Electrical Performance and Automatic Capture Characteristics of a 3.5‐mm<sup>2</sup> Passive Fixation Lead during 1‐Year Follow‐Up

Lotze, Ulrich; Fischer, Sven; Höfs, Till; Liebetrau, Johannes; Fettin, Wolfgang; Scheiner, Jörg; Lang, A.

doi:10.1111/j.1540-8159.2009.02437.x

Cited by 3 publications

(2 citation statements)

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“…Electrical performances were within ranges retrieved in the literature for the atrium: PCT was comparable to values observed by Kistler et al [9], P-wave amplitude were close to those reported by Rickard [6] and Cornacchia [10], and impedance values compared to those found by Kistler [9] and Lotze et al [11]. In the ventricle, PCT values compared with those reported by Rickard [6] and Lotze et al [11]; sensing amplitude were aligned with Nagatomo et al [12] and Schuchert et al [13]. Finally, impedances were close to those reported by Schuchert [13].…”

Section: Discussionsupporting

confidence: 88%

Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry

Benkemoun¹,

Prévôt²,

Lapuerta³

et al. 2015

WJCD

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Background: Beflex is an active fixation atrial and ventricular lead with a retractable screw; X-Fine is a passive fixation ventricular lead. These two bradycardia lead models were evaluated in the FINE study, an observational prospective trial conducted in France and Spain. Methods: Patients enlisted for pacemaker or defibrillator implants were enrolled. The primary objective was to assess acute dislodgement rates at the 3-month follow-up visit. Safety and electrical performances of the leads were assessed in acute conditions at implant and at the follow-up visit up to three months later. A handling questionnaire was submitted to implanting investigators immediately after implant. Results: A total of 2254 patients were enrolled in 95 centers; investigators implanted 1153 active atrial leads, mainly in the right atrium; 1021 active right ventricular leads, mainly in the septum and 712 passive right ventricular leads, mainly in the apex. After a mean follow-up of 54.9 ± 37.6 days, dislodgement rates were 1.0% and 1.6% for atrial and ventricular active, and 3.2% for ventricular passive leads. No unexpected adverse reactions were observed during the course of the study and the electrical performances at implant and follow-up visits remained within normal ranges. Overall, most investigators (84%) rated leads' handling as superior * Corresponding author. H. Benkemoun et al. 314 (better or best) to what observed with other bradycardia leads. Conclusion: Different bradycardia leads showed a dislodgement rate of 1.0% and 1.6% for atrial and ventricular active leads, and 3.2% for ventricular passive leads, at 3-month follow-up. Acute safety and electrical performances were within expected ranges and very good handling performances were observed.

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Section: Discussionsupporting

confidence: 88%

Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry

Benkemoun¹,

Prévôt²,

Lapuerta³

et al. 2015

WJCD

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“…At present, TVI is the only hemodynamic sensor proposed as a tool for ejection surveillance at every beat. While capture recognition based on evoked potential detection still requires the use of low polarization electrodes for full reliability [ 24 – 26 ], TVI can be recorded with any pacing lead. The TVI system demonstrated excellent sensitivity to capture failure during threshold analysis, coupled with an acceptable specificity.…”

Section: Discussionmentioning

confidence: 99%

Hemodynamic Surveillance of Ventricular Pacing Effectiveness with the Transvalvular Impedance Sensor

Calvi

Pizzimenti²,

Lisi

et al. 2014

Advances in Medicine

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The Transvalvular Impedance (TVI) is derived between atrial and ventricular pacing electrodes. A sharp TVI increase in systole is an ejection marker, allowing the hemodynamic surveillance of ventricular stimulation effectiveness in pacemaker patients. At routine follow-up checks, the ventricular threshold test was managed by the stimulator with the supervision of a physician, who monitored the surface ECG. When the energy scan resulted in capture loss, the TVI system must detect the failure and increase the output voltage. A TVI signal suitable to this purpose was present in 85% of the tested patients. A total of 230 capture failures, induced in 115 patients in both supine and sitting upright positions, were all promptly recognized by real-time TVI analysis (100% sensitivity). The procedure was never interrupted by the physician, as the automatic energy regulation ensured full patient's safety. The pulse energy was then set at 4 times the threshold to test the alarm specificity during daily activity (sitting, standing up, and walking). The median prevalence of false alarms was 0.336%. The study shows that TVI-based ejection assessment is a valuable approach to the verification of pacing reliability and the autoregulation of ventricular stimulation energy.

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Stimulation and Excitation of Cardiac Tissues

Kay¹,

Shepard²

2017

Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy

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Electrical Performance and Automatic Capture Characteristics of a 3.5‐mm² Passive Fixation Lead during 1‐Year Follow‐Up

Abstract: The bipolar ventricular pacing lead IsoFlex S 1636/1646T shows a good electrical performance and is mostly compatible with the AutoCapture algorithm.

Cited by 3 publications

References 13 publications

Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry

Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry

Hemodynamic Surveillance of Ventricular Pacing Effectiveness with the Transvalvular Impedance Sensor

Stimulation and Excitation of Cardiac Tissues

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Electrical Performance and Automatic Capture Characteristics of a 3.5‐mm2 Passive Fixation Lead during 1‐Year Follow‐Up

Abstract: The bipolar ventricular pacing lead IsoFlex S 1636/1646T shows a good electrical performance and is mostly compatible with the AutoCapture algorithm.

Cited by 3 publications

References 13 publications

Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry

Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry

Hemodynamic Surveillance of Ventricular Pacing Effectiveness with the Transvalvular Impedance Sensor

Stimulation and Excitation of Cardiac Tissues

Contact Info

Product

Resources

About

Electrical Performance and Automatic Capture Characteristics of a 3.5‐mm² Passive Fixation Lead during 1‐Year Follow‐Up