carotid stenting, is this the real world?

2
Editorial Comment Carotid Stenting, Is This the Real World? Bonnie Weiner,* MD, MSEC, MBA, FSCAI Director, Interventional Cardiology Research, Saint Vincent Hospital, Worcester, Massachusetts Carotid Artery Stenting is the most highly studied, and least widely applied technology in cardiovascular medicine [1–4]. As noted in the current publication from the CARE registry in data from 141 centers, the number of procedures per facility ranges from 1 to 303 with a median of 28. The limitation of its use is not related 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 being treated at these sites. As pointed out, although not a guideline, the clinical expert consensus document is an important perspective in that the majority of the pro- fessional societies whose members perform carotid stenting participated in developing [7]. The Society for Vascular Surgery is conspicuously absent. As such, it is a valuable reference to determine whether this is reflected in clinical practice. In the centers participat- ing in CARE the vast majority are fully compliant with 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 to be symptomatic, and therefore have more of the pre- dictors of worse outcomes. This is inevitable in the current environment as the major reimbursement path- way for asymptomatic patients at high surgical risk is the post market surveillance trials. Symptomatic patients are treated through normal clinical pathways and would therefore be more highly represented in CARE. Despite this, the outcomes are quite good and meet the acceptable level overall. A critical piece of this is the independent neurologic assessment. Although only half of the patients had it performed, and those most likely are ones that were participating in the trials, it is a milestone in setting the standard for real world assessment. This is manda- tory, if we are going to be able to compare outcomes across reports, centers, and specialties. It is imperative that this approach be uniform if we want to use these data for quality comparisons. As has previously been described, comparing outcomes from reports where this is not required to those where it is, results in the misinterpretation of the data and condemns the more rigorous approach to criticism for worse outcomes [8]. If you don’t look, you don’t find and therefore under report the event rate. It is also important to keep in perspective that par- ticularly at this stage of the experience, CARE is not designed to be a vehicle for comparison between strat- egies for revascularization or for comparison to medi- cal therapy. A recent report concluding that intensive medical therapy is a better first line strategy than re- vascularization may or may not be valid, partly because it is limited to asymptomatic patients without clear increases in surgical risk [9]. Furthermore, it uses only duplex assessment of severity as the determinant not NASCET that is used in all of the CAS trials [10]. Presumably only major strokes are used as the out- come measure, however, when compared to event rates for CAS with independent neurologic evaluation both major and minor strokes are reported. Again, not nec- essarily the correct comparison. What it does point out, however, is that trans cranial Doppler might be a tool to help better identify those asymptomatic patients most likely to benefit from revascularization. Only time 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 of these data and we can be confident of at least that seg- ment. That is not likely to continue as the post market studies are going to be winding down. Validation by an independent body will be important going forward to confirm 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 protected] Conflict of interest: I am the President of Accreditation for Cardio- vascular Excellence. Received 24 December 2009; Revision accepted 30 December 2009 DOI 10.1002/ccd.22444 Published online 8 March 2010 in Wiley InterScience (www. interscience.wiley.com). ' 2010 Wiley-Liss, Inc. Catheterization and Cardiovascular Interventions 75:528–529 (2010)

Upload: bonnie-weiner

Post on 06-Jun-2016

223 views

Category:

Documents


3 download

TRANSCRIPT

Page 1: Carotid stenting, is this the real world?

Editorial Comment

Carotid Stenting, Is This theReal World?

Bonnie Weiner,* MD, MSEC, MBA, FSCAI

Director, Interventional Cardiology Research,Saint Vincent Hospital, Worcester, Massachusetts

Carotid Artery Stenting is the most highly studied,and least widely applied technology in cardiovascularmedicine [1–4]. 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 [7]. The Society forVascular Surgery is conspicuously absent. As such, itis a valuable reference to determine whether this isreflected 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 therecently 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 neurologicassessment. 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 [8].If you don’t look, you don’t find 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 first line strategy than re-vascularization may or may not be valid, partlybecause it is limited to asymptomatic patients withoutclear increases in surgical risk [9]. Furthermore, it usesonly duplex assessment of severity as the determinantnot NASCET that is used in all of the CAS trials [10].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 benefit 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 confident 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 confirm 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 protected]

Conflict of interest: I am the President of Accreditation for Cardio-

vascular Excellence.

Received 24 December 2009; Revision accepted 30 December 2009

DOI 10.1002/ccd.22444

Published online 8 March 2010 in Wiley InterScience (www.

interscience.wiley.com).

' 2010 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 75:528–529 (2010)

Page 2: Carotid stenting, is this the real world?

rate reporting of the outcomes [11]. With that in place,CARE will become increasingly valuable to patients,practitioners, regulators, and payers who should belooking at maintaining and improving quality.

References

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;2:159–166.

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;70:1025–1033.

3. Massop D, Dave R, Metzger C, et al. Stenting and angioplasty with

protection in patients at high-risk for endarterectomy: SAPPHIRE

worldwide registry first 2,001 patients. Catheter Cardiovasc Interv

2009;73:129–136.

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;49:71–79.

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 December

22, 2009.

6. Mackey WC, Liapis C, Cao P, Perler B, et al. Comparison of

SVS and ESVS carotid disease management guidelines. J Vasc

Surg 2009;50:429–430.

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

2007;49:126–170.

8. White CJ, Liar, liar, pants on fire. Catheter Cardiovasc Interv

2008;72:430–431.

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 definition of 70% to 99% internal ca-

rotid artery stenosis with duplex scanning. J Vasc Surg

1993:17;152–157; discussion 157–159.

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