For patients hospitalized with acute decompensated heart failure, getting excess fluid off the body is often the first order of business. But for a difficult-to-treat subset, the standard tool for accomplishing that — diuretic therapy — can become progressively less effective.

A novel catheter-based system studied by Houston Methodist cardiologist Dr. Rayan Yousefzai takes a different approach. Rather than simply escalating medication, the preCARDIA system temporarily alters blood flow returning to the heart, reducing cardiac filling pressures and potentially helping the kidneys respond more effectively to the diuretics patients are already receiving.

Inserted through the internal jugular vein, the preCARDIA device positions a balloon in the superior vena cava (SVC) just before it enters the right atrium, intermittently occluding blood flow and temporarily reducing venous return to an already overloaded heart. This lowers cardiac filling pressures and may also relieve venous congestion affecting the kidneys.

Results from the multicenter VENUS-HF Early Feasibility Study, published in JACC: Heart Failure with Dr. Yousefzai as first author, suggest the strategy is feasible and well tolerated, providing early evidence that mechanically reducing cardiac preload can accelerate decongestion.

“This isn’t replacing the diuretic,” Dr. Yousefzai said. “It’s helping the diuretic and other medications work more efficiently.”

Breaking the cycle of congestion

Diuretics remain the cornerstone of treatment for volume overload in hospitalized heart failure patients, and for many, they work well. But patients with longstanding disease can develop diuretic resistance, leaving clinicians with fewer options for removing excess fluid.

Persistent congestion has consequences beyond shortness of breath and swelling. Elevated venous pressure can contribute to kidney and liver dysfunction and set patients up for another hospitalization soon after discharge.

The preCARDIA system is designed to intervene in that cycle.

“When the balloon is inflated, not as much fluid goes into the heart, which gives the heart a chance to work more effectively."

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Rayan Yousefzai, MD

That concept differentiates preCARDIA from other approaches to difficult decongestion. Rather than directly removing fluid, as ultrafiltration does, the system is intended to change the underlying hemodynamics so the patient's own kidneys and conventional pharmacologic therapy can work more effectively.

The published study notes that prior approaches involving intensified diuretic therapy and ultrafiltration have limitations, particularly among patients with diuretic-resistant heart failure.

Early results point to a physiologic effect

The VENUS-HF study enrolled 60 patients with acute decompensated heart failure at multiple centers. The preCARDIA device was successfully deployed and removed in all 60 patients, with 58 completing treatment according to the study’s definition of technical success. In one patient, investigators removed the device early after they were unable to obtain the proper position for SVC occlusion; in another, it was removed because of oozing at the vascular access site.

The study’s primary safety endpoint — freedom from device- or procedure-related major adverse events — was achieved in 98.3% of patients. The sole major event was a vascular injury associated with use of a nonstandard wire during vascular access; there were no device- or procedure-related deaths, heart attacks, hemorrhagic strokes, major thromboembolic events or prolonged heart failure hospitalizations.

Equally impressive were the physiologic findings.

Among patients receiving approximately 24 hours of preCARDIA support, right atrial pressure decreased by 23% and pulmonary capillary wedge pressure fell by 18%. Those reductions persisted three hours after device removal. Urine output also increased significantly during treatment and remained elevated after the device was removed.

Dr. Yousefzai said that continued response may be one of the system's most intriguing features: Once renal congestion was relieved, some patients continued responding more effectively to diuretics even after preCARDIA support ended.

The device is designed to be temporary. In this study, patients in the extended-treatment cohort received support for about 24 hours, after which the catheter was removed. Patients also reported improvements in shortness of breath, swelling and other symptoms during the early post-treatment period.

From feasibility to clinical outcomes

The findings are promising, but Dr. Yousefzai emphasizes that they are not yet evidence that preCARDIA improves longer-term clinical outcomes. VENUS-HF was a single-arm early feasibility study primarily designed to evaluate safety and technical performance, not to establish superiority over standard treatment.

That question is moving into the next stage of investigation. A larger randomized pivotal study, COR-ADHF, will compare the strategy with a control arm and determine whether its hemodynamic and decongestive effects translate into meaningful clinical benefits.

For Houston Methodist, the next phase continues an involvement that began early in the technology's clinical development. Houston Methodist was the highest-enrolling site in the VENUS-HF study, according to Dr. Yousefzai, who led the institution's participation and served as first author of the multicenter publication. He also contributed to key aspects of the subsequent trial design, including identifying the types of patients most likely to benefit from the approach.

“I think this study reflects how we at Houston Methodist are not only adopting new therapies once they reach clinical practice but helping determine how emerging technologies should be evaluated and where they may ultimately fit within treatment algorithms,” Dr. Yousefzai explained.

For a field that has spent decades trying to solve the persistent problem of congestion, preCARDIA offers a fundamentally different question. Instead of asking how much more fluid clinicians can force the kidneys to remove, investigators are asking whether changing the hemodynamic environment first can help the heart and kidneys do their jobs better.