Lindner Research Center at The Christ Hospital Health Network hosts clinical trial of cardiac shunt that may offer new hope for heart failure treatment
For all the great strides cardiology has made in recent years – survival rates for coronary heart disease and acute heart attacks have increased sharply – there’s one area where we’ve actually lost ground - heart failure.
At least six million people in the United States have some form of heart failure, and that figure continues to rise, driven primarily by aging and the obesity epidemic. All heart failure is associated with high rates of hospitalization and lowered quality of life, but we have failed to reduce the mortality rate for one form in particular – heart failure with preserved ejection fraction (HFpEF).
HFpEF is a particularly difficult challenge. This hard-to-diagnose condition often results in patients who breathe normally at rest but become immediately breathless with any physical activity – thus the nickname “huff-puff” for the condition. Unlike most cardiac disease, it is more likely to occur in women – 60% of HFpEF patients are female – and while it has been considered a disease of older women, obesity is driving an increased incidence in younger patients.
HFpEF patients have high pressure in the left ventricle and left atrium of the heart, which makes the heart unable to adequately fill during exertion as light as just getting up from a chair and walking. And the available drug therapies simply don’t help much.
Now, however, there’s a “hole” new option being tested – creating an opening in the heart wall to relieve the pressure.
The Lindner Research Center at The Christ Hospital is one of about 60 study sites worldwide participating in RESPONDER-HF, a randomized clinical trial of the
Corvia Atrial Shunt.
The shunt is a remarkably simple device, implanted between the two upper chambers of the heart. The passage is always open, but it transports blood only as necessary. If the patient is sitting and the pressure is normal, there is minimal or no flow across the device. But during exertion, when the left atrial pressure exceeds that of the right, blood flows from the left to the right atrium to equalize the pressure. The patient immediately feels less short of breath.
In prior studies covering a decade or so, about 600 atrial shunts have been implanted. The data show that it’s a safe, minimally invasive procedure, and certain kinds of HFpEF patients have done very well – patients with no pacemakers and no pulmonary vascular disease. These are also the patients for whom medications are least likely to be effective.
And for these people, the shunt can deliver a dramatic improvement in their quality of life. Some report feeling better the first day after the implant.
Now to most cardiologists, the idea of intentionally creating a shunt in the heart is completely counterintuitive. We’re all conditioned to believe a hole in the heart wall is a very bad thing that should be repaired, not created. But this particular device seems to provide an elegant mechanical fix to a problem that drugs can’t handle.
Every cardiac physician has patients who have been to the emergency room a dozen times, who are immensely frustrated by uncertain diagnoses, by multiple therapies that don’t work, and by an increasingly grim prognosis.
And for them, the RESPONDER-HF study presents a compelling opportunity. Even the 50% of patients who won’t receive the shunt in the randomized trial should see improvement in their condition due to the high attention level from the investigative clinical team at the study site. And these patients will have the opportunity to receive the shunt after their unblinding visit.
Physicians who can present those options to their patients, along with the opportunity to give back to the world – to contribute to scientific knowledge that could help millions of heart failure patients in the future – are likely to get a very positive response.
Physician referral/enrollment information for the RESPONDER-HF trial can be found at:
https://us.corviamedical.com/healthcare-professionals/reduce-lap-hf-clinical-program/responder-hf/