Short- and long-term performance of a tripolar down-sized single lead for implantable cardioverter defibrillator treatment: a randomized prospective European multicenter study. European Endotak DSP Investigator Group.
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 omega vs 523 +/- 135 omega (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.
Sandstedt
B
B
Division of Cardiology, Sahlgrenska University Hospital, Göteborg Sweden.
Kennergren
C
C
Schaumann
A
A
Herse
B
B
Neuzner
J
J
D000328:Adult; D000368:Aged; D002304:Cardiac Pacing, Artificial; D016009:Chi-Square Distribution; D017147:Defibrillators, Implantable; D017097:Electric Impedance; D004567:Electrodes, Implanted; D004867:Equipment Design; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018583:Pliability; D011446:Prospective Studies; D012449:Safety; D013499:Surface Properties; D017180:Tachycardia, Ventricular / Q000628:therapy; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000628:therapy