Bridge to Heart Transplantation Ulf Kjellman MD, PhD Senior Consultant Surgeon Heart Centre KFSH&RC 1
Disclosure Appointed for Proctorship by Thoratec/St.Jude/Abbott 2
To run a full overall covering transplant program is no longer possible without an additional VAD program! 3
Referral rate increasing due to better knowledge of the options for heart failure treatment local hospitals BUT! still donor shortage! 4
Europe 15 25 multi organ donors/million Saudi Arabia 5 multi organ donors/million (based on Saudis and expacts together, 25 million) Majority is from expats! 5
Why is a patient candidate for MCS? bridge to transplantation (BTT) bridge to candidacy (BTC) bridge to destination (BTD) lifelong heart transplantation ( bridge to recovery) 6
To be a suitable candidate for heart transplantation: Preserved end organ function Pulmonary vascular resistance (< 3.0 Wood units, TPG < 15) [Other contraindications (compliance, malignancies, other comorbidities)] Expected long waiting time (blood group, sensitized, malignancy without recurrence) 7
50 % on MCS at the time of tx! 8
% of Transplants Adult Heart Transplants % of Patients Bridged with Mechanical Circulatory Support* by Diagnosis and Era 60 2008-2005 2012-2009 6/2015-2013 50 40 30 20 10 0 CHD HCM ICM NICM RCM Retransplant VCM 2016 JHLT. 2016 Oct; 35(10): 1149-1205 * LVAD, RVAD, TAH, ECMO 9
Majority is from LVAD! 10
Distribution between pump type 11
The majority is the continuous flow pumps 12
When to Bridge? 13
Intermacs level 1 Intermacs level 2 Intermacs level 3 on circulatory support/cardiogenic shock progressive decline on inotropic support stable on inotropic support Intermacs level 4 Intermacs level 5 Intermacs level 6 Intermacs level 7 frequent flyer (volume overload) Housebound (stable at rest) walking wounded (minor limitation in activity) placehoulder (NYHA 2-3, no water retention) 14
No difference in outcome (death, tx, recovery) between level 1-3 and level 4-7 Level 4 7 can be medically treated! 15
INTERMACS Level at the Time of Transplant Assessment Predicts Overall Mortality and Probability of Advanced Therapy A.C. Alba, T. Wu, V. Rao, D.H. Delgado, H.J. Ross Toronto General Hospital, University Health Network, Toronto, Canada Conclusions INTERMACS level at initial HTx assessment is an independent predictor of overall mortality. Survival was similar in patients receiving VAD or HTx. However, patients with worse INTERMACS level had higher overall mortality and lower chances of undergoing HTx. These results may help physicians to make informed decisions when considering advanced therapies. 16
Risk factor analysis for patients receiving continuous-flow left VADs (LVADs) Risk factors for death Hazard ratio (early) p-value Hazard ratio (constant) p-value Demographics Age (older) 1.69 <0.0001 Body mass index (higher) 1.47 <0.0001 Clinical status Ventilator 1.65 0.009 History of stroke 1.69 0.009 INTERMACS Level 1 2.45 <0.0001 INTERMACS Level 2 1.89 0.0004 1.30 0.003 Destination therapy 1.25 0.01 Non-cardiac systems Diabetes 1.22 0.02 Creatinine (higher) 1.10 0.008 Dialysis 2.22 0.002 Blood urea nitrogen (higher) 1.10 <0.0001 Right heart dysfunction RVAD in same operation 3.73 <0.0001 Right atrial pressure (higher) 1.36 0.002 Bilirubin (higher) 1.08 <0.0001 Ascites 1.32 0.05 Surgical complexities History of cardiac surgery 1.50 <0.0001 17
Artif Organs. 2015 Dec;39(12):998-1004. doi: 10.1111/aor.12501. Epub 2015 May 25. Is Implantation of a Left Ventricular Assist Device in Patients With Critical or Impending Cardiogenic Shock an Absolute Contraindication? Looking Back at Our Past Experience Trying to Identify Contraindicative Risk Factors. Dell'Aquila AM 1, Schneider SR 1, Risso P 2, Welp H 1, Glockner DG 1, Alles S 1, Sindermann JR 1, Scherer M 1 1 Department of Cardiothoracic Surgery, Division of Cardiac Surgery, University of Münster, Münster, Germany. 2 Epidemiology and Social Psychiatry Unit, Mario Negri Institute for Pharmacological Research, Milan, Italy. AbstractPoor survival has been demonstrated after ventricular assist device (VAD) implantation for Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 and 2 patients compared with more stable levels. However, risk factors within this high-risk cohort have not been determined so far. The aim of the present study was to identify risk factors associated with this very high mortality rate. Between February 1993 and January 2013, 298 patients underwent VAD implantation in our institution. One hundred nine patients were in INTERMACS level 1 and 49 patients were in INTERMACS level 2 and were therefore defined as hemodynamically critical (overall 158 patients). Assist devices implanted were: HVAD HeartWare n = 18; Incor n = 11; VentrAssist n = 2; DeBakey n = 22; and pulsatile systems n = 105. After cumulative support duration of 815.35 months, Kaplan-Meier analysis revealed a survival of 63.9, 48.8, and 40.3% at 1, 6, and 12 months, respectively. Cox regression analyses identified age > 50 (P = 0.001, odds ratio [OR] 2.48), white blood cell count > 13.000/μL (P = 0.01, OR 2.06), preoperative renal replacement therapy (P = 0.001, OR 2.63), and postcardiotomy failure (P < 0.001, OR 2.79) as independent predictors of mortality. Of note, last generation VADs were not associated with significantly better 6-month survival (P = 0.59). Patients without the aforementioned risk factors could yield a survival of 79.2% at 6 months. This single-center experience shows that VAD implantation in hemodynamically unstable patients generally results in poor early outcome, even in third-generation pumps. However, avoiding the aforementioned risk factors could result in improved outcome. 18
1 Year survival BiVAD/TAH on 55-60% (compared to LVAD 85%) 19
Comparison between CF-LVAD and Heart Tx 1 year survival is equal! 20
RVAD in addition, more frequent in level 1 patients 21
Time to tx! After 20 months almost 50% are still on VAD:s Donor shortage! 22
Bridge to Candidacy group almost 60% on VAD after 20 months Donor shortage! 23
Comparison axial- (second generation) and centrifugal- (third generation) flow pumps 24
Recent launched results comparison between HM II and HM III 25
Complexity matters! 26
Complications infections, bleeding, malfunction, stroke or death 27
28
KFSH&RC! HM II HMI HM III TAH 29
Future? Miniaturized pumps Infection control Total implantable challenge the excellent results of heart transplantation. 30
Conclusion Bridging has become an important tool for end stage heart failure/transplantation and essential for patients in multiorgan deterioration to reach a transplantation The results of VAD implantation is strongly related to the patients status (biventricular failure/end organ failure) pre-implantation TIMING! Biventricular failure requiring BIVAD/TAH or RVAD has worse outcome Because of donor shortage, more than 50% (worldwide) of all on the waiting list are on VAD:s Having appropriate timing for implantation (Intermacs level), the 1 year survival rate is equal to the Golden Standard, heart transplantation, both for BTT and BTC 31
Thank you for your attention! Two happy guys on HM II support awaiting donors! 32
Demographics (HM III April 2016) gender age BSA diagn. Intermacs date Support(days) Tx adverse events 1. male 12 1.14 DCM 2 6/4 63 x arrhythmias 2. male 20 1.68 DCM 2 17/5 197 x arrhythmias 3. male 54 2.0 DCM 1(vent.,shock) 13/6 ongoing arrhythmias 4. male 28 1.71 DCM 2 25/8 ongoing 5. male 37 2.5 DCM 2 13/7 ongoing cerebellar infarction? 6. male 61 2.0 ICM 2 10/10 ongoing 7. male 15 1.7 DCM 2 23/10 ongoing sepsis (UTI) 8. male 43 2.0 ICM 3 6/12 ongoing 2017 1. male 56 1.6 DCM 2 3/1 ongoing repositioning inflow MOF, expired 2. male 39 1.9 retranspl. 2 16/1 ongoing 3. male 54 1.67 ICM 1(ECMO) 7/2 ongoing 4. male 18 1.64 DCM 1(ECMO) 23/2 ongoing