Heart Failure Clinical Trial
Official title:
Heart Failure Study of Multi-site Pacing Effects on Ventriculoarterial Coupling
To perform a comparative study of multi-site left ventricular pacing and cardiac resynchronization therapy effects on ventriculoarterial coupling and energy efficiency of the failing heart
Given that the main function of the cardiovascular system is to provide sufficient blood
supply to tissues in order to ensure their normal and effective function, combined with the
most efficient possible use of energy produced by ATP degradation, there has been a keen
interest in elucidating the interplay between heart and vessels, critically affecting both.
In order to achieve these goals, it is thought that in healthy humans the cardiovascular
system as a unity operates at a unique combination of parameters (arterial elastance, heart
rate and left ventricular end systolic elastance) so as to:
1. Maximize stroke work (SW) for a given left ventricular contractility. This is related to
the fact that adequate tissue perfusion is dependent both on stroke volume and on
pressure and in fluid dynamics W=∆P×∆V (thus maximizing SW leads to optimal perfusion),
OR
2. Optimize energy efficiency of the heart, in terms of energy transferred to the arterial
bed to total mechanical energy.
Ventriculoarterial coupling (VAC) is a composite parameter, defined as the ratio of arterial
elastance (Ea) to end systolic left ventricular elastance (Ees). Thus: VAC=Ea/Ees . It is a
fundamental property of the cardiovascular system, integrating and assessing the interaction
of all individual parameters of the ventricle (pump) and the arterial tree (afterload).
Furthermore, VAC may assess both whether SW produced is maximal for a given contractility of
the left ventricle (condition for maximization: VAC=1) and whether mechanical efficiency of
the ventricle is optimal (optimization condition: VAC=0.5-0.7). Consequently, simultaneous
optimization is not possible, and the cardiovascular system operates either at maximal output
(as in healthy individuals at rest) or at optimal efficiency (healthy individuals at
exercise). Multi-site pacing (MSP) of the left ventricle is a recently introduced technique
with excellent studies' findings concerning echocardiographic parameters of ventricular
function. Recently, the MultiPoint Pacing (MPP) IDE study showed that a specific choice of
electrical dipole for the first left ventricular pulse and a close to simultaneous
application of the two left ventricular pulses achieves a very high percent of clinical
response (87%), with excellent patient safety. Subsequent studies confirmed these findings,
reporting even higher NYHA response rates (95% vs 78% for conventional cardiac
resynchronization therapy - CRT).
The underlying rationale lies in the better approximation of the normal sequence of left
ventricular activation, through use of two, instead of a single, pulses. According to trial
results, one can achieve, compared to conventional CRT, improved coordination between left
ventricular segments, improved cardiac output and, possibly, tissue perfusion, and
potentially reduction of arrhythmia propensity (mechanism similar to that of CRT). Thus, it
would be interesting to study whether these can be independently confirmed by changes in VAC
values. In heart failure, VAC values increase considerably due to increases in Ea as a result
of the feedback loop regarding pressure (but not volume) maintenance. As a consequence, any
reduction would move them closed to both 1 and the 0.5-0.7 area, yielding improvement in both
SW maximization and efficiency optimization.
However, there are objective difficulties in achieving lege artis MSP (according to MPP-IDE
study standards) given that two prerequisites must be met: 1. Interpolar distance for the
first left ventricular pulse >30mm (i.e. non-sequential poles used), 2. Nearly simultaneous
(Δt=5msec) left ventricular pulses and 3. Threshold of ≤3.5V@0.5msec.
Moreover, the first pulse should, ideally, be directed to the most delayed, compared to the
normal activation sequence, viable myocardial segment, a feat not always possible due to
electrode placing constraints. Obviously, presence of scar could alter the course and shape
of the activation front and thus diminish its effects (similar to issues already discussed in
the case of CRT).
Objective:
To perform a comparative study of multi-site left ventricular pacing and cardiac
resynchronization therapy effects on ventriculoarterial coupling and energy efficiency of the
failing heart
Hypothesis:
VAC values are improved (shift closer to unity/0.5-0.7 area) and work/efficiency increase
with patients on MSP as compared to CRT pacing.
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