This Article Full Text (PDF) All Versions of this Article: 35/12/2759    most recent 01.STR.0000147152.84383.6ev1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Ammar, A. D. Search for Related Content PubMed PubMed Citation Articles by Ammar, A. D.

(Stroke. 2004;35:2759.)
© 2004 American Heart Association, Inc.

Letters to the Editor

Surgery Versus Stenting: How Medical Device Makers Influence Patient Care

Alex D. Ammar, MD

Department of Surgery, University of Kansas School of Medicine, Wichita, Kansas

To the Editor:

A recent Wall Street Journal article¹ highlighted the unfortunate tactics of medical device makers (Medtronic Inc of Minneapolis, in this instance) that influence scientific research by financial incentives to medical consultants who are investigators, aggressive marketing, and ultimately legal action.

The above article describes the controversial issues surrounding stent graft repairs of abdominal aortic aneurysms. It caused me to recall another equally disturbing debate that exists regarding the most efficacious treatment of carotid stenosis: carotid endarterectomy (CEA) versus carotid artery stenting (CAS). In a presentation at the November 2002 American Heart Association meeting in Chicago, Illinois, Dr Jay Yadav from the Cleveland Clinic reported the initial results of carotid stenting and angioplasty with protection (filters used to trap debris inside the carotid artery after the plaque is disrupted with a balloon or stent) in patients at high risk for endarterectomy (SAPPHIRE Study). The 30-day major adverse clinical event rate (stroke, myocardial infarction, death) was 5.8% for CAS with protection and 12.6% for CEA.

In a review by the Performance Improvement Committee at HCA Wesley Medical Center, an affiliate hospital of the University of Kansas at Wichita, published in the Physicians Bulletin, 530 CEAs throughout a 24-month period beginning January 1998 were reviewed.² These procedures were performed on patients admitted with the primary diagnosis of carotid stenosis who underwent CEA. All CEAs were performed by 4 vascular and 8 cardiothoracic surgeons. Included were many high-risk patients similar to those used in the SAPPHIRE Study: patients with severe heart disease, emphysema, dialysis-dependent renal failure, restenosis after previous endarterectomy, and patients with prior neck irradiation. Same-stay stroke occurred in 1 patient and same-stay mortality (due to myocardial infarction) occurred in another patient.

Carotid endarterectomy has been one of the most extensively scrutinized operations of our time.

• 90% of patients can undergo operation with preoperative ultrasound only without arteriography
  
• 90% do not require intensive care monitoring
  
• 90% require hospital stay of 24 hours or less
  
• the vast majority require no postoperative restrictions
  
• arterial complications as a result of arteriography (such as aneurysm formation) are not pertinent to CEA
  
• charges are less than that of stent procedures
  
• recurrent stenosis rates are less than 10%
  
• combined risk of stroke and death in multiple reports is less than 3%
  

The main danger of CAS is distal embolization with resultant stroke. Many patients without clinical stroke have demonstrated embolic debris after CAS if studied by various diagnostic modalities. The majority of patients with significant carotid stenosis demonstrate plaque hemorrhage, which is prone to embolize spontaneously without manipulation with a wire or catheter. Surgeons have much better means of reducing embolic complications with complete control of arterial blood flow during operation as opposed to stenting procedures.

With more than 150 000 CEAs performed in the United States annually, medical device companies have a huge financial interest in this procedure. Consequently, patients who typically would have CEA are shifted to stenting. Hospital cost for each stent alone is approximately $1500 or more, and some patients require more than one stent. In addition, these procedures necessitate multiple guide wires, catheters, balloon angioplasty catheters and protection devices, produced by the same companies who produce the stents.

The September 2003 edition of Endovascular Today devoted a section to an update on CAS.^3–6 Three of 4 clinical authors were chief medical editors of the journal and the other author was on the Editorial Advisory Board. Of these 4 authors, three are consultants to medical device companies (Cordis, Medtronic, and Guidant).

Are the reported results of CAS truly unbiased? Many of the leading investigators are paid consultants of medical device manufacturers. As a specialist in vascular disease, and specifically a vascular surgeon, I perform CEAs. I also perform stent procedures in most peripheral arteries where indicated and stent graft repairs of abdominal aortic aneurysms. These procedures are effective and offer patients potentially less morbid alternatives to open operations. On the other hand, CAS offers little advantage over CEA, a minimally invasive procedure itself. Theoretically, if one considers the pathology being treated and the sensitivity of brain tissue to a lack of blood supply, CAS is difficult to justify. If it is truly safer, I will perform the procedure like others in my specialty. Nonetheless, in such a potentially high-risk area, the public deserves meticulous analysis by unbiased investigators who have no financial tie to the results.

References

1. Mathews AW, Burton TM. After Medtronic lobbying push, the FDA had change of heart. The Wall Street Journal. July 9, 2004.
2. HCA Wesley Medical Center. Strokes and mortality outcomes for carotid endarterectomy surgery. Physicians Bulletin. November 17, 2000.
3. Ohki T. The dark side of embolic protection devices. Endovascular Today. 2003; 2: 54–64.
4. Craido FJ. Mastering carotid intervention. Endovascular Today. 2003; 2: 65–68.
5. Dieter RS, Laird JR. Carotid artery stenting risk reduction. Endovascular Today. 2003; 2: 69–73.
6. Katzen BT, Laird JR, Ohki T. The SAPPHIRE and ARCHeR updates. Endovascular Today. 2003; 2: 77–81.

This Article Full Text (PDF) All Versions of this Article: 35/12/2759    most recent 01.STR.0000147152.84383.6ev1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Ammar, A. D. Search for Related Content PubMed PubMed Citation Articles by Ammar, A. D.