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Background: Heart failure is one of the most expensive chronic diseases, as it leads to considerable expenses due to increasing hospitalisation rates. In addition to the implications of the demographic transition and the lack of available organs for transplantation, a major challenge in this context is that conservative treatment options are limited. This has led to the research and development of mechanical circulatory assist systems. Telemonitoring is anticipated to be an effective tool in outpatient management, which may be a key to improved outcomes of left ventricular assist devices therapy. In patients with chronic cardiac diseases, telemedicine is already used and has been shown to reduce premature mortality. This study aims to provide insights into the left ventricular assist device-specific requirements for telemonitoring and infrastructural translation from caregivers' and patients' points of view., Method: A qualitative investigation based on guided interview and focus group techniques was conducted at two German heart centres. The study included 15 patients and 7 caregivers (4 cardiac surgeons, 3 ventricular assist device coordinators). Qualitative content analysis was used for data analysis. The categories for analysis were (1) benefits for patients, (2) benefits for hospitals and the healthcare system, (3) acceptance and causative factors and (4) infrastructural implementation., Results: Patients and experts expect the following benefits for telemonitored patients: added safety, early detection of complications, rapid intervention in case of emergency, regular inspection of pump parameters, fewer outpatient clinic visits and the ability to provide more informed feedback and instructions to the family members who take care of the patient. However, the expected acceptance of telemonitoring in left ventricular assist device therapy differed among the interviewed groups. Alongside the aforementioned expected benefits, patients and clinical experts criticised the reduced self-determination for the patient, probable large amounts of time/effort required of the patient and caregiver and data protection/integrity issues (data misuse, device manipulation and mistransfer). Interviewees expected easy handling, proper education and safe data transmission to be necessary factors leading to acceptance. Complication rate reduction, fewer hospitalisations and cost reductions were benefits recorded for the healthcare system and clinics. Clinical experts preferred a telemonitoring centre run by ventricular assist device coordinators., Conclusion: Although positive expectations are associated with the use of telemonitoring in left ventricular assist device therapy, further action is needed. For example, software and infrastructure developers will need to address issues such as variations among patients and may need to find a balance between designing individualised solutions for compliant patients and a safe and easy-to-handle set-up. In addition, proper elucidation of users will contribute to the successful implementation of a left ventricular assist device telemonitoring programme among patients and caregivers.

Introduction:: Pump thrombosis of left ventricular assist devices remains a devastating complication with high morbidity and mortality. Despite the improvements made, the matter affects many patients and the treatment options are limited to thrombolysis and surgical replacement. An alternative approach using the aspiration Indigo catheter was tested., Methods:: An Indigo thrombectomy catheter was used within an in vitro model to assess the direct aspiration of prefabricated clots from three different positions within the HeartWare HVAD (inlet, outlet, and housing). The experiments were conducted with a straight and an angled catheter. The aspiration pressure was constant. The flow, power consumption, and pressure head of the left ventricular assist devices were measured at pre-defined measuring points., Results:: The device was more effective (success rate 71%) at inlet and outlet of the left ventricular assist device. In addition, the duration of aspiration and the aspiration volume were shorter in comparison to the aspiration in the housing (inlet M = 19.75 s, outlet M = 60.50 s, and housing M = 38.75 s). Moreover, the aspiration volume was associated with the aspiration duration and the weight of thrombi but not with their volume. Noteworthy, the angled catheter showed an improved performance compared to the straight one (67%-33%). The recorded parameters showed no major changes during the use of the catheter. After application of the Indigo catheter, flow and pressure head of the pump could be restored., Conclusions:: The aspiration system showed promising results under specific conditions for the treatment of pump thrombosis in an in vitro model. However, further examination, including in vivo experiments, will justify its effectiveness.

For several years, the standard implantation strategy of ventricular assist devices has involved a full sternotomy approach. However, less invasive implantation techniques are now becoming increasingly popular as they are associated with reduction of trauma, blood loss, and arrhythmogenic complications, as well as a decreased duration of intensive care unit and in-hospital stay. Thus, due to miniaturization and increasing technical improvement of ventricular assist devices, less invasive strategies for implantation, explantation, exchange, and concomitant cardiac procedures are on the rise. In this review article, we report on the state of the art of less invasive techniques for implantation, explantation, exchange, and combined cardiac procedures of ventricular assist devices., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: Improved outcomes over the past decade have increased confidence of physicians and patients in extended duration of left ventricular assist device (LVAD) support. This single-centre cohort study reports 5-year outcomes with the HeartMate II (HMII) LVAD., Methods: We describe a cohort of 89 patients who received a HMII LVAD between February 2004 and December 2010. The causes of death and adverse events were assessed by examination of medical records. A total of 202.74 patient-years were analysed., Results: After 5 years, of the 89 patients, 15 patients remained on device therapy, 39 patients died, 28 patients underwent heart transplantation and 7 patients underwent explantation of the HMII for recovery. One year after the HMII implantation, there was a survival of 71% in the study cohort. In the following years, the survival rate was 65% in the 2nd year, 63% in the 3rd year, 56% in the 4th year and 54% after 5 years of LVAD support. Ten LVAD exchanges were performed in 8 (11%) patients. Currently (March 2017), 12 patients still remain on their original device. The longest ongoing patient on the HMII has been supported for over 11 years (4097 days). The most common adverse events were bleeding (68%; 1.5837 events per patient-year) and LVAD infection [49%; 1.0666 events per patient-year]. Seven cases of pump thrombosis were described (8%; 0.1131 events per patient-year)., Conclusions: This is the first single-cohort study to describe a 5-year survival of HMII patients on extended duration of support. A 5-year survival of 54% was observed in this single-centre cohort., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: Whereas guidelines recommend the routine use of natriuretic peptides (NPs) in heart failure (HF) care, the clinical relevance and prognostic potential of midregional pro-adrenomedullin (MR-proADM) is less well established. We aimed to compare the prognostic potential of MR-proADM after acute decompensation for systolic HF with that of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and midregional pro-atrial NP (MR-proANP), to investigate the significance of high/rising MR-proADM, and to evaluate the incremental prognostic yield of repeat measurements., Methods and Results: The Interdisciplinary Network Heart Failure (INH) programme enrolled patients hospitalized for acute systolic HF and followed them for 18 months (100% complete). Of 1022 INH participants, 917 (68 ± 12 years, 28% female) who had biomaterials available were enrolled. High MR-proADM was associated with more impaired left ventricular function, higher comorbidity burden, lower doses of HF medications, and lower likelihood of left ventricular reverse remodelling. Compared with NPs, MR-proADM had superior prognostic significance (concordance index 0.72 for all-cause mortality), improved Cox regression models including NPs (P < 0.001), and was the only biomarker also predicting non-cardiac death (hazard ratio 1.8 vs. 1.0). In the setting of low NPs, patients with high MR-proADM experienced non-cardiac death more often. Six month MR-proADM enhanced models including baseline MR-proADM (P < 0.001) for prediction of all-cause death (net reclassification index: 0.48, 95% confidence interval 0.19-0.78)., Conclusion: MR-proADM was found to correlate with the global disease burden in HF and proved a potent prognostic indicator, capturing the risk for both cardiac and non-cardiac death. Serial MR-proADM measurements further enhanced risk assessment, thus facilitating substantial reclassification., (© 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.)

Background: The novel HeartMate 3 (HM3) left ventricular assist device (LVAD) received its CE mark in October 2015. It is a new compact LVAD featuring fully magnetically levitated pump, artificial pulse, large pump gaps, and a modular driveline. Here, we present outcomes and adverse events of a single-center cohort 6 months after HM3 implantation., Methods: We retrospectively studied a patient cohort of 27 patients who were supported with the HM3 at a single institution. We excluded patients with biventricular assist devices and other types of assist devices as well as LVAD exchange and re-operative procedures., Results: Twenty-seven patients were enrolled into the study. Within 1 year after HM3 implantation, 1 patient received a heart transplant and 3 patients died. Thirty-day survival was 88.9% and 6 months 85.2%. No pump thrombosis and no strokes were observed within 6 months. Right heart failure was diagnosed in 1 patient after HM3 implantation (3.7%). No technical complications of the pump were documented. No pump exchanges were necessary., Conclusions: The novel LVAD HM3 has already shown good CE mark trial results. Within this first report after the CE mark trial, the 6-month survival after HM3 implantation was 85.2%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 6 months after implantation., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Acquired von Willebrand syndrome (AvWS) is associated with postoperative bleeding complications in patients with continuous flow left ventricular assist devices (CF-LVADs). The aim of this study is to analyze the perioperative vWF profile comparing an axial pump (HMII) to a centrifugal pump (HVAD) regarding the correlation between perioperative occurrence of AvWS, early- and late-postoperative bleeding events., Methods: From July 2013 until March 2015 blood samples of 33 patients (12 HMII/ 8 HVAD/ 13 controls) were prospectively collected at 12 different time points and analyzed for the vWF antigen (vWF:Ag), its activity (vWF:Ac) and the vWF:Ac/vWF:Ag-ratio (vWF:ratio). The follow up period for postoperative bleeding events was from July 2013 until July 2016., Results: Postoperatively, there was no difference in the vWF-profile between HVAD and HMII groups. However, a subgroup of patients already had significantly lower vWF:ratios preoperatively. Postoperatively, both CF-LVAD groups presented significantly lower vWF:ratios compared to the control group. Bleeding events per patient-year did not differ between the two groups (HMII vs. HVAD: 0.67 vs. 0.85, p = 0.685). We detected a correlation between vWF:ratio <0.7at LVAD-start (r = -0.583, p = 0.006) or at the end of surgery (r = -0.461, p = 0.035) and the occurrence of pericardial tamponade. In the control group, the drop in both vWF:Ag and vWF:Ac recovered immediately postoperatively above preoperative values., Conclusion: A subgroup of patients with end-stage heart failure already suffers AvWS preoperatively. In both CF-LVAD groups, AvWS begins immediately after surgery. Intraoperative vWF:ratios <0.7 correlate with higher incidences of pericardial tamponade and re-operation. The presumably dilutive effect of the heart lung machine on vWF vanishes immediately at the end of surgery, possibly as part of an acute-phase response.

Long-term survival after left ventricular assist device (LVAD) implantation in heart failure patients is mainly determined by a sophisticated after-care. Ambulatory visits only take place every 12 weeks. In case of life-threatening complications (pump thrombosis, driveline infection) this might lead to delayed diagnosis and delayed intervention. It is the intention of the international project Medolution (Medical care evolution) to develop new approaches in order to create best structures for telemonitoring of LVAD patients. In the very early period of the project a questionnaire was sent to 180 LVAD patients to evaluate the need and acceptance of telemonitoring. Thereafter, a graphical user interface (GUI) mockup was developed as one of the first steps to improve the continuous contact between the LVAD patient and the physician. As a final goal the Medolution project aims to bundle all relevant informations from different data sources into one platform in order to provide the physician a comprehensive overview of a patient's situation. In the systems background a big data analysis should run permanently and should try to detect abnormalities and correlations as well. At crucial events, a notification system should inform the physician and should provide the causing data via a decision support system. With this new system we are expecting early detection and prevention of common and partially life-threatening complications, less readmissions to the hospital, an increase in quality of life for the patients and less costs for the health care system as well.

The rising prevalence and increasing disease-related costs render chronic heart failure a rapidly growing socioeconomic challenge. The concerted action of guideline-adjusted therapy and holistic patient care is essential to achieve improvements in mortality, morbidity, functional status and quality of life of patients with symptomatic heart failure. Holistic care strategies comprise consideration of comorbidities and individual needs, lifestyle recommendations and multidisciplinary management programs for high-risk symptomatic patients in addition to basic medication and surgical therapies. For optimal patient care and coaching, seamless interaction is required between in-hospital treatment and outpatient facilities. Moreover, the palliative needs of heart failure patients need to be considered, a topic that is currently not receiving enough attention.