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Valve Disease2011Journal of the American College of Cardiology

STS/ACC TVT Registry

Society of Thoracic Surgeons / American College of Cardiology Transcatheter Valve Therapy Registry

Sample Size
500,000
Study Design
National, prospective, mandatory, observational registry
Year Published
2011
Category
Valve Disease

Clinical Question

What are the real-world outcomes, trends, and quality benchmarks for transcatheter aortic valve replacement in routine clinical practice across the United States?

Population

All patients undergoing commercial TAVR at participating sites across the United States. Participation is mandated by CMS as a condition of reimbursement.

Intervention

All FDA-approved transcatheter aortic valve replacement systems used in clinical practice

Control

No control group; observational registry with internal benchmarking and temporal trend analysis

Primary Endpoint

Multiple: 30-day and 1-year mortality, stroke, vascular complications, pacemaker implantation, length of stay, quality metrics

Key Findings

1

In-hospital mortality decreased from 5.0% (2012) to under 1.5% (2022) as experience grew and technology improved.

2

30-day stroke rates declined from 2.0% to below 1.5% over the same period.

3

The proportion of low-risk patients increased from near zero before 2019 to over 40% of all TAVR cases by 2022.

4

Median hospital length of stay decreased from 6 days to 1-2 days with the adoption of minimalist approaches.

5

The registry identified centers with outlier outcomes and facilitated quality improvement interventions across the national TAVR program.

Impact on Clinical Practice

The STS/ACC TVT Registry represents one of the most comprehensive and impactful clinical registries in medicine. By mandating data collection for every commercial TAVR procedure in the United States, it created an unparalleled resource for understanding real-world outcomes, monitoring quality, and driving continuous improvement. The registry has documented the remarkable maturation of TAVR as a technology. Mortality, stroke, and complication rates have decreased steadily as operator experience grew, patient selection improved, and device technology evolved. The shift toward transfemoral-only approaches, conscious sedation, and same-day or next-day discharge reflects practice patterns informed by registry data. Beyond outcomes tracking, the TVT Registry has served as a platform for over 200 peer-reviewed publications, informed FDA regulatory decisions, and guided CMS coverage determinations. It has become the model for how large-scale registries can complement randomized trial data to guide real-world clinical practice.

Guideline Impact

The TVT Registry is cited extensively in ACC/AHA guidelines as the primary source of real-world TAVR data. CMS requires participation in the registry as a condition of TAVR reimbursement, making it integral to national coverage determinations and site credentialing requirements.

Limitations

As an observational registry, it cannot establish causality or control for confounding variables in the way randomized trials can.

Data completeness and accuracy depend on individual site reporting, with potential for missing or inconsistent data entry.

The registry captures procedural and short-term outcomes but long-term follow-up (beyond 1 year) is limited for most patients.

Reviewed by Kunal U. Gurav, MD
Echocardiography & Nuclear Cardiology

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