CardioMEMS helps decrease Heart Failure events in specific populations: GUIDE-HF substudy shows

Key Points:

• In this follow-up study to GUIDE-HF, HF patients with hemodynamic-guided therapy using a CardioMEMS device were compared to those with standard care. The primary outcome was a composite of all-cause mortality and HF events (including HF hospitalizations and urgent HF visits) at one year. In this sub-study, only patients in the pre-COVID era were examined. All results were stratified by ejection fraction (HFrEF vs HFpEF) and NYHA class (II/III vs II-IV).
• Treatment with hemodynamic-guided therapy resulted in a reduction in the primary outcome, but only in the HFpEF group in NYHA II-III populations; this was not seen in HFrEF or in NYHA II-IV populations. HF events were reduced in both HFrEF and HFpEF populations in the treatment arm, but once again only in the NYHA II-III (and not II-IV) population. The mean PA pressure was reduced in the treatment arm only in the HFrEF population.

Even with the advent of effective guideline-directed medical therapy, heart failure (HF) continues to represent a major burden of morbidity and mortality. Many efforts have been made to optimize HF care using improved methods of hemodynamic assessment. The Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF) trial (NCT03387813), first presented at the 2021 European Society of Cardiology Conference and published in the Lancet, evaluated the efficacy of the CardioMEMS hemodynamic monitoring device and its impact on all-cause mortality and HF events. This study demonstrated that the use of CardioMEMS did not result in lower composite all-cause mortality and HF events; however, the pre-COVID-19 pandemic impact analysis demonstrated lower HF hospitalizations in the CardioMEMS group. In a late- breaking presentation at the 2021 Transcatheter Cardiovascular Therapeutics Conference today, Dr. Michael Zile and his team presented the results of a follow-up study to GUIDE-HF, specifically assessing the results obtained prior to the COVID-19 pandemic when stratified by both ejection fraction and NYHA class.

The GUIDE-HF study was a randomized, single-blinded clinical trial held across 118 hospitals in the USA and Canada. Patients were all implanted with a CardioMEMS device and were subsequently divided into standard of care vs hemodynamic-guided assessment and therapy.  All recruited patients were required to have NYHA class II-IV heart failure (of any ejection fraction) and to have been stabilized on optimal medical therapy for 30 days prior to enrollment. Some relevant exclusion criteria included a) patients intolerant of all neuro-hormonal agents, b) patients who have received or were awaiting advanced therapies, c) patients previously or currently receiving inotropic agents, d) patients with unrepaired severe valvular disease and e) patients with a GFR <25mL/min or on chronic dialysis.  The sub-study specifically assessed outcomes in patients with HFrEF (EF <50%) vs HFpEF (EF >50%) as well as by NYHA Class (II/III vs II-IV).

A total of 1,000 patients were randomized, of whom 497 received hemodynamic-guided assessment and 503 did not. 398 (40%) had HFpEF, and 602 (60%) had HFrEF. At baseline, the PA pressures were similar between the HFpEF (18+/-6mmHg) and HFrEF (19+/-9mmHg) arms.

The primary outcome was a composite of all-cause mortality and HF events (including HF hospitalizations and urgent HF visits). In patients with NYHA II-IV, the primary outcome was similar in the hemodynamic-guided group versus the control in both the HFpEF (HR 0.7 (95% CI 0.47-1.03), p=0.07) and HFrEF population (HR 0.85 (95% CI 0.66-1.00), p=0.2) at one year. In the NYHA II-III only group, the results were similar for the HFrEF group, but the hemodynamic-guided group did have a reduced incidence of the primary outcome in the HFpEF group (HR 0.61 (95% CI 0.4-0.92), p=0.019). On secondary analysis, patients with hemodynamic-guided therapy did not have reduced HF events in either EF subgroup in the NYHA II-IV group, but the treatment arm was associated with reduced incidence of the primary outcome in the NYHA II-III group in both the HFpEF (HR 0.6 (95% CI 0.39-0.94), p=0.025) and the HFrEF (HR 0.73 (95% CI 0.55-0.96), p=0.025) population. Both the treatment and control arm had similar reductions in the mean PA pressure under the curve over time across both EF groups. The PA mean pressure was significantly lower in the treatment arm only in the HFrEF subgroup at one year (p-0.039).

When discussing the implications of the COVID-19 pandemic on the results of the overall GUIDE-HF study at TCT, Dr. Zile stated: “Patients in the treatment group has twice as many changes in medications as the control group. During the COVID-19 pandemic, the rates of medication changes fell in both groups…there were more decreases in doses during the pandemic. It is an amazing idea to think that patients during the pandemic required fewer medications, required lower doses of these medications, and yet their PA pressures continued to fall. This told us that there was an intrinsic change in behavior of patients during the pandemic…which we could not measure in a prospective manner. Patients in the treatment group were more aggressively treated…but there was not an intensification of medications in the control group in the pre-COVID vs the post-COVID period.”