Fluoroscopic screening of asymptomatic patients implanted with the recalled Riata lead family.
BACKGROUND
The Food and Drug Administration recently issued a class I recall of the St. Jude Medical Riata implantable cardioverter-defibrillator lead presumably because of increased risk of electric failure and mechanical separation via inside-out abrasion. We sought to examine the incidence and time dependence of inside-out abrasion in asymptomatic patients implanted with the Riata lead.


RESULTS
Asymptomatic patients implanted with the Riata lead at our institution were offered voluntary fluoroscopic screening in 3 views. Electric testing of the Riata lead with provocative isometric muscle contraction was performed at the time of fluoroscopic screening. Of the 245 patients undergoing fluoroscopic screening, 53 (21.6%) patients showed clear evidence of lead separation. Of these externalized leads, 0%, 13%, and 26% had a dwell time of <3 years, 3 to 5 years, and >5 years, respectively (P=0.037). Externalized leads had a significantly pronounced decrease in R-wave amplitude (-1.7±2.9 mV versus +0.35±2.5 mV; P<0.001), and more patients with externalized leads had ≥25% decrease in R-wave amplitude from baseline (28.0% versus 8.1%; P=0.018). One patient with externalization exhibited new noise on near-field electrogram.


CONCLUSIONS
The Riata lead exhibits time-dependent high rates of cable externalization exceeding 20% at >5 years of dwell time. Externalized leads are associated with a more pronounced decrease in R-wave amplitude, which may be an early marker of future electric failure. The use of fluoroscopic and electric screening of asymptomatic patients with the Riata lead remains controversial in the management of patients affected by the recent Food and Drug Administration recall.
Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.
Jeffrey
J
Liu
Rohit
R
Rattan
Evan
E
Adelstein
William
W
Barrington
Raveen
R
Bazaz
Susan
S
Brode
Sandeep
S
Jain
G Stuart
GS
Mendenhall
Jan
J
Nemec
Eathar
E
Razak
Alaa
A
Shalaby
David
D
Schwartzman
Andrew
A
Voigt
Norman C
NC
Wang
Samir
S
Saba
D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000295:instrumentation*; D022062:Electrophysiologic Techniques, Cardiac; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D057052:Medical Device Recalls; D008875:Middle Aged; D010414:Pennsylvania; D011237:Predictive Value of Tests; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors