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Short‐and Long‐Term Performance of a Tripolar Down‐Sized Single Lead for Implantable Cardioverter Defibrillator Treatment: A Randomized Prospective European Multicenter Study
Author(s) -
SANDSTEDT BENGT,
KENNERGREN CHARLES,
SCHAUMANN ANSELM,
HERSE BERNHARD,
NEUZNER JÖRG
Publication year - 1998
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/j.1540-8159.1998.tb01128.x
Subject(s) - medicine , lead (geology) , defibrillation threshold , implantable cardioverter defibrillator , cardiology , shock (circulatory) , defibrillation , ventricular fibrillation , prospective cohort study , ventricular tachycardia , tachycardia , geomorphology , geology
A new, thinner (10 Fr) and more flexible, single‐pass transvenous endocardial ICD lead, Endotak DSP, was compared with a conventional lead, Endotak C, as a control in a prospective randomized multicenter study in combination with a nonactive can ICD. A total of 123 patients were enrolled, 55 of whom received a down‐sized DSP lead. Lead‐alone configuration was successfully implanted in 95% of the DSP patients vs 88% in the control group. The mean defibrillation threshold (DFT) was determined by means of a step‐down protocol, and was identical in the two groups, 10.5 ± 4.8 J in the DSP group versus 10.5 ± 4.8 J in the control group. At implantation, the DSP mean pacing threshold was lower, 0.51 ± 0.18 V versus 0.62 ± 0.35 V (p < 0.05) in the control group, and the mean pacing impedance higher, 594 ± 110 Ω vs 523 ± 135 Ω (p < 0.05). During the follow‐up period, the statistically significant difference in thresholds disappeared, while the difference in impedance remained. Tachyarrhythmia treatment by shock or antitachycardia pacing (ATP) was delivered in 53% and 41%, respectively, of the patients with a 100% success rate. In the DSP group, all 28 episodes of polymorphic ventricular tachycardia or ventricular fibrillation were converted by the first shock as compared to 57 of 69 episodes (83%) in the control group (p < 0.05). Monomorphic ventricular tachycardias were terminated by ATP alone in 96% versus 94%. Lead related problems were minor and observed in 5% and 7%, respectively. In summary, both leads were safe and efficacious in the detection and treatment of ventricular tachyarrhythmias. There were no differences between the DSP and control groups regarding short‐ or long‐term lead related complications.