Measuring the Unmeasurable
2018; Lippincott Williams & Wilkins; Volume: 11; Issue: 9 Linguagem: Inglês
10.1161/circinterventions.118.007215
ISSN1941-7632
AutoresAnita Asgar, Jeremy Ben‐Shoshan,
Tópico(s)Infective Endocarditis Diagnosis and Management
ResumoHomeCirculation: Cardiovascular InterventionsVol. 11, No. 9Measuring the Unmeasurable Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBMeasuring the UnmeasurableSearching for the Holy Grail to Evaluate Transcatheter Aortic Valve Replacement Risk Anita W. Asgar, MD, MSc and Jeremy Ben-Shoshan, MD, PhD Anita W. AsgarAnita W. Asgar Anita W. Asgar, MD, MSc, Montreal Heart Institute, Universite de Montreal, 5000 Rue Belanger, Montreal, Quebec, H1T1C8, Canada. Email E-mail Address: [email protected] Department of Medicine, Montreal Heart Institute, Universite de Montreal, Canada. and Jeremy Ben-ShoshanJeremy Ben-Shoshan Department of Medicine, Montreal Heart Institute, Universite de Montreal, Canada. Originally published17 Sep 2018https://doi.org/10.1161/CIRCINTERVENTIONS.118.007215Circulation: Cardiovascular Interventions. 2018;11:e007215This article is a commentary on the followingCurrent Society of Thoracic Surgeons Model Reclassifies Mortality Risk in Patients Undergoing Transcatheter Aortic Valve ReplacementSee Article by Kumar et alTranscatheter aortic valve replacement (TAVR) is an established therapy for the treatment of inoperable and high-risk symptomatic aortic stenosis.1 Stratification of patients into risk categories has been based since the outset, on risk scoring models such as the Society of Thoracic Surgery (STS) Score, designed to estimate operative mortality and morbidity after cardiac surgery.2 In the current issue of the journal, Kumar et al3 provide an update on STS score-based stratification of TAVR patients, comparing the currently available online STS score calculator with the previous 2008 STS risk model. The authors assessed both STS score versions in a single center cohort of 1209 TAVR patients. Their findings were that compared with the 2008 STS score, the current score calculated lower mean STS values and reclassified 19% of patients to a lower risk category. In a multivariable regression analysis, patients with atrial fibrillation, congestive heart failure, or New York Heart Association (NYHA) class IV symptoms were more likely to be reclassified to a lower risk group based on the current STS risk model. Importantly, the cutoff values for classification of patients as high- and intermediate-risk categories (6.3% and 3.9 %), were lower when using the current STS model, compared with the previous (8.0% and 4.0%).This article is important for multiple reasons. First, it raises the question as to why the STS score is decreasing and the potential impact of current TAVR practice on this score. More importantly, it casts doubt on the use of this score for the purposes of patient selection and risk assessment for TAVR.Preprocedural risk stratification of surgical AVR (SAVR) and TAVR is currently based on the STS risk model, derived from a large-scale database of cardiac surgical patients (STS database), including demographic data, comorbidities, clinical presentation, and procedural aspects.2,4 The algorithm is updated and is subject to change based on the contemporary surgical population and outcomes. Such risk, however, may not in fact translate into a risk for TAVR. Historical use of the STS score for risk stratification for TAVR is rooted in the fact that the database represented one of the few data sources for risk assessment and outcomes of intervention for aortic stenosis, which was SAVR. Consequently, both in clinical trials and routine practice, TAVR eligibility and stratification has been determined by this risk score, which has been validated in surgical patients.1,5 The initial TAVR trials, therefore, enrolled high-risk and intermediate-risk patients as determined by this score to compare outcomes with SAVR. The results of these studies are the backbone of the current clinical guidelines for TAVR.6–10 The challenge lies in continuing to use a risk score based on a database that is continually changing, in an evolving clinical landscape where more and more patients are treated with TAVR.The most recent report of the TVT Registry (Transcatheter Valve Therapy) in 2016 documents an exponential increase in the number of patients undergoing TAVR, from 4627 cases annually in 2012 to >24 000 in 2015. The median STS predicted risk of mortality in this population interestingly decreased from 7.1 to 6.3 during the 4-year time period.11 During the same time period, a study evaluating surgical volumes in 1 state in the United States also demonstrated modest increases in median surgical volumes for AVR; 722 cases/y pre-TAVR, 892 cases/y during the early-TAVR implementation era, and 940 cases/y in the commercial-TAVR period (P <0.005). As predicted, the surgical risk of these patients also decreased from a median STS predicted risk of mortality of 3.7% pre-TAVR to 2.6% early-TAVR and finally to 2.4% in the commercial-TAVR era.12 This declining risk profile may be attributed to referral of higher risk patients to TAVR. In fact, in this study, SAVR patients had fewer reoperations, fewer concomitant coronary artery bypass graft surgery, and less urgent or emergent procedures. In an era of increasing TAVR procedures and what may be SAVR patients with a lower risk profile, how accurate will this database be in the future for predicting mortality in TAVR?The optimal method for calculating risk for TAVR remains unclear. Clinical experience has helped to clarify the importance of patient comorbidities in determining risk and more importantly TAVR futility.13 Procedural factors, such as femoral versus nonfemoral access site have also emerged as important considerations in determining patient outcomes and quality of life after intervention.7 Finally, patient frailty is now established as an important risk factor for mortality and morbidity in patients undergoing TAVR or SAVR.14 There are multiple TAVR risk scores that have been developed using a myriad of databases with varied levels of complexity and statistical success, as shown in the Table.15–18 Many have yet to be validated in larger databases but do represent progress toward defining true TAVR risk. Unfortunately, the ability of these scores to predict mortality remain limited, and many do not include indices of frailty or data on quality of life. The TVT model, based on registry data is promising however at present can only predict in-hospital mortality. Importantly, patient frailty is not included as a covariate in the assessment.23 The holy grail of TAVR risk scores will need to incorporate patient comorbidities, procedural factors, patient frailty, and identify those patients in whom therapy may be futile. It is the interaction of all of these components that will ultimately determine TAVR risk and outcomes.Table. Risk Scores for TAVRNo. of PatientsOutcomeC StatisticsC Statistics (Original Validation Cohort)C Statistics (Validation on TAVR Cohort)Surgical score STS score*1967 29230-d mortality0.780.760.63 EuroSCORE2022 381In-hospital mortality...0.780.6321 EuroSCORE II422 381In-hospital mortality0.800.810.6620TAVR-specific score FRANCE 2 score17383330-d mortality0.670.59... German Aortic Valve Score†1511 794In-hospital mortality0.810.738... German Aortic Valve Score II†1618 054In-hospital mortality...0.741... OBSERVANT score18187830-d mortality0.730.71... STS/ACC TVT score2213 718In-hospital mortality0.670.66ACC indicates American College of Cardiology; EuroSCORE, European System for Cardiac Operative Risk Evaluation; FRANCE-2, French Aortic National CoreValve and Edwards registry; OBSERVANT, Observational Study of Appropriateness, Efficacy and Effectiveness of AVR-TAVR Procedures for the Treatment of Severe Symptomatic Aortic Stenosis; STS, Society of Thoracic Surgeons; TAVR, transcatheter aortic valve replacement; and TVT, transcatheter valve therapy.*Aortic valve cohort.†Mixed surgical and TAVR cohort.As indications for TAVR continue to be refined with the completion of low-risk TAVR trials, it is likely that the treatment paradigm of aortic stenosis will need to be reimagined. At present, the management is focused on an evaluation of a patient's surgical risk. In the future, a patient's TAVR risk will also be important and need to be weighed against that of surgery. In a not so distant future of shifting surgical risks and fluctuating definitions of low, intermediate, and high risk, the emphasis will need to be on whether an individual patient's TAVR risk is higher or lower than their surgical risk with treatment decisions made accordingly. In the interim, the quest to find for a better way to evaluate TAVR risk remains. Unfortunately, the STS score seems more and more unlikely to be the solution.Measure what is measurable and make measurable what is not so.—Galileo Galilei (1564–1642)DisclosuresDr Asgar is a proctor and Advisory board member for Medtronic. The other author reports no conflicts.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.https://www.ahajournals.org/journal/circinterventionsAnita W. Asgar, MD, MSc, Montreal Heart Institute, Universite de Montreal, 5000 Rue Belanger, Montreal, Quebec, H1T1C8, Canada. Email anita.[email protected]caReferences1. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM, Thompson A. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.J Am Coll Cardiol. 2017; 70:252–289. doi: 10.1016/j.jacc.2017.03.011CrossrefMedlineGoogle Scholar2. D'Agostino RS, Jacobs JP, Badhwar V, Fernandez FG, Paone G, Wormuth DW, Shahian DM. 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Circulation: Cardiovascular Interventions. 2018;11 September 2018Vol 11, Issue 9 Advertisement Article InformationMetrics © 2018 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.118.007215PMID: 30354608 Originally publishedSeptember 17, 2018 Keywordstranscatheter aortic valve replacementEditorialsrisk assessmentatrial fibrillationheart failurePDF download Advertisement SubjectsCatheter-Based Coronary and Valvular Interventions
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