Search

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.)

Left ventricular assist device-associated infections represent a major complication during long-term support. Driveline exit site infections harbour the risk of ascending into the pump, causing deep-seated infections. We report on the successful treatment of a chronic recurrent left ventricular assist device pump-associated infection by the local application of bacteriophages as adjunct to standard surgical and antimicrobial treatment., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Pump thrombosis (PT) and thromboembolic events (TEs) remain major adverse events in left ventricular assist device (LVAD) therapy at an annual rate of 6-8% supported with the HeartWare HVAD and HeartMate II. PT and TEs are multifactorial events. Understanding the predisposing risk factors for PT and TE is paramount to define preventive strategies. Preoperative atrial fibrillation (AF) is considered a significant and potentially modifiable risk factor. This study investigates whether LVAD patients with AF exhibit a higher rate of PT and TE than those in sinus rhythm (SR)., Methods: We evaluated medical records of consecutive patients who underwent implantation of the HeartMate II (n = 195; 25.4%) and HeartWare HVAD (n = 574; 74.6%) at our institution between 2006 and 2015. Only visually confirmed PT was included in the study. TE was defined as any peripheral embolism or cerebral embolism according to the INTERMACS definitions., Results: SR was documented preoperatively in 211 patients (SR group) and AF in 558 patients (AF group). The median duration of support was 0.78 years in the AF group and 1.03 years in the SR group. The mean age was 60.27 years in the AF group and 52.04 years in the SR group. In the AF group, 83.0% of the patients were male, compared to 77.3% in the SR group. The cumulative incidence of PT in the SR group was 2.5% [95% confidence interval (CI) 0.3-4.7%] after 1 year and 5.7% (95% CI 2.2-9.2%) after 2 years, and in the AF group 4.9% (95% CI 3.0-6.7%) and 7.8% (95% CI 5.4-10.2%), respectively (P = 0.129). TEs were recorded in the SR group in 4.4% (95% CI 1.6-7.2%) after 1 year and in 6.3% (95% CI 2.8-9.8%) after 2 years, and occurred after a median support time of 214 days (range 120-768). In the AF group, the cumulative incidence was 8.4% (95% CI 6.0-10.7%) and 10.7% (95% CI 8.0-13.4%), respectively, after a median support time of 116 days (range 37-375), P-value = 0.163. In the multivariate analysis, event-free survival was not influenced by the preoperative SR [hazard ratio (HR) 0.86, 95% CI 0.68-1.1; P = 0.19]., Conclusions: Our study showed that the preoperative rhythm has no impact on survival, PT and TEs despite different preoperative risk factor profiles in the AF and SR group. Thus, the effect of a maze procedure, catheter ablation or left atrial appendage closure on PT and TE's for AF patients during LVAD implantation is questionable. However, to obtain a definitive answer, a prospective study would be of value., (© 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: The implantable continuous-flow left ventricular assist devices (LVADs) HeartMate II (HM II) and HeartWare HVAD (HW) underwent design modifications. The impact of these changes on life-threatening pump malfunctions was evaluated., Methods: We retrospectively analysed pump malfunctions due to thrombosis or cable damage in patients supported with primarily implanted HM II (n = 191) and HW (n = 347), separated into patients supported with the old and new pump designs. In 2010, the cable strain relief of the HM II device was improved (132 patients with old and 79 with new) and sealed grafts were introduced (68 patients with sealed inflow connector and outflow graft and 125 without). In 2011, titanium sintering of the inflow cannula of HW pumps was introduced (137 patients with a non-sintered and 210 with a sintered inflow cannula)., Results: The median support time was 1.12 (0-6.1) years for all HM II and 0.59 (0-4.2) years for all HW patients. The cumulative rate of events per patient-year (EPPY) was 0.11 in HM II patients, compared with 0.09 EPPY in HW patients (P = 0.32). After introduction of the new cable design, incidence of cable damage in HM II patients dropped from 0.06 to 0 EPPY (P = 0.03), whereas pump thrombosis increased from 0.02 to 0.14 EPPY (P < 0.001) after the sealed graft was introduced. Pump thrombosis occurred in 4% of patients supported with HW with a sintered inflow cannula vs 15% with a non-sintered pump; the incidence changed from 0.10 to 0.07 EPPY in sintered pumps (P = 0.45). Kaplan-Meier analysis showed no differences over a period of 2.5 years for events when the HM II cohort with sealed graft and new cable design (n = 68) was compared with the HW group with a sintered cannula (P = 0.14)., Conclusions: The modified cable strain relief of the HM II pump and the sintering of the inflow cannula of the HW pump demonstrated a significant reduction in the incidence of life-threatening pump-related complications, whereas the sealed inflow connector and outflow graft seem to be associated with a higher incidence of pump thrombosis. However, the overall incidence of pump-related complications after the latest design changes was similar for both pumps over a 2.5-year period., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Mechanical circulatory support (MCS) creates improvement of cardiac function in a small portion of patients with idiopathic dilated cardiomyopathy (iDCM). Among other factors, cardiomyocyte hypertrophy seems to represent an important prerequisite for MCS-related cardiac recovery. We have previously shown that connective tissue growth factor (CTGF) leads to adaptive cardiomyocyte hypertrophy associated with a protective cardiac function in transgenic mice. To test whether a functional genetic variant in the CTGF promoter impacts MCS-related cardiac recovery, three groups of iDCM patients with and without cardiac recovery on MCS were genotyped., Methods: The CTGF promoter variant (c.-945C>G) was analysed in 314 patients with iDCM receiving medical treatment only (Group I). Forty-nine iDCM patients who were either weaned from MCS for more than 6 months (Group II; n=20) or bridged to cardiac transplantation (Group III: n=29) were also genotyped. Patients on MCS were followed up for at least 12 months. Clinical characteristics and outcome on MCS were correlated with the respective genotypes., Results: The c.-945C>G allele frequencies in 314 iDCM patients (Group I) were similar to controls deposited in the HapMap database or those published in a recent study. There were no differences in allele prevalence between patients with mild to moderate iDCM (Group I) compared with patients with severe iDCM requiring MCS (Groups II and III). Intriguingly, 50% of patients who were weaned from MCS (Group II) were homozygous for the G allele compared with only 17.2% of patients included in Group III, which is a significant difference (P=0.03)., Conclusions: Homozygosity of the promoter-activating G allele in the CTGF&#95;c.-945C>G variant is overrepresented in patients with cardiac recovery on MCS when compared with iDCM patients without cardiac recovery. Further studies are needed to evaluate c.-945C>G as a genetic predictor for clinical outcome on MCS., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objective: Conflicting data still exist concerning the reversibility of secondary severe 'fixed' pulmonary hypertension (PH) by the use of left ventricular assist device (LVAD) support in terms of time necessary to provide a bridge to 'transplantability'., Methods: We retrospectively reviewed 145 patients with heart failure and severe PH treated by LVAD support between 2000 and 2009. There were 133 men (91.7%) and 12 women (8.3%) with a mean age of 52.95±12.01 years. Patients were divided into two groups depending on preoperative PH reversibility. Fixed PH was defined by a mean pulmonary arterial pressure (mPAP) >25 mmHg, a pulmonary vascular resistance (PVR) >2.5 Wood Unit (WU) and a transpulmonary gradient (TPG) >12 mmHg, despite pharmacological treatment., Results: Fifty-six patients had fixed PH (group A) and 89 reversible PH (group B). Only 27 patients of group A underwent right heart catheterization evaluation during LVAD support; the remaining 29 patients had other contraindications to heart transplantation (HTx). The 27 patients were divided into three subgroups on the basis of examination time during LVAD support: <6 months (11 patients), between 6 and 12 months (six patients) and >12 months (10 patients). The mPAP, PVR, and TPG decreased significantly during LVAD support (mPAP, 37.26±6.35 mmHg vs 21.00±7.51 mmHg, p=0.007; PVR, 3.49±1.47 WU vs 1.53±0.66 WU, p=0.000; and TPG, 15.04±5.22 mmHg vs 7.78±3.21 mmHg, p=0.019). A significant reduction of all parameters was observed during the first 6 months and later on there was no further decrease. There were no significant differences between the three subgroups (mPAP, p=0.680; PVR, p=0.723; and TPG, p=0.679) in terms of time of reversibility. LVAD support allowed 19 patients to be transplanted., Conclusions: Patients with fixed PH can be treated with LVAD support. Our data suggest that 6 months after LVAD implantation it is possible to observe an important reduction of PH and evaluate the potential transplantability of patients. Longer support does not add any effect of LVAD on PH., (Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

Objectives: Fixed pulmonary hypertension is a contraindication for heart transplantation. Left ventricular assist device support may lower it and bridge patients to heart transplantation. The aim of the study was to investigate the optimal parameters for treatment decisions and the time course of their potential reversal to normal values during preoperative inotropic support., Methods: Mean pulmonary arterial pressure, pulmonary vascular resistance and transpulmonary gradient were retrospectively analysed in 120 heart failure patients with severe pulmonary hypertension (mean age 51.7 ± 1.1 years, 93.3% males) treated between 2000 and 2009 with inotropes before left ventricular assist device implantation. The population was divided into three groups: patients with mean pulmonary arterial pressure > 25 mm Hg (group A, n = 113), patients with pulmonary vascular resistance > 2.5 Wood units (WU) (group B, n = 75) and patients with transpulmonary gradient > 12 mm Hg (group C, n = 55). Patients could be assigned to more than one group., Results: After 24h of inotropic support, pulmonary vascular resistance decreased (4.1 ± 0.2 to 3 ± 0.1, -25%, p<0.001), as did the transpulmonary gradient (17 ± 0.5 to 14 ± 0.7, -18%, p < 0.001). There was no significant decrease of mean pulmonary arterial pressure. Fifty percent of patients presented transpulmonary gradient < 12 mmHg on the 3rd day and pulmonary vascular resistance < 2.5 WU on the 4th day. No further changes were observed in the following days. Left ventricular assist device support allowed 63 patients to be listed for heart transplantation and 40 received transplantation. A 30-day mortality after heart transplantation was higher in patients with fixed pulmonary hypertension, despite inotropes, than in those with reversible hypertension in groups B and C (12.5% and 11.1% vs 0%, respectively)., Conclusions: Transpulmonary gradient and pulmonary vascular resistance, but not mean pulmonary arterial pressure, are predictive parameters for successful heart transplantation in cases of severe postcapillary pulmonary hypertension. When no significant decrease in pulmonary vascular resistance and transpulmonary gradient after 3-4 days of pharmacological therapy is observed, mechanical circulatory support is the only option to bridge end-stage heart failure patients to heart transplantation. Survival after heart transplantation is strictly related to the reversibility of pulmonary vascular resistance and transpulmonary gradient before assist implantation, but not related to mean pulmonary artery pressure., (Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

CO(2) embolism is a known, though rare, complication of procedures using CO(2) insufflation. We report massive cardiac right atrial CO(2) embolism during minimally invasive harvesting of a varicose great saphenous vein. The patient's hemodynamics deteriorated significantly and needed to be stabilized by emergency institution of cardiopulmonary bypass. Causes of this rare but potentially lethal complication are discussed, as well as its prediction, diagnosis, and prevention.

Objective: In patients with inotrope-dependent end-stage heart failure the timely application of the most suitable treatment, i.e. heart transplantation, implantation of a ventricular assist device or conservative treatment, is a key issue for therapeutic success., Methods: Seventy-six inotrope-dependent patients with end-stage heart failure were enrolled. Measurements of hemodynamics, routine laboratory parameters, and clinical examination were performed daily. Additionally, natriuretic peptides (BNP and NT-proBNP) and E-selectin were measured at the end of the study. The patients were retrospectively divided into groups with regard to the following end-points: Group I-deterioration into cardiogenic shock after an initially stable clinical course (n=26); Group II-stable clinical course without deterioration into cardiogenic (n=41); Group III-weaning from inotropic support (n=9)., Results: One day before cardiogenic shock occurred, BNP, NT-proBNP and E-selectin were significantly elevated in group I compared with group II. A logistic regression model showed that only BNP and E-selectin were independent predictors of clinical deterioration on the following day. The odds ratio (OR) for E-selectin using a cut-off point of 65ng/ml was 8.7 and for BNP using a cut-off of 500pg/ml it was 4.8. In combination, the OR increased to 11.1. Continuous decrease of NT-proBNP predicted patients in whom weaning from inotropes was possible., Conclusions: While routine parameters did not predict the clinical course, elevated BNP and E-selectin independently predicted cardiogenic shock on admission and 1 day before its occurrence. The combination showed increased predictive value.

Unlabelled: Axial flow pumps have gained increased acceptance since their first clinical use in 1998. The present report summarizes the clinical experience with patients treated for severe cardiogenic shock for the first time with a newly developed axial flow pump with magnetically levitated bearings., Material and Methods: The axial flow pump Incor was implanted in 24 patients between June 2002 and June 2003. All except one patient were men. In 16 patients dilative cardiomyopathy, in seven ischemic and in one restrictive cardiomypathy had been diagnosed. All patients presented with catecholamine-dependent end-stage heart failure, seven of them were on an artificial ventilator and three were dependent on intraaortic balloon pump support. All patients suffered from organ dysfunction resulting from low cardiac output., Results: There were no perioperative deaths. The 30-day mortality rate was 8% (n = 2); 79% ( n = 19) of patients reached a condition to be discharged home. The cumulative time on the device is 6.9 years; the longest individual time up to July 1, 2003 is 12.6 months. There were no structural defects or failures of the system. In one case the controller had to be exchanged because of intermittent malfunction. Cardiac output ranged between 4 and 6 l in all instances and there were no cases of infection of the drive-line or the system. Hemolysis was present initially but was not detectable in the later course. There were three instances of transient ischemic attacks. Two patients developed late cardiac tamponade with re-opening of the chest after 9 and 14 days. In one patient persistent gastrointestinal bleeding required re-hospitalization and transfusion therapy. Two patients were weaned from the device after 6 and 7 months of support, respectively., Conclusion: The preliminary clinical experience with Incor is promising. The flow is sufficient for recovery from multiorgan failure and the pump allows long-term hemolysis-free support. The concept of magnetically levitated bearings has proven to be durable and reliable. In the case that the heart may recover through unloading, weaning from the pump is possible.