Carotid stenting, is this the real world?
Post on 06-Jun-2016
Carotid Stenting, Is This theReal World?
Bonnie Weiner,* MD, MSEC, MBA, FSCAIDirector, Interventional Cardiology Research,Saint Vincent Hospital, Worcester, Massachusetts
Carotid Artery Stenting is the most highly studied,and least widely applied technology in cardiovascularmedicine . As noted in the current publicationfrom the CARE registry in data from 141 centers, thenumber of procedures per facility ranges from 1 to 303with a median of 28. The limitation of its use is notrelated to the limitations of patients, operators or sci-ence but rather to the politics of inter disciplinary dif-ferences and reimbursement [5,6].The current report from the CARE registry high-
lights several important aspects of the patients beingtreated at these sites. As pointed out, although not aguideline, the clinical expert consensus document is animportant perspective in that the majority of the pro-fessional societies whose members perform carotidstenting participated in developing . The Society forVascular Surgery is conspicuously absent. As such, itis a valuable reference to determine whether this isreected in clinical practice. In the centers participat-ing in CARE the vast majority are fully compliantwith these recommendations.In the current publication, the comparison with the
recently published registries adds important perspec-tive. First of all, the CARE patients are more likely tobe symptomatic, and therefore have more of the pre-dictors of worse outcomes. This is inevitable in thecurrent environment as the major reimbursement path-way for asymptomatic patients at high surgical risk isthe post market surveillance trials. Symptomaticpatients are treated through normal clinical pathwaysand would therefore be more highly represented inCARE. Despite this, the outcomes are quite good andmeet the acceptable level overall.A critical piece of this is the independent neurologic
assessment. Although only half of the patients had itperformed, and those most likely are ones that wereparticipating in the trials, it is a milestone in settingthe standard for real world assessment. This is manda-tory, if we are going to be able to compare outcomesacross reports, centers, and specialties. It is imperative
that this approach be uniform if we want to use thesedata for quality comparisons. As has previously beendescribed, comparing outcomes from reports wherethis is not required to those where it is, results in themisinterpretation of the data and condemns the morerigorous approach to criticism for worse outcomes .If you dont look, you dont nd and therefore underreport the event rate.It is also important to keep in perspective that par-
ticularly at this stage of the experience, CARE is notdesigned to be a vehicle for comparison between strat-egies for revascularization or for comparison to medi-cal therapy. A recent report concluding that intensivemedical therapy is a better rst line strategy than re-vascularization may or may not be valid, partlybecause it is limited to asymptomatic patients withoutclear increases in surgical risk . Furthermore, it usesonly duplex assessment of severity as the determinantnot NASCET that is used in all of the CAS trials .Presumably only major strokes are used as the out-come measure, however, when compared to event ratesfor CAS with independent neurologic evaluation bothmajor and minor strokes are reported. Again, not nec-essarily the correct comparison. What it does pointout, however, is that trans cranial Doppler might be atool to help better identify those asymptomatic patientsmost likely to benet from revascularization. Onlytime will tell if that is true.As pointed out by the authors, this is a self-reported
registry with all of the pros and cons that represents.Because half of the patients reported are in clinical tri-als there has been some auditing and validation ofthese data and we can be condent of at least that seg-ment. That is not likely to continue as the post marketstudies are going to be winding down. Validation byan independent body will be important going forwardto conrm appropriate use of the procedures and accu-
*Correspondence to: Dr. Bonnie Weiner, Director, Interventional
Cardiology Research, Saint Vincent Hospital, Worcester, Massachu-
setts. E-mail: email@example.com
Conict of interest: I am the President of Accreditation for Cardio-
Received 24 December 2009; Revision accepted 30 December 2009
Published online 8 March 2010 in Wiley InterScience (www.
' 2010 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions 75:528529 (2010)
rate reporting of the outcomes . With that in place,CARE will become increasingly valuable to patients,practitioners, regulators, and payers who should belooking at maintaining and improving quality.
1. Gray W, Chaturvedi S, and Verta P, 30-day outcomes for carotid
artey stenting in 6,320 patients from two prospective, multicenter,
high surgical risk registries. Circ Cardiovasc Interv 2009;2:159166.
2. Gray WA, Yadav JS, Verta P, et al. The CAPTURE registry:
Predictors of outcomes in carotid artery stenting with embolic
protection for high surgical risk patients in the early post-ap-
proval setting. Catheter Cardiovasc Interv 2007;70:10251033.
3. Massop D, Dave R, Metzger C, et al. Stenting and angioplasty with
protection in patients at high-risk for endarterectomy: SAPPHIRE
worldwide registry rst 2,001 patients. Catheter Cardiovasc Interv
4. Sidawy AN, Zwolak RM, White RA, et al. Risk-adjusted 30-day
outcomes of carotid stenting and endarterectomy: Results from
the SVS Vascular Registry. J Vasc Surg 2009;49:7179.
5. Centers for Medicare and Medicaid Services. Decision Memo
for Percutaneous Transluminal Angioplasty (PTA) of the Carotid
Artery Concurrent with Stenting (CAG-00085R7). 2009; Avail-
able from: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?
from25viewdecisionmemo.asp&id5230&. Accessed December22, 2009.
6. Mackey WC, Liapis C, Cao P, Perler B, et al. Comparison of
SVS and ESVS carotid disease management guidelines. J Vasc
7. Bates ER, Babb JD, Casey Jr DE, et al. ACCF/SCAI/SVMB/
SIR/ASITN 2007 clinical expert consensus document on carotid
stenting: A report of the American College of Cardiology Foun-
dation Task Force on Clinical Expert Consensus Documents
(ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus
Document Committee on Carotid Stenting). J Am Coll Cardiol
8. White CJ, Liar, liar, pants on re. Catheter Cardiovasc Interv
9. Spence JD, Coates V, Li H, et al. Effects of intensive medical
therapy on microemboli and cardiovascular risk in asymptomatic
carotid stenosis. Arch Neurol 2009:289;2009.
10. Moneta GL, Edwards JM, Chitwood RW, et al. Correlation of
North American Symptomatic Carotid Endarterectomy Trial
(NASCET) angiographic denition of 70% to 99% internal ca-
rotid artery stenosis with duplex scanning. J Vasc Surg
1993:17;152157; discussion 157159.
11. Accreditation for Cardiovascular Excellence. Available from:
http://cvexcel.org/. Accessed December 21, 2009.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Carotid Stenting, Is This the Real World? 529