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SATS, Stockholm 2009 Lars H Lund Recovery and Weaning from long-term LVADs

SATS, Stockholm 2009 Lars H Lund Recovery and Weaning from long-term LVADs. ECMO and short-term VAD. Impella Recover Short-term Percutanoues Axial flow 2.5-5 L/min. ECMO. Percutaneous IABP 0.5 L/min. TandemHeart pVAD Percutanoues Centrifugal axial flow.

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SATS, Stockholm 2009 Lars H Lund Recovery and Weaning from long-term LVADs

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  1. SATS, Stockholm 2009 Lars H Lund Recovery and Weaning from long-term LVADs

  2. ECMO and short-term VAD Impella Recover Short-term Percutanoues Axial flow 2.5-5 L/min ECMO Percutaneous IABP 0.5 L/min TandemHeart pVAD Percutanoues Centrifugal axial flow Centrifugal axial flow extracorporeal Bidge 3M Sarns Medtronic Bio-Medicus Levitronix Centrimag

  3. Pulsatile TAH Thoratec HeartMate I XVE Bridge Destination (REMATCH) Abiomed BVS 5000 and AB5000 Short-term. L- R- or Bi-VAD. BB (BTx) Thoratec VAD Bridge Post-cardiotomy Novacor LVAS Bridge Destination trial (INTrEPID) Abiomed Abiocor TAH Pulsatile Axial flow CardioWest TAH Pulsatile Thoratec HeartMate II Bridge Destination MicroMed DeBakey VAD Bridge Destination Jarvik 2000 Bridge Destination Ventracor VentrAssist Bridge trial (DEVICE) Destination

  4. Severe Heart Failure • - Common • - Deadly • - Treatable • In Sweden: • >100,000 systolic heart failure30-40% get β-blockers and ACEI • <10% of indicated get CRT / ICD • 10,000 NYHA IV • 3000 benefit from transplant <50 per year • 500-2000 benefit from LVAD <50 per year • Why? OBS-CHF RiksSvikt Lund, Med Clin North Am 2004 Slaughter, ISHLT 2008 Stevenson, ISHLT Monograph 2006

  5. Cost effective? • MCSD / LVAD improves quality of life and survival • 2-yr survival destination therapy 50-70% • Cost ~ € 60,000 HMII + • ~ € 60,000 hospital care • Cost per QALY ~ € 45,000 • yes • Slaughter, ISHLT 2008 • Lund, Device Therapy for HF 2009

  6. Indicated? LVAD / MCS Guidelines - ESC Bridge to Tx IIa – C Dickstein, EHJ 2008 Destination IIb – B - ACC/AHA Bridge to Tx approved 2008 Hunt, Circ 2005 / 2009 Destination IIa – B - Swedish Socialstyrelsen Bridge to Tx 6/10 Destination FoU Nationella riktlinjer för hjärtsjukvården – Beslutsstöd, 2008 yes – and becoming stronger

  7. 52% 23% 23% 6% Rose, NEJM 2001;345:1435 Improved outcomes 1: Technology REMATCH vs. HM II 79% 77% 42% 36% 19% 2% 1% HM II investigators, NEJM 2007

  8. Improved outcomes 2: ExperienceREMATCH Learning Curve: Early vs. Late Survival in LVAD Arm Legend = 21st Century = 20th Century (12) (4) P=.0338 (9) (0) 12/29/02 DatasetMoskowitz

  9. Improved outcomes 3: SelectionREMATCH survival according to pre-op risk K. Lietz et al. Circulation 2007

  10. Lund, Device Therapy for HF 2009 Lietz, in press Potapov JHLT 2008 Ochiai Circ 02 Dang JHLT 06 Scalia J Am soc Echo 00 Puwanant JHLT 2008 Matthews JACC 2008 Lietz, Miller, Circulation 2007 RVEDD PSAX >35 mm RVFAC <30% RA >50 mm RVSWI <250-300-400 / <4 RV ischemia low sPAP and mPAP (<25) low PVR SBP <96 high CVP (>15) low CI (<1,8-2.3) high PCWP low mixed venous saturation transfusions female gender low BSA non-ischemic etiology myocarditis pre-op MCS previous cardiac surgery pulmonary edema emergent implantation albumin <3.3 spontaneous INR>1.3, PTT >15 Hematocrit <34 Platelets <150 WBC >10 organ failure features: mechanical ventilation ascites bili ≥2 crea ≥2.3 AST ≥50-80 vasopressors Y STOP Contraindication AI (close valve) LV thrombus permanent HD cirrhos och port HT (HIT) spont INR>2,5 sepsis recent stroke Unclear neuro status N MOF: most or all of: ascites bili ≥ 2 creat ≥ 2.3 AST ≥ 80 mechanical ventilation vasopressors 3-4/4 TR RV S/L >0.6 TAPSE <7.5 N N many Y Y few Lund, version 6, 20-april-2009 BiVAD / TAH LVAD

  11. Indications long-term LVAD • - Bridge to Tx: EF<25% and • NYHA IV and • PCWP >20 and • SBP <90 or CI <2 • PVR>5 or • GFR <25-30 • From short-term MCS • Destination: EF<25% and • chronic inotropes or pVO2<12 • Bridge to recovery? 1. Potential for recovery • 2.Transplant or destination contraindicated or unwanted? • 3. Improvement but incomplete recovery? – • Lund, Device Therapy for HF 2009, Stevenson in ISHLT Monograph Mechanical circulatory support 2006, McCarthy, P.M., and Young, J.B. 2007. Heart failure : a combined medical and surgical approach, Aaronson, Patient selection for left ventricular assist device therapy. Ann ThoracSurg 75:S29-35, 2003 restoration

  12. Recovery? Remodelling Reverse Remodelling Lund, Device Therapy for HF 2009

  13. Frank-Starling C A: normal rest B: initial insult ↓CO C: RAAS  ↑filling pressure catecholamines  ↑contractility

  14. LVAD  Reverse remodeling Geometric: Normalize LV geometry – ”restoration” ↑ EF ↓ LVEDD Hemodynamic ↑pVO2 ↑CO ↓PCWP Neurohormonal: ↑ B1-receptor (at protein but not mRNA level) ↔ B2-receptors ↑ response to B1 stimulation Cellular: ↓ hypertrophy Extracellular: ↓ fibrosis ?? ↑ cytoskeletal dystrophin structure Ca2+ handling (molecular): ↑ mRNA for SERCA2a, RyR2, Na+/Ca2+ exchanger ↑ protein for SERCA2a ↓ phosphorylation of RyR2 (PBMC) Vatta Lancet 2002, Marx Cell 2000, Heerdt Circ 2000, Bruckner JHLT 2001, Ogletree-Hughes Circ 2001, Milting ISHLT 2008

  15. Remodelling in Heart Failure and mechanisms of MCS recovery Marks, J Clin Invest. 2003 Mar;111(5):617-25.

  16. Molecular recovery – 2000: Unloading  ↓phosphorylation of RyR Marx, Reiken et al, Cell 101:265

  17. Reproducible clinical recovery – 2006: • 15 patients idiopathic DCM: • LVAD • 2x lisinopril (Zestril) 40 x 1 • 2x carvedilol 50 x 2 • 1x spironolactone 25 x 1 • 2x losartan (Cozaar) 100 x 1 • Clenbuterol Most important: high-dose β-blocker 11/15 explant at ~320 days 9 lived 1 year, 8 lived 4 years EF 64% Peak VO2 26 ml/kg/min MLHFQ: near-normal  But other studies 1-40% recovery N Engl J Med 2006; 355:1873-1884, Nov 2, 2006.

  18. How evaluate Recovery ? Harefield Recovery Protocol, George JHLT 2007 No a priori predictors No predictors device on EF and BP predictors device off Also need exercise test?

  19. Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure HARPS Treatment: clenbuterol Georgetown Montefiore Northwestern Ohio state Texas Heart Minnesota Pennsylvania Criteria for explant: at 6000 rpm (4500 rpm or 3600) LVEDD < 6 cm LVESD < 5 cm LVEF > 45% PCWP < 12 mmHg Cardiac Index > 2.8 L/min/m2 Peak VO2 > 16 ml/kg/min VE/VCO2 < 34

  20. Weaning protocol axial flow Aaronson, Michigan Mancini, Columbia Dandel, Hetzer, D Herz El Banayoysi, Bad Oeyn. Echo pump ”on”: EF < 45% LVEDD > 55mm Mod-sev TI or MI Ischemic HF > 5 years Non-sinus rhythm Age > 65 High NT-proBNP N ”off” = heparin 300E/kg bolus, ACT>400, rpm down for max 15 min N approach 1 VO2 >14 pump ”on” Echo OK pump ”off” BP stable pump ”off” N approach 2 Y Y Y N Pump ”off” + Exercise: CVP >6 or ↑>3 PCWP >10 or ↑>5 SBP <90 Symptoms Supine bike <50W = <VO2 10 In clinic repeat 3 times: Full heparin to 6000 rpm Echo pump ”off” OK Y N Y N No recovery Explant

  21. Case 1 37 year-old African-American woman Gives birth sep 2007 10 days later pulmonary edema, cardiogenic shock, EF 5-10%, LVEDD 51 ECMO, fails weaning HM II 6 months later: NYHA I BP 80 EF 70%, LVEDD 37 mm NT-proBNP 100 ng/L furosemide 20 x1 metoprolol 50 x1 ramipril 5 x2 spironolakton 25 x1 itch from candesartan physical therapy Candidate for weaning and explant? Yes ! Case 2 47 year-old man Active hepatitis C 2 weeks fever, weakness, fatigue EF 10-15%, LVEDD 58 On dobutamine and levosimendan: BP 85/60, PCW 17, CI 1.8 Impella 5.0 L, fails weaning HM II 4 months later: NYHA I BP 100 EF 35%, LVEDD 41 mm NT-proBNP 850 ng/L No furosemide carvedilol 50 x2 enalapril 20 x2 spironolactone 25 x1 ARB to be added physical therapy Candidate for weaning and explant? Yes/ No ?

  22. Centrum för mekanisk assisterad cirkulation och Hjärttransplantation i Mälardalen LVAD sub-group Perfusion Physical Therapy Nursing Linnea Tiren Kerstin Karlsson Ann Hallberg Maria Halseth Irene Lindell Emma Isaksson Surgery Anaesthesiology Cardiology Physiology Social Work Gunilla Nilsson - Maria Eriksson: data - Conny Rundby: what we did Drs Khagani, Buckberg, Anyanwu and Weitkemper: - Optimal care during LVAD support – exercise? - Incomplete recovery enough? - HARPS criteria enough?

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