Clinical significance of device-related complications in clinical trials and implications for future trials

insights from the Antiarrhytmics Versus Implantable Defibrillators (AVID) trial.

Jack Kron

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

BACKGROUND: Implantation of transvenous implantable cardioverter-defibrillators (ICDs) utilizing a non-thoracotomy approach has become routine therapy for survivors of life-threatening tachyarrhythmias. In the Antiarrhythmics versus Implantable Defibrillator (AVID) Trial, we sought to identify and prospectively characterize the frequency of lead and ICD-related complications. Between June 1, 1993, and April 7, 1997, 539 patients received non-thoracotomy ICDs. A total of 62 first complications occurred. The subclavian route of insertion resulted in more complications than the cephalic vein route, 46 of 339 (14%) versus 6 of 135 (4%), p =.005 as did the abdominal versus pectoral generator site; 31 of 238 (13%) versus 17 of 291 (6%), p

Original languageEnglish (US)
Pages (from-to)473-478
Number of pages6
JournalCardiac Electrophysiology Review
Volume7
Issue number4
StatePublished - Dec 2003

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Implantable Defibrillators
Clinical Trials
Equipment and Supplies
Tachycardia
Survivors
Veins
Head
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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title = "Clinical significance of device-related complications in clinical trials and implications for future trials: insights from the Antiarrhytmics Versus Implantable Defibrillators (AVID) trial.",
abstract = "BACKGROUND: Implantation of transvenous implantable cardioverter-defibrillators (ICDs) utilizing a non-thoracotomy approach has become routine therapy for survivors of life-threatening tachyarrhythmias. In the Antiarrhythmics versus Implantable Defibrillator (AVID) Trial, we sought to identify and prospectively characterize the frequency of lead and ICD-related complications. Between June 1, 1993, and April 7, 1997, 539 patients received non-thoracotomy ICDs. A total of 62 first complications occurred. The subclavian route of insertion resulted in more complications than the cephalic vein route, 46 of 339 (14{\%}) versus 6 of 135 (4{\%}), p =.005 as did the abdominal versus pectoral generator site; 31 of 238 (13{\%}) versus 17 of 291 (6{\%}), p",
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