HeartMate 3 delivers survival benefit in real-world study

A recent real-world study has confirmed that the HeartMate 3 (HM3) device has good postapproval performance, yielding a 6-month survival rate that was comparable to its trial results.

“After the completion of the MOMENTUM 3 trial, the HM3 device received US FDA approval in 2018,” the researchers said, adding that postapproval survival data remain scarce. “The aim of this study was to provide real‐world US data since FDA approval of the device.”

A total of 189 patients participated in this retrospective, observational study. All participants had received the HM3 left ventricular access device (LVAD) primary implant between October 2017 and March 2020. The primary endpoint was survival after 6 months, while adverse events were set as secondary outcomes, including pump thrombosis, bleedings, stroke, and renal failure.

Of the participants, 82 (mean age 55.4 years, 75.6 percent men) had received the device implant as part of previous trials and were designated as the trial group; the remaining 92 (mean age 49.6 years, 81.5 percent men) were given the implant after FDA approval and were assigned as the postapproval group.

Two patients each in the trial and postapproval groups died within 30 days. The resulting survival rates were 97.6 percent and 97.8 percent, respectively, which did not correspond to a significant difference (p=0.99). [J Card Surg 2022;doi:10.1111/jocs.16452]

Such a trend was maintained until 6 months, at which point five trial (6.1 percent) and six postapproval (6.5 percent) patients died. The respective survival rates likewise remained statistically comparable (93.8 percent vs 93.3 percent; p=0.88).

Moreover, heart transplant within 6 months (2.4 percent vs 4.4 percent, respectively; p=0.49) and the distribution of New York Heart Association classifications 3 months after implant (p=0.77) were comparable between the two groups.

Similarly safe

Adverse events occurred at similar frequencies between the trial and postapproval groups, as well. For instance, stroke arose in 7.3 percent and 4.4 percent (p=0.52) of the respective groups, while acute limb ischaemia developed in 1.2 percent and 2.2 percent, respectively (p=0.99).

The same was true for gastrointestinal bleeding (20.7 percent vs 13 percent; p=0.22), pump thrombosis (3.7 percent vs 2.2 percent; p=0.66), driveline infections (15.9 percent vs 15.2 percent; p=0.99), and renal dysfunction requiring renal replacement therapy (9.8 percent vs 3.3 percent; p=0.12). Severe right ventricular failure requiring various interventions also occurred at comparable rates between groups.

Of note, the incidence of re-exploratory surgery for postoperative bleeding was significantly higher in the trial participants (46.3 percent vs 10.9 percent; p=0.01).

“Our postapproval, single‐centre 6‐month survival of 93.3 percent is suggestive of comparable real‐world findings when compared with the MOMENTUM 3 trial patients and the data from the ELEVATE registry,” the researchers said, noting that the study’s retrospective design is a main limitation.

“Our findings are suggestive, rather than conclusive, and based on a small number of selected patients for this single‐centre experience. Long‐term follow‐up with larger cohorts in a multicentre US experience will project a better picture of the long‐term efficacy of the device,” they added.