Thorac Cardiovasc Surg 2013; 61 - OP117
DOI: 10.1055/s-0032-1332356

Six-months results after MitraClip treatment for degenerative mitral regurgitation: Data from the ACCESS-EU Phase I Trial

L Conradi 1, F Maisano 2, S Baldus 3, J Hausleiter 4, H Treede 1, C Butter 5, U Schäfer 6, G Pedrazzini 7, H Reichenspurner 1, W Schillinger 8
  • 1Universitäres Herzzentrum Hamburg, Klinik und Poliklinik für Herz- und Gefäßchirurgie, Hamburg, Germany
  • 2Department of Cardiovascular and Thoracic Medicine, Istituto Scientifico San Raffaele, Milano, Italy
  • 3Herzzentrum Uniklinik Köln, Köln, Germany
  • 4Deutsches Herzzentrum München, München, Germany
  • 5Bernau Herzzentrum, Bernau, Germany
  • 6Asklepios Klinik St. Georg, Hamburg, Germany
  • 7Fondazione Cardiocentro Ticino, Lugano, Switzerland
  • 8Herzzentrum Göttingen, Göttingen, Germany

Objectives: Percutaneous therapy with the MitraClip device represents an alternative option for selected patients with degenerative mitral regurgitation (DMR) who are inoperable or at high risk for cardiac surgery. We describe acute and 6-months outcomes following treatment with the MitraClip device in a DMR patient subset from the multicenter ACCESS-EU Phase I Trial.

Methods: ACCESS-EU has completed enrollment of 566 patients in April, 2011. Baseline demographics, procedural and acute safety results at 30 days and survival and functional results at 6 months were evaluated in a DMR subset. Results were stratified according to high or low surgical risk (logEuroSCORE I ≥ or < 20%) respectively.

Results: 117 DMR patients underwent the MitraClip procedure with a 94.0% rate of successful clip deployment. Baseline characteristics and co-morbidities included NYHA Class III/IV (87%), LVEF < 40% (66%), prior cardiac surgery (41%) and prior MI (35%). Mean logEuroSCORE I in the entire cohort was 15.5 ± 13.4% (33.1 ± 11.5% and 8.6 ± 5.1% in high- and low-risk subgroups respectively). Overall mortality at 30 days was 6.0% (9.1%/4.8% high-risk/low-risk). At 6 months, mortality was 11.1% (12.1%/10.8% high-risk/low-risk). In patients available for follow-up, residual MR was ≤ grade 2+ in 79.3% (69/87) of patients, 77% (67/87) of patients were in NYHA classes I/II. Minnesota Living With Heart Failure Questionnaire scores improved by 36% and 6 MWT distance improved by 63 meters in these patients.

Conclusions: The MitraClip procedure resulted in significant reduction of MR and improvements in clinical outcomes at 6 months in many patients with severe DMR. Results from the ACCESS EU Trial suggest, MitraClip therapy may be considered an important therapeutic adjunct to surgery for selected DMR patients at high risk for surgery. Current clinical and functional results do not justify expansion of MitraClip treatment towards patients at low or intermediate risk. Indication of percutaneous treatment, as well as performing the procedure and postprocedural care should be the task of an interdisciplinary dedicated heart team consisting of cardiologists and cardiac surgeons.