麻豆传媒

Implantable cardiac monitoring appeared to boost outcomes consistently in a broad heart failure population across left ventricular ejection fraction categories, a GUIDE-HF trial substudy showed.

Care guided by the CardioMEMS pulmonary artery pressure monitoring device reduced the composite of all-cause mortality, hospitalizations, and urgent heart failure visits without an interaction by ejection fraction, whether measured with a 40% threshold or with a 50% threshold.

The relative risk reduction compared with controls, who had the device implanted but its data not clinically available, was likewise similar for heart failure events whether with reduced or preserved ejection fraction (HR 0.77 HFrEF and 0.72 HFpEF).

Results were consistent for milder heart failure in the New York Heart Association (NYHA) class II/III as in the trial's entire span from class II to IV, reported Michael R. Zile, MD, of the Medical University of South Carolina in Charleston, at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held in Orlando and broadcast online.

"Hemodynamic guided management of heart failure is one of a very small number of effective therapies in HFpEF patients," noted co-investigator JoAnn Lindenfeld, MD, of Vanderbilt University Medical Center in Nashville, Tennessee.

It's "very exciting as a heart failure physician to see this therapy evolve," said TCT session panelist Anu Lala-Trindade, MD, of Icahn School of Medicine at Mount Sinai in New York City. She suggested it was one more piece adding to the shift from dichotomization of ejection fraction with newer evidence on heart failure medications working across the spectrum, such as the SGLT2 inhibitors, "maybe urging us as clinicians to think about ejection fraction as a continuum rather than somewhat arbitrary thresholds."

However, Zile cautioned that this hasn't been the case for all drugs, such as beta-blockers.

There are valid reasons to think that hemodynamically guided management could have had differential effects across ejection fraction groups as well, he said at the late-breaking clinical trial session. For one, the steepness of the diastolic pressure-volume relationship makes it harder in HFpEF to determine volume status, requires differential drug management, and means more complications of therapy, he pointed out. Also, HFpEF is an aggregation of comorbid and non-hemodynamic or cardio-centric disease, he added.

The 1,000 patients included in GUIDE-HF had NYHA class II to IV heart failure, but the trial also expanded from the prior to include the entire ejection fraction spectrum and those considered high risk based on elevated natriuretic peptides, not just patients with HF hospitalization in the prior 12 months.

The trial missed its primary endpoint, but has largely been seen as a positive trial after accounting for the effects of the COVID-19 pandemic. In a prespecified analysis looking just at data from before declaration of the pandemic, the trial did reach statistical significance for the composite primary endpoint.

Losing a quarter of events that accrued in the trial did hurt the subanalysis too, Lindenfeld noted.

Despite the consistency of findings in favor of CardioMEMS monitoring, the confidence intervals were wide and missed statistical significance on all but the composite outcome in HFpEF patients with NYHA class II/III and the reduction in heart failure events for both ejection fraction groups in NYHA class II/III.

"We need to make use of all the data," Lindenfeld argued at a TCT press conference. "It also reconfirms data we already have. ... Yes, the P-values are marginal when we lose 26% of our endpoints, but it was a prespecified analysis and the story, I think, all works together."

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