Timing of delayed perforation with the St. Jude Riata lead: a single-center experience and a review of the literature.
BACKGROUND
Recent studies have reported a possible increased risk of delayed perforation with the St. Jude Riata defibrillator lead.


OBJECTIVE
The purpose of this study was to determine the incidence and time of occurrence of this complication in a large number of patients who underwent implantationm at a single center.


METHODS
We reviewed the data and clinical course on all patients who underwent implantation of the St. Jude Riata (1580/1581, 1590/1591, and the 7000/7001 ST series) right ventricular defibrillator lead at the Massachusetts General Hospital between June 2001 and October 2007. Data were compared with all Medtronic Sprint Fidelis leads implanted during the same time period.


RESULTS
Of a total of 416 implanted Riata leads, follow-up data at 6 weeks and 3 months was available for 87% and 75% of patients, respectively. There were 6 cases of lead perforation (6 of 233, 2.6%) with the 1580/1581 series, no cases of lead perforation (0 of 92) with the 1590/1591 series, and 2 cases of perforation (2 of 92, 2.2%) with the 7000/7001 ST series. Interrogation the day after implantation did not reveal any abnormalities. Patients with perforation developed symptoms of chest pain or shortness of breath within 3 weeks post-implantation; interrogation revealed pacing thresholds of >5 V at 0.5 ms within the first follow-up period of 6 weeks.


CONCLUSIONS
All cases of perforation with the St. Jude Riata lead occurred within 6 weeks post-implantation and showed pacing thresholds >5 V at 0.5 ms. There were no cases of delayed perforation after 6 weeks in 307 patients with at least 3 months of follow-up.
Danik
Stephan B
SB
Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA. sdanik@partners.org
Mansour
Moussa
M
Heist
E Kevin
EK
Ellinor
Patrick
P
Milan
David
D
Singh
Jagmeet
J
Das
Saumya
S
Reddy
Vivek
V
D'Avila
Andre
A
Ruskin
Jeremy N
JN
Mela
Theofanie
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal; D004452:Echocardiography; D004554:Electric Countershock / Q000295:instrumentation*; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006335:Heart Injuries / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D006352:Heart Ventricles / Q000293:injuries*; D006801:Humans; D015994:Incidence; D008297:Male; D008404:Massachusetts / Q000453:epidemiology; D008875:Middle Aged; D020519:Pericardiocentesis; D011379:Prognosis; D013902:Radiography, Thoracic; D012189:Retrospective Studies; D012421:Rupture; D017180:Tachycardia, Ventricular / Q000628:therapy*; D013997:Time Factors