Clinical InvestigationValve hemodynamic deterioration and cardiovascular outcomes in TAVR: A report from the STS/ACC TVT Registry
Section snippets
Methods
The STS/ACC TVT Registry is a collaborative clinical registry program developed by the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) in response to the Centers for Medicare and Medicaid Services (CMS) national coverage decisions (May 2012) requirement for national registry participation of all US TAVR centers. Participating centers use standardized definitions to collect clinical information—including patient demographics, comorbidities, functional status,
Study cohorts
A total of 34,977 patients underwent 35,268 commercial TAVRs in the United States from November 2011 to March 2015 and had data recorded in the TVT Registry. After applying eligibility criteria, there were 22,231 patients with CMS linkage undergoing 22,271 TAVRs (Figure 2). A comparison of baseline and procedural characteristics of those with and without CMS linkage is provided in Supplemental Table I. Overall, TAVR patients with and without CMS linkage were clinically similar, although those
Discussion
In this real-world analysis of a large group of patients undergoing TAVR with commercially approved devices in the United States, we found that (1) the incidence of VHD in patients undergoing TAVR (defined as an increase in mean aortic valve gradient of ≥10 mm Hg) is low in both the postprocedure to 30-day time frame (2.1%) as well as in the 30-day to 1-year time frame (2.5%); (2) VHD was not associated with a significant subsequent increase in cardiovascular events up to 18 months after TAVR;
Conclusions
Among patients with paired echocardiograms in US clinical practice, the incidence of TAVR-associated VHD is low at 2.1% in the first 30 days and 2.5% from 30 days to 1 year. TAVR VHD was not associated with a significant increase in combined death, stroke, or aortic valve reintervention at 18 months. Predictors of TAVR VHD included both patient and procedural factors such as male sex, increasing body mass index, severe chronic lung disease, valve-in-valve procedure, 23-mm TAVR valve, increasing
Sources of funding
This work was funded by the Society for Thoracic Surgeons and the American College of Cardiology.
Disclosure
Vemulapalli—research grants: American College of Cardiology (significant), Abbott Vascular (modest), Novella (modest).
Holmes—Chair of the STS/ACC TVT Registry steering committee.
Dai—none.
Matsuouaka—none.
Mack—Executive Committee of the PARTNER Trial, sponsored by Edwards Lifesciences.
Grover—Vice Chair of the STS/ACC TVT Registry steering committee.
Makkar—grant support, personal fees, and other support (significant) from Saint Jude Medical during the conduct of the study; grant support from
Acknowledgements
None.
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Funding and disclosures: See acknowledgements.