What is the clinical evidence from this study?

Study design: Observational. Population: Severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (n=1842). Intervention: Major vascular complication (MVC) vs. No major vascular complication. Primary outcome: 3-year all-cause mortality (HR 2.01, 95% CI 1.16-3.62, p=<0.001).

February 27, 2020Circulation ReportsOpen Access

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―

Q: What are the key findings of this study?

Major vascular complication after transfemoral transcatheter aortic valve replacement was associated with a significantly increased risk of 3-year mortality (HR 2.01) compared to no complication.

Q: What does this research mean for the field?

Major vascular complication after transfemoral transcatheter aortic valve replacement is associated with a significantly increased risk of 3-year mortality compared to no complication. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

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Key result

Major vascular complication after transfemoral transcatheter aortic valve replacement was associated with a significantly increased risk of 3-year mortality (HR 2.01) compared to no complication.

Why the study?

The study aimed to investigate the impact of anatomical site status and major vascular complication severity on outcomes after transfemoral transcatheter aortic valve replacement.

Does major vascular complication (MVC) access site status and bleeding severity impact 3-year mortality in patients undergoing TF-TAVR?

Study Design

Type

Observational (n=1,842)

Multicenter

Yes

Structured PICO

Does major vascular complication (MVC) access site status and bleeding severity impact 3-year mortality in patients undergoing TF-TAVR?

Population

1,842 adults undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR) for aortic valve stenosis, mean age 81.6, 56.7% female, from 5 Finnish university hospitals.

Intervention

Major vascular complication (MVC) stratified by anatomical site (non-access site-related vs. access site-related) and bleeding severity (RBC transfusion units).

Comparator

Patients undergoing TF-TAVR who did not experience a major vascular complication (non-MVC).

Outcome

Mortality over a 3-year follow-up.hard clinical

Main Result

Effect estimate: HR 2.01 (95% CI 1.16-3.62)

Absolute Event Rate: 40.8% vs 24.3%

p-value: p=<0.001

Major vascular complications after TF-TAVR significantly increase 3-year mortality, with non-access site-related complications and severe access site-related complications requiring massive transfusion driving the worst outcomes.

Limitations

Small number of patients with non-access site-related MVC
Residual confounders due to unmeasured factors such as annular size, calcification, and access-route vessel size
Potential underreporting of events due to adjudication by investigators from each participating center
3-year follow-up was not available in all patients

Implication

May warrant closer post-TAVR surveillance after major vascular complications; leaves open whether prevention reduces long-term mortality.

Abstract

Background:The aim of this study was to investigate the impact of anatomical site status and major vascular complication (MVC) severity on the outcome of transfemoral transcatheter aortic valve replacement (TF-TAVR).

Discussion

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Published by Circulation Reports · CC BY-NC-ND

Cite This Study

Laakso et al. (2020) conducted an observational in Severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (n=1,842). Major vascular complication (MVC) vs. No major vascular complication was evaluated on 3-year all-cause mortality (HR 2.01, 95% CI 1.16-3.62, p=<0.001). Major vascular complication after transfemoral transcatheter aortic valve replacement was associated with a significantly increased risk of 3-year mortality (HR 2.01) compared to no complication.

synapsesocial.com/papers/6a1c0cc7b33628da419d25f2 https://doi.org/10.1253/circrep.cr-20-0007

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Implication

May warrant closer post-TAVR surveillance after major vascular complications; leaves open whether prevention reduces long-term mortality.

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Figures from the paper

Cite This Study

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Figures from the paper

Cite This Study

Keep reading

Keep reading

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement ― Results From the FinnValve Registry ―

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement ― Results From the FinnValve Registry ―

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―