Zusammenfassung
Hintergrund
Publizierte Verlaufskontrollen nach MitraClip-Implantation in Real-World-Kohorten sind auf das 30-Tage-Outcome beschränkt.
Material und Methoden
Die ersten 50 konsekutiven Patienten unseres Zentrums mit mindestens 6-monatigem Verlauf nach MitraClip-Implantation wurden klinischen und echokardiographischen Kontrollen unterzogen.
Ergebnisse
Der MitraClip-Eingriff erwies sich als sehr sicher mit einer 30-Tage-Mortalität von 4% (log. EuroScore 28±5%, STS-Score 11±3%). Hämodynamisch relevante Blutungen erlitten 6%. Bei 6% kam es zu einer partiellen Cliplösung von einem Segel. Der Eingriff war effektiv mit einem Prozedurerfolg von 98% und einer medianen Reduktion der Mitralinsuffizienz um 2 Schweregrade. Nach dem Eingriff zeigten 80% der Patienten eine residuale Mitralinsuffizienz von ≤2. Das Ergebnis war in den 6- und 12-Monats-Kontrollen stabil. Die 6-min-Gehstrecke nahm innerhalb von 12 Monaten um 133 m zu (p<0,05). Das 6- und 12-Monats-Überleben war 85,9 bzw. 76,9%.
Schlussfolgerung
MitraClip zeigte sehr gute akute und intermediäre Ergebnisse in einer Real-World-Kohorte und stellt eine sichere Therapieoption für Patienten mit schwerer Mitralinsuffizienz und erhöhtem Operationsrisiko dar.
Abstract
Background
Published data on outcome after MitraClip implantation in real-world cohorts are limited to 30-day follow-up.
Material and Methods
The first 50 consecutive patients of our center with a minimum follow-up of 6 months after MitraClip implantation were examined clinically and by echocardiography.
Results
MitraClip was very safe. The 30-day mortality was 4% (log. EuroScore 28±5%, STS score 11±3%); 6% had a bleeding event with hemodynamic compromise, and 6% had a partial clip detachment from one leaflet. The procedure was effective in 98% with a median reduction of mitral regurgitation by two grades; 80% had a residual MR ≤ 2. The result was persistent during 6- and 12-month follow-ups. The 6-min walk distance increased by 133 m within 12 months (p<0,05). The 6- and 12-month survival was 85.9 and 76.9%, respectively.
Conclusion
MitraClip showed excellent acute and intermediate results in a real-world cohort and is a safe option for patients with severe mitral regurgitation and increased surgical risk.
This is a preview of subscription content, log in via an institution to check access.
Literatur
Alfieri O, Maisano F, De Bonis BM et al (2001) The double-orifice technique in mitral valve repair: a simple solution for complex problems. J Thorax Cardiovasc Surg 122:674–681
Auricchio A, Schillinger W, Meyer S et al (2011) Correction of mitral regurgitation in non-responders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling (eingereicht)
Feldman T, Kar S, Rinaldi M et al (2009) Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol 54:686–694
Feldman T, Mauri L, Foster E, Glower D (2010) Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) randomized clinical trial: primary safety and efficacy endpoints. American College of Cardiology, Atlanta, Ga, USA
Feldman T, Wasserman HS, Herrmann HC et al (2005) Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST phase I clinical trial. J Am Coll Cardiol 46:2134–2140
Franzen O, Baldus S, Rudolph V et al (2010) Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur Heart J 31:1373–1281
Franzen O, Heyden J van der, Schlüter M et al (2011) MitraClip therapy in patients with end-stage systolic heart failure. Eur J Heart Fail (im Druck)
Herrmann HC, Kar S, Siegel R et al (2009) Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention 4:437–442
Iung B, Baron G, Butchart EG et al (2003) A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on valvular heart disease. Eur Heart J 24:1231–1243
Lang RM, Bierig M, Devereux RB et al (2005) Chamber Quantification Writing Group; American Society of Echocardiography’s Guidelines, Standards Committee; European Association of echocardiography. Recommendations for Chamber Quantification: a report from the American Society of Echocardiography’s Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr 18:1440–1463
Levey AS, Bosch JP, Lewis JB et al (1999) A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of diet in Renal Disease Study Group. Ann Intern Med 130:461–470
Tamburino C, Ussia GP, Maisano F et al (2010) Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J 31:1382–1389
The GUSTO Investigators (1993) An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 329:673–682
Vahanian A, Baumgartner H, Bax J et al, Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; Esc Committee for Practice Guidelines (2007) Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J 28:230–268
Van den Branden BJ, Post MC, Swaans MJ et al (2010) Percutaneous mitral valve repair using the edge-to-edge technique in a high-risk population. Neth Heart J 18:437–443
Zoghbi WA, Enriquez-Sarano M, Foster E et al (2003) Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr 16:777–802
Interessenkonflikt
Der korrespondierende Autor weist auf folgende Beziehungen hin: PD Dr. Wolfgang Schillinger ist Co-Principal-Investigator der multizentrischen ACCESS-Europe-Studie mit dem MitraClip-System im Auftrag von Abbott Vascular und übt eine Tätigkeit als Proktor und Referent für Abbott Vascular aus. Dr. Wachter ist Referent für Abbott Vascular. Dr. Thomas Athanasiou erhielt Reisekostenzuschüsse von Abbott Vascular.
Author information
Authors and Affiliations
Corresponding author
Additional information
___ ___
W. Schillinger und T. Athanasiou haben gleichermaßen beigetragen.
Rights and permissions
About this article
Cite this article
Schillinger, W., Athanasiou, T., Wachter, R. et al. Perkutane Mitralklappenrekonstruktion mit MitraClip. Kardiologe 5, 91–97 (2011). https://doi.org/10.1007/s12181-011-0329-z
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12181-011-0329-z