This study sought to evaluate the feasibility and early outcomes of a percutaneous edge-to-edge repair approach for mitral valve regurgitation with the MitraClip((R)) system (Evalve, Inc., Menlo Park, CA, USA).Patients were selected for the procedure based on the consensus of a multidisciplinary team. The primary efficacy endpoint was acute device success defined as clip placement with reduction of mitral regurgitation to < 2+. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of > 2 units of blood, ventilation for > 48 h, deep wound infection, septicaemia, and new onset of atrial fibrillation. Thirty-one patients (median age 71, male 81%) were treated between August 2008 and July 2009. Eighteen patients (58%) presented with functional disease and 13 patients (42%) presented with organic degenerative disease. A clip was successfully implanted in 19 patients (61%) and two clips in 12 patients (39%). The median device implantation time was 80 min. At 30 days, there was an intra-procedural cardiac tamponade and a non-cardiac death, resulting in a primary safety endpoint of 93.6% [95% confidence interval (CI) 77.2-98.9]. Acute device success was observed in 96.8% of patients (95% CI 81.5-99.8). Compared with baseline, left ventricular diameters, diastolic left ventricular volume, diastolic annular septal-lateral dimension, and mitral valve area significantly diminished at 30 days.Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favourable short-term safety and efficacy results.

Tamburino, C., Ussia, G.p., Maisano, F., Capodanno, D., La Canna, G., Scandura, S., et al. (2010). Percutaneous mitral valve repair with the MitraClip system: Acute results from a real world setting. EUROPEAN HEART JOURNAL, 31(11), 1382-1389 [10.1093/eurheartj/ehq051].

Percutaneous mitral valve repair with the MitraClip system: Acute results from a real world setting

Ussia G. P.;Cammalleri V.;
2010-01-01

Abstract

This study sought to evaluate the feasibility and early outcomes of a percutaneous edge-to-edge repair approach for mitral valve regurgitation with the MitraClip((R)) system (Evalve, Inc., Menlo Park, CA, USA).Patients were selected for the procedure based on the consensus of a multidisciplinary team. The primary efficacy endpoint was acute device success defined as clip placement with reduction of mitral regurgitation to < 2+. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of > 2 units of blood, ventilation for > 48 h, deep wound infection, septicaemia, and new onset of atrial fibrillation. Thirty-one patients (median age 71, male 81%) were treated between August 2008 and July 2009. Eighteen patients (58%) presented with functional disease and 13 patients (42%) presented with organic degenerative disease. A clip was successfully implanted in 19 patients (61%) and two clips in 12 patients (39%). The median device implantation time was 80 min. At 30 days, there was an intra-procedural cardiac tamponade and a non-cardiac death, resulting in a primary safety endpoint of 93.6% [95% confidence interval (CI) 77.2-98.9]. Acute device success was observed in 96.8% of patients (95% CI 81.5-99.8). Compared with baseline, left ventricular diameters, diastolic left ventricular volume, diastolic annular septal-lateral dimension, and mitral valve area significantly diminished at 30 days.Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favourable short-term safety and efficacy results.
2010
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE
English
Edge-to-edge; Percutaneous mitral valve repair; MitraClip; Aged; Anesthesia, General; Cardiac Catheterization; Echocardiography, Doppler, Color; Echocardiography, Transesophageal; Feasibility Studies; Female; Humans; Male; Middle Aged; Mitral Valve; Mitral Valve Annuloplasty; Mitral Valve Insufficiency; Prospective Studies; Pulmonary Wedge Pressure; Treatment Outcome; Ventricular Dysfunction, Left; Surgical Instruments
Tamburino, C., Ussia, G.p., Maisano, F., Capodanno, D., La Canna, G., Scandura, S., et al. (2010). Percutaneous mitral valve repair with the MitraClip system: Acute results from a real world setting. EUROPEAN HEART JOURNAL, 31(11), 1382-1389 [10.1093/eurheartj/ehq051].
Tamburino, C; Ussia, Gp; Maisano, F; Capodanno, D; La Canna, G; Scandura, S; Colombo, A; Giacomini, A; Michev, I; Mangiafico, S; Cammalleri, V; Barban...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/228565
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