Transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis: National trends and in-hospital outcomes

Q: What are the key findings of this study?

TAVR use for bicuspid aortic valve stenosis increased from 0.39% to 4.16% (P<0.001) with no significant difference in matched in-hospital mortality compared to SAVR (5.9% vs 0%, adjusted P=0.119).

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Bicuspid aortic valve stenosis (n=37052). Intervention: Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR). Primary outcome: In-hospital mortality (propensity-matched cohort) (p=0.119).

Q: What does this research mean for the field?

Utilization of TAVR for bicuspid aortic valve stenosis increased significantly between 2011 and 2014, demonstrating in-hospital mortality rates comparable to SAVR alongside a decreasing length of stay. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

M. Chadi Alraies; Mohamad Soud; Yasser Al‐Khadra; Fahed Darmoch; Homam Moussa Pacha; Zaher Fanari

doi:10.4103/ajm.ajm_134_19

January 1, 2020Avicenna Journal of MedicineOpen Access

Transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis: National trends and in-hospital outcomes

View Full Paper

Ask AI

Bookmark

Share

Key result

Rising TAVR for bicuspid AS shows no significant difference in matched in-hospital mortality vs. SAVR.

P=0.119
n=37,052

Why the study?

Patients with bicuspid aortic valve stenosis were excluded from all pivotal trials that led to TAVR approval, leaving in-hospital outcomes of TAVR versus SAVR in this population uncertain.

Does transcatheter aortic valve replacement (TAVR) provide comparable in-hospital mortality and procedural outcomes compared with surgical aortic valve replacement (SAVR) in patients with bicuspid aortic valve stenosis?

Key Points

To assess national trends and compare in-hospital outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with bicuspid aortic valve stenosis.
Analyzed data from the National Inpatient Sample between 2011 and 2014 to identify patients with bicuspid aortic valve stenosis treated with SAVR (n=36,629) or TAVR (n=423).
Conducted a propensity score-matched analysis comparing 68 matched patients who underwent SAVR with 68 matched patients who underwent TAVR.
TAVR utilization among bicuspid aortic valve stenosis patients increased significantly from 0.39% in 2011 to 4.16% in 2014 (P < 0.001), while mean length of stay decreased from 12.2 ± 8.2 days to 7.1 ± 5.9 days (P < 0.001).
In the propensity-matched cohort, there was no statistically significant difference in in-hospital mortality between the SAVR and TAVR groups (0% vs. 5.9%; adjusted P = 0.119).
Respiratory complications were significantly lower among matched patients who underwent TAVR compared to those who underwent SAVR (11.8% vs. 29.4%, adjusted P = 0.011).

Study Design

Type

Cohort (n=37,052)

Multicenter

Yes

Structured PICO

Does transcatheter aortic valve replacement (TAVR) provide comparable in-hospital mortality and procedural outcomes compared with surgical aortic valve replacement (SAVR) in patients with bicuspid aortic valve stenosis?

P

Population

37,052 hospitalized US adults with bicuspid aortic valve stenosis undergoing TAVR (n=423) or SAVR (n=36,629) from 2011 to 2014 (136 in the 1:1 propensity-matched cohort), followed during index hospitalization.

E

Exposure

Transcatheter aortic valve replacement (TAVR, identified by ICD-9-CM codes 35.05 and 35.06)

C

Comparator

Surgical aortic valve replacement (SAVR, identified by ICD-9-CM codes 35.21 and 35.22), compared using 1:1 propensity score matching

O

Outcome

National trends in TAVR utilization and in-hospital mortality (defined per VARC II criteria) during the index hospitalizationhard clinical

Main Result

Absolute Event Rate: 5.9% vs 0%

p-value: p=0.119

This national database analysis demonstrates steadily increasing off-label adoption of TAVR for bicuspid aortic valve stenosis in the United States from 2011 to 2014, with decreasing length of stay, fewer respiratory complications, and no statistically significant difference in matched in-hospital mortality compared with SAVR.

Limitations

Retrospective analysis of large administrative data is inherently prone to error because of potential inaccurate coding.
Outcome analysis was limited to in-hospital outcomes with no outcomes or complications after discharge recorded.
Long-term durability of TAVR prosthesis in younger BAV patients was not captured in the database.
TAVR procedures were performed using older generation valves, and outcomes could not be delineated by specific prosthesis or delivery system.
Small sample size of the propensity-matched cohort (n=68 per group) may be underpowered to detect a statistically significant difference in in-hospital mortality.
Administrative claims data (NIS) is inherently prone to error due to potential inaccurate ICD-9 coding
Analysis was restricted to in-hospital outcomes with no post-discharge follow-up or complications recorded
Unable to assess long-term prosthetic valve durability in BAV patients
Procedures were performed using early-generation TAVR valves (2011-2014) without data on specific prosthesis or delivery system type
Small sample size of the propensity-matched population (68 per group) may be underpowered to detect a statistically significant difference in in-hospital mortality

Implication

Should not yet change practice in bicuspid aortic stenosis; leaves open need for randomized trials versus SAVR.

Abstract

Background : Bicuspid aortic valve (BAV) disease is considered the most common congenital heart disease and the main etiology of aortic valve stenosis (AS) in young adults. Although transcatheter aortic valve replacement (TAVR) is routinely used in high- and intermediate-risk patients with AS, BAV patients with AS were excluded from all pivotal trials that led to TAVR approval. We sought, therefore, to examine in-hospital outcomes of patients with BAV who underwent TAVR in comparison with surgical aortic valve replacement (SAVR). Methods : Using the National Inpatient Sample from 2011 to 2014, we identified patients with BAV with International Classification of Diseases-Ninth Revision-CM code 746.4. Patients who underwent TAVR were identified using ICD-9 codes 35.05 and 35.06 and those who underwent SAVR were identified using codes 35.21 and 35.22 during the same period. Results : A total of 37,052 patients were found to have BAV stenosis. Among them, 36,629 patients (98.8%) underwent SAVR, whereas 423 patients (1.14%) underwent TAVR. One-third of enrolled patients were female, and the majority of the patients were White with a mean age of 65.9 ± 15.1 years. TAVR use for BAV stenosis significantly increased from 0.39% in 2011 to 4.16% in 2014 ( P < 0.001), which represents a 3.77% overall growth in procedure rate. The median length of stay decreased significantly throughout the study period (mean 12.2 ± 8.2 days to 7.1 ± 5.9 days, P < 0.001). There was no statistically significant difference between SAVR and TAVR groups in the in-hospital mortality (0% vs. 5.9%; adjusted P = 0.119). Conclusion : There is a steady increase in TAVR use for BAV stenosis patients along with a significant decrease in length of stay.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Alraies et al. (2020) conducted a cohort in Bicuspid aortic valve stenosis (n=37,052). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on In-hospital mortality (propensity-matched cohort) (p=0.119). TAVR use for bicuspid aortic valve stenosis increased from 0.39% to 4.16% (P<0.001) with no significant difference in matched in-hospital mortality compared to SAVR (5.9% vs 0%, adjusted P=0.119).

synapsesocial.com/papers/6ae274da41e799d0feb3eeb8 https://doi.org/10.4103/ajm.ajm_134_19

View Full Paper

Ask AI

Bookmark

Share

Transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis: National trends and in-hospital outcomes

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis: National trends and in-hospital outcomes

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading