Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial
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Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial. / Borger, Michael A; Dohmen, Pascal M; Knosalla, Christoph; Hammerschmidt, Robert; Merk, Denis R; Richter, Markus; Doenst, Torsten; Conradi, Lenard; Treede, Hendrik; Moustafine, Vadim; Holzhey, David M; Duhay, Francis; Strauch, Justus.
in: EUR J CARDIO-THORAC, Jahrgang 50, Nr. 4, 10.2016, S. 713-720.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial
AU - Borger, Michael A
AU - Dohmen, Pascal M
AU - Knosalla, Christoph
AU - Hammerschmidt, Robert
AU - Merk, Denis R
AU - Richter, Markus
AU - Doenst, Torsten
AU - Conradi, Lenard
AU - Treede, Hendrik
AU - Moustafine, Vadim
AU - Holzhey, David M
AU - Duhay, Francis
AU - Strauch, Justus
N1 - © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
PY - 2016/10
Y1 - 2016/10
N2 - OBJECTIVES: Aortic valve replacement (AVR) via minimally invasive surgery (MIS) may provide clinical benefits in patients with aortic valve disease. A new class of bioprosthetic valves that enable rapid deployment AVR (RDAVR) may facilitate MIS. We here report the 1-year results of a randomized, multicentre trial comparing the outcomes for MIS-RDAVR with those for conventional AVR via full sternotomy (FS) with a commercially available stented aortic bioprosthesis.METHODS: A total of 100 patients with aortic stenosis were enrolled in a prospective, multicentre, randomized comparison trial (CADENCE-MIS). Key exclusion criteria included AVR requiring concomitant procedures, ejection fraction of <25% and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR via upper hemisternotomy (EDWARDS INTUITY) or AVR via FS with a commercially available stented valve. Procedural, early and late clinical outcomes were assessed for both groups. Haemodynamic performance was evaluated by an echocardiography CoreLaboratory.RESULTS: Technical success was achieved in 94% of MIS-RDAVR patients. MIS-RDAVR was associated with significantly reduced cross-clamp times compared with FS (41.3 ± 20.3 vs 54.0 ± 20.3 min, P < 0.001). Clinical and functional outcomes were similar at 30 days and 1 year postoperatively for both groups. While both groups received a similarly sized implanted valve (22.9 ± 2.1 mm MIS-RDAVR vs 23.0 ± 2.1 mm FS-AVR; P = 0.91), MIS-RDAVR patients had significantly lower peak gradients 1 year postoperatively (16.9 ± 5.3 vs 21.9 ± 8.6 mmHg; P = 0.033) and a trend towards lower mean gradients (9.1 ± 2.9 vs 11.5 ± 4.3 mmHg; P = 0.082). In addition, MIS-RDAVR patients had a significantly larger effective orifice area 1 year postoperatively (1.9 ± 0.5 vs 1.7 ± 0.4 cm2; P = 0.047). Paravalvular leaks, however, were significantly more common in the MIS-RDAVR group (P = 0.027).CONCLUSIONS: MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.
AB - OBJECTIVES: Aortic valve replacement (AVR) via minimally invasive surgery (MIS) may provide clinical benefits in patients with aortic valve disease. A new class of bioprosthetic valves that enable rapid deployment AVR (RDAVR) may facilitate MIS. We here report the 1-year results of a randomized, multicentre trial comparing the outcomes for MIS-RDAVR with those for conventional AVR via full sternotomy (FS) with a commercially available stented aortic bioprosthesis.METHODS: A total of 100 patients with aortic stenosis were enrolled in a prospective, multicentre, randomized comparison trial (CADENCE-MIS). Key exclusion criteria included AVR requiring concomitant procedures, ejection fraction of <25% and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR via upper hemisternotomy (EDWARDS INTUITY) or AVR via FS with a commercially available stented valve. Procedural, early and late clinical outcomes were assessed for both groups. Haemodynamic performance was evaluated by an echocardiography CoreLaboratory.RESULTS: Technical success was achieved in 94% of MIS-RDAVR patients. MIS-RDAVR was associated with significantly reduced cross-clamp times compared with FS (41.3 ± 20.3 vs 54.0 ± 20.3 min, P < 0.001). Clinical and functional outcomes were similar at 30 days and 1 year postoperatively for both groups. While both groups received a similarly sized implanted valve (22.9 ± 2.1 mm MIS-RDAVR vs 23.0 ± 2.1 mm FS-AVR; P = 0.91), MIS-RDAVR patients had significantly lower peak gradients 1 year postoperatively (16.9 ± 5.3 vs 21.9 ± 8.6 mmHg; P = 0.033) and a trend towards lower mean gradients (9.1 ± 2.9 vs 11.5 ± 4.3 mmHg; P = 0.082). In addition, MIS-RDAVR patients had a significantly larger effective orifice area 1 year postoperatively (1.9 ± 0.5 vs 1.7 ± 0.4 cm2; P = 0.047). Paravalvular leaks, however, were significantly more common in the MIS-RDAVR group (P = 0.027).CONCLUSIONS: MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.
KW - Aged
KW - Aortic Valve Stenosis/surgery
KW - Bioprosthesis
KW - Female
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation/instrumentation
KW - Hemodynamics
KW - Humans
KW - Male
KW - Minimally Invasive Surgical Procedures/methods
KW - Prospective Studies
U2 - 10.1093/ejcts/ezw042
DO - 10.1093/ejcts/ezw042
M3 - SCORING: Journal article
C2 - 26935407
VL - 50
SP - 713
EP - 720
JO - EUR J CARDIO-THORAC
JF - EUR J CARDIO-THORAC
SN - 1010-7940
IS - 4
ER -