HOW TO SELECT HEART FAILURE PATIENTS FOR … · HOW TO SELECT HEART FAILURE PATIENTS FOR MECHANICAL...

HOW TO SELECT HEART FAILURE PATIENTS FOR MECHANICAL ASSISTANCE: THE POINT OF VIEW

OF THE FAILURE CLINICIAN

A. Mortara

Dipartimento di Cardiologia UO di Cardiologia Clinica e Scompenso Cardiaco

Policlinico di Monza

Predic've  models  can  target  high-­‐risk  popula'ons  but  leave  wide  uncertain'es  around  es'mates  of  survival  for  an  individual.  

* Rose EA et al NEJM 2001 (Rematch trial)

 Heart Tx in Italy

•  The cornerstone of successful therapy with MCS is timely and appropriate patient selection.

•  Mortality risk in the outpatient setting: –  Seattle Heart Failure Score (but underestimates the

risk) –  INTERMACS profile

•  Mortality risk in the inpatient setting –  End-organ dysfunction –  Number, frequency and duration of hospitalizations

•  The weighing of risk vs benefit is an iterative process

ISHLT MCS/VAD Guidelines - Identifying the high-risk patient -

LVAD timing

§  Not  too  late:  The  first  hospitalization  requiring  inotropes   and   initial   signs   of   deterioration  must   prompt   decision   before   irreversible  multiorgan   dysfunction   makes   any   therapy  futile.  

§  Not   too   early:  As   for  HTx,   the   scope   of   LVAD  therapy   is   to   improve   overall   (not   just  postoperative)  pt  survival.      

Criteria for VAD Implantation (Rematch and Revive IT Pilot)

Inclusion C.

•  NYHA IIIb-IV •  Refractory to med. Therapy •  Max Med.therapy since 3 m. •  LVEF < 25% •  Peak Vo2 < 12 mL/Kg/min •  Inotropic support since 30 days •  Appropriate body size for VAD

Exclusion C.

•  Age > 80 yrs •  Inotropic Therapy snce 6 m. •  Albumine < 3.3 mg/dl •  Renal failure •  Right Vx failure •  Infections •  End organ demage •  Aortic Valve disease

1  yr  survival  less  than  30%  

* Rose EA et al NEJM 2001 (Rematch trial) ** Slaughter MS et al NEJM 2009

Advanced HF Red Flags

§  Intolerance of beta-blockers and/or ACE I/ARB

§  High diuretic requirement §  Persistence of elevated BNP/NT proBNP §  Recurrent hospitalizations §  Need for inotropes §  Hyponatremia §  Progressive renal insufficiency

J Heart Lung Transplant 2013

J Heart Lung Transplant 2013

J Heart Lung Transplant 2013

VAD-­‐  Adverse  Events  Device  Malfunc-on  

J  Heart  Lung  Transplant    2013  

J  Heart  Lung  Transplant    2013  

VAD- Risk Factors for Mortality Destination Therapy

1  

2  

3  

4  

5  

6  

7  

Dying/MOF  

Crash  &  Burn  

Sliding  fast  

Stable  but  inotropic  dependent  

Res'ng  symptoms  home  on  oral  therapy  

Exer'on  intolerant  (Housebound)    

Exer'on  limited  (Walking  wounded)  

Advanced  NYHA  III  %1-Year Survival

100%

50%

25%

10%

0%

Severity  of  End-­‐Stage  Heart  Failure  INTERMACS  Levels  

*Does  not  account  for  arrhythmia  

J Heart Lung Transplant 2013

VAD- Risk Factors for Mortality Older Age

J  Heart  Lung  Transplant    2013  

VAD- Risk Factors for Mortality Renal Dysfunction

J  Heart  Lung  Transplant    2013  

VAD- Risk Factors for Mortality Right Ventricular Dysfunction

J  Heart  Lung  Transplant    2013  

VAD-­‐  Risk  Factors  for  Mortality  

J  Heart  Lung  Transplant    2013  

VAD-­‐  Adverse  Events  Major  Neurologic  Events  

J  Heart  Lung  Transplant    2013  

VAD-­‐  Adverse  Events  Pump  Related  Infec-ons  

J  Heart  Lung  Transplant    2013  

VAD-­‐  Adverse  Events  Rate  in  the  first  12  months  aCer  implant  

Heart  Failure  2012  19-­‐22  May  2012,  Belgrade  -­‐  Serbia  

ESC Guidelines 1012 - Recommendations for surgical implantation of LVADs in patients with systolic heart failure  

Heart  Failure  2012  19-­‐22  May  2012,  Belgrade  -­‐  Serbia  

Key  evidence  ü  Ventricular  assist  devices  may  ul'mately  

become  a  more  general  alterna-ve  to  transplanta-on,  as  current  2-­‐  to  3-­‐year  survival  rates  in  carefully  selected  pa'ents  receiving  the  latest  con'nuous  flow  devices  are  much  beYer  than  with  medical  therapy  only.  

ü  Pa'ents  receiving  these  devices  also  have  a  post-­‐transplant  survival  rate  similar  to  those  not  requiring  bridging  

Patients potentially eligible for implantation of a ventricular assist device

Heart  Failure  2012  19-­‐22  May  2012,  Belgrade  -­‐  Serbia  

ESC/HFA  Guidelines  2012  

1. Evalua(on   of   right   ventricular   func(on   is   crucial   as   post-­‐operaRve  right  ventricular  failure  greatly  increases  perioperaRve  mortality  and  reduces  survival  to,  and  aCer,  transplantaRon.  

 2.  Referral  before  right  ventricular  failure  develops  is  preferable.    

•  Indeed,   earlier   ventricular   assist   device   implanta(on   in   less  severely   ill   pa(ents   (e.g.   with   an   EF<25%,   peak   oxygen  consumpRon   <12   mL/kg/min,   and   only   requiring   intermi]ent  inotropic   support),   and   before   right   ventricular   or   mul(organ  failure  develops,  leads  to  be]er  surgical  outcomes.  

Heart  Failure  2012  19-­‐22  May  2012,  Belgrade  -­‐  Serbia  

Mechanical Circulatory Support (Key Evidence)

ESC/HFA Guidelines 2012

Recommendations for MCS • MCS for BTT indication should be considered for transplant-eligible patients with end-stage HF who are failing optimal medical, surgical, and/or device therapies and at high risk of dying before receiving a heart transplantation (Class I; Level of Evidence B). • Implantation of MCS in patients before the development of advanced HF (ie, hyponatremia, hypotension, renal dysfunction, and recurrent hospitalizations) is associated with better outcomes. Therefore, early referral of advanced HF patients is reasonable (Class IIa; Level of Evidence B). • MCS with a durable, implantable device for permanent therapy or DT is beneficial for patients with advanced HF, high 1-year mortality resulting from HF, and the absence of other life-limiting organ dysfunction; who are failing medical, surgical, and/or device therapies; and who are ineligible for heart transplantation (Class I; Level of Evidence B). • Elective rather than urgent implantation of DT can be beneficial when performed after optimization of medical therapy in advanced HF patients who are failing medical, surgical, and/or device therapies (Class IIa; Level of Evidence C).  

Recommendations for MCS • Urgent nondurable MCS is reasonable in hemodynamically compromised HF patients with endorgan dysfunction and/or relative contraindications to heart transplantation/durable MCS that are expected to improve with time and restoration of an improved hemodynamic profile (Class IIa; Level of Evidence C). • These patients should be referred to a center with expertise in the management of durable MCS and patients with advanced HF (Class I; Level of Evidence C). • Patients who are ineligible for heart transplantation because of pulmonary hypertension related to HF alone should be considered for bridge to potential transplant eligibility with durable, long-term MCS (Class IIa; Level of Evidence B). • Evaluation of potential candidates by a multidisciplinary team is recommended for the selection of patients for MCS (Class I; Level of Evidence C).  

Guidelines  for  MCS  

1. AorRc  Valve  disease  2. Mitral  and  Tricuspidal  Valve  diseases  3. Renal  Failure  4. MalnutriRon  5. Liver  Disease  6. RV  Failure  

LVAD  AorRc  Insufficiency  (AI)  

•  Transcatheteric  aorRc  valve  replacement-­‐TAVI  •  Minimaly  invasive  closure  •  ConvenRonal  operaRon  

Therapy  OpRons  

Potapov,  Herzzentrum-­‐Berlin,      ISHLT  2013  

Circ Heart Fail. 2012;5:286-293  

Frailty is the aggregation of subclinical physiological insults across many organ systems resulting in a syndrome of heightened vulnerability in the face of stress  

RV  Management  Strategies  Conclusion  

•  RV  failure  is  mulR-­‐factorial  •  RV  management  strategy  for  LVAD  implant  

– MulR-­‐staged  – MulR-­‐modality  

•  Pharmacological  and  non-­‐pharmacological  

•  PrevenRon  is  >  BiVAD  •  BiVAD  if  >  persistent  RV  Failure  

Tsui,  Papworth  Hospital,  UK,  ISHLT  2013  

Inferences (I)  The  vast  majority  of  pts  treated  with  durable  LVAD  support  (95%  conRnuous    flow  device)  has  about  80%  1-­‐year  survival.    PaRent  selecRon  is  criRcal  to  succesful  operaRve  outcomes.    Worsening   general  medical   condiRon,   end-­‐organ   or   biventricular  failure   increases   operaRve   risk     advanced   HF   pts   should   be  referred  to  LVAD  Centers  earlier.    High   operaRve   risk   may   be   reduced   with   intensive   medical  treatment.  It  remains  to  be  confirmed  if  LVAD  implantaRon  in  less  severely  ill  pts,  not  requiring  IV  inotropes,  provides  survival  benefit  over  medical  treatment.      As   advances   (technology/new   devices,   infecRons,   prevenRon/  therapy,   etc…)   translate   into  measurable   improvement   in   device  outcomes,   a   wider   margin   of   benefit   encourage   broader  indicaRons  for  LVAD.    

Inferences (I)  Elderly  paRents  have  generally   favorable  outcomes  but  have   less  tolerance  for  addiRonal  risk  factors.      PaRents  in  INTERMACS  Levels  1  and  2  have  about  a  5–8%  decrease  in  1-­‐year  survival  compared  with  other  INTERMACS  levels.      Impoortant   Worsening   degrees   of   right   ventricular   failure   and  renal  dysfuncRon  are  associated  with  an  incremental  like-­‐lihood  of  early  mortality.      D.T.   represents   an   increasing     VAD   applicaRon   and   currently  accounts  for  nearly  1/3  or  overall  implantaRon    Important  subsets  of    DT  paRents    exhibit  a  survival    that    might  be  compeRRve  with  HTx  out  to  about  2  years            

As  clinicians  who  works  with  advanced  HF  pa(ents  

we  have  started  to  know  who  are  possible  candidates  to  MCS  

but  we  would  like  also  to  have    them  implanted