)-derived glomerular filtration rates (GFR), and patients were categorized into two groups based on pre-implant GFR: (1) normal renal function, defined by GFR > 60 (n=29), and (2) impaired renal function, defined by GFR Results The patient group with impaired renal function (RF) experienced a significant improvement of GFR: GFR at time of implant to month six, 41.94 ± 11.37 to 65.21± 39.52 (p=0.003), and after one-year GFR improved from 41.94 ± 11.37 to 55.73 ± 23.22 (p=0.012). Post-implant renal replacement therapy was indicated in eighteen patients (41.86%) of the impaired RF group vs. ten patients (34.48%) in the normal RF group. Post-implant survival after LVAD and temporary RVAD support at one, six, and 12 months for GFR 60 group, 89.7%, 72.4% and 72.4%, respectively (p=0.576). Conclusion LVAD and temporary RVAD support improves renal function in patients with renal dysfunction prior to implantation. Our data indicates that impaired renal function prior to implantation does not guarantee a worsened outcome.

Purpose The relation between left ventricular assist device (LVAD) inflow cannula malposition and pump thrombus has been reported. This study aimed to investigate pump position, derived from chest X-rays of HM3 patients, in correlation to any neurological dysfunction (ND) and specifically to ischemic stroke (IS) and intracranial hemorrhage (ICH). Methods This retrospective analysis was performed on routinely acquired X-rays of 33 patients (Age: 62.4±9.3 yrs, male: 89.5%, BMI: 28.3±4.9kg/m2) implanted with a HM3 between 2014 and 2017. Device position was quantified in patients with and without any neurological dysfunction (noND) from frontal and lateral X-ray parameters characterizing the inflow cannula (IC), pump depth in relation to spine, diaphragm or horizontal line. Results The analysis of X-rays (38.6±24.3 days postoperative) revealed a significant smaller IC angle of HM3 patients with any ND vs. noND (2.52±11.59° vs. 13.92±9.74°, p=0.029). Additionally, the IC angle in the frontal view (IS: 0.23±11.34° vs. noIS: 13.92±9.45°, p=0.012) as well as the pump depth (IS: 19.7±16.8mm vs. noIS: 38.3±19.6mm, p=0.044) were significantly smaller for HM3 patients with IS. Using receiver operating characteristic (ROC) curve-derived cut-points, IC angle 10.06°) and 50.4% ( Conclusion In HM3 patients, inflow cannula malposition identified from X-rays serves as a risk factor for neurological dysfunction and especially ischemic stroke.

A novel sternotomy sparing implantation technique for the Thoratec HeartMate 3 is described. Cannulation of the left ventricular apex is performed via a minithoracotomy in the left fourth or fifth intercostal space. The outflow graft is advanced through the pericardium to a second minithoracotomy in the right second intercostal space and then anastomosed to the ascending aorta. This approach was performed in three patients so far with no need for conversion. We did not observe any perioperative adverse events, such as bleeding or thromboembolic complications, as well as no short-term mortality. This technique is especially appealing in multimorbid and frail patients, future transplant candidates, and patients with impaired right ventricular function.

Peripartum cardiomyopathy (PPCMP) requiring mechanical circulatory support is rare; however, it is a life-threatening disease with recovery rates poorer than expected. Herein, we describe a case of successful recovery of a patient with PPCMP. Implantation of a biventricular ventricular assist device was performed; additionally, the patient's hyperprolactinemia was treated with cabergoline, resulting in a fast complete restoration of ventricular function.

Purpose Many surgeons prefer to use cardiopulmonary bypass (CPB) machine when durable ventricular assist devices (VAD) is implanted in patients on veno-arterial membrane oxygenation (VA-ECMO). The aim of this study was to investigate if omitting CPB machine at the time of surgery negatively influence the outcome. Methods Data of eleven high volume VA-ECMO/VAD centers are collected and evaluated to identify patients who underwent VAD implantation after ECMO support between January 2010 and July 2018. Preoperative parameters and postoperative outcome are analyzed. Propensity score analysis was performed to identify two identical groups; one who were operated on without CPB (no CPB group) and the other group were operated on using CPB (CPB group) Results A total of 531 patients met the inclusion criteria. Nineteen patients were supported with Cardiowest TAH and are excluded from this analysis. The remaining 512 patients included 306 patients in the CPB group and 206 patients in no CPB group. After 1:1 propensity score matching 207 patients remained in each group and were compared. The total surgery time was significantly longer in the CBP group (288 ± 92 vs. 206 ± 64 min, p= Conclusion This study shows, omitting CPB at the time of durable VAD implantation for patients on VA-ECMO results in shorter surgery time, lower reexploration rate for bleeding and less blood product requirements. A trend toward lower RVAD use was also observed. Survival remains similar between both Groups.

Purpose LVAD outflow graft stenosis (OGS) is increasingly recognized after left ventricular assist device implantation. We analyzed our institutional experience with (OGS) in order to better understand the clinical significance and treatment options for this new form of pump pathology. Methods We retrospectively reviewed our institutional experience with OGS in patients with contemporary centrifugal LVAD. Study endpoint were incidence and outcomes of LVAD OGS. Results From March 2006 to October 2019, 284 consecutive patients (183 (64.4%) HVAD and 101 (35.6%) HeartMate3) underwent primary LVAD implantation. Median follow up was 456 (range 1-2921) days. OGS was identified in 17 patients (total incidence 5.0%, 95% CI 3.5%-9.4%; HVAD: 5.5%, 95% CI 2.7%-9.8% vs. HeartMate3 6.9%, 95% CI 2.8%-13.8%, p=0.611). Median time to OGS development was 911 (range 281-2811) days. In all cases, OGS was located within covered segments of the outflow graft (bend relief (Heartmate 3 only) or protective Gore-Tex cover). In 13 patients (76.5%) OGS impaired LVAD flow and necessitated interventions (surgical revision n=2, endovascular stent placement n=9, surgery after failed stent placement n=1, death before intervention n=1). Two patients (11.8%) died following intervention and outflow graft stenosis recurred in two patients (11.8%) after initially successful treatment. Kaplan-Meier estimate of survival free from outflow graft stenosis is depicted on Figure 1. Conclusion Outflow graft stenosis is a potentially lethal late complication of LVAD implantation. Surgical or interventional treatment is indicated when LVAD flows are impaired. Modification of pump design may be warranted as outflow graft stenosis preferentially occur in covered portions of outflow grafts.

Purpose Patients on veno-arterial membrane oxygenation (VA-ECMO) are high-risk candidates for durable ventricular assist device (VAD) surgery. The aim of this study was to compare the outcome of patients who received durable VAD on VA-ECMO using less invasive (LIS) vs. sternotomy approach. Methods Data of eleven high volume VA-ECMO/VAD centers are collected and evaluated to identify patients who underwent VAD implantation after ECMO support between January 2010 and July 2018. Preoperative parameters and postoperative outcome are analyzed. Results A total of 531 patients met the inclusion criteria. Nineteen patients were supported with Cardiowest TAH and were excluded from this analysis. The remaining 512 patients were 1:3 propensity score matched and resulted in 99 patients remained in LIS group vs. 293 patients in sternotomy group. The total surgery time was significantly longer in the sternotomy group (270±80 vs. 203±61 min; p Conclusion This study shows that LIS approach may be superior to sternotomy approach for patients on VA-ECMO. The postoperative morbidities were comparable. However, a superior short and long term outcome was observed in LIS Group.

Purpose Several risk scores and classifications are available to predict peri- and post-operative mortality of patients with end stage heart failure receiving Left Ventricular Assist Device (LVAD) implantation. The INTERMACS classification is most commonly used but recently assessment of sarcopenia has been suggested as additional predictor for post-operative outcome. Therefore, we evaluated whether or not psoas muscle area can serve as additional prognostic marker. Methods A retrospective analysis on our patient cohort in the time span from January 2014 to April 2019 was performed. During that time period a total of 178 adult LVAD implantations were performed (Heart Ware n=42, HeartMate II n=4, HeartMate III n=61). Of those, 107 patients received an abdominal CT scan prior to surgery. Psoas mean area at level of the superior endplate of the third lumbar vertebra was measured axially corrected and correlated with patients body surface area, giving the indexed psoas mean area (PMAi). Patients then were divided in high or moderate muscle mass and low muscle mass in accordance to patient sex. Results Estimated survival calculated using the Kaplan-Meier-curve found a significant higher 30-day mortality in patients with low PMAi (log rank: 0.009). Whereas no differences were observed concerning in-hospital, 90-day and 1-year mortality. Lower muscle mass also had no impact on the length of ICU stay or necessity of temporary RVAD. Comparison of the distribution on the INTERMACS classification, revealed that patients with lower muscle mass had a higher probability to classify as INTERMACS level 1 or 2 (Level 1: 21% vs. 38.1%; Level 2: 14.8% vs. 23.8%). Conclusion Patients with low PMAi in our cohort represented the sicker patients and had statistically significant higher short-term mortality. These findings suggest that PMAi can be used as an additional tool for risk stratification in patients undergoing LVAD implantation.

Background Few reports have described associations between a bleeding revision and outcomes after implantation of a continuous-flow left ventricular assist device (LVAD). Methods We retrospectively analyzed all adult recipients of a continuous-flow LVAD who were operated on between January 2006 and December 2016 at the Division of Cardiac Surgery, Medical University of Vienna (N = 257). LVAD types were HeartWare HVAD (Medtronic, Minneapolis, MN), HeartMate II (Abbott [Thoratec], Abbott Park, IL), and HeartMate 3 (Abbott [Thoratec]). The primary outcome variable was survival during LVAD support. Secondary outcome variables were rates of prolonged ventilation, intensive care unit stay, hospital stay, renal replacement therapy, and stroke. We additionally investigated risk factors for a bleeding revision. Results Thirty-six patients (14%) underwent surgical revision for bleeding. In a multivariable Cox proportional hazards model, bleeding revision was associated with significantly reduced survival during LVAD support (3 months: hazard ratio [HR], 2.04; 95% confidence interval [CI], 1.20 to 3.48; 6 months: HR, 1.63; 95% CI, 0.95 to 2.82; 12 months: HR, 1.30; 95% CI, 0.69 to 2.46; 24 months: HR, 1.04; 95% CI 0.48 to 2.26; overall p = 0.007). Rates of secondary outcome variables were substantially higher in the revision group compared with patients who survived the hospital stay without a bleeding revision. Concomitant implantation of a temporary right ventricular assist device (p = 0.002) and age (p = 0.028) were independent risk factors for a bleeding revision. Conclusions A bleeding revision is associated with significantly reduced survival and substantially increased morbidity during LVAD support. Preoperative, intraoperative, and postoperative prophylactic strategies may help to prevent this life-threatening complication.

Purpose The implantation of durable ventricular assist devices (VAD) in patients on veno-arterial membrane oxygenation (VA-ECMO) is controversial. Available studies in this field are limited to anecdotal case reports. In this study, data of ten high volume VA-ECMO/VAD centers are collected and analysed. Methods Following approval from corresponding ethic committees, data of patients undergoing durable mechanical circulatory support implantations at ten institutions between 01.2010 - 07.2018 were reviewed. Inclusion criteria are patients with prior VA-ECMO support. Several parameters including patient´s characteristics, results of blood gas analysis, blood chemistry, and catecholamine doses prior to the assist device surgery are collected and analysed. The primary endopint was survival or cardiac transplantation at one year. Results A total of 494 patients met the inclusion criteria. The average age was 53 ± 12 yrs. The majority of the patients (82%) were male and 33% of the patients had cardiopulmonary resuscitaion prior to the VA-ECMO implantation. The mean VA-ECMO support duration prior to durable device implantation was 7 ± 8 days. Up to 34 % of the patients were on renal dialysis. Cardiopulmonary bypass was used in 63% of the patients at the time of durable device surgery. Less invasive VAD implantation was performed in 19% of the patients. Type of implanted pump included HeartWare HVAD (70%), HeartMate II (17%), HeartMate III (8%), CardioWest TAH (3.6%) and other pumps in (1.4%). The 30 day, 1 year and 2 year survival was 75 and 50% and 40% respectively. Postoperative complications included right heart failure requiring right VAD in 41% of patients, bleeding requiring resternotomy in 38%, respiratory failure in 65%, renal failure in 68% and hepatic failure in 35% of the patients. Stroke rate was 21%. Heart transplantation was performed in 33% of the patients. Conclusion In this largest ever reported series of durable assist device patients with prior VA-ECMO support, higher rate of postoperative right ventricular failure and bleeding /end organ function complications are observed compared to elective VAD implantations. Nevertheless, considering preoperative characteristics of these patients, acceptable outcome of 50% 1 year success was achieved.

Purpose Previous studies have shown a correlation between improved renal function and ventricular assist device implantation, resulting in improved survival rates. This study aims to strengthen this correlation and establish long term findings by increasing the size of the study cohort as well as study period. Methods We retrospectively reviewed the data of 389 patients who received ventricular assist device implantation due to terminal heart failure at our center from 12/2003 to 03/2018. Median duration of LVAD support was 307 days (range 1 to 2849 days). Renal function was assessed using the Modification of Diet in Renal Disease study-derived Glomerular Filtration Rates (MDRD-GFR; mL x min(-1) x 1.73m(-2)). According to pre-implantation measured GFR rates patients were categorized in three groups: normal renal function (GFR>90, n= 52); moderately impaired renal function (GFR 30-90; n=295) and severely impaired renal function (GFR Results Mean GFR showed a significant increase of renal function in both the moderately impaired and severely impaired kidney function groups at week 1 post-implantation (moderately: 56.0 ± 15.6 to 81.6 ± 39.0; severely: 22.7 ± 5.0 to 43.5 ± 19.0; p Conclusion Ventricular assist device implantation improves the renal function in terminal heart failure patients with moderate to severe kidney dysfunction. Normal renal function is correlated with better outcomes post LVAD implantation.

Objectives Fixed pulmonary hypertension (fPH) is a contraindication for heart transplantation (HTX). Left ventricular assist device (LVAD) implantation as a bridge to candidacy can reverse fPH in patients with terminal heart failure by chronic left ventricular unloading. We report our institutional experience with terminal heart failure patients and fPH that were successfully bridged to candidacy and underwent subsequent HTX. Methods We retrospectively reviewed the data of 79 patients with terminal heart failure and fPH who were successfully bridged to candidacy for HTX with 6 different LVAD devices at our centre from October 1998 to September 2016 (Novacor n = 4, MicroMed DeBakey n = 29, DuraHeart n = 2, HeartMate II n = 14, HVAD n = 29 and MVAD n = 1). Median duration of LVAD support was 288 days (range 45-2279 days). Within the same timeframe, a control group of 48 patients underwent HTX after bridge-to-transplant LVAD therapy for reasons other than PH. Study end points were (i) development of fPH after LVAD implantation, (ii) post-transplant outcomes and (iii) incidence of severe adverse events. Results Pulmonary vascular resistance, assessed by vasodynamic catheterization, was 4.3 ± 1.8 WU before LVAD implantation. After a median support period of 89 days (interquartile range 4-156 days), pulmonary vascular resistance decreased to 2.0 ± 0.9 WU (P ≤ 0.001), and patients were listed for HTX. Median duration of LVAD support in the study group was 288 days (45-2279 days). We observed 2 patients (2.5%) with acute right heart failure who required extracorporeal mechanical support after HTX in the study group. Long-term post-transplant survival between the study group (3 years: 83.5%, 5 years: 81.0%) and the control group (3 years: 87.5%, 5 years: 85.4%) was comparable (log-rank: P = 0.585). Conclusions LVAD implantation as a bridge to candidacy reverses fPH in patients with terminal heart failure. Post-HTX survival is excellent and comparable to results obtained in patients without fPH at the time of HTX listing.

We thank Heinrich-Nols and Kreuzer for their valuable and very detailed response regarding the indication of dabigatran, its dosing regimen, and relevant considerations regarding monitoring of anticoagulation. We had to shorten our initial article significantly and were not able to address all points regarding dabigatran dosing and management.1 The dose was chosen in 2010 according to the approved indication at that time, which was the primary prevention of …

BACKGROUND: Decision-making when offered a donor heart for transplantation is complex, and supportive data describing outcomes according to acceptance or non-acceptance choices are sparse. Our aim was to analyze donor heart acceptance decisions and associated outcomes at a single center, and after subsequent acceptance elsewhere.METHODS: This investigation was a retrospective analysis of data obtained from the University of Vienna Medical Center and Eurotransplant centers for the period 2001 to 2015RESULTS: Our center accepted 31.8% (699 of 2,199) of donor hearts offered. Unlike other centers, the acceptance rate, with or without transplantation, did not increase over time. Of the donor hearts rejected by our center, 38.1% (572 of 1,500) were later accepted elsewhere. Acceptance rates were twice as high for donor hearts initially rejected for non-quality reasons (339 of 601, 56.4%) compared with initial rejection for quality reasons (233 of 899, 25.9%). Three-year patient survival rate was 79% at Vienna; for donor hearts initially rejected by Vienna for non-quality reasons or quality reasons, it was 73% and 63%, respectively (p CONCLUSIONS: A less restrictive policy for accepting donor hearts at our center, particularly regarding rejection for non-quality reasons or for positive virology, high catecholamine levels, longer ischemic time, or low ejection fraction, could expand our donor pool while maintaining good outcomes. (C) 2018 International Society for Heart and Lung Transplantation. All rights reserved.

Background— Left ventricular assist device–supported patients are usually anticoagulated with a combination of aspirin and vitamin K antagonists. Long-term vitamin K antagonist therapy can be complicated by unstable international normalized ratio values and patient-related compliance problems. Therefore, direct thrombin inhibitors may represent an alternative to vitamin K antagonists. Methods and Results— Thirty HeartWare ventricular assist device patients with stable renal function were planned for this prospective, randomized, open-label, single-center study. Patients were randomized to receive either phenprocoumon or dabigatran in addition to aspirin for long-term anticoagulation. Treatment duration was scheduled for 1 year and stopped after observation of a primary end point. Dabigatran dose was 110 and 75 mg BID in patients with normal or impaired renal function (glomerular filtration rate >80 mL/min or between 80 and 30 mL/min, respectively). The study was stopped prematurely for safety reasons after 16 patients (61±8 years, 1 female) were randomized. Thromboembolic events occurred in 4 subjects receiving dabigatran (50%) and in 1 receiving phenprocoumon (13%; P =0.28). No major bleeding was recorded, and no patient died during the study. Median time to treatment termination was significantly shorter in dabigatran patients (8.5 versus 12.0 months; P =0.015). Conclusions— Thromboembolic events on dabigatran led to early termination of a randomized controlled trial of dabigatran versus phenprocoumon in left ventricular assist device patients. Clinical Trial Registration— https://www.clinicaltrials.gov . Unique identifier: NCT02872649.

OBJECTIVES Right ventricular (RV) failure complicating left ventricular assist device implantation is associated with increased mortality. Despite a lack of supporting evidence, venoarterial extracorporeal membrane oxygenation (ECMO) support is increasingly being used as an alternative to traditional temporary RV support. We report our institutional experience with ECMO-facilitated RV support after left ventricular assist device implantation. METHODS We retrospectively reviewed the concept of temporary ECMO support for perioperative RV failure in 32 consecutive left ventricular assist device (mean age 52 ± 14 years; male 84.4%; ischaemic cardiomyopathy 40.6%; INTERMACS Level I 71.8%; INTERMACS Level II 6.3%; INTERMACS Level III 12.5%; INTERMACS Level IV-VII 9.4%; HeartWare ventricular assist device 75%; HeartMate II: 25%) from May 2009 to April 2014. The study end points were RV recovery during ECMO support, mortality and causes of death. RESULTS Twenty-nine (90.6%) patients were successfully weaned from ECMO support after RV recovery. Three (9.4%) patients expired during ECMO support. ECMO support improved RV function and haemodynamic parameters (central venous pressure 13 mmHg vs 10 mmHg, P

OBJECTIVES: Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) Level I patients have the highest early mortality after ventricular assist device (VAD) implantation. This is determined by the exposure of patients in shock with acutely damaged end-organs and high catecholamine support to a significant surgical trauma. We report our experience with a bridge-to-bridge concept consisting of initial veno-arterial extracorporeal life support (ECLS) and deferral of VAD implantation to recovery of end-organ function in INTERMACS Level I patients. METHODS: We reviewed the concept of initial ECLS implantation and deferral of VAD implantation to end-organ recovery in 22 consecutive patients (mean age 54 ± 14 years; 72.2% males; 50% ischemic cardiomyopathy; 100% INTERMACS Level I; 18.2% Heartmate II, 68.2% Heartware HVAD, 4.5% Heartware BiVAD, 9.1% DeBakey LVAD) receiving a VAD for refractory cardiogenic shock between June 2004 and February 2013. Study endpoints were end-organ recovery during ECLS and survival. RESULTS: ECLS significantly improved renal (creatinine 1.86 ± 0.91 vs 1.32 ± 0.52 mg/dl, P= 0.02), hepatic (aspartate aminotransferase 1426 ± 2176 vs 277 ± 259 U/l, P= 0.04; alanine aminotransferase 982 ± 1466 vs 357 ± 447 U/l, P= 0.04) and pulmonary functions (fraction of inspired oxygen 52 ± 18 vs 26 ± 23%, P< 0.01; positive end-expiratory pressure 7 ± 3 vs 5 ± 4 mbar, P= 0.02) over a period of 8 ± 7 days. Catecholamines could be reduced during ECLS (levosimendan 0.056 ± 0.085 vs 0.010 ± 0.032 μg/kg/min, P= 0.06; dobutamine 4.362 ± 5.268 vs 0.056 ± 0.097 μg/kg/min, P= 0.06; noradrenaline 0.408 ± 0.355 vs 0.056 ± 0.097 μg/kg/min, P< 0.01). Thirty-day and inhospital mortality after VAD implantation were 4.5 and 9.1%, respectively, and 1-year survival was 86.4%. CONCLUSION: Preoperative patient optimization using ECLS improves outcomes of INTERMACS Level I patients receiving a permanent VAD.

Background Anti-coagulation is required in patients with left ventricular assist devices (LVADs). We evaluated the feasibility of low-molecular-weight heparin (LMWH) for initiation of anti-coagulation and transitioning to oral anti-coagulation after LVAD implantation. Methods This single-center study included 78 consecutive patients who underwent either Thoratec HeartMate II LVAD ( n = 27) or HeartWare ventricular assist device (HVAD, n = 51) implantation. The LMWHs enoxaparin ( n = 50) and dalteparin ( n = 28) were used. LMWH was started within 24 hours post-operatively in 79.5% of patients. No anti-coagulation was given before starting LMWH therapy. LMWH activity was monitored by determination of anti–factor Xa levels in plasma. Results The majority of patients (80.7%) had peak anti-Xa activity within the defined range of efficacy of 0.2 to 0.4 IU/ml by the second day of treatment. Mean effective peak anti-Xa activity was 0.28 ± 0.06 IU/ml. Mean duration of anti-coagulation with LMWH was 25.8 ± 18 days. Ischemic strokes were observed in 3 patients (3.8%), with a total of 4 events. Three events occurred while on LMWH, and 1 event occurred during follow-up on oral anti-coagulation. There was 1 fatal stroke. No pump thrombus was observed. Major bleeding was observed in 5 patients (6.4%), with a total of 6 events. Gastrointestinal bleeding was the most common complication ( n = 3). There were no fatal bleeding events. Conclusions LMWH in the setting of LVAD shows rapid and constant biologic efficacy. Anti-coagulation with LMWH appears feasible after LVAD implantation. These findings support further evaluation of LMWH as an alternative to unfractionated heparin in this patient cohort.