A Life-Changing Shunt in the Heart?

Allegheny General Hospital in Pittsburgh hosts landmark clinical trial of novel heart failure treatment device

For all the lifesaving progress cardiology has made over the decades, with dramatically increased survival rates for coronary heart disease and acute heart attacks, there’s one area where we’ve lost ground. 

Heart failure. The mortality rate is now higher than it was 25 years ago. 

Nearly seven million Americans have heart failure – a number projected to top 10 million by 2040 as obesity and diabetes rates soar. And more than half these patients suffer from an intractable form called heart failure with preserved ejection fraction (HFpEF).

HFpEF patients, 60% of whom are women, breathe normally at rest but become immediately breathless with any physical activity, even just rising from a chair or walking (thus the descriptive nickname for the condition, “Huff-puff”). But it’s a tricky diagnosis because shortness of breath has so many other possible causes. 

Unlike other forms of heart failure, HFpEF has resisted our best treatment efforts. HFpEF patients have high pressure in the left ventricle and left atrium of the heart, which cannot adequately fill during exertion, resulting in back pressure in the lungs. Drug therapies have little effect on these pressures. Patients face frequent hospitalizations and a steadily deteriorating quality of life.

Now, however, there’s a “hole” new option under study – creating a permanent opening in the heart wall to balance the pressure. Allegheny General Hospital is one of about 65 sites worldwide participating in RESPONDER-HF, a randomized clinical trial of the Corvia Atrial Shunt. 

The shunt is an elegantly simple device implanted between the left and right atrium. If the patient is sitting and the pressure is normal, blood does not flow across the shunt. But when exertion increases the left atrial pressure, blood flows through the device from the left to the right atrium, relieving the pressure and allowing the patient to breathe easier.

In prior studies going back more than ten years, nearly 700 atrial shunts have been implanted, confirming the device’s safety and identifying a subset of HFpEF patients who respond really well – those without latent pulmonary vascular disease and without an implanted pacemaker or defibrillator. RESPONDER-HF is enrolling these patients all over the country. 

Deliberately inserting a hole in the heart wall is counterintuitive to cardiologists, but the evidence is growing that for HFpEF patients who fit the responder profile, this device could change the treatment picture significantly. 

Heart failure patients who have been to the emergency room many times, people whose options are exhausted and whose prognosis is grim, may find this trial a window of opportunity to a better quality of life.