Elsevier

American Heart Journal

Volume 195, January 2018, Pages 1-13
American Heart Journal

Clinical Investigation
Valve hemodynamic deterioration and cardiovascular outcomes in TAVR: A report from the STS/ACC TVT Registry

https://doi.org/10.1016/j.ahj.2017.09.005Get rights and content

Background

Recent reports of leaflet abnormalities (detected using advanced imaging) have raised questions regarding transcatheter aortic valve replacement (TAVR) durability. We sought to determine the incidence of valve hemodynamic deterioration (VHD) and its association with cardiovascular outcomes.

Methods and Results

Consecutive cases with paired postimplant and follow-up echocardiograms from November 2011 to March 2015 in the STS/ACC TVT Registry were allocated into 2 overlapping cohorts: early (paired echocardiograms at 0 and 30 days) and late (paired echocardiograms at 30 days and 1 year). VHD was defined as an increase in mean aortic valve gradient ≥10 mm Hg. Eighteen-month cardiovascular outcomes were determined via linkage with Centers for Medicare & Medicaid Services claims. Backwards selection logistic regression was performed to determine predictors of VHD. Among 10,099 TAVRs with paired echocardiograms, the median age was 84 years and 48.7% were female, with Society of Thoracic Surgeons score distributions of <8% (61.7%), 8%-15% (28.8%), and >15% (9.5%). The incidence of VHD was 2.1% in the early cohort and 2.5% in the late cohort. There was no significant difference between those with and without VHD in either cohort in the combined end point of death/stroke/aortic valve reintervention or heart failure hospitalization or myocardial infarction. Independent predictors of VHD included chronic lung disease, valve-in-valve procedure, 23-mm TAVR valve, severe patient-prosthesis mismatch, increasing body mass index, and increasing baseline aortic valve gradient.

Conclusions

The incidence of VHD in US clinical practice is low, and VHD is not associated with increased cardiovascular events at 18 months. Patient and procedural predictors may help to identify patients at risk for VHD in whom surveillance or preventive strategies may be considered.

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.

References (19)

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Funding and disclosures: See acknowledgements.

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