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

Figures

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  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

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  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

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  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

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  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)

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  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)