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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

VAD-‐ Adverse Events Device Malfunc-on



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

VAD- Risk Factors for Mortality Older Age


VAD- Risk Factors for Mortality Renal Dysfunction


VAD- Risk Factors for Mortality Right Ventricular Dysfunction


VAD-‐ Risk Factors for Mortality


VAD-‐ Adverse Events Major Neurologic Events


VAD-‐ Adverse Events Pump Related Infec-ons


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


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


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.


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

how to select heart failure patients for … · how to select heart failure patients for mechanical...

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