Top

Published in:

Open Access 01-03-2021 | Aortic Valve Replacement | Original Paper

Risk modeling in transcatheter aortic valve replacement remains unsolved: an external validation study in 2946 German patients

Authors: Georg Wolff, Jasmin Shamekhi, Baravan Al-Kassou, Noriaki Tabata, Claudio Parco, Kathrin Klein, Oliver Maier, Alexander Sedaghat, Amin Polzin, Atsushi Sugiura, Christian Jung, Eberhard Grube, Ralf Westenfeld, Andrea Icks, Tobias Zeus, Jan-Malte Sinning, Stephan Baldus, Georg Nickenig, Malte Kelm, Verena Veulemans

Published in: Clinical Research in Cardiology | Issue 3/2021

Abstract

Background

Surgical risk prediction models are routinely used to guide decision-making for transcatheter aortic valve replacement (TAVR). New and updated TAVR-specific models have been developed to improve risk stratification; however, the best option remains unknown.

Objective

To perform a comparative validation study of six risk models for the prediction of 30-day mortality in TAVR

Methods and results

A total of 2946 patients undergoing transfemoral (TF, n = 2625) or transapical (TA, n = 321) TAVR from 2008 to 2018 from the German Rhine Transregio Aortic Diseases cohort were included. Six surgical and TAVR-specific risk scoring models (LogES I, ES II, STS PROM, FRANCE-2, OBSERVANT, GAVS-II) were evaluated for the prediction of 30-day mortality. Observed 30-day mortality was 3.7% (TF 3.2%; TA 7.5%), mean 30-day mortality risk prediction varied from 5.8 ± 5.0% (OBSERVANT) to 23.4 ± 15.9% (LogES I). Discrimination performance (ROC analysis, c-indices) ranged from 0.60 (OBSERVANT) to 0.67 (STS PROM), without significant differences between models, between TF or TA approach or over time. STS PROM discriminated numerically best in TF TAVR (c-index 0.66; range of c-indices 0.60 to 0.66); performance was very similar in TA TAVR (LogES I, ES II, FRANCE-2 and GAVS-II all with c-index 0.67). Regarding calibration, all risk scoring models—especially LogES I—overestimated mortality risk, especially in high-risk patients.

Conclusions

Surgical as well as TAVR-specific risk scoring models showed mediocre performance in prediction of 30-day mortality risk for TAVR in the German Rhine Transregio Aortic Diseases cohort. Development of new or updated risk models is necessary to improve risk stratification.

Graphic abstract

Available only for authorised users

Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ et al (2017) 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 38(36):2739–2791CrossRef

Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA et al (2017) 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 70(2):252–289CrossRef

Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK et al (2016) Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374(17):1609–1620CrossRef

Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M et al (2017) Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 376(14):1321–1331CrossRef

Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M et al (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380(18):1695–1705CrossRef

Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D et al (2019) Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 380(18):1706–1715CrossRef

Roques F, Michel P, Goldstone AR, Nashef SA (2003) The logistic EuroSCORE. Eur Heart J 24(9):881–882CrossRef

Nashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R (1999) European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg 16(1):9–13CrossRef

Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR et al (2012) EuroSCORE II. Eur J Cardiothorac Surg 41(4):734–44 (discussion 44–5)

10.

O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB et al (2009) The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2–isolated valve surgery. Ann Thorac Surg 88(1 Suppl):S23–42CrossRef

11.

Piazza N, Wenaweser P, van Gameren M, Pilgrim T, Tzikas A, Otten A et al (2010) Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons predicted risk of mortality score in patients implanted with the CoreValve ReValving system—a Bern-Rotterdam study. Am Heart J 159(2):323–329CrossRef

12.

Martin GP, Sperrin M, Ludman PF, de Belder MA, Gale CP, Toff WD et al (2017) Inadequacy of existing clinical prediction models for predicting mortality after transcatheter aortic valve implantation. Am Heart J 184:97–105CrossRef

13.

Wang TKM, Wang MTM, Gamble GD, Webster M, Ruygrok PN (2017) Performance of contemporary surgical risk scores for transcatheter aortic valve implantation: a meta-analysis. Int J Cardiol 236:350–355CrossRef

14.

Capodanno D, Barbanti M, Tamburino C, D'Errigo P, Ranucci M, Santoro G et al (2014) A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement. Am J Cardiol 113(11):1851–1858CrossRef

15.

Iung B, Laouenan C, Himbert D, Eltchaninoff H, Chevreul K, Donzeau-Gouge P et al (2014) Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score. Heart (British Cardiac Society) 100(13):1016–1023

16.

Schiller W, Barnewold L, Kazmaier T, Beckmann A, Masseli F, Welz A et al (2017) The German aortic valve score II. Eur J Cardiothorac Surg 52(5):881–887CrossRef

17.

Martin GP, Sperrin M, Mamas MA (2018) Pre-procedural risk models for patients undergoing transcatheter aortic valve implantation. J Thoracic Dis 10(Suppl 30):S3560–S3567CrossRef

18.

Al-Farra H, Abu-Hanna A, de Mol BAJM, ter Burg WJ, Houterman S, Henriques JPS et al (2020) External validation of existing prediction models of 30-day mortality after transcatheter aortic valve implantation (TAVI) in the Netherlands Heart Registration. Int J Cardiol

19.

Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH et al (2013) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thoracic Cardiovasc Surg 145(1):6–23CrossRef

20.

DeLong ER, DeLong DM, Clarke-Pearson DL (1988) Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics 44(3):837–845CrossRef

21.

Hosmer DWJ, Lemeshow SXSR (2013) Applied logistic regression, 3rd edn. Wiley, Hoboken

22.

Brennan JM, Curtis JP, Dai D, Fitzgerald S, Khandelwal AK, Spertus JA et al (2013) Enhanced mortality risk prediction with a focus on high-risk percutaneous coronary intervention: results from 1,208,137 procedures in the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv 6(8):790–799CrossRef

23.

Fox KA, Dabbous OH, Goldberg RJ, Pieper KS, Eagle KA, Van de Werf F et al (2006) Prediction of risk of death and myocardial infarction in the six months after presentation with acute coronary syndrome: prospective multinational observational study (GRACE). BMJ 333(7578):1091CrossRef

24.

Wolff G, Lin Y, Quade J, Bader S, Kosejian L, Brockmeyer M et al (2019) Validation of National Cardiovascular Data Registry risk models for mortality, bleeding and acute kidney injury in interventional cardiology at a German Heart Center. Clin Res Cardiol

25.

Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G et al (2017) The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med 43(12):1820–1828CrossRef

26.

Shimura T, Yamamoto M, Kano S, Kagase A, Kodama A, Koyama Y et al (2017) Impact of the clinical frailty scale on outcomes after transcatheter aortic valve replacement. Circulation 135(21):2013–2024CrossRef

27.

Wassef AWA, Rodes-Cabau J, Liu Y, Webb JG, Barbanti M, Munoz-Garcia AJ et al (2018) The learning curve and annual procedure volume standards for optimum outcomes of transcatheter aortic valve replacement: findings from an International Registry. JACC Cardiovasc Interv 11(17):1669–1679CrossRef

28.

Salemi A, Sedrakyan A, Mao J, Elmously A, Wijeysundera H, Tam DY et al (2019) Individual operator experience and outcomes in transcatheter aortic valve replacement. JACC Cardiovasc Interv 12(1):90–97CrossRef

29.

Kumar N, Khera R, Fonarow GC, Bhatt DL (2018) Comparison of outcomes of transfemoral versus transapical approach for transcatheter aortic valve implantation. Am J Cardiol 122(9):1520–1526CrossRef

30.

Halkin A, Steinvil A, Witberg G, Barsheshet A, Barkagan M, Assali A et al (2016) Mortality prediction following transcatheter aortic valve replacement: a quantitative comparison of risk scores derived from populations treated with either surgical or percutaneous aortic valve replacement. The Israeli TAVR Registry Risk Model Accuracy Assessment (IRRMA) study. Int J Cardiol 215:227–231

31.

Pilgrim T, Franzone A, Stortecky S, Nietlispach F, Haynes AG, Tueller D et al (2017) Predicting mortality after transcatheter aortic valve replacement: external validation of the transcatheter valve therapy registry model. Circ Cardiovasc Intervent 10(11)

32.

Hickey GL, Grant SW, Murphy GJ, Bhabra M, Pagano D, McAllister K et al (2013) Dynamic trends in cardiac surgery: why the logistic EuroSCORE is no longer suitable for contemporary cardiac surgery and implications for future risk models. Eur J Cardiothorac Surg 43(6):1146–1152CrossRef

33.

Matheny ME, Ohno-Machado L, Resnic FS (2005) Discrimination and calibration of mortality risk prediction models in interventional cardiology. J Biomed Inform 38(5):367–375CrossRef

34.

Martin GP, Sperrin M, Ludman PF, deBelder MA, Gunning M, Townend J et al (2018) Do frailty measures improve prediction of mortality and morbidity following transcatheter aortic valve implantation? An analysis of the UK TAVI registry. BMJ Open 8(6):e022543CrossRef

35.

van der Wulp K, van Wely MH, Schoon Y, Vart P, Olde Rikkert MGM, Morshuis WJ et al Geriatric assessment in the prediction of delirium and long-term survival after transcatheter aortic valve implantation. J Thorac Cardiovasc Surg

Title: Risk modeling in transcatheter aortic valve replacement remains unsolved: an external validation study in 2946 German patients
Authors: Georg Wolff
Jasmin Shamekhi
Baravan Al-Kassou
Noriaki Tabata
Claudio Parco
Kathrin Klein
Oliver Maier
Alexander Sedaghat
Amin Polzin
Atsushi Sugiura
Christian Jung
Eberhard Grube
Ralf Westenfeld
Andrea Icks
Tobias Zeus
Jan-Malte Sinning
Stephan Baldus
Georg Nickenig
Malte Kelm
Verena Veulemans
Publication date: 01-03-2021
Publisher: Springer Berlin Heidelberg
Keywords: Aortic Valve Replacement
Aortic Valve Replacement
Aortic Valve Replacement
Published in: Clinical Research in Cardiology / Issue 3/2021
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-020-01731-9

ACC 2024 Congress Coverage

Heart Failure Video

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Risk modeling in transcatheter aortic valve replacement remains unsolved: an external validation study in 2946 German patients

Abstract

Background

Objective

Methods and results

Conclusions

Graphic abstract

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Objective

Methods and results

Conclusions

Graphic abstract

Please log in to get access to this content

Other articles of this Issue 3/2021

PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis

Aortic valve replacement in Germany in 2019

Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve

Transcatheter or surgical aortic valve implantation in chronic dialysis patients: a German Aortic Valve Registry analysis

Machine learning-based risk prediction of intrahospital clinical outcomes in patients undergoing TAVI

Kidney injury as post-interventional complication of TAVI

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page