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• W2306464377 abstract "HomeCirculationVol. 133, No. 17Nonlinear Mathematics of Death and Vascular Access Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBNonlinear Mathematics of Death and Vascular Access Harold L. Dauerman, MD Harold L. DauermanHarold L. Dauerman From University of Vermont College of Medicine, Burlington, VT. Search for more papers by this author Originally published11 Mar 2016https://doi.org/10.1161/CIRCULATIONAHA.116.022159Circulation. 2016;133:1634–1636Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: April 26, 2016: Previous Version 1 In this issue of Circulation, the British Cardiovascular Intervention Society (BCIS) National Registry presents compelling data on trends and outcomes with respect to radial versus femoral artery access for percutaneous coronary intervention (PCI)1; 448 853 patients in the United Kingdom underwent PCI between 2005 and 2012 and radial access grew 3-fold. This is not the first BCIS study to document this march toward radial access dominance or the association of radial access with improved outcomes.2 Nor is this the largest temporal trends study demonstrating significant growth of the radial strategy: the National Cardiovascular Database Registry (NCDR) studied >2.8 million patients in the United States and documented a growth in radial access from 1.2% to 16.1% of all PCI procedures from 2007 to 20123; like the current BCIS study, the NCDR analysis also demonstrated regional heterogeneity in growth and improved outcomes among patients receiving radial as opposed to femoral access.Article, see p 1655The BCIS Registry is unique, however; both the growth curve and the associated outcomes warrant further attention. First, because this is a population-based registry, nearly every patient undergoing PCI in the United Kingdom is now represented; thus, growth rate and regional heterogeneity are broadly representative of actual practice. This is in contradistinction to other large registries that are site, but not population, based. For example, the NCDR is very large but participation is not mandatory3; thus, it can only represent practice patterns and outcomes specific to those US hospitals that have the inclination to participate in a quality improvement database.Second, the focus of this analysis is not on the relationship between vascular approach and access site bleeding complications—a foregone conclusion established uniformly in favor of radial access in contemporary clinical trials and registries.3–5 Rather, the BCIS analysis asks how many lives can be saved when a country converts to a predominantly radial approach? The authors demonstrate a 32% reduction in 30-day mortality with radial in comparison with femoral access in a multivariable model identifying many well-known predictors of death after PCI (ie, older age, diabetes mellitus, acute presentations, and preexisting renal and vascular disease). Because this is not a randomized trial, such an analysis is limited by the potential for unknown confounders. Previous studies have suggested similar radial access–related reductions in the odds of death in selected PCI populations.5–7The authors use a complex statistical approach to mortality association that is not easily critiqued by a clinical interventional cardiologist (me): “Using the combined model estimates (across the 50 data sets) with the mimrgns command (and necessarily assuming that the random-effect of the model was zero), we calculated the probability of 30 day mortality by arterial access type, within each SHA and year, while setting all covariates at their mean value within each SHA year stratum.” So, let’s assume their model is statistically sound and move on from that point of humble ignorance. The authors conclude that there are 2 congruent curves that make for a simple equation: as radial access increases, more and more lives will be saved. If we take this simple relationship to its logical conclusion, we can conclude that in a utopia of universal radial adoption, PCI mortality will get closer and closer to zero. This may not be true.The Growth Curve of Radial Artery AccessThe exponential growth of radial artery access in the BCIS Registry is shown in Figure. Radial access grew from 14% to 59% of PCI patients in the United Kingdom over an 8-year period; a linear equation would estimate the absolute growth rate as 5% to 6% per year and be incorrect. Between 2005 and 2006, radial access grew <2%, whereas, between 2008 and 2009, radial access grew by ≈9%.1 The exponential adoption pattern can be understood clinically: every time interventional cardiologists learn to be a proficient radial access operator, they do not train 1 new operator—rather they influence multiple trainees or colleagues leading to a more explosive growth pattern.Download figureDownload PowerPointFigure. The growth of radial artery access in the United Kingdom is plotted over an 8-year period. The growth rate is nonlinear and exponential. Similarly, the modeled number of lives saved by doing radial (as opposed to 100% femoral) PCI per year demonstrates exponential growth in concordance with adoption of radial access. Conversely, the multivariable adjusted odds of death 30 days after PCI is plotted over the 8-year study period with the reference mortality in 2005 set at 1.0 (×100 for scale purposes). This mortality curve is neither linear nor concordant with the growth of radial procedures: the odds ratio for 30-day post-PCI mortality reduction in 2012 is not significantly different from the reference value in 2005 (odds ratio, 0.96; 95% confidence interval, 0.85–1.07; P=0.45). PCI indicates percutaneous coronary intervention.The exponential growth rate of radial artery access is not unique to the United Kingdom, and we can use the BCIS data to calculate growth rates in other countries. The NCDR demonstrated US growth of radial artery access from 1.2% to 16% over the 2007 to 2012 period.3 This may be interpreted as a slow rate of adoption in the United States, but if one looks closely at the US radial access rate of growth, there is a similar exponential growth pattern: the rate of growth in the first 2 years is 1% to 2%, but later growth is >5% per year. If we assume that the United States is following the same growth curve as the United Kingdom (albeit left shifted because of a late, not slow, start), we can expect that the 16% radial adoption rate in the United States in 2012 is similar to the 16% adoption rate in the United Kingdom in 2006. An exponential growth curve dictates that radial access will predominate in the United States after 5 years have passed, ie, the end of 2017.Although the exponential nature of radial access growth is clear, the precise equation may not be identical from 1 region or country to the other. One of the key insights of the BCIS Registry is that heterogeneity exists across individual regions in terms of radial artery access adoption. Radial artery access adoption in 2012 ranged from 28% in the South Coast to 81% in the Northeast, and similar regional heterogeneity is seen in the NCDR analysis of US radial access adoption.3 The heterogeneity of radial access adoption can be metaphorically seen as the interventional cardiology manifestation of Newton’s Second Law: Force = Mass × Acceleration. Regions with the steepest growth curve have increased the acceleration of radial adoption via a stronger educational/societal/vendor force and a diminishing mass of resisting interventional cardiologists.The Complex Relationship Between Radial Access and DeathCan we quantify how many lives are being saved annually by the exponential growth of radial artery access? The BCIS investigators have asked this question in the United Kingdom by calculation of death rates in the first 30 days after PCI in each calendar year and comparing actual mortality with the rates expected if 100% femoral access was maintained. As shown in the Figure, there is a dramatic growth in estimated lives saved that is concordant with the growth in radial artery access. For example, radial artery access comprised only 16% of all PCI in the United Kingdom in 2006, and one can estimate 12 lives were saved in the country because of this radial access penetration. As radial access grew to 59% of all PCI cases in 2012, the estimated number of lives saved grew dramatically to 128. If one continues this mathematical model to its logical conclusion (80%, 90%, 100% radial access), the number of lives saved would continue to grow at an exponential rate, leading to remarkably little death after PCI.The problem with this model is that it does not fit all the observed or modeled findings, and it is potentially confounded by a number of factors. First, previous findings of the BCIS group demonstrate a low 2.0% mortality rate in the 30 days after PCI,2 despite the fact that most patients were not getting radial artery access during the early years of the study. Second, bleeding complications have been reduced over the past decade, even in regions that have very limited radial access adoption; thus, the relationship between radial access–induced bleeding reduction and mortality trends may be confounded.8,9Third, the curve of lives saved appears steeper than the exponential function that defines radial access growth (Figure); a simple relationship between radial access growth and lives saved is not clear. For example, 27 extra lives were saved in 2012 when radial access grew by an absolute 7% in comparison with 2011; however, only 9 extra lives are saved when radial access grew by an absolute 6% between 2007 and 2008. Finally, the exponential growth of lives saved does not fit with the BCIS predictors of 30-day mortality: when the odds ratio for 30-day death is plotted according to study year, the maximal decrease in mortality (odds ratio, 0.83; 95% confidence interval, 0.73–0.94; P=0.003) occurs very early in the study (2007) at a time when only 21% of PCIs were performed by radial access (Figure). In fact, by the final study year (2012), a patient’s chance of dying in the 30 days after PCI is nearly the same as it was before the radial access revolution (odds ratio, 0.96; 95% confidence interval, 0.85–1.07; P=0.45).This discordance between the temporal trends in odds of death and the projected lives saved with radial access growth may be a result of nonrandom heterogeneity in practice: specifically, the effect of the learning curve. When interventional cardiologists first adopt radial access, they are most likely to avoid time-pressured situations (primary PCI) and patients with smaller radial arteries (elderly, women). The BCIS study demonstrates a progressive growth in the use of radial access for more complex disease in elderly patients, patients with acute coronary syndromes, and those in cardiogenic shock.1 The same pattern of adoption is seen in the NCDR experience10; as the learning curve progresses, more high-risk patients (women, elderly, primary PCI) are incorporated into radial practice. At first glance, this would argue for an exponential growth in mortality benefit that the authors demonstrate in their steep curve of modeled lives saved—the greatest impact of a bleeding avoidance strategy should be in those high-risk patients incorporated into radial practice toward the end of the learning curve. For example, the absolute reduction in bleeding events should be much higher for women than men given the increased risk of bleeding accorded by sex.11,12 Thus, progression on the radial learning curve to more women (and to other high-risk groups, as well) should be mirrored by an increasing growth in lives saved.So how do we explain the lack of improvement in the odds of death in 2012 in comparison with 2005? The attenuation of radial access mortality benefit is likely explained by the incompleteness of access site bleeding as a correlate of death. Ndrepepa et al13 studied bleeding in 14 180 PCI patients across 7 randomized clinical trials; the adjusted hazard ratio for 1-year mortality was 1.72 (95% confidence interval, 1.19–2.47) for access site bleeding versus no bleeding; importantly, the hazard ratio is higher, 2.78 (95% confidence interval, 2.00–3.86) for nonaccess site bleeding versus no bleeding. The greater association of post-PCI mortality with nonaccess site bleeding in comparison with access site bleeding has been shown in both registries and clinical trials.2,13 Thus, for our sickest groups of patients, adoption of the radial approach is not likely to simply and exponentially decrease mortality; for example, the outcomes of patients with neurological compromise after cardiac arrest or hemodynamic instability in the setting of cardiogenic shock cannot be determined by radial versus femoral access.This complex mortality relationship does not diminish the importance of access site bleeding for patient care and secondary end points; the impressive reductions in access-related bleeding that certainly occur with exponential growth of the radial approach in the United Kingdom are important. But the relationship between death, access site choice, and time is clinically complex, and it would be surprising to see a concordant, linear relationship.ConclusionThe current BCIS Registry study on vascular access strategies for PCI conclusively demonstrates a nationwide exponential growth of radial artery access over time. We can use this representative registry to project the rates of radial growth in other countries and predict the march to radial predominance as a function of external educational forces and intrinsic mass of nonradial-trained older cardiologists. However, even a utopia of universal radial adoption will not drive post-PCI death rates on a concordant curve to zero—models that show exponential reductions in mortality are unlikely to mirror measured mortality rates over time. Delayed application of radial access to high-risk groups, increasing nonaccess site bleeding events, and ever increasing expansion of PCI to the sickest patients will change the shape of the mortality curve and provide ample opportunities for further quality improvement.DisclosuresDr Dauerman reports consulting for Medtronic and Boston Scientific and has received research grants from Boston Scientific and Medtronic.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Harold L. Dauerman, MD, University of Vermont Medical Center, Division of Cardiology, McClure 1, 111 Colchester Ave, Burlington, VT 05401. E-mail [email protected]References1. Mamas MA, Nolan J, de Belder MA, Zaman A, Kinnaird T, Curzen N, Kwok CS, Buchan I, Ludman P, Kontopantelis E. 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Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study.J Am Coll Cardiol. 2012; 60:2481–2489. doi: 10.1016/j.jacc.2012.06.017.CrossrefMedlineGoogle Scholar7. Baklanov DV, Kaltenbach LA, Marso SP, Subherwal SS, Feldman DN, Garratt KN, Curtis JP, Messenger JC, Rao SV. The prevalence and outcomes of transradial percutaneous coronary intervention for ST-segment elevation myocardial infarction: analysis from the National Cardiovascular Data Registry (2007 to 2011).J Am Coll Cardiol. 2013; 61:420–426. doi: 10.1016/j.jacc.2012.10.032.CrossrefMedlineGoogle Scholar8. Ahmed B, Piper WD, Malenka D, VerLee P, Robb J, Ryan T, Herne M, Phillips W, Dauerman HL. Significantly improved vascular complications among women undergoing percutaneous coronary intervention: a report from the Northern New England Percutaneous Coronary Intervention Registry.Circ Cardiovasc Interv. 2009; 2:423–429. doi: 10.1161/CIRCINTERVENTIONS.109.860494.LinkGoogle Scholar9. Dauerman HL, Rao SV, Resnic FS, Applegate RJ. Bleeding avoidance strategies. Consensus and controversy.J Am Coll Cardiol. 2011; 58:1–10. doi: 10.1016/j.jacc.2011.02.039.CrossrefMedlineGoogle Scholar10. Hess CN, Peterson ED, Neely ML, Dai D, Hillegass WB, Krucoff MW, Kutcher MA, Messenger JC, Pancholy S, Piana RN, Rao SV. The learning curve for transradial percutaneous coronary intervention among operators in the United States: a study from the National Cardiovascular Data Registry.Circulation. 2014; 129:2277–2286. doi: 10.1161/CIRCULATIONAHA.113.006356.LinkGoogle Scholar11. Daugherty SL, Thompson LE, Kim S, Rao SV, Subherwal S, Tsai TT, Messenger JC, Masoudi FA. 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Prognostic value of access and non-access sites bleeding after percutaneous coronary intervention.Circ Cardiovasc Interv. 2013; 6:354–361. doi: 10.1161/CIRCINTERVENTIONS.113.000433.LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Kulkarni H and Amin A (2021) Artificial intelligence in percutaneous coronary intervention: improved risk prediction of PCI-related complications using an artificial neural network, BMJ Innovations, 10.1136/bmjinnov-2020-000547, 7:3, (564-579), Online publication date: 1-Jul-2021. April 26, 2016Vol 133, Issue 17 Advertisement Article InformationMetrics © 2016 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.116.022159PMID: 26969760 Originally publishedMarch 11, 2016 Keywordsvascular access devicescatheterization, peripheralEditorialshemorrhageradial arterypercutaneous coronary interventionPDF download Advertisement SubjectsPercutaneous Coronary Intervention" @default.
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