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Objectives: The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report., Methods: All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis., Results: A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111-2.036, P = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333-0.823, P = 0.005), CHD (HR 1.641, CI 1.054-2.555, P = 0.028) and pulsatile flow support (HR 2.345, CI 1.406-3.910, P = 0.001) in multivariable analyses., Conclusions: This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Mechanical composite valve grafts (MCVGs) are the first-line therapy for aortic root replacement in young adults. Decellularized aortic homografts (DAH) present a promising novel alternative due to their lower thrombogenicity. We aimed to compare both treatment options regarding survival and valve-related adverse events., Methods: This study was designed as a single-centre retrospective cohort study including patients who underwent root replacement with MCVG or DAH between 2000 and 2022. Urgent or emergent procedures were excluded., Results: The study cohort included 289 patients (MCVG n = 216, DAH n = 73) with a mean age of 48.5 ± 12 years (MCVG 49 ± 12 years vs DAH 47 ± 11 years; P = 0.23) and a median EuroScore II of 1.7% (1.2, 2.6). The 30-day mortality was 1% (n = 3). Cumulative survival at 3 years was 99% for DAH and 94% for MCVG, respectively (P = 0.15). Mean follow-up was 98.9 ± 72.7 months. Bleeding events (n = 14, 6.5%) and thromboembolism (n = 14, 6.5%) were only observed in the MCVG group (P = 0.19 and 0.09, respectively). Four cases (5%) of moderate structural valve deterioration occurred, all in the DAH group (P ≤ 0.001). The cumulative incidence of a composite end point of valve-related adverse events was significantly higher in the MCVG group (P = 0.0295)., Conclusions: Aortic root replacement with MCVGs and decellularized aortic homografts showed low mortality in an elective setting. Patients in the homograft cohort demonstrated significantly higher freedom from valve-related adverse events. DAH present a promising treatment option for young patients requiring root replacement; however, data on long-term durability are needed., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: To evaluate the association between guideline-conforming as compared to shorter than recommended withdrawal period of P2Y12 receptor inhibitors prior to isolated on-pump coronary artery bypass grafting (CABG) and the incidence of severe bleeding and ischaemic events. Randomized controlled trials are lacking in this field., Methods: We searched PUBMED, Embase and other suitable databases for studies including patients on P2Y12 receptor inhibitors undergoing isolated CABG and reporting bleeding and postoperative ischaemic events from 2013 to March 2024. The primary outcome was incidence of Bleeding Academic Research Consortium type 4 (BARC-4) bleeding defined as any of the following: perioperative intracranial bleeding, reoperation for bleeding, transfusion of ≥5 units of red blood cells, chest tube output of ≥2 l. The secondary outcome was postoperative ischaemic events according to the Academic Research Consortium 2 Consensus Document. Patient-level data provided by each observational trial were synthesized into a single dataset and analysed using a 2-stage IPD-MA., Results: Individual data of 4837 patients from 7 observational studies were synthesized. BARC-4 bleeding, 30-day mortality and postoperative ischaemic events occurred in 20%, 2.6% and 5.2% of patients. After adjusting for EuroSCORE II and cardiopulmonary bypass time, guideline-conforming withdrawal was associated with decreased BARC-4 bleeding risk in patients on clopidogrel [adjusted odds ratio (OR) 0.48; 95% confidence intervals (CI) 0.28-0.81; P = 0.006] and a trend towards decreased risk in patients on ticagrelor (adjusted OR 0.48; 95% CI 0.22-1.05; P = 0.067). Guideline-conforming withdrawal was not significantly associated with 30-day mortality risk (clopidogrel: adjusted OR 0.70; 95% CI 0.30-1.61; ticagrelor: adjusted OR 0.89; 95% CI 0.37-2.18) but with decreased risk of postoperative ischaemic events in patients on clopidogrel (clopidogrel: adjusted OR 0.50; 95% CI 0.30-0.82; ticagrelor: adjusted OR 0.78; 95% CI 0.45-1.37). BARC-4 bleeding was associated with 30-day mortality risk (adjusted OR 4.76; 95% CI 2.67-8.47; P < 0.001)., Conclusions: Guideline-conforming preoperative withdrawal of ticagrelor and clopidogrel was associated with a 50% reduced BARC-4 bleeding risk when corrected for EuroSCORE II and cardiopulmonary bypass time but was not associated with increased risk of 30-day mortality or postoperative ischaemic events., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: Decellularized aortic homografts (DAH) were introduced in 2008 as a further option for paediatric aortic valve replacement (AVR)., Methods: Prospective, multicentre follow-up of all paediatric patients receiving DAH for AVR in 8 European centres., Results: A total of 143 DAH were implanted between February 2008 and February 2023 in 137 children (106 male, 74%) with a median age of 10.8 years (interquartile range 6.6-14.6). Eighty-four (59%) had undergone previous cardiac operations and 24 (17%) had undergone previous AVR. The median implanted DAH diameter was 21 mm (interquartile range 19-23). The median operation duration was 348 min (227-439) with a median cardiopulmonary bypass time of 212 min (171-257) and a median cross-clamp time of 135 min (113-164). After a median follow-up of 5.3 years (3.3-7.2, max. 15.2 years), the primary efficacy end-points peak gradient (median 14 mmHg, 9-28) and regurgitation (median 0.5, interquartile range 0-1, grade 0-3) showed good results but an increase over time. Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 5 years were 97.8 ± 1.2/88.7 ± 3.3/99.1 ± 0.9/100 and 99.2 ± 0.8%, respectively. Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 10 years were 96.3 ± 1.9/67.1 ± 8.0/93.6 ± 3.9/98.6 ± 1.4 and 86.9 ± 11.6%, respectively. In total, 21 DAH were explanted. Seven were replaced by a mechanical AVR, 1 Ross operation was performed and a re-do DAH was implanted in 13 patients with no redo mortality. The calculated expected adverse events were lower for DAH compared to cryopreserved homograft patients (mean age 8.4 years), and in the same range as for Ross patients (9.2 years) and mechanical AVR (13.0 years)., Conclusions: This large-scale prospective analysis demonstrates excellent mid-term survival using DAH with adverse event rates comparable to paediatric Ross procedures., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: Haemorrhagic and thrombotic complications are known obstacles in extracorporeal life support (ECLS), and patients requiring post-cardiotomy (PC)-ECLS are particularly prone. The objective of this study was to characterize the incidence, type and clinical relevance of bleeding and thrombotic events in patients on PC-ECLS., Methods: A total of 504 patients receiving PC-ECLS between 2000 and 2021 at a single centre were included in a retrospective analysis. Incidence and type of haemorrhagic and thrombotic complications in patients on PC-ECLS were assessed. Overall survival was compared, and perioperative risk factors for bleeding and thrombotic events were assessed by binary logistic regression., Results: Of the 504 patients requiring PC-ECLS, 196 patients (38.9%) had 235 bleeding events [surgical site: n = 135 (26.8%); cannulation site: n = 68(13.4%); requiring surgical revision: n = 39 (7.7%); cannulation site change: n = 17 (3.4%); fatal cannulation site bleeding: n = 4(0.8%); intracranial haemorrhage: n = 11 (2.1%); gastrointestinal haemorrhage: n = 8 (1.6%); pulmonary haemorrhage: n = 8 (1.6%); and intra-abdominal/retroperitoneal haemorrhage: n = 5 (1%)]. Overall mortality was higher in patients with major bleeding complications than in patients without bleeding complications (P < 0.0001).A total of 74 patients (14.7%) had 84 thrombotic events [ischaemic stroke, n = 39 (7.7%); cannula/circuit thrombosis, n = 26 (5.2%); peripheral embolism, n = 11 (2.2%); device exchange for haemolysis, n = 8 (1.6%)]. Another 246 patients (48.8%) had at least 1 haemocompatibility-related adverse event. Preoperative dual antiplatelet therapy [adjusted odds ratio (OR): 1.83, 95% confidence interval (CI): 1.063-3.137] and ECLS duration (adjusted OR: 1.14, 95% CI: 1.086-1.197) were identified as independent risk factors for haemorrhage. Prior stroke/transient ischaemic attack (adjusted OR: 1.91, 95% CI: 1.08-3.83) and ECLS duration (adjusted OR: 1.09, 95% CI: 1.04-1.15) were identified as risk factors for thrombotic events., Conclusions: Bleeding complications in patients on ECLS are common and significantly impair survival. Nearly half of the patients were affected by any haemocompatibility-related event., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: Mitral regurgitation (MR) is frequently observed in patients undergoing left ventricular assist device implantation. We investigated the impact of preoperative MR on left ventricular assist device patients., Methods: A retrospective propensity score-matched analysis of adult patients enrolled in the EUROMACS registry between 1 January 2011 and 30 November 2021 was performed. Patients were divided into 2 groups according to the grade of preoperative MR: none-to-mild (MR 0-II) or moderate-to-severe (MR III-IV)., Results: Following 1:1 propensity score matching, each group consisted of 914 patients. Incidence of postoperative temporary right ventricular support, reoperation for bleeding and dialysis was similar. MR III-IV demonstrated shorter median intensive care unit stay [14 days (6; 27.8) vs 10 days (5; 22), P = 0.004] and ventilation time [72 h (22, 320) vs 31 h (18, 150), P < 0.001]. Mortality was lower for MR III-IV patients [subdistribution hazard ratio: 0.66, 95% confidence interval (CI): 0.59-0.73, P < 0.001]. The 1-year survival was 68.1% (95% CI: 65.1-71.3%) in MR 0-II and 75% (95% CI: 72.1-78%) in MR III-IV. A lower incidence of total complications [odds ratio (OR): 0.93 (0.89-0.98), P = 0.003] and trend towards a lower risk of neurological dysfunction (subdistribution hazard ratio: 0.79; 95% CI: 0.61-1.01, P = 0.063) and sustained ventricular tachycardia [OR: 0.93 (0.54-1.03), P = 0.074] were demonstrated for MR III-IV. The risk of fatal stroke and pump thrombosis was similar., Conclusions: Moderate-to-severe MR in patients undergoing left ventricular assist device implantation is associated with better mid-term survival and lower incidence of total major adverse events and complications. The incidence of severe postoperative complications including fatal stroke and device thrombosis was similar., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The objective was to analyse associations between obesity and outcomes after left ventricular assist device (LVAD) implantation., Methods: A retrospective analysis of the EUROMACS Registry was performed. Adult patients undergoing primary implantation of a continuous-flow LVAD between 2006 and 2019 were included (Medtronic HeartWare® HVAD®, Abbott HeartMate II®, Abbott HeartMate 3™). Patients were classified into 4 different groups according to body mass index at the time of surgery (body mass index <20 kg/m2: n = 254; 20-24.9 kg/m2: n = 1281; 25-29.9 kg/m2: n = 1238; ≥ 30 kg/m2: n = 691)., Results: The study cohort was comprised of 3464 patients. Multivariable Cox proportional cause-specific hazards regression analysis demonstrated that obesity (body mass index ≥30 kg/m2) was independently associated with significantly increased risk of mortality (body mass index ≥30 vs 20-24.9 kg/m2: hazard ratio 1.36, 95% confidence interval 1.18-1.57, overall P < 0.001). Moreover, obesity was associated with significantly increased risk of infection and driveline infection. The probability to undergo heart transplantation was significantly decreased in obese patients (body mass index ≥30 vs 20-24.9 kg/m2: hazard ratio 0.59, 95% confidence interval 0.48-0.74, overall P < 0.001)., Conclusions: Obesity at the time of LVAD implantation is associated with significantly higher mortality and increased risk of infection as well as driveline infection. The probability to undergo heart transplantation is significantly decreased. These aspects should be considered when devising a treatment strategy before surgery., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Ventricular assist device support as a bridge to transplant or recovery is a well-established therapy in children on the cardiac transplant waiting list. The goal of this study was to investigate the incidence of and the associated factors for cerebrovascular accidents in paediatric patients supported by a Berlin Heart EXCOR., Methods: All patients <19 years of age supported by a Berlin Heart EXCOR between January 2011 and January 2021 from the European Registry for Patients with Mechanical Circulatory Support were included., Results: In total, 230 patients were included. A total of 140 (60.9%) patients had a diagnosis of dilated cardiomyopathy. 46 patients (20.0%) sustained 55 cerebrovascular accidents, with 70.9% of the episodes within 90 days after the ventricular assist device was implanted. The event rate of cerebrovascular accidents was highest in the first era (0.75). Pump thrombosis and secondary need for a right ventricular assist device were found to be associated with a cerebrovascular accident (hazard ratio 1.998, P = 0.040; hazard ratio 11.300, P = 0.037). At the 1-year follow-up, 44.4% of the patients had received a transplant, 13.1% were weaned after recovery and 24.5% had died. Event rates for mortality showed a significantly decreasing trend., Conclusions: Paediatric ventricular assist device support is associated with important adverse events, especially in the early phase after the device is implanted. Pump thrombosis and the need for a secondary right ventricular assist device are associated with cerebrovascular accidents. Furthermore, an encouragingly high rate of recovery in this patient population was shown, and death rates declined. More complete input of data into the registry, especially concerning anticoagulation protocols, would improve the data., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: A third paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight., Methods: Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (<19 years of age) performed from 1 January 2000 to 31 December 2020 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding., Results: Twenty-five hospitals contributed 537 registered implants in 480 patients. The most frequent aetiology of heart failure was any form of cardiomyopathy (59%), followed by congenital heart disease and myocarditis (15% and 14%, respectively). Competing outcomes analysis revealed that a total of 86% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 21.9% died while on support. At 12 months, 45.1% received transplants, 7.5% were weaned from their device and 20.8% died. The 3-month adverse events rate was 1.59 per patient-year for device malfunction including pump exchange, 0.7 for major bleeding, 0.78 for major infection and 0.71 for neurological events., Conclusions: The overall survival rate was 79.2% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age; P = 0.01) and lower weight (<20 kg; P = 0.015). Transplant rates at 6 months continue to be low (33.2%)., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. (J Thorac Cardiovasc Surg 2022;-:1-8)., (© 2022 Jointly between The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery. Published by Oxford University Press the European Association for Cardio-Thoracic Surgery.)

Objectives: In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era., Methods: Procedures in adult patients (January 2011-June 2020) were included. Patients from centres with <60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011-2013, 2014-2017 and 2018-2020). Adverse event rates (AERs) were calculated and stratified into early phase (<3 months) and late phase (>3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio (<3 vs >3 months)., Results: In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3-2.6) years. The annual number of implants (range: 346-600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4-7: 23, 25 and 33%; P < 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P < 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER<3 months: 1.44 vs AER>3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant., Conclusions: In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Although post-cardiotomy extracorporeal life support (PC-ECLS) is a potentially life-saving resource for patients with cardiopulmonary failure after cardiac surgery, adverse outcomes have been reported even in successfully weaned patients. The goal of this study was to assess outcome in patients weaned from PC-ECLS., Methods: Of 573 consecutive patients who received PC-ECLS at a single centre between 2000 and 2019, 478 patients were included in a retrospective analysis. Successful weaning was defined as survival >24 h after extracorporeal life support (ECLS) explantation. Mortality of patients on ECLS, as well as in-hospital mortality of weaned patients, was assessed. A binary logistic regression model with backward elimination was used to identify predictors for in-hospital mortality after successful ECLS explantation., Results: Of 478 included patients, 120 patients (25.1%) died on ECLS or within 24 h after ECLS explantation. A total of 358 patients were successfully separated from ECLS and survived for >24 h (n = 352 weaned, n = 3 transitioned to durable left ventricular assist device and n = 3 transitioned to a heart transplant). A total of 35.5% of patients who were successfully weaned from ECLS did not survive until hospital discharge. In-hospital deaths of the whole cohort were 51.7% (247/478 patients). For patients who survived to discharge (231/478 patients, 48.3%), survival was 87% after 1 year and 68.9% after 5 years., Conclusions: In-hospital mortality of patients requiring PC-ECLS is high even in case of successful weaning. Longer ECLS duration, older age, female gender and low preoperative glomerular filtration rate were risk factors for in-hospital mortality after ECLS weaning. Survival of patients discharged after PC-ECLS was encouraging., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: We reviewed our institutional experience with outflow graft stenosis (OGS) in 3 contemporary left ventricular assist devices (LVAD)., Methods: Data 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., Results: During 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., Conclusions: OGS 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., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support)., Methods: A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed., Results: Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112-771) days for HW and 376 (IQR 100-816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56-67%) vs HM3: 68% 95% CI (63-73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83-1.54), P = 0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84-1.21), P = 0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45-3.71), P < 0.001], neurological dysfunction [SHR 1.29 (1.02-1.61), P = 0.032] and intracranial bleeding [SHR 1.76 (1.13-2.70), P = 0.012]., Conclusions: Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The HeartMate 3 left ventricular assist device was first implanted in 2014 and received the Conformité Européenne mark in 2015. Since then, several trials demonstrated its high haemocompatibility associated with good survival and low adverse events rates. Herein, we report our institutional experience with patients supported with HeartMate 3 for 5 years., Methods: This prospective cohort study included patients receiving a HeartMate 3 implantation in 2014 as part of the HeartMate 3 Conformité Européenne Mark clinical trial. Patients had follow-up visits every 3 months while on left ventricular assist device support, and all patients completed the 5-year follow-up. The primary end point was survival at 5 years. Secondary end points included adverse events, health status and quality of life., Results: Eight patients (men: 75%) aged 59 years (min-max: 52-66 years) were enrolled. At 5 years, survival was 100%. Patients remained on support for a median time of 1825 days (min-max: 101-1825 days); 2 patients successfully received cardiac transplants. No right heart failure, haemolysis, pump thrombosis, pump malfunction or neurological events occurred in any patients. A driveline infection was observed in 6 patients (0.25 events/patient-year). Compared to baseline, a significant improvement in quality of life and in New York Heart Association functional class was noted after the implant and for the whole follow-up time. A slight decline in kidney function and in the 6-min walk test results occurred after 3 years., Conclusions: This study reports the longest single-centre follow-up of the HeartMate 3, showing excellent haemocompatibility over time with high survival and low complication rates at 5 years., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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 < 0.001]. Moreover, a positive BC was associated with a significantly increased risk of stroke (HR 2.41, 95% CI 1.24-4.68; P = 0.010). There was no association with the risk of pump thrombus or the probability of HTx. Independent risk factors for a positive BC included preoperative albumin and extracorporeal membrane oxygenation/intra-aortic balloon pump support., 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., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Options for paediatric aortic valve replacement (AVR) are limited if valve repair is not feasible. Results of paediatric Ross procedures are inferior to adult Ross results, and mechanical AVR imposes constant anticoagulation with the inherent risks., Methods: The study design was a prospective, multicentre follow-up of all paediatric patients receiving decellularized aortic homografts (DAHs) for AVR in 8 European centres., Results: A total of 106 children (77 boys) were operated (mean age 10.1 ± 4.8 years, DAH diameter 20.5 ± 3.8 mm). A total of 60 (57%) had undergone previous surgical interventions: 34 with 1, 15 with 2 and 11 with ≥3. There was one early death in a 12-year-old girl, who underwent her fourth aortic valve operation, due to intracerebral haemorrhage on extracorporeal membrane oxygenation after coronary reimplantation problems following 3-sinus reconstruction 1 year earlier. One 2-year-old patient died due to sepsis 2 months postoperatively with no evidence for endocarditis. In addition, a single pacemaker implantation was necessary and a 2.5-year-old girl underwent successful HTx due to chronic myocardial failure despite an intact DAH. After a mean follow-up of 3.30 ± 2.45 years, primary efficacy end points mean peak gradient (18.1 ± 20.9 mmHg) and regurgitation (mean 0.61 ± 0.63, grade 0-3) were very good. Freedom from death/explantation/endocarditis/bleeding/stroke at 5 years was 97.8 ± 1.6/85.0 ± 7.4/100/100/100% respectively. Calculated expected adverse events were lower for DAH compared to cryopreserved homograft patients (mean age 8.9 years), lower than in Ross patients (9.4 years) and in the same range as mechanical AVR (12.8 years)., Conclusions: Even though the overall number of paediatric DAH patients and the follow-up time span are still limited, our data suggest that DAHs may present a promising additional option for paediatric AVR., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: A second paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight., Methods: Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 1 July 2019 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding., Results: Twenty-nine hospitals contributed 398 registered implants in 353 patients (150 female, 203 male) to the registry. The most frequent aetiology of heart failure was any form of cardiomyopathy (61%), followed by congenital heart disease and myocarditis (16.4% and 16.1%, respectively). Competing outcomes analysis revealed that a total of 80% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 20% died while on support. At 12 months, 46.7% received transplants, 8.7% were weaned from their device and 18.5% died. The 3-month adverse events rate was 1.69 per patient-year for device malfunction including pump exchange, 0.48 for major bleeding, 0.64 for major infection and 0.78 for neurological events., Conclusions: The overall survival rate was 81.5% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age) (P = 0.01) and lower weight (<20 kg) (P = 0.015). Transplant rates at 6 months continue to be low (33.2%) The fact that the EUROMACS registry is embedded within the European Association for Cardio-Thoracic Surgery Quality Improvement Programme offers opportunities to focus on improving outcomes., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim of this study was to determine stroke rates in patients who did or did not undergo routine computed tomography angiography (CTA) aortic imaging before isolated coronary artery bypass grafting (CABG)., Methods: We conducted a retrospective analysis of a prospectively maintained single-centre registry. Between 2009 and 2016, a total of 2320 consecutive patients who underwent isolated CABG at our institution were identified. Propensity score matching was used to create a paired cohort of patients with similar baseline characteristics who did (CTA cohort) or did not (non-CTA cohort) undergo preoperative aortic CTA. The primary end point of the analysis was in-hospital stroke., Results: In 435 propensity score-matched pairs, stroke occurred in 4 patients (0.92%) in the CTA cohort and in 14 patients (3.22%) in the non-CTA cohort (P = 0.017). Routine preoperative aortic CTA was associated with a significantly reduced risk of in-hospital stroke [relative risk 0.29, 95% confidence interval (CI) 0.09-0.86; P = 0.026; absolute risk reduction 2.3%, 95% CI 0.4-4.2; P = 0.017; number needed to treat = 44, 95% CI 24-242]., Conclusions: A preoperative screening for atheromatous aortic disease using CTA is associated with reduced risk of stroke after CABG. The routine use of preoperative aortic CTA could be applied so that surgical manipulation of the ascending aorta can be selectively reduced or avoided in patients with atheromatous aortic disease., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Long-term mechanical circulatory support (LT-MCS) is an important treatment modality for patients with severe heart failure. Different devices are available, and many-sometimes contradictory-observations regarding patient selection, surgical techniques, perioperative management and follow-up have been published. With the growing expertise in this field, the European Association for Cardio-Thoracic Surgery (EACTS) recognized a need for a structured multidisciplinary consensus about the approach to patients with LT-MCS. However, the evidence published so far is insufficient to allow for generation of meaningful guidelines complying with EACTS requirements. Instead, the EACTS presents an expert opinion in the LT-MCS field. This expert opinion addresses patient evaluation and preoperative optimization as well as management of cardiac and non-cardiac comorbidities. Further, extensive operative implantation techniques are summarized and evaluated by leading experts, depending on both patient characteristics and device selection. The faculty recognized that postoperative management is multidisciplinary and includes aspects of intensive care unit stay, rehabilitation, ambulatory care, myocardial recovery and end-of-life care and mirrored this fact in this paper. Additionally, the opinions of experts on diagnosis and management of adverse events including bleeding, cerebrovascular accidents and device malfunction are presented. In this expert consensus, the evidence for the complete management from patient selection to end-of-life care is carefully reviewed with the aim of guiding clinicians in optimizing management of patients considered for or supported by an LT-MCS device., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

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.

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 < 0.01; mean pulmonary artery pressure 28 mmHg vs 21 mmHg, P < 0.01; cardiac output 5.1 l/min vs 5.9 l/min, P = 0.09) over a median period of 3 (range 1-15) days. Thirty-day and in-hospital mortality were 18.8% and 25%, respectively. One-year survival was 75%, causes of death were multiorgan dysfunction syndrome (50%), sepsis (25%), haemorrhagic stroke (12.5%) and ischaemic stroke (12.5%). Causes of death during ECMO support were ischaemic stroke, sepsis and multiorgan dysfunction syndrome., Conclusions: Temporary ECMO-facilitated RV support is associated with good long-term outcomes and high rates of RV recovery., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated multicentre, prospective, single-arm database established to collect post-Conformité Européenne Mark clinical information on patients receiving the HeartWare® Ventricular Assist System (HVAD®). The number of patients requiring longer periods of mechanical circulatory support is ever increasing and so further investigation into long-term outcomes in bridge-to-transplant populations is necessary., Methods: Data were collected on 254 commercial implants performed between February 2009 and March 2012 from nine centres in Europe (7 centres) and Australia (2 centres). Patients were followed to device explant, heart transplant or death, and the outcomes of patients who remained on support longer than 2 years were analysed. Summary statistics were used to describe patient demographics, adverse events, length of support and outcomes for this long-term cohort., Results: A total of 124 patients (49% of the original ReVOLVE population) were on support for more than 2 years (range: 731-2108 days), 76 of whom are still alive on support. Overall survival through 5 years was 59%., Conclusions: Owing to the low rate of heart transplants, a significant number of patients receiving a left ventricular assist device as a bridge to transplant remain on support for prolonged periods, often exceeding 2, 3 and even 4 years. Real-world use of the HVAD system continues to show excellent outcomes for patients on the device, including those on support beyond 2 years., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Ventricular blood stasis is a concern for continuous flow mechanical support devices and might contribute to the formation of thromboembolic events. The HeartWare® Ventricular Assist System (HVAD®) is equipped with the Lavare™ cycle that is a periodic speed modulation feature designed to alter flow patterns within the left ventricle and reduce areas of potential blood stasis. Here, we report in vitro and clinical findings on the effects of the Lavare cycle., Methods: The effect of pump speed changes on the intraventricular flow field was examined with an in vitro particle image velocimetry model. The clinical impact of the Lavare cycle was evaluated through a retrospective review of the ReVOLVE study which includes 248 patients implanted with the HVAD following Conformité Européenne Mark in nine centres in Europe and Australia. Baseline characteristics, adverse event profiles and Kaplan-Meier survival estimates were stratified by patients using/not using the Lavare cycle., Results: Particle image velocimetry showed increased ventricular washout with an active Lavare cycle as measured by the fluid velocities and angular dispersion parameters. With the Lavare cycle on, there was also a 22% decrease in the stagnation index compared with when the Lavare cycle was off. In the ReVOLVE registry, patients with the Lavare cycle turned on (n = 215) were supported for 497 patient-years, whereas patients who did not use the speed modulation (n = 33) were supported for 39.3 patient-years. The Lavare cycle did not significantly affect patient survival as both groups had approximately an 80% survival after 1 year. Patients using the Lavare cycle had significantly fewer rates of stroke [0.06 vs 0.20 events per patient-year (EPPY), P = 0.0008], sepsis (0.03 vs 0.15 EPPY, P = 0.0003) and right heart failure (0.03 vs 0.18 EPPY, P < 0.0001) with no difference in the transplant or recovery rates among the two cohorts., Conclusions: The Lavare cycle effectively generates ventricular washout and the adverse event profiles of ReVOLVE patients with the Lavare cycle on were better than those with the Lavare cycle off. Larger studies are warranted to verify the positive effect of the Lavare cycle and to optimize speed modulation settings, so additional clinically relevant improvements can be realized., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformité Européenne (CE) Mark clinical trial., Methods: Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant., Results: Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 ± 2.3 units), fresh frozen plasma (6.5 ± 5 units) and platelets (2 ± 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes., Conclusions: The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure., Clinicaltrialsgov Identifier: NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark)., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objective: Avoiding full sternotomy and cardiopulmonary bypass (CPB) could significantly reduce the invasiveness of left ventricular assist device (LVAD) implantation. Therefore, we developed minimally invasive implant strategies for the Heartware® VAD (HVAD) and the Thoratec® HeartMate II (HMII) covering isolated LVAD implantation as well as concomitant valve procedures (aortic/tricuspid). We present the surgical techniques and the initial clinical experience., Methods: From February 2012 to March 2013, 27 patients (mean age 58 ± 8 years; male 85%; Ischemic Cardiomyopathy 63%; redo surgery 22%; Interagency Registry for Mechanically Assisted Circulatory Support Level I: 29%, II: 22%, III: 33%, IV-VII: 16%) underwent minimally invasive LVAD implantation at our department. Apical cannulation was performed via a left lateral minithoracotomy in HVAD patients (n = 20) or a left subcostal incision in HMII patients (n = 7). The outflow graft anastomosis was performed to the ascending aorta via a right minithoracotomy in the second intercostal space (n = 22) or the right subclavian artery (n = 2). If additional valve procedures (aortic/tricuspid) were necessary (n = 3), a hemisternotomy was performed to access the valve and perform the outflow graft anastomosis. Circulatory support for LVAD implantation was CPB (33%), extracorporeal membrane oxygenation (48%) or off-pump (19%)., Results: The minimally invasive approach was feasible in all patients with no need for conversions. Thirty-day and in-hospital mortality were 7.4 and 14.8%, respectively. In-hospital stay was 30.0 ± 22.5 days. One patient (4%) died during follow-up from pump thrombus formation. Three patients (11%) underwent surgical revision for bleeding., Conclusions: Minimally invasive LVAD implantation is feasible and safe. The very encouraging results obtained in this initial series justify a broad application of this technique., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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 in-hospital mortality after VAD implantation were 4.5 and 9.1%, respectively, and 1-year survival was 86.4%., Conclusions: Preoperative patient optimization using ECLS improves outcomes of INTERMACS Level I patients receiving a permanent VAD., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: To determine mid-term durability of endovascular stent-graft placement in patients with penetrating atherosclerotic ulcers (PAU) involving the thoracic aorta and to identify risk factors for death as well as early and late cardiovascular events., Methods: From 1997 to 2006, 27 patients (mean age 66 yrs) presented with PAU (rupture n=7). Mean numeric EuroScore was 11 and mean logistic EuroScore was 35. Median follow-up was 42 (10-86) months, being complete in all patients. Outcome variables included death and occurrence of early and late cardiovascular events., Results: In-hospital mortality was 11%. Primary success rate was 100%. Actuarial survival rates at 1, 3 and 5 years were 93%, 78% and 70%, respectively. Hemodynamic instability (HR 2.5, 2.1-3.9; p=0.034) as well as logistic EuroScore (HR 2.8, 2.4-4.3; p=0.019) was identified as independent predictor of early and late cardiovascular events., Conclusions: Endovascular stent-graft placement in patients with PAU is an effective palliation for a life-threatening sign of a severe systemic process. Hemodynamic instability at referral and a high preoperative risk score predict adverse outcome. During mid-term follow-up, patients are mainly limited by sequelae of their underlying disease.

Objective: We have previously shown that fixed pulmonary hypertension in cardiac transplant candidates can be lowered using left ventricular assist devices (LVADs). The post-transplant survival of these patients is uncertain as pulmonary hypertension may reappear, possibly affecting post-transplant survival., Materials and Methods: Between 01/2000 and 01/2005 a total of 26 cardiac transplant candidates (92% male; mean age 56.2 years) in whom fixed pulmonary hypertension was lowered by LVAD implantation (pulmonary vascular resistance (PVR) before implantation: 5.1+/-2.8wood units (WU); PVR before cardiac transplantation: 2.0+/-.9WU) underwent cardiac transplantation at our institution. These patients were age and sex matched with 52 cardiac transplant candidates without pulmonary hypertension undergoing cardiac transplantation during the same time period. Study endpoints were peri-transplant complications and long-term survival. Mean follow-up was 36+/-14 months., Results: Peri-transplant mortality was 5% in patients after LVAD therapy and 7% in patients without prior LVAD therapy (p=.089). We observed 2 cases (4%) of acute right heart failure requiring mechanical support in patients without prior LVAD therapy. None of the patients with LVAD therapy developed peri-transplant right heart failure requiring mechanical support. Incidence of other peri-transplant complications was comparable between the two groups. Log-rank (p=.124) revealed comparable long-term survival between patients with (1 year: 85%, 2 year: 85%, 3 year: 85%) and without (1 year: 90%, 2 year 82%, 3 year prior 79%) prior LVAD therapy., Conclusion: LVAD therapy lowers fixed pulmonary hypertension in cardiac transplant candidates with fixed pulmonary hypertension. Thereafter, long-term post-transplant survival is comparable to cardiac transplant recipients without pulmonary hypertension.

Objective: To evaluate mid-term results of supraaortic transpositions for extended endovascular repair of aortic arch pathologies., Methods: From October 2002 to July 2006, 27 patients (mean age 72 years) with aortic arch diseases were treated (arch aneurysms n=18, type B dissections n=5, perforating ulcers n=4). Strategy for distal arch disease was autologous sequential transposition of the left carotid artery and of the left subclavian artery in 17 patients. Strategy for entire arch disease was total supraaortic rerouting using a reversed bifurcated prosthesis in 10 patients. Endovascular stent-graft placement was performed metachronously thereafter., Results: Two in-hospital deaths occurred (myocardial infarction on the day prior to discharge n=1, rupture while waiting for stent-graft placement n=1). At completion angiography, all reconstructions were fully patent. Four patients had small type Ia endoleaks, two of them resolving spontaneously. Mean follow-up is 15 months (1-43 months). Three late deaths occurred (myocardial infarction n=2, sudden unknown death n=1). One-year survival was 83% and 3-year survival was 72%, respectively. Redo stent-graft placement was performed in one patient after 25 months (type III endoleak). The remaining patients had normal CT scans with regular perfusion of the supraaortic branches without any signs of endoleaks., Conclusions: Mid-term results of alternative treatment approaches in elderly patients with aortic arch pathologies are satisfying. Extended applications provide safe and effective treatment in patients at high risk for conventional repair.

Background: Supraaortic branches limit extended application of endovascular aortic repair. For this purpose, we applied extensive reconstructions., Methods: Between October 2002 and March 2005, 11 patients (mean age 72.3 years) presented with acute or chronic aortic diseases originating from the aortic arch (arch aneurysms n=8, type B dissections n=3). Treatment was by autologous sequential transposition of the left carotid artery into the brachiocephalic trunk and of the left subclavian artery into the already transposed left common carotid artery in nine patients and by additional reconstruction of the brachiocephalic trunk in two patients. Endovascular stent-graft placement was successfully performed thereafter., Results: Procedure-related mortality was 0%. At completion angiography, all reconstructions were fully patent. One patient had a small type Ia endoleak that resolved spontaneously within one week. Mean follow-up was 18 months (1-29 months). One patient underwent redo stent-graft placement after 25 months due to a type III endoleak. The remaining patients had normal follow-up CT scans with regular perfusion of the supraaortic branches without any signs of endoleaks., Conclusions: Extended application of this technique will enable safe and effective treatment of a highly selected group of patients by avoiding conventional repair.

Objective: The aim of this study was to objectively measure neurocognitive deficit following aortic valve replacement with a mechanical or biological prosthesis., Materials and Methods: In this prospective, contemporary study we followed 82 consecutive patients undergoing isolated aortic valve replacement with either a mechanical (n=29, mean age=52+/-7 years) or a biological (n=53, mean age=68+/-10 years) valve prosthesis. Neurocognitive function was measured by means of objective P300 auditory evoked potentials (peak latencies, ms) and two standard psychometric tests (Trailmaking Test A, Mini Mental State Examination) before the operation, 7 days and 4 months after the operation, respectively., Results: Since P300 peak latencies increase with age, preoperative P300 measures are lower in patients receiving mechanical valves (360+/-35 ms, mean 52 years) as compared to patients receiving biological valves (381+/-34 ms, 68 years, P=0.0001). Seven days after surgery, P300 peak latencies were prolonged (-worsened) in both groups as compared to preoperative values (mechanical valves: 384+/-36 ms; P=0.0001 and biological valves: 409+/-39 ms; P=0.0001). Although on a different level (-age-related), this development was comparable within both groups (P=0.800). Four months after surgery, P300 peak latencies normalized in the mechanical valve group (372+/-27 ms, P=0.857 versus preoperative), while in contrast in the biological valve group they remained prolonged (417+/-37 ms, P=0.0001). We found no difference within patients receiving different types of biological or mechanical aortic valves., Conclusion: Postoperative neurocognitive damage is not reversible in (-elderly) patients with biological aortic valve replacement, while in contrast postoperative neurocognitive damage is reversible in (-younger) patients with mechanical valve replacement. For this contrary development, age seems to be most important, whereas damage related to type of valve prosthesis may be overestimated.

Objective: Neurocognitive deficit is an important complication in patients undergoing open heart surgery. The aim of this prospective, contemporary study was to objectively measure neurocognitive brain function following mechanical mitral valve replacement and mitral valve repair., Methods: Forty consecutive, unselected patients (mechanical valve replacement n=20, mean age 65+/-14; valve repair n=20, mean age 64+/-7, P=0.896) entered this prospective, contemporary study. Neurocognitive function was objectively measured by means of P300 auditory evoked potentials (peak latencies, ms) and two standard psychometric tests (Mini Mental State Examination, Trailmaking Test A (TTA)), preoperatively, 7 days and 4 months postoperatively., Results: Before operation, neurocognitive brain function was comparable in both patients groups (mechanical valve replacement versus valve repair: P300 potentials 374+/-25 versus 378+/-46 ms; P=0.791 and TTA 57+/-15 versus 54+/-10 s; P=0.552). Following mechanical valve replacement, neurocognitive function continuously worsened (7 day-follow-up: P300 potentials 392+/-28, P=0.001 versus preop and TTA 65+/-17, P=0.0001; 4-month follow-up: P300 potentials 406+/-39, P=0.0004; TTA 69+/-17, P=0.0001). Interestingly, neurocognitive brain function was unaffected in patients undergoing valve repair (7-day follow-up: P300 potentials 386+/-40, P=0.890 versus preop and TTA: 53+/-10, P=0.644; 4-month follow-up: P300 potentials 374+/-36, P=0.166 and TTA 54+/-11, P=0.147). At 4-month follow-up, patients with mechanical prostheses performed worse as compared to valve repair (P300 potentials: P=0.024; TTA P=0.014)., Conclusion: As shown by P300 auditory evoked potentials and Trailmaking Test A, there is marked neurocognitive damage related to mechanical valve replacement, whereas mitral valve repair does not affect neurocognitive function. This finding supports the beneficial effect of mitral valve repair over mechanical valve replacement in the decision-making tree of borderline cases, which are suitable for both types of procedure.