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A novel transcatheter device to create a shunt between the atria of the heart eased pulmonary capillary wedge pressure in heart failure with preserved ejection fraction (HFpEF), the phase II REDUCE LAP-HF I trial showed.

That measure of left atrial unloading declined significantly more when considered across all all stages of exercise in device-treated patients at 1 month compared with those given a sham procedure of femoral venous access with intracardiac echocardiography but no device placement (P=0.028).

As a secondary endpoint, peak pulmonary capillary wedge pressure fell by 3.5 mm Hg at 1 month in the device group compared with 0.5 mm Hg in the control group, albeit not a significant difference (P=0.14), Sanjiv Shah, MD, of Northwestern University in Chicago, and colleagues reported online in Circulation along with presentation at the American Heart Association meeting in Anaheim.

That order-of-magnitude difference could be clinically significant, commented Gregg Fonarow, MD, of UCLA and an AHA spokesperson. "This sets the stage for testing in a rigorous controlled trial for symptom improvement, status improvement, as well as further validating these hemodynamic effects."

The trial wasn't powered for clinical outcomes but didn't show an increase in periprocedural or 1-month major adverse cardiac, cerebrovascular, and renal events (cardiovascular death, embolic stroke, device or procedure-related adverse cardiac events, or new-onset or worsening of kidney dysfunction) as a safety endpoint.

The findings reinforce those of the prior open-label, single-arm REDUCE LAP study, but clinical outcomes in a randomized setting will be key.

Still, Fonarow said, "This is promising for a disease state where we've not really had anything that has improved symptom status, addressed the functional limitations, reduced hospitalizations, or impacted survival."

The included 44 patients with New York Heart Association class III or ambulatory class IV heart failure, at least 40% of expected ejection fraction, a baseline pulmonary capillary wedge pressure of at least 25 mm Hg during exercise and a pulmonary capillary wedge pressure-right atrial pressure gradient of at least 5 mm Hg. They were randomized to one of the two treatment groups in a blinded manner.

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