Abstract
Objective
To assess the impact of stroke volume index (SVI) and left ventricular ejection fraction
(LVEF) on prognosis in patients with severe aortic stenosis, comparing those undergoing
transcatheter aortic valve replacement (TAVR) and those with surgical AVR (SAVR).
Patients and Methods
A total of 742 patients from the CoreValve US Pivotal High-Risk Trial randomized to
TAVR (n=389) or SAVR (n=353) from February 2011 to September 2012 were stratified
by an SVI of 35 mL/m2 and LVEF of 50% for comparing all-cause mortality at 1 year.
Results
The prevalence of an SVI of less than 35 mL/m2 in patients who underwent TAVR and SAVR was 35.8% (125 of 349) and 31.3% (96 of 307),
respectively; LVEF of less than 50% was present in 18.1% (63 of 348) and 19.6% (60
of 306), respectively. Among patients with an SVI of less than 35 mL/m2, 1-year mortality was similar between patients with TAVR and SAVR (16.3% vs 22.2%;
P=.25). However, in those with an SVI of 35 mL/m2 or greater, 1-year mortality was lower in those with TAVR than SAVR (10.3% vs 17.3%;
P=.03). In patients with an LVEF of less than 50%, mortality was not affected by AVR
approach (P>.05). In patients with an LVEF of 50% or higher, TAVR was associated with lower mortality
than SAVR when SVI was preserved (9.8% vs 18.6%; P=.01). Mortality was not affected by SVI within the same AVR approach when LVEF was
50% or higher.
Conclusion
In patients with severe aortic stenosis at high risk, there is a significant interaction
between AVR approach and the status of SVI and LVEF. When LVEF or SVI was reduced,
prognosis was similar regardless of AVR approach. In those with preserved LVEF or
SVI, TAVR was associated with a better prognosis than SAVR.
Trial Registration
clinicaltrials.gov Identifier: NCT01240902
Abbreviations and Acronyms:
AS (aortic stenosis), AVA (aortic valve area), AVR (aortic valve replacement), LV (left ventricular), LVEF (LV ejection fraction), RV (right ventricular), SAVR (surgical AVR), SVI (stroke volume index), TAVR (transcatheter AVR)To read this article in full you will need to make a payment
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Article Info
Footnotes
For editorial comment, see page 9; for related article see page 57
This work was supported by Medtronic .
Potential Competing Interests: Dr Ito supports the Echo Core Lab for Medtronic trials. Dr Orsinelli has received research support from Abbott , Boston Scientific Corporation , and Medtronic (all funds paid to his institution). Dr Lin supports the Echo Core Lab for Medtronic trials. Dr Calvacante has received grant support (funds paid to his institution) and payment for lectures including service on speakers bureaus from Medtronic . Dr Popma has received institutional research grants from Medtronic , Boston Scientific Corporation , and Direct Flow Medical,Inc , and has served on a medical advisory board for Boston Scientific Corporation, Cordis Corporation, and Edwards Lifesciences Corporation. Dr Adams reports support from Medtronic during the conduct of the study, support from NeoChord,Inc , and Medtronic outside the submitted work, and patent royalties from Edwards Lifesciences Corporation ( US9526615 B2 and US9011529 B2 ) and Medtronic ( US8764821 B2 ). Dr Chetcuti has received grant support (funds paid to his institution) from and serves as a proctor for Medtronic , has received grant support for clinical trials from Abbott and Gore Medical , and serves as a consultant for JenaValve Technology GmbH. Dr Deeb serves on an advisory board and as a proctor for Medtronic, as a consultant and research investigator for Edwards Lifesciences Corporation, as a consultant and proctor for Terumo Medical Corporation, and as a research investigator for Gore Medical (he receives no personal remunerations). Drs Boulware, Huang, and Cohen are employees and shareholders of Medtronic. Dr Little has received research grants from Abbott and Medtronic . Dr Reardon has received fees from Medtronic for providing educational services. Dr Oh is the director of the Echocardiography Core Lab for CoreValve/Evolut R and a consultant for Medtronic.
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