Advanced HF syndromes Indications of LVAD

1. DEVICES IN HEART FAILURE
SYNDROMES
DR ASADULLAH KHAN SOOMRO
Adult Cardiologist
Prince Sultan Cardiac Centre Al-Ahssa. KSA ( Email,hssbasadsoomro@gmail.com )

2. Introduction
Heart Failure is not a disease itself but a complex and costly life
threatening syndrome with multiple etiologies.
At present ,approximately 30 million worldwide are living with
heart failure.
The out look for such patients is poor, with survival rates worse than
many cancers. Furthermore ,heart failure has tremendous impact on
patients, families, caregivers and healthcare system indeed, and is
predicted to increase dramatically over the next decade.
Heart failure is a major public health problem with high morbidity and
mortality, PSCCH is a prestigious advanced heart center and a regional
leader , has unique heart failure program & is certified by JCI indeed .

3. Definition of Heart Failure
Heart Failure is a costly, deadly and complex clinical syndrome
characterized by typical symptoms, like breathlessness
(orthopnoea or paroxysmal nocturnal
dyspnea), fatigue, and ankle swelling,
usually accompanied by signs ( like raised, JVP, displaced apex
impulse, gallop and murmur), according to etiology and triggering
factors with and without signs of congestion (pulmonary
crackles, ascites, peripheral edema). Caused by structural and
or functional cardiac or non- cardiac abnormality.

4. Why device therapy in Advanced Heart Failure Syndromes
Despite improvements in medical & device therapy for
treatment of heart failure ,the incidence and prevalence of HF
continue to increase.
New pharmacological therapies including ARNI are not
expected to change this situation significantly; the drug has
been shown to delay ,not eliminate the progression of heart
failure.
Novel device therapy have shown promising clinical results in
preclinical and early clinical studies.

5. Heart failure Device Therapy
1) Implanted Electrical devices ; CRT& . ICD
2) Mechanical circulatory support Devices,( MCS ) short term
versus long term devices ( ECMO & VAD ).
3) Valvular closure or replacement devices .
4) Monitoring Devices.
5) Stimulation HF devices.
6) Personal wearable devices.

6. Recommendations for Implantable Cardioverter-Defibrillator in
patients with Heart Failure
Secondary Prevention
An ICD is recommended to reduce the risk of sudden death and all cause mortality in patients who have recovered
from a ventricular arrhythmia causing hemodynamic instability, and who are expected to survive for >1 year
with good functional status (class 1A)
Primary Prevention
An ICD is recommended to reduce the risk of sudden death and all cause mortality in patients with symptomatic
HF (NYHA class II-111) and an LVEF <35% despite >3 months of Optimum Medical Treatment, provided they are
expected to survive substantially longer than 1 year with good functional status, and the have:
IHD ( unless they have had an MI in the prior 40 days ) Class 1A. And
DCM (Class 1B )
ICD Implantation is not recommended within 40 days of an MI as implantation at this time
does not improve prognosis (Class 111A).
ICD is not recommended in patients NYHA class 1V, with severe symptoms refractory to
pharmacological therapy unless they are candidates for CRT, a ventricular assist device or
cardiac transplant ( Class 111 C )

7. Recommendations for Implantable Cardiac resynchronization
therapy implantation in patients with Heart Failure
1) CRT is recommended for symptomatic patients with HF
in sinus rhythm with QRS duration > 150msec and LBBB
QRS morphology with LVEF < 35% despite optimal medical
therapy. ( Class 1 A)
2) CRT rather than RV pacing is recommended for patients
with HFrEF regardless of NYHA class who have an
indication for ventricular pacing and high degree AV block
in order to reduce morbidity. This includes patients with
AF. ( Class 1 A)

8. Recommendations for Implantable Cardiac resynchronization
therapy implantation in patients with HF
3) CRT is recommended for symptomatic patients with HF in sinus
rhythm with QRS duration of 130 – 149 msec and LBBB QRS morphology
with LVEF < 35% despite optimal medical therapy.in order to improve
symptoms and reduce morbidity and mortality( Class 1 B)
4) Patients with HFrEF who have received a conventional pacemaker or
an ICD and subsequently develop worsening heart failure despite
optimal medical therapy and who have high proprtion of RV pacing may
be considered for upgrade to CRT,but this does not apply to stable heart
failure. ( Class 11b B)
5) CRT is contraindicated in patients with QRS duration < 130 msec. (
Class 111 A)

9. Patients Potentially eligible for implantation of LV assist device.
Patients with more than 2 months of severe symptoms despite optimal medical treatment and device therapy and more
than one of the following
LVEF < 25 % and if measured peak VO2 < 12 ml/kg/min
> 3 heart failure hospitalizations in previous 12 months without an obvious precipitating cause.
Dependence on I/V ionotropic therapy
Progressive end organ dysfunction ( worsening renal and /or hepatic function) due to reduced perfusion and not to
inadequate ventricular filling pressure( PCWP>20mmHg and SBP < 80-90mm Hg or CI < 2 L /min/m2.
Absence of severe RV dysfunction together with severe tricuspid regurgitation.

10. Various indications for mechanical circulatory support. ( MCS )
Bridge to decision , Use of MCS ( eg, ECMO ) in patients with cardiogenic shock untill haemodynamics and end organ
perfusion are stablized.
Contraindications for long term MCS are excluded ( Brain damage after resuscitation) and additional therapeutic options
including long term VAD therapy or transplantation can be evaluated.
Bridge to candidacy , Use of LVAD to improve end organ function in order to make an ineligible patient eligible for
heart transplant.
Bridge to transplantation , Use of LVAD or bi VAD to keep patient alive who is other wise at high risk of death
before transplantation untill donar organ is available.
Bridge to recovery, Use of LVAD to keep patient alive untill cardiac function recovers sufficiently to remove MCS
device.
Destination therapy . Long term use of LVAD as an alternative to transplantation in patients with end stage heart
failure ineligible for transplantation or long term waiting for transplantation.

11. ADVANCED
HEART FAILURE
Syndromes

12. Advanced Heart Failure Syndrome
Prevalence of advanced heart failure range from 6% to 25%.
Largest registry of chronic advanced HF suggest that roughly 5%
patients with heart failure have end stage disease with
symptoms refractory to guideline based medical therapy.
Recognizing Advanced HF requires integration of clinical,
imaging, hemodynamic, functional and biomarker parameters in
setting of unresponsive optimal medical treatment should raise
concern over progression to stage D heart failure.

13. European society of cardiology definition of Advanced heart Failure
1) NYHA class 111or 1V symptoms.
2) Episodes of volume overload /or peripheral hypoperfusion.
3) Objective evidence of severe cardiac dysfunction ( EF <30%,
restrictive filling pattern, PCWP >16mm, or RAP >12mm Hg)
4) Severely impaired functional capacity( inability to exercise 6min
walk <300m, peak oxygen consumption<12-14ml/kg/min).
5) HF hospitalization ( >1 in past 6month).
Above occurring despite attempts to optimize diuretics, RAAS
antagonists, beta blockers, CRT or in setting of intolerance to optimal
medical treatment)

14. Advanced Heart Failure Syndrome
Dyspnea is often characteristic ,they usually have RV failure so
more of a fatigue, edema and ascites, usually become
intolerant to drugs on previously tolerated doses leads to
hypotension and major organ dysfunction. Central sleep apnea,
depression and cardiac cachexia suggestive of advanced HF.
Advanced heart failure is a discrete clinical syndrome that
deserves recognition as its own entity.
There is marked variability, and no one feature that reliably
identifies the AHF patients.

15. Advanced Heart Failure Syndrome
Aminorityof patients have a rapid progression and never achieve
sustained compensation, however, over long term, a progressive decline
to advanced heart failure with debilitating symptoms
( FC111& 1V) refractory to optimal medical treatment
( Stage D heart failure).
Usually inotropic dependent yet with repeated / prolonged
admissions, due to volume overload and dysrrhythmias
further complicated by major organ dysfunction, strokes ,
pulmonary and systemic embolization.

16. Advanced Heart Failure Syndrome
Progression to advanced heart failure from stage C
to stage D may be gradual and it is often
complex, and indeed difficult to determine weather
decompensation in a previously stable heart failure
patient is an isolated incident due to reversible
precipitants or the transition to a refractory
stage

17. Advanced Heart Failure Syndrome
To facilitate recognition of this phase so that advanced
therapy or a more palliative approach as under ( in eligible
patients) can be considered.
Like Cardiac Transplant , LVAD, ( as bridge or destination
therapy), ICD, CRT Assist devices.
A subset of patients may experience marked improvement in
symptoms with cardiac resynchronization therapy for variable length of
time ,re-setting their progressive course upward.

18. Advanced Heart Failure Syndrome
Another subset of patients may exit the “ heart failure
natural history” after receiving cardiac transplantation or
left ventricular assist device ( LVAD) placement, this
group currently represent a tiny subset of heart failure
population.
Those who survive require intense resource utilization and need
close follow up at advanced heart failure clinic .

19. Advanced Heart Failure
( ESCAPE SCORE )
1) Age>70 years
2) BUN >40
3) 6 min walk < 300met.
4) Serum sodium < 130meq.
5) Diuretics dose at discharge >240mg.
6) Absence of beta blocker at discharge.
7) CPR & mechanical ventilation.
8) Discharge BNP > 500.
Score zero had a 5% six month mortality and score 8 had a 94%
six month mortality.

20. INTERMACS
( Interagency Registry for Mechanically Assisted Circulatory Support)
Advanced heart Failure Profiles
1) Critical Cardiogenic shock. Patients with life threatening hypotension despite rapidly
escalating inotropic support, critical organ hypoperfusion, often confirmed by worsening
acidosis and /or lactate levels ” Crash and burn”.
2) Progressive decline, patient with declining function despite intravenous inotropic support, may be manifested by
worsening renal function, nutritional depletion, inability to restore volume balance “ Sliding on inotropes”.
Also describes declining status in patients unable to tolerate inotropic therapy.
3) Stable but inotrope-dependent. Patients with stable blood pressure ,organ function, nutrition,and
symptoms on continuous intravenous inotropic support( or a temporary circulatory support device or both),but
demonstrating repeated failure to wean from support because of recurrent symptomatic hypotension or renal dysfunction
“Dependent stability).
4) Resting Symptoms. Patients can be stabilized close to normal volume status but experiences daily
symptoms of congestion at rest or during activities of daily living. Doses of diuretics generally fluctuate at very
high levels. More intensive management and surveillance strategies should be considered, which may in some
cases reveal poor compliance that would compromise outcomes with any therapy. Some patients may shuttle
between profile 4 & 5.

21. INTERMACS
Advanced heart Failure Profiles
5) Exertion –intolerant. Comfortable at rest and with activities of daily living but unable to engage in
any other activity, living predominantly within the house. Patients are comfortable at rest without congestive
symptoms, but may have underlying refractory elevated volume status, often with renal dysfunction. If underlying
nutritional status and organ function are marginal, patient may be more at risk than ( INTERMACS) profile 4 and
require definitive intervention.
6) Exertion Limited. Patients without evidence of fluid overload is comfortable at rest and with activities
of daily living and minor activities outside the home but fatigue after few minutes of any meaningful activity.
Attribution to cardiac limitation requires careful measurement of peak oxygen consumption, in some cases with
hemodynamic monitoring to confirm severity of cardiac impairment “ Walking wounded”.
7) Advanced New York Heart Association Class 111. A placeholder for more -
precise specification in future ,this level includes patients who are without current or recent episodes of unstable
fluid balance ,living comfortably with meaningful activity limited to mild physical exertion.
( Patients in Profile 4 to 7 having better survival and shorter length of stay post
implantation compared with those in patients in profile 1 to 3)

22. INTERMACS
Advanced Heart Failure Profiles
Patients in Profile 1 cardiogenic shock ECMO is usually indicated untill decision.
Profile 11 ECMO and LVAD is indicated .
INTERMACS profile 1 to V are in FC 1V.
Profile 1V & V are in FC 1V yet can be ambulatory.
Profile V1 and V11 are in FC 111 , in these patients LVAD indicated and is an option to
discuss.
INTERMACS Profile 1 patients “ crash and burn” one year survival with LVAD therapy is 50-55%.
Profile 11 survival is around 63 to 66%.
Profile 111 survival is 78 to 80%.
Profile 1V survival is 79 to 82%.
Profile V survival is 93 to 97%.
Profile V1 & V11 one year survival
with LVAD therapy above 97%.

23. Patients selection and timing for destination
LVADs
The accepted criteria for LVAD implantation for DT are based on REMATCH
trial are as under.
1) NYHA FC 1V symptoms who have failed to respond to optimal medical management for at
least 45 of the past 60 days.
2) Or IABP dependent for 7 days.
3) Or IV ionotropic dependent for 14 days.
4) LV ejection fraction < 25%.
5) Functional limitation with peak oxygen consumption < 14 ml/kg/min

24. Patients selection and timing for destination
LVADs
According to 2013 International society of Heart Lung Transplant
guidelines ,
Reversible causes of Heart failure should be addressed prior to
consideration for long term MCSDs.
All patients referred for MCSDs should have their transplant
candidacy assessed prior to implantation, Destination therapy
patients generally have contraindications for heart
transplantation, such as age > 70 years, malignancy with in 5
years, elevated pulmonary vascular resistance and end organ
damage.

25. Patients selection and timing for destination
LVADs
Appropriate selection of the candidates and timing of LVAD implantation are
critical for improved outcomes.
Data from ITERMACS ,a North American registry since 2006 in patients receiving
MCSDs therapy to treat advanced HF provide valuable information.
INTERMACS scale seven levels based on hemodynamic profile and functional
capacities.
INTERMACS level 1 is used to describe the most critically ill patients with
cardiogenic shock, level 2 progressively declining despite ionotropic support
,level 3 who are stable but ionotropic dependent. level 4 who have resting
symptoms on oral therapy, level 5 have exertion intolerance ( “ house
bound”),level 6 have limited exertion tolerance and level 7 have NYHA FC 111.

26. THANK YOU