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Table 2. “I Need Help” - Markers of advanced heart failure
I Inotropes Previous or ongoing requirement for dobutamine, milrinone, dopamine, or levosimendan
N NYHA/Natriuretic peptide Persisting NYHA class III/IV and/or persistently high BNP/NT-proBNP
E End-organ dysfunction Worsening renal or liver dysfunction in the setting of heart failure
E Ejection fraction Very low ejection fraction < 20%
D Defibrillator shocks Recurrent appropriate defibrillator shocks
H Hospitalizations More than 1 hospitalization with heart failure in the last 12 months
E Edema/Escalating diuretics Persisting fluid overload and/or increasing diuretic requirement
L Low blood pressure Consistently low BP with systolic < 90-100 mmHg
P Prognostic medication Inability to up-titrate (or need to decrease/cease) ACEI, beta-blockers, ARNIs, or MRAs
ACEI: angiotensin-converting enzyme inhibitor; ARNI: angiotensin-receptor neprilysin inhibitor; BNP: B-type natriuretic peptide; BP: blood
pressure; MRA: mineralocorticoid receptor antagonist; NT-ProBNP: N-terminal pro-b-type natriuretic peptide; NYHA: New York Heart
Association

disease (PVD), etc.]. We must take this heterogeneity into consideration when examining the outcomes of
the therapies adopted.

MANAGEMENT STRATEGIES IN ADVANCED HEART FAILURE
HTx remains the best option for most patients with advanced HF. The developments in recipient and
donor selection, immunosuppression and management of infectious complications have led to considerable
improvements in survival, exercise capacity, quality of life and return to work. However, the number of
transplants seems to have reached a plateau in the last years, because of the limited availability of donor
hearts. The marked imbalance between demand and supply results in continuous expansion of waiting
lists and prolonged waiting times (over 12 months). Patients on “waiting list” are characterized by high
[12]
mortality rate, ranging between 14% at 1 year and 20% at up to 3 years . HTx candidates in the current era
are also more complex: older, antigen-sensitized and on MCS at the time of listing and transplantation. In
this setting, our goal must be to allocate the limited resources available in the best possible way and, at the
same time, achieve better outcomes.

Left ventricular assist device (LVAD) implantation is an established treatment for long-term MCS. First
introduced for transplant-ineligible patients with advanced HF, its technology has been developed enough
to make it a valid alternative as destination therapy. The Risk Assessment and Comparative Effectiveness
of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
(ROADMAP) study demonstrated higher survival with improved functional status, improved quality of life
and reduced depression in the LVAD group compared to OMT, at the expense of more hospitalizations and
greater rate of major adverse events (e.g., bleedings, stroke, driveline infections, pump thrombi, ventricular
[13]
arrhythmias and right HF) .
Several percutaneous and paracorporeal devices are available for short term MCS. Their simple
implantation and safety make them suitable for advanced HF patients until LVAD, HTx or candidacy to
LVAD/HTx. For the latter purpose, the International Society for Heart Lung Transplantation suggests
application of MCS in the case of potentially reversible or treatable comorbidities such as cancer, obesity,
renal failure, tobacco use and pharmacologically irreversible pulmonary hypertension, with subsequent
[14]
re-evaluation to establish candidacy (Class IIb; Level of Evidence: C) . Despite huge developments
in technology, a significant portion of advanced HF patients decline MCS implantation for a variety of
personal reasons or are not eligible for this therapy due to prohibitive operative risk, limited life expectancy,
irreversible renal or hepatic dysfunction and severe psychosocial limitations. For these reasons, we have to
consider the use of other devices, among which the MitraClip can play a leading role in case of advanced
HF with concomitant severe MR.