Effects of left ventricular pacing optimalisation on cardiac perfusion, contractile force, and clinical performance in patients with ventricular dysfunction and heart failure

Resynchronisation therapy has shown to reduce mortality and improve morbidity.
During biventricular pacing, optimal LV lead placement is crucial to achieve a
maximum effect. LV lead placement through the conventional transvenous route is
often hampered by unfavourable coronary sinus anatomy and diaphragm
stimulation. Furthermore this approach is time-consuming and performed using
prolonged fluoroscopy times. Often, a sub-ideal lead position is accepted and
further extensive attempts are aborted. Surgical epicardial LV lead placement
at a position anticipated being the optimal site (with maximal dyssynchrony) as
measured by preoperative tissue Doppler imaging may be a more favourable
approach. This may be expressed by a better myocardial perfusion.

To compare a surgical approach with the conventional transvenous approach by
assessment of differences on the effects on cardiac perfusion and relate this
to the clinical cardiac function.

This study is designed as a randomised, single-centre, open-label trial, with a
minimum of 26 patients in each group. Patients included have a clear indication
for resynchronization therapy. After randomization a biventricular ICD is
implanted. To analyse changes in clinical parameters, baseline data are
collected derived from the patient*s history, physical examination, NYHA
classification, ECG, laboratory testing with assessment of biomarkers such as
ANP/pro-BNP, 6-minute walk testing (6MWT), quality of life questionnaires
(QOL), 2D- and 3D echocardiography, and findings on SPECT. These data are
repeated during follow-up (at 3 and 6 months). The study is completed as soon
as the inclusion is complete 6 months after the last patient is included.

Implantation of a biventricular pacemaker, with or without ICD-function.
Depending on the randomization, a transvenous os surgical epicardial placement
of the LV lead is performed.

3 visits to the outpatient clinic ar expected of every patient, at baseline and
at 3 and 6 months after implantation. During this visits, physical examination,
NYHA classification, ECG, laboratory testing, 6-minute walk testing (6MWT),
quality of life questionnaires (QOL), 2D- and 3D echocardiography and SPECT are
performed.