Identifying Patients Who Do Not Benefit From Transcatheter Aortic Valve Replacement
2014; Lippincott Williams & Wilkins; Volume: 7; Issue: 2 Linguagem: Inglês
10.1161/circinterventions.114.001410
ISSN1941-7632
Autores Tópico(s)Coronary Interventions and Diagnostics
ResumoHomeCirculation: Cardiovascular InterventionsVol. 7, No. 2Identifying Patients Who Do Not Benefit From Transcatheter Aortic Valve Replacement Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBIdentifying Patients Who Do Not Benefit From Transcatheter Aortic Valve Replacement Howard C. Herrmann, MD and Yuchi Han, MD Howard C. HerrmannHoward C. Herrmann From the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. and Yuchi HanYuchi Han From the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. Originally published1 Apr 2014https://doi.org/10.1161/CIRCINTERVENTIONS.114.001410Circulation: Cardiovascular Interventions. 2014;7:136–138In this world, there are only two tragedies. One is not getting what one wants, and the other is getting it.—Oscar Wilde (1854–1900)Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe and symptomatic aortic stenosis. Patients at extreme risk for open surgery (inoperable) have an absolute benefit in 1-year survival that exceeds 20%,1,2 and high-risk patients have outcomes that are noninferior to surgery for 2 years.3 Nonetheless, the 1- and 3-year mortality in extreme-risk patients who undergo TAVR is ≈30% and 50%, respectively.1 These patients did not derive the anticipated survival benefit from TAVR, and it would be beneficial to be able to predict this adverse outcome preprocedure.Article see p 240In this regard, several investigations have identified factors that are associated with poor outcome after TAVR.4–12 These include noncardiac factors associated with mortality, as well as cardiac diseases and procedural complications (Table). Analyses of individual predictive factors are helpful in risk stratifying patients but have the weakness that they offer little practical help in the complex decision making of whether to offer TAVR to individual high-risk patients.Table. Factors Associated With Poor Outcome After Transcatheter Aortic Valve ReplacementNoncardiacCardiacProceduralCOPDLow EFAKICKDPulmonary HTNARDMSevere MRStrokePrior CVACADVascularLiver diseaseCPSCoagulopathyValve reinterventionHigh BMIMale sexFrailtyAKI indicates acute kidney injury; AR, aortic regurgitation; BMI, body mass index; CAD, coronary artery disease; CKD, chronic kidney disease; COPD, chronic obstructive pulmonary disease; CPS, cardiopulmonary support; CVA, cerebral vascular accident; DM, diabetes mellitus; EF, ejection fraction; HTN, hypertension; and MR, mitral regurgitation.For example, in the recently reported Italian multicenter registry of >1000 patients receiving TAVR with the CoreValve device, patients with moderate or severe mitral regurgitation (MR) had an ≈2-fold higher mortality at both 30 days and 1 year than those without significant MR.12 Modest improvement in MR occurred in close to half the patients and was predicted by a functional cause and the absence of severe pulmonary hypertension and atrial fibrillation. However, the improvement in MR did not predict better survival.12 In an observational analysis of the Partner trial database, Dvir et al13 reported that patients with chronic lung disease have higher mortality after TAVR. Combining 5 measures in a score raised the risk of 1-year mortality after TAVR from 8% to >40%. However, despite an increased mortality relative to patients without lung disease, these patients experienced a 34% improvement in 2-year survival relative to standard therapy and fared as well with TAVR as with open surgery.13 Should we, therefore, not offer TAVR to patients with aortic stenosis with lung disease or significant MR?In this issue of Circulation: Cardiovascular Interventions, investigators from the France 2 Registry confirm other reports that demonstrate that more than moderate pulmonary hypertension is another dichotomous risk factor that is associated with worse outcome after TAVR.14 Patients with systolic pulmonary artery pressure (PASP) ≥40 mm Hg had a 1-year mortality of 28% compared with a mortality of 22% in those with pressure 1000 patients with heart failure, the odds ratio for death was 2.07 for patients in the highest tertile of PASP compared with the lowest tertile.15 Sinning et al16 reported similar findings in patients with TAVR in whom the 2-year mortality was 48.4% with PASP >60 mm Hg compared with 13.9% in patients with PASP <30 mm Hg. Although useful for informing both patients and clinicians about prognosis, this information is of limited value in deciding whether to offer TAVR to an individual patient.In the France 2 Registry, the survivors with the highest PASP had a greater reduction in PASP post-TAVR (a reduction of 16 mm Hg in median pressure compared with no change in the lowest PASP group and 5 mm Hg in the intermediate group).14 Sinning et al16 demonstrated that a reduction of PASP to <60 mm Hg 90 days after TAVR was associated with improved 2-year survival. These patients likely had reversible pulmonary venous hypertension that was relieved by TAVR, possibly because of MR or left ventricular systolic dysfunction.How can we improve the usefulness of this risk factor to predict the outcome for individual patients? Although a good noninvasive measure of pulmonary pressure, PASP may be underestimated in patients with severe tricuspid regurgitation because of rapid equilibration of RV and right atrial pressures. We are not provided with any information on the degree or distribution of tricuspid regurgitation in the patients studied. PASP also does not reflect RV function. RV function estimated by tricuspid annular plane excursion or by the fractional area change has been studied in conjunction with PASP in patients with heart failure in which the combination of RV dysfunction and high PASP conferred the worst prognosis.17–19 Perhaps, teasing out the underestimation of PASP because of concomitant tricuspid regurgitation and adding RV functional estimates to PASP would enhance the discrimination between survivors and nonsurvivors after TAVR.As a result of the limitations of any single factor as a litmus test to discern benefit for patients with aortic stenosis who need therapy, one might surmise that combining factors into a score would be more helpful. Data from the Partner 1B trial demonstrated that patients with a Society for Thoracic Surgery risk score ≥15% for predicted operative mortality at 30 days derived no survival benefit from TAVR at 1 year compared with standard therapy.1 The Society for Thoracic Surgery risk calculation is not perfect and has limitations. It only includes operated patients for comparison, data are voluntarily submitted and not independently audited, and it does not include several risk factors that influence survival, such as porcelain aorta, hostile chest, advanced liver disease, frailty (both physical and mental), debility, and immobility.Recently, much attention has focused on frailty as a risk factor for poor outcome after both TAVR and surgery. Defining frailty as an impairment of physiological reserve and decreased resistance to stressors, Green et al8 demonstrated in a TAVR population that a combination of frailty measures of slowness, weakness, malnutrition, and inactivity was associated with a 3.5-fold increase in 1-year mortality. Impairment in mental and cognitive ability, mood, and mental health would likely add even greater risk.As we continue to apply TAVR to sicker and older patients, we must also consider whether mortality is the right outcome to measure. Quality of life in many elderly patients may be even more important. Arnold et al20 used the Kansas City Cardiomyopathy Questionnaire to identify 16% of patients with a poor quality-of-life outcome 6 months after TAVR, in addition to 19% who died. In a recent study of 106 survivors after TAVR, functional decline occurred in 21% and was much better predicted by measures of frailty (including cognitive impairment) than by Society for Thoracic Surgery score or EuroSCORE.21 For our sickest patients with aortic stenosis being considered for TAVR, we desperately need scores that not only combine multiple risk factors that are each properly assessed but which also use the factors to predict a combination of mortality and quality-of-life outcome to avoid Oscar Wilde's potential tragedy in life of getting what one wants.DisclosuresDr Herrmann received institutional research funding from Edwards Lifesciences and Medtronic and consultant fees/honoraria from Edwards Lifesciences. 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.Correspondence to Howard C. Herrmann, MD, Interventional Cardiology and Cardiac Catheterization Laboratories, Hospital of the University of Pennsylvania, 9038 West Gates Pavilion, 3400 Spruce St, Philadelphia, PA 19104. E-mail [email protected]References1. Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.N Engl J Med. 2012; 366:1696–1704.CrossrefMedlineGoogle Scholar2. Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiberr T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh J. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery [published online ahead of print March 19, 2014]. J Am Coll Cardiol. doi: 10.1016/j.jacc.2014.02.556. http://clicks.skem1.com/trkr/?c=14833&g=113103&p=96737e0607877c1a9f8998f9a9eb9114&u=efef8bc65ff1943ff1c6cd066b2b1c79&q=&t=1. Accessed March 14, 2014.Google Scholar3. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement.N Engl J Med. 2012; 366:1686–1695.CrossrefMedlineGoogle Scholar4. Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochellière R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.J Am Coll Cardiol. 2010; 55:1080–1090.CrossrefMedlineGoogle Scholar5. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry.J Am Coll Cardiol. 2011; 58:2130–2138.CrossrefMedlineGoogle Scholar6. Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.Circulation. 2011; 123:299–308.LinkGoogle Scholar7. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, Wendler O. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.Circulation. 2011; 124:425–433.LinkGoogle Scholar8. Green P, Woglom AE, Genereux P, Daneault B, Paradis JM, Schnell S, Hawkey M, Maurer MS, Kirtane AJ, Kodali S, Moses JW, Leon MB, Smith CR, Williams M. The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience.J Am Coll Cardiol Cardiovasc Interv. 2012; 5:974–981.CrossrefGoogle Scholar9. Pilgrim T, Kalesan B, Wenaweser P, Huber C, Stortecky S, Buellesfeld L, Khattab AA, Eberle B, Gloekler S, Gsponer T, Meier B, Jüni P, Carrel T, Windecker S. Predictors of clinical outcomes in patients with severe aortic stenosis undergoing TAVI: a multistate analysis.Circ Cardiovasc Interv. 2012; 5:856–861.LinkGoogle Scholar10. Rodés-Cabau J. Transcatheter aortic valve implantation: current and future approaches.Nat Rev Cardiol. 2012; 9:15–29.CrossrefGoogle Scholar11. Dewey TM, Brown DL, Herbert MA, Culica D, Smith CR, Leon MB, Svensson LG, Tuzcu M, Webb JG, Cribier A, Mack MJ. Effect of concomitant coronary artery disease on procedural and late outcomes of transcatheter aortic valve implantation.Ann Thorac Surg. 2010; 89:758–767, discussion 767.CrossrefMedlineGoogle Scholar12. Bedogni F, Latib A, De Marco F, Agnifili M, Oreglia J, Pizzocri S, Latini RA, Lanotte S, Petronio AS, De Carlo M, Ettori F, Fiorina C, Poli A, Cirri S, De Servi S, Ramondo A, Tarantini G, Marzocchi A, Fiorilli R, Klugmann S, Ussia GP, Tamburino C, Maisano F, Brambilla N, Colombo A, Testa L. Interplay between mitral regurgitation and transcatheter aortic valve replacement with the CoreValve Revalving System: a multicenter registry.Circulation. 2013; 128:2145–2153.LinkGoogle Scholar13. Dvir D, Waksman R, Barbash IM, Kodali SK, Svensson LG, Tuzcu EM, Xu K, Minha S, Alu MC, Szeto WY, Thourani VH, Makkar R, Kapadia S, Satler LF, Webb JG, Leon MB, Pichard AD. Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: insights from the PARTNER trial (placement of AoRTic TraNscathetER Valve).J Am Coll Cardiol. 2014; 63:269–279.CrossrefMedlineGoogle Scholar14. Lucon A, Oger E, Bedossa M, Boulmier D, Verhoye JP, Eltchaninoff H, Iung B, Leguerrier A, Lasker M, Leprince P, Gilard M, Le Breton H. Prognostic implications of pulmonary hypertension in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: study from the FRANCE 2 Registry.Circ Cardiovasc Interv. 2014; 7:240–247.LinkGoogle Scholar15. Bursi F, McNallan SM, Redfield MM, Nkomo VT, Lam CS, Weston SA, Jiang R, Roger VL. Pulmonary pressures and death in heart failure: a community study.J Am Coll Cardiol. 2012; 59:222–231.CrossrefMedlineGoogle Scholar16. Sinning JM, Hammerstingl C, Chin D, Ghanem A, Schueler R, Sedaghat A, Bence J, Spyt T, Werner N, Kovac J, Grube E, Nickenig G, Vasa-Nicotera M. Decrease of pulmonary hypertension impacts on prognosis after transcatheter aortic valve replacement.EuroIntervention. 2014; 9:1042–1049.CrossrefMedlineGoogle Scholar17. Guazzi M, Bandera F, Pelissero G, Castelvecchio S, Menicanti L, Ghio S, Temporelli PL, Arena R. Tricuspid annular plane systolic excursion and pulmonary arterial systolic pressure relationship in heart failure: an index of right ventricular contractile function and prognosis.Am J Physiol Heart Circ Physiol. 2013; 305:H1373–H1381.CrossrefMedlineGoogle Scholar18. Aronson D, Darawsha W, Atamna A, Kaplan M, Makhoul BF, Mutlak D, Lessick J, Carasso S, Reisner S, Agmon Y, Dragu R, Azzam ZS. Pulmonary hypertension, right ventricular function, and clinical outcome in acute decompensated heart failure.J Card Fail. 2013; 19:665–671.CrossrefMedlineGoogle Scholar19. Ghio S, Temporelli PL, Klersy C, Simioniuc A, Girardi B, Scelsi L, Rossi A, Cicoira M, Tarro Genta F, Dini FL. Prognostic relevance of a non-invasive evaluation of right ventricular function and pulmonary artery pressure in patients with chronic heart failure.Eur J Heart Fail. 2013; 15:408–414.CrossrefMedlineGoogle Scholar20. Arnold SV, Spertus JA, Lei Y, Green P, Kirtane AJ, Kapadia S, Thourani VH, Herrmann HC, Beohar N, Zajarias A, Mack MJ, Leon MB, Cohen DJ. How to define a poor outcome after transcatheter aortic valve replacement: conceptual framework and empirical observations from the placement of aortic transcatheter valve (PARTNER) trial.Circ Cardiovasc Qual Outcomes. 2013; 6:591–597.LinkGoogle Scholar21. Schoenenberger AW, Stortecky S, Neumann S, Moser A, Jüni P, Carrel T, Huber C, Gandon M, Bischoff S, Schoenenberger CM, Stuck AE, Windecker S, Wenaweser P. Predictors of functional decline in elderly patients undergoing transcatheter aortic valve implantation (TAVI).Eur Heart J. 2013; 34:684–692.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited ByHosen M, Goody P, Zietzer A, Xiang X, Niepmann S, Sedaghat A, Tiyerili V, Chennupati R, Moore J, Boon R, Uchida S, Sinning J, Zimmer S, Latz E, Werner N, Nickenig G and Jansen F (2022) Circulating MicroRNA-122-5p Is Associated With a Lack of Improvement in Left Ventricular Function After Transcatheter Aortic Valve Replacement and Regulates Viability of Cardiomyocytes Through Extracellular Vesicles, Circulation, 146:24, (1836-1854), Online publication date: 13-Dec-2022. Mas-Peiro S, Faerber G, Bon D, Herrmann E, Bauer T, Bleiziffer S, Bekeredjian R, Böning A, Frerker C, Beckmann A, Möllmann H, Vasa-Nicotera M, Ensminger S, Hamm C, Beyersdorf F, Fichtlscherer S, Walther T, Beyersdorf F, Hamm C, Cremer J, Kuck K, Ince H, Andresen D, Mohr F, Sack S, Walther T, Ensminger S, Haude M, Linke A, M—llmann H, Wahlers T, Welz A, Beckmann A and Papoutsis K (2021) Impact of chronic kidney disease in 29 893 patients undergoing transcatheter or surgical aortic valve replacement from the German Aortic Valve Registry, European Journal of Cardio-Thoracic Surgery, 10.1093/ejcts/ezaa446, 59:3, (532-544), Online publication date: 13-Apr-2021. Cormican D, Jayaraman A, Villablanca P and Ramakrishna H (2020) TAVR Procedural Volumes and Patient Outcomes: Analysis of Recent Data, Journal of Cardiothoracic and Vascular Anesthesia, 10.1053/j.jvca.2019.04.016, 34:2, (545-550), Online publication date: 1-Feb-2020. Neuburger P, Luria B, Rong L, Sin D, Patel P and Williams M (2019) Operational and Institutional Recommendations and Requirements for TAVR: A Review of Expert Consensus and the Impact on Health Care Policy, Journal of Cardiothoracic and Vascular Anesthesia, 10.1053/j.jvca.2019.01.062, 33:6, (1731-1741), Online publication date: 1-Jun-2019. Bavaria J, Tommaso C, Brindis R, Carroll J, Deeb G, Feldman T, Gleason T, Horlick E, Kavinsky C, Kumbhani D, Miller D, Seals A, Shahian D, Shemin R, Sundt T and Thourani V (2019) 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement, The Journal of Thoracic and Cardiovascular Surgery, 10.1016/j.jtcvs.2018.07.001, 157:3, (e77-e111), Online publication date: 1-Mar-2019. Bavaria J, Tommaso C, Brindis R, Carroll J, Michael Deeb G, Feldman T, Gleason T, Horlick E, Kavinsky C, Kumbhani D, Craig Miller D, Allen Seals A, Shahian D, Shemin R, Sundt T and Thourani V (2019) 2018 AATS/ACC/SCAI/STS expert consensus systems of care document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement, Catheterization and Cardiovascular Interventions, 10.1002/ccd.27811, 93:3, (E153-E184), Online publication date: 15-Feb-2019. Bavaria J, Tommaso C, Brindis R, Carroll J, Deeb G, Feldman T, Gleason T, Horlick E, Kavinsky C, Kumbhani D, Miller D, Seals A, Shahian D, Shemin R, Sundt T and Thourani V (2019) 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement, The Annals of Thoracic Surgery, 10.1016/j.athoracsur.2018.07.001, 107:2, (650-684), Online publication date: 1-Feb-2019. Bavaria J, Tommaso C, Brindis R, Carroll J, Deeb G, Feldman T, Gleason T, Horlick E, Kavinsky C, Kumbhani D, Miller D, Seals A, Shahian D, Shemin R, Sundt T and Thourani V (2019) 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement, Journal of the American College of Cardiology, 10.1016/j.jacc.2018.07.002, 73:3, (340-374), Online publication date: 1-Jan-2019. Thourani V, Borger M, Holmes D, Maniar H, Pinto F, Miller C, Rodés-Cabau J, Mohr F, Schröfel H, Moat N, Beyersdorf F, Patterson A and Weisel R (2017) Transatlantic Editorial on transcatheter aortic valve replacement, European Journal of Cardio-Thoracic Surgery, 10.1093/ejcts/ezx196, 52:1, (1-13), Online publication date: 1-Jul-2017., Online publication date: 1-Jul-2017. Thourani V, Borger M, Holmes D, Maniar H, Pinto F, Miller C, Rodés-Cabau J, Mohr F, Schröfel H, Moat N, Beyersdorf F, Patterson G and Weisel R (2017) Transatlantic editorial on transcatheter aortic valve replacement, The Journal of Thoracic and Cardiovascular Surgery, 10.1016/j.jtcvs.2017.03.047, 154:1, (7-21), Online publication date: 1-Jul-2017. Thourani V, Borger M, Holmes D, Maniar H, Pinto F, Miller C, Rodés-Cabau J, Mohr F, Schröfel H, Moat N, Beyersdorf F, Patterson G and Weisel R (2017) Transatlantic Editorial on Transcatheter Aortic Valve Replacement, The Annals of Thoracic Surgery, 10.1016/j.athoracsur.2017.04.030, 104:1, (1-15), Online publication date: 1-Jul-2017. Akhtar S (2015) Case 3–2015, Journal of Cardiothoracic and Vascular Anesthesia, 10.1053/j.jvca.2014.07.014, 29:2, (510-521), Online publication date: 1-Apr-2015. April 2014Vol 7, Issue 2 Advertisement Article InformationMetrics © 2014 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.114.001410PMID: 24737333 Originally publishedApril 1, 2014 KeywordsEditorialsaortic valve stenosishypertension, pulmonaryPDF download Advertisement SubjectsCatheter-Based Coronary and Valvular Interventions
Referência(s)