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.
BACKGROUND:The IMACS Registry compiles and analyzes worldwide data from patients undergoing implantation of durable left ventricular assist devices. METHODS: Data encompassing 16,286 LVAD recipients from 4 collectives and 24 individual hospitals was collected and analyzed. In this 3rd annual report we compare and contrast outcomes, adverse events and risks factors between axial flow and centrifugal flow device recipients. RESULTS: Significant differences were found in the baseline characteristics of axial vs centrifugal flow LVAD recipients. Survival was similar between pump types. INTERMACS profile 1-3 constitute 85% of implants. A survival gap persists in destination therapy compared to bridge patients. RVAD need and delay impact survival dramatically. Centrifugal flow outperforms axial flow recipients in regards to GI bleeding and freedom from hemocompatibility related adverse events. No significant difference in the actuarial freedom from all strokes or either stroke subtype (hemorrhagic or ischemic) was seen among the two types of pumps. New end points to guide decision making are proposed. CONCLUSIONS: We demonstrate a transition from axial to centrifugal flow with four-year survival that approximates 60%. A high frequency of adverse events remains an impediment to the wider adoption of these technologies. In the future, composite study endpoints examining life quality and adverse events beyond survival may help in shared decision making prior to MCS implant, and may provide the requisite data to support extension of MCS therapy into the lesser ill heart failure population.
The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363).
Compared to the first EUROMACS report, the number of participating hospitals increased from 21 to 52 (+148%), whereas the number of registered implants more than tripled from 825 to 2947 (+257%). The increase in the number of participating hospitals led us to increase the quality control measures through data input control, on-site audits and statistical analyses.
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