Last updated on November 2017

QP ExCELs – Sentus QP: Extended CRT Evaluation with Quadripolar Left Ventricular Leads

Brief description of study

QP ExCELs – Sentus QP: Extended CRT Evaluation with Quadripolar Left Ventricular Leads

Detailed Study Description

Heart failure (HF) is a major public health issue with a current prevalence of 2-3% in the total and 10-20% in the aged population (Lloyd-Jones et al., 2010). The overall prevalence for heart failure is increasing due to ageing population. Additional factors are the success of the modern therapies in prolongation of survival of patients suffering from coronary events and the effective prevention of death for patients being at high risk.

The overall mortality for the population is 50% in the first 4 years and 40% of the patients with HF-related hospitalizations have to be readmitted to hospital or die within one year (Dickstein et al., 2008).

Cardiac Resynchronization Therapy (CRT) is used in order to synchronize interventricular and intraventricular contraction pattern of the heart in patients with heart failure in whom there is evidence of electrical dyssynchrony (QRS width =120 ms). CRT with defibrillator function (CRT-D) is recommended to reduce morbidity and mortality in patients in NYHA III-IV who are symptomatic despite optimal medical therapy and suffer from a reduced left ventricular ejection fraction (LVEF = 35%, (Dickstein et al., 2008)). This indication has been recently extended to patients in NYHA II (Dickstein et al., 2010).

Despite many improvements in techniques and equipment for this device therapy, phrenic nerve stimulation (PNS) or elevated pacing thresholds are still frequent issues (Crossley et al., 2010; Romeyer-Bouchard et al., 2010).

Phrenic nerve stimulation occurs when a device's electrical output inadvertently activates the diaphragm muscle and causes muscle twitching, hiccup, or shortness of breath. Phrenic nerve stimulation is found in 2 to 37% of implanted patients, depending on different factors including the type of the left ventricular lead (Moubarak et al., 2014). A higher incidence of PNS is found in the standard pacing configuration as compared to alternative configurations (Goetze et al., 2013). With unipolar and bipolar left ventricular leads, PNS may require surgery to reposition the lead or disable the CRT. With four electrodes on the left ventricular (LV) lead and 12 programmable pacing configurations, available with the Sentus QP left ventricular lead in combination with a corresponding CRT-D device, an occurrence of PNS or increased LV pacing thresholds may be resolved by non-invasive optimization of CRT delivery. Goetze et al., 2013 have shown that in 98% of patients presenting with phrenic nerve stimulation a reprogramming of the pacing vector could successfully terminate phrenic nerve stimulation without re-operation. Therefore, by using leads with multiple pacing options, the risk of surgical revision during follow up may be reduced.

Apart from limiting risks of CRT, quadripolar (QP) leads with multiple additional pacing vectors can also increase cardiac output compared to conventional bipolar LV leads (Cabrera-Bueno et al., 2013; Thibault et al., 2013) and thus enhance the overall benefit of CRT.

The combination of the new BIOTRONIK left ventricular lead family Sentus QP, containing 4 separate electrodes, with the corresponding Cardiac Resynchronization Therapy devices (CRT), provides additional pacing options to optimize cardiac resynchronization therapy, based on the individual anatomy and needs of heart failure patients as well as the occurrence of PNS and increased thresholds.

The QP ExCELs study aims to gather safety and effectiveness data on BIOTRONIK Sentus QP leads which will be used to satisfy US FDA requirements for pre-market submission of the Sentus over-the-wire (OTW) quadripolar (QP) left ventricular (LV) leads.

Clinical Study Identifier: TX81866

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Jenny Martin

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA