What is the clinical evidence from this study?

Study design: Observational. Population: Aortic stenosis (n=23847). Intervention: Off-label TAVR vs. On-label TAVR. Primary outcome: 1-year mortality (HR 1.11, 95% CI 0.98-1.25, p=.11).

What question did this study set out to answer?

To evaluate the frequency, institutional patterns, and adverse clinical outcomes associated with off-label transcatheter aortic valve replacement (TAVR) in US clinical practice.

June 21, 2017JAMA Cardiology

Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement

Q: What are the key findings of this study?

Off-label use of TAVR was associated with similar adjusted 1-year mortality compared to on-label use (HR 1.11; 95% CI 0.98-1.25; P=0.11), despite higher unadjusted mortality rates.

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Key result

Off-label TAVR shows similar adjusted 1-year mortality compared to on-label use.

HR 1.11
95% CI 0.98-1.25
P=.11
n=23,847

Why the study?

Does off-label use of TAVR increase mortality compared to on-label use in patients undergoing transcatheter aortic valve replacement?

Key Points

To evaluate the frequency, institutional patterns, and adverse clinical outcomes associated with off-label transcatheter aortic valve replacement (TAVR) in US clinical practice.
Registry cohort study analyzing 23,847 patients who underwent commercial TAVR across 328 sites in the United States between November 2011 and September 2014.
Off-label TAVR was defined by presence of bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis.
Linked registry records with Centers for Medicare & Medicaid Services data for 15,397 patients to assess in-hospital, 30-day, and 1-year clinical outcomes.
Off-label TAVR occurred in 9.5% of cases (n = 2,272), with unadjusted mortality higher for off-label vs on-label use in-hospital (6.3% vs 4.7%; P < .001), at 30 days (8.5% vs 6.1%; P < .001), and at 1 year (25.6% vs 22.1%; P = .001).
Adjusted 30-day mortality was significantly higher among patients receiving off-label TAVR compared with on-label TAVR (hazard ratio, 1.27; 95% CI, 1.04-1.55; P = .02).
Adjusted 1-year mortality showed no statistically significant difference between the off-label and on-label groups (hazard ratio, 1.11; 95% CI, 0.98-1.25; P = .11).

Study Design

Type

Observational (n=23,847)

Multicenter

Yes

Structured PICO

Does off-label use of TAVR increase mortality compared to on-label use in patients undergoing transcatheter aortic valve replacement?

Population

23,847 patients receiving commercially funded transcatheter aortic valve replacement (TAVR) in the United States across 328 sites, median age 84 years, 49.8% female.

Intervention

Off-label use of TAVR (defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis).

Comparator

On-label use of TAVR (for severe aortic stenosis in patients who cannot undergo surgery and for patients at high operative risk).

Outcome

Frequency of off-label TAVR use and the association with in-hospital, 30-day, and 1-year adverse outcomes (mortality).hard clinical

Main Result

Effect estimate: HR 1.11 (95% CI 0.98-1.25)

Absolute Event Rate: 25.6% vs 22.1%

p-value: p=.11

Approximately 9.5% of TAVR procedures in the US are performed for off-label indications, which is associated with higher early mortality but similar adjusted 1-year mortality compared to on-label use.

Discussion

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Implication

Off-label TAVR requires careful selection given higher early mortality; this cohort study leaves open expanded indications pending randomized confirmation.

Cite This Study

Hira et al. (2017) conducted an observational in Aortic stenosis (n=23,847). Off-label TAVR vs. On-label TAVR was evaluated on 1-year mortality (HR 1.11, 95% CI 0.98-1.25, p=.11). Off-label use of TAVR was associated with similar adjusted 1-year mortality compared to on-label use (HR 1.11; 95% CI 0.98-1.25; P=0.11), despite higher unadjusted mortality rates.

synapsesocial.com/papers/6a0cfbcfb31ab1d6e01e76ee https://doi.org/10.1001/jamacardio.2017.1685

Topics

Valvular heart disease TAVR in low-risk patients Transcatheter aortic valve replacement Mitral valve intervention

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Implication

Off-label TAVR requires careful selection given higher early mortality; this cohort study leaves open expanded indications pending randomized confirmation.

Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Topics

Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider