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

Jeffrey J. Popma, Michael J. Reardon, Kamal Khabbaz, J. Kevin Harrison, G. Chad Hughes, Susheel Kodali, Isaac George, G. Michael Deeb, Stan Chetcuti, Robert Kipperman, John Brown, Hongyan Qiao, James Slater, Mathew R. Williams

Research output: Contribution to journalArticle

82 Citations (Scopus)

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).

Original languageEnglish (US)
Pages (from-to)268-275
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume10
Issue number3
DOIs
StatePublished - Feb 13 2017
Externally publishedYes

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Aortic Valve
Bioprosthesis
Aortic Valve Stenosis
Hemodynamics
Mortality
Surgical Instruments
Blood Vessels
Echocardiography
Stroke
Hemorrhage
Research

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Popma, Jeffrey J. ; Reardon, Michael J. ; Khabbaz, Kamal ; Harrison, J. Kevin ; Hughes, G. Chad ; Kodali, Susheel ; George, Isaac ; Deeb, G. Michael ; Chetcuti, Stan ; Kipperman, Robert ; Brown, John ; Qiao, Hongyan ; Slater, James ; Williams, Mathew R. / 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. In: JACC: Cardiovascular Interventions. 2017 ; Vol. 10, No. 3. pp. 268-275.
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title = "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",
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).",
author = "Popma, {Jeffrey J.} and Reardon, {Michael J.} and Kamal Khabbaz and Harrison, {J. Kevin} and Hughes, {G. Chad} and Susheel Kodali and Isaac George and Deeb, {G. Michael} and Stan Chetcuti and Robert Kipperman and John Brown and Hongyan Qiao and James Slater and Williams, {Mathew R.}",
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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. / Popma, Jeffrey J.; Reardon, Michael J.; Khabbaz, Kamal; Harrison, J. Kevin; Hughes, G. Chad; Kodali, Susheel; George, Isaac; Deeb, G. Michael; Chetcuti, Stan; Kipperman, Robert; Brown, John; Qiao, Hongyan; Slater, James; Williams, Mathew R.

In: JACC: Cardiovascular Interventions, Vol. 10, No. 3, 13.02.2017, p. 268-275.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

T2 - Results of the Evolut R U.S. Study

AU - Popma, Jeffrey J.

AU - Reardon, Michael J.

AU - Khabbaz, Kamal

AU - Harrison, J. Kevin

AU - Hughes, G. Chad

AU - Kodali, Susheel

AU - George, Isaac

AU - Deeb, G. Michael

AU - Chetcuti, Stan

AU - Kipperman, Robert

AU - Brown, John

AU - Qiao, Hongyan

AU - Slater, James

AU - Williams, Mathew R.

PY - 2017/2/13

Y1 - 2017/2/13

N2 - 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).

AB - 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).

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