Short-term single-centre experience with the HeartMate 3 left ventricular assist device for advanced heart failure

Abstract

OBJECTIVES The objective of this study was to analyse clinical characteristics, survival and adverse events of patients with advanced heart failure supported using the Abbott HeartMate 3 left ventricular assist device (LVAD). METHODS We retrospectively reviewed 42 consecutive HeartMate 3 recipients implanted in our centre between 1 November 2015 and 31 October 2019. RESULTS Our series comprised 39 males, aged 56.7 ± 11.8 years. Eleven (26%) patients had preimplant INTERMACS clinical profiles of 1 or 2. The mean duration support was 14.0 ± 10.6 months (range 0.69–44 months). During follow-up, 4 (10%) patients died while on support, 13 (35%) patients received a heart transplant and 25 patients are still ongoing. Actuarial survival after LVAD implantation was 88.4 ± 5.5% and 84.4 ± 6.6% at 1 and 2 years, respectively. There were no cases of pump thrombosis or technical malfunction. Seven (17%) patients required post-implant temporary right ventricular support. Adverse events included bleeding requiring surgery in 13 (31%) patients, gastrointestinal bleeding in 6 (14%) patients, LVAD-specific infections in 19 (45%) patients and non-disabling ischaemic stroke in 5 (12%) patients. The incidence of ischaemic stroke was significantly higher in patients where the outflow graft was anastomosed to the descending aorta as compared to those where it was anastomosed to the ascending aorta (P < 0.003). CONCLUSIONS We have observed satisfactory survival rates using the HeartMate 3 LVAD for long-term mechanical circulatory support. The absence of technical failure, pump thrombosis, haemolysis or need for pump exchange during our 4-year experience confirms its technical reliability and improved haemocompatibility, but bleeding complications and infections remain a concern.

5-year results of a newly implemented mechanical circulatory support program for terminal heart failure patients in a Swiss non-cardiac transplant university hospital

“…A recent review mentions 19-39% infection rates after implantation of second-and third-generation LVADs [25]. A Swiss group recently reported 45% LVAD-related infection after HeartMate 3 implantation, including driveline ex-site infections [26]. The latter rates correspond to our results (37.6%).…”

Cardiac Surgery in Advanced Heart Failure

“…This landmark trial showed that HM3 device treatment in BTT vs. DT study participants (197 vs. 317 patients) was associated with a higher survival rate at 1 year and 2 years after implantation (1 year: 88.8 vs. 81.5%; 2 years: 76.8 vs. 73.2%; respectively) [53]. Corresponding survival data were reported from one larger Swiss CF-LT-MCS cohort where in BTT patients the 1 and 2 year mortality rates were 88.4% and 84.4% at 1 and 2 years, respectively [54], while a DT patients cohort reported 87.5 and 70% survival at 1 and 2 years, respectively (n = 16) [55].…”

Validation of a Miniaturized Test Loop for the Assessment of Human Blood Damage by Continuous-Flow Left-Ventricular Assist Devices

“…When compared to literature data of clinical studies, the low in vitro hemolysis profile of HM3 in our mini loop with human blood might well reflect absent clinically relevant hemolysis reported for HM3 patients. 13 , 18 , 22 However, also subclinical levels of hemolysis can trigger cascades leading to severe adverse events such as thrombosis and stroke and should thus not be underestimated. 20 …”

“…When compared to literature data of clinical studies, the low in vitro hemolysis profile of HM3 in our mini loop with human blood might well reflect absent clinically relevant hemolysis reported for HM3 patients. 13,18,22 However, also subclinical levels of hemolysis can trigger cascades leading to severe adverse events such as thrombosis and stroke and should thus not be underestimated. 20 In comparison with the loop from Berk et al, 3 the smaller volume of our mini loops (160 mL) beneficially permits the paired testing of (at least) 2 pumps and 1 static reference even at the recent target hematocrit of 35% as required by the international standard for biological evaluation of medical devices (10993-4) 7 and ASTM F1841 1,2 with only one single donation of human blood.…”