麻豆传媒

A new era in aortic stenosis treatment is off to a messy start as debate continues over just how dispersed transcatheter aortic valve replacement (TAVR) should be throughout the U.S., following June's final ruling by the Centers for Medicare & Medicaid Services (CMS) to implement new volume requirements for TAVR centers seeking reimbursement.

The urgency now to ensure access for everyone who needs TAVR without sacrificing quality by spreading cases too thin (in an area where operator experience matters) was renewed when March's PARTNER 3 and CoreValve Low Risk trials established the transcatheter approach as a safe and effective alternative to surgery for patients with aortic stenosis who are at low surgical risk.

June's CMS decision "ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence," said CMS Administrator Seema Verma in a press release announcing the new National Coverage Determination for TAVR.

Surgery is still the only means of aortic valve replacement at hundreds of hospitals.

One way the updated CMS requirements make it easier for institutions to take up or maintain a TAVR program is by cutting back on the number of procedures they need to do each year. Also eliminated is the old rule that two surgeons had to approve each TAVR case; this is to be replaced by heart-team decision-making.

But it's not all good news for small centers. Major professional societies -- including the American Association for Thoracic Surgery, the American College of Cardiology, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons -- have proposed to organize valvular heart disease treatment throughout the country into a tiered system, similar to that of stroke and trauma treatment.

Level I centers are expected to perform all interventional and surgical procedures (including MitraClip and left atrial appendage closure) and house advanced imaging modalities, whereas Level II hospitals can offer at least transfemoral TAVR and SAVR.

This plan was seen by some as shutting out the competition from smaller hospitals and potentially exacerbating the touchy issue of access for people in certain geographic locations.

Nevertheless, "[w]ith the coverage decision and a green light for low-risk patients, the floodgates will soon open as more hospitals, especially smaller community hospitals, begin to perform TAVR," an interventional cardiologist and two surgeons from Banner-University Medicine Heart Institute in Phoenix, noted in a 麻豆传媒 opinion article.

"While this is amazing news that will provide better options for patients, we have some concerns about the rapid growth of TAVR," they wrote.

"Better access to TAVR should not mean poorer quality. A strategy for better access and sustained quality is pairing new centers with sister organizations. Rather than going back to 2011 and reinventing an effective process, new centers can partner with sister organizations to consult and refer difficult cases to the higher-volume center," the group added.

In the meantime, operators and researchers continue trying to iron out the kinks in TAVR with new techniques (such as leaflet laceration to split valve leaflets) and redesigned devices.

Many already want to take things further by expanding the procedure to a wider population: Some are interested in whether TAVR works for aortic stenosis patients with bicuspid valves, while others ask the same question of those with aortic regurgitation.

Notably, though, TAVR devices for use in low-risk patients with aortic stenosis have yet to be approved by the FDA.

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