Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery?

Nassir M. Thalji, Rakesh M. Suri, Hector I Michelena, Kevin L. Greason, Joseph A. Dearani, Richard C. Daly, Lyle D. Joyce, John M. Stulak, Harold M. Burkhart, Zhuo Li, Hartzell V Schaff

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objective: Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown. Methods: Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n = 99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n = 100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n = 101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P = .437). Results: Mean age was 75 ± 8 years and 164 were men (68%). Between dismissal and 1 year there were 9 deaths (3.7%) (Epic: 3.7%, Magna: 5.0%, and Mitroflow: 2.3%; P = .654), 6 episodes of heart failure (2.5%) (Epic: 1.3%, Magna: 1.3%, and Mitroflow: 5.8%; P = .265), 27 instances of atrial fibrillation/flutter (11.2%) (Epic: 8.1%, Magna: 11.0%, and Mitroflow: 7.9%; P = .577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P<.001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm2/m2, respectively; P = .015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m2, and was similar among groups (P = .262). There were no aortic valve reoperations. Conclusions: Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.

Original languageEnglish (US)
Pages (from-to)163-173
Number of pages11
JournalJournal of Thoracic and Cardiovascular Surgery
Volume149
Issue number1
DOIs
StatePublished - 2015

Fingerprint

Aortic Valve
Hemodynamics
Bioprosthesis
Echocardiography
Atrial Flutter
Transient Ischemic Attack
Aortic Valve Stenosis
Reoperation
Atrial Fibrillation
Italy
Swine
Heart Failure
Stroke
Equipment and Supplies

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery? / Thalji, Nassir M.; Suri, Rakesh M.; Michelena, Hector I; Greason, Kevin L.; Dearani, Joseph A.; Daly, Richard C.; Joyce, Lyle D.; Stulak, John M.; Burkhart, Harold M.; Li, Zhuo; Schaff, Hartzell V.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 149, No. 1, 2015, p. 163-173.

Research output: Contribution to journalArticle

Thalji, Nassir M. ; Suri, Rakesh M. ; Michelena, Hector I ; Greason, Kevin L. ; Dearani, Joseph A. ; Daly, Richard C. ; Joyce, Lyle D. ; Stulak, John M. ; Burkhart, Harold M. ; Li, Zhuo ; Schaff, Hartzell V. / Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery?. In: Journal of Thoracic and Cardiovascular Surgery. 2015 ; Vol. 149, No. 1. pp. 163-173.
@article{6826063cdf864db182243564ba2ea467,
title = "Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery?",
abstract = "Objective: Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown. Methods: Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n = 99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n = 100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n = 101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P = .437). Results: Mean age was 75 ± 8 years and 164 were men (68{\%}). Between dismissal and 1 year there were 9 deaths (3.7{\%}) (Epic: 3.7{\%}, Magna: 5.0{\%}, and Mitroflow: 2.3{\%}; P = .654), 6 episodes of heart failure (2.5{\%}) (Epic: 1.3{\%}, Magna: 1.3{\%}, and Mitroflow: 5.8{\%}; P = .265), 27 instances of atrial fibrillation/flutter (11.2{\%}) (Epic: 8.1{\%}, Magna: 11.0{\%}, and Mitroflow: 7.9{\%}; P = .577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P<.001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm2/m2, respectively; P = .015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m2, and was similar among groups (P = .262). There were no aortic valve reoperations. Conclusions: Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.",
author = "Thalji, {Nassir M.} and Suri, {Rakesh M.} and Michelena, {Hector I} and Greason, {Kevin L.} and Dearani, {Joseph A.} and Daly, {Richard C.} and Joyce, {Lyle D.} and Stulak, {John M.} and Burkhart, {Harold M.} and Zhuo Li and Schaff, {Hartzell V}",
year = "2015",
doi = "10.1016/j.jtcvs.2014.09.027",
language = "English (US)",
volume = "149",
pages = "163--173",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "1",

}

TY - JOUR

T1 - Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery?

AU - Thalji, Nassir M.

AU - Suri, Rakesh M.

AU - Michelena, Hector I

AU - Greason, Kevin L.

AU - Dearani, Joseph A.

AU - Daly, Richard C.

AU - Joyce, Lyle D.

AU - Stulak, John M.

AU - Burkhart, Harold M.

AU - Li, Zhuo

AU - Schaff, Hartzell V

PY - 2015

Y1 - 2015

N2 - Objective: Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown. Methods: Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n = 99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n = 100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n = 101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P = .437). Results: Mean age was 75 ± 8 years and 164 were men (68%). Between dismissal and 1 year there were 9 deaths (3.7%) (Epic: 3.7%, Magna: 5.0%, and Mitroflow: 2.3%; P = .654), 6 episodes of heart failure (2.5%) (Epic: 1.3%, Magna: 1.3%, and Mitroflow: 5.8%; P = .265), 27 instances of atrial fibrillation/flutter (11.2%) (Epic: 8.1%, Magna: 11.0%, and Mitroflow: 7.9%; P = .577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P<.001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm2/m2, respectively; P = .015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m2, and was similar among groups (P = .262). There were no aortic valve reoperations. Conclusions: Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.

AB - Objective: Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown. Methods: Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n = 99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n = 100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n = 101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P = .437). Results: Mean age was 75 ± 8 years and 164 were men (68%). Between dismissal and 1 year there were 9 deaths (3.7%) (Epic: 3.7%, Magna: 5.0%, and Mitroflow: 2.3%; P = .654), 6 episodes of heart failure (2.5%) (Epic: 1.3%, Magna: 1.3%, and Mitroflow: 5.8%; P = .265), 27 instances of atrial fibrillation/flutter (11.2%) (Epic: 8.1%, Magna: 11.0%, and Mitroflow: 7.9%; P = .577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P<.001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm2/m2, respectively; P = .015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m2, and was similar among groups (P = .262). There were no aortic valve reoperations. Conclusions: Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.

UR - http://www.scopus.com/inward/record.url?scp=84922320132&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84922320132&partnerID=8YFLogxK

U2 - 10.1016/j.jtcvs.2014.09.027

DO - 10.1016/j.jtcvs.2014.09.027

M3 - Article

C2 - 25439772

AN - SCOPUS:84922320132

VL - 149

SP - 163

EP - 173

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

SN - 0022-5223

IS - 1

ER -