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Study shows worse survival with Riata leads
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BOSTON — New data from a large, multicenter study demonstrate that St. Jude Medical’s Riata implantable cardioverter defibrillator leads are more likely to fail when compared with other leads.
“Riata and Riata ST ICD leads are prone to inside-out and outside-in silicone insulation defects, which can result in lead malfunction and externalization of the conductor tables,” Raed Abdelhadi, MD, of the Minneapolis Heart Institute, said during a late-breaking clinical trials session. “Our study goals were to compare survival of Riata and Riata ST leads to Medtronic’s Quattro Secure lead in all-cause failure and electrical malfunction, and to determine lead failure rates, assess signs of Riata lead failure and their consequences.”
Abdelhadi and colleagues retrospectively collected data on 1,081 patients (mean age, 64 years; 75% men) who received an 8F Riata lead (n=774) or a 7F Riata ST lead at seven centers between 2002 and 2010. Average follow-up was 4.2 years for the Riata group and 3.3 years for the Riata ST group.
Results revealed all-cause failure rates of 1.93% in the Riata leads group, 0.5% in the Riata ST leads group and 0.43% in the Quattro Secure leads group, with the difference between the Riata leads and the Quattro Secure leads reaching statistical significance (P<.0001).
During follow-up, 66% of the Riata and Riata ST leads were active and functioning normally; 28% were removed from service; 6.2% failed; and 4.3% had electrical malfunction. Of these leads, seven had externalized conductors, Abdelhadi said, yet 20 leads with externalized conductors were functioning normally.
The researchers were unable to find any predictors for Riata or Riata ST lead failure.
There were no statistically significant differences between Riata ST and Quattro Secure leads, but Abdelhadi noted that this may be attributable to the shorter follow-up period in the Riata ST leads group.
Further studies are required to understand how best to monitor and manage Riata and Riata ST leads, according to the researchers.
For more information:
- Abdelhadi R. LB01-2. Presented at: the Heart Rhythm Society’s 33rd Annual Scientific Sessions; May 9-12, 2012; Boston.
Disclosure: Dr. Abdelhadi reports no relevant financial disclosures.
Perspective
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Hugh Calkins, MD, FHRS
This study is a welcome addition to the literature. It contains high quality data from very reputable centers. It confirms the results of other studies showing that Riata leads have a higher rate of failure when compared with other leads, and provides further evidence that the Riata lead failure rate and lead recall issue is an important issue for everyone worldwide who cares for ICD patients.
There are several very important questions that require answers. One question is if you see an externalized conductor on fluoroscopy, what does that mean in terms of the chance for an electrical failure and what is the optimal management strategy for those patients? When you have electrical failure, it is clear that the lead must be replaced. However, what should be done when there is no electrical failure, the patient is asymptomatic and the leads are working fine but there is an externalized conductor identified through radiography or fluoroscopy? Once we know that answer, we will know the answer to the question of whether all patients with Riata leads should be getting surveillance fluoroscopy once a year or once every 5 years.
The main message I want to convey is that we know we have a problem on our hands and the entire arrhythmia community is working together to come up with the best recommendations on how to proceed. For the next 2 to 6 months, we will all be playing a waiting game as electrophysiologists continue to do important research, follow their patients and track outcomes. It will likely be several years before all the variables are fully understood.
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