I have nothing to disclose.

I have nothing to disclose.

Right ventricular failure and need for biventricular support Friedrich Wilhelm Mohr, MD, PhD Munich, August 27, 2012

Male; date of birth: 19.07.1984 Out clinic visit 10/ 2004: dilatative cardiomyopathy (EF ca. 33 %) => 1st diagnosis: 10/2003 Sekundary MI I bicuspid aortic valve with insufficiency I No CAD NYHA I

Copyright American Heart Association Number of patients with advanced heart failure (HF) (author estimates) Miller L W Circulation 2011;123:1552-1558

VAD + TAH History 1957:PVC 1969: full metal 1969: Diaphragma 4-chamber heart 1969: first implant TAH

First implantation of a total artificial heart in 1969. The Liotta TAH is now in the Smithsonian Institution in Washington, DC. Cooley D. A. Nature Medicine 2003; 9(1)

BVAD for bridging to transplant (1989)

Hearttransplantation and waiting list in Germany 1000 900 800 700 600 500 400 HTx Warteliste 300 200 100 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 www.eurotransplant.org

Bridge to Transplant is an obsolete idea from the 20th century

14. June 2005 TCI Heartmate

Rematch Trial 129 pts. (68 LVAD / 61 medical therapy) Enrollment May 1998 July 2001 NYHA 4 / all pts. non eligible for HTx 14. June 2005

REMATCH-Studie (enrollment 1998 2001) 100 survival (%) 80 60 40 20 0 Med n = 61 LVAD n = 68 HTx 0 5 10 15 20 25 30 Timinterval post implant (Months) Rose et al. NEJM 2001

Rematch Trial Results 1 year survival 25 % medical therapy / 52 % LVAD 2 year survival 8 % medical therapy / 23 % LVAD Adverse events Overall rate ratio 2.35 for LVAD group Neurologic dysfunction: rate ratio 4.35 14. June 2005

Rematch Trial causes of Death medical therapy LVAD Left ventricular dys. 50 1 Sepsis 1 17 LVAD failure 0 7 Stroke 0 4 Other 3 12 Total 54 41

Seattle Heart Failure Model HeartWare LVAD Strueber et al: JACC 2011

Long term mechanical circulatory support with LVADs has become a reality in Europe and the United States However, long term biventricular support with contemporary devices is not acceptable for: Complications QoL Efforts are made to: 1. prevent need for RV support and implant only LVAD 2. Develop new devices for RV support with acceptable QoL

Haddad et al; Anesth Analg 2009;108:407 21

Figure 2. Pressure-volume loops of the right ventricle under different loading conditions. The slope of maximum timevarying elastance (Emax) is displayed on the graph. Adapted from Dell Italia et al. Figure 3. The response of the right and left ventricle to experimental increase in pressure or afterload. Adapted from MacNee et al. Haddad et al; Anesth Analg 2009;108:407 21

Functional parameters of the RV are extemely load dependend --> Optimization of RV load prior to LVAD implant to prevent need of mechanical support of the RV Haddad et al; Anesth Analg 2009;108:422 33

The RV is extremely afterload sensitive Reduction of PVR at time of LVAD implantation to prevent need for mechanical support of the RVAD Nitric Oxide, PDE inhibitors, Prostacyclin etc Temp. ECMO is preferred over temp. RVADs, because of reduction of PA pressure which may allow faster RV recovery Only when RV management including temp. ECMO fail and in rare Indications (RV infarction, Amyloidosis, special forms of Myocarditis) BVAD should be implanted

HVAD als BiVAD Strueber et al, JTCVS 2010 Herz-, Thorax-, Transplantations- und Gefäßchirurgie

Time period September 2009 to October 2011: 14 Patients Indication biventricular failure: High catecholamine support (Intermacs class 1) : in 10 patients RVAD placement after failed weaning from temp. RVAD: 4 ECMO support in 7 patients 2 patients with nonsystolic heart failure 7 female, 7 male patients Age: 23 61 Overall follow up: 2360 patient days

Diagnosis n DCM 7 ICM 3 HOCM 2 toxic 1 PPCM 1

Surgical technique: RV anterior wall cannulation: 1 RV cannulation at diaphragm: 11 RA cannulation (HOCM) 2 Standard LV cannulation at apex Opening of left pleural space: 14 Opening of right pleura 8 No flow restriction of RVAD

Survival after BVAD implant (HVADs, n = 14) X X X : unstable on ECMO

Outcomes Early death due to multiorgan failure: 2 Transplant after 214 and 239 days 2 Weaning from RVAD (explant of driveline) 2 after 214 and 239 days Late deaths to sepsis (after 180 days) 2 Ongoing 6

CDAS

Patient JS24101987 Log Files

Patient 4 BIVAD From 1800 to 2600 RPM: RVAD Flow = 1.50 LPM LVAD Flow = 1.21 LPM

Patient RA21011950 Mobility Study (2 minutes walking) Sitting Standing Sitting Walking Sitting LVAD Sitting Standing Sitting Walking Sitting RVAD

Patient 3 BIVAD Effective Native RH Function From 1800 to 2600 RPM: RVAD Flow = 1.39 LPM LVAD Flow = 0.10 LPM RVAD Turned Off, LVAD flow UNCHANGED **Patient evaluated for possible weaning from RVAD support**

Analysis of flow curves suggest Adaptation of LVAD flow to RVAD output by preloadsensitivity (no adaptation of speed required) Changes of flow by activity and circadian rhythm indicate autoregulation of BIVAD flow patterns

Implantation of 2 Heartware HVADS as a TAH in a patient with massive MI and VSD Strueber et al, JTCVS 2012

Case report continued 02/2012: NYHA III IV Aortic insufficiency II EF 22% high urgency for heart transplantation Deterioration: bed ridden, aortic insufficiency II-III 08/2012 Biological Aortic valve replacement and LVAD (HVAD) RV heart failure besides optimized medical therapy ECMO implantation a week later

Conclusions for RV Failure Careful RV management prevents RVAD need in most cases ECMO for transient RV support after LVAD The HVAD can be used safely for biventricular support BVAD is used as BTT, no current long term option New technical developments may lead to long term BIVAD support with adequate QoL