Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes

Rakesh M. Suri, Hoda Javadikasgari, David A. Heimansohn, Neil J. Weissman, Gorav Ailawadi, Niv Ad, Gabriel S. Aldea, Vinod H. Thourani, Wilson Y. Szeto, Robert E. Michler, Hector I Michelena, Reza Dabir, Gregory P. Fontana, William F. Kessler, Michael G. Moront, Louis A. Brunsting, Bartley P. Griffith, Alvaro Montoya, Sreekumar Subramanian, Mark A. MostovychEric E. Roselli

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience. Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients. Results: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001). Conclusions: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.

Original languageEnglish (US)
JournalJournal of Thoracic and Cardiovascular Surgery
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Bioprosthesis
Equipment and Supplies
Aortic Valve
Mortality
Quality of Life
Safety
Aortic Diseases
Atrioventricular Block
United States Food and Drug Administration
Endocarditis
Reoperation
Hemodynamics
Stroke
Clinical Trials

Keywords

  • aortic stenosis
  • aortic valve replacement
  • concomitant procedures
  • hemodynamics
  • minimally invasive surgery
  • quality of life
  • sutureless valve

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Suri, R. M., Javadikasgari, H., Heimansohn, D. A., Weissman, N. J., Ailawadi, G., Ad, N., ... Roselli, E. E. (Accepted/In press). Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes. Journal of Thoracic and Cardiovascular Surgery. https://doi.org/10.1016/j.jtcvs.2018.08.121

Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis : One-year outcomes. / Suri, Rakesh M.; Javadikasgari, Hoda; Heimansohn, David A.; Weissman, Neil J.; Ailawadi, Gorav; Ad, Niv; Aldea, Gabriel S.; Thourani, Vinod H.; Szeto, Wilson Y.; Michler, Robert E.; Michelena, Hector I; Dabir, Reza; Fontana, Gregory P.; Kessler, William F.; Moront, Michael G.; Brunsting, Louis A.; Griffith, Bartley P.; Montoya, Alvaro; Subramanian, Sreekumar; Mostovych, Mark A.; Roselli, Eric E.

In: Journal of Thoracic and Cardiovascular Surgery, 01.01.2018.

Research output: Contribution to journalArticle

Suri, RM, Javadikasgari, H, Heimansohn, DA, Weissman, NJ, Ailawadi, G, Ad, N, Aldea, GS, Thourani, VH, Szeto, WY, Michler, RE, Michelena, HI, Dabir, R, Fontana, GP, Kessler, WF, Moront, MG, Brunsting, LA, Griffith, BP, Montoya, A, Subramanian, S, Mostovych, MA & Roselli, EE 2018, 'Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes', Journal of Thoracic and Cardiovascular Surgery. https://doi.org/10.1016/j.jtcvs.2018.08.121
Suri, Rakesh M. ; Javadikasgari, Hoda ; Heimansohn, David A. ; Weissman, Neil J. ; Ailawadi, Gorav ; Ad, Niv ; Aldea, Gabriel S. ; Thourani, Vinod H. ; Szeto, Wilson Y. ; Michler, Robert E. ; Michelena, Hector I ; Dabir, Reza ; Fontana, Gregory P. ; Kessler, William F. ; Moront, Michael G. ; Brunsting, Louis A. ; Griffith, Bartley P. ; Montoya, Alvaro ; Subramanian, Sreekumar ; Mostovych, Mark A. ; Roselli, Eric E. / Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis : One-year outcomes. In: Journal of Thoracic and Cardiovascular Surgery. 2018.
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abstract = "Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience. Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3{\%} men, 37.3{\%} ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8{\%}), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7{\%}) had a bicuspid aortic valve and 5 (1.7{\%}) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7{\%}) and concomitant procedures were performed in 113 (37.8{\%}) patients. Results: Two hundred eighty-nine patients (96.3{\%}) were successfully implanted. Operative mortality (≤30 days) was 1.3{\%} (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2{\%} (n = 15), stroke in 1{\%} (n = 3), and endocarditis in 1.7{\%} (n = 5). New permanent periprocedural pacemaker rate was 10.7{\%} (n = 30/281); 2.5{\%} (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1{\%} (n = 6). At 1-year follow-up, 98{\%} of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3{\%}) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001). Conclusions: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.",
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author = "Suri, {Rakesh M.} and Hoda Javadikasgari and Heimansohn, {David A.} and Weissman, {Neil J.} and Gorav Ailawadi and Niv Ad and Aldea, {Gabriel S.} and Thourani, {Vinod H.} and Szeto, {Wilson Y.} and Michler, {Robert E.} and Michelena, {Hector I} and Reza Dabir and Fontana, {Gregory P.} and Kessler, {William F.} and Moront, {Michael G.} and Brunsting, {Louis A.} and Griffith, {Bartley P.} and Alvaro Montoya and Sreekumar Subramanian and Mostovych, {Mark A.} and Roselli, {Eric E.}",
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T1 - Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis

T2 - One-year outcomes

AU - Suri, Rakesh M.

AU - Javadikasgari, Hoda

AU - Heimansohn, David A.

AU - Weissman, Neil J.

AU - Ailawadi, Gorav

AU - Ad, Niv

AU - Aldea, Gabriel S.

AU - Thourani, Vinod H.

AU - Szeto, Wilson Y.

AU - Michler, Robert E.

AU - Michelena, Hector I

AU - Dabir, Reza

AU - Fontana, Gregory P.

AU - Kessler, William F.

AU - Moront, Michael G.

AU - Brunsting, Louis A.

AU - Griffith, Bartley P.

AU - Montoya, Alvaro

AU - Subramanian, Sreekumar

AU - Mostovych, Mark A.

AU - Roselli, Eric E.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience. Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients. Results: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001). Conclusions: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.

AB - Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience. Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients. Results: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001). Conclusions: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.

KW - aortic stenosis

KW - aortic valve replacement

KW - concomitant procedures

KW - hemodynamics

KW - minimally invasive surgery

KW - quality of life

KW - sutureless valve

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