Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap

John K. Forrest, Abeel A. Mangi, Jeffrey J. Popma, Kamal Khabbaz, Michael J. Reardon, Neal S. Kleiman, Steven J. Yakubov, Daniel Watson, Susheel Kodali, Isaac George, Peter Tadros, George L. Zorn, John Brown, Robert Kipperman, Sara Saul, Hongyan Qiao, Jae K. Oh, Mathew R. Williams

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27 Citations (Scopus)

Abstract

Objectives This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. Background A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. Methods The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. Results All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm 2 at 30 days. Conclusions The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)

Original languageEnglish (US)
Pages (from-to)160-168
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume11
Issue number2
DOIs
StatePublished - Jan 22 2018

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Aortic Valve
Aortic Valve Stenosis
Stroke
Safety
Incidence
Hemodynamics
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Forrest, J. K., Mangi, A. A., Popma, J. J., Khabbaz, K., Reardon, M. J., Kleiman, N. S., ... Williams, M. R. (2018). Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC: Cardiovascular Interventions, 11(2), 160-168. https://doi.org/10.1016/j.jcin.2017.10.014
Forrest, John K. ; Mangi, Abeel A. ; Popma, Jeffrey J. ; Khabbaz, Kamal ; Reardon, Michael J. ; Kleiman, Neal S. ; Yakubov, Steven J. ; Watson, Daniel ; Kodali, Susheel ; George, Isaac ; Tadros, Peter ; Zorn, George L. ; Brown, John ; Kipperman, Robert ; Saul, Sara ; Qiao, Hongyan ; Oh, Jae K. ; Williams, Mathew R. / Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. In: JACC: Cardiovascular Interventions. 2018 ; Vol. 11, No. 2. pp. 160-168.
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title = "Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap",
abstract = "Objectives This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. Background A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. Methods The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. Results All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7{\%}) died and 1 patient (1.7{\%}) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4{\%} of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm 2 at 30 days. Conclusions The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)",
author = "Forrest, {John K.} and Mangi, {Abeel A.} and Popma, {Jeffrey J.} and Kamal Khabbaz and Reardon, {Michael J.} and Kleiman, {Neal S.} and Yakubov, {Steven J.} and Daniel Watson and Susheel Kodali and Isaac George and Peter Tadros and Zorn, {George L.} and John Brown and Robert Kipperman and Sara Saul and Hongyan Qiao and Oh, {Jae K.} and Williams, {Mathew R.}",
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Forrest, JK, Mangi, AA, Popma, JJ, Khabbaz, K, Reardon, MJ, Kleiman, NS, Yakubov, SJ, Watson, D, Kodali, S, George, I, Tadros, P, Zorn, GL, Brown, J, Kipperman, R, Saul, S, Qiao, H, Oh, JK & Williams, MR 2018, 'Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap', JACC: Cardiovascular Interventions, vol. 11, no. 2, pp. 160-168. https://doi.org/10.1016/j.jcin.2017.10.014

Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. / Forrest, John K.; Mangi, Abeel A.; Popma, Jeffrey J.; Khabbaz, Kamal; Reardon, Michael J.; Kleiman, Neal S.; Yakubov, Steven J.; Watson, Daniel; Kodali, Susheel; George, Isaac; Tadros, Peter; Zorn, George L.; Brown, John; Kipperman, Robert; Saul, Sara; Qiao, Hongyan; Oh, Jae K.; Williams, Mathew R.

In: JACC: Cardiovascular Interventions, Vol. 11, No. 2, 22.01.2018, p. 160-168.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap

AU - Forrest, John K.

AU - Mangi, Abeel A.

AU - Popma, Jeffrey J.

AU - Khabbaz, Kamal

AU - Reardon, Michael J.

AU - Kleiman, Neal S.

AU - Yakubov, Steven J.

AU - Watson, Daniel

AU - Kodali, Susheel

AU - George, Isaac

AU - Tadros, Peter

AU - Zorn, George L.

AU - Brown, John

AU - Kipperman, Robert

AU - Saul, Sara

AU - Qiao, Hongyan

AU - Oh, Jae K.

AU - Williams, Mathew R.

PY - 2018/1/22

Y1 - 2018/1/22

N2 - Objectives This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. Background A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. Methods The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. Results All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm 2 at 30 days. Conclusions The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)

AB - Objectives This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. Background A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. Methods The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. Results All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm 2 at 30 days. Conclusions The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)

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