PERCUTANEOUS MITRAL VALVE REPAIR IN HIGH RISK PATIENTS - THE SWISS EXPERIENCE AFTER THE FIRST 100 PATIENTS

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1 PERCUTANEOUS MITRAL VALVE REPAIR IN HIGH RISK PATIENTS - THE SWISS EXPERIENCE AFTER THE FIRST 100 PATIENTS

2 Potential conflicts of interest Speaker s name: Daniel Sürder, MD Cardiocentro Ticino, Lugano Switzerland daniel.suerder@cardiocentro.org I do not have any potential conflict of interest

3 A Percutaneous MVR using MitraClip B A- Steerable 24F guide catheter B- Clip delivery system C- Clip: 2 arms and 2 grippers Procedure: percutaneous, transvenous access, beating heart C Grippers Clip

4 NON CONTROLLED INCLUSION CONTROLLED INCLUSION SCIENTIFIC EVIDENCE EVEREST I and II REGISTRIES JACC 2009 RANDOMIZED TRIALS EVEREST II RT EVEREST HIGH RISK REG TCT 2009 NEJM 2011 SWISS EXPERIENCE Cardiovasc. Med HAMBURG EXPERIENCE Eur Heart J 2010 ITALIAN EXPERIENCE Eur Heart J 2010 END STAGE HF Eur J Heart Fail. 2011

5 AIM OF THE STUDY To evaluate the effect of percutaneous mitral valve repair using the MitraClip system in high risk patients METHOD Retrospective analysis of ALL patients, not suitable for surgery, treated with percutaneous mitral valve repair between February 2009 and March 2011 in Switzerland

6 Baseline characteristics n = 100 Patient characteristics Age (mean, --- years) 73±12 >75 y. --- (n.) 54 Male sex --- (%) 67 BMI (kg/m2) 24.4±4.3 LV-EF (%) 48±19 NYHA Class III / IV 82 Severity of MR --- (n.) Cause of MR --- (n.) Functional 62 Degenerative 38 Operative risk (logeuroscore %) 21±16 Coexisting condition Congestive heart failure 76 Coronary artery disease 45 Previous myocardial infarction 33 Atrial Fibrillation 31 Diabetes mellitus 13 COPD 20 Previous CABG 17 Previous PCI 31 Previous heart-valve or thoracic surgery Pacemaker/ICD 28 CRT-D 13 Tumor 10 Chronic renal failure (Creatinine > 200µmol/l) Stroke 9 n 9 49

7 Procedural results (n = 100) 1 Clip positioned 52 2nd/3rd Clip positioned during initial intervention (3 clips) 44 (4) 2nd Clip positioned during 2nd intervention 3 MORTALITY Procedural death 2 30-days mortality 5 COMPLICATIONS Artificial respiration > 48h 1 LVAD 1 Major bleeding (periprocedural) 4 Complication due to transseptal puncture 3 Dislocation of PM/ICD lead 1 Infection during hospital stay 1 Cardiac decompensation during hospital stay 8 Cardiac arrythmia during hospital stay 2 Cardiac surgery (Mitral valve repair / sostitution) at 30 days 4 Acute renal failure or hemodialysis 0 HOSPITAL STAY ICU/CCU stay (median / mean in days) 1.6 (2.6) Hospital stay (median / mean in days) 6.5 (8)

8 100% 80% 60% 4+ Acute Procedural Success - APS Reduction in MR grade % 1+ APS 84% 20% % BASELINE (n = 100) AT DISCHARGE (n = 97) 2 procedural death 1 intervention not done

9 Functional / Degenerative MR ( n = 62 / 38)

10 MR grade over follow up 100% 90% dead 80% 70% 60% 50% 40% % 20% 10% % Baseline Discharge 3 months 6 months 12 months N = 100 N = 99 N = 85 N = 67 N = 56

11 MR grade over follow up in the surviving patients 100% 90% 80% % 60% % 40% 1+ 30% 20% 10% % Baseline Discharge 3 months 6 months 12 months N = 100 N = 97 N = 78 N = 55 N = 41

12 NYHA class over follow up 100% 90% 80% 70% NYHA NYHA 3 7 dead NYHA % 50% % 27 30% 20% 10% NYHA % 1 Baseline 3 months 6 months 12 months N = 100 N = 99 N = 95 N = 71

13 NYHA class follow up surviving patients 100% 90% 80% 70% NYHA NYHA 3 NYHA % 50% % 30% 20% 10% NYHA % 1 Baseline 3 months 6 months 12 months N = 100 N = 92 N = 83 N = 56

14 Reduction in nt-probnp n = 61 n = 47 n = 18

15 Echocardiographic parameters from baseline to 3 months FU n = 87 / 69 n = 86 / 57 n = 86 / 69 n = 100 / 73 n = 93 / 73 n = 90 / 70

16 Acute hemodynamic effects a patient example Before MVR After MVR A B C D PCWP PCWP ECG EF 61% ESP 53 ESV 55 EDP 11 EDV 141 EF 48% ESP 107 EDP 14 ESV 85 EDV 163 ECG G H Courtesy: O. Gaemperli et al. Heart 2011 in press

17 Acute hemodynamic effects in a subset of 40 patients +32% -8% -20% -20% +3% -1% CI Mean PAP Mean PCWP PCWP v-wave MAP LVEDP O. Gaemperli et al. Heart 2011 in press

18 CONCLUSIONS I The APS rate in this high-risk population with predominant functional origin was 84 % what is similar to the results of the recently published EVEREST trial. Cardiac index acutely increased by 32%, PCWP decreased by 20% Long term FU shows consistent clinical and biohumoral benefit and promising echocardiografic results

19 CONCLUSIONS II Percutaneous mitral valve repair appears to be a valid option for patients not suitable for surgery, especially in functional MR Interdisciplinary discussion in the HEART team is essential for optimal patient selection.

20 Thank you for your kind attention The operators Roberto Corti, Jürg Grünenfelder, Patrick Biaggi Tiziano Moccetti, G.B. Pedrazzini, E. Pasotti, Franco Faletra Paul Erne, Christopf auf der Maur, Michel Zuber Christoph Kaiser, Raban Jeger, Beat Kaufmann