CardioMEMS: neutral outcome but possible benefit prior to COVID-19

In the prospective GUIDE-HF trial, even heart failure (HF) patients with mild symptoms (i.e. NYHA class II) appeared to benefit from haemodynamic-guided HF management with an implantable device. However, a significant effect could only be seen in the pre-pandemic era.

The rationale of haemodynamic-guided HF management is that the addition of information about pulmonary artery pressure to clinical signs and symptoms may allow for improved HF management as elevated or increasing pulmonary artery pressure predicts congestion [1]. The multicentre, single-blind, prospective GUIDE-HF (NCT03387813) trial assessed this approach in 1,022 patients in Canada and the USA with NYHA class II–IV HF and either a hospitalisation for HF within the preceding 12 months or elevated natriuretic peptides (i.e. B-type natriuretic peptide/N-terminal pro-B-type natriuretic peptide) within 30 days. Prof. JoAnn Lindenfeld (Vanderbilt University Medical Center, TN, USA) presented the findings, which were simultaneously published in The Lancet [2,3].

All participants underwent implantation of the wireless haemodynamic monitoring device (CardioMEMS). Previously, this device demonstrated a 28% reduction of HF hospitalisations in NYHA III patients in the CHAMPION trial (NCT00531661) [4]. In the GUIDE-HF trial, patients were then randomised 1:1 to either a treatment group, managed with provider remote access to the haemodynamic data, or a control group, managed without provider access to these data. The primary endpoint was a composite of cumulative HF hospitalisations, urgent HF visits, and mortality during a median follow-up of 11.7 months.

There were 253 primary endpoint events among 497 patients in the haemodynamic-guided management group and 289 in 503 patients in the control group. In the overall analysis, the primary endpoint was reduced by 12% in the treatment group. This difference failed to meet statistical significance (HR 0.88; 95% CI 0.74–1.05; P=0.16).

Interestingly, a pre-specified COVID-19 sensitivity analysis including the primary endpoint up to 13 March 2020 (the date of the national COVID emergency declaration in the USA) showed a different result: 177 primary events occurred in the intervention group and 224 events in the control group. This translated into a 19% reduction in primary endpoint events in the treatment group (HR 0.81; CI 0.66–1.00; P=0.049). This difference in primary events almost disappeared during COVID-19, with a 21% decrease in the control group relative to pre-COVID-19, virtually no change in the treatment group, and no difference between groups (HR 1.11; 95% CI 0.80–1.55; P=0.53). Again, HF hospitalisations were not reduced by haemodynamic-guided management (HR 0.83; 95% CI 0.68–1.01; P=0.064) in the overall study analysis but were lower in the pre-COVID-19 impact analysis (HR 0.72; 95% CI 0.57–0.92; P=0.007). Neither urgent HF visits nor mortality were reduced independently with treatment in the overall or pre-COVID-19 analyses. “This was a very safe device,” Prof. Lindenfeld said. Of the 1,022 participants, 1,014 (99%) had freedom from device- or system-related complications.

“The results suggest that the benefits of haemodynamic-guided management in reducing HF hospitalisations extend to patients with NYHA class II symptoms and to those with elevated natriuretic peptides, independent of prior HF hospitalisations in all ejection fractions. The COVID-19 pandemic clearly affected the outcomes of GUIDE-HF,” Prof. Lindenfeld concluded; however, given the overall neutral finding, additional studies are needed to clarify the utility of this approach.

1. 
   
   1. Abraham WT, Perl L. J Am Coll Cardiol 2017;70:389–398.
   2. Lindenfeld J. GUIDE-HF: haemodynamic-guided management of heart failure – randomised arm primary outcomes. Hot Line Session, ESC Congress, 27–30 August.
   3. Lindenfeld J, et al. Lancet 2021;398:991–1001.
   4. Abraham WT, et al. Lancet 2016;387:453–461.

 

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Posted on 26 October 202126 October 2021