Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU European Society of Cardiology

Transcription

1 Early hemodynamic and echocardiographic outcomes after percutaneous MitraClip therapy in patients with mitral regurgitation. Preliminary results of the MitraClip arm of the ACCESS EUROPE registry. Jörg Hausleiter, Wolfgang Schillinger, Olaf Franzen, Stephan Baldus, Ulrich Schäfer, Gian Paolo Ussia, Horst Sievert and Francesco Maisano on behalf of the ACCESS EU investigators 1

2 Disclosures Jörg Hausleiter, MD received unrestricted research grants / speaker honoraria from: Siemens Medical Solutions Abbott Vascular 2

3 ACCESS EU Study A multi-center European Union observational study of the MitraClip device for the treatment of mitral regurgitation 3

4 Percutaneous Mitral Valve Repair MitraClip System 4

5 Enrolling Centers: ACCESS EU 14 centers had enrolled MitraClip patients as of April 12, 211 Enrolling Center Principal Investigator UKE, Hamburg Dr. Franzen; Dr. Baldus Universitätsmedizin, Göttingen Dr. Schillinger Asklepios Klinik St. Georg, Hamburg Dr. Schäfer Krankenhaus Bernau, Brandenburg Dr. Butter Deutsches Herzzentrum, Munich Dr. Hausleiter Ospedale Ferrarotto, Catania Dr. Ussia San Raffaele, Milan Dr. Maisano CardioVasculares Centrum St. Katharinen, Frankfurt Dr. Sievert Rigshospital, Copenhagen Dr. Soendergaard; Dr. Franzen Segeberger Kliniken GmbH, Bad Segeberg Dr. Richardt Cardiocentro Ticino, Lugano Dr. Mocceti Medizinische Hochschule, Hannover Dr. Klein Universitätsklinikum, Aachen Dr. Hoffmann Herzzentrum, Leipzig Dr. Thiele 5

6 Methods ACCESS EU Analysis Cohort Hemodynamic measures collected in Cardiac Catheterization Laboratory: Assessed while patients under general anesthesia Performed pre-procedure and 15 minutes following attempted MitraClip deployment Cardiac output (CO) determined by thermodilution or Fick method depending on site preference Ventricular pulmonary capillary wedge pressure ( v wave) captured via Swan-Ganz catheter or transseptal catheter in the left atrium and peak LV end-diastolic pressure (LVEDP) Site assessed MR at baseline, discharge and 6 months NYHA functional class assessed at baseline and 6 months 6

7 Analysis Cohort ACCESS EU Analysis Cohort Total MitraClip Patients Treated* in ACCESS EU N = 529 Treated Patients Past 6 Month Follow-up N = 299 N = 1 Withdrawals N = 32 Data pending ACCESS EU Analysis Cohort N = month follow-up complete 86% patient data available *Treated as of April 12, 211 7

8 Baseline Demographics and Co-Morbidities ACCESS EU Analysis Cohort Demographics and Co-morbidities ACCESS EU Analysis Cohort N=257 Age (mean ± SD), years 73 ± 1 Logistic EuroSCORE, % Mean ± SD 2 ± 18 EuroSCORE 2% 34 Male Gender, % 65 Coronary Artery Disease, % 62 Previous Cardiovascular Surgery, % 37 Myocardial Infarction, % 3 Cerebro-vascular Disease, % 12 Previous stroke, % 4 Moderate to Severe Renal Failure, % 43 Atrial Fibrillation, % 64 8

9 Baseline Demographics and Co-Morbidities ACCESS-EU Analysis Cohort Demographics and Co-morbidities ACCESS EU Analysis Cohort N=257 Mitral Regurgitation Grade 3+, (%) 99 NYHA Functional Class III or IV, (%) 84 Ejection Fraction < 4%, (%) 55 Functional MR, (%) 78 Ischemic 38 Non-ischemic 4 Degenerative MR, (%) 22 9

10 Cardiac Output (CO) ACCESS EU Analysis Cohort with MitraClip Device Implanted 6 p<.1 5 Liters/min % increase in cardiac output 1 Pre-Procedure Post-Procedure Data presented as mean ± SEM N = 89 Matched Pairs 1

11 Ventricular PCWP (v-wave) ACCESS EU Analysis Cohort with MitraClip Device Implanted 3 p< mmhg % Reduction in V-wave Pressure 1 5 Pre-Procedure N = 74 Matched Pairs Post-Procedure Data presented as mean ± SEM 11

12 LV End-Diastolic Pressure (LVEDP) ACCESS EU Analysis Cohort with MitraClip Device Implanted 2 p= mmhg % Reduction in LVEDP 4 Pre-Procedure N = 39 Matched Pairs Post-Procedure Data presented as mean ± SEM 12

13 MR Grade at Baseline and Discharge ACCESS EU Analysis Cohort 1 2+ Percent Patients Baseline 3+/4+ Discharge N = 257 N =

14 MR Grade at Baseline, Discharge and 6 Months ACCESS EU Analysis Cohort Percent Patients /4+ 4+ Baseline Discharge 6 Months N = 257 N = 253 N = 28 14

15 Kaplan-Meier Freedom from Death ACCESS EU Analysis Cohort 1, Freedom from Death,8,6,4,2 87.5% at 6 Months, Days from Index Procedure At Risk: d N 257 6m

16 Kaplan-Meier Freedom from MV Surgery ACCESS EU Analysis Cohort 1. Freedom from MV Surgery % at 6 Months Days from Index Procedure At Risk: d N 257 6m

17 NYHA Class at Baseline and 6 Months ACCESS EU Analysis Cohort p<.1 1 I II I Percent Patients III II III 71% NYHA Class I or II at 6 Months IV IV Baseline 6 months N = 199 Matched Pairs 17

18 Cardiac Output (CO) by Etiology ACCESS EU Analysis Cohort with MitraClip Device Implanted 6 5 Functional MR (N = 55 Matched Pairs) p< Degenerative MR (N = 26 Matched Pairs) p=.145 Liters/min Pre- Procedure Data presented as mean ± SEM Post- Procedure Pre- Procedure Post- Procedure 18

19 Ventricular PCWP (v-wave) by Etiology ACCESS EU Analysis Cohort with MitraClip Device Implanted 35 Functional MR (N = 54 Matched Pairs) 35 Degenerative MR (N = 17 Matched Pairs) p=.24 3 p=.6 3 mmhg Pre- Procedure Data presented as mean ± SME Post- Procedure Pre- Procedure Post- Procedure 19

20 MR Grade at Baseline and 6 Months by Etiology ACCESS EU Analysis Cohort Functional MR N = 138 Matched Pairs Degenerative MR N = 45 Matched Pairs p<.1 p= Percent Patients Baseline Months Baseline 6 Months 2

21 NYHA Class at Baseline and 6 Months by Etiology ACCESS EU Analysis Cohort Functional MR N = 136 Matched Pairs p<.1 Degenerative MR N = 45 Matched Pairs p< I II I 1 8 I II I Percent Patients III IV II III IV III IV II III IV Baseline 6 months Baseline 6 months 21

22 Summary ACCESS EU 6-Month Analysis Cohort The majority of patients treated with the MitraClip device in ACCESS Europe have functional MR and extensive co-morbidities MitraClip device provides immediate improvements in hemodynamic measures Cardiac output significantly improved Ventricular wedge pressure and LV end-diastolic pressure significantly reduced Clinical benefits observed through 6 months are consistent with acute hemodynamic improvements Significant improvement in hemodynamic and clinical outcomes observed in both functional and degenerative etiologies 22

23 Conclusion ACCESS EU 6-Month Analysis Cohort The MitraClip procedure significantly improves acute hemodynamic outcomes resulting in acute and 6-month symptomatic and clinical benefits in select patients with significant functional and degenerative MR. 23