coronary computed tomography angiography after stress testing

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Transcatheter Aortic Valve Replacement: What’s in a Name? In the 2012 expert consensus document on transcatheter aortic valve replacement (TAVR), the inexact name TAVR appears in nearly every paragraph (1). But, what’s in a name? According to William Shake- speare, “That which we call a rose; by any other name would still smell as sweet” (Romeo and Juliette, c. 1597). We therefore humbly suggest reversion to the archaic name transcatheter aortic valve implantation (TAVI). TAVR has been characterized as a disrup- tive technology destined to change the landscape of valvular heart disease therapy (2). A disruptive technology refers to an innovation that ultimately displaces a proven technology already on the market, in this case, surgical valve replacement. But how can we accept such a bold declaration when the designation of the procedure is a confusing misnomer? We increasingly see poor operative candidates with severe aortic stenosis in our multidisciplinary valve clinic. Our conversation commences by reviewing the glossy educational pamphlet for the Edwards Sapien Transcatheter Valve (Edwards Lifesciences LLC, Irvine, California). The title on the front cover, above the image of the loving elderly couple sitting on a park bench, reads “Trans- catheter Aortic Valve Replacement.” Invariably, the first question from an astute octogenarian is, “What happens to the old valve?” We gracefully explain that we blow up a balloon, smash the old valve to the side, then implant a new one within their existing annulus. Their reaction is often one of bewilderment. This confusion is well founded. Webster’s dictionary defines replace as “to put something new in place of something else,” and implies filling a place once occupied by something removed. One does not have a muffler replaced at the local auto shop and expect to find the old one still in place. Technically, we are performing valve displacement. However, a valve displacement doesn’t sound like an advanced restorative therapy that marketing experts would embrace. With commercial release of the Sapien valve on November 2, 2011, the TAVR misnomer was memorialized: “The U.S. FDA today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery” (3). Suddenly, the blogosphere described “The Evolving TAVR Market” at NASDAQ.com, while the cardiology community further cemented the acronym in catheterization lab- oratories everywhere. When did this conspicuous misuse of the English language first occur? Results of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial were published in a 2010 article entitled “Transcatheter Aortic-Valve Implantation for Aortic Ste- nosis in Patients Who Cannot Undergo Surgery” (4). TAVI was the acronym used, and implantation seemed an appropriate de- scription of the technology. By 2011, with publication of the high-risk cohort of the PARTNER trial, the title somehow transformed to “Transcatheter Versus Surgical Aortic-Valve Re- placement in High-Risk Patients” (5). Why does this matter? We contend that this is not merely semantic, because an accurate name for high-risk expensive pro- cedures is pertinent to healthcare stake holders. It facilitates uniform communication among researchers, payers, regulators, clinicians, and, most importantly, patients. In a clinical landscape cluttered with jargon, we should strive toward verbal precision. Politicians, poets, and pollsters know that words matter. Powerful words launch social movements and even cultural revolutions. The right catch phrase also can launch a new product. However, there should be truth in advertising, and our regulatory bodies should be critical in determining if advertising is misleading or fails to disclose all the relevant facts (6). So what’s in a name? If TAVR is to alter the course of cardiovas- cular disease care, then we believe this rose would smell sweeter with a more accurate name. We suggest the original designation of TAVI be the acronym of choice. This title harkens back to Rudyard Kipling’s classic novel where the valiant mongoose, Rikki-Tikki-Tavi, con- fronts a dreaded cobra plotting the murder of his adoptive human family. Senile critical aortic stenosis in poor operative candidates just may be the cardiologist’s most poisonous snake. To combat such a foe, it is fitting that TAVI be anointed our protagonist. Stacey D. Clegg, MD *Mori J. Krantz, MD *Division of Cardiology Denver Health Medical Center University of Colorado–Denver Mail Code 0960 777 Bannock Street Denver, Colorado 80204-4507 E-mail: [email protected] http://dx.doi.org/10.1016/j.jacc.2012.03.049 REFERENCES 1. Holmes DR, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 2012:1–105. 2. Svensson LG. Evolution and results of aortic valve surgery, and a ‘disruptive’ technology. Cleveland Clinic J Med 2008;11:802– 4. 3. FDA News Release. November 2, 2011. FDA approves first artificial aortic heart valve placed without open-heart surgery. Available at: http:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm278348.htm. Accessed September 17, 2008. 4. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597– 607. 5. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364: 2187–98. 6. FDA News Release. FDA oversight of direct-to-consumer advertising of medical devices. Available at: http://www.fda.gov/NewsEvents/ Testimony/ucm096272.htm. Accessed September 17, 2008. Coronary Computed Tomography Angiography After Stress Testing In the ACIC (Advanced Cardiovascular Imaging Consortium) registry, Chinnaiyan et al. (1) evaluated the correlation between stress test results and extent of coronary artery disease (CAD) on coronary computed tomography angiography (CCTA) and com- pared the diagnostic performance of both noninvasive modalities in patients undergoing invasive coronary angiograms. The authors should be commended for their attempts to answer a pertinent debate on appropriate use of various diagnostic modalities in 239 JACC Vol. 60, No. 3, 2012 Correspondence July 17, 2012:235– 41

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Page 1: Coronary Computed Tomography Angiography After Stress Testing

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239JACC Vol. 60, No. 3, 2012 CorrespondenceJuly 17, 2012:235–41

Transcatheter Aortic ValveReplacement: What’s in a Name?In the 2012 expert consensus document on transcatheter aortic valvereplacement (TAVR), the inexact name TAVR appears in nearly everyparagraph (1). But, what’s in a name? According to William Shake-speare, “That which we call a rose; by any other name would stillsmell as sweet” (Romeo and Juliette, c. 1597). We therefore humblysuggest reversion to the archaic name transcatheter aortic valveimplantation (TAVI). TAVR has been characterized as a disrup-tive technology destined to change the landscape of valvular heartdisease therapy (2). A disruptive technology refers to an innovationthat ultimately displaces a proven technology already on themarket, in this case, surgical valve replacement. But how can weaccept such a bold declaration when the designation of theprocedure is a confusing misnomer?

We increasingly see poor operative candidates with severe aorticstenosis in our multidisciplinary valve clinic. Our conversationcommences by reviewing the glossy educational pamphlet for theEdwards Sapien Transcatheter Valve (Edwards Lifesciences LLC,Irvine, California). The title on the front cover, above the image ofthe loving elderly couple sitting on a park bench, reads “Trans-catheter Aortic Valve Replacement.” Invariably, the first questionfrom an astute octogenarian is, “What happens to the old valve?”We gracefully explain that we blow up a balloon, smash the old valveto the side, then implant a new one within their existing annulus.Their reaction is often one of bewilderment. This confusion is wellfounded. Webster’s dictionary defines replace as “to put somethingnew in place of something else,” and implies filling a place onceoccupied by something removed. One does not have a mufflerreplaced at the local auto shop and expect to find the old one still inplace. Technically, we are performing valve displacement. However, avalve displacement doesn’t sound like an advanced restorative therapythat marketing experts would embrace.

With commercial release of the Sapien valve on November 2,2011, the TAVR misnomer was memorialized: “The U.S. FDAtoday approved the first artificial heart valve that can replace anaortic heart valve damaged by senile aortic valve stenosis withoutopen-heart surgery” (3). Suddenly, the blogosphere described “TheEvolving TAVR Market” at NASDAQ.com, while the cardiologycommunity further cemented the acronym in catheterization lab-oratories everywhere.

When did this conspicuous misuse of the English language firstoccur? Results of the randomized PARTNER (Placement ofAortic Transcatheter Valve) trial were published in a 2010 articleentitled “Transcatheter Aortic-Valve Implantation for Aortic Ste-nosis in Patients Who Cannot Undergo Surgery” (4). TAVI wasthe acronym used, and implantation seemed an appropriate de-scription of the technology. By 2011, with publication of thehigh-risk cohort of the PARTNER trial, the title somehowtransformed to “Transcatheter Versus Surgical Aortic-Valve Re-placement in High-Risk Patients” (5).

Why does this matter? We contend that this is not merelysemantic, because an accurate name for high-risk expensive pro-cedures is pertinent to healthcare stake holders. It facilitatesuniform communication among researchers, payers, regulators,

clinicians, and, most importantly, patients. In a clinical landscape

cluttered with jargon, we should strive toward verbal precision.Politicians, poets, and pollsters know that words matter. Powerfulwords launch social movements and even cultural revolutions. Theright catch phrase also can launch a new product. However, thereshould be truth in advertising, and our regulatory bodies should becritical in determining if advertising is misleading or fails todisclose all the relevant facts (6).

So what’s in a name? If TAVR is to alter the course of cardiovas-cular disease care, then we believe this rose would smell sweeter witha more accurate name. We suggest the original designation of TAVIbe the acronym of choice. This title harkens back to Rudyard Kipling’sclassic novel where the valiant mongoose, Rikki-Tikki-Tavi, con-fronts a dreaded cobra plotting the murder of his adoptive humanfamily. Senile critical aortic stenosis in poor operative candidates justmay be the cardiologist’s most poisonous snake. To combat such a foe,it is fitting that TAVI be anointed our protagonist.

Stacey D. Clegg, MD*Mori J. Krantz, MD

*Division of CardiologyDenver Health Medical CenterUniversity of Colorado–DenverMail Code 0960777 Bannock StreetDenver, Colorado 80204-4507E-mail: [email protected]

http://dx.doi.org/10.1016/j.jacc.2012.03.049

EFERENCES

1. Holmes DR, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STSexpert consensus document on transcatheter aortic valve replacement.J Am Coll Cardiol 2012:1–105.

2. Svensson LG. Evolution and results of aortic valve surgery, and a‘disruptive’ technology. Cleveland Clinic J Med 2008;11:802–4.

3. FDA News Release. November 2, 2011. FDA approves first artificial aorticheart valve placed without open-heart surgery. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278348.htm. Accessed September 17, 2008.

4. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valveimplantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med 2010;363:1597–607.

5. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgicalaortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–98.

6. FDA News Release. FDA oversight of direct-to-consumer advertisingof medical devices. Available at: http://www.fda.gov/NewsEvents/Testimony/ucm096272.htm. Accessed September 17, 2008.

Coronary Computed TomographyAngiography After Stress TestingIn the ACIC (Advanced Cardiovascular Imaging Consortium)registry, Chinnaiyan et al. (1) evaluated the correlation betweenstress test results and extent of coronary artery disease (CAD) oncoronary computed tomography angiography (CCTA) and com-pared the diagnostic performance of both noninvasive modalitiesin patients undergoing invasive coronary angiograms. The authorsshould be commended for their attempts to answer a pertinent

debate on appropriate use of various diagnostic modalities in
Page 2: Coronary Computed Tomography Angiography After Stress Testing

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240 Correspondence JACC Vol. 60, No. 3, 2012July 17, 2012:235–41

evaluation of CAD. However, a few interesting points arise fromthe analysis, and several caveats have to be considered beforereaching a final conclusion.

First, authors defined obstructive CAD as coronary stenosis�50% rather than 70%, which might account for higher reportedsensitivity of CCTA in the study. It has been shown that �70%stenosis is a better predictor of associated physiologically signifi-cant perfusion defect and has more clinical implications (2). Itwould be interesting to know whether the investigators have datawith regard to the degree of stenoses and perfusion defect, so thatmore appropriate conclusions can be made before accepting thestudy result that stress test did not predict obstructive CAD (1).Moreover, the reported low yield of stress testing in the study canbe explained on the basis of work-up bias (inclusion of patients fordisease verification by a gold standard test based on the results ofpreliminary testing) (3).

Second, the reason why asymptomatic patients underwentinvasive coronary angiography requires clarification, because thereis no clear benefit of revascularization in these patients; the samealso applies to patients with normal stress tests and nonobstructiveCAD on CCTA.

Third, the role of CCTA in asymptomatic patients is still notestablished. With regard to the recommendations of the authors touse CCTA in the asymptomatic individual with cardiac risk factorsinstead of a stress test before surgery or beginning of a vigorousexercise program, citing low positive predictive value (PPV) ofstress, it is important to note that most patients in the study theauthors quote here were symptomatic and that the study alsocounted equivocal tests as positive while calculating PPV thatlowers the reported PPV (4).

Lastly, it would also be interesting to know whether the authorsmade any attempt to study the impact of calcium score on the roleof CCTA as “gatekeeper” to invasive coronary angiography.

*Abhishek Sharma, MD

*Maimonides Medical Center1016 50th StreetApartment 2CBrooklyn, New York 11219E-mail: [email protected]

http://dx.doi.org/10.1016/j.jacc.2012.02.062

EFERENCES

1. Chinnaiyan KM, Raff GL, Goraya T, et al. Coronary computedtomography angiography after stress testing: results from a multicenter,statewide registry, ACIC (Advanced Cardiovascular Imaging Consor-tium). J Am Coll Cardiol 2012;59:688–95.

2. Nicol ED, Stirrup J, Reyes E, et al. Sixty-four-slice computed tomo-graphy coronary angiography compared with myocardial perfusionscintigraphy for the diagnosis of functionally significant coronarystenoses in patients with a low to intermediate likelihood of coronaryartery disease. J Nucl Cardiol 2008;15:311–8.

3. Mower WR. Evaluating bias and variability in diagnostic test reports.Ann Emerg Med 1999;33:85–91.

4. Newman RJ, Darrow M, Cummings DM, et al. Predictive value ofexercise stress testing in a family medicine population. J Am Board FamMed 2008;21:531–8.

Reply

Dr. Sharma conveys reasonable concerns with regard to our

findings from the ACIC (Advanced Cardiovascular Imaging

T A A A A C

CCT

TME