National Coverage Determination Will Make TAVR Available to More Patients at More Centers

Example of an aortic valve CT imaging workup for TAVR valve sizing and assessing access routes. This patient has an aneurysm in the aortic arch. Image from GE Healthcare.

Example of an aortic valve CT imaging workup for TAVR valve sizing and assessing access routes. This patient has an aneurysm in the aortic arch. Image from GE Healthcare.

As we usher in a new era for treating patients with aortic stenosis, we have been reflecting on the evolution of the technology used for transcatheter aortic valve replacement (TAVR) and the evolution of our collaborative process as a team over years as a center in the PARTNER 3 clinical trial. Data presented in 2019 showed low-risk patients fared as well or better with TAVR as they did with surgery. This led to the broader National Coverage Determination (NCD) approved in June 2019, opening Medicare payments to most patients; and changes are coming to society guidelines and U.S. Food and Drug Administration (FDA) guidance, which will bring TAVR to more patients and centers.

Through three generations of valves, multiple clinical trials, surveillance through a national registry and nearly a decade of experience, TAVR safety has steadily improved. The replacement valve technology has evolved along with our heart team’s approach all the way from evaluation of patients to the choice of TAVR or surgery, the procedure itself and follow up.

Evolution of the TAVR technology
Manufacturers rapidly modified valves and the delivery sheaths from generation one to three. First, delivery catheters became smaller, and the lower profile catheter is less likely to cause vascular injury. Valves were also redesigned to have a skirt or a wrap around them, reducing the incidence of paravalvular leak, an Achilles heel of TAVR early on.

Evolution of the Collaborative Process
As the valves have evolved, so has our approach as a team to placing them. As surgeons, interventional cardiologists, general cardiologists and imagers working together at Banner — University Medicine Heart Institute, we learned that planning is 90 percent of the procedure. At the same time, we have come to fully appreciate the need for strong collaboration focused around the needs of each patient.

Moving from ultrasound to computed tomography (CT) scans to choose valve sizes was a significant early change in our process that helped us identify and prevent major complications, such as valve embolization. A CT angiogram (CTA) allows for better delineation of coplanar deployment angles to support proper valve positioning, which reduces the incidence of para valvular leaks. A CTA also provides information needed for careful assessment of access vessel quality and size, facilitating selection of the most suitable access for TAVR and minimizing the risk of vascular complications.

Personalizing choices for each patient is another part of our team process. For a small portion of patients, surgery remains the best choice. Certain anatomy is likely to lead to complications with TAVR, including when blood vessels in the groin are too small, when coronary height is too low, or when congenital abnormalities are found in the aortic valve. Surgery is also a better option when opening the chest is required for another reason, such as a concomitant blockage, the need for mitral valve replacement in addition to the aortic valve replacement, or when work is required on the aorta.

It takes a well-developed team pulling together in the best interest of the patient to identify an individualized approach to aortic valve replacement, considering patient history and available imaging, while pushing aside motivations related to ego, money or even uninformed patient preferences.

Sometimes a well-functioning team will determine if a third choice is in the patient’s best interest, and that is to do nothing when it would be futile because the patient is likely to die from another condition.

Editor’s note: Ashish Pershad, M.D., interventional cardiologist, and Kenith Fang, M.D., a cardiothoracic surgeon, collaborate at Banner – University Medicine Heart Institute in Phoenix, one of the centers that participated in the PARTNER 3 clinical trial.

Watch an interview with Pershad in the VIDEO: Comparison Between Watchman vs. Amulet LAA Occluders

Related TAVR Content:

CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement

TAVR Operator and Hospital Requirements Outlined in 2018 AATS/ACC/SCAI/STS Expert Consensus

Interventional Imagers: The Conductors of the Heart Team Orchestra

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Recent Advances in Transcatheter Valve Technology

VIDEO: TAVR For Asymptomatic Severe Aortic Stenosis — Philippe Genereux, M.D.

How to Perform Transcaval TAVR Access — Adam Greenbaum, M.D.