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ACCESS-EUROPE - An Observational Study of the MitraClip® System in Europe

See the press release:
Munich, Germany – August 27 2012: The percutaneous catheter-based treatment of mitral regurgitation with the MitraClip system improves symptoms and cardiac function at one-year, according to results of a prospective observational study presented here today at ESC Congress 2012...
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Valvular Heart Diseases


Presenter: Wolfgang Schillinger | see Discussant report

List of Authors: Wolfgang Schillinger , Olaf Franzen, Stephan Baldus, Jörg Hausleiter, Christian Butter, Ulrich Schäfer, Giovanni B. Pedrazzini, Gian Paolo Ussia, Horst Sievert, Lars Soendergaard, Gert Richardt and Francesco Maisano on behalf of the ACCESS EUROPE Investigators.



ACCESS-EUROPE Phase I (ACCESS-EU) is a prospective, observational, multicenter study designed to gain information regarding the use of the MitraClip System in Europe in a commercial setting and to provide further evidence of the safety and effectiveness of the MitraClip System.  As of April 13, 2011, the ACCESS-EU study had completed enrollment of 567 patients in the MitraClip Device group.  Complete 1 year safety and effectiveness results have not been reported.

Procedural data, 30 day safety results and clinical outcomes at 1 year will be presented.  Outcomes defined by freedom from death, freedom from mitral valve surgery, and reduction in mitral regurgitation (MR), as well as improvements in NYHA Functional Class, Six Minute Walk Test, and Quality of Life data, will be reported at 1 Year.

Patients enrolled in ACCESS-EU were elderly (mean age 74 ± 10 yrs) with significant baseline co-morbidities including coronary artery disease in 63% and moderate to severe renal disease in 42%.  At baseline, 77% of patients had functional MR, 85% were in NYHA Functional Class III/IV, 98% had ≥ 3+MR and 53% had left ventricular ejection fraction <40%.  The average logistic EuroSCORE was 23% ±18.  Results at 1 year are as follows:  freedom from death was 82%, freedom from MR >2+ was 79%, freedom from mitral valve surgery was 94%, the majority of patients (72%) were in NYHA Class I/II, and median improvement of 60.5 meters in six minute walk distance was observed from Baseline.  Significant improvements in Quality of Life were also noted as evidenced by a median improvement of 14.0 points between Baseline and 1 year scores on the Minnesota Living with Heart Failure Questionnaire. 

1 year results of the ACCESS-EU study demonstrate important clinical benefits in a real world patient population with significant co-morbidities who are at high surgical risk.  Results from the complete 1 year Cohort of MitraClip Device patients will be presented. 

Discussant: Simon Ray | see Presenter abstract


ACCESS-EUROPE I is the largest follow up registry to date of the MitraClip device and recruited at 14 European centres. It includes 567 patients of whom 487 were evaluated to one year post implant. It adds to previous data, notably that from the German TRAMI registry (1), and confirms that clinical practice with the device differs considerably from the evidence base provided by the EVEREST II randomised trial (2). Patients enrolled in ACCESS-EUROPE are older, have more co-morbidities, worse ventricular function, higher surgical risk and a much higher proportion of functional mitral regurgitation. Despite these adverse features the rate of technically successful device implantation is virtually 100% with no embolization, although 8% had either single leaflet attachment and/or the need for a second procedure.  Thirty day mortality was 2.3% and one year mortality 17.3%, reflecting the severity of myocardial dysfunction and degree of co-morbidity amongst the cohort. Mitral regurgitation improved to grade 2 or less in 79% of 327 patients with matched echo data and NYHA class to II or less in 72% of 343 patients with matched clinical data.
So we can conclude from ACCESS-EUROPE, TRAMI and other smaller registries that in expert hands MitraClip implantation is technically feasible with an acceptable procedural complication rate, the severity of MR is reduced in the majority and that a significant proportion of patients respond symptomatically. On this basis percutaneous edge to edge repair has been included in the 2012 ESC Heart Failure Guidelines as an option for symptom control in patients with severe mitral regurgitation in patients unfit for surgery.
It is essential to place percutaneous edge to edge repair in the broader context of the treatment of mitral regurgitation and here many questions remain unanswered. Currently there seems to be considerable heterogeneity in activity between centres recruiting to registries.  In the 15 centres recruiting to TRAMI (1) median enrolment was 12 cases but the range was 1-217 and in only 35% was the decision to perform percutaneous edge to edge repair made by a heart team including a cardiac surgeon. Involvement of the heart team in decision making is essential as where surgery is possible it is more successful in reducing mitral regurgitation than a percutaneous approach. Similarly it is essential that all other options for patients with impaired LV function and functional MR are optimised before a decision to perform a percutaneous repair is made.
Despite technically successful clip placement 20% of patients are left with severe MR and 30% are left with NYHA class III or IV symptoms.  This suggests that patient selection could be further improved, both in terms of valve anatomy but also in terms of identifying those individuals who have irreversible ventricular damage or excessive co-morbidity and who are unlikely to derive any benefit.
The final question of course is that of a randomised trial of percutaneous edge to edge repair in high risk patients with functional MR who are outside the evidence base provided by the EVEREST II randomised trial. A strong case can be made for a pragmatic trial randomising patients with proven severe functional MR to optimised medical treatment (including CRT where appropriate) against the addition of edge to edge repair. Involvement of a heart team including a cardiac surgeon and an expert in heart failure management would be an essential component of such a trial.
1. European Journal of Heart Failure 2012. Advanced Access. June 8th 2012.
2. N Engl J Med 2011;364:1395-406


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The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.