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End-Stage Heart Failure: Surgical Options ischemia (CABG) mitralis insuf. (RMA) "Dor" aneurysmectomy Surgical Ventricular Restoration mechanical /assistance replacement HTX REPAIR RESHAPE REPLACE

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Systolic restrictive motion

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> 30 > 0.2 IMR RV (ml) > 60 ERO (cm 2 ) > 0.4ORGANIC ECHO CRITERIA OF SEVERE MR M. Enriquez-Sarano

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Restrictive Mitral Annuloplasty: two sizes under

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Postoperative echo result

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Restrictive Annuloplasty for Ischaemic Mitral Regurgitation results in Reverse Left Ventricular Remodeling J. Braun, J.J. Bax, M.I.M. Versteegh, P.G. Voigt, E.R. Holman, R.J.M. Klautz, R.A.E. Dion Departments of Cardiothoracic Surgery and Cardiology, Leids Universitair Medisch Centrum

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Patient characteristics EACTS 15/09/04 Jan 2000 March 2004 87 patients age 66 10 yrs NYHA 3.0 0.9 III / IV: 82 % log EuroSCORE11.0 10.8 previous CABG7 %

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Baseline echocardiography MR grade3.1 0.5 3+ / 4+ : 81 % LA size (mm)54 6 LVESD (mm)52 8 LVEDD (mm)64 8 LVEF (%)32 10 EACTS 15/09/04

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Surgery median annuloplasty ring size26 CABG86 % mean distal anastomoses3.3 1.3 CPB time (min)189 52 Ao-clamp (min)125 37 EACTS 15/09/04

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Results (1) Time (years) 543210 Cumulative Survival 1,0,9,8,7,6,5,4,3,2,1 0,0 Early mortality 8.0 % (n=7) Late mortality 7.5 % (n=6) 87 65 43 25 9

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Results (3) Baseline3.1 0.5 Coaptation height 8 1 mm MV diastolic gradient 2.4 0.6 mmHg EACTS 15/09/04 Mitral regurgitation Early 0.4 0.3 Late 0.6 0.6

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Results (4) LVESD (mm) Baseline52 8 Late FU 44 11 EarlyLateNo reverse remodeling 40% 33% 27% (p < 0.01)

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Results (5) LVEDD (mm) Baseline64 8 Late FU 58 10 EACTS 15/09/04 42% 22% 36% EarlyLate No reverse remodeling (p < 0.01)

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LVESD and Reverse Remodeling LVESD (mm) specificity sensitivity 81 % 51 EACTS 15/09/04

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LVEDD (mm) specificity sensitivity 89 % 65 LVEDD and Reverse Remodeling EACTS 15/09/04

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RESULTS PRE-MVPPOST-MVP LVEDD65 mm53 mm LVESD49 mm32 mm LA43 mm35 mm MVA2.2 cm 2 Mean gradient2.8 mmHg

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11 patients MRI pre-surgery and follow-up MRI 7 men / 4 women mean age SD: 53 14 years mean follow-up period SD: 42 7 months Long-Term Durability after restrictive MVP

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PRE POST (note: MI jet)(note: restrictive ring) Long-Term Durability after restrictive MVP

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PREPOSTp-value LAEDV (ml)87 2690 300.98 LAESV (ml)152 34142 370.08 LVEDV (ml)219 45157 280.001 LVESV (ml)90 4559 240.08 LVEF (%)36 1053 80.01 LV Mass (g)137 49125 230.32 Long-Term Durability after restrictive MVP

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Conclusions RMA + CABG yield reverse remodeling Preoperative LV dimensions limit extent of reverse remodeling Additional techniques may be needed when LVEDD > 65 EACTS 15/09/04

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Restrictive Mitral Annuloplasty in Non-ischemic Dilating Cardiomyopathy Non-ischemic Dilating Cardiomyopathy J. Braun, J.J. Bax, M.I.M. Versteegh, P.G. Voigt, E.R. Holman, R.J.M. Klautz, R.A.E. Dion Departments of Cardiothoracic Surgery and Cardiology, Leids Universitair Medisch Centrum

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Patient Characteristics 02/02/05 July 2000 March 2004 29 patients6 RMA + CorCap 23 RMA

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Baseline echocardiography MR grade3.7 0.5 3+ / 4+ : 100 % LVESD (mm)62 10 LVEDD (mm)74 11 02/02/05

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Surgery mean annuloplasty ring size26 2 size 24 : n = 10 TVP12 ( 52 %) TEE coaptation (mm) 8 1 CPB time (min)120 27 Ao-clamp (min) 70 21 02/02/05

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Results (1) POD 3: F 63 y NYHA III LV 73 / 63 RMA 26 postop tamponade persisting AF IABP CVVH - MOF Early mortality 8.6 % (n=2)

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Results (3) Late mortality 14.2 % (n=3) 10 mo :VF resuscitation 18 mo :collapse 27 mo :septicaemia 02/02/05

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Results (4) Clinical follow-up ( 27 13 months) NYHA3.3 0.5 1.7 0.6 2 13 3 0 5 17 6 2 10 3 1 2 4 1 I II III IV death 02/02/05

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Results (5) Follow up17 9 months MR 0.7 0.9 1 MR grade 2 1 MR grade 3 LVEDD (mm)75 9 mm64 10 LVESD (mm)62 9 mm58 13 Echocardiography 02/02/05

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CorCap NVT 08/10/04

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PATIENTS Nov 2002 June 2005: 25 pts age (y)62.5 (34-76) males17 NYHA 3.4 EuroSCORE14 LVEF (%)22 (15-26) LUMC 06-05

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Concomitant Procedures MVP24 TVP19 AF ablation 4 CABG 5 AVR 1 CPB (min) 128 + 23 X clamptime (min) 66 + 21 LUMC 06-05

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Echocardiography LUMC 06-05 Pre-opDischargeFollow-up (6 m) MR3.10.30.7 LVEDD (mm) 72.769.668.3 LVESD (mm) 62.56162

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Left ventricular restoration in ischemic congestive heart failure: The Leiden Experience Klein P. 1, Versteegh M.I.M. 1, Klautz R.J.M. 1, de Weger A. 1, Tavilla G. 1, Holman E.R. 2, Bax J.J. 2, Dion R.A.E. 1 1 Department of Cardiothoracic Surgery, 2 Department of Cardiology Leids Universitair Medisch Centrum

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Study population (I) 39 patients with ICHF 30 males, mean age 62 11 years NYHA-class 3.1 0.5 LVEF 20.5 6.4% median interval after infarction 36 months (1-240) EuroSCORE 14 13 5 patients were operated in emergency (13%) 2 pre-op IABP 1 pre-op ventilation 1 acute infarction

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Surgical procedure according to DOR Fontan stitch sizing of residual LV using a saline-filled balloon (55 ml / m 2 BSA) elliptical shape !

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Dor / SVR

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Concomitant procedures CABG in 28 patients (72%) Mean number of distal anastomoses 2.4 1.2 Restrictive mitral annuloplasty in 25 patients (64%) Mean ring size 26 2 Tricuspid annuloplasty 10 (26%) VT-ablation 1 (3%) VSR-repair 1 (3%)

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Mortality / morbidity Hospital mortality10,3% Post-operative complications peri-operative MI0% postoperative IABP26% bleeding needing reoperation3% CVA3% dialysis8% 1 pre-op chronic dialysis

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Echocardiographic data Pre-operativePost-operativep-value LVEF (%)20.5 6.433.9 9.8 65 < 80:RMA + CorCap RMA + "Dor" > 80:HTX SVR (+ RMA)" title="The "Leiden Algorithm" Preop LVEDD < 65:RMA > 65 < 80:RMA + CorCap RMA + "Dor" > 80:HTX SVR (+ RMA)">

The "Leiden Algorithm" Preop LVEDD < 65:RMA > 65 < 80:RMA + CorCap RMA + "Dor" > 80:HTX SVR (+ RMA)

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Reversible cause? No Correction Recovery Follow Up NON-ISCHEMIC (medication+ lifestyle) No complete recovery RESYNCHRONIZATION? Significant Valve disease? Indication SVR? Valve surgery + SVR Valve surgery CorCap Yes No Indication SVR? Yes No INVASIVE SURGERYREVASCULARISATION/SURGERY No ISCHEMIC Ischemia and/or viability? AP and significant CAD? CABG + valve-surgery Significant Valve disease? CABG + SVR/Dor + valve surgery Indication LV- reconstruction? SVR/Dor Indication LV- reconstruction? Valve surgery + SVR/Dor Indication SVR/Dor? Significant Valve disease? CABG + SVR/Dor PCI or CABG Yes No Yes No Valve surgery ( CorCap) No Yes Indication SVR? Yes No FOLLOW UP Yes MISSION! HF

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INVASIVE MISSION! HF REVASCULARISATION/SURGERY ISCHEMIC Ischemia and/or viability? AP and significant CAD? CABG + valve-surgery Significant Valve disease? CABG + SVR/Dor + valve surgery Indication LV- reconstruction? SVR/Dor Indication LV- reconstruction? Valve surgery + SVR/Dor Indication SVR/Dor? Significant Valve disease? CABG + SVR/Dor PCI or CABG Yes No Yes No Valve surgery ( CorCap) No Yes Indication SVR? Yes No FOLLOW UP Yes RESYNCHRONIZATION?

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Reversible cause? No CorrectionRecovery Follow Up NON-ISCHEMIC (medication+ lifestyle) No complete recovery RESYNCHRONIZATION? Significant Valve disease? Indication SVR? Valve surgery + SVR Valve surgery CorCap Yes No Indication SVR? Yes No INVASIVE SURGERY No FOLLOW UP MISSION! HF

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SCREENING & ETIOLOGY History NYHA class Examination LAB ECG X-ray Chest TTE Further analysis Chronic heart failure? No LVEF < 40% NYHA III or IV Exercise testing with VO2 max Myoview stress and rest, FDG CAG (left & right) 24 hour Holter monitoring additional LAB QOL score + 6 min. walk test Old myocardial infarction and/or 1 coronair with > 50% stenosis? Yes ISCHEMIC causeNON-ISCHEMIC cause No LAB NT-proBNP Complete blood count ESR, CRP Electrolytes, Creat, BUN Liver panel Lipid profile TSH, fT4 Glucose Yes No Yes THERAPY Further analysis

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MISSION! HF BASIS NYHA I Continue medication(!), lower dosis diuretics NYHA II Atrial fibrillation VR > 100: Digoxine Diuretics ACE-inhibitor eta blocker + + Thiazide 1 dd when mild HF and clearance > 30 - start ATB in case of ACE-intolerance - c.i.: potassium > 5.5, dubbelsided renal arterystenosis - raise every 2 weeks untill (individual) maximum Persisting low potassium: start spironolacton 1 dd 12.5 mg or Inspra 1 dd 12.5 mg Loopdiuretics 1 dd Loopdiuretics 2 dd - start when no signs of decompensation - raise every 2 weeks until (individual) maximum Loopdiuretics 2 dd + Thiazide Nitrate in case of orthopnoea Consider Nitrate i.c.w. Hydralazine in case of ACE-intolerance Spironolacton 1dd 25 mg - in case of gynaecomasty: eplerenone 1 dd 25-50 mg - c.i.: potassium > 5.0, Creat > 250 - if needed, consider ATB in stead of spironolacton NYHA III or IV NYHA IV Digoxin (sinusrhythm) NYHA III MEDICATION

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MISSION! HF RESYNCHRONIZATION? Biventricular ICD FOLLOW UP EF < 30% VF or haemodynamic unstable VT ICD EF 30 - 40 % + VT/NSVT EFO Indication HTx? Stemcell therapy? ICD When pre-operative: LVEF 40 or QRS > 120ms: - epicardial LV-lead peri- operative - post-operative biventricular ICD When pre-operative: - LVEF < 30%: ICD post-operative - LVEF > 30% + (NS)VT: EFO + ICD When surgery waitinglist is long and (biv) ICD indication: consider (biv) ICD implantation pre- operatively SL delay > 40 ms (EF < 30% + NYHA III or IV) Yes No SCD RISK ASSESSMENT

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MISSION! HF FOLLOW UP and RE-EVALUATION Month 3 + Month 9 Week 2-3 AFTER INVASIVE PROCEDURE DOCTOR + HF nurse History, NYHA class Examination LAB ECG TTE (only Month 3 visit) HF nurse History, NYHA class Examination LAB (incl. NT-proBNP) ECG REGULAR FOLLOW UP Month 6 + Month 12 DOCTOR + HF nurse HF nurse History, NYHA class Examination LAB (incl. NT-proBNP) ECG QOL + 6 min. walk test Exercise + VO2max TTE Only month 12 visit: 24 hour holter RE-EVALUATION Every year or worsening NYHA When appropriate, re-evaluate indication for: - revascularisation - valve / LV surgery - resynchronization therapy - ICD - HTx - stemcell therapy every 3 months DOCTOR + HF nurse History, NYHA class Examination LAB (incl. NT-proBNP) ECG Exercise + VO2max TTE LUMC every year OWN CARDIOLOGIS T NYHA class III / IV NYHA class I / II History, NYHA class Examination LAB ECG DOCTOR + HF nurse History, NYHA class Examination LAB (incl. NT-proBNP) ECG TTE Exercise + VO2max QOL + 6 min. walk test Holter (CAG) ( Myoview) PRE-OP 2 weeks before surgery HF nurse History, NYHA class Examination LAB ECG RE-EVALUATION DOCTOR every 6 months History, NYHA class Examination LAB ECG

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Acute hemodynamic effects of restrictive mitral annuloplasty in patients with end-stage heart failure S.A.F. Tulner, P. Steendijk, R.J.M. Klautz, J.J. Bax, M.I.M. Versteegh, E.E. van der Wall, R.A.E. Dion J Thorac Cardiovascular Surgery (in press) Departments of Cardio-Thoracic Surgery and Cardiology Leiden University Medical Center

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Results: typical example of RMA

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Control group Unchanged systolic function Improved active relaxation, increased diastolic chamber stiffness Restrictive Mitral Annuloplasty No significant acute effects on global, and intrinsic systolic function Alterations in diastolic function appear similar to the control group Conclusions