Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial

Background Lead dislodgement (LD) is a well‐recognized complication during implantation of cardiac implantable electronic devices (CIEDs). An intraprocedural protocol, referred to as reduction of LD protocol, was developed to reduce the risk of LD. Methods The protocol involved (1) inserting a straight stylet down the right atrial lead and applying forward pressure while monitoring for fluoroscopic stability, (2) visualizing all leads during deep inspiration to determine if there is adequate lead redundancy, and (3) having the patient take a deep breath and cough while pacing just at capture threshold to assess for loss of capture in each lead. Any intraprocedural change in the parameters fulfilling the predefined criteria for inadequate lead implantation prompted lead repositioning. Data regarding demographic factors, clinical characteristics, and incidence of LD in the first 30 days after implant was obtained from intramural CIED database. The preintervention (control) group spanned 27 months and consisted of a total of 4,294 leads while the postintervention (intervention) group spanned 17 months and consisted of 2,361 leads implanted. Results There was no significant difference in the demographic factors and clinical characteristics in the two groups. Protocol compliance was > 90%. There were 44 occurrences of LD (1.02%) before and 10 (0.4%) after implementation of the protocol. The protocol significantly reduced the incidence of LD during the 30 days after implant (P = 0.014). No clinical characteristic predicted the risk of LD. Conclusion Intraprocedural maneuvers performed to assess the adequacy of lead implantation results in reduced risk of LD.

Section: Discussionsupporting

confidence: 62%

“…3 Similar to previous studies, there was a trend toward decreased risk of lead revisions with the use of quadripolar leads; however, this did not result in statistical significance. [10][11][12]…”

Section: Predictors Of Ldmentioning

confidence: 99%

Comprehensive strategy to reduce the incidence of lead dislodgement for cardiac implantable electronic devices

Afzal

Horner

Matre

et al. 2018

“…A more recent meta‐analysis examining the performance of a differently designed quadripolar lead reported median pacing threshold values ranging from 0.75 V (interquartile range [IQR]: 0.5–1.0V) for the DV1 – RVcoil vector to 4.25 V (IQR: 2.5–6.5V) for the P4‐M2 vector at first follow‐up (1–3 months) . Results on the electrical performance from a third quadripolar lead have also been reported; however, comparison with these results is difficult as only the best electrodes were reported . These findings suggest that SE from proximal pacing electrodes of quadripolar LV leads effectively may prevent the elevated PCTs that are observed postimplant in proximal non‐SE LV quadripolar pacing electrodes.…”

Section: Discussionmentioning

confidence: 99%

Long‐term electrical performance of Attain Performa quadripolar left ventricular leads with all steroid‐eluting electrodes: Results from a large worldwide clinical trial

Lin

Biffi

Exner

et al. 2018

“…An IS‐4 CRT device can have a maximum choice of 17 pacing vectors theoretically, greatly increasing the chance of finding a low left ventricular capture threshold, which may significantly prolong device longevity (Fig. A) …”

Section: Factors Affecting Device Longevitymentioning

confidence: 99%

“…8A). [56][57][58][59] 1 and φ 2 to boost the input voltage V in by approximately n times, where n is the number of diode/transistor-capacitor pairs in the cascade. Each diode detracts from the final output voltage V out (< nV in ) and causes some inevitable heat loss through its "forward bias" voltage V f .…”

Section: Quadripolar Left Ventricular Leads and Multiple Pacing Vectorsmentioning

confidence: 99%

Technologies for Prolonging Cardiac Implantable Electronic Device Longevity

Lau

2017

Prolonged longevity of cardiac implantable electronic devices (CIEDs) is needed not only as a passive response to match the prolonging life expectancy of patient recipients, but will also actively prolong their life expectancy by avoiding/deferring the risks (and costs) associated with device replacement. CIEDs are still exclusively powered by nonrechargeable primary batteries, and energy exhaustion is the dominant and an inevitable cause of device replacement. The longevity of a CIED is thus determined by the attrition rate of its finite energy reserve. The energy available from a battery depends on its capacity (total amount of electric charge), chemistry (anode, cathode, and electrolyte), and internal architecture (stacked plate, folded plate, and spiral wound). The energy uses of a CIED vary and include a background current for running electronic circuitry, periodic radiofrequency telemetry, high-voltage capacitor reformation, constant ventricular pacing, and sporadic shocks for the cardiac resynchronization therapy defibrillators. The energy use by a CIED is primarily determined by the patient recipient's clinical needs, but the energy stored in the device battery is entirely under the manufacturer's control. A larger battery capacity generally results in a longer-lasting device, but improved battery chemistry and architecture may allow more space-efficient designs. Armed with the necessary technical knowledge, healthcare professionals and purchasers will be empowered to make judicious selection on device models and maximize the utilization of all their energy-saving features, to prolong device longevity for the benefits of their patients and healthcare systems.