Results
Comparison between trial and postapproval group
patients
Baseline characteristics between the trial and postapproval patients
were comparable, except for age, preoperative international normalized
ratio (INR), indication for implantation (BTT vs DT), and use of
temporary assist device other than intra-aortic balloon pump (IABP)
prior to the HM3 implantation (Table 1). The postapproval group had
younger patients (49.60 ± 13.92 vs 55.40 ± 11.54 years p=0.01 ), a
higher pre-operative mean INR (1.13 ± 0.18 vs 1.08 ± 0.16p=0.04 ), more BTT patients (25% vs 13.4% p=0.05 ) and
more patients supported with Impella 5.0, Tandem, or extracorporeal
membrane oxygenation (ECMO) (7.6% vs 0% p=0.01 ) than the trial
group. Also, the postapproval group had more patients in INTERMACS
profile 1 (18.5% vs 7.3% p=0.04 ) than the trial group.
Characteristics of postapproval group
patients
Baseline characteristics for the 92 patients in the postapproval group
are provided in Table 1. The mean age at the time of an implant was
49.60 ± 13.92 years. The majority were African American (64.1%), male
(81.5%), and implanted as DT (75%). Of the 92 patients, 68 (73.9%)
had INTERMACS profile 1-2. Before receiving an LVAD, seven (7.6%)
patients were upgraded from IABP to a higher support temporary
mechanical circulatory assist device (Tandem, Impella 5.0, or ECMO) for
ongoing cardiogenic shock. As shown in Table 2, the median length of
hospital stay after the surgery was 22 (IQR 17-28) days. The average
pump speed at the time of discharge from the hospital was 5,300 ± 260
rpm with an average pump flow of 4.29 ± 0.46 L/min.
6-month survival
In the postapproval group, 30-day survival was 97.8% and 6-month
survival was 93.3% (Table 2 and Figure 2). Four patients underwent
heart transplantation during the first 6 months of follow-up. Six deaths
occurred during the first 6 months of HM3 support. Differentiating
6-month survival based on the indication of implantation, survival in
the DT group was 88.9% vs 100% (0.12) in the BTT group. At 3-month
follow-up after LVAD implant, 59 (71.1%) patients were NYHA class 2
(Table 2).