Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry

Abstract

Background and aims: HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval.

Methods: A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival.

Results: Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1-3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively).

Conclusions: Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.

Keywords: Cardiac surgery; Chronic heart failure; HF surgery; Heart failure; HeartMate 3; Left ventricular assist device; Mechanical circulatory support.

Structured Graphical Abstract

Long-term survival and outcomes after Heartmate 3 implantation

Figure 1

ELEVATE consort diagram. The consort diagram reports the disposition of patients at each follow-up interval. The ELEVATE registry included three cohorts of patients: 463 patients who received HeartMate 3 as a de novo implant (primary implant cohort), 19 patients who received HeartMate 3 as a replacement of another durable device such as an HeartMate II (HMII) or an HeartWare HVAD (pump exchange cohort), and an anonymized cohort composed of 58 patients who had an outcome prior to having the possibility of signing the informed consent form, for which data on only type of outcome and duration of support were collected. Upon completion of the first 2 years of follow-up, 247 patients in the primary implant cohort and 7 in the pump exchange cohort consented to participate in the study’s extended follow-up. Patients in the primary implant cohort contributed to the baseline demographics, survival, adverse events, quality of life (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the anonymized cohort contributed only to survival analysis

Figure 2

Competing outcomes primary implant cohort. The competing outcomes graph represents the percentages of patients who were ongoing supported with a HeartMate 3 or had an outcome during the study. At each point, the sum of all percentages plotted equals to 100% of the primary implant cohort population. Forty-four (44.1%) per cent of the primary implant cohort patients were on support at 5 years, while 16.8% were transplanted and 31.5% expired. Almost 7.6% of the patients discontinued their participation for other reasons, mainly due to the refusal to participate in the longer follow-up

Figure 3

Overall survival at 5 years—primary implant (A); primary implant and anonymized cohorts (B). Overall survival for the primary implant cohort (n = 463): the survival rate at 5 years was 63.3%. (B) Overall survival of the primary implant (n = 463) and anonymized cohort (n = 58) combined: the overall survival rate was 56.3% at 5 years

Figure 4

Survival free of non-surgical bleeding, stroke, or pump thrombosis (A), survival free of stroke (B), survival free of major bleeding (C)—primary implant cohort. (A) A combined endpoint of non-surgical bleeding, stroke, or pump thrombosis: at 5 years, 43.8% of patients did not experience any of these events. (B) Survival free of stroke and (C) survival free of major bleeding: 58.1% and 40.6% of subjects were event-free at 5 years, respectively. All graphs are for the primary implant cohort population (n = 463)

Figure 5

New York Heart Association class (A), 6 min walk distance (B) and quality of life (C) over time—primary implant cohort. Functional and quality-of-life assessments. (A) New York Heart Association class across the 5-year study duration: at baseline, the majority of patients was New York Heart Association Class III or IV, while at 5 years, the majority of patients upgraded to New York Heart Association Class I or II. (B) Dramatic improvement in the 6 min walk distance in the first year post implant, which was then sustained throughout the long-term follow-up to 5 years. (C) Visual analogue scale, a part of the EuroQoL-5 Dimensions-5 Levels questionnaire, in which the patients indicate current health status on a scale from 0 (extremely bad) to 100 (extremely good): during the first year post implant, the perceived health status improved considerably in the first year and this maintained throughout the long-term follow-up to 5 years. The lines in B and C depict median. All graphs are for the primary implant cohort population (n = 463)