Search

Background: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system., Methods: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices., Results: Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001)., Conclusions: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background and Aim of the Study: The authors' institution participated in a 28-center FDA Investigational Device Exemption study to evaluate the Sorin Mitroflow pericardial aortic bioprosthesis. Six high-enrolling sites evaluated patients on an annual basis as part of an ongoing hemodynamic study. These data represent patients followed for an average of five years after implant, with annual echocardiography., Methods: Seventy-one patients were entered into the study and constitute the basis of this review. Mean follow up was 3.3 +/- 2.0 years (range: 0-5.5 years), with a cumulative follow up of 233 patient-years. The mean patient age was 73.8 years (range: 45-89 years), and 52% were males. The majority of aortic valve lesions were stenosis (63%) or mixed (30%), and nine patients (12.7%) were reoperations. Sixty-one patients (86%) had concomitant procedures, the most common being coronary artery bypass grafting (70%)., Results: A total of 281 echocardiograms was obtained from the patients over a five-year period. The largest number of echocardiograms was obtained with 23-mm valve implants (n = 122), followed by 25 mm valve implants (n = 87). The early baseline (30-day) mean gradient was < or = 10 mm in all patients. The mean gradient decreased as the valve size increased (21 mm valve gradient = 10.0 +/- 5.6 mmHg; 27 mm valve gradient = 6.2 +/- 2.2 mmHg). The mean increase in gradient at five years was < 7 mmHg, with a trend towards increased gradients at smaller valve sizes. The effective orifice area (EOA) showed a trend to decline slightly with 21 mm valves (from 1.5 to 1.2 cm2) and 23 mm valves (1.4 to 1.2 cm2), but there was either no change or a slight increase in larger-size valves. Left ventricular mass regression occurred mainly within the first year (18.9%), but then remained stable throughout the study period. No greater than mild prosthetic aortic valve regurgitation was observed over the study period., Conclusion: The Sorin Mitroflow aortic valve provides excellent hemodynamic results up to five years, with minimal increase in mean gradients, acceptable peak gradients, and good EOAs with all valves sizes.