A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement
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A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. / Borger, Michael A; Moustafine, Vadim; Conradi, Lenard; Knosalla, Christoph; Richter, Markus; Merk, Denis R; Doenst, Torsten; Hammerschmidt, Robert; Treede, Hendrik; Dohmen, Pascal; Strauch, Justus T.
In: ANN THORAC SURG, Vol. 99, No. 1, 01.2015, p. 17-25.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement
AU - Borger, Michael A
AU - Moustafine, Vadim
AU - Conradi, Lenard
AU - Knosalla, Christoph
AU - Richter, Markus
AU - Merk, Denis R
AU - Doenst, Torsten
AU - Hammerschmidt, Robert
AU - Treede, Hendrik
AU - Dohmen, Pascal
AU - Strauch, Justus T
N1 - Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
PY - 2015/1
Y1 - 2015/1
N2 - BACKGROUND: Minimally invasive surgical procedures (MIS) may offer several advantages over conventional full sternotomy (FS) aortic valve replacement (AVR). A novel class of aortic valve prostheses has been developed for rapid-deployment AVR (RDAVR). We report a randomized, multicenter trial comparing the outcomes for MIS-RDAVR with those of conventional FS-AVR.METHODS: A total of 100 patients with aortic stenosis were enrolled in a prospective, multicenter, randomized comparison trial (CADENCE-MIS). Exclusion criteria included ejection fraction below 25%, AVR requiring concomitant procedures, and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR through an upper hemisternotomy (n = 51) or AVR by FS with a conventional stented bioprosthesis (n = 49). Three patients were excluded before the procedure, and 3 more patients who were randomized to undergo RDAVR were excluded because of their anatomy. Procedural, early clinical outcomes, and functional outcomes were assessed for the remaining 94 patients. Hemodynamic performance was assessed by an echocardiography core laboratory.RESULTS: Implanted valve sizes were similar between groups (22.9 ± 2.1 vs 23.0 ± 2.1 mm, p = 0.9). MIS-RDAVR was associated with significantly reduced aortic cross-clamp times compared with FS-AVR (41.3 ± 20.3 vs 54.0 ± 20.3 minutes, p < 0.001), although cardiopulmonary bypass times were similar (68.8 ± 29.0 vs 74.4 ± 28.4 minutes, p = 0.21). Early clinical outcomes were similar between the two groups, including quality of life measures. The RDAVR patients had a significantly lower mean transvalvular gradient (8.5 vs 10.3 mm Hg, p = 0.044) and a lower prevalence of patient-prosthesis mismatch (0% vs 15.0%, p = 0.013) 3 months postoperatively compared with the FS-AVR patients.CONCLUSIONS: RDAVR by the MIS approach is associated with significantly reduced myocardial ischemic time and better valvular hemodynamic function than FS-AVR with a conventional stented bioprosthesis. Rapid deployment valves may facilitate the performance of MIS-AVR.
AB - BACKGROUND: Minimally invasive surgical procedures (MIS) may offer several advantages over conventional full sternotomy (FS) aortic valve replacement (AVR). A novel class of aortic valve prostheses has been developed for rapid-deployment AVR (RDAVR). We report a randomized, multicenter trial comparing the outcomes for MIS-RDAVR with those of conventional FS-AVR.METHODS: A total of 100 patients with aortic stenosis were enrolled in a prospective, multicenter, randomized comparison trial (CADENCE-MIS). Exclusion criteria included ejection fraction below 25%, AVR requiring concomitant procedures, and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR through an upper hemisternotomy (n = 51) or AVR by FS with a conventional stented bioprosthesis (n = 49). Three patients were excluded before the procedure, and 3 more patients who were randomized to undergo RDAVR were excluded because of their anatomy. Procedural, early clinical outcomes, and functional outcomes were assessed for the remaining 94 patients. Hemodynamic performance was assessed by an echocardiography core laboratory.RESULTS: Implanted valve sizes were similar between groups (22.9 ± 2.1 vs 23.0 ± 2.1 mm, p = 0.9). MIS-RDAVR was associated with significantly reduced aortic cross-clamp times compared with FS-AVR (41.3 ± 20.3 vs 54.0 ± 20.3 minutes, p < 0.001), although cardiopulmonary bypass times were similar (68.8 ± 29.0 vs 74.4 ± 28.4 minutes, p = 0.21). Early clinical outcomes were similar between the two groups, including quality of life measures. The RDAVR patients had a significantly lower mean transvalvular gradient (8.5 vs 10.3 mm Hg, p = 0.044) and a lower prevalence of patient-prosthesis mismatch (0% vs 15.0%, p = 0.013) 3 months postoperatively compared with the FS-AVR patients.CONCLUSIONS: RDAVR by the MIS approach is associated with significantly reduced myocardial ischemic time and better valvular hemodynamic function than FS-AVR with a conventional stented bioprosthesis. Rapid deployment valves may facilitate the performance of MIS-AVR.
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve Stenosis/surgery
KW - Bioprosthesis
KW - Female
KW - Heart Valve Prosthesis Implantation/methods
KW - Humans
KW - Male
KW - Middle Aged
KW - Minimally Invasive Surgical Procedures
KW - Prospective Studies
KW - Stents
KW - Sternotomy
U2 - 10.1016/j.athoracsur.2014.09.022
DO - 10.1016/j.athoracsur.2014.09.022
M3 - SCORING: Journal article
C2 - 25441065
VL - 99
SP - 17
EP - 25
JO - ANN THORAC SURG
JF - ANN THORAC SURG
SN - 0003-4975
IS - 1
ER -
