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Societies release recommendations for TAVR operators, institutions
A new multisociety consensus document seeks to shift focus from volume requirements to quality-based metrics for institutions with new or existing transcatheter aortic valve replacement programs.
The expert consensus systems of care document, which was commissioned by the American Association of Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons, is the first update since 2012.
As Cardiology Today’s Intervention previously reported, the issue was discussed at a recent meeting of the Medicare Evidence Development and Coverage Advisory Committee of the CMS. The panel voted it had moderate confidence that there is sufficient evidence to support the need for procedural volume thresholds in centers with new or existing TAVR programs.
The rapidly evolving technology and emerging research in the field of TAVR prompted the update, according to the writing committee.
“TAVR has matured as a therapeutic option for patients requiring aortic valve replacement.
In the prior 2012 document, the operator requirements were based on skills that would be necessary to perform TAVR. At this time, it is felt that such skills are best learned by doing TAVR. Therefore, the prerequisite skills have been replaced by TAVR experience,” they wrote. “The 2018 document provides additional quality metrics that complement requirements that were surrogates for TAVR skills as indicators for quality of care as presented in the 2012 document. TAVR case volume requirements provide a structural measure to ensure foundational data minimums.”
Important recommendations
In an effort to focus more on outcomes vs. volume requirements, the writing group made several suggestions.
“For starting new TAVR programs, we have suggested a reduction in the number of ancillary procedures, the number of PCIs that a center does and the number of surgical aortic valve procedures that a center would do before starting a new program,” writing committee co-chair Carl L. Tommaso, MD, FACC, MSCAI, associate director of cath labs at NorthShore University HealthSystems and associate professor of medicine at Rush Medical College, told Cardiology Today’s Intervention. “Also, not only have we reduced the number of surgical aortic valve procedures, we suggest including more aortic procedures as opposed to just strict aortic valve replacement to ensure that the centers are legitimate and active cardiac centers.”
The writing committee identified several phases in the evolution of TAVR development, including an early investigative phase and the initial U.S. commercial TAVR roll-out phase that started in 2012. Now, in 2018, TAVR has entered a steady state “in which requirements can be based predominantly on quality metrics, with volume being used only to demonstrate a program’s ability to maintain a reasonable number of cases to measure quality — i.e., as a process metric rather than as a surrogate outcome metric,” they wrote.
Risk-adjusted outcome measures, such as in-hospital, 30-day and 1-year mortality, for instance, can be used as quality metrics, according to the document. Additionally, the writing committee recommends that institutions with unacceptable outcomes, regardless of volume, should immediately take corrective action to improve outcomes and processes.
However, procedural volume remains important, the writing committee noted. Because low-volume centers, for instance, may have outcomes that are less statistically reliable and therefore a certain level of volume is necessary to accurately assess quality.
A shift in care
The rationale behind moving away from volume-based requirements is fueled by the growing number of TAVR procedures being performed, according to Tommaso.
Moreover, he noted, the indications for TAVR may potentially expand to include patients at low surgical risk in addition to high- and intermediate-risk patients, which would further increase the number of patients available for TAVR.
Although these recommendations represent an update to the 2012 document, Tommaso noted that the shift toward outcomes-based quality metrics has already occurred in other areas of interventional cardiology.
“We’re hoping that as time progresses, we’re able to move to just quality outcomes rather than having volume restrictions,” Tommaso said. “We need to do what has been done in other aspects of medical care — PCI, notably — and move away from just saying we should do so many procedures to saying these are outcomes and we need to be within a certain distribution in terms of our outcomes.”
The expert consensus document was recently published in the Journal of the American College of Cardiology. – by Melissa Foster
For more information:
Carl J. Tommaso, MD, can be reached at ctommaso@northshore.org.
Disclosure: Tommaso reports no relevant financial disclosures. Please see the consensus document for full list of the authors’ relevant financial disclosures.