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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Rates and severity of perforation from implantable cardioverter-defibrillator leads: a 4-year study
Mintu Turakhia1, Megha Prasad, Jeffrey Olgin
1Electrophysiology Section, Division of Cardiology, Department of Medicine, University of California, Palo Alto VA Medical Center, 3801 Miranda Ave, Cardiology E2-426, Palo Alto, CA 94304-5588, USA. mintu.turakhia@gmail.com
Insights
This study found low perforation rates for implantable cardioverter-defibrillator (ICD) leads, including the St. Jude Riata series. Findings suggest no significant difference in complication rates across lead models, contradicting prior reports.
Area of Science:
- Cardiovascular Medicine
- Medical Device Technology
- Clinical Research
Background:
- Previous reports suggested increased perforation risks with St. Jude Riata defibrillator leads.
- These earlier findings lacked external validation from larger studies.
Purpose of the Study:
- To externally validate perforation and dislodgement rates for implantable cardioverter-defibrillator (ICD) leads.
- To compare complication rates across different ICD lead manufacturers and models.
Main Methods:
- A retrospective review of 593 ICD implants performed between 2004 and 2007.
- Systematic search of electronic medical records for lead dislodgement or perforation events.
- Analysis of leads from St. Jude (Riata series), Medtronic, and Guidant/Boston Scientific.
Main Results:
- Three perforations (0.51%) occurred in 593 ICD implants.
- Perforation rates were 0.53% for Medtronic Sprint Fidelis and 0.65% for St. Jude Riata leads.
- No statistically significant differences in perforation or dislodgement rates were found between lead manufacturers or models.
Conclusions:
- ICD lead perforation and dislodgement rates in this series were low and comparable across all tested lead types.
- Findings contradict previous reports of higher perforation rates associated with the St. Jude Riata lead.
- Recommends improved classification of complications in registry and product performance reports for comprehensive safety assessment.
Introduction:
Although recent case reports and one small single-year observational study report a substantially increased rate of perforation with the St. Jude Riata series defibrillator lead, these results have not been externally validated.
Methods And Results:
From 2004 to 2007, 593 implantable cardioverter-defibrillator (ICD) implants were performed by six faculty and 13 fellows at four University of California, San Francisco, CA, USA and affiliate hospitals. An electronic medical records system was systematically searched to identify clinically significant cases of ICD lead dislodgment or perforation. Of 307 (56%) St. Jude leads (all Riata series 6.3- and 7.3-French leads), 188 (29%) Medtronic leads (including 99 Sprint Fidelis 6.6 French leads), and 98 (15%) Guidant/Boston Scientific leads, there were three perforations in 593 cases (0.51%). One perforation occurred with a Medtronic Sprint Fidelis 6949 lead (0.53%), and two with a St. Jude Riata 1581 lead (0.65%). There were no statistically significant differences in perforation or dislodgement rates between manufacturers or lead models (p = NS for all). In both cases of perforation with the St. Jude Riata leads, the lead tip perforated through the pericardium into the pleural space.
Conclusions:
In our 4-year series of ICD implants, perforation and dislodgement rates were low, similar across all lead makes and models, and well below published and accepted complication rates. Our findings contradict previously-reported higher rates of perforation with the Riata lead. Registry and product performance reports should also classify complications by severity and outcome to provide a more complete assessment of product safety.
