From the April 2022 issue of HealthCare Business News magazine


Now, 97% of patients can be done that way.

HCB News: What is the reimbursement situation like for TAVR?
MS: It's covered by Medicare and the vast majority of patients that we do are over the age of 65. And it is widely covered by private insurance as well, though there are some pockets of patients that aren't well covered. Specifically, the younger-than-65 bicuspid patients, sometimes they're not as well covered, but the reimbursement situation is good. It's well covered.
The reimbursement has decreased over the years since its inception, but there are situations in which the providers recognized that some patients have multiple medical comorbidities and so their reimbursement slightly increases in those cases. But as TAVR has grown, reimbursement has seen small decreases.

HCB News: What were some of the watershed moments in the history of TAVR adoption and clinical validation, or viability?
MS: Two of the watershed moments were the very first Edwards Lifesciences trials, PARTNER II and PARTNER 3. [In] the initial PARTNER trial, TAVR was compared with, for inoperable patients, medical therapy. This was one of the first times where a medical device showed remarkable decrease in mortality as compared with medical therapy. So that was a huge moment, where we saw that TAVR actually saved lives in a dramatic way. Medtronic followed up with a trial that was similar.

The next seminal moments came when the population was expanded from just high and prohibitive surgical risk patients to intermediate participation. Trials were published showing that with intermediate risk patients, TAVR was just as good as surgery in terms of outcomes, and gave us a hint that for some patients, those who underwent transfemoral TAVR, which is the vast majority of them, [it] could be better in the short term than surgery.

And finally, the most recent and most seminal moment was the low-risk TAVR trials. Specifically the PARTNER 3 trials showed that actually TAVR in the short term [showed] significantly better outcomes than surgery for patients at low risk. And that was a big change, because that not only kind of opened the gates for doing TAVR on low-risk patients, but it increased the awareness that TAVR could be done in many, many patients, probably the majority of patients with aortic stenosis.

HCB News: From a technology standpoint, what kind of imaging or operating room capabilities are required for a facility to introduce TAVR to their patients?
MS: Usually what we used was something called a hybrid operating room, an additional operating room that has fluoroscopic equipment within the room, so that the procedure can be done with fluoroscopy. But if there was a complication that requires surgery, that surgery could be immediately performed with very little delay. Nowadays, we do our procedures in a hybrid OR, but there are many places that do their procedures in a cath lab with availability to transfer the patient to an OR quickly if there's a problem. So, you need a state-of-the-art cardiac catheterization lab for TAVR with surgical backup.

April 2022 Magazine

Read more stories from the April 2022 issue

Operating Room Homepage