{"id":29027,"date":"2012-05-16T23:08:28","date_gmt":"2012-05-17T03:08:28","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=29027"},"modified":"2012-05-16T23:08:28","modified_gmt":"2012-05-17T03:08:28","slug":"robert-hauser-icd-watchdog-offers-viewpoint-on-riata-controversy-at-hrs","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/05\/16\/robert-hauser-icd-watchdog-offers-viewpoint-on-riata-controversy-at-hrs\/","title":{"rendered":"Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS"},"content":{"rendered":"

The St. Jude Riata ICD lead controversy took center stage at last week\u2019s Heart Rhythm Scientific Sessions in Boston, as previously reported here<\/a>. \u00a0Near the end of the meeting a leading figure in the field, Dr. Robert Hauser<\/a>, of the Minneapolis Heart Institute, summarized the current state of the Riata crisis and discussed its broader implications. Hauser\u00a0has played key roles in the Riata and several other similar, highly disturbing cases, including those involving the Sprint Fidelis ICD leads and the Prizm 2 DR ICD device malfunction.<\/p>\n

In a troubling revelation near the end of his talk, Hauser suggested that St. Jude’s problems may not end with the now discontinued Riata leads, and that the company’s Durata leads may\u00a0have failure mechanisms not previously reported.<\/p>\n

Hauser first discussed an abstract from Steinberg and associates from Quebec.\u00a0 These investigators used chest x-rays rather than fluoroscopy to detect Riata externalizations:<\/p>\n

They, like others, found a far higher incidence of externalized conductors than what has been reported by St. Jude Medical.\u00a0 And frankly, this and other reports presented at this meeting raise serious questions about the accuracy of the data that the manufacturer has communicated to us.\u00a0 What we learned today is that this externalized cable process is time dependent.\u00a0 It seems to be occurring more frequently in the 1580 leads, particularly in the 8 French, and that with time we are going to see progression.\u00a0 The fact that these investigators were able to use special chest radiographs to identify externalized conductors is interesting and deserves further study by comparing the sensitivity and specificity of their technique to high-resolution cine-flouroscopy<\/em><\/p><\/blockquote>\n

<\/em>Hauser then discussed the Riata extraction experience from Royal Victoria Hospital in Belfast, and then offered some practical advice:<\/p>\n

[these investigators] stunned us all last summer at the European Society of Cardiology in Paris with their report of a 15% incidence of Riata externalized cables.\u00a0 Previously we saw them in isolated case reports.\u00a0 We are certainly in their debt for this important communication.\u00a0 Today, Dr. Rebecca Noad and colleagues reported their excellent results with extracting Riata and Riata ST leads with and without insulation breaches.\u00a0 There was one complication, and that was a tear in the superior vena cava.\u00a0 Everyone should take note that this patient survived that complication because the procedure was performed in the operating room with a surgeon immediately on standby.\u00a0 Veteran extractors have emphasized the difficulties encountered in extracting Riata leads, particularly with externalized cables, with frequent need for 16 French sheaths, which we know increase procedural risk.\u00a0 Importantly, these investigators point out that it may not be possible to pass a locking stylet beyond the insulation breach to the lead tip.\u00a0 And we saw that the stylet actually provoked externalization of the cable. \u00a0Perhaps we should all be passing a stylet down a Riata lead at the time of PG change, even if the externalized cables are not visible on fluoroscopy.<\/em><\/p><\/blockquote>\n

<\/em>Next up was the Danish Pacemaker Registry experience presented by Dr. Jens Johansen confirming, as have others, the inferior long term performance of ICD leads with small diameters (including Medtronic Sprint Fidelis and St. Jude Riata):<\/p>\n

This finding raises the question:\u00a0 can a small diameter lead be sufficiently robust to perform reliably over years of biologic exposure and mechanical stress in the human body?\u00a0 Hopefully, small diameter leads like Riata ST Optim and Durata are up to the challenge and will do well.<\/em><\/p><\/blockquote>\n

<\/em>Amplifying this theme was the experience from Dr. Rordorf and coworkers from Pavia, Italy again showing poor performance of thin ICD leads.\u00a0 Hauser\u2019s compelling conclusions followed:<\/p>\n

Again this study poses the provocative question:\u00a0 is it possible to produce a small diameter lead that is durable.\u00a0 Presently we do not know the answer.\u00a0 Perhaps we have pushed lead design to the limits of what can be accomplished with current designs and materials.\u00a0 Maybe it is time for us to stick with what works.\u00a0 We have defined acceptable lead performance as a lead that has a failure rate of 0.5% per year over 10 years.\u00a0 Available leads appear capable of achieving this level of reliability.\u00a0 Not perfect, but leads will never be perfect.\u00a0 But is it good enough?\u00a0 I say yes.\u00a0 For the time being at least, until a new technology is proven in long-term clinical trials to be superior to the leads we are implanting today, we should stick with what we have.\u00a0 This field needs to put the era of lead and pulse generator problems behind us.\u00a0 Industry should stop innovating to gain market share, and innovate and focus on product reliability and longevity.\u00a0 Remember the saying \u201cthe enemy of good enough is better.\u201d<\/em><\/p><\/blockquote>\n

<\/em>Hauser then summarized a talk by Dr. Mark Carlson, the Chief Medical Officer of St. Jude Medical, who presented the last study in the place of Dr. Steven Greenberg:<\/p>\n

Unfortunately, Dr. Greenberg was unable to attend today, but St. Jude\u2019s Dr. Carlson stood bravely in the breach (no pun intended) to describe the performance of St. Jude\u2019s 3500+ Durata leads in its OPTIMUM registry.\u00a0 Follow up was 2.4 years, and my only comment is that 2.4 years in my view is an early experience, not a mid-term experience.\u00a0 The event free survival was >99%.\u00a0 Excluding dislodgments and perforations, which may be operator dependent, there were only 5 lead mechanical problems, namely conductor fractures, in over 8400 implant years.\u00a0\u00a0 Now this is truly spectacular.\u00a0 There were no inside-out insulation abrasions and no all-cause abrasions.\u00a0 But I have to say, that the Durata leads that I have been looking at in the FDA\u2019s MAUDE database must not have been included in this study.\u00a0<\/em><\/p><\/blockquote>\n

<\/em>Although only hinted in the presentation quoted above, Hauser confirmed in the post session question and answer that he has submitted a manuscript for peer review on Durata failures in the MAUDE database. \u00a0He could not confirm the publication date, but implied that the paper would challenge St. Jude\u2019s assertions about the reliability of the Durata lead. Wrapping up the session, Hauser circled back to challenge the cardiac device community to improve post market surveillance and prioritize safety:<\/p>\n

A few closing comments:\u00a0 We need good data for all life-saving and life-sustaining medical devices.\u00a0 I believe that every pulse generator, every ICD pulse generator, and every lead should be registered and followed, at least annually.\u00a0 We need to apply sophisticated techniques to these registries to uncover potentially defective devices before they are implanted in a large number of patients.\u00a0 It is a goal we the caregivers should accept and drive toward.\u00a0 Lastly, and perhaps most importantly, patient safety should become the overarching goal of this society.\u00a0 Thank you.<\/em><\/p><\/blockquote>\n

\"\"<\/a>

Photo of Durata promotional truck at HRS courtesy of Dr. Wes<\/p><\/div>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

The St. Jude Riata ICD lead controversy took center stage at last week\u2019s Heart Rhythm Scientific Sessions in Boston, as previously reported here. \u00a0Near the end of the meeting a leading figure in the field, Dr. Robert Hauser, of the Minneapolis Heart Institute, summarized the current state of the Riata crisis and discussed its broader […]<\/p>\n","protected":false},"author":556,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-29027","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29027","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=29027"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29027\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=29027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=29027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=29027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}