Riata Lead Publications (138kb)
Durata Lead Publications (69kb)
Heart Rhythm Journal manuscript
On March 26, 2012, the Heart Rhythm Journal published a manuscript on their website titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.”
Dr. Carlson response
Response from Dr. Mark Carlson, Chief Medical Officer for the St. Jude Medical Cardiac Rhythm Management Division
Heart Rhythm Journal Data Clarification and Our Continuous Focus on Device Performance
Printable Version (129kb)
By Dr. Mark Carlson, Chief Medical Officer, St. Jude Medical Cardiac Rhythm Management
At St. Jude Medical, we take our role as a leading provider of medical devices very seriously. Patient safety and device quality have always been and continue to be our highest priorities. Our ongoing focus is on developing the next generation of products to perform even more reliably than the last.
We develop our products to save lives. And indeed, our products, as well as those of our competitors, have saved countless lives. A cardiac rhythm management lead is asked to survive in the harsh environment of the bloodstream and beating heart. Its energy source, the defibrillator can, contains miniature electronics developed, tested and also implanted in the human body. As much as we continue to strive to reduce the risk of anything ever going wrong, sometimes it does.
A manuscript entitled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads,” was accepted for publication in the Heart Rhythm Journal and made available online this week. This article is based on a search of the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of reported complaints and failure of our older generation silicone leads. The review compared lead-related deaths in patients with an older generation silicone-insulated St. Jude Medical Riata™ and Riata ST lead to the current generation of a competitive product that uses a polyurethane outer insulation, which was added for a similar reason that we added our newer insulation technology to our current generation leads.
In December 2010, St. Jude Medical voluntarily and proactively sent a letter to physicians to communicate a significant reduction in all-cause abrasion with our newer Optim™ insulation, as compared to silicone-only insulated leads. At that time, we also stopped selling our Riata silicone leads. Abrasion of silicone leads is acknowledged within the clinical community as a well-known risk and is clearly documented in the literature as the number one cause of lead failure with reported failure rates ranging from 3 to 10% for older-generation technologies across manufacturers. While we recognize this is an acknowledged risk, we do not find any failure rate acceptable. We continue to strive to reduce the risk of lead failure.
We are committed to ensuring that the clinical community and broader stakeholders have all of the information necessary to asses our device performance. As the manuscript noted, the MAUDE database often contains incomplete reports that do not fully reflect the conclusions following testing and review of the reported device malfunction. For this reason, it is often not possible to draw conclusions on the root cause of a failure mode based on a review of this source.
Our Analysis of the Devices in the MAUDE Reports
Given this understanding of the lack of information and reliability of the MAUDE database, it is not surprising that the manuscript published this week is not entirely accurate. We were not asked to review the information the author found in the MAUDE database prior to publication. Based on our analysis of the reports listed in the manuscript and our investigations, where possible, of the returned device, we have concluded:
- 2 of the 22 reports are duplicates
- 7 are the result of lead-to-can abrasion, which is the most common cause of abrasion for all leads
- 2 are the result of lead-to-lead abrasions
- 2 are due to internal electrical “shorts”
- These “shorts” resulted from previously referenced and published abrasion of the silicone material
- There were no cases of internal “shorts” on the Riata ST leads
- The internal shorts were limited to Riata 8F leads in this MAUDE analysis, which supports our data that the flat-wire shock coil and silicone backfill design improvements introduced in the Riata ST 7F leads have significantly reduced an already low incidence of “shorts” under the shock coil
The remaining nine leads in this analysis were not returned to the company and as a result we cannot assign a specific failure mechanism to these reports; however, it is likely that the failure rates would be similar to those that were returned to the company. Therefore, the majority of these remaining reports are likely related to lead-to-can abrasion. We continue to enroll patients in our 500 patient Riata Lead Evaluation study to further understand the electrical failures associated with these silicone-only insulated leads. We will share information resulting from that study as soon as it is available.
Update on St. Jude Medical Actions
We remain confident that the design evolution of our lead models, coupled with the addition of our Optim insulation, have reduced the potential for abrasion-related issues. The data from the Heart Rhythm Journal manuscript and the recent update of the Belfast data at the American College of Cardiology meeting support this conclusion as well. We now have more than five years of experience and data with our Optim/Durata™ lead family, and we are experiencing significantly reduced abrasion rates. We are meeting our goal to have our newer generation products perform more reliably than the last.
We announced this week as well that we have appointed Population Health Research Institute (PHRI), an academic health science research institute, to analyze data from three combined prospective, actively monitored registries involving over 10,000 patients that are documenting the performance of our current generation leads. The analysis will be entirely under the control of PHRI, who will complete a review of the raw data and report their findings independent of the company.
We are absolutely committed to the highest levels of device performance and public transparency. We have taken a number of actions to reflect this commitment related to Riata over the past two years. We remain focused on ensuring that we deliver the highest quality products possible to patients who rely on a St. Jude Medical device.
News release on retraction request
News Release: St. Jude Medical Seeks Retraction of Heart Rhythm Journal Manuscript
MAUDE database reports
Food and Drug Administration MAUDE Database Reports: 377 Quattro Model 6947 deaths
Below please find a link to the actual reports taken directly from the Food and Drug Administration’s MAUDE database showing 377 deaths associated with the Medtronic Quattro Secure lead, rather than the 62 that was stated by Dr. Robert Hauser in a manuscript published online by the Heart Rhythm Journal.
On Friday, April 6, 2012, St. Jude Medical called on Dr. Hauser to withdraw and retract the article based on this and other inaccuracies. On Monday, Medtronic indicated that it had researched the MAUDE database and provided an indication of support for Dr. Hauser's original analysis in its comments. Dr. Hauser's review of the number of deaths in the MAUDE database was wrong by an order of magnitude greater than six. All 377 reports on the Medtronic Quattro Secure lead are available below.
We have called upon Dr. Hauser to state specifically whether or not he stands behind the factual accuracy of the number 62 used in comparing St. Jude Medical’s product to the Medtronic device. We also invite Medtronic to review the MAUDE database reports contained in this link. The Heart Rhythm Journal has requested this information, and again we respectfully ask that a manuscript that is inaccurate be immediately retracted and removed from online publication.
MAUDE Entries (2mb)
New England Journal of Medicine Perspective Editorial
On Feb. 14, 2012, the New England Journal of Medicine published a Perspective editorial on their website titled, “Here we go again—Another failure of postmarketing device surveillance.”
Dr. Mark Carlson response
Response to New England Journal of Medicine Perspective Editorial
Printable Version (103kb)
By Dr. Mark Carlson, Chief Medical Officer, St. Jude Medical
In Dr. Robert G. Hauser’s Perspective editorial titled, “Here we go again—Another failure of postmarketing device surveillance,” he highlights the need for additional post-market device data across the industry and outlines how this issue is illustrated by the recall of the St. Jude Medical Riata and Riata ST silicone-only defibrillation leads.
First and most importantly, we take very seriously our responsibilities as a leading medical device company and treat product quality as our highest priority at St. Jude Medical. In this response, we would like to comment on the topic of our Riata silicone-only leads as we believe that there were inaccuracies and omissions in the editorial that are important to recognize in order to more fully understand this issue. Secondly, there is no evidence to suggest any similar issue with our new generation Durata lead and St. Jude Medical has the most active post-market surveillance program in the industry for these leads. We have explained these programs below as well.
Riata Silicone Leads
We agree with Dr. Hauser that additional data are needed to better understand the failure mechanism apparent with the Riata silicone-only leads. Specifically, St. Jude Medical, in consultation with our independent leads Medical Advisory Board (MAB), voluntarily communicated proactively to physicians and the Food and Drug Administration (FDA) regarding externalized conductors in Riata silicone-only leads and our decision to no longer sell these products beginning in December 2010. We again proactively communicated our updated experience in November 2011, and that communication was classified by the FDA as a product recall.
In reviewing the anomaly of externalized conductors in Riata silicone leads, we worked with our independent MAB to develop patient management guidelines. A Heart Rhythm Society panel of experts as well as the FDA have reviewed and independently agreed with these recommendations. Whereas these guidelines have been provided to assist physicians in managing their patients, we understand and agree that clinical decisions regarding patient management need to be individualized based upon specific patient conditions and circumstances and that patient management ultimately is a physician-patient decision.
The Perspective article states, “During the past year, neither St. Jude Medical nor the FDA has instituted the clinical studies that would be required to answer critical questions…” In fact, in December 2011, St. Jude Medical began enrolling in a 500-patient, multi-center, prospective Riata Lead Evaluation Study to further evaluate the incidence of externalized conductors and more importantly to evaluate the electrical performance of the Riata silicone-only leads that have externalized conductors over time. These results will help guide any additional future recommendations regarding patient management. Patients in the study will be monitored for any electrical abnormalities every three months for two years.
Newer Generation Durata Leads with OPTIM coating
Regarding St. Jude Medical’s newer generation Durata lead with Optim coating, the article states, “St. Jude Medical is marketing the Durata ICD lead, which has an outer sleeve made of silicone and polyurethane but is otherwise similar to the Riata ST lead.” This is incorrect as the Durata lead incorporated substantial design changes from the prior generation Riata silicone-only leads that we believe significantly reduce the risk of externalized conductors and improve overall reliability. The changes include:
- The conductors’ position in Durata was moved toward the center lumen thereby reducing cable tension.
- The Durata lead defibrillation coils were changed to flat wire with silicone backfill.
- Durata leads utilize an outer layer of Optim insulation, a material shown to be 50 times more abrasion resistant than silicone insulation.
- Durata leads have approximately 50% more insulation thickness relative to the Riata silicone-only leads.
Further, during the more than five years it has been on the market with approximately 250,000 leads implanted worldwide, the Durata lead has continued to meet our very high expectations in terms of safety and reliability, and continues to demonstrate excellent performance by any measure.
The Perspective article states that “we do not have a surveillance system in place that can detect low-frequency failures or adverse clinical events involving Durata leads.” However, this is simply not true. We have regularly communicated that St. Jude Medical began prospective, actively monitored registries assessing the performance of our Optim/Durata leads more than five years ago. Collectively, those studies now include 10,836 leads implanted at 292 sites by 571 physicians and represent the largest post-market surveillance program in the history of implantable stimulation devices. In these active registries, participating centers are required to complete a case report form for all patient follow-up visits (scheduled or unscheduled) and report the occurrence of any adverse events. In addition, a dedicated group of field employees perform on-site monitoring of these centers to ensure that the data being sent to the company is accurate and complete. This represents best practice for clinical studies and is very different than passive registries that rely solely on complaints and return information, and as the author points out, are known to have a certain amount of underreporting. To date, the studies have over 24,000 patient-years of follow-up data, which continue to confirm the excellent reliability of the Durata lead.
This investment in post-market surveillance is unprecedented in our industry and exemplifies our commitment to providing physicians and patients with the information they need to make clinical decisions.
We take our responsibilities related to communication of any product issue and the performance of our current products very seriously. Information about Riata silicone-only leads, the Riata Lead Evaluation Study, the lead design changes in our current generation of devices and our prospective, actively monitored studies have been communicated in a variety of ways, including at the Riata Summit on January 20, 2012, which was hosted by the Minneapolis Heart Institute Foundation. We have worked closely with our independent MAB, the FDA and the Heart Rhythm Society to address the issues with Riata silicone leads. In addition to our biannual Product Performance Report, we have launched the Riata Communication website (riatacommunication.com) as another resource for physicians to find all available information on our silicone-only Riata leads and will use this resource to continue to share additional information as it becomes available.
St. Jude Medical has a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients. We take our responsibilities as a leading manufacturer of cardiac rhythm management devices very seriously and recognize our primary responsibility as a global medical device manufacturer is to ensure that our devices are of the highest quality and function safely and properly.
New England Journal of Medicine correspondence
View Letter to Editor