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3D model of the heart by Dr. Matthew Bramlet. Credit: NIH
In the largest multi-institutional study to date, conducted by Penn Medicine researchers, the team found that among patients with transcatheter aortic valve replacement, a large number of patients presented with severe and moderate prostheses between patients. – say that the implanted heart valve is too small for the patient, which can lead to insufficient blood flow. The team also found that the risk of death and readmission of heart failure was respectively 19% and 12% higher after one year than in patients without severe PPM.
The results of the study were presented today as a last-minute summary at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Diego and published simultaneously online in the Journal of the American College of Cardiology.
"This is an important snapshot of what is happening in the real world with the commercial procedures of TAVR," said lead author Howard C. Herrmann, MD, FACC, MSCAI, professor of medicine and cardiovascular surgery at Penn's Perelman. School of Medicine and director of the interventional cardiology program at Penn Medicine, who presented the findings to TCT. "This is the first study large enough to demonstrate significant PPM-related data for a relatively new procedure such as the TAVR." Based on these findings, PPM is a significant problem in this population that deserves greater awareness is the first step in trying to prevent it. "
TAVR was approved by the Food and Drug Administration in 2011 for the treatment of aortic stenosis, a narrowing of the aortic valve of the heart, and has revolutionized valve replacement options in patients with this heart valve replacement disease (SAVR) . This minimally invasive, catheter-based approach allows doctors to replace the aortic valve without having to remove the old, damaged one.
Of the 62,125 patients who received ALT in the United States between 2014 and 2017 and who were evaluated, the researchers found that 12% had severe PPM, while 25% had moderate PPM. The researchers collected and analyzed patient data from the US STS / ACC Transcatheter Valve Transplant Registry, which follows all commercial procedures performed in the United States. To further investigate patient outcomes, the authors linked patients from the US STS / ACC TVT registry to the administrative data of Centers for Medicare & Medicaid Services for 37,470 patients. After 30 days, patients with severe PPM had higher rates of hospitalization for heart failure, stroke, and death.
Historically, PPM has been associated with worse outcomes after SAVR, however, less is known about the incidence, outcomes, and predictors of PPM in patients with RVAC. Previous studies have been small, with limited follow-up, and some from single centers – combined, they represent only 4,000 patients – and the techniques for measuring valve opening have been inconsistent.
PPM is a mismatch between the dynamics of the blood circulation of the prosthetic valve and the amount of blood the heart needs to pump the rest of the patient's body. For example, having a valve too small in a person with a large body surface (height and weight) affects his ability to get enough blood flow when he is exercising. In previous studies, severe PPM in SAVR and TAVR patients was associated with higher risk of death and readmission to hospital, decreased exercise capacity, and a higher rate of deterioration in valves over time.
The authors identified several predictors of PPM, including patients with a smaller valve prosthesis, those with greater body surface area, or female or younger patients.
"Severe PMP occurs frequently after RVAC procedures, and results in worse results, even after a short period of one year," Herrmann said. "Now that we are more aware of this, we need to look at strategies and compare devices and techniques used in future studies to determine what will help us better mitigate or avoid this risk in the future."
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