Just a couple of weekends ago, I sat in the crowd at the American College of Cardiology (ACC) conference in New Orleans as Dr. Leon and Dr. Reardon presented on transcatheter aortic valve replacement (TAVR) trials in low-surgical-risk aortic stenosis (AS) patients. These findings will not only raise paradigm-shifting questions for the AS market but also prompt discussion around some common industry dilemmas, especially for markets where effective but expensive procedure options become more widely accepted for broader patient populations.
At the ACC event, the great hall was filled with excitement, and attendees gave a standing ovation after the PARTNER 3 and Evolut trials were presented. The results were truly astonishing: Both trials met their primary endpoints, which essentially showed that TAVR could be a legitimate option for patients with severe aortic stenosis who are at low surgical risk.
Many may say that this was the inevitable future that’s already being observed in other parts of the surgical world. Nevertheless, the way the market adapted to TAVR usage in a very systemic way, supported by robust data from high-surgical-risk patients to now potentially low-surgical-risk patients, is very impressive, especially with such positive trial results from two different studies using two different brands of valves.
Does this mean that most patients will now go through TAVR procedures and be discharged from the hospital quickly to go back to everyday life? Well, not so fast: There are some key questions for us all to think about:
1. Will surgical risk stratification stay relevant for severe aortic stenosis patients? On one hand, we could expect to eventually see TAVR becoming the class I recommendation for all surgical risk types (low, intermediate, high), which would make risk stratification irrelevant. On the other hand, we could potentially see sub-classifications within low-risk patients, especially from reluctant cardiothoracic surgeons who would continue to perform surgical aortic valve replacement (SAVR)—more commonly known as open-heart surgery. Skeptics still can make numerous claims, such as uncertain durability, bicuspid, and surgical vs. transcatheter AVR sequencing arguments, to push for SAVR as a first-treatment plan. However, I believe that these efforts are only delaying the inevitable future as we are already seeing various studies being completed to dispute most challenges raised by skeptics.
The rest of the medtech community can learn a thing or two about this shift. Especially for those companies that must break out of any niche position they have been forced to settle into due to sub-segmentation done by the medical and payer community.
2. How will hospital capacity and financials be impacted? As much as we would like to believe that clinical evidence should drive all decisions, reality is different when it comes to broadening the approval of an expensive therapy that will put pressure on payers and on the hospitals themselves for a procedure whose economics may not be very sound (especially in the U.S.).
This is especially true for TAVR vs. SAVR as these two procedures involve different reimbursement and hospital support structures. Not only are there half as many hospitals in the U.S. that can perform TAVR as compared to the more broadly available SAVR, hospitals are required to have a much more extensive support structure with a mix of healthcare providers (such as valve clinic coordinators) to be able to offer TAVR. This then raises a couple of questions: Would hospitals have enough capacity to handle the patient volume knowing there will be more low-risk patients than intermediate- or high-risk patients? Will existing TAVR-capable hospitals be forced to increase capacity, or will we see faster growth of new TAVR-capable hospitals (which is a very timely topic to discuss as CMS recently proposed an update to its national coverage policy)? At hospitals where SAVR is more profitable than TAVR, what decisions will hospital administrators make?
3. How will the referral pathway evolve to minimize the bottleneck and patient leakage? When it comes to the TAVR procedure, when community physicians (mainly cardiologists) refer AS patients (and to whom) can put patients on different paths. Essentially, these community physicians hold the key and act as a gatekeeper. For example, AS patients who get referred to a general surgical center without a TAVR team could end up with SAVR when TAVR could have been a better choice for the patient, which is why some may argue that when TAVR becomes the top treatment choice for all severe AS patients, everyone should be referred to the TAVR hospital first for a more comprehensive evaluation—an interesting question to address that will require education, awareness and access.
One thing for certain is that this isn’t an uncommon challenge that many medtech companies will have to solve. They should look to partner closely with the medical and payer community to minimize any referral bottleneck and patient leakage that will certainly have an impact on therapeutic choice and brand usage tied to the bottom-line dollars.
4. How will trial results impact brand selection for existing and future products? For the existing giants—Medtronic and Edwards Lifesciences—it will be interesting to see how the medical community interprets the trial results as the primary endpoints differ between the two company-sponsored trials. For example, will superiority at one year vs. noninferiority at two years really drive different brand selection decisions or will it come down to other clinical or nonclinical factors? At least based on what was communicated at the ACC, both key opinion leaders were stating that this should be considered “class effect,” meaning a win for both brands.
However, what does this mean for potential future entrants (such as Abbott and Boston Scientific)? I suspect that they’ll face a steep uphill battle, which will require more than just the clinical angle to take share away from market incumbents. How this may play out could serve as a nice case study for other markets where existing incumbents with data and several entrants without data compete for their own share of the pie.
5. How will patients become more empowered and invited into the shared decision-making process? As we look to low-surgical-risk patients, we can expect to see younger patients getting TAVR procedures in the near future. We are no longer talking about 80-year-olds who may simply follow doctor’s orders. We should expect patients in their 70s or even 60s who may be much more active in making treatment decisions. It will be interesting to see how existing education materials (like print pamphlets) and channels (such as the doctor’s office) evolve to empower patients. As they become more empowered, we should expect to see a mindset shift from doctors to incorporate shared decision-making processes into their everyday practice.
We may soon see more and more patients asking for TAVR procedures as they begin the treatment conversation with interventional cardiologists and surgeons. I certainly hope that the physician community is ready to have more meaningful discussions with patients at that stage.
One thing for certain is that the answers to these questions will not be straightforward as we continue to see varying behaviors and adoption across the nation. As we open the next chapter for the management of severe aortic stenosis patients, I hope to see partnerships among providers, payers, patients and medtech companies evolve and strengthen to achieve the same end goal: better patient outcomes and satisfaction.