TY - JOUR
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.
N1 - Funding Information:
This trial (Clinical trial registry number: NCT01810679) was a medical investigational device study conducted under the authority of the Food and Drug Administration and supported by the Sponsor, LivaNova PLC, London, United Kingdom.Dr Heimansohn: Proctor LivaNova; Patient Selection Committee, Abbott Vascular. Dr Weissmann: research support recipient from Boston Scientific, Medtronic, Edwards Lifesciences, St. Jude Medical, Abbott Vascular, LivaNova. Dr Ailawadi: speaker for Atricure, Convatec; consultant for Abbott Vascular, Edwards Lifesciences, Medtronic, St Jude Medical. Dr Ad: consultant for Cryolife, Atricure, Medtronic, LivaNova; shareholder of Nido Surgical; co-owner LAA occlusion LLC. Dr Thourani: consultant for Edwards Lifesciences, Abbott Vascular; research recipient from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Medtronic. Dr Szeto: speaker for Abbott Vascular, St Jude Medical; consultant for Microinterventional Device; research support recipient from LivaNova, Edwards Lifesciences, Medtronic. Dr Michler: NIH U01 Principal Investigator; Dr Michelena: advisor of Cryolife On-X valve. Dr Dabir: proctor for LivaNova. Dr Moront: Medtronic Heart Valves, consultant and proctor; Edwards LifeSciences, consultant; LSI, consultant; Terumo, consult and trainer. Dr Subramanian: consultant and proctor for LivaNova. Dr Roselli: Speaker for Edwards Lifesciences, St Jude Medical, Vascutek; consultant for Medtronic, LivaNova. All other authors have nothing to disclose with regard to commercial support The authors are grateful to LivaNova employees Brian Duncan, MD, Giovanni Goisis, MStat, Mara Chiaro, DVM, and Sara Gaggianesi, DVM, for technical support in the analysis of data and manuscript preparation.
Publisher Copyright:
© 2018 The American Association for Thoracic Surgery
PY - 2019/5
Y1 - 2019/5
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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U2 - 10.1016/j.jtcvs.2018.08.121
DO - 10.1016/j.jtcvs.2018.08.121
M3 - Article
C2 - 30553598
AN - SCOPUS:85055187237
SN - 0022-5223
VL - 157
SP - 1773-1782.e3
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 5
ER -