First in human implantation of the mechanical expanding Lotus® valve in degenerated surgical valves in mitral position
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First in human implantation of the mechanical expanding Lotus® valve in degenerated surgical valves in mitral position. / Schaefer, Ulrich; Conradi, Lenard; Lubos, Edith; Deuschl, Florian; Schofer, Niklas; Seiffert, Moritz; Treede, Hendrik; Schirmer, Johannes; Reichenspurner, Hermann; Blankenberg, Stefan.
In: CATHETER CARDIO INTE, Vol. 86, No. 7, 01.12.2015, p. 1280-1286.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - First in human implantation of the mechanical expanding Lotus® valve in degenerated surgical valves in mitral position
AU - Schaefer, Ulrich
AU - Conradi, Lenard
AU - Lubos, Edith
AU - Deuschl, Florian
AU - Schofer, Niklas
AU - Seiffert, Moritz
AU - Treede, Hendrik
AU - Schirmer, Johannes
AU - Reichenspurner, Hermann
AU - Blankenberg, Stefan
N1 - © 2015 Wiley Periodicals, Inc.
PY - 2015/12/1
Y1 - 2015/12/1
N2 - INTRODUCTION: Implantation of transcatheter heart valves (THV) into degenerated surgical valves is an emerging therapy for selected high-risk patients. Although, CE mark of most THV is limited for native aortic valvular stenosis, transcatheter valve implantation into degenerated bioprostheses, even in mitral position is very intriguing.METHODS AND RESULTS: After placement of a cerebral protection device (Claret Sentinel®), three consecutive patients (age, 79.0 ± 6.1; log EuroSCORE I: 33.3 ± 9.2%) with a degenerated mitral bioprosthesis were treated by transapical implantation of the Lotus® valve (Boston Scientific Inc.). In addition, a SwanGanz catheter was introduced in the pulmonary artery for hemodynamic assessments all patients. Procedural success was 100%. Valve implantation was performed without rapid ventricular pacing. Resheating was performed in two patients due to suboptimal initial positioning. Invasive online hemodynamics revealed stable blood pressure in all patients. After Lotus® valve implantation, valvular mitral regurgitation was completely eliminated in all patients. One patient had a mild paravalvular leak of the surgical bioprosthesis, which was present before implantation. Invasive right and left heart hemodynamics showed an immediate improvement after Lotus® valve implantation. Mean mitral surface area (2.1 ± 0.2 cm(2) ) and mean gradient (3.7 ± 2.1 mm Hg) demonstrated satisfactory results. All patients were immediately extubated and discharged from the hospital without any adverse event.CONCLUSIONS: This study demonstrates for the first time the feasibility of transapical Lotus® Valve implantation in degenerated mitral bioprostheses. The controlled mechanical Lotus® valve expansion with remarkably stable hemodynamics throughout the procedure offers a new and valuable treatment option.
AB - INTRODUCTION: Implantation of transcatheter heart valves (THV) into degenerated surgical valves is an emerging therapy for selected high-risk patients. Although, CE mark of most THV is limited for native aortic valvular stenosis, transcatheter valve implantation into degenerated bioprostheses, even in mitral position is very intriguing.METHODS AND RESULTS: After placement of a cerebral protection device (Claret Sentinel®), three consecutive patients (age, 79.0 ± 6.1; log EuroSCORE I: 33.3 ± 9.2%) with a degenerated mitral bioprosthesis were treated by transapical implantation of the Lotus® valve (Boston Scientific Inc.). In addition, a SwanGanz catheter was introduced in the pulmonary artery for hemodynamic assessments all patients. Procedural success was 100%. Valve implantation was performed without rapid ventricular pacing. Resheating was performed in two patients due to suboptimal initial positioning. Invasive online hemodynamics revealed stable blood pressure in all patients. After Lotus® valve implantation, valvular mitral regurgitation was completely eliminated in all patients. One patient had a mild paravalvular leak of the surgical bioprosthesis, which was present before implantation. Invasive right and left heart hemodynamics showed an immediate improvement after Lotus® valve implantation. Mean mitral surface area (2.1 ± 0.2 cm(2) ) and mean gradient (3.7 ± 2.1 mm Hg) demonstrated satisfactory results. All patients were immediately extubated and discharged from the hospital without any adverse event.CONCLUSIONS: This study demonstrates for the first time the feasibility of transapical Lotus® Valve implantation in degenerated mitral bioprostheses. The controlled mechanical Lotus® valve expansion with remarkably stable hemodynamics throughout the procedure offers a new and valuable treatment option.
KW - Aged
KW - Aged, 80 and over
KW - Bioprosthesis
KW - Cardiac Catheterization/instrumentation
KW - Catheterization, Swan-Ganz
KW - Feasibility Studies
KW - Female
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation/adverse effects
KW - Hemodynamics
KW - Humans
KW - Male
KW - Mitral Valve/physiopathology
KW - Mitral Valve Insufficiency/diagnosis
KW - Prosthesis Design
KW - Prosthesis Failure
KW - Retreatment
KW - Treatment Outcome
U2 - 10.1002/ccd.26162
DO - 10.1002/ccd.26162
M3 - SCORING: Journal article
C2 - 26389782
VL - 86
SP - 1280
EP - 1286
JO - CATHETER CARDIO INTE
JF - CATHETER CARDIO INTE
SN - 1522-1946
IS - 7
ER -
