Structural
Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study

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Abstract

Objectives

This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement.

Background

A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment.

Methods

The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. An independent echocardiography laboratory was used to evaluate hemodynamic outcomes.

Results

Patients were elderly (83.3 ± 7.2 years of age) and had high surgical risk (Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4%). The majority of patients (89.5%) were treated by iliofemoral access. Resheathing or recapturing was performed in 22.6% of patients; more than 1 valve was required in 3 patients (1.3%). The 30-day outcomes included all-cause mortality (2.5%), disabling stroke (3.3%), major vascular complications (7.5%), life-threatening or disabling bleeding (7.1%), and new permanent pacemaker (16.4%). AV hemodynamics were markedly improved at 30 days: the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg (p < 0.001) and AV area increased from 0.6 ± 0.2 cm2 to 1.9 ± 0.5 cm2 (p < 0.001). Moderate residual paravalvular leak was identified in 5.3% of patients.

Conclusions

We conclude that this novel self-expanding TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery. (Medtronic CoreValve Evolut R U.S. Clinical Study; NCT02207569).

Key Words

aortic stenosis
congestive heart failure
transcatheter therapy

Abbreviations and Acronyms

PVL
paravalvular leak
TAVR
transcatheter aortic valve replacement
VARC
Valve Academic Research Consortium

Cited by (0)

Dr. Popma has received grant support to his institution from Medtronic, Boston Scientific, and Direct Flow Medical; has served on the medical advisory board for Boston Scientific; and has served as a consultant for Direct Flow Medical. Dr. Reardon has received fees from Medtronic for providing educational services. Dr. Harrison has received institutional research grants from Boston Scientific, Direct Flow Medical, Edwards Lifesciences, and Medtronic; has served on an Advisory Board for St. Jude Medical; and is on the Data Safety and Monitoring Board for CardiAQ. Dr. Kodali has received grant and research support from Boston Scientific, Claret Medical, Edwards Lifesciences, and Medtronic; has served on the steering committee for Claret Medical, Edwards Lifestyle, and Meril; has held equity in Thubrikar Aortic Valve; and has received honoraria from Claret Medical and St. Jude Medical. Dr. George is a consultant to Edwards Lifesciences and Medtronic; and is surgical national principal investigator of the Direct Flow Medical SALUS trial. Dr. Deeb has served on the advisory board and as a proctor for Medtronic; is a consultant and research investigator for Edwards Lifesciences; is a consultant and proctor for Terumo; and is a research investigator for Gore Medical. Dr. Chetcuti has received grants from Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Qiao is an employee and shareholder of Medtronic. Dr. Slater has received consulting fees and honoraria from Medtronic. Dr. Williams has served as a consultant for Edwards Lifesciences and Medtronic; is a speaker for Abbott Laboratories; and has received research grants from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.