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E1345 JACC April 5, 2011 Volume 57, Issue 14 VALVULAR HEART DISEASE ACUTE HEMODYNAMIC OUTCOME AND CLINICAL IMPACT OF PERCUTANEOUS EDGE-TO-EDGE MITRAL VALVE REPAIR USING THE MITRACLIP SYSTEM IN A REAL WORLD SETTING ACC Poster Contributions Ernest N. Morial Convention Center, Hall F Sunday, April 03, 2011, 3:30 p.m.-4:45 p.m. Session Title: Valvular Disease-Precutaneous Therapies for Valvular Heart Disease Abstract Category: 19. Valvular Disease Session-Poster Board Number: 1050-65 Authors: Hasema Lesevic, Jürgen Pache, Steffen Maßberg, Fabian Michalk, Petra Barthel, Gabriele Demetz, Albert Schömig, Jörg Hausleiter, German Heart Center Munich, Munich, Germany Background: The catheter-based MitraClip System (Abbott, former Evalve) imitates the “Alfieri suture” and is a promising alternative to surgical mitral valve repair or replacement in patients with severe mitral regurgitation (MR). This study evaluates the early hemodynamic and echocardiographic outcome after mitral clipping in a “real world setting”. Methods: 54 consecutive patients (58 procedures in 20 female and 34 male pts; mean age 72.1±10.7 yrs) with symptomatic MR were enrolled. Pre- and post-procedural severity of MR was assessed by transesophageal echocardiography (TEE) and by hemodynamic measurement of the left atrial v-wave as well as the cardiac output by thermodilution. Results: Degenerative and functional MR was present in 37 and 17 patients, respectively. In 52 of 54 pts a successful reduction of MR was achieved. The two unsuccessful procedures were performed on pts in acute cardiogenic shock with a large cleft of the posterior leaflet as bridge to surgery and in a bail-out situation due to acute myocardial infarction with rupture of the posterior papillary muscle. The grade of MR by TEE improved from 3.1±0.4 to 0.9± 0.7 (n=52 pts; p<0.0001). The left atrial v-wave was reduced from 26.5±11.9 mmHg to 18.2±9.2 mmHg (n=46 pts; p<0.0001). The cardiac output increased from 3.9±1.3 l/min to 5.0±1.5 l/min (n=36 pts; p<0.0001). One patient (86 year old female) treated in a bail-out situation (see above) died 5 days after the procedure. 40 of 54 pts presented at 30 day follow up visit and demonstrated a significant clinical improvement with a reduction in NYHA class from 2.9±0.3 to 1.9±0.7 (p<0.0001) and without any major adverse cardiac event. Conclusions: The minimally invasive catheter-based implantation of clips for significant MR, which has been shown to be safe and efficacious, represents an alternative to surgical mitral reconstructions. However, the long-term durability of the promising percutaneous mitral clipping procedure needs to be evaluated and compared with conventional surgical procedures.

ACUTE HEMODYNAMIC OUTCOME AND CLINICAL IMPACT OF PERCUTANEOUS EDGE-TO-EDGE MITRAL VALVE REPAIR USING THE MITRACLIP SYSTEM IN A REAL WORLD SETTING

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E1345

JACC April 5, 2011

Volume 57, Issue 14

VALVULAR HEART DISEASE

ACUTE HEMODYNAMIC OUTCOME AND CLINICAL IMPACT OF PERCUTANEOUS EDGE-TO-EDGE MITRAL

VALVE REPAIR USING THE MITRACLIP SYSTEM IN A REAL WORLD SETTING

ACC Poster ContributionsErnest N. Morial Convention Center, Hall F

Sunday, April 03, 2011, 3:30 p.m.-4:45 p.m.

Session Title: Valvular Disease-Precutaneous Therapies for Valvular Heart DiseaseAbstract Category: 19. Valvular Disease

Session-Poster Board Number: 1050-65

Authors: Hasema Lesevic, Jürgen Pache, Steffen Maßberg, Fabian Michalk, Petra Barthel, Gabriele Demetz, Albert Schömig, Jörg Hausleiter, German Heart Center Munich, Munich, Germany

Background: The catheter-based MitraClip System (Abbott, former Evalve) imitates the “Alfieri suture” and is a promising alternative to

surgical mitral valve repair or replacement in patients with severe mitral regurgitation (MR). This study evaluates the early hemodynamic and

echocardiographic outcome after mitral clipping in a “real world setting”.

Methods: 54 consecutive patients (58 procedures in 20 female and 34 male pts; mean age 72.1±10.7 yrs) with symptomatic MR were enrolled.

Pre- and post-procedural severity of MR was assessed by transesophageal echocardiography (TEE) and by hemodynamic measurement of the left

atrial v-wave as well as the cardiac output by thermodilution.

Results: Degenerative and functional MR was present in 37 and 17 patients, respectively. In 52 of 54 pts a successful reduction of MR was

achieved. The two unsuccessful procedures were performed on pts in acute cardiogenic shock with a large cleft of the posterior leaflet as bridge

to surgery and in a bail-out situation due to acute myocardial infarction with rupture of the posterior papillary muscle. The grade of MR by TEE

improved from 3.1±0.4 to 0.9± 0.7 (n=52 pts; p<0.0001). The left atrial v-wave was reduced from 26.5±11.9 mmHg to 18.2±9.2 mmHg (n=46 pts;

p<0.0001). The cardiac output increased from 3.9±1.3 l/min to 5.0±1.5 l/min (n=36 pts; p<0.0001). One patient (86 year old female) treated in

a bail-out situation (see above) died 5 days after the procedure. 40 of 54 pts presented at 30 day follow up visit and demonstrated a significant

clinical improvement with a reduction in NYHA class from 2.9±0.3 to 1.9±0.7 (p<0.0001) and without any major adverse cardiac event.

Conclusions: The minimally invasive catheter-based implantation of clips for significant MR, which has been shown to be safe and efficacious,

represents an alternative to surgical mitral reconstructions. However, the long-term durability of the promising percutaneous mitral clipping

procedure needs to be evaluated and compared with conventional surgical procedures.