Mitra Clip The European Experience Carlo Di Mario

Mitra. Clip The European Experience Carlo Di Mario Royal Brompton Hospital, London

Carlo Di Mario I have the following relevant financial relationships Speaker’s Bureau: Boston Scientific Research Grant (to the Institution): Abbott, Medtronic

Ø Mitra. Clip started with a randomised trial in the US but the subsequent experience of approx. 30, 000 Mitra. Clip implantations worldwide mainly came from Europe Ø Geographical distribution is very uneven with Germany doing more than all other European countries combined Ø Mitra. Clip in Europe has evolved with implantation in technically more challenging valves and sicker patients Ø Large registries have helped to understand the role of the technique in treatment of patients with MR

Registries Prospective-Multicenter Study n REALISM US Continued Access 899 REALISM Compassionate/Emergency Use 66 ACCESS Europe Phase I 567 ACCESS Europe Phase II 286 German Transcatheter Mitral Valve Interventions (TRAMI) 1002 GRASP-It 304 Mitra. Swiss registry nationwide 265 Sentinel Registry EURObservational Research Programme ESC 628 Mitra. Clip Asia-Pacific Registry (MARS) 145 ANZ Mitra. Clip Registry 45

Acute outcomes after Mitra. Clip® therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry Euro. Intervention 2013

Acute outcomes after Mitra. Clip® therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry Euro. Intervention 2013

A non-randomised single centre comparison of consecutive Mitra. Clip implants with contemporary surgical procedures and historical (immediately pre-Mitra. Clip) series on medical treatment only JACC Cardiovasc Interv 2014

Echo Features Predictive Success Single centre, 300 Pts, 68% functional, 10. 2% Failure Lubos & Baldus, JACC Cardiovasc Interv 2014

Mitra. Clip in MR due to SAM in HOCM Schafer et al, 2014

Mitraclip Participating Countries Germany Italy Switzerland UK Denmark Sweden Centres 14 6 6 2 1 Patients 373 169 114 40 43 Belgium Poland TOTA 1 2 3 35 36 26 6 807

UK Functional MR (%) 37, 5 17, 1 Log Euro. SCORE (%) Switzerland 59, 2 Sweden 44, 4 14, 7 Italy 81, 6 16, 9 Germany 76, 1 23, 5 Denmark 72, 1 18, 9 Belgium 96, 6 28, 6 0 20 40 60 80 100

9 Months Adverse Events 875 Pts from 9 European Studies Am J Cardiol 2015

Am J Cardiol 2015

173 Pts Treated 2009 -11 divided based Cr. Cl <30, 30 -60, >60 Internat J Cardiol 2015

Functional: Ischaemic vs Non-Ischaemic

304 patients from 4 centres in the GRASP-It Registry Capodanno et al, Am Heart J 2014

Mitra. Clip Procedures in Europe Outside Germany ESC long-term transcatheter valve registry restarted with 23 countries represented (Portugal, Spain, France, Ireland, UK, Belgium, Switzerland, Italy, Denmark, Finland, Latvia, Estonia, Czek Republic, Slovakia, Hungary, Serbia, Greece, Sweden, Poland, Russian Federation, Turkey, Israel) Recruitment supported by the French Health Authority for a study comparing medical treatment and Mitra. Clip in heart failure with functional severe mitral regurgitation Very active -3 centres in Zurich!- with the first nation-wide complete database with f-up In 2015 the Commissioning through evaluation program started with 180 Mitra. Clip implantations per year funded in 3 centres (Bristol and Manchester Universities; Royal Brompton London)

Ø After its approval in 2009 the growth in various European countries has been variable, greatly influenced by national reimbursement policies Ø Indications have expanded with >90% success also in challenging anatomies Ø Granting CE mark to all severe MR, including functional, has paradoxically jeopardised implementation and enrolment in randomised trials