As the 2018 statement was released in draft form for comment last summer, programs had a sense of what it might hold: Most significantly, the draft statement said the new guidelines would change the volume threshold for developing and maintaining a TAVR program. But as the statement authors are quick to point out, they address much more than volumes, tackling head on the need to balance competency requirements with defined quality outcomes and patient access.
Importantly, there's teeth to these recommendations. CMS' 2012 national coverage determination (NCD) for TAVR has been long overdue for an update due to the latest evidence available on the rapidly evolving technology. As such, CMS convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on July 25, 2018, to discuss an update to the NCD that will be completed by Summer 2019. The panel took into account the updated society recommendations released just before that meeting, which will likely largely influence the final NCD.
Given this, these guidelines may become more than just guidance; they may soon become law for what CMS will consider an eligible TAVR program, and thus reimburse for the high-cost procedure. While not all the recommendations will be incorporated, structural heart programs should take note of the key changes in the guidelines to be sure they're prepared for the new NCD next year.
Read below for my takeaways from the new statement.
Why the new guidelines?
Interest in TAVR has boomed in recent years, with the number of programs and procedures rapidly increasing. FDA indication expansion has also made the treatment available to high- and intermediate-risk patients, with low-risk patient trials in progress.
Evidence has also been quickly mounting, and as the procedure evolved with new technology and greater operator experience, it became clear that existing program and operator requirements were out of date.
At the core has been the ongoing discussion (and debate) over the volume requirements for TAVR—both volumes of other CV services required to become a TAVR program (e.g., surgical aortic valve replacement [SAVR], PCI), as well as the number of TAVR necessary to continue as a program. Some experts in favor of volume thresholds cite recent studies showing a correlation between outcomes and experience. However, those opposed to programmatic volume requirements find patient access to be a chief concern, and they are concerned that the bar may be too high for programs in rural regions where patients do not have consistent access to TAVR, even if they are eligible. As such, the writing committee aimed to update the previous guidelines on hospital and operator requirements to incorporate new evidence on competency and quality outcomes, while also looking to balance the need for patient access to TAVR.
In the new statement, the writing committee also places a renewed emphasis on quality measurement, long-term outcomes, durability, cost-effectiveness, and shared decision making, while also recognizing the shift to conscious sedation and anticipated expansion to younger and lower-risk patients.
New requirements for establishing a program
As expected, the 2018 statement recommends substantial changes in what hospitals will need to launch a new TAVR program.
On the one hand, the statement has decreased the number of SAVR and PCI a hospital must have performed in the previous year, recognizing the challenges of capturing surgical volumes as more transition to TAVR, as well as softening PCI volumes in recent years. The hospital must have performed at least 40 SAVR in the previous year (down from 50 SAVR in the current NCD), or 80 over two years, and 300 PCI (compared to 400 PCI in the current NCD).
However, as a new requirement, hospitals must have a trained TAVR operator on the heart team before they can begin performing TAVR. This primary TAVR operator (either an interventionalist or CT surgeon) must have experience performing at least 100 transfemoral (TF) TAVR, including at least 50 as the primary operator, over the course of his or her career. Additionally, the operator must spend at least 50% of his or her active practice time at the hospital with the TAVR program. If the primary operator is a surgeon, then the other physician needs to be an interventional cardiologist. The multidisciplinary heart team must also include a cardiac surgeon who has performed at least 100 SAVRs per lifetime or 50 SAVRs over two years (with at least 20 in the previous year), and he or she must also spend at least 50% of active practice time at the TAVR hospital.
While the decrease in SAVR and PCI volumes may help some programs that have been on the cusp of this requirement in the past, the addition of a trained TAVR operator will likely be a rate limiting factor for many programs, and it may lead to increased competition for experienced structural heart fellows.
Also notable is the addition of a "tiered" thresholding process for adopting alternative access (e.g., transapical) TAVR. A new TAVR program must complete at least 80 TF TAVRs and meet a set mortality threshold before adopting alternative access.
Furthermore, the program must submit to the STS database as well as actively participate in the NCDR Cath PCI Registry, neither of which were required in the previous NCD. This is further evidence of the importance the writing committee is placing on quality tracking and improvement.
Complete requirements for new TAVR programs are available on pages 60-62 of the expert consensus document.
Raising the bar for existing TAVR programs
Beginning in their third year, existing TAVR programs will be expected to meet a higher bar for demonstrating competency—in terms of volumes and outcomes—to continue performing. Most notably, existing programs will now need to perform 50 TAVR cases per year (or 100 cases over two years), up from 20 annually in the current NCD. They must also maintain at least 300 PCI per year and 30 SAVR per year (or 60 over two years).
The writing committee justified the increase based on a Duke Clinical Research Institute analysis of the latest STS-ACC TVT Registry data. This analysis found a clinically meaningful association of major complications and higher mortality for those programs below the recommended volumes of 50 TAVR per year.
As for the impact on existing programs, the statement noted that in 2017, 204 of the 525 U.S. sites performing TAVR were performing less than 50 annually. However, 86% of TAVR centers that have been open for at least two years meet the new criteria. The writing committee does caveat that it is not recommending programs should close if they don't meet these levels, but if CMS adopts these thresholds in the new NCD, there may be no choice.
Complete requirements for continued certification for existing TAVR programs are available on pages 66-67 of the expert consensus document.
A renewed focus on outcomes tracking
While volumes are still considered an important proxy for evaluating a program's ability to take on or expand TAVR offerings, the statement also incorporates performance metrics alongside recommendations of a performance infrastructure. As such, in addition to volume requirements, the statement provides thorough quality and outcomes metrics that must be hit in order to perform or maintain a TAVR program. For example, the statement stipulates that existing programs must keep 30-day TAVR mortality above the bottom 10% in order to remain a TAVR provider.
The statement also outlines recommended minimum quality benchmarks for TAVR sites across the following metrics:
- In-hospital risk-adjusted all-cause mortality;
- 30-day risk-adjusted all-cause mortality;
- 30-day all-cause neurologic events, including TIAs;
- 30-day major vascular complication;
- 30-day major bleeding; and
- 30-day moderate or severe AR.
Access the quality performance requirements and proposed future metrics on page 46 of the expert consensus document.
Re-evaluating the 2-surgeon requirement
It's not just volume requirements that are under debate. A few days before MEDCAC was set to convene, several TAVR expert physicians wrote an editorial speaking out against the current requirement for two surgeons to individually examine a patient face-to-face and sign off before a TAVR procedure. According to the authors, this requirement was the "largest barrier" to patients receiving timely care, particularly for patients travelling to receive AVR screening.
The new expert consensus statement reflects this opinion. Noting the increased experience in the assessment of risk for SAVR and the established role of TAVR with published appropriate-use criteria, the statement only requires one cardiac surgeon at the TAVR-performing institution to evaluate the patient face-to-face. Another physician involved in the heart team must also evaluate the patient face-to-face, but this individual can be an interventional or general cardiologist.
Removing this requirement could significantly streamline the evaluation and screening process for TAVR programs, as well as remove the billing challenges associated with seeing two specialists in the same day.
Not a done deal
A lot could change before the new TAVR NCD is released in June 2019. In fact, the MEDCAC panel was relatively split around the need for and type of volume requirements required for TAVR, despite the recommendations in the updated statement. The group felt more confident in the need for individual operators to have a set amount of procedural experience before beginning a TAVR program. However, some raised questions over the potential harm of limiting access to TAVR through hospital procedure requirements. While the panel does not write the final NCD, their advice will be taken into account.
Having closely watched the transformation in TAVR technology and technique across the past seven years, it certainly seems like an update to the NCD is long overdue, both to remove unnecessary hurdles to the right treatment option and ensure TAVR programs are maintaining high-quality outcomes through consistent experience—likely beyond just 20 a year.
If CMS implements the society recommendations, we will likely see fewer new programs entering the market, and even fiercer competition for volumes amongst existing TAVR programs. I for one will be eagerly awaiting the results of the national coverage analysis next summer.