Takeaways from GUIDE-HF Single-Arm Results, with Alex Hajduczok, MD

New data of the GUIDE-HF trial underlines both those identified for inclusion based on NT-proBNP and recent heart failure hospitalization benefited from use of the CardioMEMS system.

Presented at the Heart Failure Society of America 2023 Annual Scientific Meeting, data from the trial demonstrate patients in each group experienced nonequivalent risk of the trial’s primary efficacy endpoint but experienced similar benefits from CardioMEMS use for secondary outcomes, which study presenter Mandeep Mehra, MD, medical director of the Heart and Vascular Center at Brigham and Women’s Hospital, suggests support the indication for CardioMEMS use based on elevated NT-proBNP prior to occurrence of hospitalization.¹

“These patients are not equivalent when it comes to the risk of heart failure hospitalizations,” Mehra explained. “They actually represent distinctive outcome trajectories, but despite these distinctive outcome trajectories these patients demonstrate similar benefits of hemodynamic-guided management on reduction of PA pressure, improvement in NYHA class, and all quality of life domains.”

Initially approved in 2014 for patients with NYHA Class III heart failure patients with a prior heart failure hospitalization within the past year, the CardioMEMS HF System received an expanded indication in February 2022 based on the results of the GUIDE-HF trial. This expanded indication, which allowed for use in patients with NYHA Class II heart failure, expanded the patient population by an estimated 1.2 million people. Supported by findings from the GUIDE-HF trial indicating NYHA Class II heart failure patients and patients with elevated NT-proBNP had better outcomes when their therapy was guided by pulmonary pressure monitoring, with reductions of 34% and 25%, respectively, in heart failure hospitalizations, emergency visits, and death.²

Results presented at HFSA 20233 demonstrated the rate of the study’s primary efficacy endpoint was reduced among those with only elevated NT-proBNP relative to those with a prior heart failure hospitalization (Hazard Ratio [HR], 0.51; 95% Confidence Interval [CI], 0.44 to 0.60), which Mehra highlighted fell outside of the margin for equivalence. Further analysis found means changes of —2.44 mmHg in the elevated NT-proBNP group and —2.05 mmHg in the prior heart failure hospitalization group.¹

When assessing changes in NYHA class, investigators observed improvements at 12 months for 30% and 37% of the NT-proBNP and prior hospitalization arms, respectively (P=.28 between groups). Additionally, improvements of 6.26 and 5.42 points in KCCQ-OSS were observed from baseline to 12 months in the NT-proBNP and prior hospitalization arms, respectively (both P <.0001). Mehra also pointed out 50% of patients in each arm experienced an improvement of 5 or more points.¹

For more on the single arm data from the GUIDE-HF trial and how it informs use of the CardioMEMS device, check out our interview with Alex Hajduczok, MD, cardiology fellow at Thomas Jefferson university Hospital, at HFSA 2023.

Hajduczok has no relevant disclosures of note.

References:

1. Mehra, MR, Costanzo MR, Zile MR, et al. Primary Results Of The Prospective Single Arm Trial Of Hemodynamic-guided Management Of Heart Failure (GUIDE-HF). Paper presented at: Heart Failure Society of America 2023 Annual Scientific Meeting; October 6 - 9; Cleveland, OH. Accessed October 13, 2023.
2. Abbott’s CardioMEMSTM HF system receives FDA approval to support patients battling earlier-stage heart failure (2022) Abbott MediaRoom. Available at: https://abbott.mediaroom.com/2022-02-21-Abbotts-CardioMEMS-TM-HF-System-Receives-FDA-Approval-to-Support-Patients-Battling-Earlier-Stage-Heart-Failure (Accessed: 13 October 2023).