Implantable Assist Devices

When and who to
refer for implantable
assist devices.

§ The number of patients with advanced heart failure that has become
unresponsive to conventional medical therapy is increasing rapidly.
§ Patients with acute myocardial infarction complicated by acute heart
failure or cardiogenic shock have high mortality with conventional
therapy (10% -/- 50%).
§ No other field in cardiology is experiencing such explosive growth as
mechanical circulatory support for advanced heart failure (HF).
§ To date, there are no guidelines for appropriate selection for use of
these devices that are approved by national societies in the field.

Heart transplantation will never meet the demands
2015
JHLT. 2015 2014 Oct; 34(10): 33(10): 1244-1254 996-1008
NOTE: This figure includes only the heart transplants
that are reported to the ISHLT Transplant Registry. As
such, the presented data may not mirror the changes in
the number of heart transplants performed worldwide.

Heart transplantation will never meet the demands
Patients to consider
Contraindications
§ End-stage HF with severe symptoms, a poor prognosis, and
no remaining alternative treatment options.
§ Motivated, well informed, and emotionally stable.
§ Capable of complying with the intensive treatment required
post-operatively.
§ Active infection.
§ Severe peripheral arterial or cerebrovascular disease.
§ Pharmacologically irreversible pulmonary hypertension
(LVAD should be considered with a subsequent reevaluation
to establish candidacy).
§ Cancer (a collaboration with oncology specialists should
occur to stratify each patient as to their risk of tumour
recurrence).
§ Irreversible renal dysfunction (e.g. creatinine clearance 35 kg/m2 (weight loss is recommended
to achieve a BMI

Heart transplantation will never meet the demands
Patients to consider
Contraindications
§ End-stage HF with severe symptoms, a poor prognosis, and
no remaining alternative treatment options.
§ Motivated, well informed, and emotionally stable.
§ Capable of complying with the intensive treatment required
post-operatively.
§ Active infection.
§ Severe peripheral arterial or cerebrovascular disease.
§ Pharmacologically irreversible pulmonary hypertension
(LVAD should be considered with a subsequent reevaluation
to establish candidacy).
§ Cancer (a collaboration with oncology specialists should
occur to stratify each patient as to their risk of tumour
recurrence).
§ Irreversible renal dysfunction (e.g. creatinine clearance 35 kg/m2 (weight loss is recommended
to achieve a BMI

Heart transplantation will never meet the demands
Patients to consider
Contraindications
§ End-stage HF with severe symptoms, a poor prognosis, and
no remaining alternative treatment options.
§ Motivated, well informed, and emotionally stable.
§ Capable of complying with the intensive treatment required
post-operatively.
§ Active infection.
§ Severe peripheral arterial or cerebrovascular disease.
§ Pharmacologically irreversible pulmonary hypertension
(LVAD should be considered with a subsequent reevaluation
to establish candidacy).
§ Cancer (a collaboration with oncology specialists should
occur to stratify each patient as to their risk of tumour
recurrence).
§ Irreversible renal dysfunction (e.g. creatinine clearance 35 kg/m2 (weight loss is recommended
to achieve a BMI

Bridge to decision (BTD)/
Bridge to bridge (BTB)
Bridge to candidacy (BTC)
Bridge to transplantation
(BTT)
Bridge to recovery (BTR)
Destination therapy (DT)
INDICATIONS FOR VADs
Use of short-term MCS (e.g. ECLS or ECMO) in patients with
cardiogenic shock until haemodynamics and end-organ perfusion are
stabilized, contra-indications for long-term MCS are excluded (brain
damage after resuscitation) and additional therapeutic options
including long-term VAD therapy or heart transplant can
be evaluated.
Use of MCS (usually LVAD) to improve end-organ function in order to
make an ineligible patient eligible for heart transplantation.
Use of MCS (LVAD or BiVAD) to keep patient alive who is otherwise
at high risk of death before transplantation until a donor organ
becomes
available.
Use of MCS (typically LVAD) to keep patient alive until cardiac function
recovers sufficiently to remove MCS.
Long-term use of MCS (LVAD) as an alternative to transplantation in
patients with end-stage HF ineligible for transplantation or long-term
waiting for heart transplantation.
BiVAD = biventricular assist device; BTB = bridge to bridge; BTC = bridge to candidacy; BTD = bridge to decision; BTR = bridge to recovery;
BTT = bridge to transplantation; DT = destination therapy; ECLS = extracorporeal life support; ECMO = extracorporeal membrane oxygenation;
HF = heart failure; LVAD = left ventricular assist device; MCS = mechanical circulatory support; VAD = ventricular assist device
European Heart Journal
DOI:http://dx.doi.org/10.1093/eurheartj/ehw128 2129-2200 First
published online: 20 May 2016

Recommendation Class Level Reference
An LVAD should be considered in
patients who have end- stage HFrEF
despite optimal medical and device
therapy and who are eligible for
heart transplantation in order
to improve symptoms, reduce the
risk of HF hospitalization and the
risk of premature death.
(Bridge to transplant indication).
An LVAD should be considered in
patients who have end-stage HFrEF
despite optimal medical and device
therapy and who are not eligible for
heart transplantation to, reduce the
risk of premature death.
(destination therapy)
IIa
C
IIa B
§ Estep JD et al. J AmColl Cardiol
2015;66:1747–1761.
§ Rose EA et al. N Engl J Med
2001;345:1435–1443.
§ Slaughter MS et al. N Engl J Med
2009;361:2241–2251.
European Heart Journal
DOI:http://dx.doi.org/10.1093/eurheartj/ehw128 2129-2200 First
published online: 20 May 2016

When is a patient sick enough to implant a VAD?
Long Term VAD
Short Term VAD
No VAD candidate:
INTERMACS 1 or multi
-system organ
failure

INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)
stages for classifying patients with advanced heart failure
INTERMACS level
1. Cardiogenic shock
“Crash and burn”
2. Progressive decline
despite inotropic
support “Sliding on
inotropes”
3. Stable but inotrope
dependent “Dependent
stability”
4. Resting symptoms
“frequent flyer”
5. Exertion intolerant
“Housebound”
6. Exertion limited
“Walking wounded”
NYHA
Class
IV
IV
IV
IV
ambulatory
IV
ambulatory
III
Description Device 1y survival with
LVAD therapy
Haemodynamic instability in spite of increasing
doses of catecholamines
and/or mechanical circulatory support with critical
hypoperfusion of target organs (severe cardiogenic
shock).
Intravenous inotropic support with acceptable blood
pressure but rapid deterioration of renal function,
nutritional state, or signs of congestion.
Haemodynamic stability with low or intermediate
doses of inotropics, but necessary due to
hypotension, worsening of symptoms, or progressive
renal failure.
Temporary cessation of inotropic treatment is
possible, but patient presents with frequent
symptoms recurrences and typically with fluid
overload.
Complete cessation of physical activity, stable at
rest, but frequently with moderate fluid retention and
some level of renal dysfunction.
Minor limitation on physical activity and absence of
congestion while at
rest. Easily fatigued by light activity.
7. “Placeholder” III Patient in NYHA class III with no current or recent
unstable fluid balance.
ECLS, ECMO,
percutaneous
support devices
ECLS, ECMO,
LVAD
52.6±5.6%
63.1±3.1%
LVAD 78.4±2.5%
LVAD 78.7±3.0%
LVAD 93.0±3.9%
LVAD / Discuss
LVAD as option
Discuss LVAD
as option
(Due to small numbers
outcomes for INTERMACS
levels 5, 6, 7 were
combined)
ECLS ¼ extracorporeal life support; ECMO ¼ extracorporeal membrane oxygenation; INTERMACS ¼ Interagency Registry for Mechanically Assisted Circulatory Support;
LVAD ¼ left ventricular assist device; NYHA ¼ New York Heart Association.
Kaplan-Meier estimates with standard error of the mean for 1 year survival with LVAD therapy. Patients were censored at time of last contact, recovery or heart
transplantation.

INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)
stages for classifying patients with advanced heart failure
INTERMACS level
1. Cardiogenic shock
“Crash and burn”
2. Progressive decline
despite inotropic
support “Sliding on
inotropes”
3. Stable but inotrope
dependent “Dependent
stability”
4. Resting symptoms
“frequent flyer”
5. Exertion intolerant
“Housebound”
6. Exertion limited
“Walking wounded”
NYHA
Class
IV
IV
IV
IV
ambulatory
IV
ambulatory
III
Description Device 1y survival with
LVAD therapy
Haemodynamic instability in spite of increasing
doses of catecholamines
and/or mechanical circulatory support with critical
hypoperfusion of target organs (severe cardiogenic
shock).
Intravenous inotropic support with acceptable blood
pressure but rapid deterioration of renal function,
nutritional state, or signs of congestion.
Haemodynamic stability with low or intermediate
doses of inotropics, but necessary due to
hypotension, worsening of symptoms, or progressive
renal failure.
Temporary cessation of inotropic treatment is
possible, but patient presents with frequent
symptoms recurrences and typically with fluid
overload.
Complete cessation of physical activity, stable at
rest, but frequently with moderate fluid retention and
some level of renal dysfunction.
Minor limitation on physical activity and absence of
congestion while at
rest. Easily fatigued by light activity.
7. “Placeholder” III Patient in NYHA class III with no current or recent
unstable fluid balance.
ECLS, ECMO,
percutaneous
support devices
ECLS, ECMO,
LVAD
52.6±5.6%
63.1±3.1%
LVAD 78.4±2.5%
LVAD 78.7±3.0%
LVAD 93.0±3.9%
LVAD / Discuss
LVAD as option
Discuss LVAD
as option
(Due to small numbers
outcomes for INTERMACS
levels 5, 6, 7 were
combined)
ECLS ¼ extracorporeal life support; ECMO ¼ extracorporeal membrane oxygenation; INTERMACS ¼ Interagency Registry for Mechanically Assisted Circulatory Support;
LVAD ¼ left ventricular assist device; NYHA ¼ New York Heart Association.
Kaplan-Meier estimates with standard error of the mean for 1 year survival with LVAD therapy. Patients were censored at time of last contact, recovery or heart
transplantation.

Patients potentially eligible for implantation
of a left ventricular assist device
Patients with >2 months of severe symptoms despite optimal
medical and device therapy and more than one of the following:
LVEF

When is a patient sick enough to implant a VAD?
INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)
stages for classifying patients with advanced heart failure
NYHA Class III Class IIIb Class IV
(ambulatory)
INTERMACS
Profiles
% of Current
Implants in
Intermacs
Class IV (on inotropes)
7 6 5 4 3 2 1
1,0% 1,4% 3,0% 14,6% 29,9% 36,4% 14,3%
CURRENTLY NOT
SUPPORTED
LIMITED ADOPTION
GROWING ACCEPTANCE

AMI PATIENTS ARE NOT CREATED EQUAL!
J Am Coll Cardiol. 2016;67(16):1871-1880. doi:10.1016/j.jacc.2016.02.025

AMI PATIENTS HAVE THE SAME 1YR-OUTCOME,
DESPITE BEING MORE CRITICALLY ILL PRE-IMPLANTATION.
J Am Coll Cardiol. 2016;67(16):1871-1880. doi:10.1016/j.jacc.2016.02.025

AMI PATIENTS HAVE THE SAME 1YR-OUTCOME,
DESPITE BEING MORE CRITICALLY ILL PRE-IMPLANTATION.
J Am Coll Cardiol. 2016;67(16):1871-1880. doi:10.1016/j.jacc.2016.02.025

AMI PATIENTS HAVE THE SAME 1YR-OUTCOME,
DESPITE BEING MORE CRITICALLY ILL PRE-IMPLANTATION.
J Am Coll Cardiol. 2016;67(16):1871-1880. doi:10.1016/j.jacc.2016.02.025

ADVERSE EVENTS
J Am Coll Cardiol. 2016;67(16):1871-1880. doi:10.1016/j.jacc.2016.02.025

ight heart failure (RHF) is a frequent complication following left ventricular assist device (LVAD)
implantation and a major factor of postoperative morbidity and mortality.
Visual assessment
• RV EF
• TAPSE
• PAP + RAP
• TV Regurgitation
• LV/RV-balance
Echo Parameters
• Bilirubin
• AST
• ALT
• AP
• INR
• Creatinine
Clinical & Lab.
Parameters
• Trans Pulm. Δ
• PAP
• RVP
• RAP
• CO
• CI
Invasive
Monitoring
• RV-function and -
RV-function volumes and -
volumes • Cannula
• complications
Cannula
complications
CT
• RV-function and –
volumes (reference
method)
• Often contra-indicated
CMR

‘Management of RV dysfunction should focus on
prevention rather than treatment.’
RVSWI >300 mmHg*ml ⁄m²
{[meanPAP (mmHg)-meanCVP (mmHg)] x SV (ml)} ⁄ BSA (m²)
q Avoid RV-volume overload and maintain CVP 16 to18 mm Hg.
q Confirm proper function of the LVAD. High pump speeds that cause
leftward septal shift should be avoided.
q If the cardiac index is < 2.0 liters/min/m² and the CVP > 20 mm Hg,
a temporary RVAD should be considered.

§ The highest risk of death occurs within 3 months of VAD implantation
likely reflecting the pre-operative clinical acuity.
§ Compared with non-AMI patients, patients with VAD post-AMI had
significant lower adjusted late hazard for mortality (pre-existing CV
burden, absence of long term effects of heart failure)(?).
§ Once there is a systemic inflammatory state and multi organ failure,
even full mechanical support may not improve survival.
manuscript).
(not discussed in this
§ Right heart failure (RHF) is a frequent complication following left
ventricular assist device (LVAD) implantation and a major factor of
postoperative morbidity and mortality.

§ We are in the need of prospective trials, adequately powered for
meaningful clinical endpoints, to establish evidence base for use of
these invasive and expensive but live saving devices.