Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience
Identifieur interne : 000031 ( PascalFrancis/Corpus ); précédent : 000030; suivant : 000032Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience
Auteurs : Francesco Maisano ; Hugo Vanermen ; Joerg Seeburger ; Michael Mack ; Volkmar Falk ; Paolo Denti ; Maurizio Taramasso ; Ottavio AlfieriSource :
- European journal of cardio-thoracic surgery [ 1010-7940 ] ; 2012.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n=15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days. RESULTS: All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12±3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence. CONCLUSIONS: Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients.
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Pour connaître la documentation sur le format Inist Standard.
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Format Inist (serveur)
NO : | PASCAL 12-0341243 INIST |
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ET : | Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience |
AU : | MAISANO (Francesco); VANERMEN (Hugo); SEEBURGER (Joerg); MACK (Michael); FALK (Volkmar); DENTI (Paolo); TARAMASSO (Maurizio); ALFIERI (Ottavio) |
AF : | Department of Cardiac Surgery, San Raffaele Hospital/Milan/Italie (1 aut., 6 aut., 7 aut., 8 aut.); Department of Cardiothoracic Surgery, OLV Hospital/Aalst/Belgique (2 aut.); Department of Cardiothoracic Surgery, University of Leipzig Heart Center/Leipzig/Allemagne (3 aut.); Heart Hospital Baylor Plano/Dallas, TX/Etats-Unis (4 aut., 5 aut.); University of Zurich/Zurich/Suisse (5 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | European journal of cardio-thoracic surgery; ISSN 1010-7940; Coden EJCSE7; Royaume-Uni; Da. 2012; Vol. 42; No. 3; Pp. 524-529; Bibl. 25 ref. |
LA : | Anglais |
EA : | OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n=15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days. RESULTS: All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12±3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence. CONCLUSIONS: Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients. |
CC : | 002B11; 002B12A04; 002B25E |
FD : | Insuffisance mitrale; Accessibilité; Valvule mitrale; Annuloplastie; Dispositif; Asymptomatique; Expérience; Réparation; Traitement; Chirurgie correctrice; Appareil circulatoire; Cardiologie; Pneumologie |
FG : | Pathologie de l'appareil circulatoire; Cardiopathie valvulaire |
ED : | Mitral regurgitation; Accessibility; Mitral valve; Annuloplasty; Device; Asymptomatic; Experience; Repair; Treatment; Corrective surgery; Circulatory system; Cardiology; Pneumology |
EG : | Cardiovascular disease; Cardiac valvular disease |
SD : | Insuficiencia mitral; Accesibilidad; Válvula mitral; Anuloplastia; Dispositivo; Asintomático; Experiencia; Reparación; Tratamiento; Cirugía correctiva; Aparato circulatorio; Cardiología; Neumología |
LO : | INIST-21307.354000500896980210 |
ID : | 12-0341243 |
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Pascal:12-0341243Le document en format XML
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Accessibility</term>
<term>Annuloplasty</term>
<term>Asymptomatic</term>
<term>Cardiology</term>
<term>Circulatory system</term>
<term>Corrective surgery</term>
<term>Device</term>
<term>Experience</term>
<term>Mitral regurgitation</term>
<term>Mitral valve</term>
<term>Pneumology</term>
<term>Repair</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Insuffisance mitrale</term>
<term>Accessibilité</term>
<term>Valvule mitrale</term>
<term>Annuloplastie</term>
<term>Dispositif</term>
<term>Asymptomatique</term>
<term>Expérience</term>
<term>Réparation</term>
<term>Traitement</term>
<term>Chirurgie correctrice</term>
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<front><div type="abstract" xml:lang="en">OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n=15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days. RESULTS: All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12±3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence. CONCLUSIONS: Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients.</div>
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<fC01 i1="01" l="ENG"><s0>OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n=15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days. RESULTS: All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12±3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence. CONCLUSIONS: Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients.</s0>
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</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Asymptomatique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Asymptomatic</s0>
<s5>13</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Asintomático</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Expérience</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Experience</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Experiencia</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Réparation</s0>
<s5>15</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Repair</s0>
<s5>15</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Reparación</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Traitement</s0>
<s5>16</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Treatment</s0>
<s5>16</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Chirurgie correctrice</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Corrective surgery</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Cirugía correctiva</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Appareil circulatoire</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Circulatory system</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Aparato circulatorio</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Cardiologie</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Cardiology</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Cardiología</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Pneumologie</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Pneumology</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Neumología</s0>
<s5>20</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'appareil circulatoire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Cardiovascular disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Aparato circulatorio patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Cardiopathie valvulaire</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Cardiac valvular disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Cardiopatía valvular</s0>
<s5>38</s5>
</fC07>
<fN21><s1>261</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 12-0341243 INIST</NO>
<ET>Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience</ET>
<AU>MAISANO (Francesco); VANERMEN (Hugo); SEEBURGER (Joerg); MACK (Michael); FALK (Volkmar); DENTI (Paolo); TARAMASSO (Maurizio); ALFIERI (Ottavio)</AU>
<AF>Department of Cardiac Surgery, San Raffaele Hospital/Milan/Italie (1 aut., 6 aut., 7 aut., 8 aut.); Department of Cardiothoracic Surgery, OLV Hospital/Aalst/Belgique (2 aut.); Department of Cardiothoracic Surgery, University of Leipzig Heart Center/Leipzig/Allemagne (3 aut.); Heart Hospital Baylor Plano/Dallas, TX/Etats-Unis (4 aut., 5 aut.); University of Zurich/Zurich/Suisse (5 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>European journal of cardio-thoracic surgery; ISSN 1010-7940; Coden EJCSE7; Royaume-Uni; Da. 2012; Vol. 42; No. 3; Pp. 524-529; Bibl. 25 ref.</SO>
<LA>Anglais</LA>
<EA>OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n=15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days. RESULTS: All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12±3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence. CONCLUSIONS: Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients.</EA>
<CC>002B11; 002B12A04; 002B25E</CC>
<FD>Insuffisance mitrale; Accessibilité; Valvule mitrale; Annuloplastie; Dispositif; Asymptomatique; Expérience; Réparation; Traitement; Chirurgie correctrice; Appareil circulatoire; Cardiologie; Pneumologie</FD>
<FG>Pathologie de l'appareil circulatoire; Cardiopathie valvulaire</FG>
<ED>Mitral regurgitation; Accessibility; Mitral valve; Annuloplasty; Device; Asymptomatic; Experience; Repair; Treatment; Corrective surgery; Circulatory system; Cardiology; Pneumology</ED>
<EG>Cardiovascular disease; Cardiac valvular disease</EG>
<SD>Insuficiencia mitral; Accesibilidad; Válvula mitral; Anuloplastia; Dispositivo; Asintomático; Experiencia; Reparación; Tratamiento; Cirugía correctiva; Aparato circulatorio; Cardiología; Neumología</SD>
<LO>INIST-21307.354000500896980210</LO>
<ID>12-0341243</ID>
</server>
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