Hartford HealthCare Heart & Vascular Institute researchers were on hand this week when an announcement at a national conference shook industry bedrock by challenging the need for open-heart surgery for aortic valve replacement in certain low-risk patients.
They were there because they’ve been part of the research every step of the way, probing the effectiveness of transcatheter aortic valve replacement (TAVR) for aortic valve stenosis.
“Surgery has been the standard for these patients but the landmark PARTNER 3 and Evolut Low-Risk trials have shown that TAVR is equally, if not more, appropriate for patients who are considered low risk and have severe, symptomatic aortic valve stenosis,” said Dr. Raymond McKay, co-director of HVI’s Structural Heart Disease Program at Hartford Hospital.
Results of the PARTNER 3 and Evolut trials were presented at the American College of Cardiology 2019 Scientific Sessions in New Orleans, and published in the New England Journal of Medicine.
“The results of these trials will be earmarked as ground-breaking landmark trials for determining how AS patients will be treated in the future,” Dr. McKay said. “About 80 percent of surgical aortic valve replacements (SAVRs) in this country are currently being performed in low-risk patients. PARTNER 3 showed that TAVR was not only as good as SAVR but actually superior.”
Aortic valve stenosis, he said, is a common cardiac condition affecting about 2.5 million Americans over the age of 75. It is caused by calcification or scarring that narrows the aortic valve opening, restricting its ability to fully open and preventing the heart from pumping blood throughout the body.
“This is one of the most serious cardiac valve disorders, causing death 50 percent of the time within two years and 80 percent of the time within five years if the aortic valve is not replaced,” Dr. McKay said.
Aortic valve stenosis symptoms include:
- Shortness of breath.
- Exercise intolerance.
- Chest pain.
- True syncope.
The only treatment is to replace the faulty valve, either with conventional open-heart surgery or the less invasive TAVR, which involves inserting a catheter through a peripheral artery to implant the valve. Patients are examined for surgical mortality risk and are categorized as inoperable, high-, intermediate- or low-risk. TAVR is currently approved by the Food and Drug Administration for inoperable, high- and intermediate-risk patients.
The PARTNER 3 and Evolut Low-Risk trials compared outcomes in low-risk patients treated with TAVR using one of two different valves vs. open-heart surgery. After one year, PARTNER 3 revealed a lower risk of death, stroke or rehospitalization in TAVR patients compared with open-heart surgery. TAVR patients also stayed in the hospital four fewer days. The Evolut trial showed similar results over 24 months.
Hartford Hospital was one of 65 hospitals worldwide participating in the PARTNER 3 trial, serving as “one of the largest contributors” with a total of 19 patients, said Dr. McKay, who served as site principal investigator with Dr. Robert Hagberg. Such participation has led to more opportunities for Hartford, Dr. McKay said.
“Because of our excellent enrollment in PARTNERS 3, Hartford Hospital was among 35 in the United States chosen for the Edwards Low-Risk Continued Access Registry,” he said. “This allows us to continue performing TAVR in low-risk patients while waiting for FDA approval for widespread commercial use of TAVR is this patient group. We are among the top five enrollers nationally in this registry, having performed TAVR on 25 patients to date.”
Dr. McKay said more research is needed before TAVR can be used in all low-risk patients, and some will always require surgery because their anatomy will not allow for TAVR.
Hartford Hospital researchers are currently conducting other studies, assessing the role of TAVR in patients with severe, asymptomatic aortic valve stenosis, and examining the role of TAVR vs. medical therapy in patients with moderate aortic valve stenosis and congestive heart failure.
“Clinically, Hartford Hospital’s outcomes are among the top in the United States,” Dr. McKay added, noting that the hospital recently performed its 1,000th TAVR.
Patients with symptomatic, severe aortic valve stenosis should be evaluated by a multidisciplinary team of cardiac surgeons, interventional cardiologists, anesthesiologists and imaging specialists to determine their suitability for TAVR or conventional open-heart surgery.