{"id":31176,"date":"2012-08-21T13:50:06","date_gmt":"2012-08-21T17:50:06","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=31176"},"modified":"2012-08-21T21:44:56","modified_gmt":"2012-08-22T01:44:56","slug":"new-questions-about-latest-generation-icd-leads-from-st-jude","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/08\/21\/new-questions-about-latest-generation-icd-leads-from-st-jude\/","title":{"rendered":"New Questions About Latest-Generation ICD Leads from St. Jude"},"content":{"rendered":"

A highly anticipated study<\/a>\u00a0analyzing failures of St. Jude Durata and Riata ST Optim ICD leads has been published online in Europace by prominent electrophysiologist and ICD critic Dr. Robert Hauser along with associates from the Minneapolis Heart Institute.<\/p>\n

Over the past year St. Jude Medical has been beset with bad news about its ICD leads. Until recently, the criticism was confined to the older-generation Riata and Riata ST leads. These leads have been shown to be prone to both structural and electrical failures at an increased rate compared with competitive leads. St. Jude has staunchly defended its newer-generation Durata and Riata ST Optim leads, which have an additional layer of Optim copolymer insulation coating, which St. Jude believes will reduce failures by improving abrasion resistance. Last week, however, the\u00a0FDA issued a new request for postmarketing studies<\/a>,\u00a0including X-ray surveillance of these leads, calling them \u201csufficiently similar\u201d to Riata and Riata ST to merit increased scrutiny.<\/p>\n

Today\u2019s study from Hauser serves as another blow to St. Jude and may affect implanter confidence in current-generation Durata leads. In the study, Hauser queried the FDA MAUDE database for \u201cabrasion analysis\u201d and reported detailed results. He found 15 Riata ST Optim and 37 Durata reports. The predominant abnormality in both groups was external abrasion (i.e., can\/lead or lead\/lead), although several internal abrasions were also found. Most of these abrasions resulted in clinically relevant electrical abnormalities such as low voltage oversensing leading to inappropriate shocks. One high-voltage failure during a spontaneous ventricular arrhythmia resulted in an ineffective shock and subsequent patient death.<\/p>\n

Hauser shied away from making comparisons with other leads in the current study and did not make any attempt to calculate an incidence of lead failure, recognizing the limitations inherent in analysis of a voluntary database. This stands in contrast to\u00a0his last Riata\/Riata ST MAUDE analysis<\/a>,\u00a0which provoked a firestorm of criticism including\u00a0a request for article retraction from St. Jude Medical<\/a>.<\/p>\n

In comments\u00a0in the\u00a0New York Times<\/em><\/a>, Hauser expresses a lack of confidence with Durata: \u201cThere is no need to use this lead until we have more confidence in its performance.\u201d Hauser goes on to level direct criticism at Optim insulation, stating \u201cI\u2019m afraid that this material is not going to perform as advertised.\u201d<\/p>\n

As a practicing cardiac electrophysiologist and ICD implanter who has followed this matter closely, I\u2019d like to add a few comments of my own.\u00a0 It\u2019s important for all to realize that no ICD lead is bulletproof.\u00a0 All will have an incidence of failure including the types of abrasion reported in Hauser\u2019s current study. \u00a0It is critical to realize that even poor performing ICD lead models in patients with an appropriate implant indication confer lifesaving protection against sudden cardiac arrest that exceeds medical therapy alone.<\/p>\n

St Jude has taken an aggressive stance defending the Durata lead, and from a business standpoint, it is not hard to see why.\u00a0Along with others who have closely followed this situation, I have criticized this lead, given its significant similarity to the Riata ST lead and have chosen not to implant it. Today\u2019s study is a direct blow to the Optim insulation that St. Jude holds is the key to Durata\u2019s relative performance. If Optim proves to have long-term bio-instability, we can expect this lead to behave similarly to Riata ST.<\/p>\n

It is naive to think that any insulation, including Optim, will be 100% immune to abrasion. Today\u2019s study reminds us of that fact. Note, though, that it is impossible to make any assumptions about the overall incidence of Durata and Riata ST Optim failures on the basis of this data. For that reason, I agree that it would be inappropriate to replace or extract these leads in the absence of electrical failure.<\/p>\n

Because it is unlikely that Optim will worsen ICD lead performance, it should be reasonable to expect these leads to behave like Riata ST in their early life. Failures in these leads tend to accelerate about four years after implantation. As the first implanted Durata leads are only now reaching that stage, the jury on this lead will remain out for some time.<\/p>\n","protected":false},"excerpt":{"rendered":"

A highly anticipated study\u00a0analyzing failures of St. Jude Durata and Riata ST Optim ICD leads has been published online in Europace by prominent electrophysiologist and ICD critic Dr. Robert Hauser along with associates from the Minneapolis Heart Institute. Over the past year St. Jude Medical has been beset with bad news about its ICD leads. […]<\/p>\n","protected":false},"author":556,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[448,1209],"class_list":["post-31176","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","tag-icds","tag-st-jude-medical"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31176","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/556"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=31176"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31176\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31176"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31176"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}